79C3C34C52B45572883A05D425EB0F82
National Research Ethics Review Guideline
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Criminal Convictions
Searching for indicator prisoners:
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p.(None): in the design and conduct of the research.
p.(None): Risk is the probability and magnitude of some future occurrence of harm. Harm is injury and setback to interests as a
p.(None): result of being a research participant. Risks to research participants include physical, psychological, and emotional
p.(None): harm. Risks can be known or presumed. And, although no specific regulations exist, risks may include physical,
p.(None): psychological, emotional, economic, educational, legal, and social harm.
p.(None): In addition, beneficence includes whether the usual care is changed or manipulated to inflict no harm, minimize harm,
p.(None): remove harm, and maximize the benefit to re- search participants and to the community, or both.
p.(None): 3.3 Justice
p.(None): Justice connotes fairness and equity in the distribution of the benefits and burdens of research to participants.
p.(None): 3.3.1. Justice demands equitable selection of participants, i.e., avoiding popu- lations that may be unfairly coerced
p.(None): into participating, including but not limited to, prisoners, pregnant women, people with mental and physical
p.(None): disabilities, immigrants, refugees, ethnic minorities, marginalized groups and institutionalized persons, including
p.(None): children. There must be a justi- fication for inclusion of these vulnerable groups in the research. There should be no
p.(None): disproportionate use of vulnerable populations. The same recruitment approach should be used in all populations.
p.(None): Injustice may arise when selecting participants from a specific socio-economic class, age, sex, racial, cultural,
p.(None): religious, creed, and institutional make up.
p.(None): 3.3.2. The principle of justice requires equality in the distribution of benefits and burdens among the population
p.(None): groups likely to benefit from the research. Distributive justice means that no segment of the population should be
p.(None): unfairly burdened with the harms of research. It thus imposes particular obligations toward individuals who are
...
p.(None): to review and evaluate the science, medical as- pects, and ethics of the proposed research.
p.(None): • Each IRB shall be composed of at least five (5) members, with varying back- grounds to ensure complete and robust
p.(None): review of research activities commonly conducted by the institution. It must be multidisciplinary and multi-sectoral in
p.(None): composition, including persons with relevant but diverse scientific expertise, balanced age and gender
p.(None): distribution, and who have the qualifications and ex- perience to review and evaluate the scientific and
p.(None): medical ethics aspects of research protocols.
p.(None): • All IRBs shall have at least one member whose main area of expertise is in the scientific field and at least one
p.(None): member whose primary area of expertise is in a non-scientific field.
p.(None): • Each IRB shall include at least one member who is not otherwise affiliated with the institution or have a close
p.(None): family member working in the institution.
p.(None): • The IRB should have at least one community representative, who does not nec- essarily have to have any scientific
p.(None): expertise, but may be a layperson that rep- resents the interests and concerns of members of the community and is
p.(None): familiar with the community’s values, customs, traditions, and culture.
p.(None): • If an IRB regularly reviews research that involves vulnerable populations, such as children, prisoners, pregnant
p.(None): women, men/women in uniform or persons with disabilities, marginalized group, refuges, minorities, the IRB shall
p.(None): involve or co- opt one or more individuals who are knowledgeable about and experienced in working with these research
p.(None): participants.
p.(None): • All IRB members should at the minimum take one basic training on bioethics within one year of appointment.
p.(None):
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 31
p.(None):
p.(None): 6.4 External Reviewers
p.(None): • If a protocol requires expertise that is beyond the competence of the IRB mem- bers or the IRB need additional
p.(None): opinion in the review process, the IRB may engage independent experts to review and give their opinion.
p.(None): • The Secretariat should keep an updated list of experts along with their CVs, which should be reviewed annually by
p.(None): the IRB.
p.(None): • Independent experts must sign privacy and confidentiality agreements and con- flict of interest (COI) forms to
p.(None): ensure that the information in the protocol is protected and that consultants do not have any conflicts.
p.(None): • The IRB may ask questions that could guide the review of the experts.
p.(None): • The expert may be invited to attend or consult by telephone an IRB meeting but he/she cannot vote in the meeting.
p.(None): 6.5 Independence of IRB
...
p.(None): also need to ensure that there is regular evaluation of the ethics of ongoing studies that received a positive
p.(None): decision. Therefore, the functions of the IRB are:
p.(None): 6.12.1 Initial review
p.(None): The IRB must determine that the following requirements are satisfied before it ap- proves a research protocol:
p.(None): • Risks to subjects are minimized. Risk to subjects are reasonable in relation to anticipated benefit (if any) and the
p.(None): knowledge that is expected to result
p.(None): • Selection of subjects is equitable
p.(None): • Determine that informed consent will be sought from each prospective study participant, or the participants’ parent
p.(None): or guardian as appropriate
p.(None): • Determine that informed consent will be appropriately documented
p.(None): • Determine that there are adequate provisions to protect privacy of study partic- ipants and maintain confidentiality
p.(None): of all study related data
p.(None): • Determine that there are additional safeguards included in the study to protect the safety and welfare of study
p.(None): subjects who are likely to be vulnerable to coer- cion or undue influence such as such as children, prisoners, mentally
p.(None): disabled
p.(None): people, etc.
p.(None): 6.13 Informed Consent
p.(None): 6.13.1. The IRB must determine that the consent is documented using a written or verbal informed consent form,
p.(None): • The consent form should be approved by the IRB.
p.(None): • The consent form must be signed by the participant, or a parent, or next-of-kin or a guardian and by the individual
p.(None): that conducted the in- formed consent process.
p.(None): • In case the participant cannot read or write, a witness should sign that the consent process was carried out
p.(None): appropriately.
p.(None): National Research Ethics Review Guideline Fifth Edition 37
p.(None):
p.(None): • A copy of the signed informed consent form should be given to the study participant.
p.(None): 6.13.2. Research participants or persons giving proxy consent cannot give full informed consent unless the consent
p.(None): process/form contains adequate information. All such information shall be expressed in a language that is
...
p.(None): 6.14 above.
p.(None): • The research presents a realistic opportunity to further the understanding, preven- tion, or alleviation of a
p.(None): serious problem affecting the health or welfare of children.
p.(None): • Emancipated minors – working or earn their living, married, parenting – may be allowed to give an informed consent
p.(None): or an IRB may decide a waiver of consent.
p.(None): • In research related to sensitive topics like drug use and abuse, sexuality, repro- duction, STIs, where obtaining
p.(None): consent from a parent, next-of-kin, or guardian is challenging and may be problematic to the minor because of the
p.(None): nature of the research, assent with waiver of consent may be applicable.
p.(None): • In institutional children, a legally approved guardian may give consent.
p.(None): 8.3.5.4 Prisoners
p.(None): Prisoners may be under constraints because of their incarceration which could affect their ability to make a truly
p.(None): voluntary and decision which is not coerced, whether or not to participate as subjects in research. Therefore,
p.(None): additional safeguards should be included in the study to protect the rights and welfare of these subjects, as follows:
p.(None): • If an IRB regularly reviews research that involves these vulnerable populations, consideration shall be given to the
p.(None): inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.
p.(None): • Where possible, a prisoner or an ex-prisoner co-opted in to the IRB reviewing the proposed research project should
p.(None): be included.
p.(None): • Only research on conditions particularly affecting prisoners as a class and with reasonable probability of improving
p.(None): the health and well-being of the research participants should be permissible.
p.(None): • The IRB shall determine that the informed consent process is properly applied with adequate assurance that a
p.(None): prisoner’s participation or refusal to participate will not be considered in decisions regarding his or her release or
p.(None): further deten- tion and each prisoner is clearly informed in advance that his or her participa- tion in the research
p.(None): project will have no affect on his or her release.
p.(None): 8.3.5.5 Mental and Physical Disability
p.(None): Persons with disability need special attention because they are prone to being social- ly marginalized. Therefore,
p.(None): their dignity, rights and well-being in research must be respected. Careful consideration should be made where proxy
p.(None): consent is to be used, and where the use of signed consent forms is not feasible, alternative viable methods should be
p.(None): employed.
p.(None): 56 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): Persons with disabilities (mental or physical) should not be unfairly excluded from participating in research.
p.(None): Researchers should make an effort to address communi- cation, disability and comprehension constraints are often the
p.(None): excuse for exclusion.
...
p.(None): characteristics is usually called a data monitoring com- mittee (DMC) or a data and safety monitoring board (DSMB).
p.(None): Declaration of Helsinki-A statement of ethical principles to provide guidance to phy- sicians and other participants in
p.(None): medical research involving human participants; ad- opted by the World Medical Assembly in 1964 and last updated in
p.(None): 2004. See http:// www.wma.net/e/policy/b3.htm.
p.(None): Disapprove/disapproval-The determination by the IRB that the research may not be conducted at an institution
p.(None): Documentation of consent-Consent that is documented by the use of a written con- sent form approved by the IRB and
p.(None): signed by the participant or the participant’s legally authorized representative.
p.(None): Emergency response-A public health activity undertaken in an urgent or emergency situation, usually because of an
p.(None): identified or suspected imminent health threat to the population, but sometimes because the public or government
p.(None): authorities perceive an imminent threat that demands immediate action. The primary purpose of the activity is to
p.(None): document the existence and magnitude of a public health problem in the community and to implement appropriate measures
p.(None): to address the problem (Langmuir, 1980).
p.(None): Exemption/exempt research-Categories of research to which the Federal regulations for human research protections do not
p.(None): apply. Research involving prisoners and some research involving children are not exempt.
p.(None): Expected-Pertaining to an AE, the event has been previously observed or documented in humans under the research
p.(None): intervention (or one substantially similar), and the nature or severity of the event is consistent with information in
p.(None): the relevant source documents (e.g., investigator’s brochure, package insert, or non-reportable events [NRE] list).
p.(None): National Research Ethics Review Guideline Fifth Edition 79
p.(None):
p.(None): Expedited review-Review performed by the IRB Chair or a designated experienced member for research that involves no
p.(None): more than minimal risk and meets the criteria for expedited review or represents minor changes in approved research.
p.(None): Experienced reviewer -A member of an IRB who is designated by the Chair as autho- rized to conduct expedited reviews.
p.(None): Expert reviewer-A member of an IRB who is designated by the Chair as authorized to conduct expedited reviews.
p.(None): Expiration date-The expiration date is the day before the anniversary of the approval date – unless the IRB approves it
p.(None): for less than one year. For instance, a protocol approved on 12/4 has approval date of 12/4/06 and an expiration date
p.(None): of 12/3/07 midnight (which means research may be conducted on 12/3).
p.(None): Fetus-The product of conception from the time of implantation until delivery.
p.(None): Focus group-Group of individuals brought together to discuss an issue within a struc- tured environment, often for
p.(None): formative or qualitative research purposes.
...
p.(None): intervention (or one substantially similar), the na- ture or severity of the event is not consistent with information
p.(None): in the relevant source documents (e.g., investigator’s brochure, package insert, or non-reportable events [NRE] list),
p.(None): or the event is observed with higher frequency than previously observed or documented. Expectedness does not entail the
p.(None): ability to predict results from in vitro, animal, or other pharmacological models.
p.(None): Unlinked-The condition of data or specimens which had been coded but for which the key linking the code to direct
p.(None): personal identifiers has been destroyed.
p.(None): Unrelated-Pertaining to an AE, the condition in which the event is due to a docu- mented cause other than research
p.(None): procedures.
p.(None): Verbal consent-Consent obtained by communication in words; this may include spo- ken or written format.
p.(None): Voluntary/voluntariness-Freedom from coercion and undue influence
p.(None): Vulnerable-Having reduced capacity to offer free and informed consent due to pos- sible coercion, undue influence,
p.(None): or other diminished autonomy, such as children, prisoners, pregnant women, mentally disabled persons, or
p.(None): economically or education- ally disadvantaged persons as vulnerable. Vulnerability may be associated with other
p.(None): characteristics such as age, health status, or social standing. The IRB must ensure additional safeguards protect the
p.(None): rights and welfare of vulnerable persons.
p.(None): Vulnerable population-A group identified by one or more common characteristics associated with reduced
p.(None): capacity to offer free and informed consent.
p.(None): Waive/waiver-Temporarily set aside the requirement of a particular rule, regulation, or condition in a protocol or
p.(None): consent document.
p.(None): Withdraw/withdrawal-Permanently halt a research study after submission for IRB review but before human
p.(None): participants become involved, whether or not the study has been reviewed by an IRB. This term has been replaced by the
p.(None): term close/closure.
p.(None):
p.(None):
p.(None):
...
Political / Indigenous
Searching for indicator indigenous:
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p.(None): human participants in all research proposed to be conducted in Ethiopia, based upon the Health Science and Technology
p.(None): Policy and the responsibilities assigned to the MoST.
p.(None): No other guidelines and requirements are allowed to diminish or remove any of the human research participants’
p.(None): protections set forth in this National Research Ethics Review Guidelines.
p.(None): 1.4 Scope of Application
p.(None): This Guideline is applicable to all types of research that involves human participants, including but not limited to:
p.(None): • Studies of a physiological, biomedical, biochemical, or pathological processes
p.(None): • Genetic research, clinical trials, pharmaceutical, and other investigational products
p.(None): • Research studies involving clinical records or other personal information
p.(None): • Public health and epidemiological research
p.(None): • Health systems research
p.(None): • Quality improvement research
p.(None): • Human health related behavioral research, research on medical and paramedi- cal education, and research related to
p.(None): traditional healing.
p.(None): • Research that may include one or a combination of observations; interviews, in- ternet-based, mail-based, and
p.(None): telephone research; focus group research; survey and research with biological samples.
p.(None): Furthermore, the guidelines are applicable in research proposed to be conducted by all sectors and organizations. These
p.(None): include, but are not limited to, public, private, faith-based, indigenous and international non-governmental
p.(None): organizations (NGOs), bilateral, multilateral, and United Nations’ agencies.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 19
p.(None):
p.(None): 2. Objectives
p.(None): 2.1 General Objective
p.(None): The objective of this guideline is to safeguard the rights, values, and welfare of re- search participants through
p.(None): respecting the participants’ autonomy, protecting the participants from harm related to research, and ensuring
p.(None): that individual/community benefits and fairness are maintained.
p.(None): 2.2 Specific Objectives
p.(None): 2.2.1. To ensure the rights and autonomy of research participants are respected and that participation or otherwise in
p.(None): research, is entirely voluntary
p.(None): 2.2.2. To safeguard research participants from unnecessary/unjustifiable risk
p.(None): 2.2.3. To ensure fair selection of research participants and fair distribution of benefits and risks
p.(None): 2.2.4. To create awareness among investigators, sponsors, reviewers, decision and policy makers, and
p.(None): individuals/communities on basic ethics principles
p.(None): 2.2.5. To ensure that research holds/embraces/possesses/considers social and cultural responsiveness/sensitivities for
p.(None): participating individuals and com- munities
...
Political / criminal
Searching for indicator criminal:
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p.(None): Practice (GCP) and experimental designs should be conducted as necessary.
p.(None): • Current CVs and records of training of all members should be kept on file by the IRB Secretariat in the IRB office.
p.(None): 6.9 Termination of Membership
p.(None): • Membership may be terminated voluntarily. The member should write a resig- nation letter to the appointing authority
p.(None): through the IRB Chairperson giving at least a one-month notice.
p.(None): • The Chairperson may resign by sending his/her resignation letter to the appointing
p.(None): 34 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): authority after informing the committee at its next meeting.
p.(None): • Membership should be terminated by the appointing authority on the advice of the IRB if a member is going to be away
p.(None): for more than one year.
p.(None): • Membership could be terminated by the appointing authority upon advice of the IRB if the member has been absent from
p.(None): five consecutive meetings without offering an explanation.
p.(None): • Membership should be terminated by the appointing authority for misconduct that tarnishes the credibility of the IRB
p.(None): as determined by the IRB.
p.(None): • Membership should be terminated if a member is convicted of a criminal offence.
p.(None): • Membership should be terminated by the appointing authority in consultation with the IRB if a member is suffering
p.(None): from a chronic incapacitating illness that significantly reduces the ability to process information and make rational
p.(None): inde- pendent decisions.
p.(None): • Membership should automatically terminate when a member dies.
p.(None): 6.10 Dissolution of IRB
p.(None): The IRB should automatically cease to exist when the institution at which it is based ceases to exist.
p.(None): 6.11 Committee Meetings
p.(None): 6.11.1 Scheduled Full (Convened) IRB Meetings
p.(None): 6.11.1.1 The calendar dates and time of scheduled full (convened) IRB meetings should be agreed upon and
p.(None): confirmed by the committee and made public.
p.(None): 6.11.1.2 The frequency of the scheduled full (convened) IRB meetings should depend on the workload in terms of volume
p.(None): of applications submitted as well as the availability of IRB members who have other duties at their places of
p.(None): employment.
p.(None): 6.11.1.3 A quorum is more than 50% of the total number of IRB members.
p.(None): 6.11.1.4 The quorum should include members with the relevant expertise to effectively review the protocols on that
p.(None): days agenda. The presence of a non-scientist is required. The community representative, although not required, is
p.(None): essential.
p.(None): 6.11.1.5 The quorum should be present before a full (convened) IRB meeting is held.
p.(None): 6.11.1.6 The IRB Secretary should send an agenda; minutes of the previous meeting; notice about the date, venue and
p.(None): time of the next scheduled meeting; and other relevant documents to all IRB members at least ten working days before
p.(None): the meeting.
...
p.(None): 12.2.5. Suspension of eligibility to receive research grants. The IRB may black- list the investigator for a period of
p.(None): time to be determined by the IRB. During that period the IRB should not approve any research protocol submitted by the
p.(None): blacklisted investigators. The list should be copied to the relevant authorities.
p.(None): 12.2.6. In the event that serious harm/injury was caused to participants as a result of the misconduct,
p.(None): compensation for the harm/injury should be made by the investigators, or the host institution, or both. All re-
p.(None): search-related harm or injury as a result of ethically unapproved re- search shall be compensated by the
p.(None): investigator, the host institution,
p.(None): 68 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): or both. The compensation package should be determined by qualified and relevant authorities.
p.(None): 12.2.7. Temporary or permanent suspension of the PI and other investigators from research and/or professional practice.
p.(None): 12.2.8. Suspension of all research being conducted by the investigator.
p.(None): 12.2.9. Termination of the research.
p.(None): 12.2.10. The host institution may also be temporarily suspended from research activities.
p.(None): 12.2.11. Editors of journals should refuse publication of manuscripts from un- ethically conducted research and retract
p.(None): articles that are already pub- lished but eventually found to be conducted unethically.
p.(None): 12.2.12. In the case of criminal misconduct inform legal authorities.
p.(None):
p.(None): 13. Responsibilities of Investigators, Host Institutions, Sponsors
p.(None): Responsible conduct of research requires that all stakeholders discharge the duties ex- pected from them according to
p.(None): this guidelines and the law and regulations of Ethiopia.
p.(None): 13.1 Investigators
p.(None): The investigator is responsible for overall conduct of the research according to the approved research
p.(None): protocol/procedures. More specifically, the investigator:
p.(None): 13.1.1. Shall maintain adherence to basic ethics principles,
p.(None): 13.1.2. Shall possess appropriate scientific and human ethics standards,
p.(None): 13.1.3. Shall ensure the highest possible standard of health care and follow-up, within the limit of the investigator’s
p.(None): and the sponsor’s capacity, is avail- able to research participants; the available care shall be provided for a
p.(None): variable period even after the completion of the research based on the researched disease, condition or instrument;
p.(None): shall open an investiga- tor’s file where all documents related to the research are kept.
p.(None): 13.0.4. Shall keep records of informed consent document confidentially (in a locked cabinet).
p.(None): 13.1.5. Shall ensure privacy and confidentiality is maintained for research par- ticipants. The investigator shall
p.(None): ensure that hard data is kept in locked cabinets and electronic data is password protected accessible only to
p.(None): appropriate personnel.
...
p.(None): documentation of consent, informed con- sent, verbal consent.
p.(None): National Research Ethics Review Guideline Fifth Edition 81
p.(None):
p.(None): Parental permission-The agreement of a parent or guardian to the participation of their child in research.
p.(None): Personal identifier-Information obtained and recorded in such a manner that human participants can be recognized,
p.(None): directly or through links to the participants. Examples include names, social security numbers, and codes.
p.(None): Pilot study-Preliminary study to determine the feasibility of a larger study, use of a test instrument, or other
p.(None): activity.
p.(None): Pregnancy-The period of time from implantation until delivery. A woman shall be assumed to be pregnant if
p.(None): she exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until the results of a
p.(None): pregnancy test are negative or until delivery.
p.(None): Principal Investigator (PI)-Lead scientist who is working on the design of a research study, development of methods and
p.(None): procedures for the study, collection of data or specimens, analysis of data or specimens, or interpretation of data.
p.(None): Prisoner-Any individual involuntarily confined or detained in a penal institution. The term is intended to encompass
p.(None): individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other
p.(None): facilities by virtue of statutes or commit- ment procedures which provide alternatives to criminal prosecution or
p.(None): incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.
p.(None): Private information-information about individually identifiable behavior that occurs in a context in which the
p.(None): individual can reasonably expect that no observation or record- ing is taking place, and information which has been
p.(None): provided for specific purposes by an individual and which the individual can reasonably expect will not be made public
p.(None): (e.g., a medical record).
p.(None): Private/privacy-Individual person’s interest in preventing disclosure of information about himself or herself.
p.(None): Project-A planned activity or collection of activities conducted for a particular pur- pose; may encompass more than
p.(None): one protocol on the same subject matter.
p.(None): Protocol-The formal design or plan of a data collection activity; specifically, the plan submitted to a reviewing
p.(None): authority such as an IRB. The protocol includes a descrip- tion of the design or methods for conducting the data
p.(None): collection, description of the study population, methods for data handling and analysis, procedures for handling
p.(None): incidents, and methods for notification and dissemination of results.
p.(None): Quorum-The number of IRB members required to be present at a convened meeting in order for the IRB to transact
p.(None): business.
p.(None): Reimbursement-Repayment for costs incurred by virtue or participation in research, such as for lost earnings or travel
p.(None): costs.
p.(None): Related/relation-Pertaining to an AE, the likelihood that the event was caused by research procedures,
p.(None): usually relative to the likelihood it was caused by something
p.(None):
...
Political / immigrants
Searching for indicator immigrants:
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p.(None): result of being a research participant. Risks to research participants include physical, psychological, and emotional
p.(None): harm. Risks can be known or presumed. And, although no specific regulations exist, risks may include physical,
p.(None): psychological, emotional, economic, educational, legal, and social harm.
p.(None): In addition, beneficence includes whether the usual care is changed or manipulated to inflict no harm, minimize harm,
p.(None): remove harm, and maximize the benefit to re- search participants and to the community, or both.
p.(None): 3.3 Justice
p.(None): Justice connotes fairness and equity in the distribution of the benefits and burdens of research to participants.
p.(None): 3.3.1. Justice demands equitable selection of participants, i.e., avoiding popu- lations that may be unfairly coerced
p.(None): into participating, including but not limited to, prisoners, pregnant women, people with mental and physical
p.(None): disabilities, immigrants, refugees, ethnic minorities, marginalized groups and institutionalized persons, including
p.(None): children. There must be a justi- fication for inclusion of these vulnerable groups in the research. There should be no
p.(None): disproportionate use of vulnerable populations. The same recruitment approach should be used in all populations.
p.(None): Injustice may arise when selecting participants from a specific socio-economic class, age, sex, racial, cultural,
p.(None): religious, creed, and institutional make up.
p.(None): 3.3.2. The principle of justice requires equality in the distribution of benefits and burdens among the population
p.(None): groups likely to benefit from the research. Distributive justice means that no segment of the population should be
p.(None): unfairly burdened with the harms of research. It thus imposes particular obligations toward individuals who are
p.(None): vulnerable and unable to protect their own interests. Conversely, distributive justice imposes duties neither to
p.(None): neglect nor discriminate against individuals and groups who may ben- efit from advances in research.
...
Political / person in detention center
Searching for indicator detained:
(return to top)
p.(None): documentation of consent, informed con- sent, verbal consent.
p.(None): National Research Ethics Review Guideline Fifth Edition 81
p.(None):
p.(None): Parental permission-The agreement of a parent or guardian to the participation of their child in research.
p.(None): Personal identifier-Information obtained and recorded in such a manner that human participants can be recognized,
p.(None): directly or through links to the participants. Examples include names, social security numbers, and codes.
p.(None): Pilot study-Preliminary study to determine the feasibility of a larger study, use of a test instrument, or other
p.(None): activity.
p.(None): Pregnancy-The period of time from implantation until delivery. A woman shall be assumed to be pregnant if
p.(None): she exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until the results of a
p.(None): pregnancy test are negative or until delivery.
p.(None): Principal Investigator (PI)-Lead scientist who is working on the design of a research study, development of methods and
p.(None): procedures for the study, collection of data or specimens, analysis of data or specimens, or interpretation of data.
p.(None): Prisoner-Any individual involuntarily confined or detained in a penal institution. The term is intended to encompass
p.(None): individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other
p.(None): facilities by virtue of statutes or commit- ment procedures which provide alternatives to criminal prosecution or
p.(None): incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.
p.(None): Private information-information about individually identifiable behavior that occurs in a context in which the
p.(None): individual can reasonably expect that no observation or record- ing is taking place, and information which has been
p.(None): provided for specific purposes by an individual and which the individual can reasonably expect will not be made public
p.(None): (e.g., a medical record).
p.(None): Private/privacy-Individual person’s interest in preventing disclosure of information about himself or herself.
p.(None): Project-A planned activity or collection of activities conducted for a particular pur- pose; may encompass more than
p.(None): one protocol on the same subject matter.
p.(None): Protocol-The formal design or plan of a data collection activity; specifically, the plan submitted to a reviewing
p.(None): authority such as an IRB. The protocol includes a descrip- tion of the design or methods for conducting the data
p.(None): collection, description of the study population, methods for data handling and analysis, procedures for handling
p.(None): incidents, and methods for notification and dissemination of results.
p.(None): Quorum-The number of IRB members required to be present at a convened meeting in order for the IRB to transact
p.(None): business.
p.(None): Reimbursement-Repayment for costs incurred by virtue or participation in research, such as for lost earnings or travel
p.(None): costs.
p.(None): Related/relation-Pertaining to an AE, the likelihood that the event was caused by research procedures,
p.(None): usually relative to the likelihood it was caused by something
p.(None):
p.(None): 82 National Research Ethics Review Guideline Fifth Edition
p.(None):
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Political / political affiliation
Searching for indicator party:
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p.(None): psychological, and cultural harm. It refers to the obligation on the part of the investigator to respect each
p.(None): research participant as a person capable of making an informed decision regarding participation in the research
p.(None): study. It obligates in- vestigators to respect the right of human subjects to hold their views, make
p.(None): choices and take actions without controlling influences. For human subjects who are not capable of making an informed
p.(None): decision because of age, mental, or medical capacity, the next of kin or guardian shall make the decision in the best
p.(None): interest of the research participant.
p.(None): 3.1.2. Informed Consent – The importance of informed consent of research participants is unquestionable and
p.(None): the informed consent should be analyzed in terms of containing the basic elements of information, com- prehension,
p.(None): competence, disclosure, and voluntarism. Information shall be given in writing and signed or verbally approved by the
p.(None): research par- ticipant. The information to be provided should be written in a way that considers the local culture and
p.(None): values, as well as the level of understanding of the research participant. The information provided should weigh the
p.(None): re- search participants’ competence. When informed consent is that of a third party (proxy; parent, next-of-kin,
p.(None): legally authorized representative (LAR), the reasons for the indirect approach shall be stated and become part of the
p.(None): protocol.
p.(None): Research participants or persons giving proxy consent cannot give full informed consent unless the consent process/form
p.(None): contains adequate information. All such information shall be expressed in a language that is understandable to the
p.(None): participant. Generally, the consent form should explicitly indicate the points mentioned in Section 6.13 below.
p.(None): National Research Ethics Review Guideline Fifth Edition 21
p.(None):
p.(None): 3.2 Beneficence
p.(None): The principle of beneficence refers to the obligation on the part of the investiga- tor to attempt to
p.(None): maximize benefits for the individual participant and/or community, while minimizing risk or harm to the
p.(None): individual/community. As much as possible, beneficence also considers inflicting no harm. An honest and thorough
p.(None): risk/benefit assessment must be performed. Balancing the risk and benefit of the research is indispensible
p.(None): in the design and conduct of the research.
...
p.(None): the rights and welfare of participants.
p.(None): 4.2.2. The NRERC and IRB have the authority to ensure that re- search studies conducted under its
p.(None): jurisdiction are designed and con- ducted in a manner that protects the rights, welfare and privacy of re- search
p.(None): participants. Specifically:
p.(None): • The NRERC and IRB reviews, and has the authority to approve, require mod- ification in, or disapprove all research
p.(None): activities that fall within its jurisdiction.
p.(None): • The NRERC and IRB have the authority to conduct continuing review as it deems necessary to protect the
p.(None): rights, welfare, and privacy of research partici- pants, including requiring progress reports from investigators.
p.(None): • The NRERC and IRB may suspend or terminate approval of a study not being
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 23
p.(None):
p.(None): conducted in accordance with the NRERC and IRB’s requirements or that has been associated with unexpected serious harm
p.(None): to participants or others.
p.(None): • The NRERC and IRB have the authority to observe or have a third party ob- serve the informed consent process and/or
p.(None): audit the progress of any study in its jurisdiction as it deems necessary to protect the rights and welfare of human
p.(None): participants.
p.(None): • The NRERC and IRB may place restrictions on a study.
p.(None): 4.3 Use of Policies, Procedures
p.(None): The NRERC and IRB members and its Secretariat staff must maintain and follow all written policies and procedures
p.(None): consistent with Ethiopian regulations, good clinical practices, good manufacturing practices, and biomedical ethics
p.(None): when reviewing pro- posed research.
p.(None):
p.(None): 5. Ethics Review System
p.(None): The MoST through the Ministry of Justice, shall ensure that health research ethics re- view is supported by an adequate
p.(None): legal framework that resonates with this guideline. MoST shall strive to put in place an appropriate and sustainable
p.(None): system to monitor the quality and effectiveness of research ethics review. In addition, MoST is respon- sible to ensure
p.(None): existence of mechanisms for networking and cooperation among IRBs at different levels, as well as IRBs of international
p.(None): standing in collaborative research.
p.(None): All health research involving human participants must undergo review by the NRERC or an independent IRB. In Ethiopia,
...
p.(None): preserved to the fullest extent by the research team.
p.(None): • The study participation information including research results will not be given to family members, employers or
p.(None): other third parties without written permission of the subject and IRB approval.
p.(None): National Research Ethics Review Guideline Fifth Edition 51
p.(None):
p.(None): • Any shared samples must be anonymized to the recipient. Reimbursement of reasonable costs incurred by participants
p.(None): should not be of a magnitude so as to constitute an inducement to participate in the genetic study.
p.(None): • During the informed consent process, there should be a clear statement that the study is for genetic research
p.(None): purposes. It is ethically imperative that clear, balanced, adequate and appropriate information shall be provided to
p.(None): the potential participant.
p.(None): • The informed consent process should cover the human biological materials and data to be collected, data anticipated
p.(None): to be derived from the analysis of sam- ples, and the health and other records to be accessed, their intended uses,
p.(None): storage, and duration of storage.
p.(None): • The participants must be informed that specific information resulting from the study will not be available to
p.(None): participants and their families. Explanation should be given if the samples will be shared with third parties and that
p.(None): in these cases the samples will be anonymous.
p.(None): • The participant should be given the option of allowing samples to be shared or not. All secondary and third party
p.(None): uses of biological samples should be restrict- ed to anonymized or anonymous samples. This means the sample cannot be
p.(None): identified or linked to an individual by the ‘secondary-use-researcher’ or the ‘third party’. Limited,
p.(None): non-identifying, demographic information may be retained on the sample.
p.(None): • Use of genetic materials beyond what is stated in the protocol must have the consent of the research participants or
p.(None): their representatives. In case of second- ary use, i.e., research other than what it was collected, may be done only on
p.(None): anonymized samples and after getting prior approval by the IRB.
p.(None): • Where subsequent use of human biological materials or data is envisaged that would not be consistent with the
p.(None): original informed consent, a new consent should be obtained from the participant/guardian/LAR or request for
p.(None): waiver of consent from IRB.
p.(None): • The protocol should articulate clearly duration and place of storage of biological samples and data.
p.(None): 8.3.3 Socio-Behavioral Research
p.(None): There are five potential risks in qualitative and behavioral research that the IRB, the investigator and the sponsor
p.(None): should be aware of:
p.(None): • Anxiety and distress: qualitative research is aimed at in-depth understanding of sensitive topics with
p.(None): exploration of reasons and resilient issues. Involves open-ended questions and probing that give room for
p.(None): unexpected themes and variety of responses in the participant’s own terms. Besides, responses are in- timately
p.(None): dependent upon the context of the participants’ beliefs, values, behav- iors and actions. Hence, qualitative research
...
p.(None): samples in future research, potential risks and benefits of storing samples for future re- search and any other
p.(None): information deemed necessary by the Investigators, IRBs.
p.(None): • After explaining the need to store the samples, the research participant should be offered to choose whether their
p.(None): samples should or should not be stored for future studies.
p.(None): National Research Ethics Review Guideline Fifth Edition 57
p.(None):
p.(None): • The host institution in Ethiopia should hold the samples in trust on behalf of the research participant.
p.(None): • Research participants should reserve the right to withdraw their samples from storage if the samples are linked.
p.(None): • Where samples have not been obtained as part of research (for example as part of routine surveillance, emergency
p.(None): procedures, laboratory quality control, notifi- able diseases, routine counseling and testing, etc), the institution
p.(None): that collected the samples takes custodianship of the samples. Any future research study on such samples is subject to
p.(None): review by an IRB.
p.(None): 9.3 Procedure for Exchange Transfer
p.(None): • When it is necessary to transfer samples for storage abroad, the host institution shall negotiate an appropriate
p.(None): contract with the recipient institution. This con- tract shall be in the form of a Materials Transfer Agreement (MTA).
p.(None): The specific details of the MTA should include, among other things, purpose for the transfer/ export, clear
p.(None): arrangements for collaboration and benefit sharing, a framework for accessing and sharing data, restrictions to third
p.(None): party transfer, and annual reports to the host institution on the status of the samples.
p.(None): • It is required that an Ethiopian scientist must be included as co-investigator in all future studies using the human
p.(None): biological materials collected from Ethiopia.
p.(None): • The IRB in Ethiopia shall review all research studies on stored human biological samples.
p.(None):
p.(None): 10. Regulatory Oversight of Research
p.(None): Regulatory oversight of research involving human participants is exercised at two levels. At the country level, the
p.(None): NRERC, which is established by MoST, is the prima- ry responsible organ for oversight. At the institutional level, the
p.(None): organization’s IRB, accredited by MoST, oversees all research being conducted under its jurisdiction. For research
p.(None): involving experimental/clinical trials, an additional approval to import and use the drug or investigational product
p.(None): should be solicited from FMHACA.
p.(None): The legal obligations in research shall be overseen by MoST and FMHACA. IRBs, and DSMBs and are primarily responsible
p.(None): for safeguarding research participant safety. The Institutional Biosafety Committee (IBC) and Community Advisory Board
p.(None): (CAB) shall ensure public/community wellbeing.
p.(None): 10.1 Ministry of Science and Technolgy (MoST)
p.(None): MoST is established by the ‘Definition of Powers and Duties of the Executive Organs of the FDRE (Amendment)
p.(None): Proclamation No. 603/2008’ on October 24, 2008. Un- der the Proclamation, MoST took over the rights and obligations of
p.(None): the ESTA and, under Article 20, is bestowed with the powers and duties to:
p.(None):
p.(None): 58 National Research Ethics Review Guideline Fifth Edition
p.(None):
...
p.(None): interventions are safe, efficacious, and effective.
p.(None): Close/closure-Proactively and permanently end both research-related intervention or interaction with participants and
p.(None): collection and use of identifiable private research information when study objectives have been met as specified in the
p.(None): protocol.
p.(None): Coded-Replacement of identifying information (such as name or social security number that would enable one to readily
p.(None): ascertain the identity of the individual to whom the private information or specimens pertain) with a number, letter,
p.(None): symbol, or combination thereof where a key to decipher the code exists and links the identifying information to the
p.(None): private information or specimens. In contrast with linked, coded often means that the link exists but is unavailable,
p.(None): as through a nondisclosure arrangement.
p.(None): Compensation-Payment to cover actual research-related harm. Where understandability is an issue, use a simpler word
p.(None): like “payment”. Contrast with incentive, reimbursement.
p.(None): Completion of study-Point at which data analysis has ended or identifying informa- tion is removed from the data and
p.(None): biological specimens. See also close.
p.(None): Comprehension–in this context, understanding what the study is about.
p.(None): Conduct-To be engaged (in research) by obtaining data about living individuals through intervention or interaction with
p.(None): them for research purposes or by obtaining individually identifiable private information about living individuals for
p.(None): research purposes.
p.(None): Conflict of interest-A situation where the goals or obligations of an investigator or reviewer conflict with an
p.(None): obligation to uphold another party’s interest, thereby com- promising objectivity and impartiality.
p.(None):
p.(None): 78 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): Confidential/confidentiality-The condition of honoring a request or expectation that information will be protected from
p.(None): disclosure.
p.(None): Convened-A formal, joint meeting or action of a quorum of the IRB.
p.(None): Collaborative research-Research that involves more than one institution.
p.(None): Council for International Organizations of Medical Sciences (CIOMS)-An interna- tional, non-governmental,
p.(None): non-profit organization established in 1949 whose mem- bership represents many of the biomedical disciplines and
p.(None): national academies of sciences and medical research councils. A main objective of CIOMS is to facilitate and promote
p.(None): international activities in the field of biomedical sciences, especially when the participation of several
p.(None): international associations and national institutions is deemed necessary.
p.(None): Data and safety monitoring-Structured, ongoing monitoring of specified characteris- tics of a research protocol,
p.(None): generally by a small, independent body of experts appoint- ed by the study sponsor. Sometimes incorrectly called “data
p.(None): safety and monitoring”. Monitoring may pertain to study performance (such as rate of accrual), safety (such as
p.(None): occurrence of AEs), and efficacy (such as achievement of primary endpoints). A body that monitors all three
p.(None): characteristics is usually called a data monitoring com- mittee (DMC) or a data and safety monitoring board (DSMB).
...
Searching for indicator political:
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p.(None): hoc/extraordinary meeting at least 48 hours be- fore the meeting.
p.(None): 6.11.2.3. The general conduct of the meeting should be as follows:
p.(None): • Call meeting to order by the Chairperson
p.(None): • Adoption of the agenda
p.(None): • The issues for which the ad hoc meeting was convened
p.(None): 6.11.2.4. Relevant documents should be made available to IRB members at least 24 hours before the meeting.
p.(None): 6.11.2.5. A quorum must be present for the ad hoc meeting to conduct business.
p.(None): 6.11.2.6. Adjournment of the ad hoc meeting by the Chairperson
p.(None): 6.11.2.7. Minutes of the ad hoc meeting should be circulated at the next sched- uled IRB meeting. A vote to approve or
p.(None): request modifications should be made.
p.(None):
p.(None):
p.(None):
p.(None): 36 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): 6.12 Mandates and Functions of IRBs
p.(None): The purpose of IRBs is to contribute to safeguarding the dignity, rights, safety, and well-being of all actual or
p.(None): potential research participants, by making an independent scientific and ethical review of research before commencement
p.(None): of research activities. Therefore, the major responsibility of IRBs is to safeguard the rights, safety, and well-be-
p.(None): ing of research participants. The goals of research, while important, should never be permitted to override the health,
p.(None): well-being, and care of research participants.
p.(None): IRBs should provide independent, competent, and timely review of the ethics of pro- posed studies. In their
p.(None): composition, procedures, and decision-making, IRBs need to have independence from political, institutional,
p.(None): professional, and market influences. They need similarly to demonstrate competence and efficiency in their work. They
p.(None): also need to ensure that there is regular evaluation of the ethics of ongoing studies that received a positive
p.(None): decision. Therefore, the functions of the IRB are:
p.(None): 6.12.1 Initial review
p.(None): The IRB must determine that the following requirements are satisfied before it ap- proves a research protocol:
p.(None): • Risks to subjects are minimized. Risk to subjects are reasonable in relation to anticipated benefit (if any) and the
p.(None): knowledge that is expected to result
p.(None): • Selection of subjects is equitable
p.(None): • Determine that informed consent will be sought from each prospective study participant, or the participants’ parent
p.(None): or guardian as appropriate
p.(None): • Determine that informed consent will be appropriately documented
p.(None): • Determine that there are adequate provisions to protect privacy of study partic- ipants and maintain confidentiality
p.(None): of all study related data
p.(None): • Determine that there are additional safeguards included in the study to protect the safety and welfare of study
...
Political / stateless persons
Searching for indicator nation:
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p.(None): • Declaration of the potential allocation of 1.5% of the gross national income or gross domestic product (GNI/GDP) to
p.(None): research in various disciplines.
p.(None): To regulate and provide oversight for health research in light of its increasing land- scape, complexity, and
p.(None): sophistication, MoST hired three consultants with expertise in the field of bioethics to review the existing
p.(None): guidelines. The experts reviewed local and international standards, guidelines, instruments, and procedures related to
p.(None): bioethics. Furthermore, opinions and suggestions were solicited from a dozen highly educated, ethically experienced,
p.(None): reputable professionals in the country. The shortcomings and strengths of the existing guidelines, extent of
p.(None): decentralization of protocol review, man- dates of the National Research Ethics Review Committee (NRERC) and
p.(None): Institutional Review Boards (IRB), terminology, operative procedures, and general suggestions from these dozen
p.(None): professionals, was sought using a semi-structured tool. All efforts were made to strike a balance in accommodating the
p.(None): experts’ sometimes differing opinions and suggestions for these guidelines.
p.(None): 14 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): Moreover, the draft guidelines were discussed with a wider group of experts and rep- resentatives drawn from the MoST,
p.(None): Ministry of Justice, Ministry of Health, FMHACA, IRBs of universities and research institutions, international and UN
p.(None): agencies, and other relevant stakeholders. The comments and recommendations from this nation- wide consultative meeting
p.(None): were analyzed and incorporated before this guideline was endorsed and released for use to safeguard the rights and
p.(None): welfare of research partic- ipants and for oversight of research in Ethiopia.
p.(None): 1.2 Introduction
p.(None): “Research is a systematic investigation including research development, testing, and evaluation designed to contribute
p.(None): to generalizable knowledge.” Nevertheless, as a matter of principle, in research involving human participants, the
p.(None): well-being of the patient takes priority over the interests of society and the knowledge to be gained.
p.(None): “Human subject [research participant] is a living individual about whom an investi- gator conducting research obtains
p.(None): data through intervention or interaction with the individual, or identifiable private information.” Besides, research
p.(None): participants may include pregnant women where fetuses, fetal material, or abortuses are the primary subjects of
p.(None): interest. Similarly, research involving autopsy materials shall also be in- cluded as source of data.
p.(None): The main purpose of health research involving human participants is for better un- derstanding of the etiology,
p.(None): pathogenesis, and pathophysiology of disease and the related diagnostic, preventive, promotive, and therapeutic
p.(None): procedures and measures. Moreover, as evidence-based practice has become necessary at the turn of the 21st century, and
p.(None): quite understandably, existing procedures and practices are challenged continuously for their effectiveness,
p.(None): efficiency, quality, accessibility, and acceptability by the community.
...
p.(None): forms, project reports and SAE reports given to them by the IRB Secretariat in advance preparation of IRB meetings.
p.(None): • Members are obliged to keep IRB documents secure, private, and confidential.
p.(None): • Members should attend IRB meetings regularly and participate fully and actively in deliberations.
p.(None): • Members should participate in continuing education activities in research ethics, RE.
p.(None): • Members must declare any COI for any protocol, and withdraw from the review of that protocol.
p.(None): • Members must maintain privacy and confidentiality of documents and deliber- ations of IRB meetings.
p.(None): 6.8 Orientation Education of Members
p.(None): • New members should undergo orientation training upon joining the IRB in order to familiarize them with basic human
p.(None): research ethics. Such training should be organized by the IRB Secretariat, the host institutions and/or any other
p.(None): players involved in such training.
p.(None): • Continuous training of IRB members on health research ethics and other rel- evant areas such as Good Clinical
p.(None): Practice (GCP) and experimental designs should be conducted as necessary.
p.(None): • Current CVs and records of training of all members should be kept on file by the IRB Secretariat in the IRB office.
p.(None): 6.9 Termination of Membership
p.(None): • Membership may be terminated voluntarily. The member should write a resig- nation letter to the appointing authority
p.(None): through the IRB Chairperson giving at least a one-month notice.
p.(None): • The Chairperson may resign by sending his/her resignation letter to the appointing
p.(None): 34 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): authority after informing the committee at its next meeting.
p.(None): • Membership should be terminated by the appointing authority on the advice of the IRB if a member is going to be away
p.(None): for more than one year.
p.(None): • Membership could be terminated by the appointing authority upon advice of the IRB if the member has been absent from
p.(None): five consecutive meetings without offering an explanation.
p.(None): • Membership should be terminated by the appointing authority for misconduct that tarnishes the credibility of the IRB
p.(None): as determined by the IRB.
p.(None): • Membership should be terminated if a member is convicted of a criminal offence.
p.(None): • Membership should be terminated by the appointing authority in consultation with the IRB if a member is suffering
p.(None): from a chronic incapacitating illness that significantly reduces the ability to process information and make rational
p.(None): inde- pendent decisions.
p.(None): • Membership should automatically terminate when a member dies.
p.(None): 6.10 Dissolution of IRB
...
p.(None): • Support and strengthen institutions that undertake research and development activities.
p.(None): 10.2 The Ethiopian Food Medicine and Health Care Administration and Control Authority
p.(None): The Ethiopian Food Medicine and Health Care Administration and Control Authority was established by ‘Council of
p.(None): Ministers Regulation No. 189/2010’ on August 23, 2010. Under the Proclamation FMHACA took over the rights and
p.(None): obligations of the Drug Administration and Control Authority (DACA) and, under Article 5, its ‘…ob- jectives shall be
p.(None): to protect the health of consumers by ensuring: 1) food safety and quality 2) the safety, efficacy, quality, and
p.(None): proper use of medicines 3) competence and ethics of health professionals, medical practitioners and pharmacy
p.(None): professionals.
p.(None): The ‘…authority is responsible to protect the safety and rights of the subjects partici- pating in a trial and to
p.(None): ensure that trials are adequately designed to meet scientifically sound objectives.’ ‘The mandate of the Authority is
p.(None): to review protocols, and where necessary to protect the safety of subjects, to require protocol revisions and/or termi-
p.(None): nation of trials. The Authority also has a right for on-site inspection of the quality of the data obtained…’
p.(None): ‘Any clinical trial conducted in the country on human beings and/or on animals other than laboratory animals should
p.(None): have received prior permission before the commence- ment of the trial.’ Furthermore, the Authority demands that
p.(None): findings from a clinical trial need its approval before publishing. Besides, the responsibilities of the investi-
p.(None): gator, the sponsor, and the monitor should be stated clearly in the research protocol.
p.(None): The authority also requires that a specific application form for clinical trials shall be completed and submitted for
p.(None): review and approval of a research.
p.(None): 10.3 Institutional Review Boards (IRB)
p.(None): IRBs are established by institutions whose mandate includes carrying out research. The primary function of IRBs is
p.(None): initial and continuing review, monitoring research to ensure adherence to the approved protocol in order to safeguard
p.(None): the rights and welfare of research participants, train faculty on research ethics, accredit, register,
p.(None): and monitor other IRBs, and develop guidelines applicable to all research in Ethiopia.
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 59
p.(None):
p.(None): 10.4 Data and Safety Monitoring Board
p.(None): 10.4.1 Definition
p.(None): A Data and Safety Monitoring Board (DSMB) is an independent committee composed of a multidisciplinary group of experts
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Political / vulnerable
Searching for indicator vulnerable:
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p.(None): psychological, emotional, economic, educational, legal, and social harm.
p.(None): In addition, beneficence includes whether the usual care is changed or manipulated to inflict no harm, minimize harm,
p.(None): remove harm, and maximize the benefit to re- search participants and to the community, or both.
p.(None): 3.3 Justice
p.(None): Justice connotes fairness and equity in the distribution of the benefits and burdens of research to participants.
p.(None): 3.3.1. Justice demands equitable selection of participants, i.e., avoiding popu- lations that may be unfairly coerced
p.(None): into participating, including but not limited to, prisoners, pregnant women, people with mental and physical
p.(None): disabilities, immigrants, refugees, ethnic minorities, marginalized groups and institutionalized persons, including
p.(None): children. There must be a justi- fication for inclusion of these vulnerable groups in the research. There should be no
p.(None): disproportionate use of vulnerable populations. The same recruitment approach should be used in all populations.
p.(None): Injustice may arise when selecting participants from a specific socio-economic class, age, sex, racial, cultural,
p.(None): religious, creed, and institutional make up.
p.(None): 3.3.2. The principle of justice requires equality in the distribution of benefits and burdens among the population
p.(None): groups likely to benefit from the research. Distributive justice means that no segment of the population should be
p.(None): unfairly burdened with the harms of research. It thus imposes particular obligations toward individuals who are
p.(None): vulnerable and unable to protect their own interests. Conversely, distributive justice imposes duties neither to
p.(None): neglect nor discriminate against individuals and groups who may ben- efit from advances in research.
p.(None): 3.3.3. Justice also demands balancing the benefits and burdens to the commu- nity where the research is undertaken.
p.(None): 3.3.4. In addition, the investigators shall assure that information obtained in the course of the investigation
p.(None): remains confidential to protect partici-
p.(None): 22 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): pants from possible harm. Data unlinked from individuals or groups does not jeopardize confidentiality. The privacy of
p.(None): individual participants also needs to be protected throughout the investigation by the investigators.
p.(None):
p.(None): 4. Institutional Authority and Purpose
p.(None): 4.1 Institutional authority
p.(None): NRERC and IRBs are established under the authority of the Ministry of Science and Technology, but function
p.(None): independently.
p.(None): The MoST requires all research involving human participants or human biological materials to be reviewed and approved
p.(None): by NRERC or one of the MoST accredited and registered IRBs prior to initiation of any research-related activities,
p.(None): including recruit- ment and screening of participants.
...
p.(None): 6.3 Composition
p.(None): The IRB should consist of a reasonable number of members, who collectively have the qualifications and experience
p.(None): to review and evaluate the science, medical as- pects, and ethics of the proposed research.
p.(None): • Each IRB shall be composed of at least five (5) members, with varying back- grounds to ensure complete and robust
p.(None): review of research activities commonly conducted by the institution. It must be multidisciplinary and multi-sectoral in
p.(None): composition, including persons with relevant but diverse scientific expertise, balanced age and gender
p.(None): distribution, and who have the qualifications and ex- perience to review and evaluate the scientific and
p.(None): medical ethics aspects of research protocols.
p.(None): • All IRBs shall have at least one member whose main area of expertise is in the scientific field and at least one
p.(None): member whose primary area of expertise is in a non-scientific field.
p.(None): • Each IRB shall include at least one member who is not otherwise affiliated with the institution or have a close
p.(None): family member working in the institution.
p.(None): • The IRB should have at least one community representative, who does not nec- essarily have to have any scientific
p.(None): expertise, but may be a layperson that rep- resents the interests and concerns of members of the community and is
p.(None): familiar with the community’s values, customs, traditions, and culture.
p.(None): • If an IRB regularly reviews research that involves vulnerable populations, such as children, prisoners, pregnant
p.(None): women, men/women in uniform or persons with disabilities, marginalized group, refuges, minorities, the IRB shall
p.(None): involve or co- opt one or more individuals who are knowledgeable about and experienced in working with these research
p.(None): participants.
p.(None): • All IRB members should at the minimum take one basic training on bioethics within one year of appointment.
p.(None):
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 31
p.(None):
p.(None): 6.4 External Reviewers
p.(None): • If a protocol requires expertise that is beyond the competence of the IRB mem- bers or the IRB need additional
p.(None): opinion in the review process, the IRB may engage independent experts to review and give their opinion.
p.(None): • The Secretariat should keep an updated list of experts along with their CVs, which should be reviewed annually by
p.(None): the IRB.
p.(None): • Independent experts must sign privacy and confidentiality agreements and con- flict of interest (COI) forms to
p.(None): ensure that the information in the protocol is protected and that consultants do not have any conflicts.
p.(None): • The IRB may ask questions that could guide the review of the experts.
...
p.(None): composition, procedures, and decision-making, IRBs need to have independence from political, institutional,
p.(None): professional, and market influences. They need similarly to demonstrate competence and efficiency in their work. They
p.(None): also need to ensure that there is regular evaluation of the ethics of ongoing studies that received a positive
p.(None): decision. Therefore, the functions of the IRB are:
p.(None): 6.12.1 Initial review
p.(None): The IRB must determine that the following requirements are satisfied before it ap- proves a research protocol:
p.(None): • Risks to subjects are minimized. Risk to subjects are reasonable in relation to anticipated benefit (if any) and the
p.(None): knowledge that is expected to result
p.(None): • Selection of subjects is equitable
p.(None): • Determine that informed consent will be sought from each prospective study participant, or the participants’ parent
p.(None): or guardian as appropriate
p.(None): • Determine that informed consent will be appropriately documented
p.(None): • Determine that there are adequate provisions to protect privacy of study partic- ipants and maintain confidentiality
p.(None): of all study related data
p.(None): • Determine that there are additional safeguards included in the study to protect the safety and welfare of study
p.(None): subjects who are likely to be vulnerable to coer- cion or undue influence such as such as children, prisoners, mentally
p.(None): disabled
p.(None): people, etc.
p.(None): 6.13 Informed Consent
p.(None): 6.13.1. The IRB must determine that the consent is documented using a written or verbal informed consent form,
p.(None): • The consent form should be approved by the IRB.
p.(None): • The consent form must be signed by the participant, or a parent, or next-of-kin or a guardian and by the individual
p.(None): that conducted the in- formed consent process.
p.(None): • In case the participant cannot read or write, a witness should sign that the consent process was carried out
p.(None): appropriately.
p.(None): National Research Ethics Review Guideline Fifth Edition 37
p.(None):
p.(None): • A copy of the signed informed consent form should be given to the study participant.
...
p.(None): 8.1.7. All applications should be submitted to the IRBs depending on the loca- tion of the research site.
p.(None): 8.1.8. The IRBs shall give final official approval for studies under their man- date. However, if an applicant has a
p.(None): complaint(s) against the decision of the IRBs, the study should be reviewed by the NRERC.
p.(None): 8.1.9. The NRERC or other appropriate IRB shall also review all studies under the NRERC’s mandate and send the
p.(None): protocols with recommendations and remarks to the NRERC for final approval.
p.(None): 8.1.10. The Secretariat receives applications submitted using the application form from IRBs for ethics review
p.(None): and final decision as stated under NRERC mandates.
p.(None): 8.1.11. Upon receipt of complete applications, preliminary screening is done by the Secretariat.
p.(None): 8.2 Protocol Requirements
p.(None): All research protocol and related documents submitted to the IRB for review and approval must at the least
p.(None): include the following information:
p.(None): • Research protocol: title of the study, purpose of the study, sponsor of the study, background of the project, a
p.(None): rationale with full justification of the study and that there is no other alternative and less risky way of obtaining
p.(None): the data, descrip- tion of the study population, participants inclusion /exclusion criteria, precise description of
p.(None): all proposed procedures and interventions, including the duration of the study, provisions for protecting privacy and
p.(None): confidentiality, provisions for managing adverse events, plans for data management including plan for statis- tical
p.(None): analysis and publication, and budget,
p.(None): • Vulnerable population involvement requires further explanation to justify that without these vulnerable
p.(None): populations involvement there is no other way of ob- taining the relevant data.
p.(None): • All materials to be used (including advertisements) for the recruitment of re- search participants must be
p.(None): attached to the protocol.
p.(None): • Data collection tools such as questionnaires, interviews /discussion guides, checklists and case report
p.(None): forms must also be submitted.
p.(None): • Documents to be submitted for review include: Study protocol, protocol amend- ments, study/participant information
p.(None): sheet and informed consent form, current investigators’ CV, investigator’s brochure, and other materials to be used.
p.(None): The study informed consent process/form and information sheet, in both the offi-
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 47
p.(None):
p.(None): cial language and, when necessary, its translation into the local language is required. A back translation into the
p.(None): official language may be requested by the IRB. In addition contact addresses of the PI, people to contact and the IRB
p.(None): that approved the research protocol must be included in the study information sheet.
p.(None): • If the proposed study is a clinical trial, the investigator’s brochure which provides an adequate summary of all
p.(None): safety, pharmacological, pharmaceutical and toxico- logical data available on the study product, together with a
p.(None): summary of the clini- cal experience of the study product (e.g. recent investigator’s brochure, published data, summary
p.(None): of the product’s characteristics etc.), must also be submitted. Information on payment and compensation available for
p.(None): research participants for time lost and injury or harm as a result of participating in the study.
p.(None): • If the proposed study is a clinical trial, a certificate of Good Clinical Practice, of at least one of the
p.(None): investigators, and a certificate of Good Manufacturing Prac- tice based on the nature of the research, must be
p.(None): attached.
p.(None): • In studies that need transport of human biological substances, a request for a material transfer agreement, the type
p.(None): of biological material, how it is going to be processed and stored, how the material is intended to be analyzed, intent
p.(None): for possible future analysis, if there is one, as well as how and when it will be disposed of, must be included in the
p.(None): study protocol
p.(None): • A dissemination and community involvement plan should be developed.
p.(None): There are special categories of research that possess particular characteristics and demand special emphasis in ethical
p.(None): considerations. This type of research includes clinical/experimental trials, genetic, socio-behavioral, and
p.(None): collaborative research and research involving Vulnerable population.
p.(None): 8.3 Types Of Research with Special Consideration
p.(None): 8.3.1 Clinical Trials
p.(None): 8.3.1.1 Submission requirements
p.(None): • An investigator’s brochure which provides an adequate summary of all safe- ty, pharmacological, pharmaceutical, and
p.(None): toxicological data available on the study product, together with a summary of the clinical experience of the study
p.(None): product (e.g. recent investigator’s brochure, published data, summary of the product’s characteristics, etc.), must
p.(None): also be submitted.
p.(None): • If the trial involves an investigational product, prior approval and permission to import the investigational
p.(None): product must be obtained from FMHACA.
p.(None): • Information on payment and compensation available for research participants for time lost and injury or harm as a
p.(None): result of participating in the research; Insurance certificate covering research-related injuries of participants and
p.(None): er- rors in protocol implementation,
p.(None): • The PIs should attach a certificate of Good Clinical Practice (GCP), and a
p.(None): 48 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): certificate of Good Manufacturing Practice (GMP), based on the nature of the research. The investigator must assure
p.(None): that the clinical monitor and the IRB will have access to the participant’s file to verify trial procedures and data
p.(None): are kept in accordance with the approved protocol. This should be stated in the participant information sheet.
p.(None): Additionally, the research participant should be told that by signing the informed consent, the participant is
...
p.(None): be conducted.
p.(None): In all collaborative research, all involved institutions are required to review and write a recommendation of approval
p.(None): before submission to IRBs mandated to review and approve such collaborative research. In the event the involved
p.(None): institutions do not have a functioning IRB, the research protocol and other documents can be submitted directly to any
p.(None): of the IRBs mandated to review and approve collaborative research.
p.(None): However, to avoid duplication of review efforts by IRBs, the NRERC may choose to conduct joint reviews in part or in
p.(None): whole, accept the review of another qualified IRB, or make other arrangements to establish oversight responsibilities.
p.(None): Adoption of a paternalistic approach by research sponsors/donors towards institutions in Ethiopia or the research
p.(None): priorities of the government, is unacceptable.
p.(None): 8.3.4.2 Monitoring
p.(None): When conducting collaborative research studies, each institution is responsible for safeguarding the rights and welfare
p.(None): of human participants and for complying with all applicable regulations. The IRB that reviewed and approved the
p.(None): collaborative research is primarily responsible for monitoring the ethical conduct of the research procedures. However,
p.(None): the National IRB can monitor the proper conduct of the research whenever it deems further oversight is necessary. Any
p.(None): modification, amendment, or change in the approved collaborative research protocol should be made at each collaborating
p.(None): institution. Material transfer agreements must be obtained whenever applicable.
p.(None): 8.3.5 Vulnerable Population
p.(None): Vulnerable populations are those segments of the population whose capacity to safe- guard their welfare, demand their
p.(None): rights and satisfy their interests, is compromised. Because of these limitations, they cannot provide or refuse
p.(None): consent. Vulnerable pop-
p.(None): 54 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): ulations are particularly subject to undue influence, manipulation, coercion, and in- timidation. Hence, vulnerable
p.(None): populations deserve special protection from IRBs and other regulatory authorities.
p.(None): 8.3.5.1 Pregnant women and Fetuses
p.(None): To conduct research on pregnant women, the following must be fulfilled:
p.(None): • There is evidence from studies on pregnant animals and non-pregnant women that studies need to be done on risks
p.(None): related to pregnant women and fetuses.
p.(None): • If the research holds the prospect of direct benefit to the pregnant woman and the fetus, and the knowledge cannot
p.(None): be obtained through other means.
p.(None): • There should be no inducement to terminate a pregnancy.
p.(None): • If the prospect of benefit is both to the pregnant woman and the fetus, an in- formed consent form from the mother
p.(None): alone suffices to enroll the woman into the research.
...
p.(None): or an IRB may decide a waiver of consent.
p.(None): • In research related to sensitive topics like drug use and abuse, sexuality, repro- duction, STIs, where obtaining
p.(None): consent from a parent, next-of-kin, or guardian is challenging and may be problematic to the minor because of the
p.(None): nature of the research, assent with waiver of consent may be applicable.
p.(None): • In institutional children, a legally approved guardian may give consent.
p.(None): 8.3.5.4 Prisoners
p.(None): Prisoners may be under constraints because of their incarceration which could affect their ability to make a truly
p.(None): voluntary and decision which is not coerced, whether or not to participate as subjects in research. Therefore,
p.(None): additional safeguards should be included in the study to protect the rights and welfare of these subjects, as follows:
p.(None): • If an IRB regularly reviews research that involves these vulnerable populations, consideration shall be given to the
p.(None): inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.
p.(None): • Where possible, a prisoner or an ex-prisoner co-opted in to the IRB reviewing the proposed research project should
p.(None): be included.
p.(None): • Only research on conditions particularly affecting prisoners as a class and with reasonable probability of improving
p.(None): the health and well-being of the research participants should be permissible.
p.(None): • The IRB shall determine that the informed consent process is properly applied with adequate assurance that a
p.(None): prisoner’s participation or refusal to participate will not be considered in decisions regarding his or her release or
p.(None): further deten- tion and each prisoner is clearly informed in advance that his or her participa- tion in the research
p.(None): project will have no affect on his or her release.
p.(None): 8.3.5.5 Mental and Physical Disability
p.(None): Persons with disability need special attention because they are prone to being social- ly marginalized. Therefore,
p.(None): their dignity, rights and well-being in research must be respected. Careful consideration should be made where proxy
p.(None): consent is to be used, and where the use of signed consent forms is not feasible, alternative viable methods should be
p.(None): employed.
p.(None): 56 National Research Ethics Review Guideline Fifth Edition
p.(None):
...
p.(None): termination results from expiration of IRB approval or withdrawal or closure for reasons other than research risks.
p.(None): Understandable language-generally 8th grade reading level or lower/higher depending on targeted population.
p.(None): Undue influence-An excessive, unwarranted, inappropriate, or improper reward in- tended to motivate study
p.(None): participation.
p.(None): Unexpected-Pertaining to an AE, the event is previously unobserved or undocument- ed in humans under the research
p.(None): intervention (or one substantially similar), the na- ture or severity of the event is not consistent with information
p.(None): in the relevant source documents (e.g., investigator’s brochure, package insert, or non-reportable events [NRE] list),
p.(None): or the event is observed with higher frequency than previously observed or documented. Expectedness does not entail the
p.(None): ability to predict results from in vitro, animal, or other pharmacological models.
p.(None): Unlinked-The condition of data or specimens which had been coded but for which the key linking the code to direct
p.(None): personal identifiers has been destroyed.
p.(None): Unrelated-Pertaining to an AE, the condition in which the event is due to a docu- mented cause other than research
p.(None): procedures.
p.(None): Verbal consent-Consent obtained by communication in words; this may include spo- ken or written format.
p.(None): Voluntary/voluntariness-Freedom from coercion and undue influence
p.(None): Vulnerable-Having reduced capacity to offer free and informed consent due to pos- sible coercion, undue influence,
p.(None): or other diminished autonomy, such as children, prisoners, pregnant women, mentally disabled persons, or
p.(None): economically or education- ally disadvantaged persons as vulnerable. Vulnerability may be associated with other
p.(None): characteristics such as age, health status, or social standing. The IRB must ensure additional safeguards protect the
p.(None): rights and welfare of vulnerable persons.
p.(None): Vulnerable population-A group identified by one or more common characteristics associated with reduced
p.(None): capacity to offer free and informed consent.
p.(None): Waive/waiver-Temporarily set aside the requirement of a particular rule, regulation, or condition in a protocol or
p.(None): consent document.
p.(None): Withdraw/withdrawal-Permanently halt a research study after submission for IRB review but before human
p.(None): participants become involved, whether or not the study has been reviewed by an IRB. This term has been replaced by the
p.(None): term close/closure.
p.(None):
p.(None):
p.(None):
p.(None): 84 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): Appendix III: NRERC Terms of Reference
p.(None): 1. Membership
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 2. Tenure
p.(None): The tenure of the NRERC shall be three years.
p.(None): 3. Replacement of Missing Members
p.(None): Whenever a member is absent for three consecutive meetings without valid reasons, the Ministry will be notified of
p.(None): his/her absence and requested for replacement.
p.(None): 4. Meetings
p.(None): The Committee meets every two months regularly. The Chairman however, in consul- tation with the Secretariat, may call
p.(None): an extra ordinary meeting at any time if deemed necessary.
p.(None): 5. Quorum
p.(None): The quorum will consist of eight (or >50%) members. In the absence of the chair- person, temporary chairperson shall
p.(None): be elected.
p.(None): 6. Votes
...
Searching for indicator vulnerability:
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p.(None): personal identifiers has been destroyed.
p.(None): Unrelated-Pertaining to an AE, the condition in which the event is due to a docu- mented cause other than research
p.(None): procedures.
p.(None): Verbal consent-Consent obtained by communication in words; this may include spo- ken or written format.
p.(None): Voluntary/voluntariness-Freedom from coercion and undue influence
p.(None): Vulnerable-Having reduced capacity to offer free and informed consent due to pos- sible coercion, undue influence,
p.(None): or other diminished autonomy, such as children, prisoners, pregnant women, mentally disabled persons, or
p.(None): economically or education- ally disadvantaged persons as vulnerable. Vulnerability may be associated with other
p.(None): characteristics such as age, health status, or social standing. The IRB must ensure additional safeguards protect the
p.(None): rights and welfare of vulnerable persons.
p.(None): Vulnerable population-A group identified by one or more common characteristics associated with reduced
p.(None): capacity to offer free and informed consent.
p.(None): Waive/waiver-Temporarily set aside the requirement of a particular rule, regulation, or condition in a protocol or
p.(None): consent document.
p.(None): Withdraw/withdrawal-Permanently halt a research study after submission for IRB review but before human
p.(None): participants become involved, whether or not the study has been reviewed by an IRB. This term has been replaced by the
p.(None): term close/closure.
p.(None):
p.(None):
p.(None):
p.(None): 84 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): Appendix III: NRERC Terms of Reference
p.(None): 1. Membership
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 2. Tenure
p.(None): The tenure of the NRERC shall be three years.
p.(None): 3. Replacement of Missing Members
...
Health / Cognitive Impairment
Searching for indicator cognitive:
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p.(None): present, including at least one member who represents the interests of the community.
p.(None): • In order for the research project to be approved, it shall receive the approval of a simple majority of those
p.(None): members present at the meeting. The only exception to this procedure shall be in the case of expedited review as
p.(None): outlined in Section 7.3.
p.(None): • Each IRB shall decide the frequency of its meetings, which should be announced.
p.(None): • An IRB shall require that information given to research participants as part of informed consent complies with the
p.(None): general requirements for informed consent as prescribed by this guidelines.
p.(None): • An IRB shall notify investigators in writing the outcome of the review of the re- search project. Such notice shall
p.(None): be provided to the investigator within 15 days from the date of IRB review of the research protocol. In case the IRB
p.(None): does not approve a research activity, it shall include in its written notification a detailed statement of the reasons
p.(None): for its decision.
p.(None): 7.2 Exempted Review Procedures
p.(None): Research activities in which the only involvement of human participants will be in one or more of the specific
p.(None): categories stated below can be considered as exempt:
p.(None): • Education: Research conducted in established or commonly accepted educa- tional settings, involving normal
p.(None): educational practices.
p.(None): • Education: Research involving the use of educational tests (cognitive, diagnos- tic, aptitude, achievement),
p.(None): surveys, interviews, or observation of public behav-
p.(None): ior, provided the research participants can not be identified.
p.(None): 40 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): • Research, involving the collection or study of existing data, documents, records, pathological specimens, or
p.(None): diagnostic specimens, if these sources are publicly available or recorded without identifiers. Or, if the information
p.(None): is recorded by the investigator in such a manner that research participants cannot be identified, directly or through
p.(None): identifiers linked to the subjects.
p.(None): • Evaluation or examination of government projects or programs designed to ex- plore public benefit or service
p.(None): programs; procedures for obtaining benefits or services under those projects or programs; possible changes in or
p.(None): alternatives to those programs or procedures.
p.(None): • Taste and food quality evaluation and consumer acceptance studies where the foods are free of additives and where
p.(None): the ingredients are known to be safe.
p.(None): • Emergency conditions of national or regional importance, such as epidemics.
p.(None): • Quality assurance activities.
p.(None): All research including that in the exempt categories must meet, at a minimum, the principles of respect for persons,
p.(None): beneficence and justice. The exemption determina- tion other than mentioned above will be based on regulatory and
p.(None): institutional criteria and documented.
p.(None): 7.2.1. Exempt Study Submission Requirements - Research activities that meet the requirements for one or more exempt
...
p.(None): • The IRB shall determine that the informed consent process is properly applied with adequate assurance that a
p.(None): prisoner’s participation or refusal to participate will not be considered in decisions regarding his or her release or
p.(None): further deten- tion and each prisoner is clearly informed in advance that his or her participa- tion in the research
p.(None): project will have no affect on his or her release.
p.(None): 8.3.5.5 Mental and Physical Disability
p.(None): Persons with disability need special attention because they are prone to being social- ly marginalized. Therefore,
p.(None): their dignity, rights and well-being in research must be respected. Careful consideration should be made where proxy
p.(None): consent is to be used, and where the use of signed consent forms is not feasible, alternative viable methods should be
p.(None): employed.
p.(None): 56 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): Persons with disabilities (mental or physical) should not be unfairly excluded from participating in research.
p.(None): Researchers should make an effort to address communi- cation, disability and comprehension constraints are often the
p.(None): excuse for exclusion.
p.(None): People with mental disabilities or substance abuse related disorders include those people with psychiatric, cognitive,
p.(None): or developmental disorders. These groups of peo- ple are usually institutionalized and institutionalization may further
p.(None): compromise their ability to make voluntary decisions to participate in a research project. Therefore,
p.(None): research on people with cognitive disabilities or with substance abuse related disor- ders should:
p.(None): • Provide sufficient justification for involving such people;
p.(None): • Have appropriate evaluation procedures for ascertaining research participants’ ability to give informed consent. If
p.(None): research participants are deemed unable to understand and to make an informed decision, then an appropriate proxy
p.(None): should be identified.
p.(None): • Have an informed consent process that is free from coercion.
p.(None): • Be of no more than minimal risk, or if minimal risk is involved, the risk is outweighed by the anticipated benefits
p.(None): of the research project to the research participant.
p.(None):
p.(None): 9. Human Biological Materials
p.(None): 9.1 Definition
p.(None): Human biological materials include any substance obtained from a human research participant including, but not limited
p.(None): to, blood, urine, stool, saliva, hair, nail clip- pings, skin, and microorganisms, and other associated bio-products
p.(None): obtained from human research participants.
p.(None): 9.2 Acquisition, Storage, Secondary Use
p.(None): The acquisition, storage, and future use of human biological samples from research participants in Ethiopia shall be
p.(None): guided by the following procedures:
...
Health / Drug Usage
Searching for indicator drug:
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 1. General
p.(None): 1.1 Background
p.(None): Research involving human participants may have existed on Earth for several millen- nia, albeit the research may have
p.(None): been unscientific, uncoordinated, unmonitored, and largely unethical. Some of these experiments have survived the test
p.(None): of time and are still used wholly or in part, in modern healthcare and services. The development and safety of
p.(None): health-related services and practices evolved from experiments on self, other animals, and people in the community,
p.(None): although the ethics were far from acceptable in most cases.
p.(None): On the other hand, the moral principles of ancient philosophers and practitioners are still used in modern day
p.(None): medicine, as well as in the field of ethics. One such example is the use of the Hippocratic Oath taken by physicians
p.(None): and health practitioners, though recently, the Oath has been challenged by contemporary philosophers and ethicists.
p.(None): In Ethiopia, health research has been and is still being carried out by various sectors including government and
p.(None): private organizations, bilateral and multilateral agencies including United Nations (UN) agencies, and faith-based
p.(None): organizations. These orga- nizations have been conducting research of their interest independently or through
p.(None): collaborations with institutions such as medical and paramedical schools, research institutes, drug control agencies,
p.(None): and others.
p.(None): To disseminate these research findings, the grounds for formal peer-reviewed health research publication were laid
p.(None): by the Ethiopian Medical Journal in 1962. Other peer-reviewed scientific journals followed suit, namely, the
p.(None): Ethiopian Pharmaceuti- cal Journal, the Ethiopian Journal of Health Development, the Ethiopian Journal of Health
p.(None): Sciences, and Ethiopian Journal of Reproductive Health.
p.(None): Commitment of the government towards research and research ethics has been ex- pressed in various undertakings
p.(None): throughout the years. These undertakings include:
p.(None): • Endorsement of a constitution and legal codes that protect the well-being, wel- fare, and autonomy of its citizens,
p.(None): while also protecting the right to intellectual and academic freedom, as well as the pursuit of knowledge
p.(None): • Establishment of medical and public health colleges since 1952, the Central Research Laboratory in 1942 which later
p.(None): was upgraded to an institute, the Institute of Pathobiology in 1966, the Armauer Hansen Research Institute in 1969, the
p.(None): Demographic Training and Research Center in 1982, and recently, the National Science Academy.
p.(None): • Introduction of Ethics Review Committees (ERC) at the university level in the 1970s to protect the rights, safety,
p.(None): and welfare of research participants and to en- sure independent review of protocols before commencement of research
p.(None): activities.
...
p.(None): were formed to lay the foundation for standardized protection of human participants in research. National Health
p.(None): Research Ethics Review Guidelines were first developed in 1995 by the former ESTC. The guidelines were revised three
p.(None): times since its first release in 1995. At the institutional level, standard operative procedures (SOPs) for
p.(None): research ethics review came into practice by organizations that include, the Addis Ababa University Medical Faculty
p.(None): Institutional Review Board (AAUMFIRB), Armauer Hansen Research Institute (AHRI), Ethiopian Health and
p.(None): Nutrition Research Institute (EHNRI) now renamed Ethiopian Public Health Institute (EPHI), and the Ethiopian Public
p.(None): Health Association (EPHA).
p.(None): • Launching a Health Science and Technology Policy in which the country’s health research priority areas were
p.(None): explicitly listed as policy directives. The Health Sci- ence and Technology Policy in article 2.2.2.2 states the need
p.(None): “to enhance the monitoring and coordination of Health Science and Technology activities and the practical
p.(None): implementation of research outputs.” This Health Science and Technology Policy in article 4.3.5 further stresses
p.(None): the need to “Organize an ethical committee to review the ethical aspects and procedures of research undertakings as
p.(None): required” as one strategy. In addition, article 4.3.6 emphasizes the need to “encourage institutional peer reviews….”,
p.(None): • Founding the Drug Administration and Control Authority in 1999 which was re- cently renamed the Food, Medicine and
p.(None): Health Care Administration and Control Authority (FMHACA)
p.(None): • Declaration of the potential allocation of 1.5% of the gross national income or gross domestic product (GNI/GDP) to
p.(None): research in various disciplines.
p.(None): To regulate and provide oversight for health research in light of its increasing land- scape, complexity, and
p.(None): sophistication, MoST hired three consultants with expertise in the field of bioethics to review the existing
p.(None): guidelines. The experts reviewed local and international standards, guidelines, instruments, and procedures related to
p.(None): bioethics. Furthermore, opinions and suggestions were solicited from a dozen highly educated, ethically experienced,
p.(None): reputable professionals in the country. The shortcomings and strengths of the existing guidelines, extent of
p.(None): decentralization of protocol review, man- dates of the National Research Ethics Review Committee (NRERC) and
p.(None): Institutional Review Boards (IRB), terminology, operative procedures, and general suggestions from these dozen
p.(None): professionals, was sought using a semi-structured tool. All efforts were made to strike a balance in accommodating the
p.(None): experts’ sometimes differing opinions and suggestions for these guidelines.
p.(None): 14 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): Moreover, the draft guidelines were discussed with a wider group of experts and rep- resentatives drawn from the MoST,
...
p.(None): 6.15 Waiver of Informed Consent Documentation
p.(None): Waiver of informed consent or documentation of informed consent should be ap- proved by the IRB. The investigator must
p.(None): secure an explicit waiver of consent from the IRB. The IRB may waive some or all of the elements of an informed consent
p.(None): and/
p.(None):
p.(None): 38 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): or a signed or thumb printed consent form for some or all of the research participants of a particular study, if the
p.(None): IRB determines that:
p.(None): • The research project carries no more than minimal risk, If the research or demonstration project is
p.(None): to be conducted or approved by federal or regional government and is designed to study, evaluate, or otherwise
p.(None): explore public ben- efit or service programs; possible changes in or alternatives to those programs; possible changes
p.(None): in methods or levels of payment for benefits or services under those programs.
p.(None): • The research project could not practically be carried out without the waiver or alteration (whenever appropriate the
p.(None): research participants will be provided with additional pertinent information after participation); In emergency/acute
p.(None): condi- tions where a new drug (or new combination of drugs) or a new procedure(s) potentially holds a direct benefit
p.(None): but, the research participant cannot give or re- fuse informed consent because of the acute condition, the IRB may
p.(None): waive need for informed consent. However, it is the responsibility of the investigator and the sponsor to publicize
p.(None): such a study to the community before commencement of any research activity. The IRB should monitor such publicity to
p.(None): ascertain the community’s awareness.
p.(None): • In emergency conditions of national or regional importance, for example epi- demics, where a participant cannot
p.(None): refuse informed consent.
p.(None): • In situations where deception needs to be applied to achieve the objectives of the study.
p.(None): • The only record linking the research participant and the research project would be the consent document and the
p.(None): principal risk to the research participant would be potential harm resulting from a breach of confidentiality.
p.(None): 6.16 Continuing Review
p.(None): • The IRB conducts continuing review of all approved studies at intervals appro- priate to the degree of risk that the
p.(None): study participants are exposed, but not less than once a year.
p.(None): • The IRB will require continuing progress reports annually , unless it designates otherwise.
p.(None): • All changes in approved research projects should be reported and approved by the IRB before implementation, except
...
p.(None): submit progress reports on time,
p.(None): 8.3.1.2 Investigator’s File
p.(None): The investigator must prepare a file containing documents related to the trial. During the study, the investigator is
p.(None): responsible for updating the file and regularly adding trial-related documents. Identification codes of subjects shall
p.(None): be kept for 10 years.
p.(None): The Investigator’s File should contain, at the minimum:
p.(None): • Local regulatory requirements
p.(None): • IRB and other authorities’ written approval for all documents
p.(None): • IRB and other authorities’ written approval for protocol amendments
p.(None): • Correspondence with the IRB
p.(None): • Approved protocol and amendments
p.(None): • All signed and dated informed consent forms
p.(None): • Investigator’s and Co-investigators’ CVs
p.(None): • Copy of the insurance certificate/other insurance
p.(None): • Investigator’s SOPs
p.(None): • Notification and documentation of serious adverse events
p.(None): • Specimen management procedures, trial supplies/equipment
p.(None): • Participant identification list
p.(None): • Investigator interim and final report/summary of the trial
p.(None): 8.3.1.3 Participant File
p.(None): The participant file should, at the minimum, contain the following original information:
p.(None): • Subject identification: family name, given name, date of birth, sex, and identifi- cation number in the trial
p.(None): • Protocol identification number/study reference
p.(None): • Dates of first screening and/or enrolment in the trial
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 49
p.(None):
p.(None): • Name of drug or investigational product or procedure on test
p.(None): • Dates of product administration and dosage, and procedure(s)
p.(None): • Dates of assessment visit and name of individual responsible for making the assessment
p.(None): • Serious adverse event and related treatment or medication
p.(None): • Dates of laboratory specimen/sample collection.
p.(None): 8.3.1.4 Monitoring
p.(None): • Compliance to approved protocol must be followed during the course of the research.
p.(None): • Deviation from the protocol is acceptable only to manage/treat a serious adverse event that endangers the
p.(None): participant’s life or is presumed to result into serious or permanent disability. In such acceptable cases of protocol
p.(None): deviation, the IRB, clinical monitor and the sponsor must be notified immediately. The protocol deviation
p.(None): must be appended to the approved protocol. And, the investigator should subsequently make a request for
p.(None): protocol amendment while applying for renewal of the research.
p.(None): • The investigator should regularly submit a progress report; the progress report should include reports of the DSMB.
p.(None): 8.3.1.5 Medical Care for Trial Subjects
p.(None): • The highest available standard of care shall be provided to trial participants
p.(None): • In international collaborative research, the care should be equivalent to the care provided in the country where the
p.(None): sponsor or the collaborating institution is based.
p.(None): • Adequate/standard medical care should be offered to participants for adverse events.
p.(None): 8.3.1.6 In case the trial is terminated or suspended prematurely, for any reason:
p.(None):
p.(None): • The research participants must be informed with assurance of continuing care and treatment.
p.(None):
...
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 55
p.(None):
p.(None): 8.3.5.3 Children
p.(None): Children are persons who have not attained the legal age for consent to treatments or procedures involved in research.
p.(None): The following apply in research involving children.
p.(None): • The child should provide assent in addition to the informed consent by a parent or guardian as stated in Section
p.(None): 6.14 above.
p.(None): • The research presents a realistic opportunity to further the understanding, preven- tion, or alleviation of a
p.(None): serious problem affecting the health or welfare of children.
p.(None): • Emancipated minors – working or earn their living, married, parenting – may be allowed to give an informed consent
p.(None): or an IRB may decide a waiver of consent.
p.(None): • In research related to sensitive topics like drug use and abuse, sexuality, repro- duction, STIs, where obtaining
p.(None): consent from a parent, next-of-kin, or guardian is challenging and may be problematic to the minor because of the
p.(None): nature of the research, assent with waiver of consent may be applicable.
p.(None): • In institutional children, a legally approved guardian may give consent.
p.(None): 8.3.5.4 Prisoners
p.(None): Prisoners may be under constraints because of their incarceration which could affect their ability to make a truly
p.(None): voluntary and decision which is not coerced, whether or not to participate as subjects in research. Therefore,
p.(None): additional safeguards should be included in the study to protect the rights and welfare of these subjects, as follows:
p.(None): • If an IRB regularly reviews research that involves these vulnerable populations, consideration shall be given to the
p.(None): inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.
p.(None): • Where possible, a prisoner or an ex-prisoner co-opted in to the IRB reviewing the proposed research project should
p.(None): be included.
...
p.(None): procedures, laboratory quality control, notifi- able diseases, routine counseling and testing, etc), the institution
p.(None): that collected the samples takes custodianship of the samples. Any future research study on such samples is subject to
p.(None): review by an IRB.
p.(None): 9.3 Procedure for Exchange Transfer
p.(None): • When it is necessary to transfer samples for storage abroad, the host institution shall negotiate an appropriate
p.(None): contract with the recipient institution. This con- tract shall be in the form of a Materials Transfer Agreement (MTA).
p.(None): The specific details of the MTA should include, among other things, purpose for the transfer/ export, clear
p.(None): arrangements for collaboration and benefit sharing, a framework for accessing and sharing data, restrictions to third
p.(None): party transfer, and annual reports to the host institution on the status of the samples.
p.(None): • It is required that an Ethiopian scientist must be included as co-investigator in all future studies using the human
p.(None): biological materials collected from Ethiopia.
p.(None): • The IRB in Ethiopia shall review all research studies on stored human biological samples.
p.(None):
p.(None): 10. Regulatory Oversight of Research
p.(None): Regulatory oversight of research involving human participants is exercised at two levels. At the country level, the
p.(None): NRERC, which is established by MoST, is the prima- ry responsible organ for oversight. At the institutional level, the
p.(None): organization’s IRB, accredited by MoST, oversees all research being conducted under its jurisdiction. For research
p.(None): involving experimental/clinical trials, an additional approval to import and use the drug or investigational product
p.(None): should be solicited from FMHACA.
p.(None): The legal obligations in research shall be overseen by MoST and FMHACA. IRBs, and DSMBs and are primarily responsible
p.(None): for safeguarding research participant safety. The Institutional Biosafety Committee (IBC) and Community Advisory Board
p.(None): (CAB) shall ensure public/community wellbeing.
p.(None): 10.1 Ministry of Science and Technolgy (MoST)
p.(None): MoST is established by the ‘Definition of Powers and Duties of the Executive Organs of the FDRE (Amendment)
p.(None): Proclamation No. 603/2008’ on October 24, 2008. Un- der the Proclamation, MoST took over the rights and obligations of
p.(None): the ESTA and, under Article 20, is bestowed with the powers and duties to:
p.(None):
p.(None): 58 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): • Forward recommendations based on studies for adopting and revising policies, strategies, laws and directives on the
p.(None): development of science, technology and innovation activities.
p.(None): • Prepare science, technology and innovation master plans; provide guidelines for…, programs and projects;
p.(None): monitor and evaluate their implementation.
p.(None): • Set priorities for the country’s research activities.
p.(None): • Direct, coordinate and support science, technology and innovative activities, and countrywide research programs
p.(None): • Support and strengthen institutions that undertake research and development activities.
p.(None): 10.2 The Ethiopian Food Medicine and Health Care Administration and Control Authority
p.(None): The Ethiopian Food Medicine and Health Care Administration and Control Authority was established by ‘Council of
p.(None): Ministers Regulation No. 189/2010’ on August 23, 2010. Under the Proclamation FMHACA took over the rights and
p.(None): obligations of the Drug Administration and Control Authority (DACA) and, under Article 5, its ‘…ob- jectives shall be
p.(None): to protect the health of consumers by ensuring: 1) food safety and quality 2) the safety, efficacy, quality, and
p.(None): proper use of medicines 3) competence and ethics of health professionals, medical practitioners and pharmacy
p.(None): professionals.
p.(None): The ‘…authority is responsible to protect the safety and rights of the subjects partici- pating in a trial and to
p.(None): ensure that trials are adequately designed to meet scientifically sound objectives.’ ‘The mandate of the Authority is
p.(None): to review protocols, and where necessary to protect the safety of subjects, to require protocol revisions and/or termi-
p.(None): nation of trials. The Authority also has a right for on-site inspection of the quality of the data obtained…’
p.(None): ‘Any clinical trial conducted in the country on human beings and/or on animals other than laboratory animals should
p.(None): have received prior permission before the commence- ment of the trial.’ Furthermore, the Authority demands that
p.(None): findings from a clinical trial need its approval before publishing. Besides, the responsibilities of the investi-
p.(None): gator, the sponsor, and the monitor should be stated clearly in the research protocol.
p.(None): The authority also requires that a specific application form for clinical trials shall be completed and submitted for
p.(None): review and approval of a research.
p.(None): 10.3 Institutional Review Boards (IRB)
p.(None): IRBs are established by institutions whose mandate includes carrying out research. The primary function of IRBs is
p.(None): initial and continuing review, monitoring research to ensure adherence to the approved protocol in order to safeguard
p.(None): the rights and welfare of research participants, train faculty on research ethics, accredit, register,
p.(None): and monitor other IRBs, and develop guidelines applicable to all research in Ethiopia.
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 59
p.(None):
p.(None): 10.4 Data and Safety Monitoring Board
p.(None): 10.4.1 Definition
p.(None): A Data and Safety Monitoring Board (DSMB) is an independent committee composed of a multidisciplinary group of experts
p.(None): established by the research sponsors to assess and report the ongoing scientific and ethical integrity of a study by
p.(None): reviewing and evaluating (unblinded as necessary) data at regular intervals.
p.(None): • The DSMB should ensure that the study is conducted and the data are handled in accordance with the provisions of the
p.(None): research protocol and monitors adverse events and safety data.
p.(None): • A DSMB should be established before the commencement of a clinical trial and its composition submitted to the IRB.
p.(None): • All Phase I, Phase II, and Phase III, including drug efficacy and clinical trials proposed to be conducted in
p.(None): Ethiopia should have a safety monitoring plan, and a DSMB as recommended by an IRB.
p.(None): • DSMBs should be established in studies where interim data analysis is required to ensure the safety of research
p.(None): participants. Other interventional studies, such as community trials, may be required to set up DSMBs on a case by case
p.(None): basis.
p.(None): • Sponsors should consider the need for establishing a DSMB prior to undertaking a particular study. An ethics
p.(None): committee may also suggest to the sponsor that a DSMB be established for a particular study.
p.(None): • Recommendations of a DSMB are communicated directly to the sponsor, but the sponsor should notify other relevant
p.(None): parties and ensure that the recommen- dations are communicated to, and acted upon by, the various parties involved in
p.(None): the research.
p.(None): 10.4.2 Composition
p.(None): A Data Safety and Monitoring Board is composed of people external to the research team. The members of the Board:
p.(None): • Should be independent of the sponsor and the manufacturer of the investigational drug or product.
p.(None): • Have no conflict of interest in the research they are monitoring.
p.(None): • Receive no scientific recognition in the form of publications or promotions from the results.
p.(None): • Have relevant expertise (clinician with relevant specialization, clinical pharma- cology and/or toxicology,
p.(None): epidemiology, statistics, ethics and additional types of expertise depending on the type of the research,
p.(None): e.g., anthropologists or community members for research which involve assessing cultural sensitivities).
p.(None): • Have fair representation from participating countries in multi-center studies.
p.(None): 60 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): • Consist of at least three members and the size and necessary expertise of the DSMB will depend upon the research
p.(None): design.
p.(None): 10.4.3 Constituting a DSMB
p.(None): When required by the nature of a study, a sponsor should ensure the establishment of DSMB to ensure the broadest
p.(None): possible coverage of potential research participants, and the validity and scientific integrity of the data. In order
p.(None): to generate competent reviews and sound recommendations, the DSMB should be multidisciplinary and include as
p.(None): appropriate, expertise in medicine (physicians with relevant backgrounds), clinical pharmacology and/or toxicology,
p.(None): epidemiology, statistics, clinical trial process, and ethics. The suitability of members of a board should be
p.(None): determined according to the nature of the study to be monitored.
...
p.(None): adherence to an approved protocol and review to identify unapproved activities. Continuing review is the most
p.(None): common, conventional, and fundamental aspect of monitoring of an IRB.
p.(None): The primary function of monitoring is ensuring participant safety through assuring compliance with
p.(None): regulations and adherence to approved research protocols. In clinical trials, data monitoring is conducted to ensure
p.(None): data quality and safety. The DSMB is designated by the sponsor upon the recommendation of the IRB primarily to periodi-
p.(None): cally monitor data quality and participant safety. Moreover, interim analysis of risks and benefits should be a
p.(None): component of monitoring to ensure safety, whenever applicable.
p.(None): In multi-center research, monitoring at each of the research centers should primarily be carried out by the local IRBs.
p.(None): However, the NRERC is also responsible for oversight at selected, representative research centers, as deemed necessary.
p.(None): In international collaborative research, periodic progress report must be submitted, and all adverse events must be
p.(None): notified to the NEC.
p.(None): The investigator bears the major responsibility of regular monitoring and reporting of adverse events to the
p.(None): IRB. The sponsor is also obligated to report, or otherwise, ascertain the adverse events are reported to the IRB.
p.(None): Based on monitoring and reporting that includes Adverse Events (AEs) as applicable, the IRB may allow continuation,
p.(None): suspension, or termination of the research or recom- mend an amendment (a change) in the research procedure. Besides,
p.(None): if the research involves a drug or investigational product, the investigator must notify FMHACA.
p.(None): 11.1 Adverse Events: Definition, Grading, Follow-up, Reporting
p.(None): 11.1.1 Definition Grading of an Adverse Event
p.(None): Adverse events are considered to be serious when they are fatal, life threatening, cause serious or
p.(None): permanent disability, cause or protract hospitalization, cause con- genital anomaly, or lead to death.
p.(None): An AE is considered to be related with the research procedure, drug and/or an investi-
p.(None): 64 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): gational product based on temporal association with and response pattern to the proce- dure, drug or product, and the
p.(None): relationship, or otherwise, to the research participant’s clinical state, other interventions unrelated to the research
p.(None): or concomitant therapy.
p.(None): An AE shall be considered unexpected if the event has not been observed or docu- mented in a similar research involving
p.(None): humans; the characteristics or severity of the event is inconsistent with information in the investigators brochure; or
p.(None): the event is observed with higher frequency or severity than previously documented.
p.(None): An adverse event is graded as:
p.(None): Mild: if the event does not interfere with day-to-day activities and does not require treatment.
p.(None): Moderate: if the event marginally affect the day-to-day activities but can be tolerat- ed by the participant or require
p.(None): out-patient treatment.
p.(None): Severe: if the event significantly interferes with daily activities and demands hospi- talization or procedures for
p.(None): relief.
p.(None): 11.1.2 Follow-Up on an Adverse Event
p.(None): Once an AE has occurred, the investigator shall:
p.(None): • Monitor the AE closely
p.(None): • Provide a standard care to manage the AE and follow the AE until complete resolution of the AE.
p.(None): • Thoroughly investigate the likelihood and extent of relationship of the AE with the research procedure, drug and/or
p.(None): investigational product.
p.(None): • The details of the AE, from occurrence to complete resolution, must be recorded and attached to the participant’s
p.(None): file.
p.(None): 11.1.3 AE Reporting
p.(None): • A serious adverse event and the measures taken to manage the AE must be reported by the investigator, in writing, to
p.(None): the IRB Secretariat and to the clinical monitor, if one is assigned by the sponsor, within 48 hours of occurrence of
p.(None): the event, even if the AE is considered not to be related to the research procedures. Mild adverse events should be
p.(None): reported within five working days of occurrence.
p.(None): • The IRB examines the AE report and the appropriateness, or otherwise, of the measures taken, and whether the
p.(None): measures are in accordance with the ap- proved protocol. Measures beyond the approved protocol shall be documented in
p.(None): the participant’s file and reported to the IRB. The IRB ultimately decides the need for additional action.
p.(None): • The medium for reporting should be according to the communication means/ channel described in the approved protocol.
p.(None): • Anonymity of the research participant shall be respected when all information are sent/reported.
p.(None): National Research Ethics Review Guideline Fifth Edition 65
p.(None):
p.(None): 11.2 Compliance Monitoring
p.(None): Progress reports - PIs should submit progress reports at regular intervals stipulated by the IRB as a condition for
p.(None): renewal of ongoing research. Periodic progress reports enable the IRB to determine whether the research is progressing
p.(None): according to the approved protocol. In clinical trials, the progress report should include reports of the DSMB.
...
p.(None): 14.1.1. Information flow should be multidirectional.
p.(None): 14.1.2. All IRBs shall submit reports to NRERC annually.
p.(None): 14.1.3. IRBs in federal institutions shall send their biannual reports directly to the NRERC.
p.(None): 14.1.4. Reports of the respective IRBs shall include at a minimum: activities performed, support needed, problems
p.(None): encountered, etc.
p.(None): 14.1.5. For urgent matters, IRBs should seek information or technical help from NRERC at any time through its
p.(None): Secretariat.
p.(None): 14.1.6. The NRERC will distribute appropriate guidelines and other related in- formation to other IRBs and request
p.(None): feedback.
p.(None): 14.1.7. The NRERC establishes working relations with local and international IRBs through its Secretariat.
p.(None): 14.1.8. Reporting at each level should be by mail, fax or email.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 73
p.(None):
p.(None): Bibliography
p.(None): 1. The Constitution of The Federal Democratic Republic of Ethiopia. Addis Aba- ba, August 21 1995.
p.(None): 2. Federal Negarit Gazetta of The Federal Democratic Republic of Ethiopia. 15th Year No 1 Addis Ababa, October 24
p.(None): 2008.
p.(None): 3. Federal Negarit Gazetta of The Federal Democratic Republic of Ethiopia. 16th Year No 51 Addis Ababa, August 23
p.(None): 2010.
p.(None): 4. Ethiopian Science and Technology Commission. National Health Research Ethics Review Guidelines, Fourth Edition.
p.(None): Addis Ababa, Ethiopia 2005.
p.(None): 5. Guidelines for Conducting Clinical Trials. Drug Administration and Control Authority. Addis Ababa, Ethiopia.
p.(None): 6. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Council for International
p.(None): Organizations of Medical Sciences (CI- OMS) in collaboration with the World Health Organization (WHO). CIOMS Geneva
p.(None): 2002.
p.(None): 7. Code of Federal Regulations. TITLE 45 — PUBLIC WELFARE. Depart- ment of Health and Human Services. PART
p.(None): 46: PROTECTION OF HUMAN SUBJECTS. Revised June 23, 2005. Effective June 23, 2005.
p.(None): 8. The Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research. The
p.(None): National Commission for the Protec- tion of Human Subjects of Biomedical and Behavioral Research. April 18, 1979.
p.(None): 9. Nuremberg Code. 1948.
p.(None): 10. World Medical Association Declaration of Helsinki. Ethical Principles for Medical Research Involving Human
p.(None): Subjects. Adopted by the 18th WMA General Assembly. Helsinki, Finland, June 1964, and amendments in 1975, 1983,
p.(None): 1989, 1996, 2000. Note of Clarification on Paragraph 29 added in 2002. Note of Clarification on Paragraph 30 added in
p.(None): 2008.
p.(None): 11. Karbwang J, Pattou C. Standard operating procedures for clinical investi- gators. UNDP/World Bank/WHO, special
p.(None): program for research and training in tropical diseases (TDR). TDR/TDP/SOP/99.1.
...
p.(None): control. Clin Trials 2006; 3; 142.
p.(None): 21. Cowan DH. Scientific Design, Ethics, and Monitoring: IRB Review of Ran- domized Clinical Trials. IRB: Ethics and
p.(None): Human Research, 1980;2: 1-4.
p.(None): 22. Karlawish, Hall (1996). Am J Respir Crit Care Med, 1996;153:499-5-6.
p.(None): 23. Casarett, Karlawish, Sugarman. JAMA, 2000, 283 (17): 2275-80.
p.(None): 24. Richards HM, Schwartz LJ. Ethics of qualitative research: are there special issues for health services research?
p.(None): Family Practice 2002; 19: 135-139.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 75
p.(None):
p.(None): Appendix I. Acronyms
p.(None): AAUMFIRB Addis Ababa University Medical Faculty Institutional
p.(None): Review Board
p.(None): AE Adverse Event
p.(None): AHRI Armauer Hansen Research Institute
p.(None): CAB Community Advisory Board
p.(None): CIOMS Council for International Organization of Medical Sci- ences
p.(None): COI Conflict Of Interest
p.(None): CV Curriculum Vitae
p.(None): DACA Drug Administration and Control Authority
p.(None): DNA Deoxyribo Nucleic Acid
p.(None): DSMB Data and Safety Monitoring Board
p.(None): EC Ethics Committee
p.(None): EHNRI Ethiopian Health and Nutrition Research Institute
p.(None): EPHA Ethiopian Public Health Association
p.(None): ERC Ethics Review Committee
p.(None): ESTA Ethiopian Science and Technology Agency
p.(None): ESTC Ethiopian Science and Technology Commission
p.(None): FDRE Federal Democratic Republic of Ethiopia
p.(None): FMHCACA Food, Medicine and Health Care Administration and
p.(None): Control Authority
p.(None): GDP Gross Domestic Product
p.(None): GCP Good Clinical Practice
p.(None): GMP Good Manufacturing Practice
p.(None): GNI Gross National Income
p.(None): RE Research Ethics
p.(None): NRERCs National Research Ethics Review Committees
p.(None): HS&T Health Science and Technology
p.(None): IBC Institutional Bio-safety Committee
p.(None): IRB Institutional Review Board
p.(None): LAR Legally Authorized Representative
...
Searching for indicator influence:
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p.(None): are drawn from. Such generalization can result in different positive or negative impacts to the community in terms of
p.(None): stigma, resource drainage, health outcomes, and more. Hence, researchers are encouraged to involve the community in
p.(None): decision making about the design and conduct of the study. Be- sides, investigators should consider the local customs,
p.(None): traditions, culture and reli- gious practices of the community where the research is proposed to be conducted.
p.(None):
p.(None): 16 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): 1.3 Preamble
p.(None): MoST attaches the highest priority to maintaining high standards of integrity, respon- sibility, and accountability in
p.(None): all research conducted in Ethiopia.
p.(None): In addition, MoST obligates that ‘Research with human subjects should be carried out only by or strictly supervised by,
p.(None): suitably qualified and experienced investiga- tors and in accordance with a protocol that clearly states the aim of the
p.(None): research, the reasons for proposing that it involves human subjects, the nature and degree of any known risks to the
p.(None): subjects, the sources from which it is proposed to recruit subjects, and the means proposed for ensuring that subjects’
p.(None): consent will be ade- quately informed and voluntary. The protocol should be scientifically and ethically appraised by
p.(None): one or more suitably constituted review bodies, independent of the investigators.’
p.(None): MoST ensures that this guidelines basically operate within the legal framework of Ethiopia and that the IRBs operate
p.(None): independently and without influence and coer- cion. Furthermore, MoST demands that membership of IRBs should be large
p.(None): enough to ensure a robust discussion of protocols. Additionally, IRB membership should have a healthy mix of
p.(None): representation by different genders, disciplines, sectors, and layper- sons.
p.(None): While this document focuses primarily on guidelines for IRBs, it emphasizes that at- tention shall be given to the
p.(None): wider system of human research participants’ protections of which IRBs are a part. These guidelines empower IRBs to
p.(None): perform effectively and efficiently with best intentions. The review guidelines are developed to operate in the
p.(None): existing research systems with the following objective realities:
p.(None): • Constitutional and legal rights, relevant policies related to health and science research exist.
p.(None): • These guidelines are executed under the Law of Ethiopia. IRBs operate under explicit legal authority.
p.(None): • All research with human participants is subject to the oversight of an IRB.
p.(None): • MoST has the primary responsibility for ensuring that IRBs are subject to ade- quate oversight.
p.(None): • Mechanisms are in place to ensure IRBs work effectively and efficiently. IRBs are part of a larger research
p.(None): participant protection programs that also include training of IRB members and investigators.
p.(None): • Procedures exist to ensure clear and efficient communication, harmonization of standards, networking, and
p.(None): cooperation among the NRERC and other IRBs, and between different levels of review and publication committees in
p.(None): departments/ units of institutions. In addition, procedures exist for the coordinated review of multi-site research
p.(None): within Ethiopia or international collaborative research.
p.(None): • Mechanisms exist to ensure that IRB activities are coordinated with national regulatory authorities’ oversight of
p.(None): drugs and medical devices.
p.(None): National Research Ethics Review Guideline Fifth Edition 17
p.(None):
p.(None): • Mechanisms are created for obtaining community input into the ethics review system.
p.(None): • A system exists for registration of IRBs that operate in Ethiopia.
p.(None): MoST attaches emphasis that this guideline is part of an effort to establish, facilitate and strengthen an effective
p.(None): health research system in Ethiopia. The aim of the health research system is to advance and use of scientific knowledge
p.(None): to improve health and health equity. The key functions of this health system research are stewardship, of which
p.(None): research ethics is a part, finance of the systems, creation of and sustaining resources, and production and use of
p.(None): knowledge. Hence,
p.(None): Understanding and considering
p.(None): • The shortcomings of the existing guidelines in the face of the widening land- scape of research areas, complexity of
p.(None): research procedures, and evolvement of genetic studies with the consequent biobanks,
p.(None): • The critical importance of establishing a strong health research system,
p.(None): • The relevance and responsibility of ensuring standardized research ethics review all over Ethiopia,
p.(None): • The need to ensure independence of IRB operations and decision-making from influence by anyone who sponsors,
p.(None): conducts, or hosts the research it reviews,
p.(None): • The need for ensuring networking and collaboration of IRBs, both local and international,
p.(None): • The increasing number of health teaching institutions and with them the num- ber and quality of research,
p.(None): • Evidence-based practice is the order of the day, and
p.(None): Cognizant of
p.(None): • The rapidly advancing and complex research related to genetic, biomedical sci- ence, and transfer of human
p.(None): biological materials,
p.(None): • The increasing number and scope of collaborative studies by numerous investi- gators and institutions within and
p.(None): outside of Ethiopia, and with the existing pol- icy, academic and administrative environment, the increasing interest
p.(None): of donors to sponsor research in Ethiopia,
p.(None): • Research participants’ protection, that should involve not only research protocol review, but also ethically sound
p.(None): research participant-investigator interactions, continuous safety monitoring, adherence to approved protocol, and
p.(None): quality im- provement in research,
p.(None): • The duty to ensure mechanisms to make IRB operations transparent, account- able, consistent, and of high quality;
p.(None): establishing mechanisms for IRBs to em- ploy reliable means to evaluate whether the staff and members routinely follow
p.(None): 18 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): the IRB policies, rules and guidelines; the need for both internal and external evaluation; the demand to address
p.(None): complaints and grievances from all parties involved in research (researchers, research participants, communities, spon-
p.(None): sors, and others),
...
p.(None): ipants. Any amendment shall be appended to the approved research protocol.
p.(None): 13.1.10. Shall inform the IRB, clinical monitor, the sponsor and the participants if the study is terminated or
p.(None): suspended at any time during the research process.
p.(None): 13.1.11. Shall be responsible for periodic assessment of the quality of data man- agement as well as reporting on
p.(None): interim analysis whenever appropriate.
p.(None): 13.1.12. In case of clinical/experimental trials, shall ensure, at least, one of the investigators have a
p.(None): certificate on good clinical practice and/or good manufacturing practice or both or whichever is appropriate.
p.(None): 13.1.13. Shall ensure beneficial investigational products are available to the community after the research is
p.(None): completed.
p.(None): 13.1.14. Shall report to the DSMB, as applicable.
p.(None): 13.1.15. In collaborative research, shall consider the cultures and ethnic diver- sities and should make the research
p.(None): objectives particularly clear and remain aware of the concerns and welfare of the individuals or commu- nities to be
p.(None): studied.
p.(None): 13.1.16. Shall provide adequate information in all publications to the reader, and to colleagues to permit the methods
p.(None): and findings to be properly assessed. Limits of reliability and applicability should be made clear.
p.(None): 13.1.17. Shall submit final report and findings to the IRB.
p.(None): 13.1.18. Shall ensure the community where the research is conducted is in- formed about the research findings.
p.(None): 13.2 Host Institution
p.(None): The institution’s culture in which research is conducted strongly influence whether ethical conduct of research is
p.(None): supported or valued. The host institution must work closely with the investigator. The host institution shall monitor
p.(None): the investigator(s)’ research activities at the institution. More specifically, the host institution shall:
p.(None): 13.2.1. Ensure that the study design is scientific and ethical.
p.(None): 13.2.2. Ensure ethical implementation of the research.
p.(None): 70 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): 13.2.3. Comply with legal requirements and ethics regulations as stipulated in this guideline.
p.(None): 13.2.4. Ensure that the investigators conducting the study are scientifically qual- ified and com petent to carry out
p.(None): the research at the institution.
p.(None): 13.2.5. Facilitate and provide support for smooth and ethical implementation of the research.
p.(None): 13.2.6. Make sure that the results of the study are properly and publicly disseminated.
p.(None): 13.2.7. Ensure that guidelines, ethical principles, and related materials reach the end users and the investigators.
p.(None): 13.2.8. Provide periodical reports of ethical implementation of the study to the IRB’s Secretariat.
p.(None): 13.2.9. Take disciplinary action on the investigators for breach of any of this guidelines, regulatory and legal
p.(None): requirements.
p.(None): 13.3 Sponsors
p.(None): Sponsors/Donors are responsible for providing an environment that promotes integri- ty, objectivity and the highest
p.(None): ethical standards of research, including standards for design, implementation and reporting. Particularly,
p.(None): sponsors must commit to pro- tect participants in all research. Besides, sponsors are expected to ensure research
...
p.(None): substantial portions of governing regulations. Seri- ous noncompliance must be reported promptly.
p.(None): Severe/severity-The graded level of intensity of an AE and its interference with usual social and functional
p.(None): activities, often standardized in toxicity tables. Grade levels generally include normal, mild, moderate, severe,
p.(None): life-threatening, and fatal.
p.(None): Sponsor- a person or other entity that initiates a clinical investigation, but that does not actually conduct the
p.(None): investigation.
p.(None): Suspend/suspension-Temporary cessation of research-related intervention or interac- tion with participants and
p.(None): obtaining or using identifiable private research information. Partial suspension halts some but not all such
p.(None): activities, for example when enrollment is stopped but follow-up continues with enrolled participants. A suspension
p.(None): must be
p.(None): National Research Ethics Review Guideline Fifth Edition 83
p.(None):
p.(None): reported promptly unless the suspension results from expiration of IRB approval.
p.(None): Terminate/termination-Permanent cessation of research-related intervention or interac- tion with participants and
p.(None): obtaining and use of identifiable private research information. A termination must be reported promptly unless the
p.(None): termination results from expiration of IRB approval or withdrawal or closure for reasons other than research risks.
p.(None): Understandable language-generally 8th grade reading level or lower/higher depending on targeted population.
p.(None): Undue influence-An excessive, unwarranted, inappropriate, or improper reward in- tended to motivate study
p.(None): participation.
p.(None): Unexpected-Pertaining to an AE, the event is previously unobserved or undocument- ed in humans under the research
p.(None): intervention (or one substantially similar), the na- ture or severity of the event is not consistent with information
p.(None): in the relevant source documents (e.g., investigator’s brochure, package insert, or non-reportable events [NRE] list),
p.(None): or the event is observed with higher frequency than previously observed or documented. Expectedness does not entail the
p.(None): ability to predict results from in vitro, animal, or other pharmacological models.
p.(None): Unlinked-The condition of data or specimens which had been coded but for which the key linking the code to direct
p.(None): personal identifiers has been destroyed.
p.(None): Unrelated-Pertaining to an AE, the condition in which the event is due to a docu- mented cause other than research
p.(None): procedures.
p.(None): Verbal consent-Consent obtained by communication in words; this may include spo- ken or written format.
p.(None): Voluntary/voluntariness-Freedom from coercion and undue influence
p.(None): Vulnerable-Having reduced capacity to offer free and informed consent due to pos- sible coercion, undue influence,
p.(None): or other diminished autonomy, such as children, prisoners, pregnant women, mentally disabled persons, or
p.(None): economically or education- ally disadvantaged persons as vulnerable. Vulnerability may be associated with other
p.(None): characteristics such as age, health status, or social standing. The IRB must ensure additional safeguards protect the
p.(None): rights and welfare of vulnerable persons.
p.(None): Vulnerable population-A group identified by one or more common characteristics associated with reduced
p.(None): capacity to offer free and informed consent.
p.(None): Waive/waiver-Temporarily set aside the requirement of a particular rule, regulation, or condition in a protocol or
p.(None): consent document.
p.(None): Withdraw/withdrawal-Permanently halt a research study after submission for IRB review but before human
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p.(None): the health and well-being of the research participants should be permissible.
p.(None): • The IRB shall determine that the informed consent process is properly applied with adequate assurance that a
p.(None): prisoner’s participation or refusal to participate will not be considered in decisions regarding his or her release or
p.(None): further deten- tion and each prisoner is clearly informed in advance that his or her participa- tion in the research
p.(None): project will have no affect on his or her release.
p.(None): 8.3.5.5 Mental and Physical Disability
p.(None): Persons with disability need special attention because they are prone to being social- ly marginalized. Therefore,
p.(None): their dignity, rights and well-being in research must be respected. Careful consideration should be made where proxy
p.(None): consent is to be used, and where the use of signed consent forms is not feasible, alternative viable methods should be
p.(None): employed.
p.(None): 56 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): Persons with disabilities (mental or physical) should not be unfairly excluded from participating in research.
p.(None): Researchers should make an effort to address communi- cation, disability and comprehension constraints are often the
p.(None): excuse for exclusion.
p.(None): People with mental disabilities or substance abuse related disorders include those people with psychiatric, cognitive,
p.(None): or developmental disorders. These groups of peo- ple are usually institutionalized and institutionalization may further
p.(None): compromise their ability to make voluntary decisions to participate in a research project. Therefore,
p.(None): research on people with cognitive disabilities or with substance abuse related disor- ders should:
p.(None): • Provide sufficient justification for involving such people;
p.(None): • Have appropriate evaluation procedures for ascertaining research participants’ ability to give informed consent. If
p.(None): research participants are deemed unable to understand and to make an informed decision, then an appropriate proxy
p.(None): should be identified.
p.(None): • Have an informed consent process that is free from coercion.
p.(None): • Be of no more than minimal risk, or if minimal risk is involved, the risk is outweighed by the anticipated benefits
p.(None): of the research project to the research participant.
p.(None):
p.(None): 9. Human Biological Materials
p.(None): 9.1 Definition
p.(None): Human biological materials include any substance obtained from a human research participant including, but not limited
p.(None): to, blood, urine, stool, saliva, hair, nail clip- pings, skin, and microorganisms, and other associated bio-products
p.(None): obtained from human research participants.
p.(None): 9.2 Acquisition, Storage, Secondary Use
p.(None): The acquisition, storage, and future use of human biological samples from research participants in Ethiopia shall be
p.(None): guided by the following procedures:
p.(None): • There should be a separate informed consent process for obtaining human bio- logical samples for storage and for
p.(None): future use. This process includes the use of a consent form separate from that used for enrollment of research
p.(None): participants into the study.
p.(None): • Research participants should know the purpose of sample storage, quantities of samples to be stored, place where
p.(None): samples will be stored, duration of storage, measures to protect confidentiality, policies that will govern use of the
p.(None): samples in future research, potential risks and benefits of storing samples for future re- search and any other
p.(None): information deemed necessary by the Investigators, IRBs.
p.(None): • After explaining the need to store the samples, the research participant should be offered to choose whether their
p.(None): samples should or should not be stored for future studies.
p.(None): National Research Ethics Review Guideline Fifth Edition 57
p.(None):
p.(None): • The host institution in Ethiopia should hold the samples in trust on behalf of the research participant.
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p.(None): decision. Therefore, the functions of the IRB are:
p.(None): 6.12.1 Initial review
p.(None): The IRB must determine that the following requirements are satisfied before it ap- proves a research protocol:
p.(None): • Risks to subjects are minimized. Risk to subjects are reasonable in relation to anticipated benefit (if any) and the
p.(None): knowledge that is expected to result
p.(None): • Selection of subjects is equitable
p.(None): • Determine that informed consent will be sought from each prospective study participant, or the participants’ parent
p.(None): or guardian as appropriate
p.(None): • Determine that informed consent will be appropriately documented
p.(None): • Determine that there are adequate provisions to protect privacy of study partic- ipants and maintain confidentiality
p.(None): of all study related data
p.(None): • Determine that there are additional safeguards included in the study to protect the safety and welfare of study
p.(None): subjects who are likely to be vulnerable to coer- cion or undue influence such as such as children, prisoners, mentally
p.(None): disabled
p.(None): people, etc.
p.(None): 6.13 Informed Consent
p.(None): 6.13.1. The IRB must determine that the consent is documented using a written or verbal informed consent form,
p.(None): • The consent form should be approved by the IRB.
p.(None): • The consent form must be signed by the participant, or a parent, or next-of-kin or a guardian and by the individual
p.(None): that conducted the in- formed consent process.
p.(None): • In case the participant cannot read or write, a witness should sign that the consent process was carried out
p.(None): appropriately.
p.(None): National Research Ethics Review Guideline Fifth Edition 37
p.(None):
p.(None): • A copy of the signed informed consent form should be given to the study participant.
p.(None): 6.13.2. Research participants or persons giving proxy consent cannot give full informed consent unless the consent
p.(None): process/form contains adequate information. All such information shall be expressed in a language that is
...
p.(None): ability to predict results from in vitro, animal, or other pharmacological models.
p.(None): Unlinked-The condition of data or specimens which had been coded but for which the key linking the code to direct
p.(None): personal identifiers has been destroyed.
p.(None): Unrelated-Pertaining to an AE, the condition in which the event is due to a docu- mented cause other than research
p.(None): procedures.
p.(None): Verbal consent-Consent obtained by communication in words; this may include spo- ken or written format.
p.(None): Voluntary/voluntariness-Freedom from coercion and undue influence
p.(None): Vulnerable-Having reduced capacity to offer free and informed consent due to pos- sible coercion, undue influence,
p.(None): or other diminished autonomy, such as children, prisoners, pregnant women, mentally disabled persons, or
p.(None): economically or education- ally disadvantaged persons as vulnerable. Vulnerability may be associated with other
p.(None): characteristics such as age, health status, or social standing. The IRB must ensure additional safeguards protect the
p.(None): rights and welfare of vulnerable persons.
p.(None): Vulnerable population-A group identified by one or more common characteristics associated with reduced
p.(None): capacity to offer free and informed consent.
p.(None): Waive/waiver-Temporarily set aside the requirement of a particular rule, regulation, or condition in a protocol or
p.(None): consent document.
p.(None): Withdraw/withdrawal-Permanently halt a research study after submission for IRB review but before human
p.(None): participants become involved, whether or not the study has been reviewed by an IRB. This term has been replaced by the
p.(None): term close/closure.
p.(None):
p.(None):
p.(None):
p.(None): 84 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): Appendix III: NRERC Terms of Reference
p.(None): 1. Membership
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 2. Tenure
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p.(None): also need to ensure that there is regular evaluation of the ethics of ongoing studies that received a positive
p.(None): decision. Therefore, the functions of the IRB are:
p.(None): 6.12.1 Initial review
p.(None): The IRB must determine that the following requirements are satisfied before it ap- proves a research protocol:
p.(None): • Risks to subjects are minimized. Risk to subjects are reasonable in relation to anticipated benefit (if any) and the
p.(None): knowledge that is expected to result
p.(None): • Selection of subjects is equitable
p.(None): • Determine that informed consent will be sought from each prospective study participant, or the participants’ parent
p.(None): or guardian as appropriate
p.(None): • Determine that informed consent will be appropriately documented
p.(None): • Determine that there are adequate provisions to protect privacy of study partic- ipants and maintain confidentiality
p.(None): of all study related data
p.(None): • Determine that there are additional safeguards included in the study to protect the safety and welfare of study
p.(None): subjects who are likely to be vulnerable to coer- cion or undue influence such as such as children, prisoners, mentally
p.(None): disabled
p.(None): people, etc.
p.(None): 6.13 Informed Consent
p.(None): 6.13.1. The IRB must determine that the consent is documented using a written or verbal informed consent form,
p.(None): • The consent form should be approved by the IRB.
p.(None): • The consent form must be signed by the participant, or a parent, or next-of-kin or a guardian and by the individual
p.(None): that conducted the in- formed consent process.
p.(None): • In case the participant cannot read or write, a witness should sign that the consent process was carried out
p.(None): appropriately.
p.(None): National Research Ethics Review Guideline Fifth Edition 37
p.(None):
p.(None): • A copy of the signed informed consent form should be given to the study participant.
p.(None): 6.13.2. Research participants or persons giving proxy consent cannot give full informed consent unless the consent
p.(None): process/form contains adequate information. All such information shall be expressed in a language that is
...
p.(None): or the event is observed with higher frequency than previously observed or documented. Expectedness does not entail the
p.(None): ability to predict results from in vitro, animal, or other pharmacological models.
p.(None): Unlinked-The condition of data or specimens which had been coded but for which the key linking the code to direct
p.(None): personal identifiers has been destroyed.
p.(None): Unrelated-Pertaining to an AE, the condition in which the event is due to a docu- mented cause other than research
p.(None): procedures.
p.(None): Verbal consent-Consent obtained by communication in words; this may include spo- ken or written format.
p.(None): Voluntary/voluntariness-Freedom from coercion and undue influence
p.(None): Vulnerable-Having reduced capacity to offer free and informed consent due to pos- sible coercion, undue influence,
p.(None): or other diminished autonomy, such as children, prisoners, pregnant women, mentally disabled persons, or
p.(None): economically or education- ally disadvantaged persons as vulnerable. Vulnerability may be associated with other
p.(None): characteristics such as age, health status, or social standing. The IRB must ensure additional safeguards protect the
p.(None): rights and welfare of vulnerable persons.
p.(None): Vulnerable population-A group identified by one or more common characteristics associated with reduced
p.(None): capacity to offer free and informed consent.
p.(None): Waive/waiver-Temporarily set aside the requirement of a particular rule, regulation, or condition in a protocol or
p.(None): consent document.
p.(None): Withdraw/withdrawal-Permanently halt a research study after submission for IRB review but before human
p.(None): participants become involved, whether or not the study has been reviewed by an IRB. This term has been replaced by the
p.(None): term close/closure.
p.(None):
p.(None):
p.(None):
p.(None): 84 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): Appendix III: NRERC Terms of Reference
p.(None): 1. Membership
p.(None):
p.(None):
...
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p.(None): • All signed and dated informed consent forms
p.(None): • Investigator’s and Co-investigators’ CVs
p.(None): • Copy of the insurance certificate/other insurance
p.(None): • Investigator’s SOPs
p.(None): • Notification and documentation of serious adverse events
p.(None): • Specimen management procedures, trial supplies/equipment
p.(None): • Participant identification list
p.(None): • Investigator interim and final report/summary of the trial
p.(None): 8.3.1.3 Participant File
p.(None): The participant file should, at the minimum, contain the following original information:
p.(None): • Subject identification: family name, given name, date of birth, sex, and identifi- cation number in the trial
p.(None): • Protocol identification number/study reference
p.(None): • Dates of first screening and/or enrolment in the trial
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 49
p.(None):
p.(None): • Name of drug or investigational product or procedure on test
p.(None): • Dates of product administration and dosage, and procedure(s)
p.(None): • Dates of assessment visit and name of individual responsible for making the assessment
p.(None): • Serious adverse event and related treatment or medication
p.(None): • Dates of laboratory specimen/sample collection.
p.(None): 8.3.1.4 Monitoring
p.(None): • Compliance to approved protocol must be followed during the course of the research.
p.(None): • Deviation from the protocol is acceptable only to manage/treat a serious adverse event that endangers the
p.(None): participant’s life or is presumed to result into serious or permanent disability. In such acceptable cases of protocol
p.(None): deviation, the IRB, clinical monitor and the sponsor must be notified immediately. The protocol deviation
p.(None): must be appended to the approved protocol. And, the investigator should subsequently make a request for
p.(None): protocol amendment while applying for renewal of the research.
p.(None): • The investigator should regularly submit a progress report; the progress report should include reports of the DSMB.
p.(None): 8.3.1.5 Medical Care for Trial Subjects
p.(None): • The highest available standard of care shall be provided to trial participants
p.(None): • In international collaborative research, the care should be equivalent to the care provided in the country where the
p.(None): sponsor or the collaborating institution is based.
p.(None): • Adequate/standard medical care should be offered to participants for adverse events.
p.(None): 8.3.1.6 In case the trial is terminated or suspended prematurely, for any reason:
p.(None):
p.(None): • The research participants must be informed with assurance of continuing care and treatment.
p.(None):
p.(None): • The IRB and the sponsor should be informed as soon as possible.
p.(None): 8.3.1.7 In randomized, double-blinded trials, premature unblinding:
p.(None):
p.(None): • The code may be broken because of serious adverse event, if deemed necessary by the DSMB during interim report,
p.(None):
p.(None): • Must be documented in the file and reported to the clinical monitor immediately.
p.(None):
p.(None):
p.(None): 50 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): 8.3.2 Genetic Research
p.(None): Genetics Studies
...
p.(None): Prisoners may be under constraints because of their incarceration which could affect their ability to make a truly
p.(None): voluntary and decision which is not coerced, whether or not to participate as subjects in research. Therefore,
p.(None): additional safeguards should be included in the study to protect the rights and welfare of these subjects, as follows:
p.(None): • If an IRB regularly reviews research that involves these vulnerable populations, consideration shall be given to the
p.(None): inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.
p.(None): • Where possible, a prisoner or an ex-prisoner co-opted in to the IRB reviewing the proposed research project should
p.(None): be included.
p.(None): • Only research on conditions particularly affecting prisoners as a class and with reasonable probability of improving
p.(None): the health and well-being of the research participants should be permissible.
p.(None): • The IRB shall determine that the informed consent process is properly applied with adequate assurance that a
p.(None): prisoner’s participation or refusal to participate will not be considered in decisions regarding his or her release or
p.(None): further deten- tion and each prisoner is clearly informed in advance that his or her participa- tion in the research
p.(None): project will have no affect on his or her release.
p.(None): 8.3.5.5 Mental and Physical Disability
p.(None): Persons with disability need special attention because they are prone to being social- ly marginalized. Therefore,
p.(None): their dignity, rights and well-being in research must be respected. Careful consideration should be made where proxy
p.(None): consent is to be used, and where the use of signed consent forms is not feasible, alternative viable methods should be
p.(None): employed.
p.(None): 56 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): Persons with disabilities (mental or physical) should not be unfairly excluded from participating in research.
p.(None): Researchers should make an effort to address communi- cation, disability and comprehension constraints are often the
p.(None): excuse for exclusion.
p.(None): People with mental disabilities or substance abuse related disorders include those people with psychiatric, cognitive,
p.(None): or developmental disorders. These groups of peo- ple are usually institutionalized and institutionalization may further
p.(None): compromise their ability to make voluntary decisions to participate in a research project. Therefore,
p.(None): research on people with cognitive disabilities or with substance abuse related disor- ders should:
p.(None): • Provide sufficient justification for involving such people;
p.(None): • Have appropriate evaluation procedures for ascertaining research participants’ ability to give informed consent. If
p.(None): research participants are deemed unable to understand and to make an informed decision, then an appropriate proxy
p.(None): should be identified.
p.(None): • Have an informed consent process that is free from coercion.
p.(None): • Be of no more than minimal risk, or if minimal risk is involved, the risk is outweighed by the anticipated benefits
p.(None): of the research project to the research participant.
p.(None):
...
p.(None): regulations and adherence to approved research protocols. In clinical trials, data monitoring is conducted to ensure
p.(None): data quality and safety. The DSMB is designated by the sponsor upon the recommendation of the IRB primarily to periodi-
p.(None): cally monitor data quality and participant safety. Moreover, interim analysis of risks and benefits should be a
p.(None): component of monitoring to ensure safety, whenever applicable.
p.(None): In multi-center research, monitoring at each of the research centers should primarily be carried out by the local IRBs.
p.(None): However, the NRERC is also responsible for oversight at selected, representative research centers, as deemed necessary.
p.(None): In international collaborative research, periodic progress report must be submitted, and all adverse events must be
p.(None): notified to the NEC.
p.(None): The investigator bears the major responsibility of regular monitoring and reporting of adverse events to the
p.(None): IRB. The sponsor is also obligated to report, or otherwise, ascertain the adverse events are reported to the IRB.
p.(None): Based on monitoring and reporting that includes Adverse Events (AEs) as applicable, the IRB may allow continuation,
p.(None): suspension, or termination of the research or recom- mend an amendment (a change) in the research procedure. Besides,
p.(None): if the research involves a drug or investigational product, the investigator must notify FMHACA.
p.(None): 11.1 Adverse Events: Definition, Grading, Follow-up, Reporting
p.(None): 11.1.1 Definition Grading of an Adverse Event
p.(None): Adverse events are considered to be serious when they are fatal, life threatening, cause serious or
p.(None): permanent disability, cause or protract hospitalization, cause con- genital anomaly, or lead to death.
p.(None): An AE is considered to be related with the research procedure, drug and/or an investi-
p.(None): 64 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): gational product based on temporal association with and response pattern to the proce- dure, drug or product, and the
p.(None): relationship, or otherwise, to the research participant’s clinical state, other interventions unrelated to the research
p.(None): or concomitant therapy.
p.(None): An AE shall be considered unexpected if the event has not been observed or docu- mented in a similar research involving
p.(None): humans; the characteristics or severity of the event is inconsistent with information in the investigators brochure; or
p.(None): the event is observed with higher frequency or severity than previously documented.
p.(None): An adverse event is graded as:
p.(None): Mild: if the event does not interfere with day-to-day activities and does not require treatment.
p.(None): Moderate: if the event marginally affect the day-to-day activities but can be tolerat- ed by the participant or require
p.(None): out-patient treatment.
p.(None): Severe: if the event significantly interferes with daily activities and demands hospi- talization or procedures for
p.(None): relief.
p.(None): 11.1.2 Follow-Up on an Adverse Event
p.(None): Once an AE has occurred, the investigator shall:
p.(None): • Monitor the AE closely
p.(None): • Provide a standard care to manage the AE and follow the AE until complete resolution of the AE.
...
p.(None): generalizable knowledge.
p.(None): Respect for persons, principle of-The requirement to treat individuals as autonomous agents and to provide additional
p.(None): protections to persons with diminished autonomy. Respect for persons requires that participants, to the degree that
p.(None): they are capable, be given the opportunity to choose what shall or shall not happen to them.
p.(None): Response-An investigator’s written reply to an IRB report.
p.(None): Responsible conduct of research (RCR)-A collection of core areas for conducting scientific research with
p.(None): integrity: data acquisition, management, sharing and owner- ship; conflict of interest and commitment; human
p.(None): participants; animal welfare; re- search misconduct; publication practices and responsible authorship; mentor/trainee
p.(None): responsibilities; peer review; and collaborative science
p.(None): Risk-Exposure to injury, loss, or harm, expressed in terms of the probability and mag- nitude of that harm. Risks to
p.(None): participants must be minimized and must be reasonable in relation to anticipated benefits to participants and the
p.(None): importance the knowledge that may reasonably be expected to result.
p.(None): Serious adverse event (SAE)-An AE that results in death, is life-threatening (at the time of the event), requires
p.(None): inpatient hospitalization or prolongation of existing hospi- talization, results in persistent or significant
p.(None): disability or incapacity, or is a congenital anomaly or birth defect. An AE may also be considered serious if it
p.(None): jeopardizes the participant or requires intervention to prevent one of the other outcomes listed.
p.(None): Serious noncompliance-Noncompliance that results in increased risk to partici- pants or reflects a failure to apply
p.(None): substantial portions of governing regulations. Seri- ous noncompliance must be reported promptly.
p.(None): Severe/severity-The graded level of intensity of an AE and its interference with usual social and functional
p.(None): activities, often standardized in toxicity tables. Grade levels generally include normal, mild, moderate, severe,
p.(None): life-threatening, and fatal.
p.(None): Sponsor- a person or other entity that initiates a clinical investigation, but that does not actually conduct the
p.(None): investigation.
p.(None): Suspend/suspension-Temporary cessation of research-related intervention or interac- tion with participants and
p.(None): obtaining or using identifiable private research information. Partial suspension halts some but not all such
p.(None): activities, for example when enrollment is stopped but follow-up continues with enrolled participants. A suspension
p.(None): must be
p.(None): National Research Ethics Review Guideline Fifth Edition 83
p.(None):
p.(None): reported promptly unless the suspension results from expiration of IRB approval.
p.(None): Terminate/termination-Permanent cessation of research-related intervention or interac- tion with participants and
p.(None): obtaining and use of identifiable private research information. A termination must be reported promptly unless the
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p.(None): expedited review process; follow-up and monitoring of approved studies.
p.(None): • The NRERC Secretariat presents the application to the NRERC who shall ex- amine the institution’s application, and
p.(None): if satisfied, will recommend to MoST for endorsement of the registration and authorize in writing, the establishment of
p.(None): the IRB. The process of application and response from MoST should not exceed three months.
p.(None): 6.3 Composition
p.(None): The IRB should consist of a reasonable number of members, who collectively have the qualifications and experience
p.(None): to review and evaluate the science, medical as- pects, and ethics of the proposed research.
p.(None): • Each IRB shall be composed of at least five (5) members, with varying back- grounds to ensure complete and robust
p.(None): review of research activities commonly conducted by the institution. It must be multidisciplinary and multi-sectoral in
p.(None): composition, including persons with relevant but diverse scientific expertise, balanced age and gender
p.(None): distribution, and who have the qualifications and ex- perience to review and evaluate the scientific and
p.(None): medical ethics aspects of research protocols.
p.(None): • All IRBs shall have at least one member whose main area of expertise is in the scientific field and at least one
p.(None): member whose primary area of expertise is in a non-scientific field.
p.(None): • Each IRB shall include at least one member who is not otherwise affiliated with the institution or have a close
p.(None): family member working in the institution.
p.(None): • The IRB should have at least one community representative, who does not nec- essarily have to have any scientific
p.(None): expertise, but may be a layperson that rep- resents the interests and concerns of members of the community and is
p.(None): familiar with the community’s values, customs, traditions, and culture.
p.(None): • If an IRB regularly reviews research that involves vulnerable populations, such as children, prisoners, pregnant
p.(None): women, men/women in uniform or persons with disabilities, marginalized group, refuges, minorities, the IRB shall
p.(None): involve or co- opt one or more individuals who are knowledgeable about and experienced in working with these research
p.(None): participants.
p.(None): • All IRB members should at the minimum take one basic training on bioethics within one year of appointment.
p.(None):
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 31
p.(None):
p.(None): 6.4 External Reviewers
p.(None): • If a protocol requires expertise that is beyond the competence of the IRB mem- bers or the IRB need additional
p.(None): opinion in the review process, the IRB may engage independent experts to review and give their opinion.
...
p.(None): permitting access to the file by the clinical monitor and the IRB.
p.(None): • SOPs for the trial; AE reporting format
p.(None): • The investigator should affirm that he/she has sufficient time to conduct and monitor the trial, as well as to
p.(None): submit progress reports on time,
p.(None): 8.3.1.2 Investigator’s File
p.(None): The investigator must prepare a file containing documents related to the trial. During the study, the investigator is
p.(None): responsible for updating the file and regularly adding trial-related documents. Identification codes of subjects shall
p.(None): be kept for 10 years.
p.(None): The Investigator’s File should contain, at the minimum:
p.(None): • Local regulatory requirements
p.(None): • IRB and other authorities’ written approval for all documents
p.(None): • IRB and other authorities’ written approval for protocol amendments
p.(None): • Correspondence with the IRB
p.(None): • Approved protocol and amendments
p.(None): • All signed and dated informed consent forms
p.(None): • Investigator’s and Co-investigators’ CVs
p.(None): • Copy of the insurance certificate/other insurance
p.(None): • Investigator’s SOPs
p.(None): • Notification and documentation of serious adverse events
p.(None): • Specimen management procedures, trial supplies/equipment
p.(None): • Participant identification list
p.(None): • Investigator interim and final report/summary of the trial
p.(None): 8.3.1.3 Participant File
p.(None): The participant file should, at the minimum, contain the following original information:
p.(None): • Subject identification: family name, given name, date of birth, sex, and identifi- cation number in the trial
p.(None): • Protocol identification number/study reference
p.(None): • Dates of first screening and/or enrolment in the trial
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 49
p.(None):
p.(None): • Name of drug or investigational product or procedure on test
p.(None): • Dates of product administration and dosage, and procedure(s)
p.(None): • Dates of assessment visit and name of individual responsible for making the assessment
p.(None): • Serious adverse event and related treatment or medication
p.(None): • Dates of laboratory specimen/sample collection.
p.(None): 8.3.1.4 Monitoring
p.(None): • Compliance to approved protocol must be followed during the course of the research.
p.(None): • Deviation from the protocol is acceptable only to manage/treat a serious adverse event that endangers the
p.(None): participant’s life or is presumed to result into serious or permanent disability. In such acceptable cases of protocol
p.(None): deviation, the IRB, clinical monitor and the sponsor must be notified immediately. The protocol deviation
p.(None): must be appended to the approved protocol. And, the investigator should subsequently make a request for
p.(None): protocol amendment while applying for renewal of the research.
p.(None): • The investigator should regularly submit a progress report; the progress report should include reports of the DSMB.
p.(None): 8.3.1.5 Medical Care for Trial Subjects
p.(None): • The highest available standard of care shall be provided to trial participants
...
p.(None): intended to detect genetic characteristics in asymp- tomatic people;
p.(None): Genetic Counseling: A procedure to explain the possible implications of the findings of genetic testing or screening,
p.(None): its advantages and risks and where applicable to assist the individual in the long-term handling of the consequences;
p.(None): It takes place before and after genetic testing and screening:
p.(None): • The protocol submitted should contain enough information on background, na- ture and scientific justification for
p.(None): the proposed study.
p.(None): • In genetic studies involving acquisition of biological samples, the procedure to be used to obtain samples, the type
p.(None): and amount/size should be clearly stated. Issue of identifiers and how confidentiality will be maintained should be
p.(None): addressed.
p.(None): • The collection, processing, handling, storage, transfer, and destruction of human biological materials and data
p.(None): should be conducted in a manner that protects the privacy of the participants and the confidentiality of their
p.(None): specimens and data.
p.(None): • Procedures should be in place for the participant to request their sample be destroyed or stripped of
p.(None): identifiers. It should be stated that the study is for research purposes only and no individual results will
p.(None): be given back to study participants.
p.(None): • The protection of the rights and welfare of the subjects should be a priority and confidentiality should be
p.(None): preserved to the fullest extent by the research team.
p.(None): • The study participation information including research results will not be given to family members, employers or
p.(None): other third parties without written permission of the subject and IRB approval.
p.(None): National Research Ethics Review Guideline Fifth Edition 51
p.(None):
p.(None): • Any shared samples must be anonymized to the recipient. Reimbursement of reasonable costs incurred by participants
p.(None): should not be of a magnitude so as to constitute an inducement to participate in the genetic study.
p.(None): • During the informed consent process, there should be a clear statement that the study is for genetic research
p.(None): purposes. It is ethically imperative that clear, balanced, adequate and appropriate information shall be provided to
p.(None): the potential participant.
p.(None): • The informed consent process should cover the human biological materials and data to be collected, data anticipated
p.(None): to be derived from the analysis of sam- ples, and the health and other records to be accessed, their intended uses,
p.(None): storage, and duration of storage.
p.(None): • The participants must be informed that specific information resulting from the study will not be available to
p.(None): participants and their families. Explanation should be given if the samples will be shared with third parties and that
p.(None): in these cases the samples will be anonymous.
p.(None): • The participant should be given the option of allowing samples to be shared or not. All secondary and third party
p.(None): uses of biological samples should be restrict- ed to anonymized or anonymous samples. This means the sample cannot be
...
p.(None): Humans as Research Participants. Kam-
p.(None): pala – Uganda: UNCST.
p.(None): National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): 16. Statement of WHO Expert Advisory Group on Ethical issues in Medical genetics. WHO, Geneva 1998.
p.(None): 17. Ethical Guidelines for International Comparative Social Science Research in the framework of Management of Social
p.(None): Transformations, MOST. UNE- SCO, MOST Paris.
p.(None): 18. Hyder A, Dowson L, Bachani AM, Lavery J. Moving from research ethics review o research ethics systems in
p.(None): low-income and middle-income coun- tries. Lancet 2009;37:862-65.
p.(None): 19. Heath EJ. The IRB’s Monitoring Function: Four Concepts of Monitoring. IRB: Ethics and Human Research, 1979; 1:
p.(None): 1-3+12.
p.(None): 20. DeMets DL, Fost N, Powers M. An Institutional Review Board dilemma: responsible for safety monitoring but not in
p.(None): control. Clin Trials 2006; 3; 142.
p.(None): 21. Cowan DH. Scientific Design, Ethics, and Monitoring: IRB Review of Ran- domized Clinical Trials. IRB: Ethics and
p.(None): Human Research, 1980;2: 1-4.
p.(None): 22. Karlawish, Hall (1996). Am J Respir Crit Care Med, 1996;153:499-5-6.
p.(None): 23. Casarett, Karlawish, Sugarman. JAMA, 2000, 283 (17): 2275-80.
p.(None): 24. Richards HM, Schwartz LJ. Ethics of qualitative research: are there special issues for health services research?
p.(None): Family Practice 2002; 19: 135-139.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 75
p.(None):
p.(None): Appendix I. Acronyms
p.(None): AAUMFIRB Addis Ababa University Medical Faculty Institutional
p.(None): Review Board
p.(None): AE Adverse Event
p.(None): AHRI Armauer Hansen Research Institute
p.(None): CAB Community Advisory Board
p.(None): CIOMS Council for International Organization of Medical Sci- ences
p.(None): COI Conflict Of Interest
p.(None): CV Curriculum Vitae
p.(None): DACA Drug Administration and Control Authority
p.(None): DNA Deoxyribo Nucleic Acid
p.(None): DSMB Data and Safety Monitoring Board
p.(None): EC Ethics Committee
p.(None): EHNRI Ethiopian Health and Nutrition Research Institute
p.(None): EPHA Ethiopian Public Health Association
p.(None): ERC Ethics Review Committee
p.(None): ESTA Ethiopian Science and Technology Agency
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p.(None): 6.9 Termination of Membership
p.(None): • Membership may be terminated voluntarily. The member should write a resig- nation letter to the appointing authority
p.(None): through the IRB Chairperson giving at least a one-month notice.
p.(None): • The Chairperson may resign by sending his/her resignation letter to the appointing
p.(None): 34 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): authority after informing the committee at its next meeting.
p.(None): • Membership should be terminated by the appointing authority on the advice of the IRB if a member is going to be away
p.(None): for more than one year.
p.(None): • Membership could be terminated by the appointing authority upon advice of the IRB if the member has been absent from
p.(None): five consecutive meetings without offering an explanation.
p.(None): • Membership should be terminated by the appointing authority for misconduct that tarnishes the credibility of the IRB
p.(None): as determined by the IRB.
p.(None): • Membership should be terminated if a member is convicted of a criminal offence.
p.(None): • Membership should be terminated by the appointing authority in consultation with the IRB if a member is suffering
p.(None): from a chronic incapacitating illness that significantly reduces the ability to process information and make rational
p.(None): inde- pendent decisions.
p.(None): • Membership should automatically terminate when a member dies.
p.(None): 6.10 Dissolution of IRB
p.(None): The IRB should automatically cease to exist when the institution at which it is based ceases to exist.
p.(None): 6.11 Committee Meetings
p.(None): 6.11.1 Scheduled Full (Convened) IRB Meetings
p.(None): 6.11.1.1 The calendar dates and time of scheduled full (convened) IRB meetings should be agreed upon and
p.(None): confirmed by the committee and made public.
p.(None): 6.11.1.2 The frequency of the scheduled full (convened) IRB meetings should depend on the workload in terms of volume
p.(None): of applications submitted as well as the availability of IRB members who have other duties at their places of
p.(None): employment.
p.(None): 6.11.1.3 A quorum is more than 50% of the total number of IRB members.
p.(None): 6.11.1.4 The quorum should include members with the relevant expertise to effectively review the protocols on that
p.(None): days agenda. The presence of a non-scientist is required. The community representative, although not required, is
p.(None): essential.
p.(None): 6.11.1.5 The quorum should be present before a full (convened) IRB meeting is held.
p.(None): 6.11.1.6 The IRB Secretary should send an agenda; minutes of the previous meeting; notice about the date, venue and
p.(None): time of the next scheduled meeting; and other relevant documents to all IRB members at least ten working days before
p.(None): the meeting.
p.(None): National Research Ethics Review Guideline Fifth Edition 35
p.(None):
p.(None): 6.11.1.7 Applications should be submitted to the IRB Secretariat at least three
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p.(None): National Research Ethics Review Guideline Fifth Edition 65
p.(None):
p.(None): 11.2 Compliance Monitoring
p.(None): Progress reports - PIs should submit progress reports at regular intervals stipulated by the IRB as a condition for
p.(None): renewal of ongoing research. Periodic progress reports enable the IRB to determine whether the research is progressing
p.(None): according to the approved protocol. In clinical trials, the progress report should include reports of the DSMB.
p.(None): The IRB shall establish a follow-up mechanism to monitor the progress of all ethically approved research. The follow-up
p.(None): review shall be done in the following manner:
p.(None): • Ethics approval is valid for one year. For research that takes more than a year to complete, a renewal
p.(None): (continuation) application should be submitted to the Secretariat with a full progress report and justification for IRB
p.(None): approval.
p.(None): • Any amendment in the protocol at any time should be reported to the Secretar- iat and approval secured from the IRB.
p.(None): • Serious and unexpected AEs shall be reported to the Secretariat as stated above in 11.1.3
p.(None): • In case of a premature suspension or termination of a research, the investigator should notify the Secretariat
p.(None): including the reasons for the premature suspension or termination of the research and summary of the research findings.
p.(None): 11.3 Types of Monitoring Oversight Visits
p.(None): 11.3.1 Types of Monitoring
p.(None): Passive monitoring – The IRB receives information about the research that it ap- proved and uses that information to
p.(None): assess the study’s progress.
p.(None): Active monitoring – IRB members should physically visit the research site(s) in order to assess the conduct of the
p.(None): studies.
p.(None): • Approved research should be actively monitored to ensure adherence to ethics principles, as considered necessary by
p.(None): the IRB.
p.(None): • IRB members should use the IRB’s oversight checklist in order to ensure appro- priate issues are assessed during the
p.(None): visit.
p.(None): • Should research exist that has not received ethical clearance, the presence of such research should be proved
p.(None): through a site-visit, witnesses, and appropriate and prompt actions should be taken (see Section 12.2).
p.(None): • The number of IRB members needed to conduct an oversight visit depends on the workload of the monitoring team. To
p.(None): maximize objectivity, at least two (2) members of the ERC or delegated persons with diverse expertise and drawn from
p.(None): different institutions should make up the monitoring team. A monitoring team may include the community representative
p.(None): in the IRB.
p.(None):
p.(None):
p.(None): 66 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): 11.3.2 Types of Oversight Visits
p.(None): The type and frequency of oversight visits should depend on the level of risk and complexity of the research. The IRB
p.(None): can make the monitoring visit announced or unannounced.
p.(None): IRB –initiated announced oversight visit: the IRB informs the PI the date of the visit in advance.
p.(None): IRB-initiated unannounced oversight visit: the IRB does not inform the PI in advance of the visit.
p.(None): Additional monitoring visits may be made for the following reasons:
p.(None): • Response to reports made directly to the IRB or circulating in the community.
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p.(None): professionals, was sought using a semi-structured tool. All efforts were made to strike a balance in accommodating the
p.(None): experts’ sometimes differing opinions and suggestions for these guidelines.
p.(None): 14 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): Moreover, the draft guidelines were discussed with a wider group of experts and rep- resentatives drawn from the MoST,
p.(None): Ministry of Justice, Ministry of Health, FMHACA, IRBs of universities and research institutions, international and UN
p.(None): agencies, and other relevant stakeholders. The comments and recommendations from this nation- wide consultative meeting
p.(None): were analyzed and incorporated before this guideline was endorsed and released for use to safeguard the rights and
p.(None): welfare of research partic- ipants and for oversight of research in Ethiopia.
p.(None): 1.2 Introduction
p.(None): “Research is a systematic investigation including research development, testing, and evaluation designed to contribute
p.(None): to generalizable knowledge.” Nevertheless, as a matter of principle, in research involving human participants, the
p.(None): well-being of the patient takes priority over the interests of society and the knowledge to be gained.
p.(None): “Human subject [research participant] is a living individual about whom an investi- gator conducting research obtains
p.(None): data through intervention or interaction with the individual, or identifiable private information.” Besides, research
p.(None): participants may include pregnant women where fetuses, fetal material, or abortuses are the primary subjects of
p.(None): interest. Similarly, research involving autopsy materials shall also be in- cluded as source of data.
p.(None): The main purpose of health research involving human participants is for better un- derstanding of the etiology,
p.(None): pathogenesis, and pathophysiology of disease and the related diagnostic, preventive, promotive, and therapeutic
p.(None): procedures and measures. Moreover, as evidence-based practice has become necessary at the turn of the 21st century, and
p.(None): quite understandably, existing procedures and practices are challenged continuously for their effectiveness,
p.(None): efficiency, quality, accessibility, and acceptability by the community.
p.(None): However, in the quest to ensure better health and knowledge, the rights and welfare of research participants must be
p.(None): protected at all times. Participation must be voluntary and free of coercion, persuasion, manipulation, deception,
p.(None): undue influence or induce- ment, and threat or intimidation. The information shall be obtained in a private setting
p.(None): whenever necessary and confidentiality maintained throughout the lifetime of the re- search. This is even more
p.(None): important when research involves participants whose com- prehension and decision making is compromised because of age,
p.(None): lack of knowledge on medical concepts and technological terms, or severe mental or behavioral disorders.
...
p.(None): Risk is the probability and magnitude of some future occurrence of harm. Harm is injury and setback to interests as a
p.(None): result of being a research participant. Risks to research participants include physical, psychological, and emotional
p.(None): harm. Risks can be known or presumed. And, although no specific regulations exist, risks may include physical,
p.(None): psychological, emotional, economic, educational, legal, and social harm.
p.(None): In addition, beneficence includes whether the usual care is changed or manipulated to inflict no harm, minimize harm,
p.(None): remove harm, and maximize the benefit to re- search participants and to the community, or both.
p.(None): 3.3 Justice
p.(None): Justice connotes fairness and equity in the distribution of the benefits and burdens of research to participants.
p.(None): 3.3.1. Justice demands equitable selection of participants, i.e., avoiding popu- lations that may be unfairly coerced
p.(None): into participating, including but not limited to, prisoners, pregnant women, people with mental and physical
p.(None): disabilities, immigrants, refugees, ethnic minorities, marginalized groups and institutionalized persons, including
p.(None): children. There must be a justi- fication for inclusion of these vulnerable groups in the research. There should be no
p.(None): disproportionate use of vulnerable populations. The same recruitment approach should be used in all populations.
p.(None): Injustice may arise when selecting participants from a specific socio-economic class, age, sex, racial, cultural,
p.(None): religious, creed, and institutional make up.
p.(None): 3.3.2. The principle of justice requires equality in the distribution of benefits and burdens among the population
p.(None): groups likely to benefit from the research. Distributive justice means that no segment of the population should be
p.(None): unfairly burdened with the harms of research. It thus imposes particular obligations toward individuals who are
...
p.(None): • Each IRB shall be composed of at least five (5) members, with varying back- grounds to ensure complete and robust
p.(None): review of research activities commonly conducted by the institution. It must be multidisciplinary and multi-sectoral in
p.(None): composition, including persons with relevant but diverse scientific expertise, balanced age and gender
p.(None): distribution, and who have the qualifications and ex- perience to review and evaluate the scientific and
p.(None): medical ethics aspects of research protocols.
p.(None): • All IRBs shall have at least one member whose main area of expertise is in the scientific field and at least one
p.(None): member whose primary area of expertise is in a non-scientific field.
p.(None): • Each IRB shall include at least one member who is not otherwise affiliated with the institution or have a close
p.(None): family member working in the institution.
p.(None): • The IRB should have at least one community representative, who does not nec- essarily have to have any scientific
p.(None): expertise, but may be a layperson that rep- resents the interests and concerns of members of the community and is
p.(None): familiar with the community’s values, customs, traditions, and culture.
p.(None): • If an IRB regularly reviews research that involves vulnerable populations, such as children, prisoners, pregnant
p.(None): women, men/women in uniform or persons with disabilities, marginalized group, refuges, minorities, the IRB shall
p.(None): involve or co- opt one or more individuals who are knowledgeable about and experienced in working with these research
p.(None): participants.
p.(None): • All IRB members should at the minimum take one basic training on bioethics within one year of appointment.
p.(None):
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 31
p.(None):
p.(None): 6.4 External Reviewers
p.(None): • If a protocol requires expertise that is beyond the competence of the IRB mem- bers or the IRB need additional
p.(None): opinion in the review process, the IRB may engage independent experts to review and give their opinion.
p.(None): • The Secretariat should keep an updated list of experts along with their CVs, which should be reviewed annually by
p.(None): the IRB.
p.(None): • Independent experts must sign privacy and confidentiality agreements and con- flict of interest (COI) forms to
p.(None): ensure that the information in the protocol is protected and that consultants do not have any conflicts.
p.(None): • The IRB may ask questions that could guide the review of the experts.
p.(None): • The expert may be invited to attend or consult by telephone an IRB meeting but he/she cannot vote in the meeting.
p.(None): 6.5 Independence of IRB
...
p.(None): of human participants and for complying with all applicable regulations. The IRB that reviewed and approved the
p.(None): collaborative research is primarily responsible for monitoring the ethical conduct of the research procedures. However,
p.(None): the National IRB can monitor the proper conduct of the research whenever it deems further oversight is necessary. Any
p.(None): modification, amendment, or change in the approved collaborative research protocol should be made at each collaborating
p.(None): institution. Material transfer agreements must be obtained whenever applicable.
p.(None): 8.3.5 Vulnerable Population
p.(None): Vulnerable populations are those segments of the population whose capacity to safe- guard their welfare, demand their
p.(None): rights and satisfy their interests, is compromised. Because of these limitations, they cannot provide or refuse
p.(None): consent. Vulnerable pop-
p.(None): 54 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): ulations are particularly subject to undue influence, manipulation, coercion, and in- timidation. Hence, vulnerable
p.(None): populations deserve special protection from IRBs and other regulatory authorities.
p.(None): 8.3.5.1 Pregnant women and Fetuses
p.(None): To conduct research on pregnant women, the following must be fulfilled:
p.(None): • There is evidence from studies on pregnant animals and non-pregnant women that studies need to be done on risks
p.(None): related to pregnant women and fetuses.
p.(None): • If the research holds the prospect of direct benefit to the pregnant woman and the fetus, and the knowledge cannot
p.(None): be obtained through other means.
p.(None): • There should be no inducement to terminate a pregnancy.
p.(None): • If the prospect of benefit is both to the pregnant woman and the fetus, an in- formed consent form from the mother
p.(None): alone suffices to enroll the woman into the research.
p.(None): • If the prospect of benefit is solely to the fetus, informed consent should be obtained from both parents, provided
p.(None): they are competent to give or refuse the consent.
p.(None): • In both conditions, the foreseeable risks of the research on the fetus or the neo- nate must be thoroughly
p.(None): explained.
p.(None): • Viability of the fetus should be determined by a health care provider who is not a member of the investigation team.
p.(None): 8.3.5.2 Newborns/Neonates
p.(None): In research involving neonates with uncertain viability, the following must be met:
p.(None): • Previous research provides data to assess potential risks to neonates.
p.(None): • Viability of the fetus should be determined by a health care provider who is not a member of the investigator team.
p.(None): • There should be no other means of obtaining the knowledge to be derived from the research.
p.(None): • There should be no added risk to the neonate due to the research.
...
p.(None): the protocol has been deemed to pose more than minimal risk to participants.
p.(None): Noncompliance-Failure by investigators, research staff, IRB members, or IRB staff to follow regulations for human
p.(None): research protections
p.(None): Oral consent-Consent obtained only through speaking, generally in the absence of documentation of consent. See also
p.(None): documentation of consent, informed con- sent, verbal consent.
p.(None): National Research Ethics Review Guideline Fifth Edition 81
p.(None):
p.(None): Parental permission-The agreement of a parent or guardian to the participation of their child in research.
p.(None): Personal identifier-Information obtained and recorded in such a manner that human participants can be recognized,
p.(None): directly or through links to the participants. Examples include names, social security numbers, and codes.
p.(None): Pilot study-Preliminary study to determine the feasibility of a larger study, use of a test instrument, or other
p.(None): activity.
p.(None): Pregnancy-The period of time from implantation until delivery. A woman shall be assumed to be pregnant if
p.(None): she exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until the results of a
p.(None): pregnancy test are negative or until delivery.
p.(None): Principal Investigator (PI)-Lead scientist who is working on the design of a research study, development of methods and
p.(None): procedures for the study, collection of data or specimens, analysis of data or specimens, or interpretation of data.
p.(None): Prisoner-Any individual involuntarily confined or detained in a penal institution. The term is intended to encompass
p.(None): individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other
p.(None): facilities by virtue of statutes or commit- ment procedures which provide alternatives to criminal prosecution or
p.(None): incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.
p.(None): Private information-information about individually identifiable behavior that occurs in a context in which the
p.(None): individual can reasonably expect that no observation or record- ing is taking place, and information which has been
p.(None): provided for specific purposes by an individual and which the individual can reasonably expect will not be made public
p.(None): (e.g., a medical record).
p.(None): Private/privacy-Individual person’s interest in preventing disclosure of information about himself or herself.
p.(None): Project-A planned activity or collection of activities conducted for a particular pur- pose; may encompass more than
p.(None): one protocol on the same subject matter.
...
p.(None): in the relevant source documents (e.g., investigator’s brochure, package insert, or non-reportable events [NRE] list),
p.(None): or the event is observed with higher frequency than previously observed or documented. Expectedness does not entail the
p.(None): ability to predict results from in vitro, animal, or other pharmacological models.
p.(None): Unlinked-The condition of data or specimens which had been coded but for which the key linking the code to direct
p.(None): personal identifiers has been destroyed.
p.(None): Unrelated-Pertaining to an AE, the condition in which the event is due to a docu- mented cause other than research
p.(None): procedures.
p.(None): Verbal consent-Consent obtained by communication in words; this may include spo- ken or written format.
p.(None): Voluntary/voluntariness-Freedom from coercion and undue influence
p.(None): Vulnerable-Having reduced capacity to offer free and informed consent due to pos- sible coercion, undue influence,
p.(None): or other diminished autonomy, such as children, prisoners, pregnant women, mentally disabled persons, or
p.(None): economically or education- ally disadvantaged persons as vulnerable. Vulnerability may be associated with other
p.(None): characteristics such as age, health status, or social standing. The IRB must ensure additional safeguards protect the
p.(None): rights and welfare of vulnerable persons.
p.(None): Vulnerable population-A group identified by one or more common characteristics associated with reduced
p.(None): capacity to offer free and informed consent.
p.(None): Waive/waiver-Temporarily set aside the requirement of a particular rule, regulation, or condition in a protocol or
p.(None): consent document.
p.(None): Withdraw/withdrawal-Permanently halt a research study after submission for IRB review but before human
p.(None): participants become involved, whether or not the study has been reviewed by an IRB. This term has been replaced by the
p.(None): term close/closure.
p.(None):
p.(None):
p.(None):
p.(None): 84 National Research Ethics Review Guideline Fifth Edition
p.(None):
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Health / patients in emergency situations
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p.(None): international activities in the field of biomedical sciences, especially when the participation of several
p.(None): international associations and national institutions is deemed necessary.
p.(None): Data and safety monitoring-Structured, ongoing monitoring of specified characteris- tics of a research protocol,
p.(None): generally by a small, independent body of experts appoint- ed by the study sponsor. Sometimes incorrectly called “data
p.(None): safety and monitoring”. Monitoring may pertain to study performance (such as rate of accrual), safety (such as
p.(None): occurrence of AEs), and efficacy (such as achievement of primary endpoints). A body that monitors all three
p.(None): characteristics is usually called a data monitoring com- mittee (DMC) or a data and safety monitoring board (DSMB).
p.(None): Declaration of Helsinki-A statement of ethical principles to provide guidance to phy- sicians and other participants in
p.(None): medical research involving human participants; ad- opted by the World Medical Assembly in 1964 and last updated in
p.(None): 2004. See http:// www.wma.net/e/policy/b3.htm.
p.(None): Disapprove/disapproval-The determination by the IRB that the research may not be conducted at an institution
p.(None): Documentation of consent-Consent that is documented by the use of a written con- sent form approved by the IRB and
p.(None): signed by the participant or the participant’s legally authorized representative.
p.(None): Emergency response-A public health activity undertaken in an urgent or emergency situation, usually because of an
p.(None): identified or suspected imminent health threat to the population, but sometimes because the public or government
p.(None): authorities perceive an imminent threat that demands immediate action. The primary purpose of the activity is to
p.(None): document the existence and magnitude of a public health problem in the community and to implement appropriate measures
p.(None): to address the problem (Langmuir, 1980).
p.(None): Exemption/exempt research-Categories of research to which the Federal regulations for human research protections do not
p.(None): apply. Research involving prisoners and some research involving children are not exempt.
p.(None): Expected-Pertaining to an AE, the event has been previously observed or documented in humans under the research
p.(None): intervention (or one substantially similar), and the nature or severity of the event is consistent with information in
p.(None): the relevant source documents (e.g., investigator’s brochure, package insert, or non-reportable events [NRE] list).
p.(None): National Research Ethics Review Guideline Fifth Edition 79
p.(None):
p.(None): Expedited review-Review performed by the IRB Chair or a designated experienced member for research that involves no
p.(None): more than minimal risk and meets the criteria for expedited review or represents minor changes in approved research.
p.(None): Experienced reviewer -A member of an IRB who is designated by the Chair as autho- rized to conduct expedited reviews.
...
Health / visual impairment
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p.(None): • Serious adverse event and related treatment or medication
p.(None): • Dates of laboratory specimen/sample collection.
p.(None): 8.3.1.4 Monitoring
p.(None): • Compliance to approved protocol must be followed during the course of the research.
p.(None): • Deviation from the protocol is acceptable only to manage/treat a serious adverse event that endangers the
p.(None): participant’s life or is presumed to result into serious or permanent disability. In such acceptable cases of protocol
p.(None): deviation, the IRB, clinical monitor and the sponsor must be notified immediately. The protocol deviation
p.(None): must be appended to the approved protocol. And, the investigator should subsequently make a request for
p.(None): protocol amendment while applying for renewal of the research.
p.(None): • The investigator should regularly submit a progress report; the progress report should include reports of the DSMB.
p.(None): 8.3.1.5 Medical Care for Trial Subjects
p.(None): • The highest available standard of care shall be provided to trial participants
p.(None): • In international collaborative research, the care should be equivalent to the care provided in the country where the
p.(None): sponsor or the collaborating institution is based.
p.(None): • Adequate/standard medical care should be offered to participants for adverse events.
p.(None): 8.3.1.6 In case the trial is terminated or suspended prematurely, for any reason:
p.(None):
p.(None): • The research participants must be informed with assurance of continuing care and treatment.
p.(None):
p.(None): • The IRB and the sponsor should be informed as soon as possible.
p.(None): 8.3.1.7 In randomized, double-blinded trials, premature unblinding:
p.(None):
p.(None): • The code may be broken because of serious adverse event, if deemed necessary by the DSMB during interim report,
p.(None):
p.(None): • Must be documented in the file and reported to the clinical monitor immediately.
p.(None):
p.(None):
p.(None): 50 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): 8.3.2 Genetic Research
p.(None): Genetics Studies
p.(None): Genetic screening should be distinguished from genetic testing at the outset. The terms are often used interchangeably,
p.(None): although they represent two different forms of genetic practice. Genetic screening is carried out on groups of people,
p.(None): which could consist of a section of the population defined by age, sex, or other risk factor, or a subgroup within the
p.(None): population, or within broad groups in which genetic factors may be responsible for certain disabilities.
p.(None): Genetic Research: is defined as research conducted by investigators solely for the purpose of generating
p.(None): scientific knowledge about genes and/or the genetic basis of disease. Genetic data can be used for medical diagnosis,
p.(None): disease prevention, and population genetics studies.
p.(None): Genetic Testing: A procedure to detect the presence or absence of, or change in, a particular gene or chromosome,
p.(None): including an indirect test for a gene product or other specific metabolite that is primarily indicative of a specific
p.(None): genetic change.
p.(None): Genetic Screening: Large-scale systematic genetic testing offered in a program to a population or subsection thereof
p.(None): intended to detect genetic characteristics in asymp- tomatic people;
...
Social / Access to Social Goods
Searching for indicator access:
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p.(None): NRERC chairman or delegate.
p.(None): • Facilitate regular and extraordinary meetings in consultation with the Chairper- son of the NRERC.
p.(None): • Communicate decisions of the NRERC to the applying institution with a copy to the PI.
p.(None): • Archive all project-related protocols, correspondence, decisions and minutes of the NRERC.
p.(None): • Receive periodic progress reports from investigators and annual reports from other IRBs.
p.(None): • Facilitate the accreditation and registration of IRBs based on the recommenda- tion of the NRERC and endorsement by
p.(None): MoST.
p.(None): • Propose revision criteria for registration and accreditation of IRBs.
p.(None): • Support networking among the NRERC and other IRBs.
p.(None): • Facilitate the monitoring and evaluation of the ethical implementation of research.
p.(None): • Organize, support, and facilitate the conduct of research ethics training at Na- tional and Institutional levels.
p.(None): 28 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): • Manage and facilitate all official correspondence of the NRERC and
p.(None): • Solicit funds for realization of the duties of the NRERC.
p.(None): 5.6 Terms of Reference
p.(None): Each IRB shall develop its own terms of reference. The TOR of the NRERC can be found in Appendix III.
p.(None): 5.7 NRERC Office
p.(None): 5.7.1. Physical Location and Security - The NRERC should have a dedi- cated office located in the premises of MoST.
p.(None): 5.7.2. Only the NRERC Secretariat should be authorized to have access to the NRERC documents unless ordered by a court
p.(None): of law.
p.(None): 5.7.3. NRERC documents should be kept secure in locked cabinets and only accessed by authorized personnel.
p.(None): 5.8 NRERC Operations
p.(None): 5.8.1. The NRERC operations office should be spearheaded by the NRERC Secretariat as per instructions from the NRERC
p.(None): through the Chairperson or his/her designate.
p.(None): 5.8.2. The NRERC operations office should be separate and independent of the administration of MoST.
p.(None): 5.8.3. Applications to the NRERC must be channeled through the NRERC Secretariat.
p.(None): 5.8.4. All decisions and communication from the NRERC to the appli- cant must be conveyed through the Secretariat.
p.(None): 5.9 Registration and Accreditation
p.(None): 5.9.1. All IRBs in Ethiopia have to be accredited by the NRERC, and registered and licensed by the
p.(None): Secretariat of the NRERC at MoST.
p.(None): 5.9.2. Registration and renewal of all IRBs shall be done every two years from the date of registration or renewal of
p.(None): the IRB.
p.(None): 5.9.3. When IRB members are replaced for any reason, these outgoing members shall be notified in writing. The reason
p.(None): for termination of membership shall be clearly described in the letter.
p.(None): 5.9.4. Review procedures, TORs, and the review forms should be standardized.
p.(None): 5.9.5. The minimum acceptable number of members on any IRB is five. No IRB can have even numbered members for the sake
p.(None): of deci- sions, particularly when there is a need to vote.
p.(None): 5.9.6. IRBs shall have members with a varied professional mix and there
p.(None): National Research Ethics Review Guideline Fifth Edition 29
p.(None):
...
p.(None): There are special categories of research that possess particular characteristics and demand special emphasis in ethical
p.(None): considerations. This type of research includes clinical/experimental trials, genetic, socio-behavioral, and
p.(None): collaborative research and research involving Vulnerable population.
p.(None): 8.3 Types Of Research with Special Consideration
p.(None): 8.3.1 Clinical Trials
p.(None): 8.3.1.1 Submission requirements
p.(None): • An investigator’s brochure which provides an adequate summary of all safe- ty, pharmacological, pharmaceutical, and
p.(None): toxicological data available on the study product, together with a summary of the clinical experience of the study
p.(None): product (e.g. recent investigator’s brochure, published data, summary of the product’s characteristics, etc.), must
p.(None): also be submitted.
p.(None): • If the trial involves an investigational product, prior approval and permission to import the investigational
p.(None): product must be obtained from FMHACA.
p.(None): • Information on payment and compensation available for research participants for time lost and injury or harm as a
p.(None): result of participating in the research; Insurance certificate covering research-related injuries of participants and
p.(None): er- rors in protocol implementation,
p.(None): • The PIs should attach a certificate of Good Clinical Practice (GCP), and a
p.(None): 48 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): certificate of Good Manufacturing Practice (GMP), based on the nature of the research. The investigator must assure
p.(None): that the clinical monitor and the IRB will have access to the participant’s file to verify trial procedures and data
p.(None): are kept in accordance with the approved protocol. This should be stated in the participant information sheet.
p.(None): Additionally, the research participant should be told that by signing the informed consent, the participant is
p.(None): permitting access to the file by the clinical monitor and the IRB.
p.(None): • SOPs for the trial; AE reporting format
p.(None): • The investigator should affirm that he/she has sufficient time to conduct and monitor the trial, as well as to
p.(None): submit progress reports on time,
p.(None): 8.3.1.2 Investigator’s File
p.(None): The investigator must prepare a file containing documents related to the trial. During the study, the investigator is
p.(None): responsible for updating the file and regularly adding trial-related documents. Identification codes of subjects shall
p.(None): be kept for 10 years.
p.(None): The Investigator’s File should contain, at the minimum:
p.(None): • Local regulatory requirements
p.(None): • IRB and other authorities’ written approval for all documents
p.(None): • IRB and other authorities’ written approval for protocol amendments
p.(None): • Correspondence with the IRB
p.(None): • Approved protocol and amendments
p.(None): • All signed and dated informed consent forms
p.(None): • Investigator’s and Co-investigators’ CVs
p.(None): • Copy of the insurance certificate/other insurance
p.(None): • Investigator’s SOPs
p.(None): • Notification and documentation of serious adverse events
p.(None): • Specimen management procedures, trial supplies/equipment
p.(None): • Participant identification list
p.(None): • Investigator interim and final report/summary of the trial
p.(None): 8.3.1.3 Participant File
p.(None): The participant file should, at the minimum, contain the following original information:
p.(None): • Subject identification: family name, given name, date of birth, sex, and identifi- cation number in the trial
p.(None): • Protocol identification number/study reference
p.(None): • Dates of first screening and/or enrolment in the trial
p.(None):
...
p.(None): 8.3.4 Collaborative Research
p.(None): Collaborative research is research that is conducted by investigators from more than one institution. If one of the
p.(None): collaborating institutions or investigators is based outside of Ethiopia, then, the research is termed “international
p.(None): collaborative research”.
p.(None): There are different potential reasons for conducting collaborative research. The rea- sons may include greater
p.(None): prevalence, convenience of or familiarity with the setting and the researchers, scientific or public health
p.(None): justification, and the research question or intervention is only relevant to the type of health problem in Ethiopia.
p.(None): Hence, the reason for choosing to conduct the research in Ethiopia should be explicitly stated.
p.(None): National Research Ethics Review Guideline Fifth Edition 53
p.(None):
p.(None): 8.3.4.1 Requirements
p.(None): International collaborative research should be in line with the health research prior- ities of Ethiopia.
p.(None): The research must be consistent with the Health Science and Technology Policy and must be responsive to the health
p.(None): needs of Ethiopians.
p.(None): The research should contribute towards strengthening national research capacity to carry out similar research
p.(None): independently, including providing research ethics training to members of the investigation team.
p.(None): The sponsor/donor should agree in advance that products will be made reasonably available after completion of the
p.(None): study, and the community must have access to the fruits of research.
p.(None): All collaborative research must have a Principal Investigator or a Co-PI actively work- ing in Ethiopia. Also, the PI
p.(None): or Co-PI must be employed or affiliated to a recognized institution or organization in Ethiopia. The research procedure
p.(None): should consider, to the extent possible, socio-cultural conditions in the community where the research is presumed to
p.(None): be conducted.
p.(None): In all collaborative research, all involved institutions are required to review and write a recommendation of approval
p.(None): before submission to IRBs mandated to review and approve such collaborative research. In the event the involved
p.(None): institutions do not have a functioning IRB, the research protocol and other documents can be submitted directly to any
p.(None): of the IRBs mandated to review and approve collaborative research.
p.(None): However, to avoid duplication of review efforts by IRBs, the NRERC may choose to conduct joint reviews in part or in
p.(None): whole, accept the review of another qualified IRB, or make other arrangements to establish oversight responsibilities.
p.(None): Adoption of a paternalistic approach by research sponsors/donors towards institutions in Ethiopia or the research
p.(None): priorities of the government, is unacceptable.
p.(None): 8.3.4.2 Monitoring
p.(None): When conducting collaborative research studies, each institution is responsible for safeguarding the rights and welfare
p.(None): of human participants and for complying with all applicable regulations. The IRB that reviewed and approved the
p.(None): collaborative research is primarily responsible for monitoring the ethical conduct of the research procedures. However,
...
p.(None): Reviewer Name:
p.(None): Criteria/Item Rating
p.(None): 1. Consent Form Yes
p.(None): • Does the consent form contain all the necessary information Requires revision
p.(None):
p.(None): that the subject should be aware of?
p.(None):
p.(None):
p.(None): 2. Are the objectives of the study clearly stated?
p.(None):
p.(None): 3. Are the methods ethically sound?
p.(None): No
p.(None): Not applicable
p.(None): Not attached
p.(None): Yes
p.(None): No
p.(None): Yes
p.(None): (in respect to Beneficence, Justice and Respect for Person) Not well described
p.(None): No
p.(None): 4. Are provisions to overcome risks well described and acceptable? Yes
p.(None):
p.(None): • DSMC
p.(None):
p.(None): 5. Are there provisions to provide standard/best proven care?
p.(None): No
p.(None): Not applicable
p.(None): Yes
p.(None): No
p.(None): Not applicable
p.(None): 6. Are the safety procedures in the use of vaccines, drugs and Yes
p.(None):
p.(None): other biological products acceptable?
p.(None):
p.(None): 7. Are the procedures to keep confidentiality well described?
p.(None): No
p.(None): Not applicable
p.(None): Yes
p.(None): No
p.(None): Not applicable
p.(None): 8. Are the proposed researchers competent to carry out the study Yes
p.(None):
p.(None): in a scientifically sound manner?
p.(None):
p.(None):
p.(None): 9. Does it have material Transfer Agreement?
p.(None): No
p.(None): Not applicable
p.(None): Unable to access
p.(None): Yes
p.(None): No
p.(None): Not applicable
p.(None):
p.(None): Recommendation Remarks (If any)
p.(None): Approved Approved on Conditions Not Approved
p.(None): (Please use additional paper if you comments to forward)
p.(None): 88 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): Appendix VI. Material Transfer Agreement Form
p.(None): Ministry of Science and Technology, Federal Democratic Republic of Ethiopia National Research Ethics Review Committee
p.(None):
p.(None): Address: Tel.: +251011-4-674353 P.O. Box: 2490 Fax: +251-011-4-660241
p.(None): e-mail:
p.(None): Addis Ababa –Ethiopia
p.(None):
p.(None): Annex #: Material Transfer Agreement
p.(None):
p.(None): This Material Transfer Agreement (MTA) has been prepared for use by and in
p.(None): all transfer of research material (samples, derivatives, and speci- mens) related to the protocol.
p.(None):
p.(None): Provider:
p.(None): Recipient:
p.(None):
p.(None): 1. Provider agrees to transfer to recipient’s designated ( ) the following research materials
p.(None): /specimen.
p.(None):
p.(None): The research material will only be used for research purposes as described in the protocol by recipient’s investigator
p.(None): in designated laboratory for the research project described below, under suitable containment conditions. This
p.(None): research material will not be used for commercial purposes such as screening, production or sale for which a
p.(None): commercialization license may be required. Recipient agrees to comply with all National and International guidelines
p.(None): rules and regulations appli- cable to the Research Project and the handling of the Research Material.
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Social / Age
Searching for indicator age:
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p.(None): participants may include pregnant women where fetuses, fetal material, or abortuses are the primary subjects of
p.(None): interest. Similarly, research involving autopsy materials shall also be in- cluded as source of data.
p.(None): The main purpose of health research involving human participants is for better un- derstanding of the etiology,
p.(None): pathogenesis, and pathophysiology of disease and the related diagnostic, preventive, promotive, and therapeutic
p.(None): procedures and measures. Moreover, as evidence-based practice has become necessary at the turn of the 21st century, and
p.(None): quite understandably, existing procedures and practices are challenged continuously for their effectiveness,
p.(None): efficiency, quality, accessibility, and acceptability by the community.
p.(None): However, in the quest to ensure better health and knowledge, the rights and welfare of research participants must be
p.(None): protected at all times. Participation must be voluntary and free of coercion, persuasion, manipulation, deception,
p.(None): undue influence or induce- ment, and threat or intimidation. The information shall be obtained in a private setting
p.(None): whenever necessary and confidentiality maintained throughout the lifetime of the re- search. This is even more
p.(None): important when research involves participants whose com- prehension and decision making is compromised because of age,
p.(None): lack of knowledge on medical concepts and technological terms, or severe mental or behavioral disorders.
p.(None): For all research involving human participants and human biological materials/speci- mens, investigators should be aware
p.(None): of, and are obligated to, respect and adhere to all ethical, legal, and regulatory requirements applicable in Ethiopia.
p.(None): In this rapidly advancing, complex, and sophisticated era of genetic studies, preven- tive, diagnostic, and therapeutic
p.(None): clinical trials, as well as collaborative research and human biological material transfer being common place, oversight
p.(None): and regulation is imperative to properly safeguard the rights and welfare of human research subjects.
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 15
p.(None):
p.(None): For research to be ethical, all of the following eight criteria must be met:
p.(None): 1. Ethical justification and scientific validity: The research must be rigorous in its methodology. For
p.(None): research to be ethical, the methods must be valid and practically feasible, the research must have a clear objective,
p.(None): be designed using sound scientif- ic principles, have sufficient statistical power, and be based on adequate knowledge
p.(None): of the scientific literature.
p.(None): 2. Science and social value: The proposed protocol should demonstrate valid scientific basis/ground, enhance health
p.(None): or generalizable knowledge, and benefit individuals and the community where the research is conducted. However, the
p.(None): research partic- ipants’ rights and welfare outweigh any benefit to the society or gain in knowledge.
...
p.(None): issues, specifically that no harm will be done and no resources wasted in the name of research, regardless of the
p.(None): research ques- tion planned for exploration. However, in certain circumstances, the weight given to each of these
p.(None): three basic ethical principles may differ in accordance with the type of the research and the setting where the
p.(None): research is conducted. Nevertheless, the IRB should ensure that the following basic ethics principles are met.
p.(None): 3.1 Respect for Persons
p.(None): Out of respect, participants must be informed about the research and allowed to decide about participation. Research
p.(None): participants unable to make decisions inde- pendently deserve extra protection.
p.(None): 3.1.1. Autonomy - This principle aspires to protect the interests of hu- man research participants from physical,
p.(None): psychological, and cultural harm. It refers to the obligation on the part of the investigator to respect each
p.(None): research participant as a person capable of making an informed decision regarding participation in the research
p.(None): study. It obligates in- vestigators to respect the right of human subjects to hold their views, make
p.(None): choices and take actions without controlling influences. For human subjects who are not capable of making an informed
p.(None): decision because of age, mental, or medical capacity, the next of kin or guardian shall make the decision in the best
p.(None): interest of the research participant.
p.(None): 3.1.2. Informed Consent – The importance of informed consent of research participants is unquestionable and
p.(None): the informed consent should be analyzed in terms of containing the basic elements of information, com- prehension,
p.(None): competence, disclosure, and voluntarism. Information shall be given in writing and signed or verbally approved by the
p.(None): research par- ticipant. The information to be provided should be written in a way that considers the local culture and
p.(None): values, as well as the level of understanding of the research participant. The information provided should weigh the
p.(None): re- search participants’ competence. When informed consent is that of a third party (proxy; parent, next-of-kin,
p.(None): legally authorized representative (LAR), the reasons for the indirect approach shall be stated and become part of the
p.(None): protocol.
p.(None): Research participants or persons giving proxy consent cannot give full informed consent unless the consent process/form
p.(None): contains adequate information. All such information shall be expressed in a language that is understandable to the
...
p.(None): remove harm, and maximize the benefit to re- search participants and to the community, or both.
p.(None): 3.3 Justice
p.(None): Justice connotes fairness and equity in the distribution of the benefits and burdens of research to participants.
p.(None): 3.3.1. Justice demands equitable selection of participants, i.e., avoiding popu- lations that may be unfairly coerced
p.(None): into participating, including but not limited to, prisoners, pregnant women, people with mental and physical
p.(None): disabilities, immigrants, refugees, ethnic minorities, marginalized groups and institutionalized persons, including
p.(None): children. There must be a justi- fication for inclusion of these vulnerable groups in the research. There should be no
p.(None): disproportionate use of vulnerable populations. The same recruitment approach should be used in all populations.
p.(None): Injustice may arise when selecting participants from a specific socio-economic class, age, sex, racial, cultural,
p.(None): religious, creed, and institutional make up.
p.(None): 3.3.2. The principle of justice requires equality in the distribution of benefits and burdens among the population
p.(None): groups likely to benefit from the research. Distributive justice means that no segment of the population should be
p.(None): unfairly burdened with the harms of research. It thus imposes particular obligations toward individuals who are
p.(None): vulnerable and unable to protect their own interests. Conversely, distributive justice imposes duties neither to
p.(None): neglect nor discriminate against individuals and groups who may ben- efit from advances in research.
p.(None): 3.3.3. Justice also demands balancing the benefits and burdens to the commu- nity where the research is undertaken.
p.(None): 3.3.4. In addition, the investigators shall assure that information obtained in the course of the investigation
p.(None): remains confidential to protect partici-
p.(None): 22 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): pants from possible harm. Data unlinked from individuals or groups does not jeopardize confidentiality. The privacy of
...
p.(None): community representative.
p.(None): 5.9.7. Following registration, a letter of accreditation shall be given to IRBs by the Secretariat.
p.(None):
p.(None): 6. Establishment, Functions, Review Procedures
p.(None): 6.1 Definition
p.(None): Institutional Review Boards (IRBs) are independent committees established in an in- stitution to conduct initial and
p.(None): continuing review of research projects with the primary goal of protecting the rights and welfare of research
p.(None): participants. All institutions in Ethiopia that conduct research involving humans as research participants should set
p.(None): up IRBs in accordance with these guidelines. Where an institution cannot set up an IRB, that institution may rely on an
p.(None): IRB of another institution to review their research projects, provided the IRB is registered by the National IRB.
p.(None): 6.2 Establishment
p.(None): 6.2.1 Appointing Authority
p.(None): • The Head of the Institution is the authority responsible for the appointment of IRB members. In cases where
p.(None): members come from diverse institutions, the appointment should be upon the recommendation of the institution where the
p.(None): potential IRB member is based.
p.(None): • Members are selected in their personal capacities based on their scientific knowledge and expertise, as
p.(None): well as on their commitment and willingness to volunteer the necessary time and efforts for the Board’s function.
p.(None): • Appointments should consider age and gender distribution, and relevant but diverse professional
p.(None): representation.
p.(None): • The appointing authority should write an appointment letter to the prospective member inviting him/her to be a
p.(None): member of the IRB.
p.(None): • Members will sign a confidentiality agreement and conflict of interest (COI) form.
p.(None): 6.2.2 Applying to Establish an IRB
p.(None): An institution that needs to establish an IRB shall apply in writing for approval and reg- istration at the National
p.(None): Secretariat at MoST, and include the following requirements:-
p.(None): • Statement that the IRB will follow the guidelines as stipulated in this document, law, relevant regulations.
p.(None): • A list of IRB members identified by name, qualifications, profession, current
p.(None): 30 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): CV, representative capacity; any changes, in due process or in IRB membership must be reported to the secretariat.
p.(None): • Written SOPs for the activities of the IRB: composition of IRB members; con- ducting initial and continuing review
p.(None): of research, and for reporting its sugges- tions/opinion and decisions to the investigator and the institution;
p.(None): expedited review process; follow-up and monitoring of approved studies.
p.(None): • The NRERC Secretariat presents the application to the NRERC who shall ex- amine the institution’s application, and
p.(None): if satisfied, will recommend to MoST for endorsement of the registration and authorize in writing, the establishment of
p.(None): the IRB. The process of application and response from MoST should not exceed three months.
p.(None): 6.3 Composition
p.(None): The IRB should consist of a reasonable number of members, who collectively have the qualifications and experience
p.(None): to review and evaluate the science, medical as- pects, and ethics of the proposed research.
p.(None): • Each IRB shall be composed of at least five (5) members, with varying back- grounds to ensure complete and robust
p.(None): review of research activities commonly conducted by the institution. It must be multidisciplinary and multi-sectoral in
p.(None): composition, including persons with relevant but diverse scientific expertise, balanced age and gender
p.(None): distribution, and who have the qualifications and ex- perience to review and evaluate the scientific and
p.(None): medical ethics aspects of research protocols.
p.(None): • All IRBs shall have at least one member whose main area of expertise is in the scientific field and at least one
p.(None): member whose primary area of expertise is in a non-scientific field.
p.(None): • Each IRB shall include at least one member who is not otherwise affiliated with the institution or have a close
p.(None): family member working in the institution.
p.(None): • The IRB should have at least one community representative, who does not nec- essarily have to have any scientific
p.(None): expertise, but may be a layperson that rep- resents the interests and concerns of members of the community and is
p.(None): familiar with the community’s values, customs, traditions, and culture.
p.(None): • If an IRB regularly reviews research that involves vulnerable populations, such as children, prisoners, pregnant
p.(None): women, men/women in uniform or persons with disabilities, marginalized group, refuges, minorities, the IRB shall
p.(None): involve or co- opt one or more individuals who are knowledgeable about and experienced in working with these research
p.(None): participants.
...
p.(None): • A statement that the study involves research, the purpose of the re- search, the expected duration of participants’
p.(None): involvement and identifi- cation of any experimental procedures.
p.(None): • Foreseeable risks and discomforts.
p.(None): • Reasonably expected benefits to the participants as well as the community.
p.(None): • Disclosure of appropriate alternatives procedures or treatments.
p.(None): • Extent to which confidentiality will be maintained.
p.(None): • Compensation for possible injury if the research is greater than minimal risk; if so, an explanation is needed as to
p.(None): whether any medical treat- ments are available if injury occurs and what they consist of, or where further information
p.(None): may be obtained.
p.(None): • An explanation of whom to contact for answers to pertinent questions about the research and research
p.(None): participants’ rights, and whom to contact in the event of a research-related injury to the participant; A statement
p.(None): that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the
p.(None): participant is oth- erwise entitled. The consent form should also clearly indicate that re- search participants are
p.(None): free to withdraw from the study at any time and that the participant may discontinue participation at any time without
p.(None): penalty or loss of benefits. Research participants also are not obliged to respond to all questions in a study
p.(None): questionnaire.
p.(None): 6.14 Assent
p.(None): Assent will be sought from a study participant under the age of 18 years old. The minor child should be given
p.(None): appropriate information based on the child’s level of comprehen- sion whatever the complexity of the research
p.(None): procedures. Then, an assent, a child’s affirmative agreement to participate in research shall be sought from all
p.(None): children 12 years of age and above, in addition to the consent of a parent, next-of-kin, or guardian.
p.(None): 6.15 Waiver of Informed Consent Documentation
p.(None): Waiver of informed consent or documentation of informed consent should be ap- proved by the IRB. The investigator must
p.(None): secure an explicit waiver of consent from the IRB. The IRB may waive some or all of the elements of an informed consent
p.(None): and/
p.(None):
p.(None): 38 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): or a signed or thumb printed consent form for some or all of the research participants of a particular study, if the
p.(None): IRB determines that:
p.(None): • The research project carries no more than minimal risk, If the research or demonstration project is
p.(None): to be conducted or approved by federal or regional government and is designed to study, evaluate, or otherwise
p.(None): explore public ben- efit or service programs; possible changes in or alternatives to those programs; possible changes
p.(None): in methods or levels of payment for benefits or services under those programs.
p.(None): • The research project could not practically be carried out without the waiver or alteration (whenever appropriate the
...
p.(None): • The investigator should regularly submit a progress report; the progress report should include reports of the DSMB.
p.(None): 8.3.1.5 Medical Care for Trial Subjects
p.(None): • The highest available standard of care shall be provided to trial participants
p.(None): • In international collaborative research, the care should be equivalent to the care provided in the country where the
p.(None): sponsor or the collaborating institution is based.
p.(None): • Adequate/standard medical care should be offered to participants for adverse events.
p.(None): 8.3.1.6 In case the trial is terminated or suspended prematurely, for any reason:
p.(None):
p.(None): • The research participants must be informed with assurance of continuing care and treatment.
p.(None):
p.(None): • The IRB and the sponsor should be informed as soon as possible.
p.(None): 8.3.1.7 In randomized, double-blinded trials, premature unblinding:
p.(None):
p.(None): • The code may be broken because of serious adverse event, if deemed necessary by the DSMB during interim report,
p.(None):
p.(None): • Must be documented in the file and reported to the clinical monitor immediately.
p.(None):
p.(None):
p.(None): 50 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): 8.3.2 Genetic Research
p.(None): Genetics Studies
p.(None): Genetic screening should be distinguished from genetic testing at the outset. The terms are often used interchangeably,
p.(None): although they represent two different forms of genetic practice. Genetic screening is carried out on groups of people,
p.(None): which could consist of a section of the population defined by age, sex, or other risk factor, or a subgroup within the
p.(None): population, or within broad groups in which genetic factors may be responsible for certain disabilities.
p.(None): Genetic Research: is defined as research conducted by investigators solely for the purpose of generating
p.(None): scientific knowledge about genes and/or the genetic basis of disease. Genetic data can be used for medical diagnosis,
p.(None): disease prevention, and population genetics studies.
p.(None): Genetic Testing: A procedure to detect the presence or absence of, or change in, a particular gene or chromosome,
p.(None): including an indirect test for a gene product or other specific metabolite that is primarily indicative of a specific
p.(None): genetic change.
p.(None): Genetic Screening: Large-scale systematic genetic testing offered in a program to a population or subsection thereof
p.(None): intended to detect genetic characteristics in asymp- tomatic people;
p.(None): Genetic Counseling: A procedure to explain the possible implications of the findings of genetic testing or screening,
p.(None): its advantages and risks and where applicable to assist the individual in the long-term handling of the consequences;
p.(None): It takes place before and after genetic testing and screening:
p.(None): • The protocol submitted should contain enough information on background, na- ture and scientific justification for
p.(None): the proposed study.
p.(None): • In genetic studies involving acquisition of biological samples, the procedure to be used to obtain samples, the type
p.(None): and amount/size should be clearly stated. Issue of identifiers and how confidentiality will be maintained should be
p.(None): addressed.
p.(None): • The collection, processing, handling, storage, transfer, and destruction of human biological materials and data
...
p.(None): • Anxiety and distress: qualitative research is aimed at in-depth understanding of sensitive topics with
p.(None): exploration of reasons and resilient issues. Involves open-ended questions and probing that give room for
p.(None): unexpected themes and variety of responses in the participant’s own terms. Besides, responses are in- timately
p.(None): dependent upon the context of the participants’ beliefs, values, behav- iors and actions. Hence, qualitative research
p.(None): possesses higher risk of anxiety and distress. Moreover, the differing experience of the participants largely makes
p.(None): 52 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): predicting who may experience the anxiety and distress difficult/problematic.
p.(None): • Intrusion in life: exploring behavior related to health may require observation of participants at various places
p.(None): including the household, and sometimes, for a prolonged period of time.
p.(None): • Exploitation: power imbalance between the researcher and the subject, or ex- erting undue influence.
p.(None): • Misrepresentation: participants’ opinion are taken out of context or interpreted in the researcher’s perspective,
p.(None): dynamics of the qualitative interviews and the nature of data collected can be affected by the professional background
p.(None): of the researcher.
p.(None): • Identification of participant: (by self or others) in published papers due to clues provided to describe the
p.(None): participant’s age, gender, educational and economic status, place of residence, profession, etc.
p.(None): Hence, to minimize these risks of harm, the following ethical issues should be given special emphasis during protocol
p.(None): review, conduct, and monitoring of qualitative re- search:
p.(None): • Ensuring scientific soundness
p.(None): • Organizing follow-up care where appropriate
p.(None): • Considering obtaining consent as a process that should be subject to negotiation during and even after the end of
p.(None): the interview; the informed consent process should include auhorization of recording (audio, video) of interviews,
p.(None): focus group discussions, and observations.
p.(None): • Ensuring confidentiality through securing storage of audio and video tapes and transcripts.
p.(None): • Making ‘respondent validation’ of the researcher’s analysis before dissemination of the research findings.
p.(None): • Publicizing the research before commencement such that the community is aware of the observation that can be in
p.(None): public domains: at market places, sport events, brothels, theatres, etc. In such cases, the IRB may decide waiver of
p.(None): consent and documentation of consent.
p.(None): 8.3.4 Collaborative Research
p.(None): Collaborative research is research that is conducted by investigators from more than one institution. If one of the
p.(None): collaborating institutions or investigators is based outside of Ethiopia, then, the research is termed “international
p.(None): collaborative research”.
...
p.(None): • Previous research provides data to assess potential risks to neonates.
p.(None): • Viability of the fetus should be determined by a health care provider who is not a member of the investigator team.
p.(None): • There should be no other means of obtaining the knowledge to be derived from the research.
p.(None): • There should be no added risk to the neonate due to the research.
p.(None): • The research is likely to enhance viability and survival.
p.(None): • Informed consent should be obtained from either of the parents.
p.(None): For, research involving dead fetuses or organs or tissues of the dead fetus:
p.(None): • There should be a prospect of important knowledge that can be possibly used in the prevention and treatment of
p.(None): similar or related conditions.
p.(None): • Informed consent should be obtained from either of the parents of the dead fetus.
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 55
p.(None):
p.(None): 8.3.5.3 Children
p.(None): Children are persons who have not attained the legal age for consent to treatments or procedures involved in research.
p.(None): The following apply in research involving children.
p.(None): • The child should provide assent in addition to the informed consent by a parent or guardian as stated in Section
p.(None): 6.14 above.
p.(None): • The research presents a realistic opportunity to further the understanding, preven- tion, or alleviation of a
p.(None): serious problem affecting the health or welfare of children.
p.(None): • Emancipated minors – working or earn their living, married, parenting – may be allowed to give an informed consent
p.(None): or an IRB may decide a waiver of consent.
p.(None): • In research related to sensitive topics like drug use and abuse, sexuality, repro- duction, STIs, where obtaining
p.(None): consent from a parent, next-of-kin, or guardian is challenging and may be problematic to the minor because of the
p.(None): nature of the research, assent with waiver of consent may be applicable.
...
p.(None): Adverse Event (AE)-Any untoward health-related occurrence in a participant admin- istered a health-research
p.(None): intervention and which does not necessarily have to have a causal relationship with this intervention. An AE can be any
p.(None): unfavorable and unin- tended sign, symptom, or condition temporally associated with the administration of the
p.(None): health-research intervention, whether or not considered related to the interven- tion. This also includes unfavorable
p.(None): deviations from baseline health.
p.(None): Amendment-A material change to study procedures. Such changes, including minor changes, must be reviewed by an IRB
p.(None): before they may be implemented.
p.(None): Anonymous/anonymized-Lacking identification because identifiers or other informa- tion that could identify the
p.(None): individual were not collected or were removed. Information may or may not be considered anonymous if there is a
p.(None): reasonable basis to believe that one can use the information to identify and individual, even if one cannot readily
p.(None): ascertain the individual’s identity; see further discussion at individually identifiable information. For example, it
p.(None): might be possible to determine a survey respondent’s identity from a combination of demographic factors in a survey
p.(None): together with public or proprietary data sources, even if the surveyor did not jointly record the respondent’s identity
p.(None): and those demographic characteristics..
p.(None): Approve/approval-The determination of the IRB that the research has been reviewed and may be conducted at an
p.(None): institution within the constraints set forth by the IRB and by other institutional and federal requirements.
p.(None): Assent-Participant not of legal age (i.e., child); affirmative agreement to participate in research. Mere failure to
p.(None): object should not be construed as assent.
p.(None): Autonomy-Self-rule that is free from both controlling interference by others and from limitations that prevent
p.(None): meaningful choice. See also respect for persons.
p.(None): Belmont Report-Statement of ethical principles and guidelines for the protection of
p.(None): National Research Ethics Review Guideline Fifth Edition 77
p.(None):
p.(None): human participants of research. The National Commission for the Protection of Hu- man Subjects of Biomedical and
p.(None): Behavioral Research published this report in 1979. The three principles are respect for persons, beneficence, and
p.(None): justice. See: https://www.hhs.gov/orhp[/humansubjects/guidance/belmont.htm
p.(None): Beneficence, principle of-Ethical precept asserting an obligation to prevent harm, to remove harm, or to do or
p.(None): promote good; two-part rule: (1) do not harm and (2) maximize possible benefits and minimize possible harms.
p.(None): Benefit-A potential advantage or gain.
p.(None): Breach of protocol-Material departure from approved procedures of the study, such as the consent process, violations
p.(None): of data confidentiality, or complaints by partici- pants; may be a reportable incident.
p.(None): Child/children-Person who has not attained the legal age for consent to treatments or procedures involved in the
p.(None): research, under the Ethiopian law
p.(None): Clinical trial-A prospective research study in human participants that is designed to answer specific questions about
p.(None): health-related interventions (such as medications, herbal supplements, nutritional strategies, physical interventions,
p.(None): behavioral inter- ventions, prevention trials, or diagnostic tools), particularly to determine whether these
p.(None): interventions are safe, efficacious, and effective.
p.(None): Close/closure-Proactively and permanently end both research-related intervention or interaction with participants and
p.(None): collection and use of identifiable private research information when study objectives have been met as specified in the
p.(None): protocol.
p.(None): Coded-Replacement of identifying information (such as name or social security number that would enable one to readily
p.(None): ascertain the identity of the individual to whom the private information or specimens pertain) with a number, letter,
p.(None): symbol, or combination thereof where a key to decipher the code exists and links the identifying information to the
p.(None): private information or specimens. In contrast with linked, coded often means that the link exists but is unavailable,
p.(None): as through a nondisclosure arrangement.
p.(None): Compensation-Payment to cover actual research-related harm. Where understandability is an issue, use a simpler word
p.(None): like “payment”. Contrast with incentive, reimbursement.
p.(None): Completion of study-Point at which data analysis has ended or identifying informa- tion is removed from the data and
p.(None): biological specimens. See also close.
p.(None): Comprehension–in this context, understanding what the study is about.
...
p.(None): Unrelated-Pertaining to an AE, the condition in which the event is due to a docu- mented cause other than research
p.(None): procedures.
p.(None): Verbal consent-Consent obtained by communication in words; this may include spo- ken or written format.
p.(None): Voluntary/voluntariness-Freedom from coercion and undue influence
p.(None): Vulnerable-Having reduced capacity to offer free and informed consent due to pos- sible coercion, undue influence,
p.(None): or other diminished autonomy, such as children, prisoners, pregnant women, mentally disabled persons, or
p.(None): economically or education- ally disadvantaged persons as vulnerable. Vulnerability may be associated with other
p.(None): characteristics such as age, health status, or social standing. The IRB must ensure additional safeguards protect the
p.(None): rights and welfare of vulnerable persons.
p.(None): Vulnerable population-A group identified by one or more common characteristics associated with reduced
p.(None): capacity to offer free and informed consent.
p.(None): Waive/waiver-Temporarily set aside the requirement of a particular rule, regulation, or condition in a protocol or
p.(None): consent document.
p.(None): Withdraw/withdrawal-Permanently halt a research study after submission for IRB review but before human
p.(None): participants become involved, whether or not the study has been reviewed by an IRB. This term has been replaced by the
p.(None): term close/closure.
p.(None):
p.(None):
p.(None):
p.(None): 84 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): Appendix III: NRERC Terms of Reference
p.(None): 1. Membership
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 2. Tenure
p.(None): The tenure of the NRERC shall be three years.
p.(None): 3. Replacement of Missing Members
p.(None): Whenever a member is absent for three consecutive meetings without valid reasons, the Ministry will be notified of
p.(None): his/her absence and requested for replacement.
p.(None): 4. Meetings
...
Social / Child
Searching for indicator child:
(return to top)
p.(None): • A statement that the study involves research, the purpose of the re- search, the expected duration of participants’
p.(None): involvement and identifi- cation of any experimental procedures.
p.(None): • Foreseeable risks and discomforts.
p.(None): • Reasonably expected benefits to the participants as well as the community.
p.(None): • Disclosure of appropriate alternatives procedures or treatments.
p.(None): • Extent to which confidentiality will be maintained.
p.(None): • Compensation for possible injury if the research is greater than minimal risk; if so, an explanation is needed as to
p.(None): whether any medical treat- ments are available if injury occurs and what they consist of, or where further information
p.(None): may be obtained.
p.(None): • An explanation of whom to contact for answers to pertinent questions about the research and research
p.(None): participants’ rights, and whom to contact in the event of a research-related injury to the participant; A statement
p.(None): that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the
p.(None): participant is oth- erwise entitled. The consent form should also clearly indicate that re- search participants are
p.(None): free to withdraw from the study at any time and that the participant may discontinue participation at any time without
p.(None): penalty or loss of benefits. Research participants also are not obliged to respond to all questions in a study
p.(None): questionnaire.
p.(None): 6.14 Assent
p.(None): Assent will be sought from a study participant under the age of 18 years old. The minor child should be given
p.(None): appropriate information based on the child’s level of comprehen- sion whatever the complexity of the research
p.(None): procedures. Then, an assent, a child’s affirmative agreement to participate in research shall be sought from all
p.(None): children 12 years of age and above, in addition to the consent of a parent, next-of-kin, or guardian.
p.(None): 6.15 Waiver of Informed Consent Documentation
p.(None): Waiver of informed consent or documentation of informed consent should be ap- proved by the IRB. The investigator must
p.(None): secure an explicit waiver of consent from the IRB. The IRB may waive some or all of the elements of an informed consent
p.(None): and/
p.(None):
p.(None): 38 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): or a signed or thumb printed consent form for some or all of the research participants of a particular study, if the
p.(None): IRB determines that:
p.(None): • The research project carries no more than minimal risk, If the research or demonstration project is
p.(None): to be conducted or approved by federal or regional government and is designed to study, evaluate, or otherwise
p.(None): explore public ben- efit or service programs; possible changes in or alternatives to those programs; possible changes
...
p.(None): • The research is likely to enhance viability and survival.
p.(None): • Informed consent should be obtained from either of the parents.
p.(None): For, research involving dead fetuses or organs or tissues of the dead fetus:
p.(None): • There should be a prospect of important knowledge that can be possibly used in the prevention and treatment of
p.(None): similar or related conditions.
p.(None): • Informed consent should be obtained from either of the parents of the dead fetus.
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 55
p.(None):
p.(None): 8.3.5.3 Children
p.(None): Children are persons who have not attained the legal age for consent to treatments or procedures involved in research.
p.(None): The following apply in research involving children.
p.(None): • The child should provide assent in addition to the informed consent by a parent or guardian as stated in Section
p.(None): 6.14 above.
p.(None): • The research presents a realistic opportunity to further the understanding, preven- tion, or alleviation of a
p.(None): serious problem affecting the health or welfare of children.
p.(None): • Emancipated minors – working or earn their living, married, parenting – may be allowed to give an informed consent
p.(None): or an IRB may decide a waiver of consent.
p.(None): • In research related to sensitive topics like drug use and abuse, sexuality, repro- duction, STIs, where obtaining
p.(None): consent from a parent, next-of-kin, or guardian is challenging and may be problematic to the minor because of the
p.(None): nature of the research, assent with waiver of consent may be applicable.
p.(None): • In institutional children, a legally approved guardian may give consent.
...
p.(None): intervention and which does not necessarily have to have a causal relationship with this intervention. An AE can be any
p.(None): unfavorable and unin- tended sign, symptom, or condition temporally associated with the administration of the
p.(None): health-research intervention, whether or not considered related to the interven- tion. This also includes unfavorable
p.(None): deviations from baseline health.
p.(None): Amendment-A material change to study procedures. Such changes, including minor changes, must be reviewed by an IRB
p.(None): before they may be implemented.
p.(None): Anonymous/anonymized-Lacking identification because identifiers or other informa- tion that could identify the
p.(None): individual were not collected or were removed. Information may or may not be considered anonymous if there is a
p.(None): reasonable basis to believe that one can use the information to identify and individual, even if one cannot readily
p.(None): ascertain the individual’s identity; see further discussion at individually identifiable information. For example, it
p.(None): might be possible to determine a survey respondent’s identity from a combination of demographic factors in a survey
p.(None): together with public or proprietary data sources, even if the surveyor did not jointly record the respondent’s identity
p.(None): and those demographic characteristics..
p.(None): Approve/approval-The determination of the IRB that the research has been reviewed and may be conducted at an
p.(None): institution within the constraints set forth by the IRB and by other institutional and federal requirements.
p.(None): Assent-Participant not of legal age (i.e., child); affirmative agreement to participate in research. Mere failure to
p.(None): object should not be construed as assent.
p.(None): Autonomy-Self-rule that is free from both controlling interference by others and from limitations that prevent
p.(None): meaningful choice. See also respect for persons.
p.(None): Belmont Report-Statement of ethical principles and guidelines for the protection of
p.(None): National Research Ethics Review Guideline Fifth Edition 77
p.(None):
p.(None): human participants of research. The National Commission for the Protection of Hu- man Subjects of Biomedical and
p.(None): Behavioral Research published this report in 1979. The three principles are respect for persons, beneficence, and
p.(None): justice. See: https://www.hhs.gov/orhp[/humansubjects/guidance/belmont.htm
p.(None): Beneficence, principle of-Ethical precept asserting an obligation to prevent harm, to remove harm, or to do or
p.(None): promote good; two-part rule: (1) do not harm and (2) maximize possible benefits and minimize possible harms.
p.(None): Benefit-A potential advantage or gain.
p.(None): Breach of protocol-Material departure from approved procedures of the study, such as the consent process, violations
p.(None): of data confidentiality, or complaints by partici- pants; may be a reportable incident.
p.(None): Child/children-Person who has not attained the legal age for consent to treatments or procedures involved in the
p.(None): research, under the Ethiopian law
p.(None): Clinical trial-A prospective research study in human participants that is designed to answer specific questions about
p.(None): health-related interventions (such as medications, herbal supplements, nutritional strategies, physical interventions,
p.(None): behavioral inter- ventions, prevention trials, or diagnostic tools), particularly to determine whether these
p.(None): interventions are safe, efficacious, and effective.
p.(None): Close/closure-Proactively and permanently end both research-related intervention or interaction with participants and
p.(None): collection and use of identifiable private research information when study objectives have been met as specified in the
p.(None): protocol.
p.(None): Coded-Replacement of identifying information (such as name or social security number that would enable one to readily
p.(None): ascertain the identity of the individual to whom the private information or specimens pertain) with a number, letter,
p.(None): symbol, or combination thereof where a key to decipher the code exists and links the identifying information to the
p.(None): private information or specimens. In contrast with linked, coded often means that the link exists but is unavailable,
p.(None): as through a nondisclosure arrangement.
p.(None): Compensation-Payment to cover actual research-related harm. Where understandability is an issue, use a simpler word
p.(None): like “payment”. Contrast with incentive, reimbursement.
...
p.(None):
p.(None): Expedited review-Review performed by the IRB Chair or a designated experienced member for research that involves no
p.(None): more than minimal risk and meets the criteria for expedited review or represents minor changes in approved research.
p.(None): Experienced reviewer -A member of an IRB who is designated by the Chair as autho- rized to conduct expedited reviews.
p.(None): Expert reviewer-A member of an IRB who is designated by the Chair as authorized to conduct expedited reviews.
p.(None): Expiration date-The expiration date is the day before the anniversary of the approval date – unless the IRB approves it
p.(None): for less than one year. For instance, a protocol approved on 12/4 has approval date of 12/4/06 and an expiration date
p.(None): of 12/3/07 midnight (which means research may be conducted on 12/3).
p.(None): Fetus-The product of conception from the time of implantation until delivery.
p.(None): Focus group-Group of individuals brought together to discuss an issue within a struc- tured environment, often for
p.(None): formative or qualitative research purposes.
p.(None): Generalizable knowledge-New information that has relevance beyond the population or program from which it was collected
p.(None): Good Clinical Practice (GCP)-An international ethical and scientific quality standard for designing, conducting,
p.(None): recording, and reporting trials that involve the participation of human participants. See also
p.(None): http://www.fda.gov/oc/gcp/default.htm.
p.(None): Guardian-An individual who is authorized under applicable local law to consent on behalf of a child to general medical
p.(None): care.
p.(None): Harm-Injury, damage, or hurt; an experience in which one’s interests are thwarted, defeated, or set back, especially
p.(None): one’s physical or psychological interests.
p.(None): Human subject/human participant-A living person about whom an investigator con- ducting research obtains (1) data
p.(None): through intervention or interaction with the in- dividual, or (2) identifiable private information (e.g., medical
p.(None): records, employment records, or school records).
p.(None): Identifiable private information-Information (data or biological specimens) such that the identity of a participant
p.(None): is or may readily be ascertained by the investigator or associated with the information, and either the information
p.(None): concerns behavior that occurs in a context in which an individual can reasonably expect that no observation or
p.(None): recording is taking place, or the information has been provided for specific purposes by an individual and which the
p.(None): individual can reasonably expect will not be made public.
p.(None): Incentive-Payment or other goods or services offered to motivate study participation.
p.(None): Incident-An instance of one of the following: an unanticipated problem involving risks to participants or
p.(None): others, serious or continuing noncompliance, or suspension or termination (for reasons other than expiration).
p.(None): Informed consent-The free and informed decision by a prospective participant or
p.(None): 80 National Research Ethics Review Guideline Fifth Edition
p.(None):
...
p.(None): greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine
p.(None): physical or psycholog- ical examinations or tests.
p.(None): Minor changes-Changes to a research protocol that do not result in a net increase in risk, a change in the harm-benefit
p.(None): balance, or provide minor clarification or correc- tion. Minor changes may be reviewed under expedited review, even if
p.(None): the protocol has been deemed to pose more than minimal risk to participants.
p.(None): Noncompliance-Failure by investigators, research staff, IRB members, or IRB staff to follow regulations for human
p.(None): research protections
p.(None): Oral consent-Consent obtained only through speaking, generally in the absence of documentation of consent. See also
p.(None): documentation of consent, informed con- sent, verbal consent.
p.(None): National Research Ethics Review Guideline Fifth Edition 81
p.(None):
p.(None): Parental permission-The agreement of a parent or guardian to the participation of their child in research.
p.(None): Personal identifier-Information obtained and recorded in such a manner that human participants can be recognized,
p.(None): directly or through links to the participants. Examples include names, social security numbers, and codes.
p.(None): Pilot study-Preliminary study to determine the feasibility of a larger study, use of a test instrument, or other
p.(None): activity.
p.(None): Pregnancy-The period of time from implantation until delivery. A woman shall be assumed to be pregnant if
p.(None): she exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until the results of a
p.(None): pregnancy test are negative or until delivery.
p.(None): Principal Investigator (PI)-Lead scientist who is working on the design of a research study, development of methods and
p.(None): procedures for the study, collection of data or specimens, analysis of data or specimens, or interpretation of data.
p.(None): Prisoner-Any individual involuntarily confined or detained in a penal institution. The term is intended to encompass
p.(None): individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other
p.(None): facilities by virtue of statutes or commit- ment procedures which provide alternatives to criminal prosecution or
p.(None): incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.
p.(None): Private information-information about individually identifiable behavior that occurs in a context in which the
...
Searching for indicator children:
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p.(None): psychological, emotional, economic, educational, legal, and social harm.
p.(None): In addition, beneficence includes whether the usual care is changed or manipulated to inflict no harm, minimize harm,
p.(None): remove harm, and maximize the benefit to re- search participants and to the community, or both.
p.(None): 3.3 Justice
p.(None): Justice connotes fairness and equity in the distribution of the benefits and burdens of research to participants.
p.(None): 3.3.1. Justice demands equitable selection of participants, i.e., avoiding popu- lations that may be unfairly coerced
p.(None): into participating, including but not limited to, prisoners, pregnant women, people with mental and physical
p.(None): disabilities, immigrants, refugees, ethnic minorities, marginalized groups and institutionalized persons, including
p.(None): children. There must be a justi- fication for inclusion of these vulnerable groups in the research. There should be no
p.(None): disproportionate use of vulnerable populations. The same recruitment approach should be used in all populations.
p.(None): Injustice may arise when selecting participants from a specific socio-economic class, age, sex, racial, cultural,
p.(None): religious, creed, and institutional make up.
p.(None): 3.3.2. The principle of justice requires equality in the distribution of benefits and burdens among the population
p.(None): groups likely to benefit from the research. Distributive justice means that no segment of the population should be
p.(None): unfairly burdened with the harms of research. It thus imposes particular obligations toward individuals who are
p.(None): vulnerable and unable to protect their own interests. Conversely, distributive justice imposes duties neither to
p.(None): neglect nor discriminate against individuals and groups who may ben- efit from advances in research.
p.(None): 3.3.3. Justice also demands balancing the benefits and burdens to the commu- nity where the research is undertaken.
p.(None): 3.3.4. In addition, the investigators shall assure that information obtained in the course of the investigation
...
p.(None): to review and evaluate the science, medical as- pects, and ethics of the proposed research.
p.(None): • Each IRB shall be composed of at least five (5) members, with varying back- grounds to ensure complete and robust
p.(None): review of research activities commonly conducted by the institution. It must be multidisciplinary and multi-sectoral in
p.(None): composition, including persons with relevant but diverse scientific expertise, balanced age and gender
p.(None): distribution, and who have the qualifications and ex- perience to review and evaluate the scientific and
p.(None): medical ethics aspects of research protocols.
p.(None): • All IRBs shall have at least one member whose main area of expertise is in the scientific field and at least one
p.(None): member whose primary area of expertise is in a non-scientific field.
p.(None): • Each IRB shall include at least one member who is not otherwise affiliated with the institution or have a close
p.(None): family member working in the institution.
p.(None): • The IRB should have at least one community representative, who does not nec- essarily have to have any scientific
p.(None): expertise, but may be a layperson that rep- resents the interests and concerns of members of the community and is
p.(None): familiar with the community’s values, customs, traditions, and culture.
p.(None): • If an IRB regularly reviews research that involves vulnerable populations, such as children, prisoners, pregnant
p.(None): women, men/women in uniform or persons with disabilities, marginalized group, refuges, minorities, the IRB shall
p.(None): involve or co- opt one or more individuals who are knowledgeable about and experienced in working with these research
p.(None): participants.
p.(None): • All IRB members should at the minimum take one basic training on bioethics within one year of appointment.
p.(None):
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 31
p.(None):
p.(None): 6.4 External Reviewers
p.(None): • If a protocol requires expertise that is beyond the competence of the IRB mem- bers or the IRB need additional
p.(None): opinion in the review process, the IRB may engage independent experts to review and give their opinion.
p.(None): • The Secretariat should keep an updated list of experts along with their CVs, which should be reviewed annually by
p.(None): the IRB.
p.(None): • Independent experts must sign privacy and confidentiality agreements and con- flict of interest (COI) forms to
p.(None): ensure that the information in the protocol is protected and that consultants do not have any conflicts.
p.(None): • The IRB may ask questions that could guide the review of the experts.
p.(None): • The expert may be invited to attend or consult by telephone an IRB meeting but he/she cannot vote in the meeting.
p.(None): 6.5 Independence of IRB
...
p.(None): professional, and market influences. They need similarly to demonstrate competence and efficiency in their work. They
p.(None): also need to ensure that there is regular evaluation of the ethics of ongoing studies that received a positive
p.(None): decision. Therefore, the functions of the IRB are:
p.(None): 6.12.1 Initial review
p.(None): The IRB must determine that the following requirements are satisfied before it ap- proves a research protocol:
p.(None): • Risks to subjects are minimized. Risk to subjects are reasonable in relation to anticipated benefit (if any) and the
p.(None): knowledge that is expected to result
p.(None): • Selection of subjects is equitable
p.(None): • Determine that informed consent will be sought from each prospective study participant, or the participants’ parent
p.(None): or guardian as appropriate
p.(None): • Determine that informed consent will be appropriately documented
p.(None): • Determine that there are adequate provisions to protect privacy of study partic- ipants and maintain confidentiality
p.(None): of all study related data
p.(None): • Determine that there are additional safeguards included in the study to protect the safety and welfare of study
p.(None): subjects who are likely to be vulnerable to coer- cion or undue influence such as such as children, prisoners, mentally
p.(None): disabled
p.(None): people, etc.
p.(None): 6.13 Informed Consent
p.(None): 6.13.1. The IRB must determine that the consent is documented using a written or verbal informed consent form,
p.(None): • The consent form should be approved by the IRB.
p.(None): • The consent form must be signed by the participant, or a parent, or next-of-kin or a guardian and by the individual
p.(None): that conducted the in- formed consent process.
p.(None): • In case the participant cannot read or write, a witness should sign that the consent process was carried out
p.(None): appropriately.
p.(None): National Research Ethics Review Guideline Fifth Edition 37
p.(None):
p.(None): • A copy of the signed informed consent form should be given to the study participant.
p.(None): 6.13.2. Research participants or persons giving proxy consent cannot give full informed consent unless the consent
...
p.(None): whether any medical treat- ments are available if injury occurs and what they consist of, or where further information
p.(None): may be obtained.
p.(None): • An explanation of whom to contact for answers to pertinent questions about the research and research
p.(None): participants’ rights, and whom to contact in the event of a research-related injury to the participant; A statement
p.(None): that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the
p.(None): participant is oth- erwise entitled. The consent form should also clearly indicate that re- search participants are
p.(None): free to withdraw from the study at any time and that the participant may discontinue participation at any time without
p.(None): penalty or loss of benefits. Research participants also are not obliged to respond to all questions in a study
p.(None): questionnaire.
p.(None): 6.14 Assent
p.(None): Assent will be sought from a study participant under the age of 18 years old. The minor child should be given
p.(None): appropriate information based on the child’s level of comprehen- sion whatever the complexity of the research
p.(None): procedures. Then, an assent, a child’s affirmative agreement to participate in research shall be sought from all
p.(None): children 12 years of age and above, in addition to the consent of a parent, next-of-kin, or guardian.
p.(None): 6.15 Waiver of Informed Consent Documentation
p.(None): Waiver of informed consent or documentation of informed consent should be ap- proved by the IRB. The investigator must
p.(None): secure an explicit waiver of consent from the IRB. The IRB may waive some or all of the elements of an informed consent
p.(None): and/
p.(None):
p.(None): 38 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): or a signed or thumb printed consent form for some or all of the research participants of a particular study, if the
p.(None): IRB determines that:
p.(None): • The research project carries no more than minimal risk, If the research or demonstration project is
p.(None): to be conducted or approved by federal or regional government and is designed to study, evaluate, or otherwise
p.(None): explore public ben- efit or service programs; possible changes in or alternatives to those programs; possible changes
p.(None): in methods or levels of payment for benefits or services under those programs.
p.(None): • The research project could not practically be carried out without the waiver or alteration (whenever appropriate the
...
p.(None): In research involving neonates with uncertain viability, the following must be met:
p.(None): • Previous research provides data to assess potential risks to neonates.
p.(None): • Viability of the fetus should be determined by a health care provider who is not a member of the investigator team.
p.(None): • There should be no other means of obtaining the knowledge to be derived from the research.
p.(None): • There should be no added risk to the neonate due to the research.
p.(None): • The research is likely to enhance viability and survival.
p.(None): • Informed consent should be obtained from either of the parents.
p.(None): For, research involving dead fetuses or organs or tissues of the dead fetus:
p.(None): • There should be a prospect of important knowledge that can be possibly used in the prevention and treatment of
p.(None): similar or related conditions.
p.(None): • Informed consent should be obtained from either of the parents of the dead fetus.
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 55
p.(None):
p.(None): 8.3.5.3 Children
p.(None): Children are persons who have not attained the legal age for consent to treatments or procedures involved in research.
p.(None): The following apply in research involving children.
p.(None): • The child should provide assent in addition to the informed consent by a parent or guardian as stated in Section
p.(None): 6.14 above.
p.(None): • The research presents a realistic opportunity to further the understanding, preven- tion, or alleviation of a
p.(None): serious problem affecting the health or welfare of children.
p.(None): • Emancipated minors – working or earn their living, married, parenting – may be allowed to give an informed consent
p.(None): or an IRB may decide a waiver of consent.
p.(None): • In research related to sensitive topics like drug use and abuse, sexuality, repro- duction, STIs, where obtaining
p.(None): consent from a parent, next-of-kin, or guardian is challenging and may be problematic to the minor because of the
p.(None): nature of the research, assent with waiver of consent may be applicable.
p.(None): • In institutional children, a legally approved guardian may give consent.
p.(None): 8.3.5.4 Prisoners
p.(None): Prisoners may be under constraints because of their incarceration which could affect their ability to make a truly
p.(None): voluntary and decision which is not coerced, whether or not to participate as subjects in research. Therefore,
p.(None): additional safeguards should be included in the study to protect the rights and welfare of these subjects, as follows:
p.(None): • If an IRB regularly reviews research that involves these vulnerable populations, consideration shall be given to the
p.(None): inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.
p.(None): • Where possible, a prisoner or an ex-prisoner co-opted in to the IRB reviewing the proposed research project should
p.(None): be included.
p.(None): • Only research on conditions particularly affecting prisoners as a class and with reasonable probability of improving
p.(None): the health and well-being of the research participants should be permissible.
p.(None): • The IRB shall determine that the informed consent process is properly applied with adequate assurance that a
p.(None): prisoner’s participation or refusal to participate will not be considered in decisions regarding his or her release or
...
p.(None): meaningful choice. See also respect for persons.
p.(None): Belmont Report-Statement of ethical principles and guidelines for the protection of
p.(None): National Research Ethics Review Guideline Fifth Edition 77
p.(None):
p.(None): human participants of research. The National Commission for the Protection of Hu- man Subjects of Biomedical and
p.(None): Behavioral Research published this report in 1979. The three principles are respect for persons, beneficence, and
p.(None): justice. See: https://www.hhs.gov/orhp[/humansubjects/guidance/belmont.htm
p.(None): Beneficence, principle of-Ethical precept asserting an obligation to prevent harm, to remove harm, or to do or
p.(None): promote good; two-part rule: (1) do not harm and (2) maximize possible benefits and minimize possible harms.
p.(None): Benefit-A potential advantage or gain.
p.(None): Breach of protocol-Material departure from approved procedures of the study, such as the consent process, violations
p.(None): of data confidentiality, or complaints by partici- pants; may be a reportable incident.
p.(None): Child/children-Person who has not attained the legal age for consent to treatments or procedures involved in the
p.(None): research, under the Ethiopian law
p.(None): Clinical trial-A prospective research study in human participants that is designed to answer specific questions about
p.(None): health-related interventions (such as medications, herbal supplements, nutritional strategies, physical interventions,
p.(None): behavioral inter- ventions, prevention trials, or diagnostic tools), particularly to determine whether these
p.(None): interventions are safe, efficacious, and effective.
p.(None): Close/closure-Proactively and permanently end both research-related intervention or interaction with participants and
p.(None): collection and use of identifiable private research information when study objectives have been met as specified in the
p.(None): protocol.
p.(None): Coded-Replacement of identifying information (such as name or social security number that would enable one to readily
p.(None): ascertain the identity of the individual to whom the private information or specimens pertain) with a number, letter,
p.(None): symbol, or combination thereof where a key to decipher the code exists and links the identifying information to the
p.(None): private information or specimens. In contrast with linked, coded often means that the link exists but is unavailable,
p.(None): as through a nondisclosure arrangement.
p.(None): Compensation-Payment to cover actual research-related harm. Where understandability is an issue, use a simpler word
p.(None): like “payment”. Contrast with incentive, reimbursement.
p.(None): Completion of study-Point at which data analysis has ended or identifying informa- tion is removed from the data and
...
p.(None): Declaration of Helsinki-A statement of ethical principles to provide guidance to phy- sicians and other participants in
p.(None): medical research involving human participants; ad- opted by the World Medical Assembly in 1964 and last updated in
p.(None): 2004. See http:// www.wma.net/e/policy/b3.htm.
p.(None): Disapprove/disapproval-The determination by the IRB that the research may not be conducted at an institution
p.(None): Documentation of consent-Consent that is documented by the use of a written con- sent form approved by the IRB and
p.(None): signed by the participant or the participant’s legally authorized representative.
p.(None): Emergency response-A public health activity undertaken in an urgent or emergency situation, usually because of an
p.(None): identified or suspected imminent health threat to the population, but sometimes because the public or government
p.(None): authorities perceive an imminent threat that demands immediate action. The primary purpose of the activity is to
p.(None): document the existence and magnitude of a public health problem in the community and to implement appropriate measures
p.(None): to address the problem (Langmuir, 1980).
p.(None): Exemption/exempt research-Categories of research to which the Federal regulations for human research protections do not
p.(None): apply. Research involving prisoners and some research involving children are not exempt.
p.(None): Expected-Pertaining to an AE, the event has been previously observed or documented in humans under the research
p.(None): intervention (or one substantially similar), and the nature or severity of the event is consistent with information in
p.(None): the relevant source documents (e.g., investigator’s brochure, package insert, or non-reportable events [NRE] list).
p.(None): National Research Ethics Review Guideline Fifth Edition 79
p.(None):
p.(None): Expedited review-Review performed by the IRB Chair or a designated experienced member for research that involves no
p.(None): more than minimal risk and meets the criteria for expedited review or represents minor changes in approved research.
p.(None): Experienced reviewer -A member of an IRB who is designated by the Chair as autho- rized to conduct expedited reviews.
p.(None): Expert reviewer-A member of an IRB who is designated by the Chair as authorized to conduct expedited reviews.
p.(None): Expiration date-The expiration date is the day before the anniversary of the approval date – unless the IRB approves it
p.(None): for less than one year. For instance, a protocol approved on 12/4 has approval date of 12/4/06 and an expiration date
p.(None): of 12/3/07 midnight (which means research may be conducted on 12/3).
p.(None): Fetus-The product of conception from the time of implantation until delivery.
p.(None): Focus group-Group of individuals brought together to discuss an issue within a struc- tured environment, often for
p.(None): formative or qualitative research purposes.
p.(None): Generalizable knowledge-New information that has relevance beyond the population or program from which it was collected
...
p.(None): intervention (or one substantially similar), the na- ture or severity of the event is not consistent with information
p.(None): in the relevant source documents (e.g., investigator’s brochure, package insert, or non-reportable events [NRE] list),
p.(None): or the event is observed with higher frequency than previously observed or documented. Expectedness does not entail the
p.(None): ability to predict results from in vitro, animal, or other pharmacological models.
p.(None): Unlinked-The condition of data or specimens which had been coded but for which the key linking the code to direct
p.(None): personal identifiers has been destroyed.
p.(None): Unrelated-Pertaining to an AE, the condition in which the event is due to a docu- mented cause other than research
p.(None): procedures.
p.(None): Verbal consent-Consent obtained by communication in words; this may include spo- ken or written format.
p.(None): Voluntary/voluntariness-Freedom from coercion and undue influence
p.(None): Vulnerable-Having reduced capacity to offer free and informed consent due to pos- sible coercion, undue influence,
p.(None): or other diminished autonomy, such as children, prisoners, pregnant women, mentally disabled persons, or
p.(None): economically or education- ally disadvantaged persons as vulnerable. Vulnerability may be associated with other
p.(None): characteristics such as age, health status, or social standing. The IRB must ensure additional safeguards protect the
p.(None): rights and welfare of vulnerable persons.
p.(None): Vulnerable population-A group identified by one or more common characteristics associated with reduced
p.(None): capacity to offer free and informed consent.
p.(None): Waive/waiver-Temporarily set aside the requirement of a particular rule, regulation, or condition in a protocol or
p.(None): consent document.
p.(None): Withdraw/withdrawal-Permanently halt a research study after submission for IRB review but before human
p.(None): participants become involved, whether or not the study has been reviewed by an IRB. This term has been replaced by the
p.(None): term close/closure.
p.(None):
p.(None):
p.(None):
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Social / Ethnicity
Searching for indicator ethnic:
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p.(None): result of being a research participant. Risks to research participants include physical, psychological, and emotional
p.(None): harm. Risks can be known or presumed. And, although no specific regulations exist, risks may include physical,
p.(None): psychological, emotional, economic, educational, legal, and social harm.
p.(None): In addition, beneficence includes whether the usual care is changed or manipulated to inflict no harm, minimize harm,
p.(None): remove harm, and maximize the benefit to re- search participants and to the community, or both.
p.(None): 3.3 Justice
p.(None): Justice connotes fairness and equity in the distribution of the benefits and burdens of research to participants.
p.(None): 3.3.1. Justice demands equitable selection of participants, i.e., avoiding popu- lations that may be unfairly coerced
p.(None): into participating, including but not limited to, prisoners, pregnant women, people with mental and physical
p.(None): disabilities, immigrants, refugees, ethnic minorities, marginalized groups and institutionalized persons, including
p.(None): children. There must be a justi- fication for inclusion of these vulnerable groups in the research. There should be no
p.(None): disproportionate use of vulnerable populations. The same recruitment approach should be used in all populations.
p.(None): Injustice may arise when selecting participants from a specific socio-economic class, age, sex, racial, cultural,
p.(None): religious, creed, and institutional make up.
p.(None): 3.3.2. The principle of justice requires equality in the distribution of benefits and burdens among the population
p.(None): groups likely to benefit from the research. Distributive justice means that no segment of the population should be
p.(None): unfairly burdened with the harms of research. It thus imposes particular obligations toward individuals who are
p.(None): vulnerable and unable to protect their own interests. Conversely, distributive justice imposes duties neither to
p.(None): neglect nor discriminate against individuals and groups who may ben- efit from advances in research.
...
p.(None): National Research Ethics Review Guideline Fifth Edition 69
p.(None):
p.(None): research, i.e., the higher the risk the shorter the reporting interval.
p.(None): 13.1.8. Shall promptly investigate serious adverse events and take appropriate measures to safeguard the safety of
p.(None): human subjects. The investigator shall inform such adverse events and measures taken, if any, to the IRB, clinical
p.(None): monitor and the sponsor.
p.(None): 13.1.9. Shall inform the IRB and obtain approval for any changes or amend- ments in the approved
p.(None): protocol/procedures except in circumstances where an apparent immediate hazard or danger to the research partic-
p.(None): ipants. Any amendment shall be appended to the approved research protocol.
p.(None): 13.1.10. Shall inform the IRB, clinical monitor, the sponsor and the participants if the study is terminated or
p.(None): suspended at any time during the research process.
p.(None): 13.1.11. Shall be responsible for periodic assessment of the quality of data man- agement as well as reporting on
p.(None): interim analysis whenever appropriate.
p.(None): 13.1.12. In case of clinical/experimental trials, shall ensure, at least, one of the investigators have a
p.(None): certificate on good clinical practice and/or good manufacturing practice or both or whichever is appropriate.
p.(None): 13.1.13. Shall ensure beneficial investigational products are available to the community after the research is
p.(None): completed.
p.(None): 13.1.14. Shall report to the DSMB, as applicable.
p.(None): 13.1.15. In collaborative research, shall consider the cultures and ethnic diver- sities and should make the research
p.(None): objectives particularly clear and remain aware of the concerns and welfare of the individuals or commu- nities to be
p.(None): studied.
p.(None): 13.1.16. Shall provide adequate information in all publications to the reader, and to colleagues to permit the methods
p.(None): and findings to be properly assessed. Limits of reliability and applicability should be made clear.
p.(None): 13.1.17. Shall submit final report and findings to the IRB.
p.(None): 13.1.18. Shall ensure the community where the research is conducted is in- formed about the research findings.
p.(None): 13.2 Host Institution
p.(None): The institution’s culture in which research is conducted strongly influence whether ethical conduct of research is
p.(None): supported or valued. The host institution must work closely with the investigator. The host institution shall monitor
p.(None): the investigator(s)’ research activities at the institution. More specifically, the host institution shall:
p.(None): 13.2.1. Ensure that the study design is scientific and ethical.
p.(None): 13.2.2. Ensure ethical implementation of the research.
p.(None): 70 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): 13.2.3. Comply with legal requirements and ethics regulations as stipulated in this guideline.
p.(None): 13.2.4. Ensure that the investigators conducting the study are scientifically qual- ified and com petent to carry out
p.(None): the research at the institution.
p.(None): 13.2.5. Facilitate and provide support for smooth and ethical implementation of the research.
...
Social / Fetus/Neonate
Searching for indicator fetus:
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p.(None): 54 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): ulations are particularly subject to undue influence, manipulation, coercion, and in- timidation. Hence, vulnerable
p.(None): populations deserve special protection from IRBs and other regulatory authorities.
p.(None): 8.3.5.1 Pregnant women and Fetuses
p.(None): To conduct research on pregnant women, the following must be fulfilled:
p.(None): • There is evidence from studies on pregnant animals and non-pregnant women that studies need to be done on risks
p.(None): related to pregnant women and fetuses.
p.(None): • If the research holds the prospect of direct benefit to the pregnant woman and the fetus, and the knowledge cannot
p.(None): be obtained through other means.
p.(None): • There should be no inducement to terminate a pregnancy.
p.(None): • If the prospect of benefit is both to the pregnant woman and the fetus, an in- formed consent form from the mother
p.(None): alone suffices to enroll the woman into the research.
p.(None): • If the prospect of benefit is solely to the fetus, informed consent should be obtained from both parents, provided
p.(None): they are competent to give or refuse the consent.
p.(None): • In both conditions, the foreseeable risks of the research on the fetus or the neo- nate must be thoroughly
p.(None): explained.
p.(None): • Viability of the fetus should be determined by a health care provider who is not a member of the investigation team.
p.(None): 8.3.5.2 Newborns/Neonates
p.(None): In research involving neonates with uncertain viability, the following must be met:
p.(None): • Previous research provides data to assess potential risks to neonates.
p.(None): • Viability of the fetus should be determined by a health care provider who is not a member of the investigator team.
p.(None): • There should be no other means of obtaining the knowledge to be derived from the research.
p.(None): • There should be no added risk to the neonate due to the research.
p.(None): • The research is likely to enhance viability and survival.
p.(None): • Informed consent should be obtained from either of the parents.
p.(None): For, research involving dead fetuses or organs or tissues of the dead fetus:
p.(None): • There should be a prospect of important knowledge that can be possibly used in the prevention and treatment of
p.(None): similar or related conditions.
p.(None): • Informed consent should be obtained from either of the parents of the dead fetus.
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 55
p.(None):
p.(None): 8.3.5.3 Children
p.(None): Children are persons who have not attained the legal age for consent to treatments or procedures involved in research.
p.(None): The following apply in research involving children.
p.(None): • The child should provide assent in addition to the informed consent by a parent or guardian as stated in Section
p.(None): 6.14 above.
p.(None): • The research presents a realistic opportunity to further the understanding, preven- tion, or alleviation of a
p.(None): serious problem affecting the health or welfare of children.
p.(None): • Emancipated minors – working or earn their living, married, parenting – may be allowed to give an informed consent
p.(None): or an IRB may decide a waiver of consent.
p.(None): • In research related to sensitive topics like drug use and abuse, sexuality, repro- duction, STIs, where obtaining
...
p.(None): to address the problem (Langmuir, 1980).
p.(None): Exemption/exempt research-Categories of research to which the Federal regulations for human research protections do not
p.(None): apply. Research involving prisoners and some research involving children are not exempt.
p.(None): Expected-Pertaining to an AE, the event has been previously observed or documented in humans under the research
p.(None): intervention (or one substantially similar), and the nature or severity of the event is consistent with information in
p.(None): the relevant source documents (e.g., investigator’s brochure, package insert, or non-reportable events [NRE] list).
p.(None): National Research Ethics Review Guideline Fifth Edition 79
p.(None):
p.(None): Expedited review-Review performed by the IRB Chair or a designated experienced member for research that involves no
p.(None): more than minimal risk and meets the criteria for expedited review or represents minor changes in approved research.
p.(None): Experienced reviewer -A member of an IRB who is designated by the Chair as autho- rized to conduct expedited reviews.
p.(None): Expert reviewer-A member of an IRB who is designated by the Chair as authorized to conduct expedited reviews.
p.(None): Expiration date-The expiration date is the day before the anniversary of the approval date – unless the IRB approves it
p.(None): for less than one year. For instance, a protocol approved on 12/4 has approval date of 12/4/06 and an expiration date
p.(None): of 12/3/07 midnight (which means research may be conducted on 12/3).
p.(None): Fetus-The product of conception from the time of implantation until delivery.
p.(None): Focus group-Group of individuals brought together to discuss an issue within a struc- tured environment, often for
p.(None): formative or qualitative research purposes.
p.(None): Generalizable knowledge-New information that has relevance beyond the population or program from which it was collected
p.(None): Good Clinical Practice (GCP)-An international ethical and scientific quality standard for designing, conducting,
p.(None): recording, and reporting trials that involve the participation of human participants. See also
p.(None): http://www.fda.gov/oc/gcp/default.htm.
p.(None): Guardian-An individual who is authorized under applicable local law to consent on behalf of a child to general medical
p.(None): care.
p.(None): Harm-Injury, damage, or hurt; an experience in which one’s interests are thwarted, defeated, or set back, especially
p.(None): one’s physical or psychological interests.
p.(None): Human subject/human participant-A living person about whom an investigator con- ducting research obtains (1) data
p.(None): through intervention or interaction with the in- dividual, or (2) identifiable private information (e.g., medical
p.(None): records, employment records, or school records).
p.(None): Identifiable private information-Information (data or biological specimens) such that the identity of a participant
p.(None): is or may readily be ascertained by the investigator or associated with the information, and either the information
p.(None): concerns behavior that occurs in a context in which an individual can reasonably expect that no observation or
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Searching for indicator neonate:
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p.(None): they are competent to give or refuse the consent.
p.(None): • In both conditions, the foreseeable risks of the research on the fetus or the neo- nate must be thoroughly
p.(None): explained.
p.(None): • Viability of the fetus should be determined by a health care provider who is not a member of the investigation team.
p.(None): 8.3.5.2 Newborns/Neonates
p.(None): In research involving neonates with uncertain viability, the following must be met:
p.(None): • Previous research provides data to assess potential risks to neonates.
p.(None): • Viability of the fetus should be determined by a health care provider who is not a member of the investigator team.
p.(None): • There should be no other means of obtaining the knowledge to be derived from the research.
p.(None): • There should be no added risk to the neonate due to the research.
p.(None): • The research is likely to enhance viability and survival.
p.(None): • Informed consent should be obtained from either of the parents.
p.(None): For, research involving dead fetuses or organs or tissues of the dead fetus:
p.(None): • There should be a prospect of important knowledge that can be possibly used in the prevention and treatment of
p.(None): similar or related conditions.
p.(None): • Informed consent should be obtained from either of the parents of the dead fetus.
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 55
p.(None):
p.(None): 8.3.5.3 Children
p.(None): Children are persons who have not attained the legal age for consent to treatments or procedures involved in research.
p.(None): The following apply in research involving children.
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Searching for indicator fetuses:
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p.(None): experts’ sometimes differing opinions and suggestions for these guidelines.
p.(None): 14 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): Moreover, the draft guidelines were discussed with a wider group of experts and rep- resentatives drawn from the MoST,
p.(None): Ministry of Justice, Ministry of Health, FMHACA, IRBs of universities and research institutions, international and UN
p.(None): agencies, and other relevant stakeholders. The comments and recommendations from this nation- wide consultative meeting
p.(None): were analyzed and incorporated before this guideline was endorsed and released for use to safeguard the rights and
p.(None): welfare of research partic- ipants and for oversight of research in Ethiopia.
p.(None): 1.2 Introduction
p.(None): “Research is a systematic investigation including research development, testing, and evaluation designed to contribute
p.(None): to generalizable knowledge.” Nevertheless, as a matter of principle, in research involving human participants, the
p.(None): well-being of the patient takes priority over the interests of society and the knowledge to be gained.
p.(None): “Human subject [research participant] is a living individual about whom an investi- gator conducting research obtains
p.(None): data through intervention or interaction with the individual, or identifiable private information.” Besides, research
p.(None): participants may include pregnant women where fetuses, fetal material, or abortuses are the primary subjects of
p.(None): interest. Similarly, research involving autopsy materials shall also be in- cluded as source of data.
p.(None): The main purpose of health research involving human participants is for better un- derstanding of the etiology,
p.(None): pathogenesis, and pathophysiology of disease and the related diagnostic, preventive, promotive, and therapeutic
p.(None): procedures and measures. Moreover, as evidence-based practice has become necessary at the turn of the 21st century, and
p.(None): quite understandably, existing procedures and practices are challenged continuously for their effectiveness,
p.(None): efficiency, quality, accessibility, and acceptability by the community.
p.(None): However, in the quest to ensure better health and knowledge, the rights and welfare of research participants must be
p.(None): protected at all times. Participation must be voluntary and free of coercion, persuasion, manipulation, deception,
p.(None): undue influence or induce- ment, and threat or intimidation. The information shall be obtained in a private setting
p.(None): whenever necessary and confidentiality maintained throughout the lifetime of the re- search. This is even more
p.(None): important when research involves participants whose com- prehension and decision making is compromised because of age,
p.(None): lack of knowledge on medical concepts and technological terms, or severe mental or behavioral disorders.
p.(None): For all research involving human participants and human biological materials/speci- mens, investigators should be aware
...
p.(None): collaborative research is primarily responsible for monitoring the ethical conduct of the research procedures. However,
p.(None): the National IRB can monitor the proper conduct of the research whenever it deems further oversight is necessary. Any
p.(None): modification, amendment, or change in the approved collaborative research protocol should be made at each collaborating
p.(None): institution. Material transfer agreements must be obtained whenever applicable.
p.(None): 8.3.5 Vulnerable Population
p.(None): Vulnerable populations are those segments of the population whose capacity to safe- guard their welfare, demand their
p.(None): rights and satisfy their interests, is compromised. Because of these limitations, they cannot provide or refuse
p.(None): consent. Vulnerable pop-
p.(None): 54 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): ulations are particularly subject to undue influence, manipulation, coercion, and in- timidation. Hence, vulnerable
p.(None): populations deserve special protection from IRBs and other regulatory authorities.
p.(None): 8.3.5.1 Pregnant women and Fetuses
p.(None): To conduct research on pregnant women, the following must be fulfilled:
p.(None): • There is evidence from studies on pregnant animals and non-pregnant women that studies need to be done on risks
p.(None): related to pregnant women and fetuses.
p.(None): • If the research holds the prospect of direct benefit to the pregnant woman and the fetus, and the knowledge cannot
p.(None): be obtained through other means.
p.(None): • There should be no inducement to terminate a pregnancy.
p.(None): • If the prospect of benefit is both to the pregnant woman and the fetus, an in- formed consent form from the mother
p.(None): alone suffices to enroll the woman into the research.
p.(None): • If the prospect of benefit is solely to the fetus, informed consent should be obtained from both parents, provided
p.(None): they are competent to give or refuse the consent.
p.(None): • In both conditions, the foreseeable risks of the research on the fetus or the neo- nate must be thoroughly
p.(None): explained.
p.(None): • Viability of the fetus should be determined by a health care provider who is not a member of the investigation team.
p.(None): 8.3.5.2 Newborns/Neonates
p.(None): In research involving neonates with uncertain viability, the following must be met:
p.(None): • Previous research provides data to assess potential risks to neonates.
p.(None): • Viability of the fetus should be determined by a health care provider who is not a member of the investigator team.
p.(None): • There should be no other means of obtaining the knowledge to be derived from the research.
p.(None): • There should be no added risk to the neonate due to the research.
p.(None): • The research is likely to enhance viability and survival.
p.(None): • Informed consent should be obtained from either of the parents.
p.(None): For, research involving dead fetuses or organs or tissues of the dead fetus:
p.(None): • There should be a prospect of important knowledge that can be possibly used in the prevention and treatment of
p.(None): similar or related conditions.
p.(None): • Informed consent should be obtained from either of the parents of the dead fetus.
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 55
p.(None):
p.(None): 8.3.5.3 Children
p.(None): Children are persons who have not attained the legal age for consent to treatments or procedures involved in research.
p.(None): The following apply in research involving children.
p.(None): • The child should provide assent in addition to the informed consent by a parent or guardian as stated in Section
p.(None): 6.14 above.
p.(None): • The research presents a realistic opportunity to further the understanding, preven- tion, or alleviation of a
p.(None): serious problem affecting the health or welfare of children.
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Searching for indicator neonates:
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p.(None): • If the research holds the prospect of direct benefit to the pregnant woman and the fetus, and the knowledge cannot
p.(None): be obtained through other means.
p.(None): • There should be no inducement to terminate a pregnancy.
p.(None): • If the prospect of benefit is both to the pregnant woman and the fetus, an in- formed consent form from the mother
p.(None): alone suffices to enroll the woman into the research.
p.(None): • If the prospect of benefit is solely to the fetus, informed consent should be obtained from both parents, provided
p.(None): they are competent to give or refuse the consent.
p.(None): • In both conditions, the foreseeable risks of the research on the fetus or the neo- nate must be thoroughly
p.(None): explained.
p.(None): • Viability of the fetus should be determined by a health care provider who is not a member of the investigation team.
p.(None): 8.3.5.2 Newborns/Neonates
p.(None): In research involving neonates with uncertain viability, the following must be met:
p.(None): • Previous research provides data to assess potential risks to neonates.
p.(None): • Viability of the fetus should be determined by a health care provider who is not a member of the investigator team.
p.(None): • There should be no other means of obtaining the knowledge to be derived from the research.
p.(None): • There should be no added risk to the neonate due to the research.
p.(None): • The research is likely to enhance viability and survival.
p.(None): • Informed consent should be obtained from either of the parents.
p.(None): For, research involving dead fetuses or organs or tissues of the dead fetus:
p.(None): • There should be a prospect of important knowledge that can be possibly used in the prevention and treatment of
p.(None): similar or related conditions.
p.(None): • Informed consent should be obtained from either of the parents of the dead fetus.
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 55
p.(None):
p.(None): 8.3.5.3 Children
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Social / Institutionalized
Searching for indicator institutionalized:
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p.(None): harm. Risks can be known or presumed. And, although no specific regulations exist, risks may include physical,
p.(None): psychological, emotional, economic, educational, legal, and social harm.
p.(None): In addition, beneficence includes whether the usual care is changed or manipulated to inflict no harm, minimize harm,
p.(None): remove harm, and maximize the benefit to re- search participants and to the community, or both.
p.(None): 3.3 Justice
p.(None): Justice connotes fairness and equity in the distribution of the benefits and burdens of research to participants.
p.(None): 3.3.1. Justice demands equitable selection of participants, i.e., avoiding popu- lations that may be unfairly coerced
p.(None): into participating, including but not limited to, prisoners, pregnant women, people with mental and physical
p.(None): disabilities, immigrants, refugees, ethnic minorities, marginalized groups and institutionalized persons, including
p.(None): children. There must be a justi- fication for inclusion of these vulnerable groups in the research. There should be no
p.(None): disproportionate use of vulnerable populations. The same recruitment approach should be used in all populations.
p.(None): Injustice may arise when selecting participants from a specific socio-economic class, age, sex, racial, cultural,
p.(None): religious, creed, and institutional make up.
p.(None): 3.3.2. The principle of justice requires equality in the distribution of benefits and burdens among the population
p.(None): groups likely to benefit from the research. Distributive justice means that no segment of the population should be
p.(None): unfairly burdened with the harms of research. It thus imposes particular obligations toward individuals who are
p.(None): vulnerable and unable to protect their own interests. Conversely, distributive justice imposes duties neither to
p.(None): neglect nor discriminate against individuals and groups who may ben- efit from advances in research.
p.(None): 3.3.3. Justice also demands balancing the benefits and burdens to the commu- nity where the research is undertaken.
...
p.(None): prisoner’s participation or refusal to participate will not be considered in decisions regarding his or her release or
p.(None): further deten- tion and each prisoner is clearly informed in advance that his or her participa- tion in the research
p.(None): project will have no affect on his or her release.
p.(None): 8.3.5.5 Mental and Physical Disability
p.(None): Persons with disability need special attention because they are prone to being social- ly marginalized. Therefore,
p.(None): their dignity, rights and well-being in research must be respected. Careful consideration should be made where proxy
p.(None): consent is to be used, and where the use of signed consent forms is not feasible, alternative viable methods should be
p.(None): employed.
p.(None): 56 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): Persons with disabilities (mental or physical) should not be unfairly excluded from participating in research.
p.(None): Researchers should make an effort to address communi- cation, disability and comprehension constraints are often the
p.(None): excuse for exclusion.
p.(None): People with mental disabilities or substance abuse related disorders include those people with psychiatric, cognitive,
p.(None): or developmental disorders. These groups of peo- ple are usually institutionalized and institutionalization may further
p.(None): compromise their ability to make voluntary decisions to participate in a research project. Therefore,
p.(None): research on people with cognitive disabilities or with substance abuse related disor- ders should:
p.(None): • Provide sufficient justification for involving such people;
p.(None): • Have appropriate evaluation procedures for ascertaining research participants’ ability to give informed consent. If
p.(None): research participants are deemed unable to understand and to make an informed decision, then an appropriate proxy
p.(None): should be identified.
p.(None): • Have an informed consent process that is free from coercion.
p.(None): • Be of no more than minimal risk, or if minimal risk is involved, the risk is outweighed by the anticipated benefits
p.(None): of the research project to the research participant.
p.(None):
p.(None): 9. Human Biological Materials
p.(None): 9.1 Definition
p.(None): Human biological materials include any substance obtained from a human research participant including, but not limited
p.(None): to, blood, urine, stool, saliva, hair, nail clip- pings, skin, and microorganisms, and other associated bio-products
p.(None): obtained from human research participants.
p.(None): 9.2 Acquisition, Storage, Secondary Use
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Social / Laboratory Staff
Searching for indicator research staff:
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p.(None):
p.(None): 13. Responsibilities of Investigators, Host Institutions, Sponsors
p.(None): Responsible conduct of research requires that all stakeholders discharge the duties ex- pected from them according to
p.(None): this guidelines and the law and regulations of Ethiopia.
p.(None): 13.1 Investigators
p.(None): The investigator is responsible for overall conduct of the research according to the approved research
p.(None): protocol/procedures. More specifically, the investigator:
p.(None): 13.1.1. Shall maintain adherence to basic ethics principles,
p.(None): 13.1.2. Shall possess appropriate scientific and human ethics standards,
p.(None): 13.1.3. Shall ensure the highest possible standard of health care and follow-up, within the limit of the investigator’s
p.(None): and the sponsor’s capacity, is avail- able to research participants; the available care shall be provided for a
p.(None): variable period even after the completion of the research based on the researched disease, condition or instrument;
p.(None): shall open an investiga- tor’s file where all documents related to the research are kept.
p.(None): 13.0.4. Shall keep records of informed consent document confidentially (in a locked cabinet).
p.(None): 13.1.5. Shall ensure privacy and confidentiality is maintained for research par- ticipants. The investigator shall
p.(None): ensure that hard data is kept in locked cabinets and electronic data is password protected accessible only to
p.(None): appropriate personnel.
p.(None): 13.1.6. Monitor research staff to ensure the research is done according to the approved research protocol/procedures.
p.(None): 13.1.7. Periodically submit a progress report to the IRB. The frequency of the report is to be determined according to
p.(None): the level of risk inherent in the
p.(None): National Research Ethics Review Guideline Fifth Edition 69
p.(None):
p.(None): research, i.e., the higher the risk the shorter the reporting interval.
p.(None): 13.1.8. Shall promptly investigate serious adverse events and take appropriate measures to safeguard the safety of
p.(None): human subjects. The investigator shall inform such adverse events and measures taken, if any, to the IRB, clinical
p.(None): monitor and the sponsor.
p.(None): 13.1.9. Shall inform the IRB and obtain approval for any changes or amend- ments in the approved
p.(None): protocol/procedures except in circumstances where an apparent immediate hazard or danger to the research partic-
p.(None): ipants. Any amendment shall be appended to the approved research protocol.
p.(None): 13.1.10. Shall inform the IRB, clinical monitor, the sponsor and the participants if the study is terminated or
p.(None): suspended at any time during the research process.
p.(None): 13.1.11. Shall be responsible for periodic assessment of the quality of data man- agement as well as reporting on
p.(None): interim analysis whenever appropriate.
p.(None): 13.1.12. In case of clinical/experimental trials, shall ensure, at least, one of the investigators have a
p.(None): certificate on good clinical practice and/or good manufacturing practice or both or whichever is appropriate.
...
p.(None): supplement to them; (b) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation,
p.(None): treatment, or prevention of disease, in humans or other animals; or (c) intended to affect the structure or any
p.(None): function of the human body or in animals; and does not achieve any of its principal intended purposes through chemical
p.(None): action within or on the human body or in animals and is not dependent upon being metabolized for the achievement of its
p.(None): principal intended purposes.
p.(None): Minimal risk-(a) Risk such that the probability and magnitude of harm or discomfort anticipated in the research are not
p.(None): greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine
p.(None): physical or psycholog- ical examinations or tests.
p.(None): Minor changes-Changes to a research protocol that do not result in a net increase in risk, a change in the harm-benefit
p.(None): balance, or provide minor clarification or correc- tion. Minor changes may be reviewed under expedited review, even if
p.(None): the protocol has been deemed to pose more than minimal risk to participants.
p.(None): Noncompliance-Failure by investigators, research staff, IRB members, or IRB staff to follow regulations for human
p.(None): research protections
p.(None): Oral consent-Consent obtained only through speaking, generally in the absence of documentation of consent. See also
p.(None): documentation of consent, informed con- sent, verbal consent.
p.(None): National Research Ethics Review Guideline Fifth Edition 81
p.(None):
p.(None): Parental permission-The agreement of a parent or guardian to the participation of their child in research.
p.(None): Personal identifier-Information obtained and recorded in such a manner that human participants can be recognized,
p.(None): directly or through links to the participants. Examples include names, social security numbers, and codes.
p.(None): Pilot study-Preliminary study to determine the feasibility of a larger study, use of a test instrument, or other
p.(None): activity.
p.(None): Pregnancy-The period of time from implantation until delivery. A woman shall be assumed to be pregnant if
p.(None): she exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until the results of a
p.(None): pregnancy test are negative or until delivery.
p.(None): Principal Investigator (PI)-Lead scientist who is working on the design of a research study, development of methods and
...
Social / Linguistic Proficiency
Searching for indicator language:
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p.(None): interest of the research participant.
p.(None): 3.1.2. Informed Consent – The importance of informed consent of research participants is unquestionable and
p.(None): the informed consent should be analyzed in terms of containing the basic elements of information, com- prehension,
p.(None): competence, disclosure, and voluntarism. Information shall be given in writing and signed or verbally approved by the
p.(None): research par- ticipant. The information to be provided should be written in a way that considers the local culture and
p.(None): values, as well as the level of understanding of the research participant. The information provided should weigh the
p.(None): re- search participants’ competence. When informed consent is that of a third party (proxy; parent, next-of-kin,
p.(None): legally authorized representative (LAR), the reasons for the indirect approach shall be stated and become part of the
p.(None): protocol.
p.(None): Research participants or persons giving proxy consent cannot give full informed consent unless the consent process/form
p.(None): contains adequate information. All such information shall be expressed in a language that is understandable to the
p.(None): participant. Generally, the consent form should explicitly indicate the points mentioned in Section 6.13 below.
p.(None): National Research Ethics Review Guideline Fifth Edition 21
p.(None):
p.(None): 3.2 Beneficence
p.(None): The principle of beneficence refers to the obligation on the part of the investiga- tor to attempt to
p.(None): maximize benefits for the individual participant and/or community, while minimizing risk or harm to the
p.(None): individual/community. As much as possible, beneficence also considers inflicting no harm. An honest and thorough
p.(None): risk/benefit assessment must be performed. Balancing the risk and benefit of the research is indispensible
p.(None): in the design and conduct of the research.
p.(None): Risk is the probability and magnitude of some future occurrence of harm. Harm is injury and setback to interests as a
p.(None): result of being a research participant. Risks to research participants include physical, psychological, and emotional
p.(None): harm. Risks can be known or presumed. And, although no specific regulations exist, risks may include physical,
...
p.(None): disabled
p.(None): people, etc.
p.(None): 6.13 Informed Consent
p.(None): 6.13.1. The IRB must determine that the consent is documented using a written or verbal informed consent form,
p.(None): • The consent form should be approved by the IRB.
p.(None): • The consent form must be signed by the participant, or a parent, or next-of-kin or a guardian and by the individual
p.(None): that conducted the in- formed consent process.
p.(None): • In case the participant cannot read or write, a witness should sign that the consent process was carried out
p.(None): appropriately.
p.(None): National Research Ethics Review Guideline Fifth Edition 37
p.(None):
p.(None): • A copy of the signed informed consent form should be given to the study participant.
p.(None): 6.13.2. Research participants or persons giving proxy consent cannot give full informed consent unless the consent
p.(None): process/form contains adequate information. All such information shall be expressed in a language that is
p.(None): understandable to the participant. Generally, the consent form should explicitly indicate the following:
p.(None): • A statement that the study involves research, the purpose of the re- search, the expected duration of participants’
p.(None): involvement and identifi- cation of any experimental procedures.
p.(None): • Foreseeable risks and discomforts.
p.(None): • Reasonably expected benefits to the participants as well as the community.
p.(None): • Disclosure of appropriate alternatives procedures or treatments.
p.(None): • Extent to which confidentiality will be maintained.
p.(None): • Compensation for possible injury if the research is greater than minimal risk; if so, an explanation is needed as to
p.(None): whether any medical treat- ments are available if injury occurs and what they consist of, or where further information
p.(None): may be obtained.
p.(None): • An explanation of whom to contact for answers to pertinent questions about the research and research
p.(None): participants’ rights, and whom to contact in the event of a research-related injury to the participant; A statement
p.(None): that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the
p.(None): participant is oth- erwise entitled. The consent form should also clearly indicate that re- search participants are
p.(None): free to withdraw from the study at any time and that the participant may discontinue participation at any time without
p.(None): penalty or loss of benefits. Research participants also are not obliged to respond to all questions in a study
p.(None): questionnaire.
p.(None): 6.14 Assent
...
p.(None): 7.2.8. Investigator and IRB members notification
p.(None): • The investigator will be notified by appropriate medium of the exempt determination.
p.(None): • Each month claims of exemptions will be listed on the IRB meeting agenda.
p.(None): 7.3 Expedited Review Procedures
p.(None): Expedited review is review of a protocol that need not be seen by the full (convened) IRB, but by one or two IRB
p.(None): members assigned by the chair.
p.(None): 7.3.1 Eligibility Criteria
p.(None): For the review to be expedited the proposed research must:
p.(None): • Involve minimal risk, meaning that the probability and magnitude of harm or discomfort anticipated in the research
p.(None): are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of
p.(None): routine physical or psychological examinations or tests.
p.(None): • Appropriately protect privacy/confidentiality.
p.(None): • Fall into one of the following categories:
p.(None): 1. Research employing survey, interview, oral history, focus group, or human fac- tors evaluation.
p.(None): 2. Research involving materials (data, document, records, or specimens) that were originally colected for non-research
p.(None): purposes.
p.(None): 3. Collection of data from voice, video, digital or image recordings previously made for research purposes.
p.(None): 42 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): 4. Research on individual or group characteristics or behavior (including, but not limited to, research on perception,
p.(None): cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior).
p.(None): • Follow-up on changes, amendments and annual renewals:
p.(None): 1. Follow-up on changes or information requested by the Review Committee as a condition of approval.
p.(None): 2. Minor amendments to previously approved research.
p.(None): 3. Annual renewals, if the original approval was through expedited review.
p.(None): 4. The only remaining activities involve long-term follow-up of previously en- rolled participants.
p.(None): 5. The only remaining activities involve data analysis.
p.(None): • The review committee has determined and documented at a convened meet- ing that the research involves no greater
p.(None): than minimal risk (and there are no proposed changes that involve additional risk).
p.(None): 7.3.2 Applying for an Expedited Review
p.(None): Requests for an expedited review can be submitted at any time to the Secretariat.
p.(None): • An investigator who wishes to apply for an expedited review should submit an application indicating the reason(s)
p.(None): for the eligibility of the study for expedited review.
p.(None): • Upon receiving an application for expedited review, the IRB Secretary/Adminis- trator in consultation with the
p.(None): Chairperson/Vice Chair makes the initial assess- ment to determine if it qualifies for expedited review.
p.(None): • If the study qualifies for expedited review, IRB chairperson or by one or more experienced reviewers designated by
p.(None): the chairperson from among the members of the IRB should be assigned to review the protocol. If the review involves a
...
p.(None): rationale with full justification of the study and that there is no other alternative and less risky way of obtaining
p.(None): the data, descrip- tion of the study population, participants inclusion /exclusion criteria, precise description of
p.(None): all proposed procedures and interventions, including the duration of the study, provisions for protecting privacy and
p.(None): confidentiality, provisions for managing adverse events, plans for data management including plan for statis- tical
p.(None): analysis and publication, and budget,
p.(None): • Vulnerable population involvement requires further explanation to justify that without these vulnerable
p.(None): populations involvement there is no other way of ob- taining the relevant data.
p.(None): • All materials to be used (including advertisements) for the recruitment of re- search participants must be
p.(None): attached to the protocol.
p.(None): • Data collection tools such as questionnaires, interviews /discussion guides, checklists and case report
p.(None): forms must also be submitted.
p.(None): • Documents to be submitted for review include: Study protocol, protocol amend- ments, study/participant information
p.(None): sheet and informed consent form, current investigators’ CV, investigator’s brochure, and other materials to be used.
p.(None): The study informed consent process/form and information sheet, in both the offi-
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 47
p.(None):
p.(None): cial language and, when necessary, its translation into the local language is required. A back translation into the
p.(None): official language may be requested by the IRB. In addition contact addresses of the PI, people to contact and the IRB
p.(None): that approved the research protocol must be included in the study information sheet.
p.(None): • If the proposed study is a clinical trial, the investigator’s brochure which provides an adequate summary of all
p.(None): safety, pharmacological, pharmaceutical and toxico- logical data available on the study product, together with a
p.(None): summary of the clini- cal experience of the study product (e.g. recent investigator’s brochure, published data, summary
p.(None): of the product’s characteristics etc.), must also be submitted. Information on payment and compensation available for
p.(None): research participants for time lost and injury or harm as a result of participating in the study.
p.(None): • If the proposed study is a clinical trial, a certificate of Good Clinical Practice, of at least one of the
p.(None): investigators, and a certificate of Good Manufacturing Prac- tice based on the nature of the research, must be
p.(None): attached.
p.(None): • In studies that need transport of human biological substances, a request for a material transfer agreement, the type
p.(None): of biological material, how it is going to be processed and stored, how the material is intended to be analyzed, intent
p.(None): for possible future analysis, if there is one, as well as how and when it will be disposed of, must be included in the
p.(None): study protocol
p.(None): • A dissemination and community involvement plan should be developed.
p.(None): There are special categories of research that possess particular characteristics and demand special emphasis in ethical
p.(None): considerations. This type of research includes clinical/experimental trials, genetic, socio-behavioral, and
...
p.(None): jeopardizes the participant or requires intervention to prevent one of the other outcomes listed.
p.(None): Serious noncompliance-Noncompliance that results in increased risk to partici- pants or reflects a failure to apply
p.(None): substantial portions of governing regulations. Seri- ous noncompliance must be reported promptly.
p.(None): Severe/severity-The graded level of intensity of an AE and its interference with usual social and functional
p.(None): activities, often standardized in toxicity tables. Grade levels generally include normal, mild, moderate, severe,
p.(None): life-threatening, and fatal.
p.(None): Sponsor- a person or other entity that initiates a clinical investigation, but that does not actually conduct the
p.(None): investigation.
p.(None): Suspend/suspension-Temporary cessation of research-related intervention or interac- tion with participants and
p.(None): obtaining or using identifiable private research information. Partial suspension halts some but not all such
p.(None): activities, for example when enrollment is stopped but follow-up continues with enrolled participants. A suspension
p.(None): must be
p.(None): National Research Ethics Review Guideline Fifth Edition 83
p.(None):
p.(None): reported promptly unless the suspension results from expiration of IRB approval.
p.(None): Terminate/termination-Permanent cessation of research-related intervention or interac- tion with participants and
p.(None): obtaining and use of identifiable private research information. A termination must be reported promptly unless the
p.(None): termination results from expiration of IRB approval or withdrawal or closure for reasons other than research risks.
p.(None): Understandable language-generally 8th grade reading level or lower/higher depending on targeted population.
p.(None): Undue influence-An excessive, unwarranted, inappropriate, or improper reward in- tended to motivate study
p.(None): participation.
p.(None): Unexpected-Pertaining to an AE, the event is previously unobserved or undocument- ed in humans under the research
p.(None): intervention (or one substantially similar), the na- ture or severity of the event is not consistent with information
p.(None): in the relevant source documents (e.g., investigator’s brochure, package insert, or non-reportable events [NRE] list),
p.(None): or the event is observed with higher frequency than previously observed or documented. Expectedness does not entail the
p.(None): ability to predict results from in vitro, animal, or other pharmacological models.
p.(None): Unlinked-The condition of data or specimens which had been coded but for which the key linking the code to direct
p.(None): personal identifiers has been destroyed.
p.(None): Unrelated-Pertaining to an AE, the condition in which the event is due to a docu- mented cause other than research
p.(None): procedures.
p.(None): Verbal consent-Consent obtained by communication in words; this may include spo- ken or written format.
p.(None): Voluntary/voluntariness-Freedom from coercion and undue influence
...
Social / Marital Status
Searching for indicator married:
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p.(None): • There should be a prospect of important knowledge that can be possibly used in the prevention and treatment of
p.(None): similar or related conditions.
p.(None): • Informed consent should be obtained from either of the parents of the dead fetus.
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 55
p.(None):
p.(None): 8.3.5.3 Children
p.(None): Children are persons who have not attained the legal age for consent to treatments or procedures involved in research.
p.(None): The following apply in research involving children.
p.(None): • The child should provide assent in addition to the informed consent by a parent or guardian as stated in Section
p.(None): 6.14 above.
p.(None): • The research presents a realistic opportunity to further the understanding, preven- tion, or alleviation of a
p.(None): serious problem affecting the health or welfare of children.
p.(None): • Emancipated minors – working or earn their living, married, parenting – may be allowed to give an informed consent
p.(None): or an IRB may decide a waiver of consent.
p.(None): • In research related to sensitive topics like drug use and abuse, sexuality, repro- duction, STIs, where obtaining
p.(None): consent from a parent, next-of-kin, or guardian is challenging and may be problematic to the minor because of the
p.(None): nature of the research, assent with waiver of consent may be applicable.
p.(None): • In institutional children, a legally approved guardian may give consent.
p.(None): 8.3.5.4 Prisoners
p.(None): Prisoners may be under constraints because of their incarceration which could affect their ability to make a truly
p.(None): voluntary and decision which is not coerced, whether or not to participate as subjects in research. Therefore,
p.(None): additional safeguards should be included in the study to protect the rights and welfare of these subjects, as follows:
...
Searching for indicator single:
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p.(None): through the Chairperson or his/her designate.
p.(None): 5.8.2. The NRERC operations office should be separate and independent of the administration of MoST.
p.(None): 5.8.3. Applications to the NRERC must be channeled through the NRERC Secretariat.
p.(None): 5.8.4. All decisions and communication from the NRERC to the appli- cant must be conveyed through the Secretariat.
p.(None): 5.9 Registration and Accreditation
p.(None): 5.9.1. All IRBs in Ethiopia have to be accredited by the NRERC, and registered and licensed by the
p.(None): Secretariat of the NRERC at MoST.
p.(None): 5.9.2. Registration and renewal of all IRBs shall be done every two years from the date of registration or renewal of
p.(None): the IRB.
p.(None): 5.9.3. When IRB members are replaced for any reason, these outgoing members shall be notified in writing. The reason
p.(None): for termination of membership shall be clearly described in the letter.
p.(None): 5.9.4. Review procedures, TORs, and the review forms should be standardized.
p.(None): 5.9.5. The minimum acceptable number of members on any IRB is five. No IRB can have even numbered members for the sake
p.(None): of deci- sions, particularly when there is a need to vote.
p.(None): 5.9.6. IRBs shall have members with a varied professional mix and there
p.(None): National Research Ethics Review Guideline Fifth Edition 29
p.(None):
p.(None): should be at least, one member from behavioral sciences, law, or humanities, be gender sensitive and ensure community
p.(None): represen- tation by a lay person. No IRB can be composed entirely of a single profession, similar gender, or without a
p.(None): community representative.
p.(None): 5.9.7. Following registration, a letter of accreditation shall be given to IRBs by the Secretariat.
p.(None):
p.(None): 6. Establishment, Functions, Review Procedures
p.(None): 6.1 Definition
p.(None): Institutional Review Boards (IRBs) are independent committees established in an in- stitution to conduct initial and
p.(None): continuing review of research projects with the primary goal of protecting the rights and welfare of research
p.(None): participants. All institutions in Ethiopia that conduct research involving humans as research participants should set
p.(None): up IRBs in accordance with these guidelines. Where an institution cannot set up an IRB, that institution may rely on an
p.(None): IRB of another institution to review their research projects, provided the IRB is registered by the National IRB.
p.(None): 6.2 Establishment
p.(None): 6.2.1 Appointing Authority
p.(None): • The Head of the Institution is the authority responsible for the appointment of IRB members. In cases where
p.(None): members come from diverse institutions, the appointment should be upon the recommendation of the institution where the
p.(None): potential IRB member is based.
p.(None): • Members are selected in their personal capacities based on their scientific knowledge and expertise, as
p.(None): well as on their commitment and willingness to volunteer the necessary time and efforts for the Board’s function.
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Social / Police Officer
Searching for indicator officer:
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p.(None): PI.
p.(None): • Protect the safety of the study participants.
p.(None): • Conduct interim analysis of efficacy in accordance with stopping rules which are clearly defined in advance of data
p.(None): analysis.
p.(None): • Ensure the confidentiality of the trial data and the results of monitoring.
p.(None): National Research Ethics Review Guideline Fifth Edition 61
p.(None):
p.(None): • Assist the sponsor through remarking on any problems related with study con- duct, enrollment, sample size, and/or
p.(None): data collection.
p.(None): • Report on the safety and progress of the trial and make recommendations to the IRB and the sponsor regarding
p.(None): continuation, termination, or other modifications of the trial based on the observed benefits or adverse effects.
p.(None): • Report the decisions to investigators who must submit those reports to the IRBs, which shall further
p.(None): report to the National IRB.
p.(None): 10.5 Institutional Bio-Safety Committee
p.(None): 10.5.1 Establishment
p.(None): The IBC evaluates research projects that use recombinant DNA, agents that are in- fectious to humans, animals and
p.(None): plants, other potentially infectious materials, select agents and biological toxins. Institutional Bio-safety
p.(None): Committees (IBC) are estab- lished by institutions that undertake research on potentially hazardous substances of a
p.(None): physical, chemical, biological, or any other nature. Any institution involved in or planning to conduct research with
p.(None): potentially hazardous substances is required to set up or designate a competent IBC. Each IBC once formed shall consist
p.(None): of a bio-safety officer and at least three other officers with appropriate expertise in DNA, biological safety and
p.(None): physical containment. The IBC shall be certified by the MoST.
p.(None): It is the responsibility of the Principal Investigator to notify and provide the IBC with the research
p.(None): proposal involving potentially hazardous substances of a physical, chemical, biological, or any other nature. The
p.(None): Principal Investigator is ultimately re- sponsible for the registration, training, and safe handling of research
p.(None): materials han- dled by their personnel.
p.(None): Members of the IBC shall protect confidentiality of all information given to them in the course of their work, and
p.(None): shall sign confidentiality agreements with their institutions.
p.(None): 10.5.2 Functions of an IBC
p.(None): The IBC’s function is to minimize potential human and environmental harm that may be associated with research on or
p.(None): with potentially hazardous substances such as pathogens, biological toxins, radioactive material and applications of
p.(None): bio-technology, especially recombinant DNA techniques and processes.
p.(None): The purpose of an IBC is to ensure adequate containment of potentially hazardous biological agents, add a level of
p.(None): expert review and monitoring of potentially hazardous experiments, and provide a means of communication among
p.(None): researchers and health- care providers about potentially hazardous protocols.
p.(None): IBCs shall:
p.(None): • Notify NRERC and other IRBs of any research with potentially hazardous sub- stances in their institutions.
p.(None): • Conduct bio-safety review and approval of research proposals involving recom-
...
Social / Presence of Coercion
Searching for indicator coerced:
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p.(None): in the design and conduct of the research.
p.(None): Risk is the probability and magnitude of some future occurrence of harm. Harm is injury and setback to interests as a
p.(None): result of being a research participant. Risks to research participants include physical, psychological, and emotional
p.(None): harm. Risks can be known or presumed. And, although no specific regulations exist, risks may include physical,
p.(None): psychological, emotional, economic, educational, legal, and social harm.
p.(None): In addition, beneficence includes whether the usual care is changed or manipulated to inflict no harm, minimize harm,
p.(None): remove harm, and maximize the benefit to re- search participants and to the community, or both.
p.(None): 3.3 Justice
p.(None): Justice connotes fairness and equity in the distribution of the benefits and burdens of research to participants.
p.(None): 3.3.1. Justice demands equitable selection of participants, i.e., avoiding popu- lations that may be unfairly coerced
p.(None): into participating, including but not limited to, prisoners, pregnant women, people with mental and physical
p.(None): disabilities, immigrants, refugees, ethnic minorities, marginalized groups and institutionalized persons, including
p.(None): children. There must be a justi- fication for inclusion of these vulnerable groups in the research. There should be no
p.(None): disproportionate use of vulnerable populations. The same recruitment approach should be used in all populations.
p.(None): Injustice may arise when selecting participants from a specific socio-economic class, age, sex, racial, cultural,
p.(None): religious, creed, and institutional make up.
p.(None): 3.3.2. The principle of justice requires equality in the distribution of benefits and burdens among the population
p.(None): groups likely to benefit from the research. Distributive justice means that no segment of the population should be
p.(None): unfairly burdened with the harms of research. It thus imposes particular obligations toward individuals who are
...
p.(None): • The research presents a realistic opportunity to further the understanding, preven- tion, or alleviation of a
p.(None): serious problem affecting the health or welfare of children.
p.(None): • Emancipated minors – working or earn their living, married, parenting – may be allowed to give an informed consent
p.(None): or an IRB may decide a waiver of consent.
p.(None): • In research related to sensitive topics like drug use and abuse, sexuality, repro- duction, STIs, where obtaining
p.(None): consent from a parent, next-of-kin, or guardian is challenging and may be problematic to the minor because of the
p.(None): nature of the research, assent with waiver of consent may be applicable.
p.(None): • In institutional children, a legally approved guardian may give consent.
p.(None): 8.3.5.4 Prisoners
p.(None): Prisoners may be under constraints because of their incarceration which could affect their ability to make a truly
p.(None): voluntary and decision which is not coerced, whether or not to participate as subjects in research. Therefore,
p.(None): additional safeguards should be included in the study to protect the rights and welfare of these subjects, as follows:
p.(None): • If an IRB regularly reviews research that involves these vulnerable populations, consideration shall be given to the
p.(None): inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.
p.(None): • Where possible, a prisoner or an ex-prisoner co-opted in to the IRB reviewing the proposed research project should
p.(None): be included.
p.(None): • Only research on conditions particularly affecting prisoners as a class and with reasonable probability of improving
p.(None): the health and well-being of the research participants should be permissible.
p.(None): • The IRB shall determine that the informed consent process is properly applied with adequate assurance that a
p.(None): prisoner’s participation or refusal to participate will not be considered in decisions regarding his or her release or
p.(None): further deten- tion and each prisoner is clearly informed in advance that his or her participa- tion in the research
p.(None): project will have no affect on his or her release.
p.(None): 8.3.5.5 Mental and Physical Disability
p.(None): Persons with disability need special attention because they are prone to being social- ly marginalized. Therefore,
p.(None): their dignity, rights and well-being in research must be respected. Careful consideration should be made where proxy
...
Social / Property Ownership
Searching for indicator property:
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p.(None): provider and acknowledge provider’s contribution of this research material unless requested otherwise.
p.(None): 4. This research material represents a significant contribution on the part of provid- er and is considered proprietary
p.(None): to provider. Recipient therefore agrees to retain control over this research Material and further agrees not to
p.(None): transfer the research material to other people not under her/his direct supervision with out advance written approval
p.(None): of provider. The research material will be disposed of as agreed upon per protocol at the end of completion of the
p.(None): project on .
p.(None): 5. The provider does not take any responsibility for loss, damage, wastage or spoilage of the research material during
p.(None): or after shipment to the address provided by the recipient under conditions agreed to in the protocol on shipment of
p.(None): the samples. This research material is provided as a service to the research community. IT IS BEING SUPPLIED TO
p.(None): RECIPIANT WITH NO WARRANTIES, EXPRESS OR IM- PLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
p.(None): PARTICULAR PURPOSE. Provider makes no representations that the use of the research material will not infringe any
p.(None): patent or proprietary right of third parties.
p.(None): 6. The recipient shall notify the provider in witting of any intention, improvement, modification discovery or
p.(None): development to the material or the information made by recipient or parties, collaborating with recipient, here in
p.(None): after referred to as “invention”. Nothing in this agreement shall, however, be construed as conveying to the provider
p.(None): any rights under any patents or other intellectual property to such invention, other than as explicitly provided
p.(None): herein. At its option the provider shall be entitled to receive sample of any materials derived from the Materials for
p.(None): its own research and evaluation purposes only.
p.(None): 7. The under- signed provider and recipient expressly certify and affirm that the contents of any statements
p.(None): made here in are truthful and accurate.
p.(None): 8. Any additional terms ( use an attached page if necessary):
p.(None): 9. The provider maintains, ownership right of the research material and its deriva- tives unless stated otherwise.
p.(None): The provider will retain a copy (aliquot ) of every sample sent abroad as much as possible for local research needs.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 90 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): Material Transfer Agreement Signature page
p.(None):
p.(None): For Recipient:
p.(None): Recipient’s Investigator Duly Authorized
p.(None):
p.(None): ---------------------- ----------------------
p.(None): Signature Signature/ Stamp
p.(None):
p.(None): ---------------------- ----------------------
p.(None): ---------------------- ----------------------
p.(None):
p.(None): Date --------------- Date ----------------
p.(None): Mailing Address for Material: Mailing Address for Notices:
p.(None): -------------------------------- ---------------------------------
p.(None): -------------------------------- ---------------------------------
p.(None):
...
Social / Racial Minority
Searching for indicator racial:
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p.(None): remove harm, and maximize the benefit to re- search participants and to the community, or both.
p.(None): 3.3 Justice
p.(None): Justice connotes fairness and equity in the distribution of the benefits and burdens of research to participants.
p.(None): 3.3.1. Justice demands equitable selection of participants, i.e., avoiding popu- lations that may be unfairly coerced
p.(None): into participating, including but not limited to, prisoners, pregnant women, people with mental and physical
p.(None): disabilities, immigrants, refugees, ethnic minorities, marginalized groups and institutionalized persons, including
p.(None): children. There must be a justi- fication for inclusion of these vulnerable groups in the research. There should be no
p.(None): disproportionate use of vulnerable populations. The same recruitment approach should be used in all populations.
p.(None): Injustice may arise when selecting participants from a specific socio-economic class, age, sex, racial, cultural,
p.(None): religious, creed, and institutional make up.
p.(None): 3.3.2. The principle of justice requires equality in the distribution of benefits and burdens among the population
p.(None): groups likely to benefit from the research. Distributive justice means that no segment of the population should be
p.(None): unfairly burdened with the harms of research. It thus imposes particular obligations toward individuals who are
p.(None): vulnerable and unable to protect their own interests. Conversely, distributive justice imposes duties neither to
p.(None): neglect nor discriminate against individuals and groups who may ben- efit from advances in research.
p.(None): 3.3.3. Justice also demands balancing the benefits and burdens to the commu- nity where the research is undertaken.
p.(None): 3.3.4. In addition, the investigators shall assure that information obtained in the course of the investigation
p.(None): remains confidential to protect partici-
p.(None): 22 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): pants from possible harm. Data unlinked from individuals or groups does not jeopardize confidentiality. The privacy of
p.(None): individual participants also needs to be protected throughout the investigation by the investigators.
p.(None):
...
Social / Religion
Searching for indicator faith:
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 1. General
p.(None): 1.1 Background
p.(None): Research involving human participants may have existed on Earth for several millen- nia, albeit the research may have
p.(None): been unscientific, uncoordinated, unmonitored, and largely unethical. Some of these experiments have survived the test
p.(None): of time and are still used wholly or in part, in modern healthcare and services. The development and safety of
p.(None): health-related services and practices evolved from experiments on self, other animals, and people in the community,
p.(None): although the ethics were far from acceptable in most cases.
p.(None): On the other hand, the moral principles of ancient philosophers and practitioners are still used in modern day
p.(None): medicine, as well as in the field of ethics. One such example is the use of the Hippocratic Oath taken by physicians
p.(None): and health practitioners, though recently, the Oath has been challenged by contemporary philosophers and ethicists.
p.(None): In Ethiopia, health research has been and is still being carried out by various sectors including government and
p.(None): private organizations, bilateral and multilateral agencies including United Nations (UN) agencies, and faith-based
p.(None): organizations. These orga- nizations have been conducting research of their interest independently or through
p.(None): collaborations with institutions such as medical and paramedical schools, research institutes, drug control agencies,
p.(None): and others.
p.(None): To disseminate these research findings, the grounds for formal peer-reviewed health research publication were laid
p.(None): by the Ethiopian Medical Journal in 1962. Other peer-reviewed scientific journals followed suit, namely, the
p.(None): Ethiopian Pharmaceuti- cal Journal, the Ethiopian Journal of Health Development, the Ethiopian Journal of Health
p.(None): Sciences, and Ethiopian Journal of Reproductive Health.
p.(None): Commitment of the government towards research and research ethics has been ex- pressed in various undertakings
p.(None): throughout the years. These undertakings include:
p.(None): • Endorsement of a constitution and legal codes that protect the well-being, wel- fare, and autonomy of its citizens,
p.(None): while also protecting the right to intellectual and academic freedom, as well as the pursuit of knowledge
p.(None): • Establishment of medical and public health colleges since 1952, the Central Research Laboratory in 1942 which later
p.(None): was upgraded to an institute, the Institute of Pathobiology in 1966, the Armauer Hansen Research Institute in 1969, the
p.(None): Demographic Training and Research Center in 1982, and recently, the National Science Academy.
...
p.(None): human participants in all research proposed to be conducted in Ethiopia, based upon the Health Science and Technology
p.(None): Policy and the responsibilities assigned to the MoST.
p.(None): No other guidelines and requirements are allowed to diminish or remove any of the human research participants’
p.(None): protections set forth in this National Research Ethics Review Guidelines.
p.(None): 1.4 Scope of Application
p.(None): This Guideline is applicable to all types of research that involves human participants, including but not limited to:
p.(None): • Studies of a physiological, biomedical, biochemical, or pathological processes
p.(None): • Genetic research, clinical trials, pharmaceutical, and other investigational products
p.(None): • Research studies involving clinical records or other personal information
p.(None): • Public health and epidemiological research
p.(None): • Health systems research
p.(None): • Quality improvement research
p.(None): • Human health related behavioral research, research on medical and paramedi- cal education, and research related to
p.(None): traditional healing.
p.(None): • Research that may include one or a combination of observations; interviews, in- ternet-based, mail-based, and
p.(None): telephone research; focus group research; survey and research with biological samples.
p.(None): Furthermore, the guidelines are applicable in research proposed to be conducted by all sectors and organizations. These
p.(None): include, but are not limited to, public, private, faith-based, indigenous and international non-governmental
p.(None): organizations (NGOs), bilateral, multilateral, and United Nations’ agencies.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 19
p.(None):
p.(None): 2. Objectives
p.(None): 2.1 General Objective
p.(None): The objective of this guideline is to safeguard the rights, values, and welfare of re- search participants through
p.(None): respecting the participants’ autonomy, protecting the participants from harm related to research, and ensuring
p.(None): that individual/community benefits and fairness are maintained.
p.(None): 2.2 Specific Objectives
p.(None): 2.2.1. To ensure the rights and autonomy of research participants are respected and that participation or otherwise in
p.(None): research, is entirely voluntary
p.(None): 2.2.2. To safeguard research participants from unnecessary/unjustifiable risk
p.(None): 2.2.3. To ensure fair selection of research participants and fair distribution of benefits and risks
p.(None): 2.2.4. To create awareness among investigators, sponsors, reviewers, decision and policy makers, and
p.(None): individuals/communities on basic ethics principles
p.(None): 2.2.5. To ensure that research holds/embraces/possesses/considers social and cultural responsiveness/sensitivities for
...
Searching for indicator religious:
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p.(None): 3.3 Justice
p.(None): Justice connotes fairness and equity in the distribution of the benefits and burdens of research to participants.
p.(None): 3.3.1. Justice demands equitable selection of participants, i.e., avoiding popu- lations that may be unfairly coerced
p.(None): into participating, including but not limited to, prisoners, pregnant women, people with mental and physical
p.(None): disabilities, immigrants, refugees, ethnic minorities, marginalized groups and institutionalized persons, including
p.(None): children. There must be a justi- fication for inclusion of these vulnerable groups in the research. There should be no
p.(None): disproportionate use of vulnerable populations. The same recruitment approach should be used in all populations.
p.(None): Injustice may arise when selecting participants from a specific socio-economic class, age, sex, racial, cultural,
p.(None): religious, creed, and institutional make up.
p.(None): 3.3.2. The principle of justice requires equality in the distribution of benefits and burdens among the population
p.(None): groups likely to benefit from the research. Distributive justice means that no segment of the population should be
p.(None): unfairly burdened with the harms of research. It thus imposes particular obligations toward individuals who are
p.(None): vulnerable and unable to protect their own interests. Conversely, distributive justice imposes duties neither to
p.(None): neglect nor discriminate against individuals and groups who may ben- efit from advances in research.
p.(None): 3.3.3. Justice also demands balancing the benefits and burdens to the commu- nity where the research is undertaken.
p.(None): 3.3.4. In addition, the investigators shall assure that information obtained in the course of the investigation
p.(None): remains confidential to protect partici-
p.(None): 22 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): pants from possible harm. Data unlinked from individuals or groups does not jeopardize confidentiality. The privacy of
p.(None): individual participants also needs to be protected throughout the investigation by the investigators.
p.(None):
p.(None): 4. Institutional Authority and Purpose
...
p.(None): • Continued review of approved research projects.
p.(None): • Ensure the provision of suitable and safe storage and disposal facilities for all materials involved in work with
p.(None): potentially hazardous substances.
p.(None): • Ensure that all appropriate technical personnel of the institution have adequate training in bio-safety.
p.(None): • Establish a health-monitoring plan for all high-risk personnel involved in appli- cation, use and production of
p.(None): potentially hazardous substances.
p.(None): 10.6 Community Advisory Board
p.(None): 10.6.1 Establishment
p.(None): Community Advisory Boards (CABs) are established by the investigator team. They are indispensable in orienting the
p.(None): investigator team about the local customs, tradi- tions, terminologies, culture, and attitude towards research and
p.(None): development. Be- sides, CABs are important bridges to liaise the researchers with the community. CABs are critical
p.(None): forums to facilitate dialogue between community members, research par- ticipants and investigators.
p.(None): CAB members shall be selected from the community where research is to be under- taken through a stakeholder
p.(None): consultative process. The CAB’s role and expectations should be explicitly described in their terms of reference.
p.(None): Members of the CAB may include but are not limited to the following:
p.(None): • Individuals familiar with local laws, customs, cultural values and gender issues
p.(None): • Elders, opinion leaders, local chiefs
p.(None): • Peer leaders, women leaders
p.(None): • Religious leaders
p.(None): • Representatives of the study population
p.(None): • Media personnel
p.(None): • Professionals who understand research or science issues
p.(None): 10.6.2 Functions
p.(None): The main function of a CAB is to assist investigators with understanding and incorpo- rating community concerns into
p.(None): their research procedures. The functions are expressed through different ways like advising on issues central to the
p.(None): informed consent process, achieving successful volunteer recruitment and retention, and other related issues.
p.(None): The responsibilities of the CABs may vary according to the study location, size, com- plexity, familiarity of the
p.(None): investigators with the local setting, to mention but few. CABs functions are to:
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 63
p.(None):
p.(None): • Provide information on traditional beliefs and needs of the study population and their concerns regarding the
p.(None): research project
p.(None): • Provide input into the design of the research protocol as appropriate especially in the recruitment and the informed
p.(None): consent process
p.(None): • Advise investigators on acceptable and effective methods for disseminating in- formation about the research project
p.(None): and its outcomes
p.(None): • Provide advice and support regarding retention of research participants includ- ing gender equity
p.(None):
p.(None): 11. Monitoring Reporting
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Social / Student
Searching for indicator student:
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p.(None): the health research directives as stipulated on the Health Science and Technology Policy.
p.(None): 5.2.1 Composition
p.(None): • Shall have members with professional competence and mix of varying backgrounds, gender representation, a community
p.(None): representative, re- search ethics training and experience.
p.(None): • Minimum number of members is fifteen (15). The details are described in Section 6.3 below.
p.(None): 5.2.2 Mandates and Functions of NRERC
p.(None): 5.2.2.1. Develop research review guidelines and standards
p.(None): 5.2.2.2. Accredit and recommend licensing and registration of IRBs by MoST
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 25
p.(None):
p.(None): 5.2.2.3. Solicit funds to build capacity at all levels of IRBs
p.(None): 5.2.2.4. Organize and deliver research ethics training to IRBs at all levels using different media (classroom, on-site,
p.(None): internet-based); develop standardized training materials for countrywide use
p.(None): 5.2.2.5. NRERC Protocol Review - The NRERC is responsible for giving final eth- ical decisions on:
p.(None): • All clinical trials involving new drugs, or new combinations of drugs, vaccines, new therapeutic regimens, and other
p.(None): biological products as well as invasive diagnostic procedures. For all research that involves investigational products,
p.(None): authorization and monitoring by FMHACA is a requirement before submitting a protocol for review and approval.
p.(None): • Multi-center collaborative research, including student theses (MSc, PhD, specialization studies) that
p.(None): inherently exhibit more than minimal risk, and experimental/clinical trials.
p.(None): • Research which is funded by companies producing the experimental product.
p.(None): • Experimental research which is carried out by a national agency or agencies with international collaboration.
p.(None): • Projects that require transfer of human biological materials (samples/ specimens).
p.(None): 5.2.2.6. Umpire complaints, disputes, appeals and grievances on functions and review processes of IRBs submitted by
p.(None): researchers or institutions.
p.(None): 5.2.2.7. Monitor and evaluate IRBs at all levels.
p.(None): 5.2.2.8. Facilitate experience sharing among local and international IRBs.
p.(None): 5.2.2.9. Facilitate international registration of Level A IRBs such that their reviews are accepted by funding
p.(None): agencies.
p.(None): 5.2.2.10. Review of trials that are funded by manufacturers and pharmaceuticals,
p.(None): 5.2.2.11. Review very urgent research projects that are of national interest and priority, and
p.(None): 5.2.2.12. Policy-advocacy and creating community awareness on ethical principles in research, and legal and regulatory
p.(None): reforms, and changes related to re- search involving human participants.
p.(None): 5.3 Institutional Review Board, Level A
p.(None): These IRBs can be regional or institutional. These are IRBs that have the capacity to review, monitor, document
p.(None): research protocols and undertakings involving humans in the region or the institution where they are based, or other
p.(None): institutions that do not have their own IRBs and beyond. Similarly, Level A IRBs shall be capable of safe-
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Social / Threat of Stigma
Searching for indicator stigma:
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p.(None): inclusion criteria for individuals…” The justification for selection and the equitable nature of selection of research
p.(None): subjects should be described.
p.(None): 5. Privacy: Privacy should be respected, confidentiality maintained, the opportunity to withdraw at anytime or
p.(None): refuse any component(s) of the research should be avail- able, and the well-being of research participants should be
p.(None): monitored, while infor- mation related to research participants should be kept confidential.
p.(None): 6. Independent/IRB review: “Individuals that are not affiliated with the research must review the research
p.(None): and approve, amend, or terminate the research.” How- ever, individuals involved in independent review with any
p.(None): conflicts of interest may be summoned to provide information to the IRB.
p.(None): 7. Informed consent process: The information provided to research participants should be complete and appropriate to
p.(None): the participants’ level of understanding. The partici- pant should be competent to give or refuse consent and research
p.(None): participants should provide their entirely voluntary informed consent without coercion, manipulation, undue influence,
p.(None): or intimidation.
p.(None): 8. Community engagement: Research is quite often generalized to the community from which individual participants
p.(None): are drawn from. Such generalization can result in different positive or negative impacts to the community in terms of
p.(None): stigma, resource drainage, health outcomes, and more. Hence, researchers are encouraged to involve the community in
p.(None): decision making about the design and conduct of the study. Be- sides, investigators should consider the local customs,
p.(None): traditions, culture and reli- gious practices of the community where the research is proposed to be conducted.
p.(None):
p.(None): 16 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): 1.3 Preamble
p.(None): MoST attaches the highest priority to maintaining high standards of integrity, respon- sibility, and accountability in
p.(None): all research conducted in Ethiopia.
p.(None): In addition, MoST obligates that ‘Research with human subjects should be carried out only by or strictly supervised by,
p.(None): suitably qualified and experienced investiga- tors and in accordance with a protocol that clearly states the aim of the
p.(None): research, the reasons for proposing that it involves human subjects, the nature and degree of any known risks to the
p.(None): subjects, the sources from which it is proposed to recruit subjects, and the means proposed for ensuring that subjects’
p.(None): consent will be ade- quately informed and voluntary. The protocol should be scientifically and ethically appraised by
p.(None): one or more suitably constituted review bodies, independent of the investigators.’
p.(None): MoST ensures that this guidelines basically operate within the legal framework of Ethiopia and that the IRBs operate
p.(None): independently and without influence and coer- cion. Furthermore, MoST demands that membership of IRBs should be large
p.(None): enough to ensure a robust discussion of protocols. Additionally, IRB membership should have a healthy mix of
...
Searching for indicator threat:
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p.(None): well-being of the patient takes priority over the interests of society and the knowledge to be gained.
p.(None): “Human subject [research participant] is a living individual about whom an investi- gator conducting research obtains
p.(None): data through intervention or interaction with the individual, or identifiable private information.” Besides, research
p.(None): participants may include pregnant women where fetuses, fetal material, or abortuses are the primary subjects of
p.(None): interest. Similarly, research involving autopsy materials shall also be in- cluded as source of data.
p.(None): The main purpose of health research involving human participants is for better un- derstanding of the etiology,
p.(None): pathogenesis, and pathophysiology of disease and the related diagnostic, preventive, promotive, and therapeutic
p.(None): procedures and measures. Moreover, as evidence-based practice has become necessary at the turn of the 21st century, and
p.(None): quite understandably, existing procedures and practices are challenged continuously for their effectiveness,
p.(None): efficiency, quality, accessibility, and acceptability by the community.
p.(None): However, in the quest to ensure better health and knowledge, the rights and welfare of research participants must be
p.(None): protected at all times. Participation must be voluntary and free of coercion, persuasion, manipulation, deception,
p.(None): undue influence or induce- ment, and threat or intimidation. The information shall be obtained in a private setting
p.(None): whenever necessary and confidentiality maintained throughout the lifetime of the re- search. This is even more
p.(None): important when research involves participants whose com- prehension and decision making is compromised because of age,
p.(None): lack of knowledge on medical concepts and technological terms, or severe mental or behavioral disorders.
p.(None): For all research involving human participants and human biological materials/speci- mens, investigators should be aware
p.(None): of, and are obligated to, respect and adhere to all ethical, legal, and regulatory requirements applicable in Ethiopia.
p.(None): In this rapidly advancing, complex, and sophisticated era of genetic studies, preven- tive, diagnostic, and therapeutic
p.(None): clinical trials, as well as collaborative research and human biological material transfer being common place, oversight
p.(None): and regulation is imperative to properly safeguard the rights and welfare of human research subjects.
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 15
p.(None):
p.(None): For research to be ethical, all of the following eight criteria must be met:
p.(None): 1. Ethical justification and scientific validity: The research must be rigorous in its methodology. For
p.(None): research to be ethical, the methods must be valid and practically feasible, the research must have a clear objective,
p.(None): be designed using sound scientif- ic principles, have sufficient statistical power, and be based on adequate knowledge
p.(None): of the scientific literature.
...
p.(None): • In situations where deception needs to be applied to achieve the objectives of the study.
p.(None): • The only record linking the research participant and the research project would be the consent document and the
p.(None): principal risk to the research participant would be potential harm resulting from a breach of confidentiality.
p.(None): 6.16 Continuing Review
p.(None): • The IRB conducts continuing review of all approved studies at intervals appro- priate to the degree of risk that the
p.(None): study participants are exposed, but not less than once a year.
p.(None): • The IRB will require continuing progress reports annually , unless it designates otherwise.
p.(None): • All changes in approved research projects should be reported and approved by the IRB before implementation, except
p.(None): where necessary to eliminate immediate apparent risks.
p.(None): 6.17 Suspension and Termination of Approval
p.(None): The IRB has the authority to terminate or suspend its approval for research projects if it considers is appropriate
p.(None): such as:
p.(None): • The research is not being conducted according to the approved protocol, or according to applicable guidelines,
p.(None): National Research Ethics Review Guideline Fifth Edition 39
p.(None):
p.(None): • The research has been associated with serious harm to subjects, and
p.(None): • The research creates a potential threat to the safety and welfare of research participants or the community.
p.(None): The termination or suspension of approval should include a statement of the reasons verifying the IRBs decision and be
p.(None): reported to the investigator; the sponsor of the research and appropriate institutional officials.
p.(None): Upon notification of the suspension or termination of the research, the investigator must promptly inform the research
p.(None): participants about the status of the research with assurance of continuing care and treatment.
p.(None):
p.(None): 7. Review Mechanisms
p.(None): Each IRB must have written procedures, including procedures to be followed in their review mechanism. The following are
p.(None): the minimum requirements for an IRB review mechanism.
p.(None): 7.1 General Requirement
p.(None): The IRB shall review proposed research at convened meetings at which more than 50% of the members of the IRB are
p.(None): present, including at least one member who represents the interests of the community.
p.(None): • In order for the research project to be approved, it shall receive the approval of a simple majority of those
p.(None): members present at the meeting. The only exception to this procedure shall be in the case of expedited review as
p.(None): outlined in Section 7.3.
p.(None): • Each IRB shall decide the frequency of its meetings, which should be announced.
p.(None): • An IRB shall require that information given to research participants as part of informed consent complies with the
p.(None): general requirements for informed consent as prescribed by this guidelines.
p.(None): • An IRB shall notify investigators in writing the outcome of the review of the re- search project. Such notice shall
...
p.(None): international associations and national institutions is deemed necessary.
p.(None): Data and safety monitoring-Structured, ongoing monitoring of specified characteris- tics of a research protocol,
p.(None): generally by a small, independent body of experts appoint- ed by the study sponsor. Sometimes incorrectly called “data
p.(None): safety and monitoring”. Monitoring may pertain to study performance (such as rate of accrual), safety (such as
p.(None): occurrence of AEs), and efficacy (such as achievement of primary endpoints). A body that monitors all three
p.(None): characteristics is usually called a data monitoring com- mittee (DMC) or a data and safety monitoring board (DSMB).
p.(None): Declaration of Helsinki-A statement of ethical principles to provide guidance to phy- sicians and other participants in
p.(None): medical research involving human participants; ad- opted by the World Medical Assembly in 1964 and last updated in
p.(None): 2004. See http:// www.wma.net/e/policy/b3.htm.
p.(None): Disapprove/disapproval-The determination by the IRB that the research may not be conducted at an institution
p.(None): Documentation of consent-Consent that is documented by the use of a written con- sent form approved by the IRB and
p.(None): signed by the participant or the participant’s legally authorized representative.
p.(None): Emergency response-A public health activity undertaken in an urgent or emergency situation, usually because of an
p.(None): identified or suspected imminent health threat to the population, but sometimes because the public or government
p.(None): authorities perceive an imminent threat that demands immediate action. The primary purpose of the activity is to
p.(None): document the existence and magnitude of a public health problem in the community and to implement appropriate measures
p.(None): to address the problem (Langmuir, 1980).
p.(None): Exemption/exempt research-Categories of research to which the Federal regulations for human research protections do not
p.(None): apply. Research involving prisoners and some research involving children are not exempt.
p.(None): Expected-Pertaining to an AE, the event has been previously observed or documented in humans under the research
p.(None): intervention (or one substantially similar), and the nature or severity of the event is consistent with information in
p.(None): the relevant source documents (e.g., investigator’s brochure, package insert, or non-reportable events [NRE] list).
p.(None): National Research Ethics Review Guideline Fifth Edition 79
p.(None):
p.(None): Expedited review-Review performed by the IRB Chair or a designated experienced member for research that involves no
p.(None): more than minimal risk and meets the criteria for expedited review or represents minor changes in approved research.
p.(None): Experienced reviewer -A member of an IRB who is designated by the Chair as autho- rized to conduct expedited reviews.
p.(None): Expert reviewer-A member of an IRB who is designated by the Chair as authorized to conduct expedited reviews.
p.(None): Expiration date-The expiration date is the day before the anniversary of the approval date – unless the IRB approves it
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Social / Victim of Abuse
Searching for indicator abuse:
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p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 55
p.(None):
p.(None): 8.3.5.3 Children
p.(None): Children are persons who have not attained the legal age for consent to treatments or procedures involved in research.
p.(None): The following apply in research involving children.
p.(None): • The child should provide assent in addition to the informed consent by a parent or guardian as stated in Section
p.(None): 6.14 above.
p.(None): • The research presents a realistic opportunity to further the understanding, preven- tion, or alleviation of a
p.(None): serious problem affecting the health or welfare of children.
p.(None): • Emancipated minors – working or earn their living, married, parenting – may be allowed to give an informed consent
p.(None): or an IRB may decide a waiver of consent.
p.(None): • In research related to sensitive topics like drug use and abuse, sexuality, repro- duction, STIs, where obtaining
p.(None): consent from a parent, next-of-kin, or guardian is challenging and may be problematic to the minor because of the
p.(None): nature of the research, assent with waiver of consent may be applicable.
p.(None): • In institutional children, a legally approved guardian may give consent.
p.(None): 8.3.5.4 Prisoners
p.(None): Prisoners may be under constraints because of their incarceration which could affect their ability to make a truly
p.(None): voluntary and decision which is not coerced, whether or not to participate as subjects in research. Therefore,
p.(None): additional safeguards should be included in the study to protect the rights and welfare of these subjects, as follows:
p.(None): • If an IRB regularly reviews research that involves these vulnerable populations, consideration shall be given to the
p.(None): inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.
p.(None): • Where possible, a prisoner or an ex-prisoner co-opted in to the IRB reviewing the proposed research project should
p.(None): be included.
...
p.(None): the health and well-being of the research participants should be permissible.
p.(None): • The IRB shall determine that the informed consent process is properly applied with adequate assurance that a
p.(None): prisoner’s participation or refusal to participate will not be considered in decisions regarding his or her release or
p.(None): further deten- tion and each prisoner is clearly informed in advance that his or her participa- tion in the research
p.(None): project will have no affect on his or her release.
p.(None): 8.3.5.5 Mental and Physical Disability
p.(None): Persons with disability need special attention because they are prone to being social- ly marginalized. Therefore,
p.(None): their dignity, rights and well-being in research must be respected. Careful consideration should be made where proxy
p.(None): consent is to be used, and where the use of signed consent forms is not feasible, alternative viable methods should be
p.(None): employed.
p.(None): 56 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): Persons with disabilities (mental or physical) should not be unfairly excluded from participating in research.
p.(None): Researchers should make an effort to address communi- cation, disability and comprehension constraints are often the
p.(None): excuse for exclusion.
p.(None): People with mental disabilities or substance abuse related disorders include those people with psychiatric, cognitive,
p.(None): or developmental disorders. These groups of peo- ple are usually institutionalized and institutionalization may further
p.(None): compromise their ability to make voluntary decisions to participate in a research project. Therefore,
p.(None): research on people with cognitive disabilities or with substance abuse related disor- ders should:
p.(None): • Provide sufficient justification for involving such people;
p.(None): • Have appropriate evaluation procedures for ascertaining research participants’ ability to give informed consent. If
p.(None): research participants are deemed unable to understand and to make an informed decision, then an appropriate proxy
p.(None): should be identified.
p.(None): • Have an informed consent process that is free from coercion.
p.(None): • Be of no more than minimal risk, or if minimal risk is involved, the risk is outweighed by the anticipated benefits
p.(None): of the research project to the research participant.
p.(None):
p.(None): 9. Human Biological Materials
p.(None): 9.1 Definition
p.(None): Human biological materials include any substance obtained from a human research participant including, but not limited
p.(None): to, blood, urine, stool, saliva, hair, nail clip- pings, skin, and microorganisms, and other associated bio-products
p.(None): obtained from human research participants.
p.(None): 9.2 Acquisition, Storage, Secondary Use
p.(None): The acquisition, storage, and future use of human biological samples from research participants in Ethiopia shall be
p.(None): guided by the following procedures:
p.(None): • There should be a separate informed consent process for obtaining human bio- logical samples for storage and for
...
Social / Women
Searching for indicator women:
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p.(None): professionals, was sought using a semi-structured tool. All efforts were made to strike a balance in accommodating the
p.(None): experts’ sometimes differing opinions and suggestions for these guidelines.
p.(None): 14 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): Moreover, the draft guidelines were discussed with a wider group of experts and rep- resentatives drawn from the MoST,
p.(None): Ministry of Justice, Ministry of Health, FMHACA, IRBs of universities and research institutions, international and UN
p.(None): agencies, and other relevant stakeholders. The comments and recommendations from this nation- wide consultative meeting
p.(None): were analyzed and incorporated before this guideline was endorsed and released for use to safeguard the rights and
p.(None): welfare of research partic- ipants and for oversight of research in Ethiopia.
p.(None): 1.2 Introduction
p.(None): “Research is a systematic investigation including research development, testing, and evaluation designed to contribute
p.(None): to generalizable knowledge.” Nevertheless, as a matter of principle, in research involving human participants, the
p.(None): well-being of the patient takes priority over the interests of society and the knowledge to be gained.
p.(None): “Human subject [research participant] is a living individual about whom an investi- gator conducting research obtains
p.(None): data through intervention or interaction with the individual, or identifiable private information.” Besides, research
p.(None): participants may include pregnant women where fetuses, fetal material, or abortuses are the primary subjects of
p.(None): interest. Similarly, research involving autopsy materials shall also be in- cluded as source of data.
p.(None): The main purpose of health research involving human participants is for better un- derstanding of the etiology,
p.(None): pathogenesis, and pathophysiology of disease and the related diagnostic, preventive, promotive, and therapeutic
p.(None): procedures and measures. Moreover, as evidence-based practice has become necessary at the turn of the 21st century, and
p.(None): quite understandably, existing procedures and practices are challenged continuously for their effectiveness,
p.(None): efficiency, quality, accessibility, and acceptability by the community.
p.(None): However, in the quest to ensure better health and knowledge, the rights and welfare of research participants must be
p.(None): protected at all times. Participation must be voluntary and free of coercion, persuasion, manipulation, deception,
p.(None): undue influence or induce- ment, and threat or intimidation. The information shall be obtained in a private setting
p.(None): whenever necessary and confidentiality maintained throughout the lifetime of the re- search. This is even more
p.(None): important when research involves participants whose com- prehension and decision making is compromised because of age,
p.(None): lack of knowledge on medical concepts and technological terms, or severe mental or behavioral disorders.
...
p.(None): result of being a research participant. Risks to research participants include physical, psychological, and emotional
p.(None): harm. Risks can be known or presumed. And, although no specific regulations exist, risks may include physical,
p.(None): psychological, emotional, economic, educational, legal, and social harm.
p.(None): In addition, beneficence includes whether the usual care is changed or manipulated to inflict no harm, minimize harm,
p.(None): remove harm, and maximize the benefit to re- search participants and to the community, or both.
p.(None): 3.3 Justice
p.(None): Justice connotes fairness and equity in the distribution of the benefits and burdens of research to participants.
p.(None): 3.3.1. Justice demands equitable selection of participants, i.e., avoiding popu- lations that may be unfairly coerced
p.(None): into participating, including but not limited to, prisoners, pregnant women, people with mental and physical
p.(None): disabilities, immigrants, refugees, ethnic minorities, marginalized groups and institutionalized persons, including
p.(None): children. There must be a justi- fication for inclusion of these vulnerable groups in the research. There should be no
p.(None): disproportionate use of vulnerable populations. The same recruitment approach should be used in all populations.
p.(None): Injustice may arise when selecting participants from a specific socio-economic class, age, sex, racial, cultural,
p.(None): religious, creed, and institutional make up.
p.(None): 3.3.2. The principle of justice requires equality in the distribution of benefits and burdens among the population
p.(None): groups likely to benefit from the research. Distributive justice means that no segment of the population should be
p.(None): unfairly burdened with the harms of research. It thus imposes particular obligations toward individuals who are
p.(None): vulnerable and unable to protect their own interests. Conversely, distributive justice imposes duties neither to
...
p.(None): • Each IRB shall be composed of at least five (5) members, with varying back- grounds to ensure complete and robust
p.(None): review of research activities commonly conducted by the institution. It must be multidisciplinary and multi-sectoral in
p.(None): composition, including persons with relevant but diverse scientific expertise, balanced age and gender
p.(None): distribution, and who have the qualifications and ex- perience to review and evaluate the scientific and
p.(None): medical ethics aspects of research protocols.
p.(None): • All IRBs shall have at least one member whose main area of expertise is in the scientific field and at least one
p.(None): member whose primary area of expertise is in a non-scientific field.
p.(None): • Each IRB shall include at least one member who is not otherwise affiliated with the institution or have a close
p.(None): family member working in the institution.
p.(None): • The IRB should have at least one community representative, who does not nec- essarily have to have any scientific
p.(None): expertise, but may be a layperson that rep- resents the interests and concerns of members of the community and is
p.(None): familiar with the community’s values, customs, traditions, and culture.
p.(None): • If an IRB regularly reviews research that involves vulnerable populations, such as children, prisoners, pregnant
p.(None): women, men/women in uniform or persons with disabilities, marginalized group, refuges, minorities, the IRB shall
p.(None): involve or co- opt one or more individuals who are knowledgeable about and experienced in working with these research
p.(None): participants.
p.(None): • All IRB members should at the minimum take one basic training on bioethics within one year of appointment.
p.(None):
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 31
p.(None):
p.(None): 6.4 External Reviewers
p.(None): • If a protocol requires expertise that is beyond the competence of the IRB mem- bers or the IRB need additional
p.(None): opinion in the review process, the IRB may engage independent experts to review and give their opinion.
p.(None): • The Secretariat should keep an updated list of experts along with their CVs, which should be reviewed annually by
p.(None): the IRB.
p.(None): • Independent experts must sign privacy and confidentiality agreements and con- flict of interest (COI) forms to
p.(None): ensure that the information in the protocol is protected and that consultants do not have any conflicts.
p.(None): • The IRB may ask questions that could guide the review of the experts.
p.(None): • The expert may be invited to attend or consult by telephone an IRB meeting but he/she cannot vote in the meeting.
p.(None): 6.5 Independence of IRB
p.(None): 6.5.1. The IRB must be independent from the appointing authority, hosting institution, investigators, sponsors and any
p.(None): other stakeholders in its review and decision-making processes.
...
p.(None): collaborative research is primarily responsible for monitoring the ethical conduct of the research procedures. However,
p.(None): the National IRB can monitor the proper conduct of the research whenever it deems further oversight is necessary. Any
p.(None): modification, amendment, or change in the approved collaborative research protocol should be made at each collaborating
p.(None): institution. Material transfer agreements must be obtained whenever applicable.
p.(None): 8.3.5 Vulnerable Population
p.(None): Vulnerable populations are those segments of the population whose capacity to safe- guard their welfare, demand their
p.(None): rights and satisfy their interests, is compromised. Because of these limitations, they cannot provide or refuse
p.(None): consent. Vulnerable pop-
p.(None): 54 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): ulations are particularly subject to undue influence, manipulation, coercion, and in- timidation. Hence, vulnerable
p.(None): populations deserve special protection from IRBs and other regulatory authorities.
p.(None): 8.3.5.1 Pregnant women and Fetuses
p.(None): To conduct research on pregnant women, the following must be fulfilled:
p.(None): • There is evidence from studies on pregnant animals and non-pregnant women that studies need to be done on risks
p.(None): related to pregnant women and fetuses.
p.(None): • If the research holds the prospect of direct benefit to the pregnant woman and the fetus, and the knowledge cannot
p.(None): be obtained through other means.
p.(None): • There should be no inducement to terminate a pregnancy.
p.(None): • If the prospect of benefit is both to the pregnant woman and the fetus, an in- formed consent form from the mother
p.(None): alone suffices to enroll the woman into the research.
p.(None): • If the prospect of benefit is solely to the fetus, informed consent should be obtained from both parents, provided
p.(None): they are competent to give or refuse the consent.
p.(None): • In both conditions, the foreseeable risks of the research on the fetus or the neo- nate must be thoroughly
p.(None): explained.
p.(None): • Viability of the fetus should be determined by a health care provider who is not a member of the investigation team.
p.(None): 8.3.5.2 Newborns/Neonates
p.(None): In research involving neonates with uncertain viability, the following must be met:
...
p.(None):
p.(None): binant DNA and potentially hazardous substances.
p.(None): • Continued review of approved research projects.
p.(None): • Ensure the provision of suitable and safe storage and disposal facilities for all materials involved in work with
p.(None): potentially hazardous substances.
p.(None): • Ensure that all appropriate technical personnel of the institution have adequate training in bio-safety.
p.(None): • Establish a health-monitoring plan for all high-risk personnel involved in appli- cation, use and production of
p.(None): potentially hazardous substances.
p.(None): 10.6 Community Advisory Board
p.(None): 10.6.1 Establishment
p.(None): Community Advisory Boards (CABs) are established by the investigator team. They are indispensable in orienting the
p.(None): investigator team about the local customs, tradi- tions, terminologies, culture, and attitude towards research and
p.(None): development. Be- sides, CABs are important bridges to liaise the researchers with the community. CABs are critical
p.(None): forums to facilitate dialogue between community members, research par- ticipants and investigators.
p.(None): CAB members shall be selected from the community where research is to be under- taken through a stakeholder
p.(None): consultative process. The CAB’s role and expectations should be explicitly described in their terms of reference.
p.(None): Members of the CAB may include but are not limited to the following:
p.(None): • Individuals familiar with local laws, customs, cultural values and gender issues
p.(None): • Elders, opinion leaders, local chiefs
p.(None): • Peer leaders, women leaders
p.(None): • Religious leaders
p.(None): • Representatives of the study population
p.(None): • Media personnel
p.(None): • Professionals who understand research or science issues
p.(None): 10.6.2 Functions
p.(None): The main function of a CAB is to assist investigators with understanding and incorpo- rating community concerns into
p.(None): their research procedures. The functions are expressed through different ways like advising on issues central to the
p.(None): informed consent process, achieving successful volunteer recruitment and retention, and other related issues.
p.(None): The responsibilities of the CABs may vary according to the study location, size, com- plexity, familiarity of the
p.(None): investigators with the local setting, to mention but few. CABs functions are to:
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 63
p.(None):
p.(None): • Provide information on traditional beliefs and needs of the study population and their concerns regarding the
p.(None): research project
p.(None): • Provide input into the design of the research protocol as appropriate especially in the recruitment and the informed
p.(None): consent process
p.(None): • Advise investigators on acceptable and effective methods for disseminating in- formation about the research project
p.(None): and its outcomes
p.(None): • Provide advice and support regarding retention of research participants includ- ing gender equity
p.(None):
p.(None): 11. Monitoring Reporting
...
p.(None): in the relevant source documents (e.g., investigator’s brochure, package insert, or non-reportable events [NRE] list),
p.(None): or the event is observed with higher frequency than previously observed or documented. Expectedness does not entail the
p.(None): ability to predict results from in vitro, animal, or other pharmacological models.
p.(None): Unlinked-The condition of data or specimens which had been coded but for which the key linking the code to direct
p.(None): personal identifiers has been destroyed.
p.(None): Unrelated-Pertaining to an AE, the condition in which the event is due to a docu- mented cause other than research
p.(None): procedures.
p.(None): Verbal consent-Consent obtained by communication in words; this may include spo- ken or written format.
p.(None): Voluntary/voluntariness-Freedom from coercion and undue influence
p.(None): Vulnerable-Having reduced capacity to offer free and informed consent due to pos- sible coercion, undue influence,
p.(None): or other diminished autonomy, such as children, prisoners, pregnant women, mentally disabled persons, or
p.(None): economically or education- ally disadvantaged persons as vulnerable. Vulnerability may be associated with other
p.(None): characteristics such as age, health status, or social standing. The IRB must ensure additional safeguards protect the
p.(None): rights and welfare of vulnerable persons.
p.(None): Vulnerable population-A group identified by one or more common characteristics associated with reduced
p.(None): capacity to offer free and informed consent.
p.(None): Waive/waiver-Temporarily set aside the requirement of a particular rule, regulation, or condition in a protocol or
p.(None): consent document.
p.(None): Withdraw/withdrawal-Permanently halt a research study after submission for IRB review but before human
p.(None): participants become involved, whether or not the study has been reviewed by an IRB. This term has been replaced by the
p.(None): term close/closure.
p.(None):
p.(None):
p.(None):
p.(None): 84 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): Appendix III: NRERC Terms of Reference
p.(None): 1. Membership
...
Social / Youth/Minors
Searching for indicator minor:
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p.(None): • A statement that the study involves research, the purpose of the re- search, the expected duration of participants’
p.(None): involvement and identifi- cation of any experimental procedures.
p.(None): • Foreseeable risks and discomforts.
p.(None): • Reasonably expected benefits to the participants as well as the community.
p.(None): • Disclosure of appropriate alternatives procedures or treatments.
p.(None): • Extent to which confidentiality will be maintained.
p.(None): • Compensation for possible injury if the research is greater than minimal risk; if so, an explanation is needed as to
p.(None): whether any medical treat- ments are available if injury occurs and what they consist of, or where further information
p.(None): may be obtained.
p.(None): • An explanation of whom to contact for answers to pertinent questions about the research and research
p.(None): participants’ rights, and whom to contact in the event of a research-related injury to the participant; A statement
p.(None): that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the
p.(None): participant is oth- erwise entitled. The consent form should also clearly indicate that re- search participants are
p.(None): free to withdraw from the study at any time and that the participant may discontinue participation at any time without
p.(None): penalty or loss of benefits. Research participants also are not obliged to respond to all questions in a study
p.(None): questionnaire.
p.(None): 6.14 Assent
p.(None): Assent will be sought from a study participant under the age of 18 years old. The minor child should be given
p.(None): appropriate information based on the child’s level of comprehen- sion whatever the complexity of the research
p.(None): procedures. Then, an assent, a child’s affirmative agreement to participate in research shall be sought from all
p.(None): children 12 years of age and above, in addition to the consent of a parent, next-of-kin, or guardian.
p.(None): 6.15 Waiver of Informed Consent Documentation
p.(None): Waiver of informed consent or documentation of informed consent should be ap- proved by the IRB. The investigator must
p.(None): secure an explicit waiver of consent from the IRB. The IRB may waive some or all of the elements of an informed consent
p.(None): and/
p.(None):
p.(None): 38 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): or a signed or thumb printed consent form for some or all of the research participants of a particular study, if the
p.(None): IRB determines that:
p.(None): • The research project carries no more than minimal risk, If the research or demonstration project is
...
p.(None): members assigned by the chair.
p.(None): 7.3.1 Eligibility Criteria
p.(None): For the review to be expedited the proposed research must:
p.(None): • Involve minimal risk, meaning that the probability and magnitude of harm or discomfort anticipated in the research
p.(None): are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of
p.(None): routine physical or psychological examinations or tests.
p.(None): • Appropriately protect privacy/confidentiality.
p.(None): • Fall into one of the following categories:
p.(None): 1. Research employing survey, interview, oral history, focus group, or human fac- tors evaluation.
p.(None): 2. Research involving materials (data, document, records, or specimens) that were originally colected for non-research
p.(None): purposes.
p.(None): 3. Collection of data from voice, video, digital or image recordings previously made for research purposes.
p.(None): 42 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): 4. Research on individual or group characteristics or behavior (including, but not limited to, research on perception,
p.(None): cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior).
p.(None): • Follow-up on changes, amendments and annual renewals:
p.(None): 1. Follow-up on changes or information requested by the Review Committee as a condition of approval.
p.(None): 2. Minor amendments to previously approved research.
p.(None): 3. Annual renewals, if the original approval was through expedited review.
p.(None): 4. The only remaining activities involve long-term follow-up of previously en- rolled participants.
p.(None): 5. The only remaining activities involve data analysis.
p.(None): • The review committee has determined and documented at a convened meet- ing that the research involves no greater
p.(None): than minimal risk (and there are no proposed changes that involve additional risk).
p.(None): 7.3.2 Applying for an Expedited Review
p.(None): Requests for an expedited review can be submitted at any time to the Secretariat.
p.(None): • An investigator who wishes to apply for an expedited review should submit an application indicating the reason(s)
p.(None): for the eligibility of the study for expedited review.
p.(None): • Upon receiving an application for expedited review, the IRB Secretary/Adminis- trator in consultation with the
p.(None): Chairperson/Vice Chair makes the initial assess- ment to determine if it qualifies for expedited review.
p.(None): • If the study qualifies for expedited review, IRB chairperson or by one or more experienced reviewers designated by
p.(None): the chairperson from among the members of the IRB should be assigned to review the protocol. If the review involves a
p.(None): study amendment, the selected member should be a member who reviewed the previous version of the protocol.
p.(None): • When the protocol is approved, the investigator(s) will be notified immediately through the Secretariat.
p.(None): 7.3.3. A summary of the protocols reviewed through the expedited process should be submitted to the full
p.(None): (convened) IRB at its next meeting.
...
p.(None): The following apply in research involving children.
p.(None): • The child should provide assent in addition to the informed consent by a parent or guardian as stated in Section
p.(None): 6.14 above.
p.(None): • The research presents a realistic opportunity to further the understanding, preven- tion, or alleviation of a
p.(None): serious problem affecting the health or welfare of children.
p.(None): • Emancipated minors – working or earn their living, married, parenting – may be allowed to give an informed consent
p.(None): or an IRB may decide a waiver of consent.
p.(None): • In research related to sensitive topics like drug use and abuse, sexuality, repro- duction, STIs, where obtaining
p.(None): consent from a parent, next-of-kin, or guardian is challenging and may be problematic to the minor because of the
p.(None): nature of the research, assent with waiver of consent may be applicable.
p.(None): • In institutional children, a legally approved guardian may give consent.
p.(None): 8.3.5.4 Prisoners
p.(None): Prisoners may be under constraints because of their incarceration which could affect their ability to make a truly
p.(None): voluntary and decision which is not coerced, whether or not to participate as subjects in research. Therefore,
p.(None): additional safeguards should be included in the study to protect the rights and welfare of these subjects, as follows:
p.(None): • If an IRB regularly reviews research that involves these vulnerable populations, consideration shall be given to the
p.(None): inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.
p.(None): • Where possible, a prisoner or an ex-prisoner co-opted in to the IRB reviewing the proposed research project should
p.(None): be included.
p.(None): • Only research on conditions particularly affecting prisoners as a class and with reasonable probability of improving
p.(None): the health and well-being of the research participants should be permissible.
p.(None): • The IRB shall determine that the informed consent process is properly applied with adequate assurance that a
...
p.(None): MOST Ministry of Science and Technology
p.(None): MTA Materials Transfer Agreement
p.(None): 76 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): NEC National Ethics Committee
p.(None): NGO Non-Governmental Organization
p.(None): PI(s) Principle Investigator(s)
p.(None): SAE Serious Adverse Event
p.(None): SOP Standard Operating Procedures
p.(None): S&T Science & Technology
p.(None): TOR Terms of Reference
p.(None): UN United Nations
p.(None): WHO World Health Organization
p.(None):
p.(None): Appendix II. Glossary of Terms
p.(None): Accreditation-The act of granting credit or recognition for meeting established stan- dards; a process to ensure
p.(None): quality and stimulate continuing improvement.
p.(None): Adverse Event (AE)-Any untoward health-related occurrence in a participant admin- istered a health-research
p.(None): intervention and which does not necessarily have to have a causal relationship with this intervention. An AE can be any
p.(None): unfavorable and unin- tended sign, symptom, or condition temporally associated with the administration of the
p.(None): health-research intervention, whether or not considered related to the interven- tion. This also includes unfavorable
p.(None): deviations from baseline health.
p.(None): Amendment-A material change to study procedures. Such changes, including minor changes, must be reviewed by an IRB
p.(None): before they may be implemented.
p.(None): Anonymous/anonymized-Lacking identification because identifiers or other informa- tion that could identify the
p.(None): individual were not collected or were removed. Information may or may not be considered anonymous if there is a
p.(None): reasonable basis to believe that one can use the information to identify and individual, even if one cannot readily
p.(None): ascertain the individual’s identity; see further discussion at individually identifiable information. For example, it
p.(None): might be possible to determine a survey respondent’s identity from a combination of demographic factors in a survey
p.(None): together with public or proprietary data sources, even if the surveyor did not jointly record the respondent’s identity
p.(None): and those demographic characteristics..
p.(None): Approve/approval-The determination of the IRB that the research has been reviewed and may be conducted at an
p.(None): institution within the constraints set forth by the IRB and by other institutional and federal requirements.
p.(None): Assent-Participant not of legal age (i.e., child); affirmative agreement to participate in research. Mere failure to
p.(None): object should not be construed as assent.
p.(None): Autonomy-Self-rule that is free from both controlling interference by others and from limitations that prevent
p.(None): meaningful choice. See also respect for persons.
p.(None): Belmont Report-Statement of ethical principles and guidelines for the protection of
...
p.(None): identified or suspected imminent health threat to the population, but sometimes because the public or government
p.(None): authorities perceive an imminent threat that demands immediate action. The primary purpose of the activity is to
p.(None): document the existence and magnitude of a public health problem in the community and to implement appropriate measures
p.(None): to address the problem (Langmuir, 1980).
p.(None): Exemption/exempt research-Categories of research to which the Federal regulations for human research protections do not
p.(None): apply. Research involving prisoners and some research involving children are not exempt.
p.(None): Expected-Pertaining to an AE, the event has been previously observed or documented in humans under the research
p.(None): intervention (or one substantially similar), and the nature or severity of the event is consistent with information in
p.(None): the relevant source documents (e.g., investigator’s brochure, package insert, or non-reportable events [NRE] list).
p.(None): National Research Ethics Review Guideline Fifth Edition 79
p.(None):
p.(None): Expedited review-Review performed by the IRB Chair or a designated experienced member for research that involves no
p.(None): more than minimal risk and meets the criteria for expedited review or represents minor changes in approved research.
p.(None): Experienced reviewer -A member of an IRB who is designated by the Chair as autho- rized to conduct expedited reviews.
p.(None): Expert reviewer-A member of an IRB who is designated by the Chair as authorized to conduct expedited reviews.
p.(None): Expiration date-The expiration date is the day before the anniversary of the approval date – unless the IRB approves it
p.(None): for less than one year. For instance, a protocol approved on 12/4 has approval date of 12/4/06 and an expiration date
p.(None): of 12/3/07 midnight (which means research may be conducted on 12/3).
p.(None): Fetus-The product of conception from the time of implantation until delivery.
p.(None): Focus group-Group of individuals brought together to discuss an issue within a struc- tured environment, often for
p.(None): formative or qualitative research purposes.
p.(None): Generalizable knowledge-New information that has relevance beyond the population or program from which it was collected
p.(None): Good Clinical Practice (GCP)-An international ethical and scientific quality standard for designing, conducting,
p.(None): recording, and reporting trials that involve the participation of human participants. See also
p.(None): http://www.fda.gov/oc/gcp/default.htm.
p.(None): Guardian-An individual who is authorized under applicable local law to consent on behalf of a child to general medical
p.(None): care.
p.(None): Harm-Injury, damage, or hurt; an experience in which one’s interests are thwarted, defeated, or set back, especially
p.(None): one’s physical or psychological interests.
...
p.(None): ought not, to participate in any particular kind of research.
p.(None): Legally Authorized Representative (LAR)-An individual or judicial or other body au- thorized under applicable State law
p.(None): who may consent on behalf of another individual to participate in the procedure(s) involved in the research.
p.(None): Local IRB-IRB located in the institution where the research is to be conducted.
p.(None): Medical device-Any instrument, apparatus, or other similar or related article, includ- ing component, part, or
p.(None): accessory, which is (a) recognized in the official National For- mulary, or the United States Pharmacopeia, or any
p.(None): supplement to them; (b) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation,
p.(None): treatment, or prevention of disease, in humans or other animals; or (c) intended to affect the structure or any
p.(None): function of the human body or in animals; and does not achieve any of its principal intended purposes through chemical
p.(None): action within or on the human body or in animals and is not dependent upon being metabolized for the achievement of its
p.(None): principal intended purposes.
p.(None): Minimal risk-(a) Risk such that the probability and magnitude of harm or discomfort anticipated in the research are not
p.(None): greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine
p.(None): physical or psycholog- ical examinations or tests.
p.(None): Minor changes-Changes to a research protocol that do not result in a net increase in risk, a change in the harm-benefit
p.(None): balance, or provide minor clarification or correc- tion. Minor changes may be reviewed under expedited review, even if
p.(None): the protocol has been deemed to pose more than minimal risk to participants.
p.(None): Noncompliance-Failure by investigators, research staff, IRB members, or IRB staff to follow regulations for human
p.(None): research protections
p.(None): Oral consent-Consent obtained only through speaking, generally in the absence of documentation of consent. See also
p.(None): documentation of consent, informed con- sent, verbal consent.
p.(None): National Research Ethics Review Guideline Fifth Edition 81
p.(None):
p.(None): Parental permission-The agreement of a parent or guardian to the participation of their child in research.
p.(None): Personal identifier-Information obtained and recorded in such a manner that human participants can be recognized,
p.(None): directly or through links to the participants. Examples include names, social security numbers, and codes.
p.(None): Pilot study-Preliminary study to determine the feasibility of a larger study, use of a test instrument, or other
p.(None): activity.
p.(None): Pregnancy-The period of time from implantation until delivery. A woman shall be assumed to be pregnant if
...
Social / education
Searching for indicator education:
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p.(None): complaints and grievances from all parties involved in research (researchers, research participants, communities, spon-
p.(None): sors, and others),
p.(None): • That research should be carried out in full compliance with, and awareness of, standards, laws, regulations of the
p.(None): country, as well as local customs, commu- nity, and the mix of social, traditional, and cultural diversity,
p.(None): MoST developed this National Research Ethics Review Guidelines to safeguard the rights, safety and welfare of all
p.(None): human participants in all research proposed to be conducted in Ethiopia, based upon the Health Science and Technology
p.(None): Policy and the responsibilities assigned to the MoST.
p.(None): No other guidelines and requirements are allowed to diminish or remove any of the human research participants’
p.(None): protections set forth in this National Research Ethics Review Guidelines.
p.(None): 1.4 Scope of Application
p.(None): This Guideline is applicable to all types of research that involves human participants, including but not limited to:
p.(None): • Studies of a physiological, biomedical, biochemical, or pathological processes
p.(None): • Genetic research, clinical trials, pharmaceutical, and other investigational products
p.(None): • Research studies involving clinical records or other personal information
p.(None): • Public health and epidemiological research
p.(None): • Health systems research
p.(None): • Quality improvement research
p.(None): • Human health related behavioral research, research on medical and paramedi- cal education, and research related to
p.(None): traditional healing.
p.(None): • Research that may include one or a combination of observations; interviews, in- ternet-based, mail-based, and
p.(None): telephone research; focus group research; survey and research with biological samples.
p.(None): Furthermore, the guidelines are applicable in research proposed to be conducted by all sectors and organizations. These
p.(None): include, but are not limited to, public, private, faith-based, indigenous and international non-governmental
p.(None): organizations (NGOs), bilateral, multilateral, and United Nations’ agencies.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 19
p.(None):
p.(None): 2. Objectives
p.(None): 2.1 General Objective
p.(None): The objective of this guideline is to safeguard the rights, values, and welfare of re- search participants through
p.(None): respecting the participants’ autonomy, protecting the participants from harm related to research, and ensuring
p.(None): that individual/community benefits and fairness are maintained.
p.(None): 2.2 Specific Objectives
p.(None): 2.2.1. To ensure the rights and autonomy of research participants are respected and that participation or otherwise in
p.(None): research, is entirely voluntary
p.(None): 2.2.2. To safeguard research participants from unnecessary/unjustifiable risk
...
p.(None): • The Acting Chairperson should not have authority to sign official IRB documents such as approval certificates
p.(None): but may sign minutes confirmed during his/her Chairpersonship.
p.(None): • The process of resignation should be the same as that for the Chairperson.
p.(None): National Research Ethics Review Guideline Fifth Edition 33
p.(None):
p.(None): 6.7.3 Members
p.(None): • Membership becomes effective upon accepting an invitation from the appoint- ing authority. Acceptance must be
p.(None): indicated by the member’s dated signature.
p.(None): • A member should be willing to have his/her full name, profession and affilia- tion(s) published in the public
p.(None): domain.
p.(None): • Members are responsible for reviewing protocols to safeguard the rights, dignity and welfare of study participants.
p.(None): • Members are responsible for reviewing progress reports.
p.(None): • Members are responsible for oversight visits in order to monitor ongoing studies approved by the IRB.
p.(None): • Members are obliged to read protocols, including ancillary documents (e.g., pa- tient brochures, informed consent
p.(None): forms, project reports and SAE reports given to them by the IRB Secretariat in advance preparation of IRB meetings.
p.(None): • Members are obliged to keep IRB documents secure, private, and confidential.
p.(None): • Members should attend IRB meetings regularly and participate fully and actively in deliberations.
p.(None): • Members should participate in continuing education activities in research ethics, RE.
p.(None): • Members must declare any COI for any protocol, and withdraw from the review of that protocol.
p.(None): • Members must maintain privacy and confidentiality of documents and deliber- ations of IRB meetings.
p.(None): 6.8 Orientation Education of Members
p.(None): • New members should undergo orientation training upon joining the IRB in order to familiarize them with basic human
p.(None): research ethics. Such training should be organized by the IRB Secretariat, the host institutions and/or any other
p.(None): players involved in such training.
p.(None): • Continuous training of IRB members on health research ethics and other rel- evant areas such as Good Clinical
p.(None): Practice (GCP) and experimental designs should be conducted as necessary.
p.(None): • Current CVs and records of training of all members should be kept on file by the IRB Secretariat in the IRB office.
p.(None): 6.9 Termination of Membership
p.(None): • Membership may be terminated voluntarily. The member should write a resig- nation letter to the appointing authority
p.(None): through the IRB Chairperson giving at least a one-month notice.
p.(None): • The Chairperson may resign by sending his/her resignation letter to the appointing
p.(None): 34 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): authority after informing the committee at its next meeting.
p.(None): • Membership should be terminated by the appointing authority on the advice of the IRB if a member is going to be away
p.(None): for more than one year.
p.(None): • Membership could be terminated by the appointing authority upon advice of the IRB if the member has been absent from
...
p.(None):
p.(None): 7. Review Mechanisms
p.(None): Each IRB must have written procedures, including procedures to be followed in their review mechanism. The following are
p.(None): the minimum requirements for an IRB review mechanism.
p.(None): 7.1 General Requirement
p.(None): The IRB shall review proposed research at convened meetings at which more than 50% of the members of the IRB are
p.(None): present, including at least one member who represents the interests of the community.
p.(None): • In order for the research project to be approved, it shall receive the approval of a simple majority of those
p.(None): members present at the meeting. The only exception to this procedure shall be in the case of expedited review as
p.(None): outlined in Section 7.3.
p.(None): • Each IRB shall decide the frequency of its meetings, which should be announced.
p.(None): • An IRB shall require that information given to research participants as part of informed consent complies with the
p.(None): general requirements for informed consent as prescribed by this guidelines.
p.(None): • An IRB shall notify investigators in writing the outcome of the review of the re- search project. Such notice shall
p.(None): be provided to the investigator within 15 days from the date of IRB review of the research protocol. In case the IRB
p.(None): does not approve a research activity, it shall include in its written notification a detailed statement of the reasons
p.(None): for its decision.
p.(None): 7.2 Exempted Review Procedures
p.(None): Research activities in which the only involvement of human participants will be in one or more of the specific
p.(None): categories stated below can be considered as exempt:
p.(None): • Education: Research conducted in established or commonly accepted educa- tional settings, involving normal
p.(None): educational practices.
p.(None): • Education: Research involving the use of educational tests (cognitive, diagnos- tic, aptitude, achievement),
p.(None): surveys, interviews, or observation of public behav-
p.(None): ior, provided the research participants can not be identified.
p.(None): 40 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): • Research, involving the collection or study of existing data, documents, records, pathological specimens, or
p.(None): diagnostic specimens, if these sources are publicly available or recorded without identifiers. Or, if the information
p.(None): is recorded by the investigator in such a manner that research participants cannot be identified, directly or through
p.(None): identifiers linked to the subjects.
p.(None): • Evaluation or examination of government projects or programs designed to ex- plore public benefit or service
p.(None): programs; procedures for obtaining benefits or services under those projects or programs; possible changes in or
p.(None): alternatives to those programs or procedures.
p.(None): • Taste and food quality evaluation and consumer acceptance studies where the foods are free of additives and where
p.(None): the ingredients are known to be safe.
p.(None): • Emergency conditions of national or regional importance, such as epidemics.
p.(None): • Quality assurance activities.
p.(None): All research including that in the exempt categories must meet, at a minimum, the principles of respect for persons,
...
p.(None): ability to predict results from in vitro, animal, or other pharmacological models.
p.(None): Unlinked-The condition of data or specimens which had been coded but for which the key linking the code to direct
p.(None): personal identifiers has been destroyed.
p.(None): Unrelated-Pertaining to an AE, the condition in which the event is due to a docu- mented cause other than research
p.(None): procedures.
p.(None): Verbal consent-Consent obtained by communication in words; this may include spo- ken or written format.
p.(None): Voluntary/voluntariness-Freedom from coercion and undue influence
p.(None): Vulnerable-Having reduced capacity to offer free and informed consent due to pos- sible coercion, undue influence,
p.(None): or other diminished autonomy, such as children, prisoners, pregnant women, mentally disabled persons, or
p.(None): economically or education- ally disadvantaged persons as vulnerable. Vulnerability may be associated with other
p.(None): characteristics such as age, health status, or social standing. The IRB must ensure additional safeguards protect the
p.(None): rights and welfare of vulnerable persons.
p.(None): Vulnerable population-A group identified by one or more common characteristics associated with reduced
p.(None): capacity to offer free and informed consent.
p.(None): Waive/waiver-Temporarily set aside the requirement of a particular rule, regulation, or condition in a protocol or
p.(None): consent document.
p.(None): Withdraw/withdrawal-Permanently halt a research study after submission for IRB review but before human
p.(None): participants become involved, whether or not the study has been reviewed by an IRB. This term has been replaced by the
p.(None): term close/closure.
p.(None):
p.(None):
p.(None):
p.(None): 84 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): Appendix III: NRERC Terms of Reference
p.(None): 1. Membership
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 2. Tenure
p.(None): The tenure of the NRERC shall be three years.
p.(None): 3. Replacement of Missing Members
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Searching for indicator educational:
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p.(None): participant. Generally, the consent form should explicitly indicate the points mentioned in Section 6.13 below.
p.(None): National Research Ethics Review Guideline Fifth Edition 21
p.(None):
p.(None): 3.2 Beneficence
p.(None): The principle of beneficence refers to the obligation on the part of the investiga- tor to attempt to
p.(None): maximize benefits for the individual participant and/or community, while minimizing risk or harm to the
p.(None): individual/community. As much as possible, beneficence also considers inflicting no harm. An honest and thorough
p.(None): risk/benefit assessment must be performed. Balancing the risk and benefit of the research is indispensible
p.(None): in the design and conduct of the research.
p.(None): Risk is the probability and magnitude of some future occurrence of harm. Harm is injury and setback to interests as a
p.(None): result of being a research participant. Risks to research participants include physical, psychological, and emotional
p.(None): harm. Risks can be known or presumed. And, although no specific regulations exist, risks may include physical,
p.(None): psychological, emotional, economic, educational, legal, and social harm.
p.(None): In addition, beneficence includes whether the usual care is changed or manipulated to inflict no harm, minimize harm,
p.(None): remove harm, and maximize the benefit to re- search participants and to the community, or both.
p.(None): 3.3 Justice
p.(None): Justice connotes fairness and equity in the distribution of the benefits and burdens of research to participants.
p.(None): 3.3.1. Justice demands equitable selection of participants, i.e., avoiding popu- lations that may be unfairly coerced
p.(None): into participating, including but not limited to, prisoners, pregnant women, people with mental and physical
p.(None): disabilities, immigrants, refugees, ethnic minorities, marginalized groups and institutionalized persons, including
p.(None): children. There must be a justi- fication for inclusion of these vulnerable groups in the research. There should be no
...
p.(None): 7.1 General Requirement
p.(None): The IRB shall review proposed research at convened meetings at which more than 50% of the members of the IRB are
p.(None): present, including at least one member who represents the interests of the community.
p.(None): • In order for the research project to be approved, it shall receive the approval of a simple majority of those
p.(None): members present at the meeting. The only exception to this procedure shall be in the case of expedited review as
p.(None): outlined in Section 7.3.
p.(None): • Each IRB shall decide the frequency of its meetings, which should be announced.
p.(None): • An IRB shall require that information given to research participants as part of informed consent complies with the
p.(None): general requirements for informed consent as prescribed by this guidelines.
p.(None): • An IRB shall notify investigators in writing the outcome of the review of the re- search project. Such notice shall
p.(None): be provided to the investigator within 15 days from the date of IRB review of the research protocol. In case the IRB
p.(None): does not approve a research activity, it shall include in its written notification a detailed statement of the reasons
p.(None): for its decision.
p.(None): 7.2 Exempted Review Procedures
p.(None): Research activities in which the only involvement of human participants will be in one or more of the specific
p.(None): categories stated below can be considered as exempt:
p.(None): • Education: Research conducted in established or commonly accepted educa- tional settings, involving normal
p.(None): educational practices.
p.(None): • Education: Research involving the use of educational tests (cognitive, diagnos- tic, aptitude, achievement),
p.(None): surveys, interviews, or observation of public behav-
p.(None): ior, provided the research participants can not be identified.
p.(None): 40 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): • Research, involving the collection or study of existing data, documents, records, pathological specimens, or
p.(None): diagnostic specimens, if these sources are publicly available or recorded without identifiers. Or, if the information
p.(None): is recorded by the investigator in such a manner that research participants cannot be identified, directly or through
p.(None): identifiers linked to the subjects.
p.(None): • Evaluation or examination of government projects or programs designed to ex- plore public benefit or service
p.(None): programs; procedures for obtaining benefits or services under those projects or programs; possible changes in or
p.(None): alternatives to those programs or procedures.
p.(None): • Taste and food quality evaluation and consumer acceptance studies where the foods are free of additives and where
p.(None): the ingredients are known to be safe.
p.(None): • Emergency conditions of national or regional importance, such as epidemics.
p.(None): • Quality assurance activities.
p.(None): All research including that in the exempt categories must meet, at a minimum, the principles of respect for persons,
p.(None): beneficence and justice. The exemption determina- tion other than mentioned above will be based on regulatory and
p.(None): institutional criteria and documented.
...
p.(None): exploration of reasons and resilient issues. Involves open-ended questions and probing that give room for
p.(None): unexpected themes and variety of responses in the participant’s own terms. Besides, responses are in- timately
p.(None): dependent upon the context of the participants’ beliefs, values, behav- iors and actions. Hence, qualitative research
p.(None): possesses higher risk of anxiety and distress. Moreover, the differing experience of the participants largely makes
p.(None): 52 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): predicting who may experience the anxiety and distress difficult/problematic.
p.(None): • Intrusion in life: exploring behavior related to health may require observation of participants at various places
p.(None): including the household, and sometimes, for a prolonged period of time.
p.(None): • Exploitation: power imbalance between the researcher and the subject, or ex- erting undue influence.
p.(None): • Misrepresentation: participants’ opinion are taken out of context or interpreted in the researcher’s perspective,
p.(None): dynamics of the qualitative interviews and the nature of data collected can be affected by the professional background
p.(None): of the researcher.
p.(None): • Identification of participant: (by self or others) in published papers due to clues provided to describe the
p.(None): participant’s age, gender, educational and economic status, place of residence, profession, etc.
p.(None): Hence, to minimize these risks of harm, the following ethical issues should be given special emphasis during protocol
p.(None): review, conduct, and monitoring of qualitative re- search:
p.(None): • Ensuring scientific soundness
p.(None): • Organizing follow-up care where appropriate
p.(None): • Considering obtaining consent as a process that should be subject to negotiation during and even after the end of
p.(None): the interview; the informed consent process should include auhorization of recording (audio, video) of interviews,
p.(None): focus group discussions, and observations.
p.(None): • Ensuring confidentiality through securing storage of audio and video tapes and transcripts.
p.(None): • Making ‘respondent validation’ of the researcher’s analysis before dissemination of the research findings.
p.(None): • Publicizing the research before commencement such that the community is aware of the observation that can be in
p.(None): public domains: at market places, sport events, brothels, theatres, etc. In such cases, the IRB may decide waiver of
p.(None): consent and documentation of consent.
p.(None): 8.3.4 Collaborative Research
p.(None): Collaborative research is research that is conducted by investigators from more than one institution. If one of the
p.(None): collaborating institutions or investigators is based outside of Ethiopia, then, the research is termed “international
p.(None): collaborative research”.
p.(None): There are different potential reasons for conducting collaborative research. The rea- sons may include greater
...
p.(None):
p.(None): and anonymized samples if the justifications are considered to be ethically and scientifically sound by the IRB.
p.(None): • Failure to submit mandatory reports such as SAE reports, progress reports and final reports to the IRB.
p.(None): • Failure to uphold the confidentiality of research participants’ information includ- ing informed consent documents.
p.(None): • Failure to report deviations from the approved protocol procedure(s) in time. Deviation from approved protocol
p.(None): procedure(s) should not be made without the agreement of the IRB that approved the protocol except when it is necessary
p.(None): to avoid immediate danger to a research participant.
p.(None): • Unjustifiable deviations.
p.(None): • Fabricating or falsifying data, or knowingly plagiarizing others’ work.
p.(None): • Misuse of research funds.
p.(None): • Forgery of IRB documents (e.g., alteration of approval letter/certificate; Material Transfer Agreement, etc).
p.(None): 12.2 Possible Actions Against Research Misconduct
p.(None): The IRB may receive reports of cases of misconduct via investigators, community members, voluntary whistle-blowers,
p.(None): research participants, or through its oversight activities. Upon receiving such reports, the IRB should confirm
p.(None): the validity of the alleged misconduct before deciding on an appropriate course of action. The actions that the IRB
p.(None): may take after confirming the misconduct include:
p.(None): 12.2.1. A letter of warning written to the PI by the IRB Chair with instructions for the misconduct to be stopped
p.(None): and/or rectified. The head of the in- stitution, partners, and sponsors should be copied.
p.(None): 12.2.2. Corrective or educational measures.
p.(None): 12.2.3. Frequent monitoring of research activities.
p.(None): 12.2.4. Recommended and more frequent reporting by the investigator of his/ her research activities.
p.(None): 12.2.5. Suspension of eligibility to receive research grants. The IRB may black- list the investigator for a period of
p.(None): time to be determined by the IRB. During that period the IRB should not approve any research protocol submitted by the
p.(None): blacklisted investigators. The list should be copied to the relevant authorities.
p.(None): 12.2.6. In the event that serious harm/injury was caused to participants as a result of the misconduct,
p.(None): compensation for the harm/injury should be made by the investigators, or the host institution, or both. All re-
p.(None): search-related harm or injury as a result of ethically unapproved re- search shall be compensated by the
p.(None): investigator, the host institution,
p.(None): 68 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): or both. The compensation package should be determined by qualified and relevant authorities.
p.(None): 12.2.7. Temporary or permanent suspension of the PI and other investigators from research and/or professional practice.
p.(None): 12.2.8. Suspension of all research being conducted by the investigator.
p.(None): 12.2.9. Termination of the research.
p.(None): 12.2.10. The host institution may also be temporarily suspended from research activities.
p.(None): 12.2.11. Editors of journals should refuse publication of manuscripts from un- ethically conducted research and retract
...
Social / gender
Searching for indicator gender:
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p.(None): activities of the NRERC and subsequent establishment of new and empowerment of already existing Institutional IRBs,
p.(None): shall be realized.
p.(None): 5.1 Organizational Structure
p.(None): To effectively and efficiently deliver research ethics review services, functional and structural arrangements are
p.(None): established at the National, and Institutional levels as depicted in the Organogram below.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 24 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 5.2 National Research Ethics Review Committee
p.(None): The purpose of the NRERC is to safeguard the dignity, rights, safety, and welfare of all actual or potential research
p.(None): participants and/or communities. The NRERC is mandat- ed to review research protocols and the supporting documents on
p.(None): their scientific and ethical merit. Furthermore, the NRERC is mandated to assure that proposed research resonates with
p.(None): the health research directives as stipulated on the Health Science and Technology Policy.
p.(None): 5.2.1 Composition
p.(None): • Shall have members with professional competence and mix of varying backgrounds, gender representation, a community
p.(None): representative, re- search ethics training and experience.
p.(None): • Minimum number of members is fifteen (15). The details are described in Section 6.3 below.
p.(None): 5.2.2 Mandates and Functions of NRERC
p.(None): 5.2.2.1. Develop research review guidelines and standards
p.(None): 5.2.2.2. Accredit and recommend licensing and registration of IRBs by MoST
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 25
p.(None):
p.(None): 5.2.2.3. Solicit funds to build capacity at all levels of IRBs
p.(None): 5.2.2.4. Organize and deliver research ethics training to IRBs at all levels using different media (classroom, on-site,
p.(None): internet-based); develop standardized training materials for countrywide use
p.(None): 5.2.2.5. NRERC Protocol Review - The NRERC is responsible for giving final eth- ical decisions on:
p.(None): • All clinical trials involving new drugs, or new combinations of drugs, vaccines, new therapeutic regimens, and other
p.(None): biological products as well as invasive diagnostic procedures. For all research that involves investigational products,
p.(None): authorization and monitoring by FMHACA is a requirement before submitting a protocol for review and approval.
p.(None): • Multi-center collaborative research, including student theses (MSc, PhD, specialization studies) that
p.(None): inherently exhibit more than minimal risk, and experimental/clinical trials.
p.(None): • Research which is funded by companies producing the experimental product.
...
p.(None): 5.2.2.6. Umpire complaints, disputes, appeals and grievances on functions and review processes of IRBs submitted by
p.(None): researchers or institutions.
p.(None): 5.2.2.7. Monitor and evaluate IRBs at all levels.
p.(None): 5.2.2.8. Facilitate experience sharing among local and international IRBs.
p.(None): 5.2.2.9. Facilitate international registration of Level A IRBs such that their reviews are accepted by funding
p.(None): agencies.
p.(None): 5.2.2.10. Review of trials that are funded by manufacturers and pharmaceuticals,
p.(None): 5.2.2.11. Review very urgent research projects that are of national interest and priority, and
p.(None): 5.2.2.12. Policy-advocacy and creating community awareness on ethical principles in research, and legal and regulatory
p.(None): reforms, and changes related to re- search involving human participants.
p.(None): 5.3 Institutional Review Board, Level A
p.(None): These IRBs can be regional or institutional. These are IRBs that have the capacity to review, monitor, document
p.(None): research protocols and undertakings involving humans in the region or the institution where they are based, or other
p.(None): institutions that do not have their own IRBs and beyond. Similarly, Level A IRBs shall be capable of safe-
p.(None): 26 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): guarding the rights, autonomy, safety, and welfare of human research participants.
p.(None): 5.3.1 Composition
p.(None): • Shall have members with professional competence and a mix of varying back- grounds, gender representation, a
p.(None): community representative, research ethics training, and experience similar to or equivalent with the NRERC.
p.(None): • Minimum number of members is five (5).
p.(None): 5.3.2 Mandates and Functions
p.(None): 5.3.2.1. Organize and deliver research ethics training to researchers in the region or the institutions.
p.(None): 5.3.2.2. Develop SOPs, that govern the IRB’s research review procedures.
p.(None): 5.3.2.3. Submit progress report of the IRB’s functions annually to the NRERC.
p.(None): 5.3.2.4. Inform the NRERC on occurrence of frequent, unexpected severe adverse effects (SAEs) related to research
p.(None): reviewed and approved by the IRB,
p.(None): 5.3.2.5. Review and approve research protocols similar to the NRERC except:
p.(None): • Genetic research, stem cell research
p.(None): • Research involving human biological material transfer outside of Ethi- opia provided that the IRB notifies the NRERC
p.(None): Multicenter interna- tional collaborative research of experimental nature
p.(None): • Investigation of new devices, drugs or vaccines not registered for use in Ethiopia
p.(None): • Review of trials that are funded by manufacturers and pharmaceutical companies
p.(None): 5.3.2.6. Solicit funds to build its own capacity
p.(None): 5.4 Institutional Review Board, Level B
p.(None): These can be regional or institutional IRBs. These are IRBs that have the capaci- ty to review, monitor, and document
p.(None): research protocols and undertakings involving humans from the institution where they are based or other institutions
p.(None): that do not have their own IRBs, according to the mandates and functions stated below. Simi- larly, Level B IRBs shall
p.(None): be capable of safeguarding the rights, autonomy, safety, and welfare of human research participants. These IRBs may not
p.(None): have the expertise and experience of Level A IRBs, in which case the protocols can be reviewed by Level A IRBs of other
p.(None): institutions.
p.(None): 5.4.1 Composition
p.(None): • Shall have members with professional competence and a mix of gender repre- sentation, a community representative,
p.(None): research ethics training, and experience,
p.(None): National Research Ethics Review Guideline Fifth Edition 27
p.(None):
p.(None): which may not be similar to or equivalent with NRERC or Level A IRB.
p.(None): • Minimum number of members is five (5).
p.(None): 5.4.2 Mandates and Functions
p.(None): 5.4.2.1. Organize and deliver research ethics training to researchers in the region or the institution.
p.(None): 5.4.2.2. Develop SOPs that govern the IRB’s research review procedures.
p.(None): 5.4.2.3. Submit progress report of the IRB’s functions annually to the NRERC.
p.(None): 5.4.2.4. Inform the NRERC on occurrence of frequent, unexpected SAEs related with research reviewed and approved by the
p.(None): IRB.
p.(None): 5.4.2.5. Review and approve research protocols that involve minimal risk.
p.(None): 5.4.2.6. Solicit funds to build its own capacity
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Responsibilities of the Secretariat:
p.(None): • Receive applications from other IRBs.
p.(None): • Ensure the completeness of application documents for ethical review.
p.(None): • Distribute protocols to all ethics committee members and/or external reviewers, as applicable and when directed by
p.(None): NRERC chairman or delegate.
p.(None): • Facilitate regular and extraordinary meetings in consultation with the Chairper- son of the NRERC.
p.(None): • Communicate decisions of the NRERC to the applying institution with a copy to the PI.
...
p.(None): of law.
p.(None): 5.7.3. NRERC documents should be kept secure in locked cabinets and only accessed by authorized personnel.
p.(None): 5.8 NRERC Operations
p.(None): 5.8.1. The NRERC operations office should be spearheaded by the NRERC Secretariat as per instructions from the NRERC
p.(None): through the Chairperson or his/her designate.
p.(None): 5.8.2. The NRERC operations office should be separate and independent of the administration of MoST.
p.(None): 5.8.3. Applications to the NRERC must be channeled through the NRERC Secretariat.
p.(None): 5.8.4. All decisions and communication from the NRERC to the appli- cant must be conveyed through the Secretariat.
p.(None): 5.9 Registration and Accreditation
p.(None): 5.9.1. All IRBs in Ethiopia have to be accredited by the NRERC, and registered and licensed by the
p.(None): Secretariat of the NRERC at MoST.
p.(None): 5.9.2. Registration and renewal of all IRBs shall be done every two years from the date of registration or renewal of
p.(None): the IRB.
p.(None): 5.9.3. When IRB members are replaced for any reason, these outgoing members shall be notified in writing. The reason
p.(None): for termination of membership shall be clearly described in the letter.
p.(None): 5.9.4. Review procedures, TORs, and the review forms should be standardized.
p.(None): 5.9.5. The minimum acceptable number of members on any IRB is five. No IRB can have even numbered members for the sake
p.(None): of deci- sions, particularly when there is a need to vote.
p.(None): 5.9.6. IRBs shall have members with a varied professional mix and there
p.(None): National Research Ethics Review Guideline Fifth Edition 29
p.(None):
p.(None): should be at least, one member from behavioral sciences, law, or humanities, be gender sensitive and ensure community
p.(None): represen- tation by a lay person. No IRB can be composed entirely of a single profession, similar gender, or without a
p.(None): community representative.
p.(None): 5.9.7. Following registration, a letter of accreditation shall be given to IRBs by the Secretariat.
p.(None):
p.(None): 6. Establishment, Functions, Review Procedures
p.(None): 6.1 Definition
p.(None): Institutional Review Boards (IRBs) are independent committees established in an in- stitution to conduct initial and
p.(None): continuing review of research projects with the primary goal of protecting the rights and welfare of research
p.(None): participants. All institutions in Ethiopia that conduct research involving humans as research participants should set
p.(None): up IRBs in accordance with these guidelines. Where an institution cannot set up an IRB, that institution may rely on an
p.(None): IRB of another institution to review their research projects, provided the IRB is registered by the National IRB.
p.(None): 6.2 Establishment
p.(None): 6.2.1 Appointing Authority
p.(None): • The Head of the Institution is the authority responsible for the appointment of IRB members. In cases where
p.(None): members come from diverse institutions, the appointment should be upon the recommendation of the institution where the
p.(None): potential IRB member is based.
p.(None): • Members are selected in their personal capacities based on their scientific knowledge and expertise, as
p.(None): well as on their commitment and willingness to volunteer the necessary time and efforts for the Board’s function.
p.(None): • Appointments should consider age and gender distribution, and relevant but diverse professional
p.(None): representation.
p.(None): • The appointing authority should write an appointment letter to the prospective member inviting him/her to be a
p.(None): member of the IRB.
p.(None): • Members will sign a confidentiality agreement and conflict of interest (COI) form.
p.(None): 6.2.2 Applying to Establish an IRB
p.(None): An institution that needs to establish an IRB shall apply in writing for approval and reg- istration at the National
p.(None): Secretariat at MoST, and include the following requirements:-
p.(None): • Statement that the IRB will follow the guidelines as stipulated in this document, law, relevant regulations.
p.(None): • A list of IRB members identified by name, qualifications, profession, current
p.(None): 30 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): CV, representative capacity; any changes, in due process or in IRB membership must be reported to the secretariat.
p.(None): • Written SOPs for the activities of the IRB: composition of IRB members; con- ducting initial and continuing review
p.(None): of research, and for reporting its sugges- tions/opinion and decisions to the investigator and the institution;
p.(None): expedited review process; follow-up and monitoring of approved studies.
p.(None): • The NRERC Secretariat presents the application to the NRERC who shall ex- amine the institution’s application, and
p.(None): if satisfied, will recommend to MoST for endorsement of the registration and authorize in writing, the establishment of
p.(None): the IRB. The process of application and response from MoST should not exceed three months.
p.(None): 6.3 Composition
p.(None): The IRB should consist of a reasonable number of members, who collectively have the qualifications and experience
p.(None): to review and evaluate the science, medical as- pects, and ethics of the proposed research.
p.(None): • Each IRB shall be composed of at least five (5) members, with varying back- grounds to ensure complete and robust
p.(None): review of research activities commonly conducted by the institution. It must be multidisciplinary and multi-sectoral in
p.(None): composition, including persons with relevant but diverse scientific expertise, balanced age and gender
p.(None): distribution, and who have the qualifications and ex- perience to review and evaluate the scientific and
p.(None): medical ethics aspects of research protocols.
p.(None): • All IRBs shall have at least one member whose main area of expertise is in the scientific field and at least one
p.(None): member whose primary area of expertise is in a non-scientific field.
p.(None): • Each IRB shall include at least one member who is not otherwise affiliated with the institution or have a close
p.(None): family member working in the institution.
p.(None): • The IRB should have at least one community representative, who does not nec- essarily have to have any scientific
p.(None): expertise, but may be a layperson that rep- resents the interests and concerns of members of the community and is
p.(None): familiar with the community’s values, customs, traditions, and culture.
p.(None): • If an IRB regularly reviews research that involves vulnerable populations, such as children, prisoners, pregnant
p.(None): women, men/women in uniform or persons with disabilities, marginalized group, refuges, minorities, the IRB shall
p.(None): involve or co- opt one or more individuals who are knowledgeable about and experienced in working with these research
p.(None): participants.
p.(None): • All IRB members should at the minimum take one basic training on bioethics within one year of appointment.
p.(None):
p.(None):
...
p.(None): exploration of reasons and resilient issues. Involves open-ended questions and probing that give room for
p.(None): unexpected themes and variety of responses in the participant’s own terms. Besides, responses are in- timately
p.(None): dependent upon the context of the participants’ beliefs, values, behav- iors and actions. Hence, qualitative research
p.(None): possesses higher risk of anxiety and distress. Moreover, the differing experience of the participants largely makes
p.(None): 52 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): predicting who may experience the anxiety and distress difficult/problematic.
p.(None): • Intrusion in life: exploring behavior related to health may require observation of participants at various places
p.(None): including the household, and sometimes, for a prolonged period of time.
p.(None): • Exploitation: power imbalance between the researcher and the subject, or ex- erting undue influence.
p.(None): • Misrepresentation: participants’ opinion are taken out of context or interpreted in the researcher’s perspective,
p.(None): dynamics of the qualitative interviews and the nature of data collected can be affected by the professional background
p.(None): of the researcher.
p.(None): • Identification of participant: (by self or others) in published papers due to clues provided to describe the
p.(None): participant’s age, gender, educational and economic status, place of residence, profession, etc.
p.(None): Hence, to minimize these risks of harm, the following ethical issues should be given special emphasis during protocol
p.(None): review, conduct, and monitoring of qualitative re- search:
p.(None): • Ensuring scientific soundness
p.(None): • Organizing follow-up care where appropriate
p.(None): • Considering obtaining consent as a process that should be subject to negotiation during and even after the end of
p.(None): the interview; the informed consent process should include auhorization of recording (audio, video) of interviews,
p.(None): focus group discussions, and observations.
p.(None): • Ensuring confidentiality through securing storage of audio and video tapes and transcripts.
p.(None): • Making ‘respondent validation’ of the researcher’s analysis before dissemination of the research findings.
p.(None): • Publicizing the research before commencement such that the community is aware of the observation that can be in
p.(None): public domains: at market places, sport events, brothels, theatres, etc. In such cases, the IRB may decide waiver of
p.(None): consent and documentation of consent.
p.(None): 8.3.4 Collaborative Research
p.(None): Collaborative research is research that is conducted by investigators from more than one institution. If one of the
p.(None): collaborating institutions or investigators is based outside of Ethiopia, then, the research is termed “international
p.(None): collaborative research”.
...
p.(None): 62 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): binant DNA and potentially hazardous substances.
p.(None): • Continued review of approved research projects.
p.(None): • Ensure the provision of suitable and safe storage and disposal facilities for all materials involved in work with
p.(None): potentially hazardous substances.
p.(None): • Ensure that all appropriate technical personnel of the institution have adequate training in bio-safety.
p.(None): • Establish a health-monitoring plan for all high-risk personnel involved in appli- cation, use and production of
p.(None): potentially hazardous substances.
p.(None): 10.6 Community Advisory Board
p.(None): 10.6.1 Establishment
p.(None): Community Advisory Boards (CABs) are established by the investigator team. They are indispensable in orienting the
p.(None): investigator team about the local customs, tradi- tions, terminologies, culture, and attitude towards research and
p.(None): development. Be- sides, CABs are important bridges to liaise the researchers with the community. CABs are critical
p.(None): forums to facilitate dialogue between community members, research par- ticipants and investigators.
p.(None): CAB members shall be selected from the community where research is to be under- taken through a stakeholder
p.(None): consultative process. The CAB’s role and expectations should be explicitly described in their terms of reference.
p.(None): Members of the CAB may include but are not limited to the following:
p.(None): • Individuals familiar with local laws, customs, cultural values and gender issues
p.(None): • Elders, opinion leaders, local chiefs
p.(None): • Peer leaders, women leaders
p.(None): • Religious leaders
p.(None): • Representatives of the study population
p.(None): • Media personnel
p.(None): • Professionals who understand research or science issues
p.(None): 10.6.2 Functions
p.(None): The main function of a CAB is to assist investigators with understanding and incorpo- rating community concerns into
p.(None): their research procedures. The functions are expressed through different ways like advising on issues central to the
p.(None): informed consent process, achieving successful volunteer recruitment and retention, and other related issues.
p.(None): The responsibilities of the CABs may vary according to the study location, size, com- plexity, familiarity of the
p.(None): investigators with the local setting, to mention but few. CABs functions are to:
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 63
p.(None):
p.(None): • Provide information on traditional beliefs and needs of the study population and their concerns regarding the
p.(None): research project
p.(None): • Provide input into the design of the research protocol as appropriate especially in the recruitment and the informed
p.(None): consent process
p.(None): • Advise investigators on acceptable and effective methods for disseminating in- formation about the research project
p.(None): and its outcomes
p.(None): • Provide advice and support regarding retention of research participants includ- ing gender equity
p.(None):
p.(None): 11. Monitoring Reporting
p.(None): Monitoring essentially encompass four activities: continuing review, review of the consent process, review for
p.(None): adherence to an approved protocol and review to identify unapproved activities. Continuing review is the most
p.(None): common, conventional, and fundamental aspect of monitoring of an IRB.
p.(None): The primary function of monitoring is ensuring participant safety through assuring compliance with
p.(None): regulations and adherence to approved research protocols. In clinical trials, data monitoring is conducted to ensure
p.(None): data quality and safety. The DSMB is designated by the sponsor upon the recommendation of the IRB primarily to periodi-
p.(None): cally monitor data quality and participant safety. Moreover, interim analysis of risks and benefits should be a
p.(None): component of monitoring to ensure safety, whenever applicable.
p.(None): In multi-center research, monitoring at each of the research centers should primarily be carried out by the local IRBs.
p.(None): However, the NRERC is also responsible for oversight at selected, representative research centers, as deemed necessary.
p.(None): In international collaborative research, periodic progress report must be submitted, and all adverse events must be
p.(None): notified to the NEC.
p.(None): The investigator bears the major responsibility of regular monitoring and reporting of adverse events to the
p.(None): IRB. The sponsor is also obligated to report, or otherwise, ascertain the adverse events are reported to the IRB.
p.(None): Based on monitoring and reporting that includes Adverse Events (AEs) as applicable, the IRB may allow continuation,
p.(None): suspension, or termination of the research or recom- mend an amendment (a change) in the research procedure. Besides,
...
Social / marginalized group
Searching for indicator marginalized group:
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p.(None): composition, including persons with relevant but diverse scientific expertise, balanced age and gender
p.(None): distribution, and who have the qualifications and ex- perience to review and evaluate the scientific and
p.(None): medical ethics aspects of research protocols.
p.(None): • All IRBs shall have at least one member whose main area of expertise is in the scientific field and at least one
p.(None): member whose primary area of expertise is in a non-scientific field.
p.(None): • Each IRB shall include at least one member who is not otherwise affiliated with the institution or have a close
p.(None): family member working in the institution.
p.(None): • The IRB should have at least one community representative, who does not nec- essarily have to have any scientific
p.(None): expertise, but may be a layperson that rep- resents the interests and concerns of members of the community and is
p.(None): familiar with the community’s values, customs, traditions, and culture.
p.(None): • If an IRB regularly reviews research that involves vulnerable populations, such as children, prisoners, pregnant
p.(None): women, men/women in uniform or persons with disabilities, marginalized group, refuges, minorities, the IRB shall
p.(None): involve or co- opt one or more individuals who are knowledgeable about and experienced in working with these research
p.(None): participants.
p.(None): • All IRB members should at the minimum take one basic training on bioethics within one year of appointment.
p.(None):
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 31
p.(None):
p.(None): 6.4 External Reviewers
p.(None): • If a protocol requires expertise that is beyond the competence of the IRB mem- bers or the IRB need additional
p.(None): opinion in the review process, the IRB may engage independent experts to review and give their opinion.
p.(None): • The Secretariat should keep an updated list of experts along with their CVs, which should be reviewed annually by
p.(None): the IRB.
p.(None): • Independent experts must sign privacy and confidentiality agreements and con- flict of interest (COI) forms to
p.(None): ensure that the information in the protocol is protected and that consultants do not have any conflicts.
p.(None): • The IRB may ask questions that could guide the review of the experts.
p.(None): • The expert may be invited to attend or consult by telephone an IRB meeting but he/she cannot vote in the meeting.
p.(None): 6.5 Independence of IRB
p.(None): 6.5.1. The IRB must be independent from the appointing authority, hosting institution, investigators, sponsors and any
p.(None): other stakeholders in its review and decision-making processes.
p.(None): 6.5.2. If there is any conflict of interest, COI, regarding a particular proto- col, IRB members must declare their COI
...
Social / parents
Searching for indicator parent:
(return to top)
p.(None): research participant as a person capable of making an informed decision regarding participation in the research
p.(None): study. It obligates in- vestigators to respect the right of human subjects to hold their views, make
p.(None): choices and take actions without controlling influences. For human subjects who are not capable of making an informed
p.(None): decision because of age, mental, or medical capacity, the next of kin or guardian shall make the decision in the best
p.(None): interest of the research participant.
p.(None): 3.1.2. Informed Consent – The importance of informed consent of research participants is unquestionable and
p.(None): the informed consent should be analyzed in terms of containing the basic elements of information, com- prehension,
p.(None): competence, disclosure, and voluntarism. Information shall be given in writing and signed or verbally approved by the
p.(None): research par- ticipant. The information to be provided should be written in a way that considers the local culture and
p.(None): values, as well as the level of understanding of the research participant. The information provided should weigh the
p.(None): re- search participants’ competence. When informed consent is that of a third party (proxy; parent, next-of-kin,
p.(None): legally authorized representative (LAR), the reasons for the indirect approach shall be stated and become part of the
p.(None): protocol.
p.(None): Research participants or persons giving proxy consent cannot give full informed consent unless the consent process/form
p.(None): contains adequate information. All such information shall be expressed in a language that is understandable to the
p.(None): participant. Generally, the consent form should explicitly indicate the points mentioned in Section 6.13 below.
p.(None): National Research Ethics Review Guideline Fifth Edition 21
p.(None):
p.(None): 3.2 Beneficence
p.(None): The principle of beneficence refers to the obligation on the part of the investiga- tor to attempt to
p.(None): maximize benefits for the individual participant and/or community, while minimizing risk or harm to the
p.(None): individual/community. As much as possible, beneficence also considers inflicting no harm. An honest and thorough
p.(None): risk/benefit assessment must be performed. Balancing the risk and benefit of the research is indispensible
p.(None): in the design and conduct of the research.
...
p.(None): The purpose of IRBs is to contribute to safeguarding the dignity, rights, safety, and well-being of all actual or
p.(None): potential research participants, by making an independent scientific and ethical review of research before commencement
p.(None): of research activities. Therefore, the major responsibility of IRBs is to safeguard the rights, safety, and well-be-
p.(None): ing of research participants. The goals of research, while important, should never be permitted to override the health,
p.(None): well-being, and care of research participants.
p.(None): IRBs should provide independent, competent, and timely review of the ethics of pro- posed studies. In their
p.(None): composition, procedures, and decision-making, IRBs need to have independence from political, institutional,
p.(None): professional, and market influences. They need similarly to demonstrate competence and efficiency in their work. They
p.(None): also need to ensure that there is regular evaluation of the ethics of ongoing studies that received a positive
p.(None): decision. Therefore, the functions of the IRB are:
p.(None): 6.12.1 Initial review
p.(None): The IRB must determine that the following requirements are satisfied before it ap- proves a research protocol:
p.(None): • Risks to subjects are minimized. Risk to subjects are reasonable in relation to anticipated benefit (if any) and the
p.(None): knowledge that is expected to result
p.(None): • Selection of subjects is equitable
p.(None): • Determine that informed consent will be sought from each prospective study participant, or the participants’ parent
p.(None): or guardian as appropriate
p.(None): • Determine that informed consent will be appropriately documented
p.(None): • Determine that there are adequate provisions to protect privacy of study partic- ipants and maintain confidentiality
p.(None): of all study related data
p.(None): • Determine that there are additional safeguards included in the study to protect the safety and welfare of study
p.(None): subjects who are likely to be vulnerable to coer- cion or undue influence such as such as children, prisoners, mentally
p.(None): disabled
p.(None): people, etc.
p.(None): 6.13 Informed Consent
p.(None): 6.13.1. The IRB must determine that the consent is documented using a written or verbal informed consent form,
p.(None): • The consent form should be approved by the IRB.
p.(None): • The consent form must be signed by the participant, or a parent, or next-of-kin or a guardian and by the individual
p.(None): that conducted the in- formed consent process.
p.(None): • In case the participant cannot read or write, a witness should sign that the consent process was carried out
p.(None): appropriately.
p.(None): National Research Ethics Review Guideline Fifth Edition 37
p.(None):
p.(None): • A copy of the signed informed consent form should be given to the study participant.
p.(None): 6.13.2. Research participants or persons giving proxy consent cannot give full informed consent unless the consent
p.(None): process/form contains adequate information. All such information shall be expressed in a language that is
p.(None): understandable to the participant. Generally, the consent form should explicitly indicate the following:
p.(None): • A statement that the study involves research, the purpose of the re- search, the expected duration of participants’
p.(None): involvement and identifi- cation of any experimental procedures.
p.(None): • Foreseeable risks and discomforts.
p.(None): • Reasonably expected benefits to the participants as well as the community.
p.(None): • Disclosure of appropriate alternatives procedures or treatments.
p.(None): • Extent to which confidentiality will be maintained.
...
p.(None): may be obtained.
p.(None): • An explanation of whom to contact for answers to pertinent questions about the research and research
p.(None): participants’ rights, and whom to contact in the event of a research-related injury to the participant; A statement
p.(None): that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the
p.(None): participant is oth- erwise entitled. The consent form should also clearly indicate that re- search participants are
p.(None): free to withdraw from the study at any time and that the participant may discontinue participation at any time without
p.(None): penalty or loss of benefits. Research participants also are not obliged to respond to all questions in a study
p.(None): questionnaire.
p.(None): 6.14 Assent
p.(None): Assent will be sought from a study participant under the age of 18 years old. The minor child should be given
p.(None): appropriate information based on the child’s level of comprehen- sion whatever the complexity of the research
p.(None): procedures. Then, an assent, a child’s affirmative agreement to participate in research shall be sought from all
p.(None): children 12 years of age and above, in addition to the consent of a parent, next-of-kin, or guardian.
p.(None): 6.15 Waiver of Informed Consent Documentation
p.(None): Waiver of informed consent or documentation of informed consent should be ap- proved by the IRB. The investigator must
p.(None): secure an explicit waiver of consent from the IRB. The IRB may waive some or all of the elements of an informed consent
p.(None): and/
p.(None):
p.(None): 38 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): or a signed or thumb printed consent form for some or all of the research participants of a particular study, if the
p.(None): IRB determines that:
p.(None): • The research project carries no more than minimal risk, If the research or demonstration project is
p.(None): to be conducted or approved by federal or regional government and is designed to study, evaluate, or otherwise
p.(None): explore public ben- efit or service programs; possible changes in or alternatives to those programs; possible changes
p.(None): in methods or levels of payment for benefits or services under those programs.
p.(None): • The research project could not practically be carried out without the waiver or alteration (whenever appropriate the
p.(None): research participants will be provided with additional pertinent information after participation); In emergency/acute
...
p.(None): • The research is likely to enhance viability and survival.
p.(None): • Informed consent should be obtained from either of the parents.
p.(None): For, research involving dead fetuses or organs or tissues of the dead fetus:
p.(None): • There should be a prospect of important knowledge that can be possibly used in the prevention and treatment of
p.(None): similar or related conditions.
p.(None): • Informed consent should be obtained from either of the parents of the dead fetus.
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 55
p.(None):
p.(None): 8.3.5.3 Children
p.(None): Children are persons who have not attained the legal age for consent to treatments or procedures involved in research.
p.(None): The following apply in research involving children.
p.(None): • The child should provide assent in addition to the informed consent by a parent or guardian as stated in Section
p.(None): 6.14 above.
p.(None): • The research presents a realistic opportunity to further the understanding, preven- tion, or alleviation of a
p.(None): serious problem affecting the health or welfare of children.
p.(None): • Emancipated minors – working or earn their living, married, parenting – may be allowed to give an informed consent
p.(None): or an IRB may decide a waiver of consent.
p.(None): • In research related to sensitive topics like drug use and abuse, sexuality, repro- duction, STIs, where obtaining
p.(None): consent from a parent, next-of-kin, or guardian is challenging and may be problematic to the minor because of the
p.(None): nature of the research, assent with waiver of consent may be applicable.
p.(None): • In institutional children, a legally approved guardian may give consent.
p.(None): 8.3.5.4 Prisoners
p.(None): Prisoners may be under constraints because of their incarceration which could affect their ability to make a truly
p.(None): voluntary and decision which is not coerced, whether or not to participate as subjects in research. Therefore,
p.(None): additional safeguards should be included in the study to protect the rights and welfare of these subjects, as follows:
p.(None): • If an IRB regularly reviews research that involves these vulnerable populations, consideration shall be given to the
p.(None): inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.
p.(None): • Where possible, a prisoner or an ex-prisoner co-opted in to the IRB reviewing the proposed research project should
p.(None): be included.
p.(None): • Only research on conditions particularly affecting prisoners as a class and with reasonable probability of improving
p.(None): the health and well-being of the research participants should be permissible.
...
p.(None): greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine
p.(None): physical or psycholog- ical examinations or tests.
p.(None): Minor changes-Changes to a research protocol that do not result in a net increase in risk, a change in the harm-benefit
p.(None): balance, or provide minor clarification or correc- tion. Minor changes may be reviewed under expedited review, even if
p.(None): the protocol has been deemed to pose more than minimal risk to participants.
p.(None): Noncompliance-Failure by investigators, research staff, IRB members, or IRB staff to follow regulations for human
p.(None): research protections
p.(None): Oral consent-Consent obtained only through speaking, generally in the absence of documentation of consent. See also
p.(None): documentation of consent, informed con- sent, verbal consent.
p.(None): National Research Ethics Review Guideline Fifth Edition 81
p.(None):
p.(None): Parental permission-The agreement of a parent or guardian to the participation of their child in research.
p.(None): Personal identifier-Information obtained and recorded in such a manner that human participants can be recognized,
p.(None): directly or through links to the participants. Examples include names, social security numbers, and codes.
p.(None): Pilot study-Preliminary study to determine the feasibility of a larger study, use of a test instrument, or other
p.(None): activity.
p.(None): Pregnancy-The period of time from implantation until delivery. A woman shall be assumed to be pregnant if
p.(None): she exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until the results of a
p.(None): pregnancy test are negative or until delivery.
p.(None): Principal Investigator (PI)-Lead scientist who is working on the design of a research study, development of methods and
p.(None): procedures for the study, collection of data or specimens, analysis of data or specimens, or interpretation of data.
p.(None): Prisoner-Any individual involuntarily confined or detained in a penal institution. The term is intended to encompass
p.(None): individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other
p.(None): facilities by virtue of statutes or commit- ment procedures which provide alternatives to criminal prosecution or
p.(None): incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.
...
Searching for indicator parents:
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p.(None): 8.3.5.1 Pregnant women and Fetuses
p.(None): To conduct research on pregnant women, the following must be fulfilled:
p.(None): • There is evidence from studies on pregnant animals and non-pregnant women that studies need to be done on risks
p.(None): related to pregnant women and fetuses.
p.(None): • If the research holds the prospect of direct benefit to the pregnant woman and the fetus, and the knowledge cannot
p.(None): be obtained through other means.
p.(None): • There should be no inducement to terminate a pregnancy.
p.(None): • If the prospect of benefit is both to the pregnant woman and the fetus, an in- formed consent form from the mother
p.(None): alone suffices to enroll the woman into the research.
p.(None): • If the prospect of benefit is solely to the fetus, informed consent should be obtained from both parents, provided
p.(None): they are competent to give or refuse the consent.
p.(None): • In both conditions, the foreseeable risks of the research on the fetus or the neo- nate must be thoroughly
p.(None): explained.
p.(None): • Viability of the fetus should be determined by a health care provider who is not a member of the investigation team.
p.(None): 8.3.5.2 Newborns/Neonates
p.(None): In research involving neonates with uncertain viability, the following must be met:
p.(None): • Previous research provides data to assess potential risks to neonates.
p.(None): • Viability of the fetus should be determined by a health care provider who is not a member of the investigator team.
p.(None): • There should be no other means of obtaining the knowledge to be derived from the research.
p.(None): • There should be no added risk to the neonate due to the research.
p.(None): • The research is likely to enhance viability and survival.
p.(None): • Informed consent should be obtained from either of the parents.
p.(None): For, research involving dead fetuses or organs or tissues of the dead fetus:
p.(None): • There should be a prospect of important knowledge that can be possibly used in the prevention and treatment of
p.(None): similar or related conditions.
p.(None): • Informed consent should be obtained from either of the parents of the dead fetus.
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 55
p.(None):
p.(None): 8.3.5.3 Children
p.(None): Children are persons who have not attained the legal age for consent to treatments or procedures involved in research.
p.(None): The following apply in research involving children.
p.(None): • The child should provide assent in addition to the informed consent by a parent or guardian as stated in Section
p.(None): 6.14 above.
p.(None): • The research presents a realistic opportunity to further the understanding, preven- tion, or alleviation of a
p.(None): serious problem affecting the health or welfare of children.
p.(None): • Emancipated minors – working or earn their living, married, parenting – may be allowed to give an informed consent
p.(None): or an IRB may decide a waiver of consent.
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.(None): • Members are selected in their personal capacities based on their scientific knowledge and expertise, as
p.(None): well as on their commitment and willingness to volunteer the necessary time and efforts for the Board’s function.
p.(None): • Appointments should consider age and gender distribution, and relevant but diverse professional
p.(None): representation.
p.(None): • The appointing authority should write an appointment letter to the prospective member inviting him/her to be a
p.(None): member of the IRB.
p.(None): • Members will sign a confidentiality agreement and conflict of interest (COI) form.
p.(None): 6.2.2 Applying to Establish an IRB
p.(None): An institution that needs to establish an IRB shall apply in writing for approval and reg- istration at the National
p.(None): Secretariat at MoST, and include the following requirements:-
p.(None): • Statement that the IRB will follow the guidelines as stipulated in this document, law, relevant regulations.
p.(None): • A list of IRB members identified by name, qualifications, profession, current
p.(None): 30 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): CV, representative capacity; any changes, in due process or in IRB membership must be reported to the secretariat.
p.(None): • Written SOPs for the activities of the IRB: composition of IRB members; con- ducting initial and continuing review
p.(None): of research, and for reporting its sugges- tions/opinion and decisions to the investigator and the institution;
p.(None): expedited review process; follow-up and monitoring of approved studies.
p.(None): • The NRERC Secretariat presents the application to the NRERC who shall ex- amine the institution’s application, and
p.(None): if satisfied, will recommend to MoST for endorsement of the registration and authorize in writing, the establishment of
p.(None): the IRB. The process of application and response from MoST should not exceed three months.
p.(None): 6.3 Composition
p.(None): The IRB should consist of a reasonable number of members, who collectively have the qualifications and experience
p.(None): to review and evaluate the science, medical as- pects, and ethics of the proposed research.
p.(None): • Each IRB shall be composed of at least five (5) members, with varying back- grounds to ensure complete and robust
p.(None): review of research activities commonly conducted by the institution. It must be multidisciplinary and multi-sectoral in
p.(None): composition, including persons with relevant but diverse scientific expertise, balanced age and gender
p.(None): distribution, and who have the qualifications and ex- perience to review and evaluate the scientific and
p.(None): medical ethics aspects of research protocols.
p.(None): • All IRBs shall have at least one member whose main area of expertise is in the scientific field and at least one
p.(None): member whose primary area of expertise is in a non-scientific field.
p.(None): • Each IRB shall include at least one member who is not otherwise affiliated with the institution or have a close
p.(None): family member working in the institution.
p.(None): • The IRB should have at least one community representative, who does not nec- essarily have to have any scientific
p.(None): expertise, but may be a layperson that rep- resents the interests and concerns of members of the community and is
p.(None): familiar with the community’s values, customs, traditions, and culture.
p.(None): • If an IRB regularly reviews research that involves vulnerable populations, such as children, prisoners, pregnant
p.(None): women, men/women in uniform or persons with disabilities, marginalized group, refuges, minorities, the IRB shall
p.(None): involve or co- opt one or more individuals who are knowledgeable about and experienced in working with these research
p.(None): participants.
p.(None): • All IRB members should at the minimum take one basic training on bioethics within one year of appointment.
p.(None):
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 31
p.(None):
p.(None): 6.4 External Reviewers
p.(None): • If a protocol requires expertise that is beyond the competence of the IRB mem- bers or the IRB need additional
p.(None): opinion in the review process, the IRB may engage independent experts to review and give their opinion.
p.(None): • The Secretariat should keep an updated list of experts along with their CVs, which should be reviewed annually by
p.(None): the IRB.
p.(None): • Independent experts must sign privacy and confidentiality agreements and con- flict of interest (COI) forms to
p.(None): ensure that the information in the protocol is protected and that consultants do not have any conflicts.
p.(None): • The IRB may ask questions that could guide the review of the experts.
p.(None): • The expert may be invited to attend or consult by telephone an IRB meeting but he/she cannot vote in the meeting.
p.(None): 6.5 Independence of IRB
p.(None): 6.5.1. The IRB must be independent from the appointing authority, hosting institution, investigators, sponsors and any
p.(None): other stakeholders in its review and decision-making processes.
p.(None): 6.5.2. If there is any conflict of interest, COI, regarding a particular proto- col, IRB members must declare their COI
p.(None): and excuse themselves from the review process of that particular research protocol. This is critical to ensure an
p.(None): objective assessment of the protocol.
p.(None): • COI can be declared at the time research protocols are submitted, upon receiving the IRB agenda prior to the meeting
p.(None): and at the beginning of each meeting.
p.(None): • IRB members who have a COI related to any research protocol must not participate in any initial or continuing review
p.(None): of that specific protocol or related matters except to provide relevant, factual information which may be requested by
p.(None): the IRB. The conflicted IRB member cannot deliberate or vote on those protocols or related matters.
p.(None): • The IRB member or invited expert with a COI will be required to excuse himself/herself from the meeting during
p.(None): discussion and decision.
...
p.(None): waiver of consent from IRB.
p.(None): • The protocol should articulate clearly duration and place of storage of biological samples and data.
p.(None): 8.3.3 Socio-Behavioral Research
p.(None): There are five potential risks in qualitative and behavioral research that the IRB, the investigator and the sponsor
p.(None): should be aware of:
p.(None): • Anxiety and distress: qualitative research is aimed at in-depth understanding of sensitive topics with
p.(None): exploration of reasons and resilient issues. Involves open-ended questions and probing that give room for
p.(None): unexpected themes and variety of responses in the participant’s own terms. Besides, responses are in- timately
p.(None): dependent upon the context of the participants’ beliefs, values, behav- iors and actions. Hence, qualitative research
p.(None): possesses higher risk of anxiety and distress. Moreover, the differing experience of the participants largely makes
p.(None): 52 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): predicting who may experience the anxiety and distress difficult/problematic.
p.(None): • Intrusion in life: exploring behavior related to health may require observation of participants at various places
p.(None): including the household, and sometimes, for a prolonged period of time.
p.(None): • Exploitation: power imbalance between the researcher and the subject, or ex- erting undue influence.
p.(None): • Misrepresentation: participants’ opinion are taken out of context or interpreted in the researcher’s perspective,
p.(None): dynamics of the qualitative interviews and the nature of data collected can be affected by the professional background
p.(None): of the researcher.
p.(None): • Identification of participant: (by self or others) in published papers due to clues provided to describe the
p.(None): participant’s age, gender, educational and economic status, place of residence, profession, etc.
p.(None): Hence, to minimize these risks of harm, the following ethical issues should be given special emphasis during protocol
p.(None): review, conduct, and monitoring of qualitative re- search:
p.(None): • Ensuring scientific soundness
p.(None): • Organizing follow-up care where appropriate
p.(None): • Considering obtaining consent as a process that should be subject to negotiation during and even after the end of
p.(None): the interview; the informed consent process should include auhorization of recording (audio, video) of interviews,
p.(None): focus group discussions, and observations.
p.(None): • Ensuring confidentiality through securing storage of audio and video tapes and transcripts.
p.(None): • Making ‘respondent validation’ of the researcher’s analysis before dissemination of the research findings.
p.(None): • Publicizing the research before commencement such that the community is aware of the observation that can be in
p.(None): public domains: at market places, sport events, brothels, theatres, etc. In such cases, the IRB may decide waiver of
...
p.(None):
p.(None): binant DNA and potentially hazardous substances.
p.(None): • Continued review of approved research projects.
p.(None): • Ensure the provision of suitable and safe storage and disposal facilities for all materials involved in work with
p.(None): potentially hazardous substances.
p.(None): • Ensure that all appropriate technical personnel of the institution have adequate training in bio-safety.
p.(None): • Establish a health-monitoring plan for all high-risk personnel involved in appli- cation, use and production of
p.(None): potentially hazardous substances.
p.(None): 10.6 Community Advisory Board
p.(None): 10.6.1 Establishment
p.(None): Community Advisory Boards (CABs) are established by the investigator team. They are indispensable in orienting the
p.(None): investigator team about the local customs, tradi- tions, terminologies, culture, and attitude towards research and
p.(None): development. Be- sides, CABs are important bridges to liaise the researchers with the community. CABs are critical
p.(None): forums to facilitate dialogue between community members, research par- ticipants and investigators.
p.(None): CAB members shall be selected from the community where research is to be under- taken through a stakeholder
p.(None): consultative process. The CAB’s role and expectations should be explicitly described in their terms of reference.
p.(None): Members of the CAB may include but are not limited to the following:
p.(None): • Individuals familiar with local laws, customs, cultural values and gender issues
p.(None): • Elders, opinion leaders, local chiefs
p.(None): • Peer leaders, women leaders
p.(None): • Religious leaders
p.(None): • Representatives of the study population
p.(None): • Media personnel
p.(None): • Professionals who understand research or science issues
p.(None): 10.6.2 Functions
p.(None): The main function of a CAB is to assist investigators with understanding and incorpo- rating community concerns into
p.(None): their research procedures. The functions are expressed through different ways like advising on issues central to the
p.(None): informed consent process, achieving successful volunteer recruitment and retention, and other related issues.
p.(None): The responsibilities of the CABs may vary according to the study location, size, com- plexity, familiarity of the
p.(None): investigators with the local setting, to mention but few. CABs functions are to:
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 63
p.(None):
p.(None): • Provide information on traditional beliefs and needs of the study population and their concerns regarding the
p.(None): research project
p.(None): • Provide input into the design of the research protocol as appropriate especially in the recruitment and the informed
p.(None): consent process
p.(None): • Advise investigators on acceptable and effective methods for disseminating in- formation about the research project
p.(None): and its outcomes
p.(None): • Provide advice and support regarding retention of research participants includ- ing gender equity
...
Economic / Economic/Poverty
Searching for indicator low-income:
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p.(None): Subjects. Adopted by the 18th WMA General Assembly. Helsinki, Finland, June 1964, and amendments in 1975, 1983,
p.(None): 1989, 1996, 2000. Note of Clarification on Paragraph 29 added in 2002. Note of Clarification on Paragraph 30 added in
p.(None): 2008.
p.(None): 11. Karbwang J, Pattou C. Standard operating procedures for clinical investi- gators. UNDP/World Bank/WHO, special
p.(None): program for research and training in tropical diseases (TDR). TDR/TDP/SOP/99.1.
p.(None): 12. Operational Guidelines for Ethics Committees that Review Biomedical Re- search. WHO, 2000.
p.(None): 13. International Declaration on Human Genetic Data, UNESCO, 2003.
p.(None): 14. Operational Guidelines for the Establishment and Functioning of Data and Safety Monitoring Boards, TDR-WHO, Geneva
p.(None): 2005.
p.(None): 15. Uganda National Council for Science and Technology, 2007. National Guidelines for Research involving
p.(None): Humans as Research Participants. Kam-
p.(None): pala – Uganda: UNCST.
p.(None): National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): 16. Statement of WHO Expert Advisory Group on Ethical issues in Medical genetics. WHO, Geneva 1998.
p.(None): 17. Ethical Guidelines for International Comparative Social Science Research in the framework of Management of Social
p.(None): Transformations, MOST. UNE- SCO, MOST Paris.
p.(None): 18. Hyder A, Dowson L, Bachani AM, Lavery J. Moving from research ethics review o research ethics systems in
p.(None): low-income and middle-income coun- tries. Lancet 2009;37:862-65.
p.(None): 19. Heath EJ. The IRB’s Monitoring Function: Four Concepts of Monitoring. IRB: Ethics and Human Research, 1979; 1:
p.(None): 1-3+12.
p.(None): 20. DeMets DL, Fost N, Powers M. An Institutional Review Board dilemma: responsible for safety monitoring but not in
p.(None): control. Clin Trials 2006; 3; 142.
p.(None): 21. Cowan DH. Scientific Design, Ethics, and Monitoring: IRB Review of Ran- domized Clinical Trials. IRB: Ethics and
p.(None): Human Research, 1980;2: 1-4.
p.(None): 22. Karlawish, Hall (1996). Am J Respir Crit Care Med, 1996;153:499-5-6.
p.(None): 23. Casarett, Karlawish, Sugarman. JAMA, 2000, 283 (17): 2275-80.
p.(None): 24. Richards HM, Schwartz LJ. Ethics of qualitative research: are there special issues for health services research?
p.(None): Family Practice 2002; 19: 135-139.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 75
p.(None):
p.(None): Appendix I. Acronyms
p.(None): AAUMFIRB Addis Ababa University Medical Faculty Institutional
p.(None): Review Board
p.(None): AE Adverse Event
p.(None): AHRI Armauer Hansen Research Institute
p.(None): CAB Community Advisory Board
...
General/Other / Dependent
Searching for indicator dependent:
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p.(None): appropriate):
p.(None): • Questionnaires, surveys, assessments, interview questions, and tools.
p.(None): • Consent statements, informed consent forms/scripts, and as- sent forms/scripts.
p.(None): • Advertisements and letters of permission.
p.(None): 7.2.3. Exemption Categories and Determinations - Research activities in which the only involvement of human
p.(None): participants will be in one or more of the exempt categories, can be approved as exempt. The Chair or the Chair’s
p.(None): designee, the IRB Secretary/Administrator, will complete the appropriate Exempt Category Form to review the protocol
p.(None): and make a determination.
p.(None): 7.2.4. Assessment of the research - The review of the research will also in- clude:
p.(None): • Whether the research has a sound research design
p.(None): • Assuring there is minimal risk to participants
p.(None): • Ensuring that the investigator has the resources, time, and expertise to conduct the study
p.(None): National Research Ethics Review Guideline Fifth Edition 41
p.(None):
p.(None): The reviewer may require additional protections to meet the principles, including a level of informed consent
p.(None): appropriate to the research, or review by the full (convened) IRB.
p.(None): 7.2.5. Policies do not allow exemption of research involving video or digital recordings, and surveys or
p.(None): interviews that are extremely sensitive or personal. Allowance of audio recording is dependent on the research, is
p.(None): determined on a case-by-case basis, and must be documented.
p.(None): 7.2.6. Approval Period - At the one-year anniversary of the approval, an email is sent to the investigator requesting
p.(None): an update on the status of the study. During the approval period, the investigator needs to keep the IRB informed of
p.(None): any changes in the study, so that the IRB can ensure that the study continues to meet the exempt criteria. The
p.(None): investigator may close the study when data collection has ended or contact with the subject is complete.
p.(None): 7.2.7. Documentation of Exempt Review - If the study qualifies for exempt re- view, the reviewer will complete the
p.(None): appropriate Exempt Category Form which will be used as documentation.
p.(None): 7.2.8. Investigator and IRB members notification
p.(None): • The investigator will be notified by appropriate medium of the exempt determination.
p.(None): • Each month claims of exemptions will be listed on the IRB meeting agenda.
p.(None): 7.3 Expedited Review Procedures
p.(None): Expedited review is review of a protocol that need not be seen by the full (convened) IRB, but by one or two IRB
p.(None): members assigned by the chair.
p.(None): 7.3.1 Eligibility Criteria
p.(None): For the review to be expedited the proposed research must:
p.(None): • Involve minimal risk, meaning that the probability and magnitude of harm or discomfort anticipated in the research
p.(None): are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of
p.(None): routine physical or psychological examinations or tests.
p.(None): • Appropriately protect privacy/confidentiality.
...
p.(None): identified or linked to an individual by the ‘secondary-use-researcher’ or the ‘third party’. Limited,
p.(None): non-identifying, demographic information may be retained on the sample.
p.(None): • Use of genetic materials beyond what is stated in the protocol must have the consent of the research participants or
p.(None): their representatives. In case of second- ary use, i.e., research other than what it was collected, may be done only on
p.(None): anonymized samples and after getting prior approval by the IRB.
p.(None): • Where subsequent use of human biological materials or data is envisaged that would not be consistent with the
p.(None): original informed consent, a new consent should be obtained from the participant/guardian/LAR or request for
p.(None): waiver of consent from IRB.
p.(None): • The protocol should articulate clearly duration and place of storage of biological samples and data.
p.(None): 8.3.3 Socio-Behavioral Research
p.(None): There are five potential risks in qualitative and behavioral research that the IRB, the investigator and the sponsor
p.(None): should be aware of:
p.(None): • Anxiety and distress: qualitative research is aimed at in-depth understanding of sensitive topics with
p.(None): exploration of reasons and resilient issues. Involves open-ended questions and probing that give room for
p.(None): unexpected themes and variety of responses in the participant’s own terms. Besides, responses are in- timately
p.(None): dependent upon the context of the participants’ beliefs, values, behav- iors and actions. Hence, qualitative research
p.(None): possesses higher risk of anxiety and distress. Moreover, the differing experience of the participants largely makes
p.(None): 52 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): predicting who may experience the anxiety and distress difficult/problematic.
p.(None): • Intrusion in life: exploring behavior related to health may require observation of participants at various places
p.(None): including the household, and sometimes, for a prolonged period of time.
p.(None): • Exploitation: power imbalance between the researcher and the subject, or ex- erting undue influence.
p.(None): • Misrepresentation: participants’ opinion are taken out of context or interpreted in the researcher’s perspective,
p.(None): dynamics of the qualitative interviews and the nature of data collected can be affected by the professional background
p.(None): of the researcher.
p.(None): • Identification of participant: (by self or others) in published papers due to clues provided to describe the
p.(None): participant’s age, gender, educational and economic status, place of residence, profession, etc.
p.(None): Hence, to minimize these risks of harm, the following ethical issues should be given special emphasis during protocol
p.(None): review, conduct, and monitoring of qualitative re- search:
p.(None): • Ensuring scientific soundness
...
p.(None): involving human participants conforms to ethical principles
p.(None): Intervention-Physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the
p.(None): participant or the participant’s environment that are per- formed for research purposes.
p.(None): Justice, principle of-Ethical precept asserting an obligation to treat persons fairly and give to each person what
p.(None): she is due; two-part rule: (1) exhibit fairness and (2) distinguish between classes of participants that ought, and
p.(None): ought not, to participate in any particular kind of research.
p.(None): Legally Authorized Representative (LAR)-An individual or judicial or other body au- thorized under applicable State law
p.(None): who may consent on behalf of another individual to participate in the procedure(s) involved in the research.
p.(None): Local IRB-IRB located in the institution where the research is to be conducted.
p.(None): Medical device-Any instrument, apparatus, or other similar or related article, includ- ing component, part, or
p.(None): accessory, which is (a) recognized in the official National For- mulary, or the United States Pharmacopeia, or any
p.(None): supplement to them; (b) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation,
p.(None): treatment, or prevention of disease, in humans or other animals; or (c) intended to affect the structure or any
p.(None): function of the human body or in animals; and does not achieve any of its principal intended purposes through chemical
p.(None): action within or on the human body or in animals and is not dependent upon being metabolized for the achievement of its
p.(None): principal intended purposes.
p.(None): Minimal risk-(a) Risk such that the probability and magnitude of harm or discomfort anticipated in the research are not
p.(None): greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine
p.(None): physical or psycholog- ical examinations or tests.
p.(None): Minor changes-Changes to a research protocol that do not result in a net increase in risk, a change in the harm-benefit
p.(None): balance, or provide minor clarification or correc- tion. Minor changes may be reviewed under expedited review, even if
p.(None): the protocol has been deemed to pose more than minimal risk to participants.
p.(None): Noncompliance-Failure by investigators, research staff, IRB members, or IRB staff to follow regulations for human
p.(None): research protections
p.(None): Oral consent-Consent obtained only through speaking, generally in the absence of documentation of consent. See also
p.(None): documentation of consent, informed con- sent, verbal consent.
...
General/Other / Diminished Autonomy
Searching for indicator diminished:
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p.(None): authority such as an IRB. The protocol includes a descrip- tion of the design or methods for conducting the data
p.(None): collection, description of the study population, methods for data handling and analysis, procedures for handling
p.(None): incidents, and methods for notification and dissemination of results.
p.(None): Quorum-The number of IRB members required to be present at a convened meeting in order for the IRB to transact
p.(None): business.
p.(None): Reimbursement-Repayment for costs incurred by virtue or participation in research, such as for lost earnings or travel
p.(None): costs.
p.(None): Related/relation-Pertaining to an AE, the likelihood that the event was caused by research procedures,
p.(None): usually relative to the likelihood it was caused by something
p.(None):
p.(None): 82 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): other than research procedures.
p.(None): Report-A written account of the IRB’s findings, conditions for approval, or reasons for disapproval regarding human
p.(None): research protections in a research protocol.
p.(None): Repository-An entity that collects, stores and manages, and distributes data or hu- man tissue materials to recipient
p.(None): investigators for research and other purposes. See also http://www.hhs.gov/ohrp/humansubjects/guidance/reposit.htm.
p.(None): Research-Systematic investigation, including development, testing, and evaluation, designed to develop or contribute to
p.(None): generalizable knowledge.
p.(None): Respect for persons, principle of-The requirement to treat individuals as autonomous agents and to provide additional
p.(None): protections to persons with diminished autonomy. Respect for persons requires that participants, to the degree that
p.(None): they are capable, be given the opportunity to choose what shall or shall not happen to them.
p.(None): Response-An investigator’s written reply to an IRB report.
p.(None): Responsible conduct of research (RCR)-A collection of core areas for conducting scientific research with
p.(None): integrity: data acquisition, management, sharing and owner- ship; conflict of interest and commitment; human
p.(None): participants; animal welfare; re- search misconduct; publication practices and responsible authorship; mentor/trainee
p.(None): responsibilities; peer review; and collaborative science
p.(None): Risk-Exposure to injury, loss, or harm, expressed in terms of the probability and mag- nitude of that harm. Risks to
p.(None): participants must be minimized and must be reasonable in relation to anticipated benefits to participants and the
p.(None): importance the knowledge that may reasonably be expected to result.
p.(None): Serious adverse event (SAE)-An AE that results in death, is life-threatening (at the time of the event), requires
p.(None): inpatient hospitalization or prolongation of existing hospi- talization, results in persistent or significant
p.(None): disability or incapacity, or is a congenital anomaly or birth defect. An AE may also be considered serious if it
p.(None): jeopardizes the participant or requires intervention to prevent one of the other outcomes listed.
...
p.(None): participation.
p.(None): Unexpected-Pertaining to an AE, the event is previously unobserved or undocument- ed in humans under the research
p.(None): intervention (or one substantially similar), the na- ture or severity of the event is not consistent with information
p.(None): in the relevant source documents (e.g., investigator’s brochure, package insert, or non-reportable events [NRE] list),
p.(None): or the event is observed with higher frequency than previously observed or documented. Expectedness does not entail the
p.(None): ability to predict results from in vitro, animal, or other pharmacological models.
p.(None): Unlinked-The condition of data or specimens which had been coded but for which the key linking the code to direct
p.(None): personal identifiers has been destroyed.
p.(None): Unrelated-Pertaining to an AE, the condition in which the event is due to a docu- mented cause other than research
p.(None): procedures.
p.(None): Verbal consent-Consent obtained by communication in words; this may include spo- ken or written format.
p.(None): Voluntary/voluntariness-Freedom from coercion and undue influence
p.(None): Vulnerable-Having reduced capacity to offer free and informed consent due to pos- sible coercion, undue influence,
p.(None): or other diminished autonomy, such as children, prisoners, pregnant women, mentally disabled persons, or
p.(None): economically or education- ally disadvantaged persons as vulnerable. Vulnerability may be associated with other
p.(None): characteristics such as age, health status, or social standing. The IRB must ensure additional safeguards protect the
p.(None): rights and welfare of vulnerable persons.
p.(None): Vulnerable population-A group identified by one or more common characteristics associated with reduced
p.(None): capacity to offer free and informed consent.
p.(None): Waive/waiver-Temporarily set aside the requirement of a particular rule, regulation, or condition in a protocol or
p.(None): consent document.
p.(None): Withdraw/withdrawal-Permanently halt a research study after submission for IRB review but before human
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
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p.(None): medicine, as well as in the field of ethics. One such example is the use of the Hippocratic Oath taken by physicians
p.(None): and health practitioners, though recently, the Oath has been challenged by contemporary philosophers and ethicists.
p.(None): In Ethiopia, health research has been and is still being carried out by various sectors including government and
p.(None): private organizations, bilateral and multilateral agencies including United Nations (UN) agencies, and faith-based
p.(None): organizations. These orga- nizations have been conducting research of their interest independently or through
p.(None): collaborations with institutions such as medical and paramedical schools, research institutes, drug control agencies,
p.(None): and others.
p.(None): To disseminate these research findings, the grounds for formal peer-reviewed health research publication were laid
p.(None): by the Ethiopian Medical Journal in 1962. Other peer-reviewed scientific journals followed suit, namely, the
p.(None): Ethiopian Pharmaceuti- cal Journal, the Ethiopian Journal of Health Development, the Ethiopian Journal of Health
p.(None): Sciences, and Ethiopian Journal of Reproductive Health.
p.(None): Commitment of the government towards research and research ethics has been ex- pressed in various undertakings
p.(None): throughout the years. These undertakings include:
p.(None): • Endorsement of a constitution and legal codes that protect the well-being, wel- fare, and autonomy of its citizens,
p.(None): while also protecting the right to intellectual and academic freedom, as well as the pursuit of knowledge
p.(None): • Establishment of medical and public health colleges since 1952, the Central Research Laboratory in 1942 which later
p.(None): was upgraded to an institute, the Institute of Pathobiology in 1966, the Armauer Hansen Research Institute in 1969, the
p.(None): Demographic Training and Research Center in 1982, and recently, the National Science Academy.
p.(None): • Introduction of Ethics Review Committees (ERC) at the university level in the 1970s to protect the rights, safety,
p.(None): and welfare of research participants and to en- sure independent review of protocols before commencement of research
p.(None): activities.
p.(None): • Establishment of the Ethiopian Science and Technology Commission (ESTC) in 1975, with the mandate to guide,
p.(None): coordinate, and facilitate all Science and Technology-related activities including health-related activities. ESTC was
p.(None): later
p.(None): National Research Ethics Review Guideline Fifth Edition 13
p.(None):
p.(None): changed to the Ethiopian Science and Technology Agency (ESTA) to lead the development and application of science,
p.(None): technology and innovation in Ethiopia, and further coordinate, regulate, and oversee research. On October 24, 2008,
p.(None): under proclamation No. 603/2008’, ESTA was formally renamed as the Min- istry of Science and Technology (MoST) by the
p.(None): Federal Democratic Republic of Ethiopia (FDRE).
...
p.(None): • Studies of a physiological, biomedical, biochemical, or pathological processes
p.(None): • Genetic research, clinical trials, pharmaceutical, and other investigational products
p.(None): • Research studies involving clinical records or other personal information
p.(None): • Public health and epidemiological research
p.(None): • Health systems research
p.(None): • Quality improvement research
p.(None): • Human health related behavioral research, research on medical and paramedi- cal education, and research related to
p.(None): traditional healing.
p.(None): • Research that may include one or a combination of observations; interviews, in- ternet-based, mail-based, and
p.(None): telephone research; focus group research; survey and research with biological samples.
p.(None): Furthermore, the guidelines are applicable in research proposed to be conducted by all sectors and organizations. These
p.(None): include, but are not limited to, public, private, faith-based, indigenous and international non-governmental
p.(None): organizations (NGOs), bilateral, multilateral, and United Nations’ agencies.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 19
p.(None):
p.(None): 2. Objectives
p.(None): 2.1 General Objective
p.(None): The objective of this guideline is to safeguard the rights, values, and welfare of re- search participants through
p.(None): respecting the participants’ autonomy, protecting the participants from harm related to research, and ensuring
p.(None): that individual/community benefits and fairness are maintained.
p.(None): 2.2 Specific Objectives
p.(None): 2.2.1. To ensure the rights and autonomy of research participants are respected and that participation or otherwise in
p.(None): research, is entirely voluntary
p.(None): 2.2.2. To safeguard research participants from unnecessary/unjustifiable risk
p.(None): 2.2.3. To ensure fair selection of research participants and fair distribution of benefits and risks
p.(None): 2.2.4. To create awareness among investigators, sponsors, reviewers, decision and policy makers, and
p.(None): individuals/communities on basic ethics principles
p.(None): 2.2.5. To ensure that research holds/embraces/possesses/considers social and cultural responsiveness/sensitivities for
p.(None): participating individuals and com- munities
p.(None): 2.2.6. To ensure the scientific integrity, ethical standards, and appropriate proce- dures for the conduct of research
p.(None): involving human participants
p.(None): 2.2.7. To monitor and evaluate ongoing and post-research ethical implications to the participants and the community, at
p.(None): large
p.(None): 2.2.8. To regulate human biological materials (sample/specimen) transfer
p.(None): 2.2.9. To ensure rigorous and robust ethical review of research protocols
p.(None): 2.2.10. To ensure timely review and communication of decision of submitted proto- col to investigators
p.(None): 2.2.11. To facilitate cooperation and networking among IRBs at local and interna- tional levels
p.(None): 2.2.12. To comply with and regulate the complexity of research procedures
p.(None): 2.2.13. To put in place legal considerations against research investigators/ studies undertaken prior to appropriate
p.(None): ethics review or unethical implementation of studies.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 20 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): 3. Ethical Principles
p.(None): High ethical standards in health research can be achieved only when investigators aspire to such standards in their
p.(None): research activities. To safeguard the rights and wel- fare of human subjects in research, all Research Ethics Review
p.(None): Committees (RERCs) and IRBs, regardless of their level, shall promote three basic ethical principles: 1) respect for
p.(None): persons 2) beneficence and 3) justice. In general, RERCs shall ensure that investigators have thought of ethical
p.(None): issues, specifically that no harm will be done and no resources wasted in the name of research, regardless of the
p.(None): research ques- tion planned for exploration. However, in certain circumstances, the weight given to each of these
p.(None): three basic ethical principles may differ in accordance with the type of the research and the setting where the
p.(None): research is conducted. Nevertheless, the IRB should ensure that the following basic ethics principles are met.
p.(None): 3.1 Respect for Persons
p.(None): Out of respect, participants must be informed about the research and allowed to decide about participation. Research
p.(None): participants unable to make decisions inde- pendently deserve extra protection.
p.(None): 3.1.1. Autonomy - This principle aspires to protect the interests of hu- man research participants from physical,
p.(None): psychological, and cultural harm. It refers to the obligation on the part of the investigator to respect each
p.(None): research participant as a person capable of making an informed decision regarding participation in the research
p.(None): study. It obligates in- vestigators to respect the right of human subjects to hold their views, make
p.(None): choices and take actions without controlling influences. For human subjects who are not capable of making an informed
p.(None): decision because of age, mental, or medical capacity, the next of kin or guardian shall make the decision in the best
p.(None): interest of the research participant.
p.(None): 3.1.2. Informed Consent – The importance of informed consent of research participants is unquestionable and
p.(None): the informed consent should be analyzed in terms of containing the basic elements of information, com- prehension,
p.(None): competence, disclosure, and voluntarism. Information shall be given in writing and signed or verbally approved by the
p.(None): research par- ticipant. The information to be provided should be written in a way that considers the local culture and
p.(None): values, as well as the level of understanding of the research participant. The information provided should weigh the
...
p.(None): • Research which is funded by companies producing the experimental product.
p.(None): • Experimental research which is carried out by a national agency or agencies with international collaboration.
p.(None): • Projects that require transfer of human biological materials (samples/ specimens).
p.(None): 5.2.2.6. Umpire complaints, disputes, appeals and grievances on functions and review processes of IRBs submitted by
p.(None): researchers or institutions.
p.(None): 5.2.2.7. Monitor and evaluate IRBs at all levels.
p.(None): 5.2.2.8. Facilitate experience sharing among local and international IRBs.
p.(None): 5.2.2.9. Facilitate international registration of Level A IRBs such that their reviews are accepted by funding
p.(None): agencies.
p.(None): 5.2.2.10. Review of trials that are funded by manufacturers and pharmaceuticals,
p.(None): 5.2.2.11. Review very urgent research projects that are of national interest and priority, and
p.(None): 5.2.2.12. Policy-advocacy and creating community awareness on ethical principles in research, and legal and regulatory
p.(None): reforms, and changes related to re- search involving human participants.
p.(None): 5.3 Institutional Review Board, Level A
p.(None): These IRBs can be regional or institutional. These are IRBs that have the capacity to review, monitor, document
p.(None): research protocols and undertakings involving humans in the region or the institution where they are based, or other
p.(None): institutions that do not have their own IRBs and beyond. Similarly, Level A IRBs shall be capable of safe-
p.(None): 26 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): guarding the rights, autonomy, safety, and welfare of human research participants.
p.(None): 5.3.1 Composition
p.(None): • Shall have members with professional competence and a mix of varying back- grounds, gender representation, a
p.(None): community representative, research ethics training, and experience similar to or equivalent with the NRERC.
p.(None): • Minimum number of members is five (5).
p.(None): 5.3.2 Mandates and Functions
p.(None): 5.3.2.1. Organize and deliver research ethics training to researchers in the region or the institutions.
p.(None): 5.3.2.2. Develop SOPs, that govern the IRB’s research review procedures.
p.(None): 5.3.2.3. Submit progress report of the IRB’s functions annually to the NRERC.
p.(None): 5.3.2.4. Inform the NRERC on occurrence of frequent, unexpected severe adverse effects (SAEs) related to research
p.(None): reviewed and approved by the IRB,
p.(None): 5.3.2.5. Review and approve research protocols similar to the NRERC except:
p.(None): • Genetic research, stem cell research
p.(None): • Research involving human biological material transfer outside of Ethi- opia provided that the IRB notifies the NRERC
p.(None): Multicenter interna- tional collaborative research of experimental nature
p.(None): • Investigation of new devices, drugs or vaccines not registered for use in Ethiopia
p.(None): • Review of trials that are funded by manufacturers and pharmaceutical companies
p.(None): 5.3.2.6. Solicit funds to build its own capacity
p.(None): 5.4 Institutional Review Board, Level B
p.(None): These can be regional or institutional IRBs. These are IRBs that have the capaci- ty to review, monitor, and document
p.(None): research protocols and undertakings involving humans from the institution where they are based or other institutions
p.(None): that do not have their own IRBs, according to the mandates and functions stated below. Simi- larly, Level B IRBs shall
p.(None): be capable of safeguarding the rights, autonomy, safety, and welfare of human research participants. These IRBs may not
p.(None): have the expertise and experience of Level A IRBs, in which case the protocols can be reviewed by Level A IRBs of other
p.(None): institutions.
p.(None): 5.4.1 Composition
p.(None): • Shall have members with professional competence and a mix of gender repre- sentation, a community representative,
p.(None): research ethics training, and experience,
p.(None): National Research Ethics Review Guideline Fifth Edition 27
p.(None):
p.(None): which may not be similar to or equivalent with NRERC or Level A IRB.
p.(None): • Minimum number of members is five (5).
p.(None): 5.4.2 Mandates and Functions
p.(None): 5.4.2.1. Organize and deliver research ethics training to researchers in the region or the institution.
p.(None): 5.4.2.2. Develop SOPs that govern the IRB’s research review procedures.
p.(None): 5.4.2.3. Submit progress report of the IRB’s functions annually to the NRERC.
p.(None): 5.4.2.4. Inform the NRERC on occurrence of frequent, unexpected SAEs related with research reviewed and approved by the
p.(None): IRB.
p.(None): 5.4.2.5. Review and approve research protocols that involve minimal risk.
p.(None): 5.4.2.6. Solicit funds to build its own capacity
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Responsibilities of the Secretariat:
p.(None): • Receive applications from other IRBs.
p.(None): • Ensure the completeness of application documents for ethical review.
...
p.(None): unfavorable and unin- tended sign, symptom, or condition temporally associated with the administration of the
p.(None): health-research intervention, whether or not considered related to the interven- tion. This also includes unfavorable
p.(None): deviations from baseline health.
p.(None): Amendment-A material change to study procedures. Such changes, including minor changes, must be reviewed by an IRB
p.(None): before they may be implemented.
p.(None): Anonymous/anonymized-Lacking identification because identifiers or other informa- tion that could identify the
p.(None): individual were not collected or were removed. Information may or may not be considered anonymous if there is a
p.(None): reasonable basis to believe that one can use the information to identify and individual, even if one cannot readily
p.(None): ascertain the individual’s identity; see further discussion at individually identifiable information. For example, it
p.(None): might be possible to determine a survey respondent’s identity from a combination of demographic factors in a survey
p.(None): together with public or proprietary data sources, even if the surveyor did not jointly record the respondent’s identity
p.(None): and those demographic characteristics..
p.(None): Approve/approval-The determination of the IRB that the research has been reviewed and may be conducted at an
p.(None): institution within the constraints set forth by the IRB and by other institutional and federal requirements.
p.(None): Assent-Participant not of legal age (i.e., child); affirmative agreement to participate in research. Mere failure to
p.(None): object should not be construed as assent.
p.(None): Autonomy-Self-rule that is free from both controlling interference by others and from limitations that prevent
p.(None): meaningful choice. See also respect for persons.
p.(None): Belmont Report-Statement of ethical principles and guidelines for the protection of
p.(None): National Research Ethics Review Guideline Fifth Edition 77
p.(None):
p.(None): human participants of research. The National Commission for the Protection of Hu- man Subjects of Biomedical and
p.(None): Behavioral Research published this report in 1979. The three principles are respect for persons, beneficence, and
p.(None): justice. See: https://www.hhs.gov/orhp[/humansubjects/guidance/belmont.htm
p.(None): Beneficence, principle of-Ethical precept asserting an obligation to prevent harm, to remove harm, or to do or
p.(None): promote good; two-part rule: (1) do not harm and (2) maximize possible benefits and minimize possible harms.
p.(None): Benefit-A potential advantage or gain.
p.(None): Breach of protocol-Material departure from approved procedures of the study, such as the consent process, violations
p.(None): of data confidentiality, or complaints by partici- pants; may be a reportable incident.
...
p.(None): collection, description of the study population, methods for data handling and analysis, procedures for handling
p.(None): incidents, and methods for notification and dissemination of results.
p.(None): Quorum-The number of IRB members required to be present at a convened meeting in order for the IRB to transact
p.(None): business.
p.(None): Reimbursement-Repayment for costs incurred by virtue or participation in research, such as for lost earnings or travel
p.(None): costs.
p.(None): Related/relation-Pertaining to an AE, the likelihood that the event was caused by research procedures,
p.(None): usually relative to the likelihood it was caused by something
p.(None):
p.(None): 82 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): other than research procedures.
p.(None): Report-A written account of the IRB’s findings, conditions for approval, or reasons for disapproval regarding human
p.(None): research protections in a research protocol.
p.(None): Repository-An entity that collects, stores and manages, and distributes data or hu- man tissue materials to recipient
p.(None): investigators for research and other purposes. See also http://www.hhs.gov/ohrp/humansubjects/guidance/reposit.htm.
p.(None): Research-Systematic investigation, including development, testing, and evaluation, designed to develop or contribute to
p.(None): generalizable knowledge.
p.(None): Respect for persons, principle of-The requirement to treat individuals as autonomous agents and to provide additional
p.(None): protections to persons with diminished autonomy. Respect for persons requires that participants, to the degree that
p.(None): they are capable, be given the opportunity to choose what shall or shall not happen to them.
p.(None): Response-An investigator’s written reply to an IRB report.
p.(None): Responsible conduct of research (RCR)-A collection of core areas for conducting scientific research with
p.(None): integrity: data acquisition, management, sharing and owner- ship; conflict of interest and commitment; human
p.(None): participants; animal welfare; re- search misconduct; publication practices and responsible authorship; mentor/trainee
p.(None): responsibilities; peer review; and collaborative science
p.(None): Risk-Exposure to injury, loss, or harm, expressed in terms of the probability and mag- nitude of that harm. Risks to
p.(None): participants must be minimized and must be reasonable in relation to anticipated benefits to participants and the
p.(None): importance the knowledge that may reasonably be expected to result.
p.(None): Serious adverse event (SAE)-An AE that results in death, is life-threatening (at the time of the event), requires
p.(None): inpatient hospitalization or prolongation of existing hospi- talization, results in persistent or significant
p.(None): disability or incapacity, or is a congenital anomaly or birth defect. An AE may also be considered serious if it
p.(None): jeopardizes the participant or requires intervention to prevent one of the other outcomes listed.
...
p.(None): participation.
p.(None): Unexpected-Pertaining to an AE, the event is previously unobserved or undocument- ed in humans under the research
p.(None): intervention (or one substantially similar), the na- ture or severity of the event is not consistent with information
p.(None): in the relevant source documents (e.g., investigator’s brochure, package insert, or non-reportable events [NRE] list),
p.(None): or the event is observed with higher frequency than previously observed or documented. Expectedness does not entail the
p.(None): ability to predict results from in vitro, animal, or other pharmacological models.
p.(None): Unlinked-The condition of data or specimens which had been coded but for which the key linking the code to direct
p.(None): personal identifiers has been destroyed.
p.(None): Unrelated-Pertaining to an AE, the condition in which the event is due to a docu- mented cause other than research
p.(None): procedures.
p.(None): Verbal consent-Consent obtained by communication in words; this may include spo- ken or written format.
p.(None): Voluntary/voluntariness-Freedom from coercion and undue influence
p.(None): Vulnerable-Having reduced capacity to offer free and informed consent due to pos- sible coercion, undue influence,
p.(None): or other diminished autonomy, such as children, prisoners, pregnant women, mentally disabled persons, or
p.(None): economically or education- ally disadvantaged persons as vulnerable. Vulnerability may be associated with other
p.(None): characteristics such as age, health status, or social standing. The IRB must ensure additional safeguards protect the
p.(None): rights and welfare of vulnerable persons.
p.(None): Vulnerable population-A group identified by one or more common characteristics associated with reduced
p.(None): capacity to offer free and informed consent.
p.(None): Waive/waiver-Temporarily set aside the requirement of a particular rule, regulation, or condition in a protocol or
p.(None): consent document.
p.(None): Withdraw/withdrawal-Permanently halt a research study after submission for IRB review but before human
p.(None): participants become involved, whether or not the study has been reviewed by an IRB. This term has been replaced by the
p.(None): term close/closure.
...
General/Other / Incapacitated
Searching for indicator incapacity:
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p.(None): generalizable knowledge.
p.(None): Respect for persons, principle of-The requirement to treat individuals as autonomous agents and to provide additional
p.(None): protections to persons with diminished autonomy. Respect for persons requires that participants, to the degree that
p.(None): they are capable, be given the opportunity to choose what shall or shall not happen to them.
p.(None): Response-An investigator’s written reply to an IRB report.
p.(None): Responsible conduct of research (RCR)-A collection of core areas for conducting scientific research with
p.(None): integrity: data acquisition, management, sharing and owner- ship; conflict of interest and commitment; human
p.(None): participants; animal welfare; re- search misconduct; publication practices and responsible authorship; mentor/trainee
p.(None): responsibilities; peer review; and collaborative science
p.(None): Risk-Exposure to injury, loss, or harm, expressed in terms of the probability and mag- nitude of that harm. Risks to
p.(None): participants must be minimized and must be reasonable in relation to anticipated benefits to participants and the
p.(None): importance the knowledge that may reasonably be expected to result.
p.(None): Serious adverse event (SAE)-An AE that results in death, is life-threatening (at the time of the event), requires
p.(None): inpatient hospitalization or prolongation of existing hospi- talization, results in persistent or significant
p.(None): disability or incapacity, or is a congenital anomaly or birth defect. An AE may also be considered serious if it
p.(None): jeopardizes the participant or requires intervention to prevent one of the other outcomes listed.
p.(None): Serious noncompliance-Noncompliance that results in increased risk to partici- pants or reflects a failure to apply
p.(None): substantial portions of governing regulations. Seri- ous noncompliance must be reported promptly.
p.(None): Severe/severity-The graded level of intensity of an AE and its interference with usual social and functional
p.(None): activities, often standardized in toxicity tables. Grade levels generally include normal, mild, moderate, severe,
p.(None): life-threatening, and fatal.
p.(None): Sponsor- a person or other entity that initiates a clinical investigation, but that does not actually conduct the
p.(None): investigation.
p.(None): Suspend/suspension-Temporary cessation of research-related intervention or interac- tion with participants and
p.(None): obtaining or using identifiable private research information. Partial suspension halts some but not all such
p.(None): activities, for example when enrollment is stopped but follow-up continues with enrolled participants. A suspension
p.(None): must be
p.(None): National Research Ethics Review Guideline Fifth Edition 83
p.(None):
p.(None): reported promptly unless the suspension results from expiration of IRB approval.
p.(None): Terminate/termination-Permanent cessation of research-related intervention or interac- tion with participants and
p.(None): obtaining and use of identifiable private research information. A termination must be reported promptly unless the
p.(None): termination results from expiration of IRB approval or withdrawal or closure for reasons other than research risks.
...
General/Other / Manipulable
Searching for indicator manipulated:
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p.(None): National Research Ethics Review Guideline Fifth Edition 21
p.(None):
p.(None): 3.2 Beneficence
p.(None): The principle of beneficence refers to the obligation on the part of the investiga- tor to attempt to
p.(None): maximize benefits for the individual participant and/or community, while minimizing risk or harm to the
p.(None): individual/community. As much as possible, beneficence also considers inflicting no harm. An honest and thorough
p.(None): risk/benefit assessment must be performed. Balancing the risk and benefit of the research is indispensible
p.(None): in the design and conduct of the research.
p.(None): Risk is the probability and magnitude of some future occurrence of harm. Harm is injury and setback to interests as a
p.(None): result of being a research participant. Risks to research participants include physical, psychological, and emotional
p.(None): harm. Risks can be known or presumed. And, although no specific regulations exist, risks may include physical,
p.(None): psychological, emotional, economic, educational, legal, and social harm.
p.(None): In addition, beneficence includes whether the usual care is changed or manipulated to inflict no harm, minimize harm,
p.(None): remove harm, and maximize the benefit to re- search participants and to the community, or both.
p.(None): 3.3 Justice
p.(None): Justice connotes fairness and equity in the distribution of the benefits and burdens of research to participants.
p.(None): 3.3.1. Justice demands equitable selection of participants, i.e., avoiding popu- lations that may be unfairly coerced
p.(None): into participating, including but not limited to, prisoners, pregnant women, people with mental and physical
p.(None): disabilities, immigrants, refugees, ethnic minorities, marginalized groups and institutionalized persons, including
p.(None): children. There must be a justi- fication for inclusion of these vulnerable groups in the research. There should be no
p.(None): disproportionate use of vulnerable populations. The same recruitment approach should be used in all populations.
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General/Other / Natural Hazards
Searching for indicator hazard:
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p.(None): variable period even after the completion of the research based on the researched disease, condition or instrument;
p.(None): shall open an investiga- tor’s file where all documents related to the research are kept.
p.(None): 13.0.4. Shall keep records of informed consent document confidentially (in a locked cabinet).
p.(None): 13.1.5. Shall ensure privacy and confidentiality is maintained for research par- ticipants. The investigator shall
p.(None): ensure that hard data is kept in locked cabinets and electronic data is password protected accessible only to
p.(None): appropriate personnel.
p.(None): 13.1.6. Monitor research staff to ensure the research is done according to the approved research protocol/procedures.
p.(None): 13.1.7. Periodically submit a progress report to the IRB. The frequency of the report is to be determined according to
p.(None): the level of risk inherent in the
p.(None): National Research Ethics Review Guideline Fifth Edition 69
p.(None):
p.(None): research, i.e., the higher the risk the shorter the reporting interval.
p.(None): 13.1.8. Shall promptly investigate serious adverse events and take appropriate measures to safeguard the safety of
p.(None): human subjects. The investigator shall inform such adverse events and measures taken, if any, to the IRB, clinical
p.(None): monitor and the sponsor.
p.(None): 13.1.9. Shall inform the IRB and obtain approval for any changes or amend- ments in the approved
p.(None): protocol/procedures except in circumstances where an apparent immediate hazard or danger to the research partic-
p.(None): ipants. Any amendment shall be appended to the approved research protocol.
p.(None): 13.1.10. Shall inform the IRB, clinical monitor, the sponsor and the participants if the study is terminated or
p.(None): suspended at any time during the research process.
p.(None): 13.1.11. Shall be responsible for periodic assessment of the quality of data man- agement as well as reporting on
p.(None): interim analysis whenever appropriate.
p.(None): 13.1.12. In case of clinical/experimental trials, shall ensure, at least, one of the investigators have a
p.(None): certificate on good clinical practice and/or good manufacturing practice or both or whichever is appropriate.
p.(None): 13.1.13. Shall ensure beneficial investigational products are available to the community after the research is
p.(None): completed.
p.(None): 13.1.14. Shall report to the DSMB, as applicable.
p.(None): 13.1.15. In collaborative research, shall consider the cultures and ethnic diver- sities and should make the research
p.(None): objectives particularly clear and remain aware of the concerns and welfare of the individuals or commu- nities to be
p.(None): studied.
p.(None): 13.1.16. Shall provide adequate information in all publications to the reader, and to colleagues to permit the methods
p.(None): and findings to be properly assessed. Limits of reliability and applicability should be made clear.
p.(None): 13.1.17. Shall submit final report and findings to the IRB.
p.(None): 13.1.18. Shall ensure the community where the research is conducted is in- formed about the research findings.
p.(None): 13.2 Host Institution
...
General/Other / Public Emergency
Searching for indicator emergency:
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p.(None): 6.15 Waiver of Informed Consent Documentation
p.(None): Waiver of informed consent or documentation of informed consent should be ap- proved by the IRB. The investigator must
p.(None): secure an explicit waiver of consent from the IRB. The IRB may waive some or all of the elements of an informed consent
p.(None): and/
p.(None):
p.(None): 38 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): or a signed or thumb printed consent form for some or all of the research participants of a particular study, if the
p.(None): IRB determines that:
p.(None): • The research project carries no more than minimal risk, If the research or demonstration project is
p.(None): to be conducted or approved by federal or regional government and is designed to study, evaluate, or otherwise
p.(None): explore public ben- efit or service programs; possible changes in or alternatives to those programs; possible changes
p.(None): in methods or levels of payment for benefits or services under those programs.
p.(None): • The research project could not practically be carried out without the waiver or alteration (whenever appropriate the
p.(None): research participants will be provided with additional pertinent information after participation); In emergency/acute
p.(None): condi- tions where a new drug (or new combination of drugs) or a new procedure(s) potentially holds a direct benefit
p.(None): but, the research participant cannot give or re- fuse informed consent because of the acute condition, the IRB may
p.(None): waive need for informed consent. However, it is the responsibility of the investigator and the sponsor to publicize
p.(None): such a study to the community before commencement of any research activity. The IRB should monitor such publicity to
p.(None): ascertain the community’s awareness.
p.(None): • In emergency conditions of national or regional importance, for example epi- demics, where a participant cannot
p.(None): refuse informed consent.
p.(None): • In situations where deception needs to be applied to achieve the objectives of the study.
p.(None): • The only record linking the research participant and the research project would be the consent document and the
p.(None): principal risk to the research participant would be potential harm resulting from a breach of confidentiality.
p.(None): 6.16 Continuing Review
p.(None): • The IRB conducts continuing review of all approved studies at intervals appro- priate to the degree of risk that the
p.(None): study participants are exposed, but not less than once a year.
p.(None): • The IRB will require continuing progress reports annually , unless it designates otherwise.
p.(None): • All changes in approved research projects should be reported and approved by the IRB before implementation, except
p.(None): where necessary to eliminate immediate apparent risks.
p.(None): 6.17 Suspension and Termination of Approval
p.(None): The IRB has the authority to terminate or suspend its approval for research projects if it considers is appropriate
p.(None): such as:
p.(None): • The research is not being conducted according to the approved protocol, or according to applicable guidelines,
p.(None): National Research Ethics Review Guideline Fifth Edition 39
p.(None):
...
p.(None): categories stated below can be considered as exempt:
p.(None): • Education: Research conducted in established or commonly accepted educa- tional settings, involving normal
p.(None): educational practices.
p.(None): • Education: Research involving the use of educational tests (cognitive, diagnos- tic, aptitude, achievement),
p.(None): surveys, interviews, or observation of public behav-
p.(None): ior, provided the research participants can not be identified.
p.(None): 40 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): • Research, involving the collection or study of existing data, documents, records, pathological specimens, or
p.(None): diagnostic specimens, if these sources are publicly available or recorded without identifiers. Or, if the information
p.(None): is recorded by the investigator in such a manner that research participants cannot be identified, directly or through
p.(None): identifiers linked to the subjects.
p.(None): • Evaluation or examination of government projects or programs designed to ex- plore public benefit or service
p.(None): programs; procedures for obtaining benefits or services under those projects or programs; possible changes in or
p.(None): alternatives to those programs or procedures.
p.(None): • Taste and food quality evaluation and consumer acceptance studies where the foods are free of additives and where
p.(None): the ingredients are known to be safe.
p.(None): • Emergency conditions of national or regional importance, such as epidemics.
p.(None): • Quality assurance activities.
p.(None): All research including that in the exempt categories must meet, at a minimum, the principles of respect for persons,
p.(None): beneficence and justice. The exemption determina- tion other than mentioned above will be based on regulatory and
p.(None): institutional criteria and documented.
p.(None): 7.2.1. Exempt Study Submission Requirements - Research activities that meet the requirements for one or more exempt
p.(None): research categories must be endorsed by the IRB.
p.(None): 7.2.2. The investigator must complete the appropriate Exempt Application and submit the application along with (if
p.(None): appropriate):
p.(None): • Questionnaires, surveys, assessments, interview questions, and tools.
p.(None): • Consent statements, informed consent forms/scripts, and as- sent forms/scripts.
p.(None): • Advertisements and letters of permission.
p.(None): 7.2.3. Exemption Categories and Determinations - Research activities in which the only involvement of human
p.(None): participants will be in one or more of the exempt categories, can be approved as exempt. The Chair or the Chair’s
p.(None): designee, the IRB Secretary/Administrator, will complete the appropriate Exempt Category Form to review the protocol
p.(None): and make a determination.
p.(None): 7.2.4. Assessment of the research - The review of the research will also in- clude:
p.(None): • Whether the research has a sound research design
p.(None): • Assuring there is minimal risk to participants
p.(None): • Ensuring that the investigator has the resources, time, and expertise to conduct the study
...
p.(None): obtained from human research participants.
p.(None): 9.2 Acquisition, Storage, Secondary Use
p.(None): The acquisition, storage, and future use of human biological samples from research participants in Ethiopia shall be
p.(None): guided by the following procedures:
p.(None): • There should be a separate informed consent process for obtaining human bio- logical samples for storage and for
p.(None): future use. This process includes the use of a consent form separate from that used for enrollment of research
p.(None): participants into the study.
p.(None): • Research participants should know the purpose of sample storage, quantities of samples to be stored, place where
p.(None): samples will be stored, duration of storage, measures to protect confidentiality, policies that will govern use of the
p.(None): samples in future research, potential risks and benefits of storing samples for future re- search and any other
p.(None): information deemed necessary by the Investigators, IRBs.
p.(None): • After explaining the need to store the samples, the research participant should be offered to choose whether their
p.(None): samples should or should not be stored for future studies.
p.(None): National Research Ethics Review Guideline Fifth Edition 57
p.(None):
p.(None): • The host institution in Ethiopia should hold the samples in trust on behalf of the research participant.
p.(None): • Research participants should reserve the right to withdraw their samples from storage if the samples are linked.
p.(None): • Where samples have not been obtained as part of research (for example as part of routine surveillance, emergency
p.(None): procedures, laboratory quality control, notifi- able diseases, routine counseling and testing, etc), the institution
p.(None): that collected the samples takes custodianship of the samples. Any future research study on such samples is subject to
p.(None): review by an IRB.
p.(None): 9.3 Procedure for Exchange Transfer
p.(None): • When it is necessary to transfer samples for storage abroad, the host institution shall negotiate an appropriate
p.(None): contract with the recipient institution. This con- tract shall be in the form of a Materials Transfer Agreement (MTA).
p.(None): The specific details of the MTA should include, among other things, purpose for the transfer/ export, clear
p.(None): arrangements for collaboration and benefit sharing, a framework for accessing and sharing data, restrictions to third
p.(None): party transfer, and annual reports to the host institution on the status of the samples.
p.(None): • It is required that an Ethiopian scientist must be included as co-investigator in all future studies using the human
p.(None): biological materials collected from Ethiopia.
p.(None): • The IRB in Ethiopia shall review all research studies on stored human biological samples.
p.(None):
p.(None): 10. Regulatory Oversight of Research
p.(None): Regulatory oversight of research involving human participants is exercised at two levels. At the country level, the
p.(None): NRERC, which is established by MoST, is the prima- ry responsible organ for oversight. At the institutional level, the
p.(None): organization’s IRB, accredited by MoST, oversees all research being conducted under its jurisdiction. For research
p.(None): involving experimental/clinical trials, an additional approval to import and use the drug or investigational product
p.(None): should be solicited from FMHACA.
...
p.(None): national academies of sciences and medical research councils. A main objective of CIOMS is to facilitate and promote
p.(None): international activities in the field of biomedical sciences, especially when the participation of several
p.(None): international associations and national institutions is deemed necessary.
p.(None): Data and safety monitoring-Structured, ongoing monitoring of specified characteris- tics of a research protocol,
p.(None): generally by a small, independent body of experts appoint- ed by the study sponsor. Sometimes incorrectly called “data
p.(None): safety and monitoring”. Monitoring may pertain to study performance (such as rate of accrual), safety (such as
p.(None): occurrence of AEs), and efficacy (such as achievement of primary endpoints). A body that monitors all three
p.(None): characteristics is usually called a data monitoring com- mittee (DMC) or a data and safety monitoring board (DSMB).
p.(None): Declaration of Helsinki-A statement of ethical principles to provide guidance to phy- sicians and other participants in
p.(None): medical research involving human participants; ad- opted by the World Medical Assembly in 1964 and last updated in
p.(None): 2004. See http:// www.wma.net/e/policy/b3.htm.
p.(None): Disapprove/disapproval-The determination by the IRB that the research may not be conducted at an institution
p.(None): Documentation of consent-Consent that is documented by the use of a written con- sent form approved by the IRB and
p.(None): signed by the participant or the participant’s legally authorized representative.
p.(None): Emergency response-A public health activity undertaken in an urgent or emergency situation, usually because of an
p.(None): identified or suspected imminent health threat to the population, but sometimes because the public or government
p.(None): authorities perceive an imminent threat that demands immediate action. The primary purpose of the activity is to
p.(None): document the existence and magnitude of a public health problem in the community and to implement appropriate measures
p.(None): to address the problem (Langmuir, 1980).
p.(None): Exemption/exempt research-Categories of research to which the Federal regulations for human research protections do not
p.(None): apply. Research involving prisoners and some research involving children are not exempt.
p.(None): Expected-Pertaining to an AE, the event has been previously observed or documented in humans under the research
p.(None): intervention (or one substantially similar), and the nature or severity of the event is consistent with information in
p.(None): the relevant source documents (e.g., investigator’s brochure, package insert, or non-reportable events [NRE] list).
p.(None): National Research Ethics Review Guideline Fifth Edition 79
p.(None):
p.(None): Expedited review-Review performed by the IRB Chair or a designated experienced member for research that involves no
p.(None): more than minimal risk and meets the criteria for expedited review or represents minor changes in approved research.
...
p.(None): 28. Mr Geberemariam Birhanu NRERC, Member
p.(None): 29. Mr.Teshome Sahelemariam, MoST
p.(None): 30. Mr Girma Yosef, MoST
p.(None): 31. Mr Getachew Atente, MoST
p.(None): 32. Mr. Abdisa Yilma MoST
p.(None): 33. Mr. Babesha Kenaw MoST
p.(None):
p.(None): 94 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None):
p.(None): 34. Mr Melaku Arage MoST
p.(None): 35. Mr Sisay Gardew MoST
p.(None): 36. Mr Hailegnaw Eshete, EPHA
p.(None): 37. Mr Derje Syium EPHA
p.(None): 38. Mrs. wudenshe Mamo EPHA
p.(None): 39. Mr Mustefa Abdulsemed MoST
p.(None): 40. Mr. Mulugeta wube MoST
p.(None): 41. Mrs. Serkalem Ketema MoST
p.(None): 42. Mr Shibeshi Kasa MoST
p.(None): 43. Mr. Solomon Getachew MoST
p.(None): 44. Mrs Tigist Yeheyis MoST
p.(None): 45. Mr. Tewodros Wakuma MoST
p.(None): 46. Mr. Zelalem Dagne, MoST
p.(None): 47. Mr. Frew Hailu MoST
p.(None):
p.(None):
p.(None):
p.(None):
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p.(None):
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p.(None):
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p.(None):
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 95
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): This Guideline was produced with Technical and Financial support from the United States Presidents Emergency Plan for
p.(None): AIDS Relief (PEPFAR) through the U.S. Department of Health and Human Services, Centers for Disease Control and
p.(None): Prevention (HHS/CDC).
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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p.(None):
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p.(None):
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Contact Address:
p.(None):
p.(None):
p.(None): NRERC Secretariat, Ministry of Science and Technology,
p.(None): Tel: +251118962583/4
...
General/Other / Relationship to Authority
Searching for indicator authority:
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p.(None): were formed to lay the foundation for standardized protection of human participants in research. National Health
p.(None): Research Ethics Review Guidelines were first developed in 1995 by the former ESTC. The guidelines were revised three
p.(None): times since its first release in 1995. At the institutional level, standard operative procedures (SOPs) for
p.(None): research ethics review came into practice by organizations that include, the Addis Ababa University Medical Faculty
p.(None): Institutional Review Board (AAUMFIRB), Armauer Hansen Research Institute (AHRI), Ethiopian Health and
p.(None): Nutrition Research Institute (EHNRI) now renamed Ethiopian Public Health Institute (EPHI), and the Ethiopian Public
p.(None): Health Association (EPHA).
p.(None): • Launching a Health Science and Technology Policy in which the country’s health research priority areas were
p.(None): explicitly listed as policy directives. The Health Sci- ence and Technology Policy in article 2.2.2.2 states the need
p.(None): “to enhance the monitoring and coordination of Health Science and Technology activities and the practical
p.(None): implementation of research outputs.” This Health Science and Technology Policy in article 4.3.5 further stresses
p.(None): the need to “Organize an ethical committee to review the ethical aspects and procedures of research undertakings as
p.(None): required” as one strategy. In addition, article 4.3.6 emphasizes the need to “encourage institutional peer reviews….”,
p.(None): • Founding the Drug Administration and Control Authority in 1999 which was re- cently renamed the Food, Medicine and
p.(None): Health Care Administration and Control Authority (FMHACA)
p.(None): • Declaration of the potential allocation of 1.5% of the gross national income or gross domestic product (GNI/GDP) to
p.(None): research in various disciplines.
p.(None): To regulate and provide oversight for health research in light of its increasing land- scape, complexity, and
p.(None): sophistication, MoST hired three consultants with expertise in the field of bioethics to review the existing
p.(None): guidelines. The experts reviewed local and international standards, guidelines, instruments, and procedures related to
p.(None): bioethics. Furthermore, opinions and suggestions were solicited from a dozen highly educated, ethically experienced,
p.(None): reputable professionals in the country. The shortcomings and strengths of the existing guidelines, extent of
p.(None): decentralization of protocol review, man- dates of the National Research Ethics Review Committee (NRERC) and
p.(None): Institutional Review Boards (IRB), terminology, operative procedures, and general suggestions from these dozen
p.(None): professionals, was sought using a semi-structured tool. All efforts were made to strike a balance in accommodating the
p.(None): experts’ sometimes differing opinions and suggestions for these guidelines.
p.(None): 14 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): Moreover, the draft guidelines were discussed with a wider group of experts and rep- resentatives drawn from the MoST,
p.(None): Ministry of Justice, Ministry of Health, FMHACA, IRBs of universities and research institutions, international and UN
...
p.(None): suitably qualified and experienced investiga- tors and in accordance with a protocol that clearly states the aim of the
p.(None): research, the reasons for proposing that it involves human subjects, the nature and degree of any known risks to the
p.(None): subjects, the sources from which it is proposed to recruit subjects, and the means proposed for ensuring that subjects’
p.(None): consent will be ade- quately informed and voluntary. The protocol should be scientifically and ethically appraised by
p.(None): one or more suitably constituted review bodies, independent of the investigators.’
p.(None): MoST ensures that this guidelines basically operate within the legal framework of Ethiopia and that the IRBs operate
p.(None): independently and without influence and coer- cion. Furthermore, MoST demands that membership of IRBs should be large
p.(None): enough to ensure a robust discussion of protocols. Additionally, IRB membership should have a healthy mix of
p.(None): representation by different genders, disciplines, sectors, and layper- sons.
p.(None): While this document focuses primarily on guidelines for IRBs, it emphasizes that at- tention shall be given to the
p.(None): wider system of human research participants’ protections of which IRBs are a part. These guidelines empower IRBs to
p.(None): perform effectively and efficiently with best intentions. The review guidelines are developed to operate in the
p.(None): existing research systems with the following objective realities:
p.(None): • Constitutional and legal rights, relevant policies related to health and science research exist.
p.(None): • These guidelines are executed under the Law of Ethiopia. IRBs operate under explicit legal authority.
p.(None): • All research with human participants is subject to the oversight of an IRB.
p.(None): • MoST has the primary responsibility for ensuring that IRBs are subject to ade- quate oversight.
p.(None): • Mechanisms are in place to ensure IRBs work effectively and efficiently. IRBs are part of a larger research
p.(None): participant protection programs that also include training of IRB members and investigators.
p.(None): • Procedures exist to ensure clear and efficient communication, harmonization of standards, networking, and
p.(None): cooperation among the NRERC and other IRBs, and between different levels of review and publication committees in
p.(None): departments/ units of institutions. In addition, procedures exist for the coordinated review of multi-site research
p.(None): within Ethiopia or international collaborative research.
p.(None): • Mechanisms exist to ensure that IRB activities are coordinated with national regulatory authorities’ oversight of
p.(None): drugs and medical devices.
p.(None): National Research Ethics Review Guideline Fifth Edition 17
p.(None):
p.(None): • Mechanisms are created for obtaining community input into the ethics review system.
p.(None): • A system exists for registration of IRBs that operate in Ethiopia.
p.(None): MoST attaches emphasis that this guideline is part of an effort to establish, facilitate and strengthen an effective
p.(None): health research system in Ethiopia. The aim of the health research system is to advance and use of scientific knowledge
p.(None): to improve health and health equity. The key functions of this health system research are stewardship, of which
...
p.(None): 3.3.2. The principle of justice requires equality in the distribution of benefits and burdens among the population
p.(None): groups likely to benefit from the research. Distributive justice means that no segment of the population should be
p.(None): unfairly burdened with the harms of research. It thus imposes particular obligations toward individuals who are
p.(None): vulnerable and unable to protect their own interests. Conversely, distributive justice imposes duties neither to
p.(None): neglect nor discriminate against individuals and groups who may ben- efit from advances in research.
p.(None): 3.3.3. Justice also demands balancing the benefits and burdens to the commu- nity where the research is undertaken.
p.(None): 3.3.4. In addition, the investigators shall assure that information obtained in the course of the investigation
p.(None): remains confidential to protect partici-
p.(None): 22 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): pants from possible harm. Data unlinked from individuals or groups does not jeopardize confidentiality. The privacy of
p.(None): individual participants also needs to be protected throughout the investigation by the investigators.
p.(None):
p.(None): 4. Institutional Authority and Purpose
p.(None): 4.1 Institutional authority
p.(None): NRERC and IRBs are established under the authority of the Ministry of Science and Technology, but function
p.(None): independently.
p.(None): The MoST requires all research involving human participants or human biological materials to be reviewed and approved
p.(None): by NRERC or one of the MoST accredited and registered IRBs prior to initiation of any research-related activities,
p.(None): including recruit- ment and screening of participants.
p.(None): 4.2 Purpose of NRERC, IRBs
p.(None): The NRERC and IRB’s objective is to protect the rights and welfare of human partic- ipants in biomedical and behavioral
p.(None): research. The IRB reviews and oversees human participant research to ensure that it meets the ethical principles cited
p.(None): in this guide- line, FMHACA regulations, and that it complies with legal requirements and other pertinent regulations,
p.(None): guidance, and local laws.
p.(None): 4.2.1. The NRERC and IRB’s duty is to inform and assist the in- vestigators and advisors on ethical and
p.(None): procedural standards related to the use of human participants in research, to facilitate compliance with this
p.(None): guidelines, Ethiopian law, and international regulations.
p.(None): However, the primary responsibility for assuring that the rights and welfare of indi- viduals are protected rests upon
p.(None): the investigators conducting the research. Others engaged in the conduct of the research including host institutions
p.(None): and sponsors share this responsibility. Faculty advisors serving as Principal Investigators (PIs) to students who
p.(None): conduct research have an obligation to carefully consider whether the students are qualified to safeguard adequately
p.(None): the rights and welfare of participants.
p.(None): 4.2.2. The NRERC and IRB have the authority to ensure that re- search studies conducted under its
p.(None): jurisdiction are designed and con- ducted in a manner that protects the rights, welfare and privacy of re- search
p.(None): participants. Specifically:
p.(None): • The NRERC and IRB reviews, and has the authority to approve, require mod- ification in, or disapprove all research
p.(None): activities that fall within its jurisdiction.
p.(None): • The NRERC and IRB have the authority to conduct continuing review as it deems necessary to protect the
p.(None): rights, welfare, and privacy of research partici- pants, including requiring progress reports from investigators.
p.(None): • The NRERC and IRB may suspend or terminate approval of a study not being
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 23
p.(None):
p.(None): conducted in accordance with the NRERC and IRB’s requirements or that has been associated with unexpected serious harm
p.(None): to participants or others.
p.(None): • The NRERC and IRB have the authority to observe or have a third party ob- serve the informed consent process and/or
p.(None): audit the progress of any study in its jurisdiction as it deems necessary to protect the rights and welfare of human
p.(None): participants.
p.(None): • The NRERC and IRB may place restrictions on a study.
p.(None): 4.3 Use of Policies, Procedures
p.(None): The NRERC and IRB members and its Secretariat staff must maintain and follow all written policies and procedures
p.(None): consistent with Ethiopian regulations, good clinical practices, good manufacturing practices, and biomedical ethics
p.(None): when reviewing pro- posed research.
p.(None):
p.(None): 5. Ethics Review System
p.(None): The MoST through the Ministry of Justice, shall ensure that health research ethics re- view is supported by an adequate
p.(None): legal framework that resonates with this guideline. MoST shall strive to put in place an appropriate and sustainable
p.(None): system to monitor the quality and effectiveness of research ethics review. In addition, MoST is respon- sible to ensure
p.(None): existence of mechanisms for networking and cooperation among IRBs at different levels, as well as IRBs of international
p.(None): standing in collaborative research.
p.(None): All health research involving human participants must undergo review by the NRERC or an independent IRB. In Ethiopia,
...
p.(None): of deci- sions, particularly when there is a need to vote.
p.(None): 5.9.6. IRBs shall have members with a varied professional mix and there
p.(None): National Research Ethics Review Guideline Fifth Edition 29
p.(None):
p.(None): should be at least, one member from behavioral sciences, law, or humanities, be gender sensitive and ensure community
p.(None): represen- tation by a lay person. No IRB can be composed entirely of a single profession, similar gender, or without a
p.(None): community representative.
p.(None): 5.9.7. Following registration, a letter of accreditation shall be given to IRBs by the Secretariat.
p.(None):
p.(None): 6. Establishment, Functions, Review Procedures
p.(None): 6.1 Definition
p.(None): Institutional Review Boards (IRBs) are independent committees established in an in- stitution to conduct initial and
p.(None): continuing review of research projects with the primary goal of protecting the rights and welfare of research
p.(None): participants. All institutions in Ethiopia that conduct research involving humans as research participants should set
p.(None): up IRBs in accordance with these guidelines. Where an institution cannot set up an IRB, that institution may rely on an
p.(None): IRB of another institution to review their research projects, provided the IRB is registered by the National IRB.
p.(None): 6.2 Establishment
p.(None): 6.2.1 Appointing Authority
p.(None): • The Head of the Institution is the authority responsible for the appointment of IRB members. In cases where
p.(None): members come from diverse institutions, the appointment should be upon the recommendation of the institution where the
p.(None): potential IRB member is based.
p.(None): • Members are selected in their personal capacities based on their scientific knowledge and expertise, as
p.(None): well as on their commitment and willingness to volunteer the necessary time and efforts for the Board’s function.
p.(None): • Appointments should consider age and gender distribution, and relevant but diverse professional
p.(None): representation.
p.(None): • The appointing authority should write an appointment letter to the prospective member inviting him/her to be a
p.(None): member of the IRB.
p.(None): • Members will sign a confidentiality agreement and conflict of interest (COI) form.
p.(None): 6.2.2 Applying to Establish an IRB
p.(None): An institution that needs to establish an IRB shall apply in writing for approval and reg- istration at the National
p.(None): Secretariat at MoST, and include the following requirements:-
p.(None): • Statement that the IRB will follow the guidelines as stipulated in this document, law, relevant regulations.
p.(None): • A list of IRB members identified by name, qualifications, profession, current
p.(None): 30 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): CV, representative capacity; any changes, in due process or in IRB membership must be reported to the secretariat.
p.(None): • Written SOPs for the activities of the IRB: composition of IRB members; con- ducting initial and continuing review
p.(None): of research, and for reporting its sugges- tions/opinion and decisions to the investigator and the institution;
p.(None): expedited review process; follow-up and monitoring of approved studies.
p.(None): • The NRERC Secretariat presents the application to the NRERC who shall ex- amine the institution’s application, and
p.(None): if satisfied, will recommend to MoST for endorsement of the registration and authorize in writing, the establishment of
p.(None): the IRB. The process of application and response from MoST should not exceed three months.
p.(None): 6.3 Composition
p.(None): The IRB should consist of a reasonable number of members, who collectively have the qualifications and experience
...
p.(None): women, men/women in uniform or persons with disabilities, marginalized group, refuges, minorities, the IRB shall
p.(None): involve or co- opt one or more individuals who are knowledgeable about and experienced in working with these research
p.(None): participants.
p.(None): • All IRB members should at the minimum take one basic training on bioethics within one year of appointment.
p.(None):
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 31
p.(None):
p.(None): 6.4 External Reviewers
p.(None): • If a protocol requires expertise that is beyond the competence of the IRB mem- bers or the IRB need additional
p.(None): opinion in the review process, the IRB may engage independent experts to review and give their opinion.
p.(None): • The Secretariat should keep an updated list of experts along with their CVs, which should be reviewed annually by
p.(None): the IRB.
p.(None): • Independent experts must sign privacy and confidentiality agreements and con- flict of interest (COI) forms to
p.(None): ensure that the information in the protocol is protected and that consultants do not have any conflicts.
p.(None): • The IRB may ask questions that could guide the review of the experts.
p.(None): • The expert may be invited to attend or consult by telephone an IRB meeting but he/she cannot vote in the meeting.
p.(None): 6.5 Independence of IRB
p.(None): 6.5.1. The IRB must be independent from the appointing authority, hosting institution, investigators, sponsors and any
p.(None): other stakeholders in its review and decision-making processes.
p.(None): 6.5.2. If there is any conflict of interest, COI, regarding a particular proto- col, IRB members must declare their COI
p.(None): and excuse themselves from the review process of that particular research protocol. This is critical to ensure an
p.(None): objective assessment of the protocol.
p.(None): • COI can be declared at the time research protocols are submitted, upon receiving the IRB agenda prior to the meeting
p.(None): and at the beginning of each meeting.
p.(None): • IRB members who have a COI related to any research protocol must not participate in any initial or continuing review
p.(None): of that specific protocol or related matters except to provide relevant, factual information which may be requested by
p.(None): the IRB. The conflicted IRB member cannot deliberate or vote on those protocols or related matters.
p.(None): • The IRB member or invited expert with a COI will be required to excuse himself/herself from the meeting during
p.(None): discussion and decision.
p.(None): • An IRB member or invited expert assigned to carry out an expedited review on a protocol (or related matter) for
p.(None): which a conflict has been identified must notify the IRB Chairperson or Secretary so that the pro- tocol may be
p.(None): reassigned to another person.
p.(None): 6.6 Terms of Office
p.(None): 6.6.1. Membership should be for a period of two (2) years.
p.(None): 6.2.2. Membership may be renewed for two terms, however at least one-third
p.(None): 32 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): of the former members should be retained at every point in time. Thus, the maximum tenure of IRB members is four (4)
p.(None): years.
p.(None): 6.2.3. For continuity and the smooth operation of the IRB office, the IRB Sec- retariat may serve up to a maximum of
p.(None): five (5) terms, which translates to a maximum of fifteen (15) years.
p.(None): 6.2.4. For a permanently employed secretariat, tenure is not limited provided he/she is still under the employment of
p.(None): the IRB. If, in the event of addi- tional qualified personnel being hired/trained, this time limit may need to be
p.(None): reviewed.
p.(None): 6.7 Duties and Responsibilities of IRB Members
p.(None): 6.7.1 Chairperson
p.(None): • In order to enhance independence of the NRERC, the Chairperson should not be affil- iated with MoST. In other IRBs,
p.(None): the Chairperson can be a member of the institution.
p.(None): • The Chairperson should be selected by the IRB members through a process of nominations followed by secret ballot
p.(None): voting; the committee is obliged to inform the appointing authority.
p.(None): • The Chairperson should have the authority to sign official IRB documents such as approval certificates.
p.(None): • Should the Chairperson decide to step down as Chairperson of the IRB, he/she should inform the board in writing at
p.(None): least one month in advance; the commit- tee is obliged to inform the appointing authority.
p.(None): 6.7.2 Vice Chairperson
p.(None): • The Vice Chairperson should be selected using the same process as for the Chairperson.
p.(None): • The Vice Chairperson should Chair meetings and sign official IRB documents when the Chairperson is not available.
p.(None): • The Vice Chairperson may sign official IRB documents such as approval certifi- cates if the Chairperson is not
p.(None): available.
p.(None): • In the absence of both the Chairperson and Vice Chairperson, the IRB members should select an Acting Chairperson
p.(None): to chair the current meeting provided a quorum is satisfied.
p.(None): • The selected Acting Chairperson should sign minutes of previous meetings con- firmed during his/her Chairpersonship.
p.(None): • The Acting Chairperson should not have authority to sign official IRB documents such as approval certificates
p.(None): but may sign minutes confirmed during his/her Chairpersonship.
p.(None): • The process of resignation should be the same as that for the Chairperson.
p.(None): National Research Ethics Review Guideline Fifth Edition 33
p.(None):
p.(None): 6.7.3 Members
p.(None): • Membership becomes effective upon accepting an invitation from the appoint- ing authority. Acceptance must be
p.(None): indicated by the member’s dated signature.
p.(None): • A member should be willing to have his/her full name, profession and affilia- tion(s) published in the public
p.(None): domain.
p.(None): • Members are responsible for reviewing protocols to safeguard the rights, dignity and welfare of study participants.
p.(None): • Members are responsible for reviewing progress reports.
p.(None): • Members are responsible for oversight visits in order to monitor ongoing studies approved by the IRB.
p.(None): • Members are obliged to read protocols, including ancillary documents (e.g., pa- tient brochures, informed consent
p.(None): forms, project reports and SAE reports given to them by the IRB Secretariat in advance preparation of IRB meetings.
p.(None): • Members are obliged to keep IRB documents secure, private, and confidential.
p.(None): • Members should attend IRB meetings regularly and participate fully and actively in deliberations.
p.(None): • Members should participate in continuing education activities in research ethics, RE.
p.(None): • Members must declare any COI for any protocol, and withdraw from the review of that protocol.
p.(None): • Members must maintain privacy and confidentiality of documents and deliber- ations of IRB meetings.
p.(None): 6.8 Orientation Education of Members
p.(None): • New members should undergo orientation training upon joining the IRB in order to familiarize them with basic human
p.(None): research ethics. Such training should be organized by the IRB Secretariat, the host institutions and/or any other
p.(None): players involved in such training.
p.(None): • Continuous training of IRB members on health research ethics and other rel- evant areas such as Good Clinical
p.(None): Practice (GCP) and experimental designs should be conducted as necessary.
p.(None): • Current CVs and records of training of all members should be kept on file by the IRB Secretariat in the IRB office.
p.(None): 6.9 Termination of Membership
p.(None): • Membership may be terminated voluntarily. The member should write a resig- nation letter to the appointing authority
p.(None): through the IRB Chairperson giving at least a one-month notice.
p.(None): • The Chairperson may resign by sending his/her resignation letter to the appointing
p.(None): 34 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): authority after informing the committee at its next meeting.
p.(None): • Membership should be terminated by the appointing authority on the advice of the IRB if a member is going to be away
p.(None): for more than one year.
p.(None): • Membership could be terminated by the appointing authority upon advice of the IRB if the member has been absent from
p.(None): five consecutive meetings without offering an explanation.
p.(None): • Membership should be terminated by the appointing authority for misconduct that tarnishes the credibility of the IRB
p.(None): as determined by the IRB.
p.(None): • Membership should be terminated if a member is convicted of a criminal offence.
p.(None): • Membership should be terminated by the appointing authority in consultation with the IRB if a member is suffering
p.(None): from a chronic incapacitating illness that significantly reduces the ability to process information and make rational
p.(None): inde- pendent decisions.
p.(None): • Membership should automatically terminate when a member dies.
p.(None): 6.10 Dissolution of IRB
p.(None): The IRB should automatically cease to exist when the institution at which it is based ceases to exist.
p.(None): 6.11 Committee Meetings
p.(None): 6.11.1 Scheduled Full (Convened) IRB Meetings
p.(None): 6.11.1.1 The calendar dates and time of scheduled full (convened) IRB meetings should be agreed upon and
p.(None): confirmed by the committee and made public.
p.(None): 6.11.1.2 The frequency of the scheduled full (convened) IRB meetings should depend on the workload in terms of volume
p.(None): of applications submitted as well as the availability of IRB members who have other duties at their places of
p.(None): employment.
p.(None): 6.11.1.3 A quorum is more than 50% of the total number of IRB members.
p.(None): 6.11.1.4 The quorum should include members with the relevant expertise to effectively review the protocols on that
p.(None): days agenda. The presence of a non-scientist is required. The community representative, although not required, is
p.(None): essential.
p.(None): 6.11.1.5 The quorum should be present before a full (convened) IRB meeting is held.
p.(None): 6.11.1.6 The IRB Secretary should send an agenda; minutes of the previous meeting; notice about the date, venue and
p.(None): time of the next scheduled meeting; and other relevant documents to all IRB members at least ten working days before
p.(None): the meeting.
p.(None): National Research Ethics Review Guideline Fifth Edition 35
p.(None):
...
p.(None): waive need for informed consent. However, it is the responsibility of the investigator and the sponsor to publicize
p.(None): such a study to the community before commencement of any research activity. The IRB should monitor such publicity to
p.(None): ascertain the community’s awareness.
p.(None): • In emergency conditions of national or regional importance, for example epi- demics, where a participant cannot
p.(None): refuse informed consent.
p.(None): • In situations where deception needs to be applied to achieve the objectives of the study.
p.(None): • The only record linking the research participant and the research project would be the consent document and the
p.(None): principal risk to the research participant would be potential harm resulting from a breach of confidentiality.
p.(None): 6.16 Continuing Review
p.(None): • The IRB conducts continuing review of all approved studies at intervals appro- priate to the degree of risk that the
p.(None): study participants are exposed, but not less than once a year.
p.(None): • The IRB will require continuing progress reports annually , unless it designates otherwise.
p.(None): • All changes in approved research projects should be reported and approved by the IRB before implementation, except
p.(None): where necessary to eliminate immediate apparent risks.
p.(None): 6.17 Suspension and Termination of Approval
p.(None): The IRB has the authority to terminate or suspend its approval for research projects if it considers is appropriate
p.(None): such as:
p.(None): • The research is not being conducted according to the approved protocol, or according to applicable guidelines,
p.(None): National Research Ethics Review Guideline Fifth Edition 39
p.(None):
p.(None): • The research has been associated with serious harm to subjects, and
p.(None): • The research creates a potential threat to the safety and welfare of research participants or the community.
p.(None): The termination or suspension of approval should include a statement of the reasons verifying the IRBs decision and be
p.(None): reported to the investigator; the sponsor of the research and appropriate institutional officials.
p.(None): Upon notification of the suspension or termination of the research, the investigator must promptly inform the research
p.(None): participants about the status of the research with assurance of continuing care and treatment.
p.(None):
p.(None): 7. Review Mechanisms
p.(None): Each IRB must have written procedures, including procedures to be followed in their review mechanism. The following are
p.(None): the minimum requirements for an IRB review mechanism.
p.(None): 7.1 General Requirement
p.(None): The IRB shall review proposed research at convened meetings at which more than 50% of the members of the IRB are
p.(None): present, including at least one member who represents the interests of the community.
p.(None): • In order for the research project to be approved, it shall receive the approval of a simple majority of those
...
p.(None): 7.3.2 Applying for an Expedited Review
p.(None): Requests for an expedited review can be submitted at any time to the Secretariat.
p.(None): • An investigator who wishes to apply for an expedited review should submit an application indicating the reason(s)
p.(None): for the eligibility of the study for expedited review.
p.(None): • Upon receiving an application for expedited review, the IRB Secretary/Adminis- trator in consultation with the
p.(None): Chairperson/Vice Chair makes the initial assess- ment to determine if it qualifies for expedited review.
p.(None): • If the study qualifies for expedited review, IRB chairperson or by one or more experienced reviewers designated by
p.(None): the chairperson from among the members of the IRB should be assigned to review the protocol. If the review involves a
p.(None): study amendment, the selected member should be a member who reviewed the previous version of the protocol.
p.(None): • When the protocol is approved, the investigator(s) will be notified immediately through the Secretariat.
p.(None): 7.3.3. A summary of the protocols reviewed through the expedited process should be submitted to the full
p.(None): (convened) IRB at its next meeting.
p.(None): 7.3.4. A decision arising from an expedited review will be provisional pending approval from the Chair/Vice Chair or
p.(None): the IRB. Such decisions should be communicated to the investigator in writing.
p.(None): 7.3.5. Should a protocol be disapproved by the expedited review, it should be submitted for a full (convened) IRB
p.(None): review.
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 43
p.(None):
p.(None): 7.3. 6. The full (convened) IRB has the authority to confirm, modify or reverse a decision of the expedited reviewer.
p.(None): If the decision of the full (convened) IRB is contrary to the decision of the expedited review, detailed reasons and
p.(None): explanations should be recorded in the minutes.
p.(None): 7.3.7. The applicant should be informed of any modifications that the full (con- vened) IRB recommends and the ethical
p.(None): justification for such a decision.
p.(None): 7.3.3 Review Procedure
p.(None): An expedited review covers the same issues as a full (convened) review. The reviewer has the same options as the full
p.(None): (convened) review committee, i.e., to approve, re- quest modifications, or disapprove a protocol. An expediting
p.(None): reviewer, however, may not disapprove a protocol.
p.(None): Expedited and exempt research: The chairperson should notify the IRB members about decisions made pertaining to such
p.(None): research using a suitable medium (full board meeting, internet, post, telephone). At that time, any member or the
p.(None): committee may request a re-review of the approved protocol at the full (convened) committee meet- ing. If this were to
p.(None): occur, the investigator would be notified and asked to suspend the study pending full review. Expedited reviewers refer
p.(None): the issue to the full committee if there is any question about the level of risk or the applicability of the activity
p.(None): catego- ries before approving the protocol.
p.(None): 7.4 Decision Making Procedures
p.(None): 7.4.1. The IRB can only make decisions if a quorum is met.
p.(None): 7.4.2. A member with conflict must excuse himself/herself from the review process and voting.
p.(None): 7.4.3. Non-members such as project PIs and independent experts may be con- sulted as part of the review process, but do
p.(None): not vote.
...
p.(None): involving experimental/clinical trials, an additional approval to import and use the drug or investigational product
p.(None): should be solicited from FMHACA.
p.(None): The legal obligations in research shall be overseen by MoST and FMHACA. IRBs, and DSMBs and are primarily responsible
p.(None): for safeguarding research participant safety. The Institutional Biosafety Committee (IBC) and Community Advisory Board
p.(None): (CAB) shall ensure public/community wellbeing.
p.(None): 10.1 Ministry of Science and Technolgy (MoST)
p.(None): MoST is established by the ‘Definition of Powers and Duties of the Executive Organs of the FDRE (Amendment)
p.(None): Proclamation No. 603/2008’ on October 24, 2008. Un- der the Proclamation, MoST took over the rights and obligations of
p.(None): the ESTA and, under Article 20, is bestowed with the powers and duties to:
p.(None):
p.(None): 58 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): • Forward recommendations based on studies for adopting and revising policies, strategies, laws and directives on the
p.(None): development of science, technology and innovation activities.
p.(None): • Prepare science, technology and innovation master plans; provide guidelines for…, programs and projects;
p.(None): monitor and evaluate their implementation.
p.(None): • Set priorities for the country’s research activities.
p.(None): • Direct, coordinate and support science, technology and innovative activities, and countrywide research programs
p.(None): • Support and strengthen institutions that undertake research and development activities.
p.(None): 10.2 The Ethiopian Food Medicine and Health Care Administration and Control Authority
p.(None): The Ethiopian Food Medicine and Health Care Administration and Control Authority was established by ‘Council of
p.(None): Ministers Regulation No. 189/2010’ on August 23, 2010. Under the Proclamation FMHACA took over the rights and
p.(None): obligations of the Drug Administration and Control Authority (DACA) and, under Article 5, its ‘…ob- jectives shall be
p.(None): to protect the health of consumers by ensuring: 1) food safety and quality 2) the safety, efficacy, quality, and
p.(None): proper use of medicines 3) competence and ethics of health professionals, medical practitioners and pharmacy
p.(None): professionals.
p.(None): The ‘…authority is responsible to protect the safety and rights of the subjects partici- pating in a trial and to
p.(None): ensure that trials are adequately designed to meet scientifically sound objectives.’ ‘The mandate of the Authority is
p.(None): to review protocols, and where necessary to protect the safety of subjects, to require protocol revisions and/or termi-
p.(None): nation of trials. The Authority also has a right for on-site inspection of the quality of the data obtained…’
p.(None): ‘Any clinical trial conducted in the country on human beings and/or on animals other than laboratory animals should
p.(None): have received prior permission before the commence- ment of the trial.’ Furthermore, the Authority demands that
p.(None): findings from a clinical trial need its approval before publishing. Besides, the responsibilities of the investi-
p.(None): gator, the sponsor, and the monitor should be stated clearly in the research protocol.
p.(None): The authority also requires that a specific application form for clinical trials shall be completed and submitted for
p.(None): review and approval of a research.
p.(None): 10.3 Institutional Review Boards (IRB)
p.(None): IRBs are established by institutions whose mandate includes carrying out research. The primary function of IRBs is
p.(None): initial and continuing review, monitoring research to ensure adherence to the approved protocol in order to safeguard
p.(None): the rights and welfare of research participants, train faculty on research ethics, accredit, register,
p.(None): and monitor other IRBs, and develop guidelines applicable to all research in Ethiopia.
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 59
p.(None):
p.(None): 10.4 Data and Safety Monitoring Board
p.(None): 10.4.1 Definition
p.(None): A Data and Safety Monitoring Board (DSMB) is an independent committee composed of a multidisciplinary group of experts
p.(None): established by the research sponsors to assess and report the ongoing scientific and ethical integrity of a study by
p.(None): reviewing and evaluating (unblinded as necessary) data at regular intervals.
p.(None): • The DSMB should ensure that the study is conducted and the data are handled in accordance with the provisions of the
p.(None): research protocol and monitors adverse events and safety data.
p.(None): • A DSMB should be established before the commencement of a clinical trial and its composition submitted to the IRB.
p.(None): • All Phase I, Phase II, and Phase III, including drug efficacy and clinical trials proposed to be conducted in
...
p.(None): 14.1.2. All IRBs shall submit reports to NRERC annually.
p.(None): 14.1.3. IRBs in federal institutions shall send their biannual reports directly to the NRERC.
p.(None): 14.1.4. Reports of the respective IRBs shall include at a minimum: activities performed, support needed, problems
p.(None): encountered, etc.
p.(None): 14.1.5. For urgent matters, IRBs should seek information or technical help from NRERC at any time through its
p.(None): Secretariat.
p.(None): 14.1.6. The NRERC will distribute appropriate guidelines and other related in- formation to other IRBs and request
p.(None): feedback.
p.(None): 14.1.7. The NRERC establishes working relations with local and international IRBs through its Secretariat.
p.(None): 14.1.8. Reporting at each level should be by mail, fax or email.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 73
p.(None):
p.(None): Bibliography
p.(None): 1. The Constitution of The Federal Democratic Republic of Ethiopia. Addis Aba- ba, August 21 1995.
p.(None): 2. Federal Negarit Gazetta of The Federal Democratic Republic of Ethiopia. 15th Year No 1 Addis Ababa, October 24
p.(None): 2008.
p.(None): 3. Federal Negarit Gazetta of The Federal Democratic Republic of Ethiopia. 16th Year No 51 Addis Ababa, August 23
p.(None): 2010.
p.(None): 4. Ethiopian Science and Technology Commission. National Health Research Ethics Review Guidelines, Fourth Edition.
p.(None): Addis Ababa, Ethiopia 2005.
p.(None): 5. Guidelines for Conducting Clinical Trials. Drug Administration and Control Authority. Addis Ababa, Ethiopia.
p.(None): 6. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Council for International
p.(None): Organizations of Medical Sciences (CI- OMS) in collaboration with the World Health Organization (WHO). CIOMS Geneva
p.(None): 2002.
p.(None): 7. Code of Federal Regulations. TITLE 45 — PUBLIC WELFARE. Depart- ment of Health and Human Services. PART
p.(None): 46: PROTECTION OF HUMAN SUBJECTS. Revised June 23, 2005. Effective June 23, 2005.
p.(None): 8. The Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research. The
p.(None): National Commission for the Protec- tion of Human Subjects of Biomedical and Behavioral Research. April 18, 1979.
p.(None): 9. Nuremberg Code. 1948.
p.(None): 10. World Medical Association Declaration of Helsinki. Ethical Principles for Medical Research Involving Human
p.(None): Subjects. Adopted by the 18th WMA General Assembly. Helsinki, Finland, June 1964, and amendments in 1975, 1983,
p.(None): 1989, 1996, 2000. Note of Clarification on Paragraph 29 added in 2002. Note of Clarification on Paragraph 30 added in
p.(None): 2008.
p.(None): 11. Karbwang J, Pattou C. Standard operating procedures for clinical investi- gators. UNDP/World Bank/WHO, special
p.(None): program for research and training in tropical diseases (TDR). TDR/TDP/SOP/99.1.
...
p.(None): Human Research, 1980;2: 1-4.
p.(None): 22. Karlawish, Hall (1996). Am J Respir Crit Care Med, 1996;153:499-5-6.
p.(None): 23. Casarett, Karlawish, Sugarman. JAMA, 2000, 283 (17): 2275-80.
p.(None): 24. Richards HM, Schwartz LJ. Ethics of qualitative research: are there special issues for health services research?
p.(None): Family Practice 2002; 19: 135-139.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 75
p.(None):
p.(None): Appendix I. Acronyms
p.(None): AAUMFIRB Addis Ababa University Medical Faculty Institutional
p.(None): Review Board
p.(None): AE Adverse Event
p.(None): AHRI Armauer Hansen Research Institute
p.(None): CAB Community Advisory Board
p.(None): CIOMS Council for International Organization of Medical Sci- ences
p.(None): COI Conflict Of Interest
p.(None): CV Curriculum Vitae
p.(None): DACA Drug Administration and Control Authority
p.(None): DNA Deoxyribo Nucleic Acid
p.(None): DSMB Data and Safety Monitoring Board
p.(None): EC Ethics Committee
p.(None): EHNRI Ethiopian Health and Nutrition Research Institute
p.(None): EPHA Ethiopian Public Health Association
p.(None): ERC Ethics Review Committee
p.(None): ESTA Ethiopian Science and Technology Agency
p.(None): ESTC Ethiopian Science and Technology Commission
p.(None): FDRE Federal Democratic Republic of Ethiopia
p.(None): FMHCACA Food, Medicine and Health Care Administration and
p.(None): Control Authority
p.(None): GDP Gross Domestic Product
p.(None): GCP Good Clinical Practice
p.(None): GMP Good Manufacturing Practice
p.(None): GNI Gross National Income
p.(None): RE Research Ethics
p.(None): NRERCs National Research Ethics Review Committees
p.(None): HS&T Health Science and Technology
p.(None): IBC Institutional Bio-safety Committee
p.(None): IRB Institutional Review Board
p.(None): LAR Legally Authorized Representative
p.(None): MOST Ministry of Science and Technology
p.(None): MTA Materials Transfer Agreement
p.(None): 76 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): NEC National Ethics Committee
p.(None): NGO Non-Governmental Organization
p.(None): PI(s) Principle Investigator(s)
p.(None): SAE Serious Adverse Event
p.(None): SOP Standard Operating Procedures
p.(None): S&T Science & Technology
p.(None): TOR Terms of Reference
p.(None): UN United Nations
p.(None): WHO World Health Organization
p.(None):
p.(None): Appendix II. Glossary of Terms
...
p.(None): Principal Investigator (PI)-Lead scientist who is working on the design of a research study, development of methods and
p.(None): procedures for the study, collection of data or specimens, analysis of data or specimens, or interpretation of data.
p.(None): Prisoner-Any individual involuntarily confined or detained in a penal institution. The term is intended to encompass
p.(None): individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other
p.(None): facilities by virtue of statutes or commit- ment procedures which provide alternatives to criminal prosecution or
p.(None): incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.
p.(None): Private information-information about individually identifiable behavior that occurs in a context in which the
p.(None): individual can reasonably expect that no observation or record- ing is taking place, and information which has been
p.(None): provided for specific purposes by an individual and which the individual can reasonably expect will not be made public
p.(None): (e.g., a medical record).
p.(None): Private/privacy-Individual person’s interest in preventing disclosure of information about himself or herself.
p.(None): Project-A planned activity or collection of activities conducted for a particular pur- pose; may encompass more than
p.(None): one protocol on the same subject matter.
p.(None): Protocol-The formal design or plan of a data collection activity; specifically, the plan submitted to a reviewing
p.(None): authority such as an IRB. The protocol includes a descrip- tion of the design or methods for conducting the data
p.(None): collection, description of the study population, methods for data handling and analysis, procedures for handling
p.(None): incidents, and methods for notification and dissemination of results.
p.(None): Quorum-The number of IRB members required to be present at a convened meeting in order for the IRB to transact
p.(None): business.
p.(None): Reimbursement-Repayment for costs incurred by virtue or participation in research, such as for lost earnings or travel
p.(None): costs.
p.(None): Related/relation-Pertaining to an AE, the likelihood that the event was caused by research procedures,
p.(None): usually relative to the likelihood it was caused by something
p.(None):
p.(None): 82 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): other than research procedures.
p.(None): Report-A written account of the IRB’s findings, conditions for approval, or reasons for disapproval regarding human
p.(None): research protections in a research protocol.
p.(None): Repository-An entity that collects, stores and manages, and distributes data or hu- man tissue materials to recipient
p.(None): investigators for research and other purposes. See also http://www.hhs.gov/ohrp/humansubjects/guidance/reposit.htm.
p.(None): Research-Systematic investigation, including development, testing, and evaluation, designed to develop or contribute to
p.(None): generalizable knowledge.
p.(None): Respect for persons, principle of-The requirement to treat individuals as autonomous agents and to provide additional
...
General/Other / Undue Influence
Searching for indicator undue influence:
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p.(None): to generalizable knowledge.” Nevertheless, as a matter of principle, in research involving human participants, the
p.(None): well-being of the patient takes priority over the interests of society and the knowledge to be gained.
p.(None): “Human subject [research participant] is a living individual about whom an investi- gator conducting research obtains
p.(None): data through intervention or interaction with the individual, or identifiable private information.” Besides, research
p.(None): participants may include pregnant women where fetuses, fetal material, or abortuses are the primary subjects of
p.(None): interest. Similarly, research involving autopsy materials shall also be in- cluded as source of data.
p.(None): The main purpose of health research involving human participants is for better un- derstanding of the etiology,
p.(None): pathogenesis, and pathophysiology of disease and the related diagnostic, preventive, promotive, and therapeutic
p.(None): procedures and measures. Moreover, as evidence-based practice has become necessary at the turn of the 21st century, and
p.(None): quite understandably, existing procedures and practices are challenged continuously for their effectiveness,
p.(None): efficiency, quality, accessibility, and acceptability by the community.
p.(None): However, in the quest to ensure better health and knowledge, the rights and welfare of research participants must be
p.(None): protected at all times. Participation must be voluntary and free of coercion, persuasion, manipulation, deception,
p.(None): undue influence or induce- ment, and threat or intimidation. The information shall be obtained in a private setting
p.(None): whenever necessary and confidentiality maintained throughout the lifetime of the re- search. This is even more
p.(None): important when research involves participants whose com- prehension and decision making is compromised because of age,
p.(None): lack of knowledge on medical concepts and technological terms, or severe mental or behavioral disorders.
p.(None): For all research involving human participants and human biological materials/speci- mens, investigators should be aware
p.(None): of, and are obligated to, respect and adhere to all ethical, legal, and regulatory requirements applicable in Ethiopia.
p.(None): In this rapidly advancing, complex, and sophisticated era of genetic studies, preven- tive, diagnostic, and therapeutic
p.(None): clinical trials, as well as collaborative research and human biological material transfer being common place, oversight
p.(None): and regulation is imperative to properly safeguard the rights and welfare of human research subjects.
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 15
p.(None):
p.(None): For research to be ethical, all of the following eight criteria must be met:
p.(None): 1. Ethical justification and scientific validity: The research must be rigorous in its methodology. For
p.(None): research to be ethical, the methods must be valid and practically feasible, the research must have a clear objective,
p.(None): be designed using sound scientif- ic principles, have sufficient statistical power, and be based on adequate knowledge
p.(None): of the scientific literature.
...
p.(None): in relation to anticipated benefits.
p.(None): 4. Fair selection and enrollment of human subjects: “Scientific objectives, not vul- nerability or privilege, and
p.(None): the potential for and distribution of risks and benefits, should determine communities selected as study sites and the
p.(None): inclusion criteria for individuals…” The justification for selection and the equitable nature of selection of research
p.(None): subjects should be described.
p.(None): 5. Privacy: Privacy should be respected, confidentiality maintained, the opportunity to withdraw at anytime or
p.(None): refuse any component(s) of the research should be avail- able, and the well-being of research participants should be
p.(None): monitored, while infor- mation related to research participants should be kept confidential.
p.(None): 6. Independent/IRB review: “Individuals that are not affiliated with the research must review the research
p.(None): and approve, amend, or terminate the research.” How- ever, individuals involved in independent review with any
p.(None): conflicts of interest may be summoned to provide information to the IRB.
p.(None): 7. Informed consent process: The information provided to research participants should be complete and appropriate to
p.(None): the participants’ level of understanding. The partici- pant should be competent to give or refuse consent and research
p.(None): participants should provide their entirely voluntary informed consent without coercion, manipulation, undue influence,
p.(None): or intimidation.
p.(None): 8. Community engagement: Research is quite often generalized to the community from which individual participants
p.(None): are drawn from. Such generalization can result in different positive or negative impacts to the community in terms of
p.(None): stigma, resource drainage, health outcomes, and more. Hence, researchers are encouraged to involve the community in
p.(None): decision making about the design and conduct of the study. Be- sides, investigators should consider the local customs,
p.(None): traditions, culture and reli- gious practices of the community where the research is proposed to be conducted.
p.(None):
p.(None): 16 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): 1.3 Preamble
p.(None): MoST attaches the highest priority to maintaining high standards of integrity, respon- sibility, and accountability in
p.(None): all research conducted in Ethiopia.
p.(None): In addition, MoST obligates that ‘Research with human subjects should be carried out only by or strictly supervised by,
p.(None): suitably qualified and experienced investiga- tors and in accordance with a protocol that clearly states the aim of the
p.(None): research, the reasons for proposing that it involves human subjects, the nature and degree of any known risks to the
p.(None): subjects, the sources from which it is proposed to recruit subjects, and the means proposed for ensuring that subjects’
p.(None): consent will be ade- quately informed and voluntary. The protocol should be scientifically and ethically appraised by
p.(None): one or more suitably constituted review bodies, independent of the investigators.’
...
p.(None): professional, and market influences. They need similarly to demonstrate competence and efficiency in their work. They
p.(None): also need to ensure that there is regular evaluation of the ethics of ongoing studies that received a positive
p.(None): decision. Therefore, the functions of the IRB are:
p.(None): 6.12.1 Initial review
p.(None): The IRB must determine that the following requirements are satisfied before it ap- proves a research protocol:
p.(None): • Risks to subjects are minimized. Risk to subjects are reasonable in relation to anticipated benefit (if any) and the
p.(None): knowledge that is expected to result
p.(None): • Selection of subjects is equitable
p.(None): • Determine that informed consent will be sought from each prospective study participant, or the participants’ parent
p.(None): or guardian as appropriate
p.(None): • Determine that informed consent will be appropriately documented
p.(None): • Determine that there are adequate provisions to protect privacy of study partic- ipants and maintain confidentiality
p.(None): of all study related data
p.(None): • Determine that there are additional safeguards included in the study to protect the safety and welfare of study
p.(None): subjects who are likely to be vulnerable to coer- cion or undue influence such as such as children, prisoners, mentally
p.(None): disabled
p.(None): people, etc.
p.(None): 6.13 Informed Consent
p.(None): 6.13.1. The IRB must determine that the consent is documented using a written or verbal informed consent form,
p.(None): • The consent form should be approved by the IRB.
p.(None): • The consent form must be signed by the participant, or a parent, or next-of-kin or a guardian and by the individual
p.(None): that conducted the in- formed consent process.
p.(None): • In case the participant cannot read or write, a witness should sign that the consent process was carried out
p.(None): appropriately.
p.(None): National Research Ethics Review Guideline Fifth Edition 37
p.(None):
p.(None): • A copy of the signed informed consent form should be given to the study participant.
p.(None): 6.13.2. Research participants or persons giving proxy consent cannot give full informed consent unless the consent
...
p.(None): waiver of consent from IRB.
p.(None): • The protocol should articulate clearly duration and place of storage of biological samples and data.
p.(None): 8.3.3 Socio-Behavioral Research
p.(None): There are five potential risks in qualitative and behavioral research that the IRB, the investigator and the sponsor
p.(None): should be aware of:
p.(None): • Anxiety and distress: qualitative research is aimed at in-depth understanding of sensitive topics with
p.(None): exploration of reasons and resilient issues. Involves open-ended questions and probing that give room for
p.(None): unexpected themes and variety of responses in the participant’s own terms. Besides, responses are in- timately
p.(None): dependent upon the context of the participants’ beliefs, values, behav- iors and actions. Hence, qualitative research
p.(None): possesses higher risk of anxiety and distress. Moreover, the differing experience of the participants largely makes
p.(None): 52 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): predicting who may experience the anxiety and distress difficult/problematic.
p.(None): • Intrusion in life: exploring behavior related to health may require observation of participants at various places
p.(None): including the household, and sometimes, for a prolonged period of time.
p.(None): • Exploitation: power imbalance between the researcher and the subject, or ex- erting undue influence.
p.(None): • Misrepresentation: participants’ opinion are taken out of context or interpreted in the researcher’s perspective,
p.(None): dynamics of the qualitative interviews and the nature of data collected can be affected by the professional background
p.(None): of the researcher.
p.(None): • Identification of participant: (by self or others) in published papers due to clues provided to describe the
p.(None): participant’s age, gender, educational and economic status, place of residence, profession, etc.
p.(None): Hence, to minimize these risks of harm, the following ethical issues should be given special emphasis during protocol
p.(None): review, conduct, and monitoring of qualitative re- search:
p.(None): • Ensuring scientific soundness
p.(None): • Organizing follow-up care where appropriate
p.(None): • Considering obtaining consent as a process that should be subject to negotiation during and even after the end of
p.(None): the interview; the informed consent process should include auhorization of recording (audio, video) of interviews,
p.(None): focus group discussions, and observations.
p.(None): • Ensuring confidentiality through securing storage of audio and video tapes and transcripts.
p.(None): • Making ‘respondent validation’ of the researcher’s analysis before dissemination of the research findings.
p.(None): • Publicizing the research before commencement such that the community is aware of the observation that can be in
...
p.(None): Adoption of a paternalistic approach by research sponsors/donors towards institutions in Ethiopia or the research
p.(None): priorities of the government, is unacceptable.
p.(None): 8.3.4.2 Monitoring
p.(None): When conducting collaborative research studies, each institution is responsible for safeguarding the rights and welfare
p.(None): of human participants and for complying with all applicable regulations. The IRB that reviewed and approved the
p.(None): collaborative research is primarily responsible for monitoring the ethical conduct of the research procedures. However,
p.(None): the National IRB can monitor the proper conduct of the research whenever it deems further oversight is necessary. Any
p.(None): modification, amendment, or change in the approved collaborative research protocol should be made at each collaborating
p.(None): institution. Material transfer agreements must be obtained whenever applicable.
p.(None): 8.3.5 Vulnerable Population
p.(None): Vulnerable populations are those segments of the population whose capacity to safe- guard their welfare, demand their
p.(None): rights and satisfy their interests, is compromised. Because of these limitations, they cannot provide or refuse
p.(None): consent. Vulnerable pop-
p.(None): 54 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): ulations are particularly subject to undue influence, manipulation, coercion, and in- timidation. Hence, vulnerable
p.(None): populations deserve special protection from IRBs and other regulatory authorities.
p.(None): 8.3.5.1 Pregnant women and Fetuses
p.(None): To conduct research on pregnant women, the following must be fulfilled:
p.(None): • There is evidence from studies on pregnant animals and non-pregnant women that studies need to be done on risks
p.(None): related to pregnant women and fetuses.
p.(None): • If the research holds the prospect of direct benefit to the pregnant woman and the fetus, and the knowledge cannot
p.(None): be obtained through other means.
p.(None): • There should be no inducement to terminate a pregnancy.
p.(None): • If the prospect of benefit is both to the pregnant woman and the fetus, an in- formed consent form from the mother
...
p.(None): through intervention or interaction with the in- dividual, or (2) identifiable private information (e.g., medical
p.(None): records, employment records, or school records).
p.(None): Identifiable private information-Information (data or biological specimens) such that the identity of a participant
p.(None): is or may readily be ascertained by the investigator or associated with the information, and either the information
p.(None): concerns behavior that occurs in a context in which an individual can reasonably expect that no observation or
p.(None): recording is taking place, or the information has been provided for specific purposes by an individual and which the
p.(None): individual can reasonably expect will not be made public.
p.(None): Incentive-Payment or other goods or services offered to motivate study participation.
p.(None): Incident-An instance of one of the following: an unanticipated problem involving risks to participants or
p.(None): others, serious or continuing noncompliance, or suspension or termination (for reasons other than expiration).
p.(None): Informed consent-The free and informed decision by a prospective participant or
p.(None): 80 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): participant’s legally authorized representative to participate in research. The consent process should ensure that the
p.(None): participant has been provided full information regard- ing the research, the participant comprehends the research, and
p.(None): the participant is volunteering free of coercion and undue influence.
p.(None): Injury-Physical harm to a participant in a research study.
p.(None): Institutional Review Board (IRB)-The formally appointed ethics review committee estab- lished to ensure that research
p.(None): involving human participants conforms to ethical principles
p.(None): Intervention-Physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the
p.(None): participant or the participant’s environment that are per- formed for research purposes.
p.(None): Justice, principle of-Ethical precept asserting an obligation to treat persons fairly and give to each person what
p.(None): she is due; two-part rule: (1) exhibit fairness and (2) distinguish between classes of participants that ought, and
p.(None): ought not, to participate in any particular kind of research.
p.(None): Legally Authorized Representative (LAR)-An individual or judicial or other body au- thorized under applicable State law
p.(None): who may consent on behalf of another individual to participate in the procedure(s) involved in the research.
p.(None): Local IRB-IRB located in the institution where the research is to be conducted.
p.(None): Medical device-Any instrument, apparatus, or other similar or related article, includ- ing component, part, or
p.(None): accessory, which is (a) recognized in the official National For- mulary, or the United States Pharmacopeia, or any
p.(None): supplement to them; (b) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation,
p.(None): treatment, or prevention of disease, in humans or other animals; or (c) intended to affect the structure or any
...
p.(None): obtaining and use of identifiable private research information. A termination must be reported promptly unless the
p.(None): termination results from expiration of IRB approval or withdrawal or closure for reasons other than research risks.
p.(None): Understandable language-generally 8th grade reading level or lower/higher depending on targeted population.
p.(None): Undue influence-An excessive, unwarranted, inappropriate, or improper reward in- tended to motivate study
p.(None): participation.
p.(None): Unexpected-Pertaining to an AE, the event is previously unobserved or undocument- ed in humans under the research
p.(None): intervention (or one substantially similar), the na- ture or severity of the event is not consistent with information
p.(None): in the relevant source documents (e.g., investigator’s brochure, package insert, or non-reportable events [NRE] list),
p.(None): or the event is observed with higher frequency than previously observed or documented. Expectedness does not entail the
p.(None): ability to predict results from in vitro, animal, or other pharmacological models.
p.(None): Unlinked-The condition of data or specimens which had been coded but for which the key linking the code to direct
p.(None): personal identifiers has been destroyed.
p.(None): Unrelated-Pertaining to an AE, the condition in which the event is due to a docu- mented cause other than research
p.(None): procedures.
p.(None): Verbal consent-Consent obtained by communication in words; this may include spo- ken or written format.
p.(None): Voluntary/voluntariness-Freedom from coercion and undue influence
p.(None): Vulnerable-Having reduced capacity to offer free and informed consent due to pos- sible coercion, undue influence,
p.(None): or other diminished autonomy, such as children, prisoners, pregnant women, mentally disabled persons, or
p.(None): economically or education- ally disadvantaged persons as vulnerable. Vulnerability may be associated with other
p.(None): characteristics such as age, health status, or social standing. The IRB must ensure additional safeguards protect the
p.(None): rights and welfare of vulnerable persons.
p.(None): Vulnerable population-A group identified by one or more common characteristics associated with reduced
...
General/Other / belmont
Searching for indicator belmont:
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 73
p.(None):
p.(None): Bibliography
p.(None): 1. The Constitution of The Federal Democratic Republic of Ethiopia. Addis Aba- ba, August 21 1995.
p.(None): 2. Federal Negarit Gazetta of The Federal Democratic Republic of Ethiopia. 15th Year No 1 Addis Ababa, October 24
p.(None): 2008.
p.(None): 3. Federal Negarit Gazetta of The Federal Democratic Republic of Ethiopia. 16th Year No 51 Addis Ababa, August 23
p.(None): 2010.
p.(None): 4. Ethiopian Science and Technology Commission. National Health Research Ethics Review Guidelines, Fourth Edition.
p.(None): Addis Ababa, Ethiopia 2005.
p.(None): 5. Guidelines for Conducting Clinical Trials. Drug Administration and Control Authority. Addis Ababa, Ethiopia.
p.(None): 6. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Council for International
p.(None): Organizations of Medical Sciences (CI- OMS) in collaboration with the World Health Organization (WHO). CIOMS Geneva
p.(None): 2002.
p.(None): 7. Code of Federal Regulations. TITLE 45 — PUBLIC WELFARE. Depart- ment of Health and Human Services. PART
p.(None): 46: PROTECTION OF HUMAN SUBJECTS. Revised June 23, 2005. Effective June 23, 2005.
p.(None): 8. The Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research. The
p.(None): National Commission for the Protec- tion of Human Subjects of Biomedical and Behavioral Research. April 18, 1979.
p.(None): 9. Nuremberg Code. 1948.
p.(None): 10. World Medical Association Declaration of Helsinki. Ethical Principles for Medical Research Involving Human
p.(None): Subjects. Adopted by the 18th WMA General Assembly. Helsinki, Finland, June 1964, and amendments in 1975, 1983,
p.(None): 1989, 1996, 2000. Note of Clarification on Paragraph 29 added in 2002. Note of Clarification on Paragraph 30 added in
p.(None): 2008.
p.(None): 11. Karbwang J, Pattou C. Standard operating procedures for clinical investi- gators. UNDP/World Bank/WHO, special
p.(None): program for research and training in tropical diseases (TDR). TDR/TDP/SOP/99.1.
p.(None): 12. Operational Guidelines for Ethics Committees that Review Biomedical Re- search. WHO, 2000.
p.(None): 13. International Declaration on Human Genetic Data, UNESCO, 2003.
p.(None): 14. Operational Guidelines for the Establishment and Functioning of Data and Safety Monitoring Boards, TDR-WHO, Geneva
p.(None): 2005.
p.(None): 15. Uganda National Council for Science and Technology, 2007. National Guidelines for Research involving
p.(None): Humans as Research Participants. Kam-
p.(None): pala – Uganda: UNCST.
p.(None): National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): 16. Statement of WHO Expert Advisory Group on Ethical issues in Medical genetics. WHO, Geneva 1998.
...
p.(None): deviations from baseline health.
p.(None): Amendment-A material change to study procedures. Such changes, including minor changes, must be reviewed by an IRB
p.(None): before they may be implemented.
p.(None): Anonymous/anonymized-Lacking identification because identifiers or other informa- tion that could identify the
p.(None): individual were not collected or were removed. Information may or may not be considered anonymous if there is a
p.(None): reasonable basis to believe that one can use the information to identify and individual, even if one cannot readily
p.(None): ascertain the individual’s identity; see further discussion at individually identifiable information. For example, it
p.(None): might be possible to determine a survey respondent’s identity from a combination of demographic factors in a survey
p.(None): together with public or proprietary data sources, even if the surveyor did not jointly record the respondent’s identity
p.(None): and those demographic characteristics..
p.(None): Approve/approval-The determination of the IRB that the research has been reviewed and may be conducted at an
p.(None): institution within the constraints set forth by the IRB and by other institutional and federal requirements.
p.(None): Assent-Participant not of legal age (i.e., child); affirmative agreement to participate in research. Mere failure to
p.(None): object should not be construed as assent.
p.(None): Autonomy-Self-rule that is free from both controlling interference by others and from limitations that prevent
p.(None): meaningful choice. See also respect for persons.
p.(None): Belmont Report-Statement of ethical principles and guidelines for the protection of
p.(None): National Research Ethics Review Guideline Fifth Edition 77
p.(None):
p.(None): human participants of research. The National Commission for the Protection of Hu- man Subjects of Biomedical and
p.(None): Behavioral Research published this report in 1979. The three principles are respect for persons, beneficence, and
p.(None): justice. See: https://www.hhs.gov/orhp[/humansubjects/guidance/belmont.htm
p.(None): Beneficence, principle of-Ethical precept asserting an obligation to prevent harm, to remove harm, or to do or
p.(None): promote good; two-part rule: (1) do not harm and (2) maximize possible benefits and minimize possible harms.
p.(None): Benefit-A potential advantage or gain.
p.(None): Breach of protocol-Material departure from approved procedures of the study, such as the consent process, violations
p.(None): of data confidentiality, or complaints by partici- pants; may be a reportable incident.
p.(None): Child/children-Person who has not attained the legal age for consent to treatments or procedures involved in the
p.(None): research, under the Ethiopian law
p.(None): Clinical trial-A prospective research study in human participants that is designed to answer specific questions about
p.(None): health-related interventions (such as medications, herbal supplements, nutritional strategies, physical interventions,
p.(None): behavioral inter- ventions, prevention trials, or diagnostic tools), particularly to determine whether these
p.(None): interventions are safe, efficacious, and effective.
p.(None): Close/closure-Proactively and permanently end both research-related intervention or interaction with participants and
p.(None): collection and use of identifiable private research information when study objectives have been met as specified in the
p.(None): protocol.
...
General/Other / cioms guidelines
Searching for indicator cioms:
(return to top)
p.(None): 14.1.5. For urgent matters, IRBs should seek information or technical help from NRERC at any time through its
p.(None): Secretariat.
p.(None): 14.1.6. The NRERC will distribute appropriate guidelines and other related in- formation to other IRBs and request
p.(None): feedback.
p.(None): 14.1.7. The NRERC establishes working relations with local and international IRBs through its Secretariat.
p.(None): 14.1.8. Reporting at each level should be by mail, fax or email.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 73
p.(None):
p.(None): Bibliography
p.(None): 1. The Constitution of The Federal Democratic Republic of Ethiopia. Addis Aba- ba, August 21 1995.
p.(None): 2. Federal Negarit Gazetta of The Federal Democratic Republic of Ethiopia. 15th Year No 1 Addis Ababa, October 24
p.(None): 2008.
p.(None): 3. Federal Negarit Gazetta of The Federal Democratic Republic of Ethiopia. 16th Year No 51 Addis Ababa, August 23
p.(None): 2010.
p.(None): 4. Ethiopian Science and Technology Commission. National Health Research Ethics Review Guidelines, Fourth Edition.
p.(None): Addis Ababa, Ethiopia 2005.
p.(None): 5. Guidelines for Conducting Clinical Trials. Drug Administration and Control Authority. Addis Ababa, Ethiopia.
p.(None): 6. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Council for International
p.(None): Organizations of Medical Sciences (CI- OMS) in collaboration with the World Health Organization (WHO). CIOMS Geneva
p.(None): 2002.
p.(None): 7. Code of Federal Regulations. TITLE 45 — PUBLIC WELFARE. Depart- ment of Health and Human Services. PART
p.(None): 46: PROTECTION OF HUMAN SUBJECTS. Revised June 23, 2005. Effective June 23, 2005.
p.(None): 8. The Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research. The
p.(None): National Commission for the Protec- tion of Human Subjects of Biomedical and Behavioral Research. April 18, 1979.
p.(None): 9. Nuremberg Code. 1948.
p.(None): 10. World Medical Association Declaration of Helsinki. Ethical Principles for Medical Research Involving Human
p.(None): Subjects. Adopted by the 18th WMA General Assembly. Helsinki, Finland, June 1964, and amendments in 1975, 1983,
p.(None): 1989, 1996, 2000. Note of Clarification on Paragraph 29 added in 2002. Note of Clarification on Paragraph 30 added in
p.(None): 2008.
p.(None): 11. Karbwang J, Pattou C. Standard operating procedures for clinical investi- gators. UNDP/World Bank/WHO, special
p.(None): program for research and training in tropical diseases (TDR). TDR/TDP/SOP/99.1.
p.(None): 12. Operational Guidelines for Ethics Committees that Review Biomedical Re- search. WHO, 2000.
p.(None): 13. International Declaration on Human Genetic Data, UNESCO, 2003.
p.(None): 14. Operational Guidelines for the Establishment and Functioning of Data and Safety Monitoring Boards, TDR-WHO, Geneva
p.(None): 2005.
...
p.(None): 19. Heath EJ. The IRB’s Monitoring Function: Four Concepts of Monitoring. IRB: Ethics and Human Research, 1979; 1:
p.(None): 1-3+12.
p.(None): 20. DeMets DL, Fost N, Powers M. An Institutional Review Board dilemma: responsible for safety monitoring but not in
p.(None): control. Clin Trials 2006; 3; 142.
p.(None): 21. Cowan DH. Scientific Design, Ethics, and Monitoring: IRB Review of Ran- domized Clinical Trials. IRB: Ethics and
p.(None): Human Research, 1980;2: 1-4.
p.(None): 22. Karlawish, Hall (1996). Am J Respir Crit Care Med, 1996;153:499-5-6.
p.(None): 23. Casarett, Karlawish, Sugarman. JAMA, 2000, 283 (17): 2275-80.
p.(None): 24. Richards HM, Schwartz LJ. Ethics of qualitative research: are there special issues for health services research?
p.(None): Family Practice 2002; 19: 135-139.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 75
p.(None):
p.(None): Appendix I. Acronyms
p.(None): AAUMFIRB Addis Ababa University Medical Faculty Institutional
p.(None): Review Board
p.(None): AE Adverse Event
p.(None): AHRI Armauer Hansen Research Institute
p.(None): CAB Community Advisory Board
p.(None): CIOMS Council for International Organization of Medical Sci- ences
p.(None): COI Conflict Of Interest
p.(None): CV Curriculum Vitae
p.(None): DACA Drug Administration and Control Authority
p.(None): DNA Deoxyribo Nucleic Acid
p.(None): DSMB Data and Safety Monitoring Board
p.(None): EC Ethics Committee
p.(None): EHNRI Ethiopian Health and Nutrition Research Institute
p.(None): EPHA Ethiopian Public Health Association
p.(None): ERC Ethics Review Committee
p.(None): ESTA Ethiopian Science and Technology Agency
p.(None): ESTC Ethiopian Science and Technology Commission
p.(None): FDRE Federal Democratic Republic of Ethiopia
p.(None): FMHCACA Food, Medicine and Health Care Administration and
p.(None): Control Authority
p.(None): GDP Gross Domestic Product
p.(None): GCP Good Clinical Practice
p.(None): GMP Good Manufacturing Practice
p.(None): GNI Gross National Income
p.(None): RE Research Ethics
...
p.(None): private information or specimens. In contrast with linked, coded often means that the link exists but is unavailable,
p.(None): as through a nondisclosure arrangement.
p.(None): Compensation-Payment to cover actual research-related harm. Where understandability is an issue, use a simpler word
p.(None): like “payment”. Contrast with incentive, reimbursement.
p.(None): Completion of study-Point at which data analysis has ended or identifying informa- tion is removed from the data and
p.(None): biological specimens. See also close.
p.(None): Comprehension–in this context, understanding what the study is about.
p.(None): Conduct-To be engaged (in research) by obtaining data about living individuals through intervention or interaction with
p.(None): them for research purposes or by obtaining individually identifiable private information about living individuals for
p.(None): research purposes.
p.(None): Conflict of interest-A situation where the goals or obligations of an investigator or reviewer conflict with an
p.(None): obligation to uphold another party’s interest, thereby com- promising objectivity and impartiality.
p.(None):
p.(None): 78 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): Confidential/confidentiality-The condition of honoring a request or expectation that information will be protected from
p.(None): disclosure.
p.(None): Convened-A formal, joint meeting or action of a quorum of the IRB.
p.(None): Collaborative research-Research that involves more than one institution.
p.(None): Council for International Organizations of Medical Sciences (CIOMS)-An interna- tional, non-governmental,
p.(None): non-profit organization established in 1949 whose mem- bership represents many of the biomedical disciplines and
p.(None): national academies of sciences and medical research councils. A main objective of CIOMS is to facilitate and promote
p.(None): international activities in the field of biomedical sciences, especially when the participation of several
p.(None): international associations and national institutions is deemed necessary.
p.(None): Data and safety monitoring-Structured, ongoing monitoring of specified characteris- tics of a research protocol,
p.(None): generally by a small, independent body of experts appoint- ed by the study sponsor. Sometimes incorrectly called “data
p.(None): safety and monitoring”. Monitoring may pertain to study performance (such as rate of accrual), safety (such as
p.(None): occurrence of AEs), and efficacy (such as achievement of primary endpoints). A body that monitors all three
p.(None): characteristics is usually called a data monitoring com- mittee (DMC) or a data and safety monitoring board (DSMB).
p.(None): Declaration of Helsinki-A statement of ethical principles to provide guidance to phy- sicians and other participants in
p.(None): medical research involving human participants; ad- opted by the World Medical Assembly in 1964 and last updated in
p.(None): 2004. See http:// www.wma.net/e/policy/b3.htm.
p.(None): Disapprove/disapproval-The determination by the IRB that the research may not be conducted at an institution
p.(None): Documentation of consent-Consent that is documented by the use of a written con- sent form approved by the IRB and
p.(None): signed by the participant or the participant’s legally authorized representative.
p.(None): Emergency response-A public health activity undertaken in an urgent or emergency situation, usually because of an
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.(None): 2. Federal Negarit Gazetta of The Federal Democratic Republic of Ethiopia. 15th Year No 1 Addis Ababa, October 24
p.(None): 2008.
p.(None): 3. Federal Negarit Gazetta of The Federal Democratic Republic of Ethiopia. 16th Year No 51 Addis Ababa, August 23
p.(None): 2010.
p.(None): 4. Ethiopian Science and Technology Commission. National Health Research Ethics Review Guidelines, Fourth Edition.
p.(None): Addis Ababa, Ethiopia 2005.
p.(None): 5. Guidelines for Conducting Clinical Trials. Drug Administration and Control Authority. Addis Ababa, Ethiopia.
p.(None): 6. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Council for International
p.(None): Organizations of Medical Sciences (CI- OMS) in collaboration with the World Health Organization (WHO). CIOMS Geneva
p.(None): 2002.
p.(None): 7. Code of Federal Regulations. TITLE 45 — PUBLIC WELFARE. Depart- ment of Health and Human Services. PART
p.(None): 46: PROTECTION OF HUMAN SUBJECTS. Revised June 23, 2005. Effective June 23, 2005.
p.(None): 8. The Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research. The
p.(None): National Commission for the Protec- tion of Human Subjects of Biomedical and Behavioral Research. April 18, 1979.
p.(None): 9. Nuremberg Code. 1948.
p.(None): 10. World Medical Association Declaration of Helsinki. Ethical Principles for Medical Research Involving Human
p.(None): Subjects. Adopted by the 18th WMA General Assembly. Helsinki, Finland, June 1964, and amendments in 1975, 1983,
p.(None): 1989, 1996, 2000. Note of Clarification on Paragraph 29 added in 2002. Note of Clarification on Paragraph 30 added in
p.(None): 2008.
p.(None): 11. Karbwang J, Pattou C. Standard operating procedures for clinical investi- gators. UNDP/World Bank/WHO, special
p.(None): program for research and training in tropical diseases (TDR). TDR/TDP/SOP/99.1.
p.(None): 12. Operational Guidelines for Ethics Committees that Review Biomedical Re- search. WHO, 2000.
p.(None): 13. International Declaration on Human Genetic Data, UNESCO, 2003.
p.(None): 14. Operational Guidelines for the Establishment and Functioning of Data and Safety Monitoring Boards, TDR-WHO, Geneva
p.(None): 2005.
p.(None): 15. Uganda National Council for Science and Technology, 2007. National Guidelines for Research involving
p.(None): Humans as Research Participants. Kam-
p.(None): pala – Uganda: UNCST.
p.(None): National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): 16. Statement of WHO Expert Advisory Group on Ethical issues in Medical genetics. WHO, Geneva 1998.
p.(None): 17. Ethical Guidelines for International Comparative Social Science Research in the framework of Management of Social
p.(None): Transformations, MOST. UNE- SCO, MOST Paris.
p.(None): 18. Hyder A, Dowson L, Bachani AM, Lavery J. Moving from research ethics review o research ethics systems in
p.(None): low-income and middle-income coun- tries. Lancet 2009;37:862-65.
...
p.(None):
p.(None): 78 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): Confidential/confidentiality-The condition of honoring a request or expectation that information will be protected from
p.(None): disclosure.
p.(None): Convened-A formal, joint meeting or action of a quorum of the IRB.
p.(None): Collaborative research-Research that involves more than one institution.
p.(None): Council for International Organizations of Medical Sciences (CIOMS)-An interna- tional, non-governmental,
p.(None): non-profit organization established in 1949 whose mem- bership represents many of the biomedical disciplines and
p.(None): national academies of sciences and medical research councils. A main objective of CIOMS is to facilitate and promote
p.(None): international activities in the field of biomedical sciences, especially when the participation of several
p.(None): international associations and national institutions is deemed necessary.
p.(None): Data and safety monitoring-Structured, ongoing monitoring of specified characteris- tics of a research protocol,
p.(None): generally by a small, independent body of experts appoint- ed by the study sponsor. Sometimes incorrectly called “data
p.(None): safety and monitoring”. Monitoring may pertain to study performance (such as rate of accrual), safety (such as
p.(None): occurrence of AEs), and efficacy (such as achievement of primary endpoints). A body that monitors all three
p.(None): characteristics is usually called a data monitoring com- mittee (DMC) or a data and safety monitoring board (DSMB).
p.(None): Declaration of Helsinki-A statement of ethical principles to provide guidance to phy- sicians and other participants in
p.(None): medical research involving human participants; ad- opted by the World Medical Assembly in 1964 and last updated in
p.(None): 2004. See http:// www.wma.net/e/policy/b3.htm.
p.(None): Disapprove/disapproval-The determination by the IRB that the research may not be conducted at an institution
p.(None): Documentation of consent-Consent that is documented by the use of a written con- sent form approved by the IRB and
p.(None): signed by the participant or the participant’s legally authorized representative.
p.(None): Emergency response-A public health activity undertaken in an urgent or emergency situation, usually because of an
p.(None): identified or suspected imminent health threat to the population, but sometimes because the public or government
p.(None): authorities perceive an imminent threat that demands immediate action. The primary purpose of the activity is to
p.(None): document the existence and magnitude of a public health problem in the community and to implement appropriate measures
p.(None): to address the problem (Langmuir, 1980).
p.(None): Exemption/exempt research-Categories of research to which the Federal regulations for human research protections do not
p.(None): apply. Research involving prisoners and some research involving children are not exempt.
...
Orphaned Trigger Words
p.(None): lack of knowledge on medical concepts and technological terms, or severe mental or behavioral disorders.
p.(None): For all research involving human participants and human biological materials/speci- mens, investigators should be aware
p.(None): of, and are obligated to, respect and adhere to all ethical, legal, and regulatory requirements applicable in Ethiopia.
p.(None): In this rapidly advancing, complex, and sophisticated era of genetic studies, preven- tive, diagnostic, and therapeutic
p.(None): clinical trials, as well as collaborative research and human biological material transfer being common place, oversight
p.(None): and regulation is imperative to properly safeguard the rights and welfare of human research subjects.
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 15
p.(None):
p.(None): For research to be ethical, all of the following eight criteria must be met:
p.(None): 1. Ethical justification and scientific validity: The research must be rigorous in its methodology. For
p.(None): research to be ethical, the methods must be valid and practically feasible, the research must have a clear objective,
p.(None): be designed using sound scientif- ic principles, have sufficient statistical power, and be based on adequate knowledge
p.(None): of the scientific literature.
p.(None): 2. Science and social value: The proposed protocol should demonstrate valid scientific basis/ground, enhance health
p.(None): or generalizable knowledge, and benefit individuals and the community where the research is conducted. However, the
p.(None): research partic- ipants’ rights and welfare outweigh any benefit to the society or gain in knowledge.
p.(None): 3. Favorable risk-benefit ratio to research participants and their communities: Risks to subjects shall be minimized
p.(None): through using procedures that are consistent with acceptable research design and potential benefits enhanced. The
p.(None): maximum benefit should be provided at the lowest possible risk, and risks to research participants shall be reasonable
p.(None): in relation to anticipated benefits.
p.(None): 4. Fair selection and enrollment of human subjects: “Scientific objectives, not vul- nerability or privilege, and
p.(None): the potential for and distribution of risks and benefits, should determine communities selected as study sites and the
p.(None): inclusion criteria for individuals…” The justification for selection and the equitable nature of selection of research
p.(None): subjects should be described.
p.(None): 5. Privacy: Privacy should be respected, confidentiality maintained, the opportunity to withdraw at anytime or
p.(None): refuse any component(s) of the research should be avail- able, and the well-being of research participants should be
p.(None): monitored, while infor- mation related to research participants should be kept confidential.
p.(None): 6. Independent/IRB review: “Individuals that are not affiliated with the research must review the research
p.(None): and approve, amend, or terminate the research.” How- ever, individuals involved in independent review with any
p.(None): conflicts of interest may be summoned to provide information to the IRB.
p.(None): 7. Informed consent process: The information provided to research participants should be complete and appropriate to
p.(None): the participants’ level of understanding. The partici- pant should be competent to give or refuse consent and research
...
p.(None): research using a suitable medium (full board meeting, internet, post, telephone). At that time, any member or the
p.(None): committee may request a re-review of the approved protocol at the full (convened) committee meet- ing. If this were to
p.(None): occur, the investigator would be notified and asked to suspend the study pending full review. Expedited reviewers refer
p.(None): the issue to the full committee if there is any question about the level of risk or the applicability of the activity
p.(None): catego- ries before approving the protocol.
p.(None): 7.4 Decision Making Procedures
p.(None): 7.4.1. The IRB can only make decisions if a quorum is met.
p.(None): 7.4.2. A member with conflict must excuse himself/herself from the review process and voting.
p.(None): 7.4.3. Non-members such as project PIs and independent experts may be con- sulted as part of the review process, but do
p.(None): not vote.
p.(None): 7.4.4. Only IRB members who participated in the review process and delibera- tions should take part in the
p.(None): decision-making process.
p.(None): 7.4.5. IRB decisions shall be either unanimous or by consensus where there is a majority decision. If the decision is
p.(None): by voting the number for and against should be recorded in the minutes.
p.(None): 7.5 IRB Decisions
p.(None): The IRB may reach the following decisions after reviewing the research protocol:
p.(None): 7.5.1. Approved: if a protocol fulfills all requirements as stipulated in this guideline or
p.(None): 7.5.2. Approved on conditions: if a protocol needs modifications.
p.(None): 7.5.3. Not approved: if a protocol is found to be unscientific and/or unethical.
p.(None):
p.(None): 44 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): 7.6 Communicating Decisions to Applicants
p.(None): 7.6.1. Decisions regarding protocols should be officially communicated, in writ- ing, to the applicant within 10
p.(None): working days of the meeting where the decision was made.
p.(None): 7.6.2. Communication of the IRB decision shall include but not be limited to the following:
p.(None): 7.6.2.1. The name, title, and address of the applicant.
p.(None): 7.6.2.2. The exact title of the protocol.
p.(None): 7.6.2.3. The name of the study site(s) or study area.
p.(None): 7.6.2.4. The names and identification numbers (versions numbers/dates) of the reviewed documents.
p.(None): 7.6.2.5. A clear statement of the decision reached by the IRB.
p.(None): 7.6.2.6. The name of the IRB making the decision (letterhead of the IRB suffices),
p.(None): 7.6.2.7. The date of the decision and the signature of the Secretary/Admin- istrator or Chairperson/Vice Chairperson.
p.(None): 7.6.2.8. In case of a conditional decision (approved on condition), any re- quirements by the IRB, including
p.(None): suggestions for revisions, should be clearly explained in writing to the applicant.
p.(None): 7.6.2.9. In case of a positive decision (approval), a statement of responsi- bilities of
p.(None): the applicant and any requirements as stipulated in the decision by the ERC.
p.(None): 7.6.2.10. The validity period of the approval.
p.(None): 7.6.2.11. The final approval certificate/letter shall be countersigned by the Chair- person/Vice Chairperson.
p.(None): 7.7 IRB Records
p.(None): 7.7.1 Documentation
p.(None): The IRB should maintain adequate documentation of all its activities, and maintain the following:
p.(None): • File of detailed written procedures for the IRB.
p.(None): • File of each protocol, containing all versions of protocol submitted and accom- panying documents such as informed
p.(None): consent, approved versions, approval let- ters, progress reports submitted by investigators, reports of injuries to
p.(None): research participants, and other relevant documents.
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 45
p.(None):
p.(None): • Agenda of IRB meetings, minutes of IRB meetings which shall be in sufficient detail to show attendance at the
p.(None): meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and
p.(None): abstain- ing; the basis for requiring changes in or disapproving research; and a written summary of the discussion of
p.(None): controversial issues and their resolution.
p.(None): • Records of continuing review activities.
p.(None): • Updated member files with CVs, training documents, etc.
p.(None): • SAE reports submitted by investigators.
p.(None): • Final reports from investigators.
p.(None): 7.7.2 Archiving
p.(None): All closed files shall be retained for, at least, five (5) years after completion of the research project. All
p.(None): documents should be kept under a proper system that ensures confidentiality. All records shall be accessible for
p.(None): inspection by authorized personnel.
p.(None): 7.8 IRB Review fee
p.(None): The Federal Ministry of Science and Technology will determine the condition and the amount of review fee for protocols.
p.(None):
p.(None): 8. Requirements for Submission to an IRB
p.(None): There are requirements that must be fulfilled in order for the research protocol to be accepted by the IRB Secretariat
p.(None): for IRB review and approval. The requirements are administrative and research protocol related issues. Special
p.(None): categories of research entail fulfillment of particular requirements inherent in the type of research.
p.(None): 8.1 Administrative Requirements
p.(None): 8.1.1. The applicant must be the Principal Investigator (PI) or co-PI of the pro- posed research study.
p.(None): 8.1.2 A Protocol Application Form should be completed, signed, and dated by the PI/co-PI or his/her designee.
p.(None): 8.1.3. A signed cover letter from the PI or co-PI and the institutional details where the investigator is based (which
p.(None): should include a physical ad- dress, fax number, telephone number, mobile number and email ad- dress) also
p.(None): must be submitted.
p.(None): 8.1.4. The applicant should submit hard copies of the full research protocol and an electronic version.
p.(None): 8.1.5. All materials to be used in “advertising” the research study (e.g., cam- paign materials, brochures etc.)
p.(None): should be submitted along with the protocol.
p.(None): 46 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): 8.1.6. Up-to-date signed and dated CVs of the PI and/or co-PI should be sub- mitted. Also, bio-sketches of
p.(None): co-investigators should be submitted al- though full CVs may be requested by the IRB.
p.(None): 8.1.7. All applications should be submitted to the IRBs depending on the loca- tion of the research site.
p.(None): 8.1.8. The IRBs shall give final official approval for studies under their man- date. However, if an applicant has a
p.(None): complaint(s) against the decision of the IRBs, the study should be reviewed by the NRERC.
p.(None): 8.1.9. The NRERC or other appropriate IRB shall also review all studies under the NRERC’s mandate and send the
p.(None): protocols with recommendations and remarks to the NRERC for final approval.
p.(None): 8.1.10. The Secretariat receives applications submitted using the application form from IRBs for ethics review
p.(None): and final decision as stated under NRERC mandates.
p.(None): 8.1.11. Upon receipt of complete applications, preliminary screening is done by the Secretariat.
p.(None): 8.2 Protocol Requirements
p.(None): All research protocol and related documents submitted to the IRB for review and approval must at the least
p.(None): include the following information:
p.(None): • Research protocol: title of the study, purpose of the study, sponsor of the study, background of the project, a
p.(None): rationale with full justification of the study and that there is no other alternative and less risky way of obtaining
p.(None): the data, descrip- tion of the study population, participants inclusion /exclusion criteria, precise description of
p.(None): all proposed procedures and interventions, including the duration of the study, provisions for protecting privacy and
...
p.(None):
p.(None): • Consist of at least three members and the size and necessary expertise of the DSMB will depend upon the research
p.(None): design.
p.(None): 10.4.3 Constituting a DSMB
p.(None): When required by the nature of a study, a sponsor should ensure the establishment of DSMB to ensure the broadest
p.(None): possible coverage of potential research participants, and the validity and scientific integrity of the data. In order
p.(None): to generate competent reviews and sound recommendations, the DSMB should be multidisciplinary and include as
p.(None): appropriate, expertise in medicine (physicians with relevant backgrounds), clinical pharmacology and/or toxicology,
p.(None): epidemiology, statistics, clinical trial process, and ethics. The suitability of members of a board should be
p.(None): determined according to the nature of the study to be monitored.
p.(None): The sponsor is responsible for establishing the DSMB’s charter that defines the rela- tionship between the sponsor and
p.(None): the DSMB, which should be included (or referred to) in the research protocol.
p.(None): Members should not be affiliated with the sponsor, investigators, IRB reviewing the project, regulatory authorities,
p.(None): sites, or study staff. Members should also not have vested interest (e.g. a financial or other interest in an
p.(None): intervention or product similar to the intervention being studied).
p.(None): A procedure should be established concerning the requirements for candidacy, in- cluding an outline of the
p.(None): duties and responsibilities of DSMB members
p.(None): Procedures for reporting and addressing potential or real conflicts of interest for mem- bers and independent
p.(None): consultants should be clearly defined in the charter.
p.(None): 10.4.4 Responsibilities
p.(None): • Review research protocol, informed consent documents and plans for data safe- ty and monitoring.
p.(None): • Evaluate the progress of the trial, including periodic assessments of data quality and timeliness, participant
p.(None): recruitment, accrual and retention, participant risk versus benefit, performance of the trial site, and other factors
p.(None): that can affect the study outcome.
p.(None): • Consider factors external to the study when relevant information becomes avail- able, such as scientific or
p.(None): therapeutic developments that may have an impact on the safety of the participants or the ethics of the trial.
p.(None): • Review clinical center performance, make recommendations and assist in the resolution of problems reported by the
p.(None): PI.
p.(None): • Protect the safety of the study participants.
p.(None): • Conduct interim analysis of efficacy in accordance with stopping rules which are clearly defined in advance of data
p.(None): analysis.
p.(None): • Ensure the confidentiality of the trial data and the results of monitoring.
p.(None): National Research Ethics Review Guideline Fifth Edition 61
p.(None):
p.(None): • Assist the sponsor through remarking on any problems related with study con- duct, enrollment, sample size, and/or
p.(None): data collection.
p.(None): • Report on the safety and progress of the trial and make recommendations to the IRB and the sponsor regarding
p.(None): continuation, termination, or other modifications of the trial based on the observed benefits or adverse effects.
p.(None): • Report the decisions to investigators who must submit those reports to the IRBs, which shall further
p.(None): report to the National IRB.
p.(None): 10.5 Institutional Bio-Safety Committee
p.(None): 10.5.1 Establishment
p.(None): The IBC evaluates research projects that use recombinant DNA, agents that are in- fectious to humans, animals and
p.(None): plants, other potentially infectious materials, select agents and biological toxins. Institutional Bio-safety
p.(None): Committees (IBC) are estab- lished by institutions that undertake research on potentially hazardous substances of a
p.(None): physical, chemical, biological, or any other nature. Any institution involved in or planning to conduct research with
p.(None): potentially hazardous substances is required to set up or designate a competent IBC. Each IBC once formed shall consist
...
p.(None):
p.(None): 11.3.2 Types of Oversight Visits
p.(None): The type and frequency of oversight visits should depend on the level of risk and complexity of the research. The IRB
p.(None): can make the monitoring visit announced or unannounced.
p.(None): IRB –initiated announced oversight visit: the IRB informs the PI the date of the visit in advance.
p.(None): IRB-initiated unannounced oversight visit: the IRB does not inform the PI in advance of the visit.
p.(None): Additional monitoring visits may be made for the following reasons:
p.(None): • Response to reports made directly to the IRB or circulating in the community.
p.(None): • Increased frequency of SAE reports.
p.(None): • Failure to submit progress reports or a final report in time.
p.(None): • Reports of suspected research misconduct.
p.(None): • Investigators who extend their research beyond the approved time frame with- out formal approval from the IRB.
p.(None): • Investigators that are suspected of having changed their objectives and study design without the IRB’s approval.
p.(None): • Any other reason that the IRB feels warrants further follow-up.
p.(None):
p.(None): 12. Research Misconduct
p.(None): All researchers are obliged to respect the requirements set in this guidelines and the law and regulations related to
p.(None): research. Misconduct in health research is one of the aspects that make research unethical.
p.(None): 12.1 Research Misconduct
p.(None): Research Misconduct includes but is not limited to:
p.(None): • Conducting health research involving human participants or that which poten- tially affects humans without first
p.(None): obtaining ethical approval.
p.(None): • Collecting samples or information from human participants without first ob- taining valid, voluntary
p.(None): informed consent except in conditions where waiver of informed consent is applicable.
p.(None): • Sharing with other investigators samples collected from human participants or institutions without ethical
p.(None): approval and without a signed Material Transfer Agreement.
p.(None): • Sharing samples collected prospectively from human participants with other investigators or institutions without the
p.(None): informed consent of the participant. The IRB may waive the requirement for informed consent in the case of archived
p.(None): National Research Ethics Review Guideline Fifth Edition 67
p.(None):
p.(None): and anonymized samples if the justifications are considered to be ethically and scientifically sound by the IRB.
p.(None): • Failure to submit mandatory reports such as SAE reports, progress reports and final reports to the IRB.
p.(None): • Failure to uphold the confidentiality of research participants’ information includ- ing informed consent documents.
p.(None): • Failure to report deviations from the approved protocol procedure(s) in time. Deviation from approved protocol
p.(None): procedure(s) should not be made without the agreement of the IRB that approved the protocol except when it is necessary
p.(None): to avoid immediate danger to a research participant.
p.(None): • Unjustifiable deviations.
p.(None): • Fabricating or falsifying data, or knowingly plagiarizing others’ work.
p.(None): • Misuse of research funds.
p.(None): • Forgery of IRB documents (e.g., alteration of approval letter/certificate; Material Transfer Agreement, etc).
p.(None): 12.2 Possible Actions Against Research Misconduct
p.(None): The IRB may receive reports of cases of misconduct via investigators, community members, voluntary whistle-blowers,
p.(None): research participants, or through its oversight activities. Upon receiving such reports, the IRB should confirm
p.(None): the validity of the alleged misconduct before deciding on an appropriate course of action. The actions that the IRB
p.(None): may take after confirming the misconduct include:
p.(None): 12.2.1. A letter of warning written to the PI by the IRB Chair with instructions for the misconduct to be stopped
p.(None): and/or rectified. The head of the in- stitution, partners, and sponsors should be copied.
...
p.(None): 13.2.8. Provide periodical reports of ethical implementation of the study to the IRB’s Secretariat.
p.(None): 13.2.9. Take disciplinary action on the investigators for breach of any of this guidelines, regulatory and legal
p.(None): requirements.
p.(None): 13.3 Sponsors
p.(None): Sponsors/Donors are responsible for providing an environment that promotes integri- ty, objectivity and the highest
p.(None): ethical standards of research, including standards for design, implementation and reporting. Particularly,
p.(None): sponsors must commit to pro- tect participants in all research. Besides, sponsors are expected to ensure research
p.(None): subjects and communities are not made worse off during or after completion of the research. Sponsors can accomplish
p.(None): these goals in the following ways:
p.(None): 13.3.1. Ensure appropriate review and approval by appropriate IRBs. If the spon- sor is based outside of Ethiopia, the
p.(None): sponsor must in addition produce ap- proval from an appropriate IRB where the sponsor is based. If the sponsor is an
p.(None): international organization, the review of protocol must maintain rigor in accordance with its own independent IRB.
p.(None): 13.3.2. Monitor the research according to a plan approved by the IRB.
p.(None): 13.3.3. Select qualified investigators and institutions as collaborators, spon- sors.
p.(None): 13.3.4. Provide ethical guidelines to all investigators.
p.(None): 13.3.5. Complying with the local ethical, regulatory and legal requirments.
p.(None): 13.3.6. Promoting research integrity.
p.(None): 13.3.7. Ensuring the local relevance of the research by involving local partners in the developmental stages.
p.(None): 13.3.8. Financing the study.
p.(None): 13.3.9. Ensuring adequate safety and efficacy of investigational products, if applicable.
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 71
p.(None):
p.(None): 13.3.10. Ensuring safety and efficacy of investigational products, if applicable; the sponsor shall ensure
p.(None): investigational products are manufactured following good manufacturing practice,
p.(None): 13.3.11. Supplying and handling investigational products.
p.(None): 13.3.12. Updating investigators’ brochure as significant new information is made available.
p.(None): 13.3.13. Establishing a DSMB, if applicable.
p.(None): 13.3.14. Assigning clinical monitors, if applicable.
p.(None): 13.3.15. Providing insurance to study participants in case of injury.
p.(None): 13.3.16. Providing special forms for recording and reporting of serious adverse events and ensure adverse events are
p.(None): appropriately investigated and managed until resolution or stabilization.
p.(None): 13.3.17. Informing the IRB if it suspends or terminates a research with detailed explanation for the termination or
p.(None): suspension.
p.(None): 13.3.18. Ensuring the community where the research is conducted is informed about the research findings.
p.(None): 13.4 Donors
p.(None): Donors are responsible for providing an environment that promotes integrity, objectiv- ity and the highest ethical
p.(None): standards of research. Donors can accomplish these goals in the following ways:
p.(None): 13.4.1. Ensure appropriate review and approval by appropriate IRBs.
p.(None): 13.4.2. Monitor the research according to a plan approved by the IRB.
p.(None): 13.4.3. Complying with the local ethical, regulatory and legal requirements.
p.(None): 13.4.4. Promoting research integrity.
p.(None): 13.4.5. Ensuring the local relevance of the research by involving local partners in the developmental stages.
p.(None): 13.4.6. Financing the study.
p.(None): 13.4.7. Providing insurance to study participants in case of injury.
p.(None): 13.4.8. Informing the IRB if it suspends or terminates the financial support.
p.(None): 13.4.9. Ensuring the community where the research is conducted is informed about the research findings.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 72 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): 14. Networking
p.(None): Networking and creating a dynamic relationship among IRBs is essential for:
p.(None): • Establishing a strong data base system to standardize and streamline set of data elements.
p.(None): • Facilitating coordination among IRBs.
p.(None): • Establishing a strong and standard ethical review system within Ethiopia and harmonize safety reporting.
p.(None): • Building capacity and strengthening partnership among IRBs.
p.(None): • Sharing of experiences among local and international IRBs.
p.(None): • Establishing a central web-based repository.
p.(None): 14.1 Networking Mechanisms/Modalities
p.(None): 14.1.1. Information flow should be multidirectional.
p.(None): 14.1.2. All IRBs shall submit reports to NRERC annually.
p.(None): 14.1.3. IRBs in federal institutions shall send their biannual reports directly to the NRERC.
p.(None): 14.1.4. Reports of the respective IRBs shall include at a minimum: activities performed, support needed, problems
p.(None): encountered, etc.
p.(None): 14.1.5. For urgent matters, IRBs should seek information or technical help from NRERC at any time through its
p.(None): Secretariat.
p.(None): 14.1.6. The NRERC will distribute appropriate guidelines and other related in- formation to other IRBs and request
p.(None): feedback.
p.(None): 14.1.7. The NRERC establishes working relations with local and international IRBs through its Secretariat.
p.(None): 14.1.8. Reporting at each level should be by mail, fax or email.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 73
p.(None):
p.(None): Bibliography
p.(None): 1. The Constitution of The Federal Democratic Republic of Ethiopia. Addis Aba- ba, August 21 1995.
p.(None): 2. Federal Negarit Gazetta of The Federal Democratic Republic of Ethiopia. 15th Year No 1 Addis Ababa, October 24
p.(None): 2008.
p.(None): 3. Federal Negarit Gazetta of The Federal Democratic Republic of Ethiopia. 16th Year No 51 Addis Ababa, August 23
p.(None): 2010.
...
p.(None): Waive/waiver-Temporarily set aside the requirement of a particular rule, regulation, or condition in a protocol or
p.(None): consent document.
p.(None): Withdraw/withdrawal-Permanently halt a research study after submission for IRB review but before human
p.(None): participants become involved, whether or not the study has been reviewed by an IRB. This term has been replaced by the
p.(None): term close/closure.
p.(None):
p.(None):
p.(None):
p.(None): 84 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): Appendix III: NRERC Terms of Reference
p.(None): 1. Membership
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 2. Tenure
p.(None): The tenure of the NRERC shall be three years.
p.(None): 3. Replacement of Missing Members
p.(None): Whenever a member is absent for three consecutive meetings without valid reasons, the Ministry will be notified of
p.(None): his/her absence and requested for replacement.
p.(None): 4. Meetings
p.(None): The Committee meets every two months regularly. The Chairman however, in consul- tation with the Secretariat, may call
p.(None): an extra ordinary meeting at any time if deemed necessary.
p.(None): 5. Quorum
p.(None): The quorum will consist of eight (or >50%) members. In the absence of the chair- person, temporary chairperson shall
p.(None): be elected.
p.(None): 6. Votes
p.(None): Decisions will be made on a consensus basis. Whenever there is a difference among committee members that cannot be
p.(None): resolved by discussion, decisions will be made by majority votes; all members have equal voting rights. When votes are
p.(None): at par, the decision the chairperson supports will be final.
p.(None): 7. Deadline for ethics review
p.(None): Every project proposal will get cleared by this Committee with a maximum period of three months from the time the NRERC
p.(None): seats to review the protocol.
p.(None): 8. Review procedures
p.(None): Upon receiving the proposal, the secretariat shall circulate the proposal among NRERC members for evaluation
p.(None): using the Ethics Review Form. Opinions of the com- mittee members will be sought during the regular meetings and
p.(None): minutes will be taken on the final decision and communicated to the applying institution and the Principal Investigator
p.(None): should be copied through the Secretariat. All minutes shall be signed by both the Chairperson and Secretary.
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 85
p.(None):
p.(None): 9. Information to Investigators
p.(None): In order to save time, all the necessary requirements for the Ethics review will be provided to investigators in
p.(None): advance along with the National Ethics Review Form.
p.(None): 10. Ethics of the NRERC
p.(None): Documents that reach the Committee will be strictly confidential.
p.(None): 11. Monitoring & Evaluation
p.(None): The NRERC shall ensure the establishment of a Data Safety and Monitoring Board for all clinical trials. It also
p.(None): evaluates the ethical implementation of projects by con- ducting site visits, assessing progress reports, and/or
p.(None): consulting study participants.
p.(None): 12. Legal Issues
p.(None): The NRERC presents to the MoST all legal issues related to breach of health research ethics for appropriate action.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 86 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): Appendix IV: National Research Ethics Review Application Form
p.(None): Fill in the spaces and mark (X) wherever appropriate
p.(None): A. General
p.(None): 1. Title of the project
p.(None): 2. Name and address of the principal investigator(s)
p.(None): 3. Name and address of the applying institution(s)
p.(None): 4. Specific request of the application
p.(None): a)Ethics Review
p.(None): b)Renewal (extension)
p.(None): c)Termination
p.(None): d)Resubmission
p.(None): e)Specify if any other
p.(None): B. Specifics
p.(None): 5. Number of submitted copies
p.(None): 6. Number of submitted pages excluding all attachments
p.(None): 7. Number of submitted pages including all attachments
p.(None): 8. Required annexes/attachments
p.(None): 8.1. Written informed consent form
p.(None): 8.2. Information sheet
p.(None): 8.3. Officially endorsed minutes of IRB
p.(None): 8.4. Letter(s) of collaboration from all collaborating institution(s)
p.(None): 8.5. Ethics review letter from collaborating and host institution(s)
p.(None): 8.6. CVs of the PI and relevant senior
p.(None): co- investigator(s)
p.(None): 8.7. Material transfer agreement (MTA)
p.(None): 8.8. Specify if any other
p.(None): 9. Name and signature of applying PI and host institution (s) as an expression of accountability, responsibility and
p.(None): authenticity of the request and prior commit- ment of ethical implementation of the research after approval.
p.(None):
p.(None): Name (PI) Signature Date
p.(None):
p.(None): Name (Host, institution) Signature (Head) Date
p.(None):
p.(None): Seal and stamp
p.(None):
p.(None):
p.(None): Appendix V. Research Ethics Review Form
p.(None): Research Ethics Review Form Title:
p.(None): Reviewer Name:
p.(None): Criteria/Item Rating
p.(None): 1. Consent Form Yes
p.(None): • Does the consent form contain all the necessary information Requires revision
p.(None):
p.(None): that the subject should be aware of?
p.(None):
p.(None):
p.(None): 2. Are the objectives of the study clearly stated?
p.(None):
p.(None): 3. Are the methods ethically sound?
p.(None): No
p.(None): Not applicable
p.(None): Not attached
p.(None): Yes
p.(None): No
p.(None): Yes
p.(None): (in respect to Beneficence, Justice and Respect for Person) Not well described
p.(None): No
p.(None): 4. Are provisions to overcome risks well described and acceptable? Yes
p.(None):
p.(None): • DSMC
p.(None):
p.(None): 5. Are there provisions to provide standard/best proven care?
p.(None): No
p.(None): Not applicable
p.(None): Yes
p.(None): No
p.(None): Not applicable
p.(None): 6. Are the safety procedures in the use of vaccines, drugs and Yes
p.(None):
p.(None): other biological products acceptable?
p.(None):
p.(None): 7. Are the procedures to keep confidentiality well described?
p.(None): No
p.(None): Not applicable
p.(None): Yes
p.(None): No
p.(None): Not applicable
p.(None): 8. Are the proposed researchers competent to carry out the study Yes
p.(None):
p.(None): in a scientifically sound manner?
p.(None):
p.(None):
p.(None): 9. Does it have material Transfer Agreement?
p.(None): No
p.(None): Not applicable
...
p.(None): 88 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): Appendix VI. Material Transfer Agreement Form
p.(None): Ministry of Science and Technology, Federal Democratic Republic of Ethiopia National Research Ethics Review Committee
p.(None):
p.(None): Address: Tel.: +251011-4-674353 P.O. Box: 2490 Fax: +251-011-4-660241
p.(None): e-mail:
p.(None): Addis Ababa –Ethiopia
p.(None):
p.(None): Annex #: Material Transfer Agreement
p.(None):
p.(None): This Material Transfer Agreement (MTA) has been prepared for use by and in
p.(None): all transfer of research material (samples, derivatives, and speci- mens) related to the protocol.
p.(None):
p.(None): Provider:
p.(None): Recipient:
p.(None):
p.(None): 1. Provider agrees to transfer to recipient’s designated ( ) the following research materials
p.(None): /specimen.
p.(None):
p.(None): The research material will only be used for research purposes as described in the protocol by recipient’s investigator
p.(None): in designated laboratory for the research project described below, under suitable containment conditions. This
p.(None): research material will not be used for commercial purposes such as screening, production or sale for which a
p.(None): commercialization license may be required. Recipient agrees to comply with all National and International guidelines
p.(None): rules and regulations appli- cable to the Research Project and the handling of the Research Material.
p.(None): a) Are the research materials of human origin?
p.(None): Yes No
p.(None): b) If yes, are they collected according to the details in the protocol and in adherence to National Research Ethics
p.(None): Review Committee (NRERC) and Ethics Review Committee recom- mendations and their approval.
p.(None): Yes No
p.(None): 2. This research material and its derivatives will be used by recipient’s investigator solely in connection with the
p.(None): following research project (“Research Project”) de-
p.(None): National Research Ethics Review Guideline Fifth Edition 89
p.(None):
p.(None): scribed with specificity as follows
p.(None):
p.(None): 3. In all presentations or written publications concerning the research project, recip- ient will seek agreement of
p.(None): provider and acknowledge provider’s contribution of this research material unless requested otherwise.
p.(None): 4. This research material represents a significant contribution on the part of provid- er and is considered proprietary
p.(None): to provider. Recipient therefore agrees to retain control over this research Material and further agrees not to
p.(None): transfer the research material to other people not under her/his direct supervision with out advance written approval
p.(None): of provider. The research material will be disposed of as agreed upon per protocol at the end of completion of the
p.(None): project on .
p.(None): 5. The provider does not take any responsibility for loss, damage, wastage or spoilage of the research material during
p.(None): or after shipment to the address provided by the recipient under conditions agreed to in the protocol on shipment of
p.(None): the samples. This research material is provided as a service to the research community. IT IS BEING SUPPLIED TO
p.(None): RECIPIANT WITH NO WARRANTIES, EXPRESS OR IM- PLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
p.(None): PARTICULAR PURPOSE. Provider makes no representations that the use of the research material will not infringe any
p.(None): patent or proprietary right of third parties.
p.(None): 6. The recipient shall notify the provider in witting of any intention, improvement, modification discovery or
p.(None): development to the material or the information made by recipient or parties, collaborating with recipient, here in
...
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 90 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): Material Transfer Agreement Signature page
p.(None):
p.(None): For Recipient:
p.(None): Recipient’s Investigator Duly Authorized
p.(None):
p.(None): ---------------------- ----------------------
p.(None): Signature Signature/ Stamp
p.(None):
p.(None): ---------------------- ----------------------
p.(None): ---------------------- ----------------------
p.(None):
p.(None): Date --------------- Date ----------------
p.(None): Mailing Address for Material: Mailing Address for Notices:
p.(None): -------------------------------- ---------------------------------
p.(None): -------------------------------- ---------------------------------
p.(None):
p.(None): Tel: Fax:
p.(None): Tel: Fax:
p.(None):
p.(None): For Provider
p.(None): Provider’s Investigator Duly Authorized
p.(None):
p.(None): Signature Signature
p.(None): Date Date
p.(None):
p.(None): Mailing Address : Mailing Address for Notices:
p.(None):
p.(None): P.o.Box Tel: Fax:
p.(None): P.o.Box Tel: Fax:
p.(None):
p.(None):
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 91
p.(None):
p.(None): Appendix VII. List of Participants to enrich NRERC Guideline
p.(None): 1. National Consultative Workshop To Finalize the National Research Ethics Re- view Guideline
p.(None): December 1-2, 2011, Gion hotel, Addis Ababa
p.(None): No Name Organization
p.(None): 1. Prof.Berhanu Erko NRERC Chair Person /Aklilu Lema Institute of Pathobiology
p.(None): 2. prof. Beyene Petros AAU, Collage of Natural Science
p.(None): 3. Ms. Fran Sanden CDC
p.(None): 4. prof. Melakeberhane Dagne AAU, Collage of Health Science
p.(None): 5. prof.Asrat Hailu AAU, Collage of Health Science
p.(None): 6. Dr .Alemayehu Mekonnen CDC
p.(None): 7. Dr Getnet Yimer AAU, Collage of Health Science
p.(None): 8. Mr .Solomon Shiferaw FMHACA
p.(None): 9. Mr. Yonas Girmay FMHACA
p.(None): 10. Mr. Abrham G/giorgis WHO
p.(None): 11. Dr. Solomon Kumbi NRERC Vic. Chairperson/ AAU, Collage of Health Science
p.(None): 12. Mr. Hailegnaw Eshete EPHA
p.(None): 13. Prof. Yemane Berhane ACIPH
p.(None): 14. Dr.Yemane Teklaye Consultant
p.(None): 15. Prof.Yeweyenhareg Feleke AAU/EMA
p.(None): 16. Dr. Yemtubezinah W/A AAU, Collage of Health Science
p.(None): 17. Miluet tamirat AAU, Collage of Health Science
p.(None): 18. Abraham Tarekegn AAU, Collage of Health Science
p.(None): 19. Dr Eshetu Lema EHNRI
p.(None): 20. Dr Belete Tegberu EHNRI
p.(None): 21. Dr Zelke W/Tensge Ethiopian Biodiversity institute
p.(None): 22. Dr Wubjege Tshome AAU, Collage of Health Science
p.(None): 23. Meka Metkiyqa Head, health research dep.
p.(None): 24. Tadesse Bekele Harmaye university
p.(None): 25. Wendemu Gebeyehu Amhara Regional Health Bureau
p.(None): 26. Wendemu Ashenafi Harmaye university
p.(None): 27. Dr Adrajew Amsalu Hawassa Universty
p.(None): 28. Dr Tamerat Degafu National Veterinary Institute
p.(None):
p.(None): 92 National Research Ethics Review Guideline Fifth Edition
p.(None):
p.(None): 29. Tesfaye Lema National Veterinary Institute
p.(None): 30. Afework Mulugeta (Dr) Mekelle University
p.(None): 31. Mulu Adere Gondar University
p.(None): 32. Mekonnen Hailsilas Mekelle University
p.(None): 33. Hassen Mowhid Somalia regional Health bureau
p.(None): 34. Shetaye Alemu (Dr) Gondar University
p.(None): 35. Yared Merid Hawassa University
p.(None): 36. Beyene Wondafrash Jima University
p.(None): 37. Alemseged Abdissa Jima University
p.(None): 38. Dr. Ermias Diro Gondar University
p.(None): 39. Dr .Daniel Girma Miz-hasab R.C
p.(None): 40. Tujuma Guta Oromia health bureau
p.(None): 41. Girma Desta EPHA
p.(None): 42. Kebede Abera AAU
p.(None): 43. Yared Awugechew MoST, NRERC Secretary
p.(None): 44. Germa Yosef MoST
p.(None): 45. Mustefa Abdulsemed MoST
p.(None): 46. MuluGegta Wube MoST
p.(None): 47. Yohannes Sitotaw MoST
p.(None): 2. Validation workshop to finalize National research Ethics Review Guideline, October 2,2013,Dreamland Hotel,
p.(None): Bisoftu
p.(None):
p.(None): No Name Organization
p.(None): 1. Prof. Demesie Habte Ethiopian Science Academy
p.(None): 2. Dr Abraham Aseffa AHRI
p.(None): 3. Prof. Endashaw Bekele AAU, college of Natural Science
p.(None): 4. Dr Geremu Tarkegne ALERT, Training Center
p.(None): 5. Dr Hassen Mamo AAU, College of Natural Science
p.(None): 6. Dr Mekonen Hailsilase Tigray Science and Technology Agency
p.(None): 7. Dr Belayneh Admasu, Biotechnology research Institute ,Minis-
p.(None): try of Agriculture
p.(None): 8. Dr Ermias Diro University of Gondar
p.(None):
p.(None): National Research Ethics Review Guideline Fifth Edition 93
p.(None):
p.(None): 9. Mr Techalew Schemels Hawasa University
p.(None): 10. Prof. Yeweyenhareg Felek AAU, College of Health Science
p.(None): 11. Prof. Melakberhane Dagne AAU, College of Health Science
p.(None): 12. Dr. Getnet Yemer AAU, College of Health Science
p.(None): 13. Dr Efrem Engedawerk, AAU, College of Health Science
p.(None): 14. Dr .Yimtubezenash W/Aregaye AAU, College of Health Science
p.(None): 15. Prof. Sleshie Lulseged ICAP
p.(None): 16. Dr Mengestu Leges AAU, College of Social Science, School of So- cial work
p.(None): 17. Dr Adamu Adessie Addis Ababa University, College of Health Science
p.(None): 18. Dr Mengistu Legesse AAU, Aklilu Lema Patobiology
p.(None): 19. Dr Degu Jerene JHU
p.(None): 20. Dr Esayas National Veterinary Institute
p.(None): 21. Mr Araya feseha Ethiopian National Accreditation office,
p.(None): Addis Ababa
p.(None): 22. Ms Wubjege Teshome FMHACA
p.(None): 23. Prof. Brihanu Erko NRERC, Chairperson
p.(None): 24. Dr Solomon Kumbi, NRER, Vice chairperson
p.(None): 25. Dr Workenesh Ayele NRERC ,Member
p.(None): 26. Mr Yohannes Sitotaw NRERC Secretary
p.(None): 27. Dr Liya Wassie NRERC, Member
p.(None): 28. Mr Geberemariam Birhanu NRERC, Member
p.(None): 29. Mr.Teshome Sahelemariam, MoST
p.(None): 30. Mr Girma Yosef, MoST
p.(None): 31. Mr Getachew Atente, MoST
p.(None): 32. Mr. Abdisa Yilma MoST
p.(None): 33. Mr. Babesha Kenaw MoST
p.(None):
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| belmont | belmont |
| blinded | visual impairment |
| child | Child |
| children | Child |
| cioms | cioms guidelines |
| coerced | Presence of Coercion |
| cognitive | Cognitive Impairment |
| criminal | criminal |
| dependent | Dependent |
| detained | person in detention center |
| diminished | Diminished Autonomy |
| disability | Mentally Disabled |
| disabled | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| educational | education |
| emergency | Public Emergency |
| emergency situation | patients in emergency situations |
| ethnic | Ethnicity |
| faith | Religion |
| family | Motherhood/Family |
| fetus | Fetus/Neonate |
| fetuses | Fetus/Neonate |
| gender | gender |
| hazard | Natural Hazards |
| helsinki | declaration of helsinki |
| illness | Physically Disabled |
| immigrants | immigrants |
| incapacity | Incapacitated |
| indigenous | Indigenous |
| influence | Drug Usage |
| institutionalized | Institutionalized |
| language | Linguistic Proficiency |
| low-income | Economic/Poverty |
| manipulated | Manipulable |
| marginalized group | marginalized group |
| married | Marital Status |
| mentally | Mentally Disabled |
| minor | Youth/Minors |
| nation | stateless persons |
| neonate | Fetus/Neonate |
| neonates | Fetus/Neonate |
| officer | Police Officer |
| opinion | philosophical differences/differences of opinion |
| parent | parents |
| parents | parents |
| party | political affiliation |
| physically | Physically Disabled |
| political | political affiliation |
| pregnant | Pregnant |
| prisoners | Criminal Convictions |
| property | Property Ownership |
| racial | Racial Minority |
| religious | Religion |
| research staff | Laboratory Staff |
| single | Marital Status |
| stigma | Threat of Stigma |
| student | Student |
| substance | Drug Usage |
| threat | Threat of Stigma |
| undue influence | Undue Influence |
| vulnerability | vulnerable |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| child | ['children'] |
| children | ['child'] |
| disability | ['disabled', 'mentally'] |
| disabled | ['mentally', 'disability'] |
| drug | ['influence', 'substance'] |
| education | ['educational'] |
| educational | ['education'] |
| faith | ['religious'] |
| fetus | ['neonate', 'fetuses', 'neonates'] |
| fetuses | ['fetus', 'neonate', 'neonates'] |
| illness | ['physically'] |
| influence | ['drug', 'substance'] |
| married | ['single'] |
| mentally | ['disabled', 'disability'] |
| neonate | ['fetus', 'fetuses', 'neonates'] |
| neonates | ['fetus', 'neonate', 'fetuses'] |
| parent | ['parents'] |
| parents | ['parent'] |
| party | ['political'] |
| physically | ['illness'] |
| political | ['party'] |
| religious | ['faith'] |
| single | ['married'] |
| stigma | ['threat'] |
| substance | ['drug', 'influence'] |
| threat | ['stigma'] |
| vulnerability | ['vulnerable'] |
| vulnerable | ['vulnerability'] |
Trigger Words
capacity
coercion
consent
cultural
ethics
harm
justice
protect
protection
risk
sensitive
volunteer
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input