79C3C34C52B45572883A05D425EB0F82
National Code of Health Research Ethics
http://www.nhrec.net/nhrec/NCHRE_10.pdf
http://leaux.net/URLS/ConvertAPI Text Files/5DCC64D6FBE3825DB42B91012CFCF8C7.en.txt
Examining the file media/Synopses/5DCC64D6FBE3825DB42B91012CFCF8C7.html:
This file was generated: 2020-12-01 09:18:37
| 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.000021: attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of researchers and
p.000021: research participants. Members should have varying academic and professional backgrounds to promote complete and
p.000021: adequate review of health research conducted by the promoting institution.
p.000021: (d) In addition to possessing the professional competence necessary to review specific research activities, the HREC
p.000021: shall be able to ascertain the acceptability of proposed research in terms of institutional regulations, applicable
p.000021: laws, and standards of professional conduct and practice. The HREC shall therefore include persons knowledgeable in
p.000021: these areas and whenever feasible, a lawyer.
p.000021: (e) Each HREC shall include at least one member whose primary concerns are in scientific areas and at least one member
p.000021: whose primary concerns are in non-scientific areas.
p.000021: (f) Each HREC shall include at least one member who is not affiliated with the institution and who is not part of the
p.000021: immediate family of a person who is affiliated with the institution.
p.000021: (g) No HREC may have a member participate in the HREC initial or continuing review of any project in which the member
p.000021: has a conflicting interest.
p.000021: (h) If HREC wishes to review research that involves vulnerable participants, such as children, prisoners, pregnant
p.000021: women, physically and psychologically disabled persons, the HREC shall co-opt one or more individuals knowledgeable
p.000021: about and experienced in working with
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p.000022:
p.000022: these participants for the review process. These individuals may not vote during the HREC meeting.
p.000022: (i) Each HREC member must pledge to maintain confidentiality regarding all meetings, deliberations, applications,
p.000022: information on research participants and related matters that shall come to his/her knowledge during service on HREC
p.000022: even after leaving the HREC assignment. There is no time limit for this prohibition.
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p.000023: 23
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p.000023: Section E
p.000023:
p.000023: HREC functions and operations
p.000023:
p.000023: In order to fulfil the requirements of this code, each HREC shall:
p.000023:
p.000023: (a) Operate in accordance with the provisions of the current version of the National Code of Health Research Ethics
p.000023: issued by the NHREC. Additional guidance may be obtained from the Standard Operating Procedure (SOP) issued by the
p.000023: NHREC.
p.000023:
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p.000025: forms etc. that are related to the research and necessary for the HREC to conduct its oversight function.
p.000025:
p.000025: (3) This shall be at least once a year or at least once during the lifetime of the research where the duration of the
p.000025: research is less than a year.
p.000025:
p.000025: (4) HREC shall have authority to observe or cause to be observed on its behalf, the research and its consent process to
p.000025: ensure compliance with the highest scientific and ethical standards.
p.000025:
p.000025: (5) HREC may initiate process of oversight of research in the event of receipt of complaints, information or data
p.000025: relevant to the research from any source.
p.000025:
p.000025: (f) Process for expedited review
p.000025:
p.000025: (1) HREC may expedite review of research in the following circumstances:
p.000025:
p.000025: (a) Research is found to involve no more than minimal risk – meaning that the probability and magnitude of harm is no
p.000025: greater than that encountered in the daily lives of all (or the great majority) persons in the population (under normal
p.000025: circumstances) from which research participants are to be recruited. Note that minimal risk is applicable in
p.000025: non-therapeutic research only.
p.000025:
p.000025: (b) Research does not involve vulnerable populations such as children, prisoners, pregnant women etc.
p.000025:
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p.000026: (c) Research does not contain serious methodological or ethical flaws
p.000026:
p.000026: (d) Minor changes in previously approved research during the period for which approval is authorized.
p.000026:
p.000026: (2) Expedited review may be carried out by the HREC chairperson or his designee from among members of HREC. In
p.000026: reviewing the research, the reviewer(s) shall exercise all of the authorities of HREC except that the reviewer(s) may
p.000026: not disapprove the research.
p.000026:
p.000026: (3) The Chairman of HREC shall bring all research reviewed expeditiously to the next meeting of HREC for notice,
p.000026: discussion and ratification.
p.000026:
p.000026: (g) Process for amendment of research
p.000026:
p.000026: (1) HREC shall require that applicants apply for permission to amend protocols in any of the following circumstances:
p.000026:
p.000026: (a) Where there are changes in any part of the research protocol that alters the risk benefit ratio of the research.
p.000026:
p.000026: (b) Where there are changes in the named members of the team conducting the research.
p.000026:
p.000026: (c) Where there are changes in research sites.
p.000026:
p.000026: (c) Where there are changes in sponsorship, institutional guidelines, institutional structure, HREC requirements,
p.000026: national laws or exigencies that impact on the ethical conduct of research.
p.000026:
p.000026: (2) HREC shall require that researcher submit an application for original research approval where in its opinion, the
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Political / Indigenous
Searching for indicator indigenous:
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p.000043: outcome of the research.
p.000043:
p.000043: (h) For research to be ethical, nothing must be done to undermine the trust relationship that is at the heart of
p.000043: the researcher(s)-participant(s) relationships. This requires that
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p.000044: there is transparency in all matters relating to the research enterprise including clear description of goals, risks,
p.000044: benefits, alternatives to participation and voluntariness. It is also necessary to determine the social value of the
p.000044: research and engage in creative approaches for effective representations and involvement of researchers and communities
p.000044: in the entire enterprise. Strategies for dynamic and reciprocal collaboration that leads to transformation of essential
p.000044: relationships based on reciprocity are also essential. This trust principle encourages the engagement of individual
p.000044: participants and communities, respects local socio-cultural values and encourages the provision of relevant and timely
p.000044: feedback to communities.
p.000044:
p.000044: (i) For research to be ethical, the interest of participants, researchers, sponsors and communities must be
p.000044: protected. This will ensure that the research has lasting impact, transfers technology where appropriate, contributes
p.000044: to capacity building and demonstrates respect for socio-cultural and other differences. Risks, benefits and
p.000044: responsibilities of research must be shared during the development, planning, conduct, dissemination of results.
p.000044: Intellectual property, indigenous knowledge and contributions of all parties must be taken into consideration,
p.000044: adequately protected and compensated particularly where research leads to tangible or intangible benefits. Satisfactory
p.000044: parameter(s) that shall determine sharing of commercial and other benefits should be clearly articulated and where
p.000044: indicated, benefit sharing agreements, materials transfer agreements, patent rights, intellectual property and
p.000044: royalties’ distribution agreements should be signed before initiation of research.
p.000044:
p.000044: (j) For research to be ethical, it must be conducted in accordance with the principles of good clinical and laboratory
p.000044: practices. These are international standards for designing, conducting, and reporting clinical trials that involve
p.000044: human participants. Compliance with these standards is additional assurance that the rights, safety and well-being of
p.000044: trial participants are protected in a manner that is consistent with the highest ethical and scientific standards.
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p.000044: Section G
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p.000045: HREC Education and Training Responsibility
p.000045:
p.000045: (a) HREC shall organise, cause to be organized on its behalf, sponsor, support or associate with training and
p.000045: educational programs for biomedical, social and behavioural sciences’ researchers.
p.000045:
p.000045: (b) In order for such programs to be accepted for purposes of membership of HREC and as evidence of satisfactory
p.000045: training of biomedical researchers for purposes of research review, the curriculum must be certified by NHREC.
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Political / criminal
Searching for indicator criminal:
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p.000011:
p.000011: Health research that is conducted anywhere in Nigeria must comply with all sections of this code.
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p.000012: Section B Exemption
p.000012: Research activities in which the only involvement of human participants will be in one or more of the following
p.000012: categories are exempt from health research ethics committee oversight:
p.000012:
p.000012: (a) Research conducted in established or commonly accepted educational settings, involving normal educational
p.000012: practices, such as:
p.000012:
p.000012: (1) Research on regular and special education instructional strategies, or
p.000012:
p.000012: (2) Research on the effectiveness of or comparison among instructional techniques, curricula, or classroom management
p.000012: methods.
p.000012:
p.000012: (b) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures,
p.000012: interview procedures or observation of public behaviour, unless:
p.000012:
p.000012: (1) Information obtained is recorded in such a manner that human participants can be identified, directly or through
p.000012: identifiers linked to the participants; and
p.000012:
p.000012: (2) Any disclosure of the human participants' responses outside the research could reasonably place the participants at
p.000012: risk of criminal or civil liability or be damaging to the participants' financial standing, employability, or
p.000012: reputation.
p.000012:
p.000012: (c) Research involving the collection or study of existing data, documents, records, pathological specimens, or
p.000012: diagnostic specimens, if these sources are publicly available (note that this refers to availability of data and not
p.000012: the status of the custodian
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p.000013: of the information/data) or if the information is recorded by the investigator in such a manner that participants
p.000013: cannot be identified, directly or through identifiers linked to the participants.
p.000013:
p.000013: (d) Studies that are meant to evaluate the outcome of procedures, programs and services are exempt because they are
p.000013: designed to produce information leading to improvement in delivery of procedures, programs and services. Such studies
p.000013: usually evaluate measures that are already in use and considered part of standard practice. They may include collection
p.000013: and analysis of data or collection of new data but they do not involve allocation into groups or randomisation.
p.000013:
p.000013: (e) Studies that are designed to evaluate or assess quality of services, programs and procedures and formulate
p.000013: guidelines leading to their improvement are exempt. Such studies may involve the collection and analysis of some data.
p.000013:
p.000013: (f) Innovative or non-validated medical treatment – treatment that is designed solely for the benefit of the patient
p.000013: but in which the ability of the treatment to result in the desired result is to some degree not proven. Such activities
p.000013: are exempt while recommending that they should be subjected to research in order to generate information about their
p.000013: efficacy as soon as possible.
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p.000052:
p.000052: (b) NHREC shall review materials from HREC to ensure that registration status is maintained.
p.000052:
p.000052: (c) NHREC shall review the commitment of institution(s) to provide resources for proper functioning of HREC.
p.000052:
p.000052: (d) NHREC shall, at its own discretion, conduct oversight visits to HREC.
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p.000052: (e) NHREC shall conduct any other activities in the exercise of its functions as enumerated in the relevant laws and
p.000052: guidelines.
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p.000053: Section M
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p.000053: HREC Compliance and Disciplinary Powers
p.000053:
p.000053: HREC shall have the power to recommend to NHREC that disciplinary action is taken against researcher(s) who violates
p.000053: the norms, standards and guidelines set out in this code, institutional guidelines, rules and regulations and the law.
p.000053:
p.000053: (a) Such recommendations shall be made after exhaustion of all steps outlined in this code for resolution of problems
p.000053: identified in research.
p.000053:
p.000053: (b) Such recommendations shall be made after the matter is discussed at a regularly convened ordinary meeting of the
p.000053: HREC.
p.000053:
p.000053: (c) All records pertinent to the matter shall be forwarded to the NHREC within 2 weeks of the HREC meeting at which the
p.000053: decision is taken to recommend the matter to NHREC and a formal notice shall be issued to the researcher(s),
p.000053: institution(s) or sponsors(s) by the HREC.
p.000053:
p.000053: (d) Such recommendation shall not preclude the HREC from reporting acts that are clear violations of civil and criminal
p.000053: law such as fraud, assault and battery to constituted authorities or clear violations of institutional rules and
p.000053: guidelines to the institution where the researcher is based.
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p.000054: Section N
p.000054:
p.000054: NHREC Compliance and Disciplinary Powers
p.000054:
p.000054: (a) NHREC may advertise all cases of research misconduct reported to it, its plan of action and the resolution of cases
p.000054: to the public.
p.000054:
p.000054: (b) NHREC shall recommend disciplinary action against researcher(s) to the institutional and legally constituted
p.000054: authorities.
p.000054:
p.000054: (c) NHREC shall report all cases of fraud, deception, infamous conduct, plagiarism, fabrication, falsification to the
p.000054: appropriate regulatory, the police and other relevant authorities.
p.000054:
p.000054: (d) NHREC shall bar researchers from conducting research for variable periods of time depending on the severity of
p.000054: findings of misconduct.
p.000054:
p.000054: (e) NHREC shall cause researchers to make restitution appropriate to the case under consideration to research
p.000054: participants, collaborators, institutions, sponsors or any other persons as may be required by the facts of the case.
p.000054:
p.000054: (f) NHREC shall institute legal action against researchers and institutions found in violation of these guidelines
p.000054:
p.000054: (g) In international collaborative research, NHREC shall report its findings of misconduct against researchers,
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Political / stateless persons
Searching for indicator nation:
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p.000031: ethics committees their institutional HREC for consideration and possible reconciliation.
p.000031:
p.000031: (d) Where the outcome of review is favourable but different modifications are requested, the applicant shall submit the
p.000031: comments from the different HREC or ethics committees their institutional HREC for consideration and possible
p.000031: reconciliation.
p.000031:
p.000031: (e) HREC and ethics committees shall, as much as possible, consult with each other in order to resolve discordant
p.000031: reviews and generate consistent single response to multi-site research.
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p.000031: (n) Materials Transfer Agreement
p.000031:
p.000031: Transfer of samples and biological materials such as animals, herbs and plants out of Nigeria shall require a Materials
p.000031: Transfer Agreement (MTA) detailing the type of materials, anticipated use, location of storage outside Nigeria,
p.000031: duration of such storage, limitations on use, transfer and termination of use of such materials subject to any law,
p.000031: regulations and enactment in Nigeria.
p.000031:
p.000031: The purpose of MTA is to protect the interests of local researchers and Nigeria’s human and natural resources in all
p.000031: its biodiversity as well as how they can be legitimately used. It ensures that the interests of all relevant parties,
p.000031: human
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p.000032: and community participants in research and the Nigerian nation are protected from exploitation and egregious harm.
p.000032:
p.000032: (a) The MTA shall be signed by all parties involved in the research including local and international principal
p.000032: investigators, heads of local institutions, research sponsors and other relevant parties.
p.000032:
p.000032: (b) HREC shall review the MTA to ensure consistency with the stated objectives of the research, the contents of the
p.000032: informed consent documents and the principles enumerated above. The HREC shall grant provisional approval pending the
p.000032: submission of MTA to NHREC and receipt of acknowledgement from the NHREC.
p.000032:
p.000032: (c) The applicant for research review shall file a copy of the MTA and provisional approval by the institutional HREC
p.000032: with the NHREC for record purposes only.
p.000032:
p.000032: (d) NHREC shall acknowledge receipt of the MTA to the applicant who shall inform the institutional HREC.
p.000032:
p.000032: (e) Institutional HREC shall grant final approval to research involving international transfer of Nigerian samples
p.000032: after all other criteria stated in this code for approval of research has been met and upon receipt of acknowledgement
p.000032: of MTA.
p.000032:
p.000032: (f) The MTA does not vitiate the right of research participants or communities to request that their samples be
p.000032: withdrawn from research according to the terms of the informed consent process.
p.000032:
p.000032: (g) Where there is any change in the MTA, a request for amendment of protocol shall be submitted to HREC and HREC shall
p.000032: consider this in the usual manner used for amendment of protocol.
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p.000033: (h) Where there is verifiable proof that the applicant has sent a copy of the MTA to the NHREC and has not received an
p.000033: acknowledgement in 2 weeks, the applicant shall file evidence of this with the institutional HREC who shall proceed to
p.000033: issue the final approval for the research.
p.000033:
p.000033: (o) Communication with other regulatory agencies
p.000033:
p.000033: HREC(s) shall have the authority to communicate with other ethics regulatory agencies and institutions about matters
p.000033: relevant to review of research. In such instances, HREC shall notify researcher(s), sponsor(s) and institution(s) about
p.000033: the communication(s).
p.000033:
p.000033: (p) Process for NHREC review of research
p.000033:
p.000033: (1) The NHREC may decide to review a research
p.000033: where:
p.000033:
p.000033: (a) The research is nation-wide in coverage or
p.000033:
p.000033: (b) The research involves more than 3 sites in Nigeria or
p.000033:
p.000033: (c) The research was referred to NHREC by HREC(s) or
p.000033:
p.000033: (d) There is no HREC in an institution and the institution does not have a HREC cooperative agreement or
p.000033:
p.000033: (e) The researcher considers the researcher of such complexity that there may be inadequate expertise in any one local
p.000033: institution or
p.000033:
p.000033: (f) At its discretion.
p.000033:
p.000033: (2) The NHREC may review research by:
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p.000034: (a) Mandating review by any HREC in the country to act as a “HREC of record” and review the research on its behalf.
p.000034:
p.000034: (b) Constituting itself into a review committee and exercising all the powers applicable therein as outlined for HREC
p.000034: in this code.
p.000034:
p.000034: (c) Constituting an ad hoc HREC at its discretion.
p.000034:
p.000034: (3) Where NHREC utilizes any of these methods, it shall assign continuing oversight of research to institutional HREC.
p.000034:
p.000034: (4) Where NHREC assigns continuing oversight functions to institutional HREC, the institutional HREC shall have all the
p.000034: authority of oversight function as outlined in relevant sections of this code
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p.000035:
p.000035: (q) Fees
p.000035:
p.000035: HREC may charge fees for any or all of its activities, at its discretion and in consultation with the principal
p.000035: officers of the institution.
p.000035:
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p.000036: this circumstance, the HREC cannot change its decision on the approval status of the research once the community
p.000036: engagement process has commenced. If the community engagement fails, then the research cannot proceed in that community
p.000036:
p.000036: (c) Where applicable, such community assent or engagement efforts shall be documented and evidence of same submitted to
p.000036: HREC during the research review process.
p.000036:
p.000036: (d) In some instances, it will be necessary to set up a community advisory board (CAB). Such boards may be established
p.000036: by the study investigators in consultation with the community.
p.000036:
p.000036: (e) Members of CAG shall be selected by the community through their usual consultative process and it shall include
p.000036: broad representation of community members based on age, sex, religion and other community parameters that may be
p.000036: relevant to the study. It may include relatively more representation from population of interest to the study. It may
p.000036: include representatives from the research group and
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p.000037: other non-community members whose special knowledge or expertise may be considered necessary for effective functioning
p.000037: of the community advisory group. In all instances, members of the community must constitute a simple majority of the
p.000037: CAB.
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p.000037: (f) The function of the CAB is to provide community members opportunity to share their views about ethical issues that
p.000037: proposed research raises for individual community members, community as a whole, neighbouring communities and their
p.000037: region/nation. The CAB also provides a forum for dissemination of pre, intra and post-research information to the
p.000037: community. Members of CAB may provide advice and support as needed for the successful implementation of research.
p.000037:
p.000037: (g) The definition of community shall vary with research and shall be based on application of the best scientific
p.000037: principles.
p.000037:
p.000037: (4) HREC must protect researcher(s) from undue pressure from sponsor(s), institution(s), participant(s) or any other
p.000037: source by ensuring that no researcher enters into an agreement or is subjected to circumstances that limits his/her
p.000037: legal rights, freedoms and obligations under Nigerian law to pursue his/her research activities.
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p.000038: Section F
p.000038:
p.000038: Ethical Principles and Guidelines for HREC approval of research
p.000038:
p.000038: In order to approve research covered by this code the HREC, shall determine a balance between the various principles
p.000038: guiding the ethical conduct of research, some of which are outlined below. Since some of these will inevitably
p.000038: conflict, judgement and consensus are essential in determining whether a research should be conducted.
p.000038:
p.000038: a. Research must have social or scientific value to either participants, the population they represent, the
p.000038: local community, the host country or the world, in order to justify the use of finite resources and risk exposure of
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Political / vulnerable
Searching for indicator vulnerable:
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p.000021: consideration of age, gender, socio-cultural backgrounds, religion and sensitivity to such issues as community
p.000021: attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of researchers and
p.000021: research participants. Members should have varying academic and professional backgrounds to promote complete and
p.000021: adequate review of health research conducted by the promoting institution.
p.000021: (d) In addition to possessing the professional competence necessary to review specific research activities, the HREC
p.000021: shall be able to ascertain the acceptability of proposed research in terms of institutional regulations, applicable
p.000021: laws, and standards of professional conduct and practice. The HREC shall therefore include persons knowledgeable in
p.000021: these areas and whenever feasible, a lawyer.
p.000021: (e) Each HREC shall include at least one member whose primary concerns are in scientific areas and at least one member
p.000021: whose primary concerns are in non-scientific areas.
p.000021: (f) Each HREC shall include at least one member who is not affiliated with the institution and who is not part of the
p.000021: immediate family of a person who is affiliated with the institution.
p.000021: (g) No HREC may have a member participate in the HREC initial or continuing review of any project in which the member
p.000021: has a conflicting interest.
p.000021: (h) If HREC wishes to review research that involves vulnerable participants, such as children, prisoners, pregnant
p.000021: women, physically and psychologically disabled persons, the HREC shall co-opt one or more individuals knowledgeable
p.000021: about and experienced in working with
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p.000022:
p.000022: these participants for the review process. These individuals may not vote during the HREC meeting.
p.000022: (i) Each HREC member must pledge to maintain confidentiality regarding all meetings, deliberations, applications,
p.000022: information on research participants and related matters that shall come to his/her knowledge during service on HREC
p.000022: even after leaving the HREC assignment. There is no time limit for this prohibition.
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p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000023: 23
p.000023:
p.000023: Section E
p.000023:
p.000023: HREC functions and operations
p.000023:
p.000023: In order to fulfil the requirements of this code, each HREC shall:
p.000023:
p.000023: (a) Operate in accordance with the provisions of the current version of the National Code of Health Research Ethics
...
p.000025:
p.000025: (2) HREC shall have authority to examine all aspects and documents including consent forms, questionnaires, case report
p.000025: forms etc. that are related to the research and necessary for the HREC to conduct its oversight function.
p.000025:
p.000025: (3) This shall be at least once a year or at least once during the lifetime of the research where the duration of the
p.000025: research is less than a year.
p.000025:
p.000025: (4) HREC shall have authority to observe or cause to be observed on its behalf, the research and its consent process to
p.000025: ensure compliance with the highest scientific and ethical standards.
p.000025:
p.000025: (5) HREC may initiate process of oversight of research in the event of receipt of complaints, information or data
p.000025: relevant to the research from any source.
p.000025:
p.000025: (f) Process for expedited review
p.000025:
p.000025: (1) HREC may expedite review of research in the following circumstances:
p.000025:
p.000025: (a) Research is found to involve no more than minimal risk – meaning that the probability and magnitude of harm is no
p.000025: greater than that encountered in the daily lives of all (or the great majority) persons in the population (under normal
p.000025: circumstances) from which research participants are to be recruited. Note that minimal risk is applicable in
p.000025: non-therapeutic research only.
p.000025:
p.000025: (b) Research does not involve vulnerable populations such as children, prisoners, pregnant women etc.
p.000025:
p.000025:
p.000026: 26
p.000026:
p.000026: (c) Research does not contain serious methodological or ethical flaws
p.000026:
p.000026: (d) Minor changes in previously approved research during the period for which approval is authorized.
p.000026:
p.000026: (2) Expedited review may be carried out by the HREC chairperson or his designee from among members of HREC. In
p.000026: reviewing the research, the reviewer(s) shall exercise all of the authorities of HREC except that the reviewer(s) may
p.000026: not disapprove the research.
p.000026:
p.000026: (3) The Chairman of HREC shall bring all research reviewed expeditiously to the next meeting of HREC for notice,
p.000026: discussion and ratification.
p.000026:
p.000026: (g) Process for amendment of research
p.000026:
p.000026: (1) HREC shall require that applicants apply for permission to amend protocols in any of the following circumstances:
p.000026:
p.000026: (a) Where there are changes in any part of the research protocol that alters the risk benefit ratio of the research.
p.000026:
p.000026: (b) Where there are changes in the named members of the team conducting the research.
p.000026:
p.000026: (c) Where there are changes in research sites.
p.000026:
p.000026: (c) Where there are changes in sponsorship, institutional guidelines, institutional structure, HREC requirements,
p.000026: national laws or exigencies that impact on the ethical conduct of research.
p.000026:
...
p.000038: communities and the country.
p.000038: b. For research to be ethical, it must be have scientific validity. Research lacking clear scientific
p.000038: objective(s); using invalid methodology; that is underpowered; lacking equipoise (for clinical studies); whose
p.000038: operationalizing plans are inadequate within the context of the environment where research would be conducted; lacks
p.000038: plausible data analysis plan (including a specific role for a Data and Safety Monitoring Board [DSMB] in clinical
p.000038: trials) and research with biased measurement(s) of outcome(s) is unethical.
p.000038: c. Ethical research must ensure fair selection of participants based on the scientific objective(s) of the
p.000038: research while minimizing risk. This requirement refers to both who is included and who is excluded from recruitment
p.000038: and the strategies employed for participants’ recruitment (including choice of research sites and communities).
p.000038: Regardless of this requirement, participants who are at
p.000039: 39
p.000039:
p.000039: excessively increased risk of harm should be excluded. Children, pregnant women, socially, culturally, economically,
p.000039: politically, educationally, physically and psychologically disadvantaged groups, groups with constrained autonomy and
p.000039: other vulnerable populations should not be excluded from research without explicit reasons for doing so; particularly
p.000039: from studies that can advance their health and well being. However specific safeguards should be included to protect
p.000039: the vulnerable, appropriate to degree of risk. Groups, communities, participants and researchers who bear the burden of
p.000039: research should share in the benefits.
p.000039: d. All research involve risks; to be ethical therefore, there must be valid attempts to minimize risks and
p.000039: maximize health related benefits (as distinguished from risks and benefits of therapies that participants would be
p.000039: exposed to even if they were not participating in research or incidental risks or benefits) to participants in order to
p.000039: engender favourable risk benefit ratio within the context of where the research is being conducted.
p.000039:
p.000039: (1) Where the risks outweigh the benefits to the participants, other criteria outlined in this code must justify such
p.000039: risks.
p.000039:
p.000039: (2) Risks and benefits should be considered at the level of individual research participants and at the community,
p.000039: whenever appropriate.
p.000039:
p.000039: (3) Comprehensive delineation of risks and benefits should be done for participants during the research, the population
p.000039: hosting the research and for both participants and population after completion of research
p.000039:
p.000039: (3) Therapeutic procedures must fulfil requirements of clinical equipoise – there must be genuine uncertainty, among at
p.000039: least a significant minority of unbiased acknowledged experts who are not associated with the study under
p.000039: consideration, about preferred treatment.
p.000039:
p.000039: (4) The risks associated with non-therapeutic procedures must be minimized by:
p.000039:
p.000039: (a) Procedures consistent with sound research designs
p.000040: 40
p.000040:
...
p.000042:
p.000042: (7) Where appropriate, researcher(s) may be required to undertake a re-consenting process during the course of research
p.000042: as determined by the HREC.
p.000042:
p.000042: (8) Where, in ordinary circumstances, participant(s) are unable to provide written consent, researcher(s) must propose
p.000042: a process of consent that adequately records participants’ informed decision such as witnessed thumb- printing or
p.000042: witnessed audio recording. The process proposed must be approved by the HREC before the research commences.
p.000042:
p.000042: (9) HREC may require that all or some types of consent process be witnessed.
p.000042:
p.000042: (10) Researcher(s) must keep all copies of consent form and make them available for examination by participant(s),
p.000042: sponsor(s), institution(s), HREC and NHREC.
p.000042:
p.000042: (11) Where appropriate, HREC may require researchers to provide translations of consent processes appropriate to the
p.000042: socio-cultural characteristics of the population to be studied.
p.000042:
p.000042: (12) All consent activities must be documented.
p.000042:
p.000042: (13) Consent in other situations, including research involving children, persons with diminished autonomy, vulnerable
p.000042: populations and other extraordinary situations, including waiver of consent, are described in other guidance documents
p.000042: issued by NHREC.
p.000042:
p.000042: (g) For research to be ethical there must be respect for potential and enrolled participants. This implies that
p.000042: potential participants be treated with respect from the
p.000043: 43
p.000043:
p.000043: moment that they are approached to the conclusion of the research should they choose to participate. Their right to
p.000043: privacy may not be needlessly compromised. Participants must know that their involvement is voluntary and that they can
p.000043: withdraw at any time without penalties. However, data, samples, etc. already contributed to the research up to that
p.000043: point may not needlessly be withdrawn as this may jeopardise the scientific validity of the research, unjust to those
p.000043: who remain in the study and all or part of their sample or data may have been used or modified into different form(s),
p.000043: including presentation at meetings or publications by the researchers.
p.000043:
p.000043: Respect entails that participants must be treated as partners in the research enterprise with every opportunity taken
p.000043: to inform them of the progress of the research and any new finding that may have potential impact on their health and
p.000043: well being, and on their continued participation in the research. It also entails protection of the welfare of research
p.000043: participants. This means that the process of research must be carefully monitored to ensure that participants are not
...
Health / Cognitive Impairment
Searching for indicator cognitive:
(return to top)
p.000011: participant
p.000011: (b) Non-therapeutic procedures – interventions that are not administered with therapeutic intent and are only intended
p.000011: to answer the scientific question of the study
p.000011:
p.000011: Activities which meet this definition constitute research for purposes of this code, whether or not they are conducted
p.000011: or supported under a program which is considered research for other purposes. For example, some demonstration and
p.000011: service programs may include research activities.
p.000011:
p.000011: Health research that is conducted anywhere in Nigeria must comply with all sections of this code.
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000012: 12
p.000012:
p.000012: Section B Exemption
p.000012: Research activities in which the only involvement of human participants will be in one or more of the following
p.000012: categories are exempt from health research ethics committee oversight:
p.000012:
p.000012: (a) Research conducted in established or commonly accepted educational settings, involving normal educational
p.000012: practices, such as:
p.000012:
p.000012: (1) Research on regular and special education instructional strategies, or
p.000012:
p.000012: (2) Research on the effectiveness of or comparison among instructional techniques, curricula, or classroom management
p.000012: methods.
p.000012:
p.000012: (b) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures,
p.000012: interview procedures or observation of public behaviour, unless:
p.000012:
p.000012: (1) Information obtained is recorded in such a manner that human participants can be identified, directly or through
p.000012: identifiers linked to the participants; and
p.000012:
p.000012: (2) Any disclosure of the human participants' responses outside the research could reasonably place the participants at
p.000012: risk of criminal or civil liability or be damaging to the participants' financial standing, employability, or
p.000012: reputation.
p.000012:
p.000012: (c) Research involving the collection or study of existing data, documents, records, pathological specimens, or
p.000012: diagnostic specimens, if these sources are publicly available (note that this refers to availability of data and not
p.000012: the status of the custodian
p.000013: 13
p.000013:
p.000013: of the information/data) or if the information is recorded by the investigator in such a manner that participants
p.000013: cannot be identified, directly or through identifiers linked to the participants.
p.000013:
p.000013: (d) Studies that are meant to evaluate the outcome of procedures, programs and services are exempt because they are
p.000013: designed to produce information leading to improvement in delivery of procedures, programs and services. Such studies
p.000013: usually evaluate measures that are already in use and considered part of standard practice. They may include collection
p.000013: and analysis of data or collection of new data but they do not involve allocation into groups or randomisation.
p.000013:
p.000013: (e) Studies that are designed to evaluate or assess quality of services, programs and procedures and formulate
...
Health / Drug Usage
Searching for indicator influence:
(return to top)
p.000043: who remain in the study and all or part of their sample or data may have been used or modified into different form(s),
p.000043: including presentation at meetings or publications by the researchers.
p.000043:
p.000043: Respect entails that participants must be treated as partners in the research enterprise with every opportunity taken
p.000043: to inform them of the progress of the research and any new finding that may have potential impact on their health and
p.000043: well being, and on their continued participation in the research. It also entails protection of the welfare of research
p.000043: participants. This means that the process of research must be carefully monitored to ensure that participants are not
p.000043: exposed to excessive risk and all adverse events are examined in detail and promptly. Such adverse events must also be
p.000043: reported to HREC and efforts made to prevent future occurrences. Full medical care must be provided to participants who
p.000043: have suffered such adverse events and where warranted compensations paid.
p.000043:
p.000043: The requirement to respect both enrolled and potential participants means that researchers should engage with
p.000043: communities where research is being conducted whenever this is appropriate. In certain instances, community
p.000043: consultation or assent may have to precede research activities in order to engender community buy-in and to respect the
p.000043: socio-cultural values of the community and its institutions. It may also be necessary to inform the community from time
p.000043: to time about the progress of the research, pertinent findings that may influence their health and well being, and the
p.000043: outcome of the research.
p.000043:
p.000043: (h) For research to be ethical, nothing must be done to undermine the trust relationship that is at the heart of
p.000043: the researcher(s)-participant(s) relationships. This requires that
p.000044: 44
p.000044:
p.000044: there is transparency in all matters relating to the research enterprise including clear description of goals, risks,
p.000044: benefits, alternatives to participation and voluntariness. It is also necessary to determine the social value of the
p.000044: research and engage in creative approaches for effective representations and involvement of researchers and communities
p.000044: in the entire enterprise. Strategies for dynamic and reciprocal collaboration that leads to transformation of essential
p.000044: relationships based on reciprocity are also essential. This trust principle encourages the engagement of individual
p.000044: participants and communities, respects local socio-cultural values and encourages the provision of relevant and timely
p.000044: feedback to communities.
p.000044:
p.000044: (i) For research to be ethical, the interest of participants, researchers, sponsors and communities must be
p.000044: protected. This will ensure that the research has lasting impact, transfers technology where appropriate, contributes
p.000044: to capacity building and demonstrates respect for socio-cultural and other differences. Risks, benefits and
p.000044: responsibilities of research must be shared during the development, planning, conduct, dissemination of results.
...
Health / Mentally Disabled
Searching for indicator disabled:
(return to top)
p.000021: research participants. Members should have varying academic and professional backgrounds to promote complete and
p.000021: adequate review of health research conducted by the promoting institution.
p.000021: (d) In addition to possessing the professional competence necessary to review specific research activities, the HREC
p.000021: shall be able to ascertain the acceptability of proposed research in terms of institutional regulations, applicable
p.000021: laws, and standards of professional conduct and practice. The HREC shall therefore include persons knowledgeable in
p.000021: these areas and whenever feasible, a lawyer.
p.000021: (e) Each HREC shall include at least one member whose primary concerns are in scientific areas and at least one member
p.000021: whose primary concerns are in non-scientific areas.
p.000021: (f) Each HREC shall include at least one member who is not affiliated with the institution and who is not part of the
p.000021: immediate family of a person who is affiliated with the institution.
p.000021: (g) No HREC may have a member participate in the HREC initial or continuing review of any project in which the member
p.000021: has a conflicting interest.
p.000021: (h) If HREC wishes to review research that involves vulnerable participants, such as children, prisoners, pregnant
p.000021: women, physically and psychologically disabled persons, the HREC shall co-opt one or more individuals knowledgeable
p.000021: about and experienced in working with
p.000022: 22
p.000022:
p.000022: these participants for the review process. These individuals may not vote during the HREC meeting.
p.000022: (i) Each HREC member must pledge to maintain confidentiality regarding all meetings, deliberations, applications,
p.000022: information on research participants and related matters that shall come to his/her knowledge during service on HREC
p.000022: even after leaving the HREC assignment. There is no time limit for this prohibition.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000023: 23
p.000023:
p.000023: Section E
p.000023:
p.000023: HREC functions and operations
p.000023:
p.000023: In order to fulfil the requirements of this code, each HREC shall:
p.000023:
p.000023: (a) Operate in accordance with the provisions of the current version of the National Code of Health Research Ethics
p.000023: issued by the NHREC. Additional guidance may be obtained from the Standard Operating Procedure (SOP) issued by the
p.000023: NHREC.
p.000023:
p.000023: (b) Except when an expedited review procedure is used, research proposals shall be considered at regularly convened
p.000023: ordinary meetings of HREC at which a majority of the members are present, including at least one member whose primary
p.000023: concerns are in non-scientific areas.
p.000023:
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.000021: institution.
p.000021: (b) Each HREC shall have at least five members and if more, then the total membership must always be an odd number.
p.000021: (c) The HREC shall be sufficiently qualified through the experience, expertise and diversity of its members, including
p.000021: consideration of age, gender, socio-cultural backgrounds, religion and sensitivity to such issues as community
p.000021: attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of researchers and
p.000021: research participants. Members should have varying academic and professional backgrounds to promote complete and
p.000021: adequate review of health research conducted by the promoting institution.
p.000021: (d) In addition to possessing the professional competence necessary to review specific research activities, the HREC
p.000021: shall be able to ascertain the acceptability of proposed research in terms of institutional regulations, applicable
p.000021: laws, and standards of professional conduct and practice. The HREC shall therefore include persons knowledgeable in
p.000021: these areas and whenever feasible, a lawyer.
p.000021: (e) Each HREC shall include at least one member whose primary concerns are in scientific areas and at least one member
p.000021: whose primary concerns are in non-scientific areas.
p.000021: (f) Each HREC shall include at least one member who is not affiliated with the institution and who is not part of the
p.000021: immediate family of a person who is affiliated with the institution.
p.000021: (g) No HREC may have a member participate in the HREC initial or continuing review of any project in which the member
p.000021: has a conflicting interest.
p.000021: (h) If HREC wishes to review research that involves vulnerable participants, such as children, prisoners, pregnant
p.000021: women, physically and psychologically disabled persons, the HREC shall co-opt one or more individuals knowledgeable
p.000021: about and experienced in working with
p.000022: 22
p.000022:
p.000022: these participants for the review process. These individuals may not vote during the HREC meeting.
p.000022: (i) Each HREC member must pledge to maintain confidentiality regarding all meetings, deliberations, applications,
p.000022: information on research participants and related matters that shall come to his/her knowledge during service on HREC
p.000022: even after leaving the HREC assignment. There is no time limit for this prohibition.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000023: 23
p.000023:
p.000023: Section E
p.000023:
p.000023: HREC functions and operations
p.000023:
...
Health / Physically Disabled
Searching for indicator physically:
(return to top)
p.000021: attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of researchers and
p.000021: research participants. Members should have varying academic and professional backgrounds to promote complete and
p.000021: adequate review of health research conducted by the promoting institution.
p.000021: (d) In addition to possessing the professional competence necessary to review specific research activities, the HREC
p.000021: shall be able to ascertain the acceptability of proposed research in terms of institutional regulations, applicable
p.000021: laws, and standards of professional conduct and practice. The HREC shall therefore include persons knowledgeable in
p.000021: these areas and whenever feasible, a lawyer.
p.000021: (e) Each HREC shall include at least one member whose primary concerns are in scientific areas and at least one member
p.000021: whose primary concerns are in non-scientific areas.
p.000021: (f) Each HREC shall include at least one member who is not affiliated with the institution and who is not part of the
p.000021: immediate family of a person who is affiliated with the institution.
p.000021: (g) No HREC may have a member participate in the HREC initial or continuing review of any project in which the member
p.000021: has a conflicting interest.
p.000021: (h) If HREC wishes to review research that involves vulnerable participants, such as children, prisoners, pregnant
p.000021: women, physically and psychologically disabled persons, the HREC shall co-opt one or more individuals knowledgeable
p.000021: about and experienced in working with
p.000022: 22
p.000022:
p.000022: these participants for the review process. These individuals may not vote during the HREC meeting.
p.000022: (i) Each HREC member must pledge to maintain confidentiality regarding all meetings, deliberations, applications,
p.000022: information on research participants and related matters that shall come to his/her knowledge during service on HREC
p.000022: even after leaving the HREC assignment. There is no time limit for this prohibition.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000023: 23
p.000023:
p.000023: Section E
p.000023:
p.000023: HREC functions and operations
p.000023:
p.000023: In order to fulfil the requirements of this code, each HREC shall:
p.000023:
p.000023: (a) Operate in accordance with the provisions of the current version of the National Code of Health Research Ethics
p.000023: issued by the NHREC. Additional guidance may be obtained from the Standard Operating Procedure (SOP) issued by the
p.000023: NHREC.
p.000023:
p.000023: (b) Except when an expedited review procedure is used, research proposals shall be considered at regularly convened
p.000023: ordinary meetings of HREC at which a majority of the members are present, including at least one member whose primary
p.000023: concerns are in non-scientific areas.
p.000023:
p.000023: (c) Where a member cannot physically attend a meeting, the member shall be accounted as being present if he/she can
p.000023: participate electronically, for example by teleconferencing for the majority of the duration of the meeting.
p.000023:
p.000023: (d) Process for regular research approval
p.000023:
p.000023: (1) HREC shall review prescribed application materials and have authority to approve, require modifications in (to
p.000023: secure approval) or disapprove all health research activities covered by this code.
p.000023:
p.000023: (2) In order for research to be approved, the decision shall ordinarily be arrived at by discussion and consensus or
p.000023: it shall receive the support of a simple majority of those members present at the meeting.
p.000023:
p.000023: (3) HREC may, at its own discretion, invite representations from the applicant(s), sponsor(s), institution(s) or any
p.000023: other person(s) that it may consider relevant to provide information pertinent to the research during the review
p.000023: process.
p.000023:
p.000023:
p.000024: 24
p.000024:
p.000024: (4) HREC shall notify investigator(s) in writing of its decision to approve, disapprove or require modifications of the
p.000024: research activity.
p.000024:
p.000024: (5) HREC shall have a maximum of 3 months from the date of receipt of a valid application to give its decision to the
p.000024: applicant. An application shall be considered valid only after receipt of all materials required by HREC to give a
p.000024: determination.
p.000024:
p.000024: (6) Where HREC considers an application of such complexity that it cannot conclude the review, the application shall be
p.000024: referred to NHREC and the applicant duly informed within the stipulated 3 months.
p.000024:
p.000024: (7) Where HREC does not conclude its review in 3 months and has not referred the case to the NHREC, the applicant shall
...
p.000038: significant local health problems and add value to local participants of research, including researchers, institutions,
p.000038: communities and the country.
p.000038: b. For research to be ethical, it must be have scientific validity. Research lacking clear scientific
p.000038: objective(s); using invalid methodology; that is underpowered; lacking equipoise (for clinical studies); whose
p.000038: operationalizing plans are inadequate within the context of the environment where research would be conducted; lacks
p.000038: plausible data analysis plan (including a specific role for a Data and Safety Monitoring Board [DSMB] in clinical
p.000038: trials) and research with biased measurement(s) of outcome(s) is unethical.
p.000038: c. Ethical research must ensure fair selection of participants based on the scientific objective(s) of the
p.000038: research while minimizing risk. This requirement refers to both who is included and who is excluded from recruitment
p.000038: and the strategies employed for participants’ recruitment (including choice of research sites and communities).
p.000038: Regardless of this requirement, participants who are at
p.000039: 39
p.000039:
p.000039: excessively increased risk of harm should be excluded. Children, pregnant women, socially, culturally, economically,
p.000039: politically, educationally, physically and psychologically disadvantaged groups, groups with constrained autonomy and
p.000039: other vulnerable populations should not be excluded from research without explicit reasons for doing so; particularly
p.000039: from studies that can advance their health and well being. However specific safeguards should be included to protect
p.000039: the vulnerable, appropriate to degree of risk. Groups, communities, participants and researchers who bear the burden of
p.000039: research should share in the benefits.
p.000039: d. All research involve risks; to be ethical therefore, there must be valid attempts to minimize risks and
p.000039: maximize health related benefits (as distinguished from risks and benefits of therapies that participants would be
p.000039: exposed to even if they were not participating in research or incidental risks or benefits) to participants in order to
p.000039: engender favourable risk benefit ratio within the context of where the research is being conducted.
p.000039:
p.000039: (1) Where the risks outweigh the benefits to the participants, other criteria outlined in this code must justify such
p.000039: risks.
p.000039:
p.000039: (2) Risks and benefits should be considered at the level of individual research participants and at the community,
p.000039: whenever appropriate.
p.000039:
p.000039: (3) Comprehensive delineation of risks and benefits should be done for participants during the research, the population
p.000039: hosting the research and for both participants and population after completion of research
p.000039:
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.000021: attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of researchers and
p.000021: research participants. Members should have varying academic and professional backgrounds to promote complete and
p.000021: adequate review of health research conducted by the promoting institution.
p.000021: (d) In addition to possessing the professional competence necessary to review specific research activities, the HREC
p.000021: shall be able to ascertain the acceptability of proposed research in terms of institutional regulations, applicable
p.000021: laws, and standards of professional conduct and practice. The HREC shall therefore include persons knowledgeable in
p.000021: these areas and whenever feasible, a lawyer.
p.000021: (e) Each HREC shall include at least one member whose primary concerns are in scientific areas and at least one member
p.000021: whose primary concerns are in non-scientific areas.
p.000021: (f) Each HREC shall include at least one member who is not affiliated with the institution and who is not part of the
p.000021: immediate family of a person who is affiliated with the institution.
p.000021: (g) No HREC may have a member participate in the HREC initial or continuing review of any project in which the member
p.000021: has a conflicting interest.
p.000021: (h) If HREC wishes to review research that involves vulnerable participants, such as children, prisoners, pregnant
p.000021: women, physically and psychologically disabled persons, the HREC shall co-opt one or more individuals knowledgeable
p.000021: about and experienced in working with
p.000022: 22
p.000022:
p.000022: these participants for the review process. These individuals may not vote during the HREC meeting.
p.000022: (i) Each HREC member must pledge to maintain confidentiality regarding all meetings, deliberations, applications,
p.000022: information on research participants and related matters that shall come to his/her knowledge during service on HREC
p.000022: even after leaving the HREC assignment. There is no time limit for this prohibition.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
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p.000022:
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p.000022:
p.000022:
p.000022:
p.000022:
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p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000023: 23
p.000023:
p.000023: Section E
p.000023:
p.000023: HREC functions and operations
p.000023:
p.000023: In order to fulfil the requirements of this code, each HREC shall:
p.000023:
p.000023: (a) Operate in accordance with the provisions of the current version of the National Code of Health Research Ethics
p.000023: issued by the NHREC. Additional guidance may be obtained from the Standard Operating Procedure (SOP) issued by the
p.000023: NHREC.
p.000023:
p.000023: (b) Except when an expedited review procedure is used, research proposals shall be considered at regularly convened
...
p.000025: forms etc. that are related to the research and necessary for the HREC to conduct its oversight function.
p.000025:
p.000025: (3) This shall be at least once a year or at least once during the lifetime of the research where the duration of the
p.000025: research is less than a year.
p.000025:
p.000025: (4) HREC shall have authority to observe or cause to be observed on its behalf, the research and its consent process to
p.000025: ensure compliance with the highest scientific and ethical standards.
p.000025:
p.000025: (5) HREC may initiate process of oversight of research in the event of receipt of complaints, information or data
p.000025: relevant to the research from any source.
p.000025:
p.000025: (f) Process for expedited review
p.000025:
p.000025: (1) HREC may expedite review of research in the following circumstances:
p.000025:
p.000025: (a) Research is found to involve no more than minimal risk – meaning that the probability and magnitude of harm is no
p.000025: greater than that encountered in the daily lives of all (or the great majority) persons in the population (under normal
p.000025: circumstances) from which research participants are to be recruited. Note that minimal risk is applicable in
p.000025: non-therapeutic research only.
p.000025:
p.000025: (b) Research does not involve vulnerable populations such as children, prisoners, pregnant women etc.
p.000025:
p.000025:
p.000026: 26
p.000026:
p.000026: (c) Research does not contain serious methodological or ethical flaws
p.000026:
p.000026: (d) Minor changes in previously approved research during the period for which approval is authorized.
p.000026:
p.000026: (2) Expedited review may be carried out by the HREC chairperson or his designee from among members of HREC. In
p.000026: reviewing the research, the reviewer(s) shall exercise all of the authorities of HREC except that the reviewer(s) may
p.000026: not disapprove the research.
p.000026:
p.000026: (3) The Chairman of HREC shall bring all research reviewed expeditiously to the next meeting of HREC for notice,
p.000026: discussion and ratification.
p.000026:
p.000026: (g) Process for amendment of research
p.000026:
p.000026: (1) HREC shall require that applicants apply for permission to amend protocols in any of the following circumstances:
p.000026:
p.000026: (a) Where there are changes in any part of the research protocol that alters the risk benefit ratio of the research.
p.000026:
p.000026: (b) Where there are changes in the named members of the team conducting the research.
p.000026:
p.000026: (c) Where there are changes in research sites.
p.000026:
p.000026: (c) Where there are changes in sponsorship, institutional guidelines, institutional structure, HREC requirements,
p.000026: national laws or exigencies that impact on the ethical conduct of research.
p.000026:
p.000026: (2) HREC shall require that researcher submit an application for original research approval where in its opinion, the
...
p.000038: of research. In certain instances, for example in some international collaborative studies, research should be
p.000038: integrated with comprehensive capacity building, technology transfer and health care delivery strategies that address
p.000038: significant local health problems and add value to local participants of research, including researchers, institutions,
p.000038: communities and the country.
p.000038: b. For research to be ethical, it must be have scientific validity. Research lacking clear scientific
p.000038: objective(s); using invalid methodology; that is underpowered; lacking equipoise (for clinical studies); whose
p.000038: operationalizing plans are inadequate within the context of the environment where research would be conducted; lacks
p.000038: plausible data analysis plan (including a specific role for a Data and Safety Monitoring Board [DSMB] in clinical
p.000038: trials) and research with biased measurement(s) of outcome(s) is unethical.
p.000038: c. Ethical research must ensure fair selection of participants based on the scientific objective(s) of the
p.000038: research while minimizing risk. This requirement refers to both who is included and who is excluded from recruitment
p.000038: and the strategies employed for participants’ recruitment (including choice of research sites and communities).
p.000038: Regardless of this requirement, participants who are at
p.000039: 39
p.000039:
p.000039: excessively increased risk of harm should be excluded. Children, pregnant women, socially, culturally, economically,
p.000039: politically, educationally, physically and psychologically disadvantaged groups, groups with constrained autonomy and
p.000039: other vulnerable populations should not be excluded from research without explicit reasons for doing so; particularly
p.000039: from studies that can advance their health and well being. However specific safeguards should be included to protect
p.000039: the vulnerable, appropriate to degree of risk. Groups, communities, participants and researchers who bear the burden of
p.000039: research should share in the benefits.
p.000039: d. All research involve risks; to be ethical therefore, there must be valid attempts to minimize risks and
p.000039: maximize health related benefits (as distinguished from risks and benefits of therapies that participants would be
p.000039: exposed to even if they were not participating in research or incidental risks or benefits) to participants in order to
p.000039: engender favourable risk benefit ratio within the context of where the research is being conducted.
p.000039:
p.000039: (1) Where the risks outweigh the benefits to the participants, other criteria outlined in this code must justify such
p.000039: risks.
p.000039:
p.000039: (2) Risks and benefits should be considered at the level of individual research participants and at the community,
p.000039: whenever appropriate.
p.000039:
...
Social / Access to Social Goods
Searching for indicator socialXwelfare:
(return to top)
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: 2
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
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p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: Foreword
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: Acknowledgement
p.000004:
p.000004: This document is the property of the Federal Ministry of Health, and was developed with technical support of the West
p.000004: African Bioethics Training Programme (WAB).
p.000004:
p.000004: We thank the members of the WAB team which included
p.000004: Ven. Dr. Adefolarin Obanishola Malomo MB,BS, FWACS, FICS; Dr Emmanuel Babatunde Omobowale Ph.D (English), M.A
p.000004: (Bioethics; Dr. (Mrs.) Jane Roli Adebusuyi PhD (Social Welfare); Dr. (Mrs.) Bolatito Asiata Lanre-Abass, PhD
p.000004: (Philosophy); Dr. John Oluwole A. Akintayo LL.B, LL.M, PhD (Law); Dr Adebayo Olayiwola Adejumo BSc (Nursing), MHSc
p.000004: (Bioethics), PhD (Psychology); Dr. Ademola J. Ajuwon BSc, MPH, PhD; Professor (Mrs.) Olaitan Soyannwo MBBS, DA, M.Med,
p.000004: FWACS, FAS; Arc. Mrs. Eugenious Adebamowo BSc, MSc; Dr. Ayodele Samuel Jegede BSc, MSc, MHSc (Bioethics), PhD; Mrs.
p.000004: Oluwatoyin Siminsola Akintola LLM; Dr. Christopher Agulanna, B.A., M.A. (Lagos); PhD (Ibadan)
p.000004:
p.000004: The following members of the Federal Ministry of Health; Dr. Jonathan Jiya, Dr. A. Nasidi, Dr. J. M. Adekeye, and Mr.
p.000004: Aminu Yakubu; also made significant contributions to the development of the code.
p.000004:
p.000004: Special thanks to Professor Clement Adebamowo BM, ChB Hons (Jos), FWACS, FACS, Sc.D. (Harvard) who developed the
p.000004: preliminary draft code, coordinated and supported the entire technical consultation process with his NIH Research Grant
p.000004: No. D43 TW007091 funded by the Fogarty International Center and the National Human Genome Research Institute.
p.000004:
p.000004: Thanks also to Mr. M. L. Oladejo and Mr. Ali Gubio for providing support towards the final editing and printing of the
p.000004: code.
p.000004:
p.000004: Thanks are also due to the all the departments of the Federal Ministry of Health and the various stakeholders for their
p.000004: contributions during the consultation process.
p.000004:
p.000005: 5
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
...
Searching for indicator access:
(return to top)
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000035: 35
p.000035:
p.000035: (q) Fees
p.000035:
p.000035: HREC may charge fees for any or all of its activities, at its discretion and in consultation with the principal
p.000035: officers of the institution.
p.000035:
p.000035: (1) Fees may vary depending on the size, complexity, duration, status of researcher and sponsor of the researcher.
p.000035:
p.000035: (2) Fees must be commensurate with anticipated expenses required for adequate oversight of research.
p.000035:
p.000035: (r) Protection of participants in the research enterprise
p.000035:
p.000035: HREC must protect the rights of researcher(s)
p.000035:
p.000035: (1) HREC shall protect the right of researcher(s) to publish their research.
p.000035:
p.000035: (a) In certain situations, this will require the submission of an agreement between sponsor(s), institution(s) and
p.000035: researcher(s) allowing researcher(s) to use the outcome of research in manner consistent with current practice within
p.000035: the research community.
p.000035:
p.000035: (b) HREC shall evaluate whether such agreement is necessary when the research is being reviewed and if found necessary,
p.000035: request same before approval is given.
p.000035:
p.000035: (2) HREC shall protect researchers from exploitation.
p.000035:
p.000035: (a) In certain situations, this will require the submission of an agreement between sponsor(s), institution(s) and
p.000035: researcher(s) indicating rights to, ownership of and rights of access to data, resources, intellectual property and
p.000035: infrastructure generated in the course of the research.
p.000035:
p.000035: (b) HREC should evaluate whether such agreement is necessary when the research is being
p.000035:
p.000036: 36
p.000036:
p.000036: reviewed and if found necessary, request same before approval is given.
p.000036:
p.000036: (3) HREC shall protect communities participating in research from exploitation.
p.000036:
p.000036: (a) In certain situations, this will require the submission of an agreement between sponsor(s), institution(s),
p.000036: researcher(s) and the community indicating adequate community consultation and agreement with the proposed research.
p.000036:
p.000036: (b) HREC should evaluate whether such agreement is necessary when the research is being reviewed and if found
p.000036: necessary, request same before approval is given. This implies that the HREC has ordinarily found the study approvable
p.000036: but requires that the community should be engaged and their assent sought before research is allowed to proceed. In
p.000036: this circumstance, the HREC cannot change its decision on the approval status of the research once the community
p.000036: engagement process has commenced. If the community engagement fails, then the research cannot proceed in that community
p.000036:
p.000036: (c) Where applicable, such community assent or engagement efforts shall be documented and evidence of same submitted to
p.000036: HREC during the research review process.
p.000036:
p.000036: (d) In some instances, it will be necessary to set up a community advisory board (CAB). Such boards may be established
p.000036: by the study investigators in consultation with the community.
p.000036:
...
Social / Age
Searching for indicator age:
(return to top)
p.000019: qualifications, training and experience of its members in research ethics and science, history of the committee (when
p.000019: established, past review activities, record keeping and compliance with requirements of the Code), resources available
p.000019: to the committee, supporting personnel and infrastructure of both the committee and the proposing institution.
p.000019:
p.000019: (1) NHREC shall outline from time to time detailed criteria for categorization of HREC.
p.000019:
p.000019: (2) Categorization of HREC shall be approved during regularly scheduled meetings of the NHREC.
p.000019:
p.000020: 20
p.000020:
p.000020: (3) NHREC shall outline the types of research that different categories of HREC shall review.
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000021: 21
p.000021:
p.000021: Section D
p.000021:
p.000021: HREC membership
p.000021:
p.000021: (a) The authority to establish a HREC and the procedure of selecting members is vested in the Headship of the proposing
p.000021: institution.
p.000021: (b) Each HREC shall have at least five members and if more, then the total membership must always be an odd number.
p.000021: (c) The HREC shall be sufficiently qualified through the experience, expertise and diversity of its members, including
p.000021: consideration of age, gender, socio-cultural backgrounds, religion and sensitivity to such issues as community
p.000021: attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of researchers and
p.000021: research participants. Members should have varying academic and professional backgrounds to promote complete and
p.000021: adequate review of health research conducted by the promoting institution.
p.000021: (d) In addition to possessing the professional competence necessary to review specific research activities, the HREC
p.000021: shall be able to ascertain the acceptability of proposed research in terms of institutional regulations, applicable
p.000021: laws, and standards of professional conduct and practice. The HREC shall therefore include persons knowledgeable in
p.000021: these areas and whenever feasible, a lawyer.
p.000021: (e) Each HREC shall include at least one member whose primary concerns are in scientific areas and at least one member
p.000021: whose primary concerns are in non-scientific areas.
p.000021: (f) Each HREC shall include at least one member who is not affiliated with the institution and who is not part of the
p.000021: immediate family of a person who is affiliated with the institution.
p.000021: (g) No HREC may have a member participate in the HREC initial or continuing review of any project in which the member
p.000021: has a conflicting interest.
...
p.000035:
p.000035: (b) HREC should evaluate whether such agreement is necessary when the research is being
p.000035:
p.000036: 36
p.000036:
p.000036: reviewed and if found necessary, request same before approval is given.
p.000036:
p.000036: (3) HREC shall protect communities participating in research from exploitation.
p.000036:
p.000036: (a) In certain situations, this will require the submission of an agreement between sponsor(s), institution(s),
p.000036: researcher(s) and the community indicating adequate community consultation and agreement with the proposed research.
p.000036:
p.000036: (b) HREC should evaluate whether such agreement is necessary when the research is being reviewed and if found
p.000036: necessary, request same before approval is given. This implies that the HREC has ordinarily found the study approvable
p.000036: but requires that the community should be engaged and their assent sought before research is allowed to proceed. In
p.000036: this circumstance, the HREC cannot change its decision on the approval status of the research once the community
p.000036: engagement process has commenced. If the community engagement fails, then the research cannot proceed in that community
p.000036:
p.000036: (c) Where applicable, such community assent or engagement efforts shall be documented and evidence of same submitted to
p.000036: HREC during the research review process.
p.000036:
p.000036: (d) In some instances, it will be necessary to set up a community advisory board (CAB). Such boards may be established
p.000036: by the study investigators in consultation with the community.
p.000036:
p.000036: (e) Members of CAG shall be selected by the community through their usual consultative process and it shall include
p.000036: broad representation of community members based on age, sex, religion and other community parameters that may be
p.000036: relevant to the study. It may include relatively more representation from population of interest to the study. It may
p.000036: include representatives from the research group and
p.000037: 37
p.000037:
p.000037: other non-community members whose special knowledge or expertise may be considered necessary for effective functioning
p.000037: of the community advisory group. In all instances, members of the community must constitute a simple majority of the
p.000037: CAB.
p.000037:
p.000037: (f) The function of the CAB is to provide community members opportunity to share their views about ethical issues that
p.000037: proposed research raises for individual community members, community as a whole, neighbouring communities and their
p.000037: region/nation. The CAB also provides a forum for dissemination of pre, intra and post-research information to the
p.000037: community. Members of CAB may provide advice and support as needed for the successful implementation of research.
p.000037:
p.000037: (g) The definition of community shall vary with research and shall be based on application of the best scientific
p.000037: principles.
p.000037:
p.000037: (4) HREC must protect researcher(s) from undue pressure from sponsor(s), institution(s), participant(s) or any other
p.000037: source by ensuring that no researcher enters into an agreement or is subjected to circumstances that limits his/her
p.000037: legal rights, freedoms and obligations under Nigerian law to pursue his/her research activities.
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
...
Social / Child
Searching for indicator children:
(return to top)
p.000021: attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of researchers and
p.000021: research participants. Members should have varying academic and professional backgrounds to promote complete and
p.000021: adequate review of health research conducted by the promoting institution.
p.000021: (d) In addition to possessing the professional competence necessary to review specific research activities, the HREC
p.000021: shall be able to ascertain the acceptability of proposed research in terms of institutional regulations, applicable
p.000021: laws, and standards of professional conduct and practice. The HREC shall therefore include persons knowledgeable in
p.000021: these areas and whenever feasible, a lawyer.
p.000021: (e) Each HREC shall include at least one member whose primary concerns are in scientific areas and at least one member
p.000021: whose primary concerns are in non-scientific areas.
p.000021: (f) Each HREC shall include at least one member who is not affiliated with the institution and who is not part of the
p.000021: immediate family of a person who is affiliated with the institution.
p.000021: (g) No HREC may have a member participate in the HREC initial or continuing review of any project in which the member
p.000021: has a conflicting interest.
p.000021: (h) If HREC wishes to review research that involves vulnerable participants, such as children, prisoners, pregnant
p.000021: women, physically and psychologically disabled persons, the HREC shall co-opt one or more individuals knowledgeable
p.000021: about and experienced in working with
p.000022: 22
p.000022:
p.000022: these participants for the review process. These individuals may not vote during the HREC meeting.
p.000022: (i) Each HREC member must pledge to maintain confidentiality regarding all meetings, deliberations, applications,
p.000022: information on research participants and related matters that shall come to his/her knowledge during service on HREC
p.000022: even after leaving the HREC assignment. There is no time limit for this prohibition.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000023: 23
p.000023:
p.000023: Section E
p.000023:
p.000023: HREC functions and operations
p.000023:
p.000023: In order to fulfil the requirements of this code, each HREC shall:
p.000023:
p.000023: (a) Operate in accordance with the provisions of the current version of the National Code of Health Research Ethics
p.000023: issued by the NHREC. Additional guidance may be obtained from the Standard Operating Procedure (SOP) issued by the
p.000023: NHREC.
p.000023:
...
p.000025: forms etc. that are related to the research and necessary for the HREC to conduct its oversight function.
p.000025:
p.000025: (3) This shall be at least once a year or at least once during the lifetime of the research where the duration of the
p.000025: research is less than a year.
p.000025:
p.000025: (4) HREC shall have authority to observe or cause to be observed on its behalf, the research and its consent process to
p.000025: ensure compliance with the highest scientific and ethical standards.
p.000025:
p.000025: (5) HREC may initiate process of oversight of research in the event of receipt of complaints, information or data
p.000025: relevant to the research from any source.
p.000025:
p.000025: (f) Process for expedited review
p.000025:
p.000025: (1) HREC may expedite review of research in the following circumstances:
p.000025:
p.000025: (a) Research is found to involve no more than minimal risk – meaning that the probability and magnitude of harm is no
p.000025: greater than that encountered in the daily lives of all (or the great majority) persons in the population (under normal
p.000025: circumstances) from which research participants are to be recruited. Note that minimal risk is applicable in
p.000025: non-therapeutic research only.
p.000025:
p.000025: (b) Research does not involve vulnerable populations such as children, prisoners, pregnant women etc.
p.000025:
p.000025:
p.000026: 26
p.000026:
p.000026: (c) Research does not contain serious methodological or ethical flaws
p.000026:
p.000026: (d) Minor changes in previously approved research during the period for which approval is authorized.
p.000026:
p.000026: (2) Expedited review may be carried out by the HREC chairperson or his designee from among members of HREC. In
p.000026: reviewing the research, the reviewer(s) shall exercise all of the authorities of HREC except that the reviewer(s) may
p.000026: not disapprove the research.
p.000026:
p.000026: (3) The Chairman of HREC shall bring all research reviewed expeditiously to the next meeting of HREC for notice,
p.000026: discussion and ratification.
p.000026:
p.000026: (g) Process for amendment of research
p.000026:
p.000026: (1) HREC shall require that applicants apply for permission to amend protocols in any of the following circumstances:
p.000026:
p.000026: (a) Where there are changes in any part of the research protocol that alters the risk benefit ratio of the research.
p.000026:
p.000026: (b) Where there are changes in the named members of the team conducting the research.
p.000026:
p.000026: (c) Where there are changes in research sites.
p.000026:
p.000026: (c) Where there are changes in sponsorship, institutional guidelines, institutional structure, HREC requirements,
p.000026: national laws or exigencies that impact on the ethical conduct of research.
p.000026:
...
p.000038: meaningful knowledge. Such knowledge should be disseminated to all relevant stakeholders during and after the conduct
p.000038: of research. In certain instances, for example in some international collaborative studies, research should be
p.000038: integrated with comprehensive capacity building, technology transfer and health care delivery strategies that address
p.000038: significant local health problems and add value to local participants of research, including researchers, institutions,
p.000038: communities and the country.
p.000038: b. For research to be ethical, it must be have scientific validity. Research lacking clear scientific
p.000038: objective(s); using invalid methodology; that is underpowered; lacking equipoise (for clinical studies); whose
p.000038: operationalizing plans are inadequate within the context of the environment where research would be conducted; lacks
p.000038: plausible data analysis plan (including a specific role for a Data and Safety Monitoring Board [DSMB] in clinical
p.000038: trials) and research with biased measurement(s) of outcome(s) is unethical.
p.000038: c. Ethical research must ensure fair selection of participants based on the scientific objective(s) of the
p.000038: research while minimizing risk. This requirement refers to both who is included and who is excluded from recruitment
p.000038: and the strategies employed for participants’ recruitment (including choice of research sites and communities).
p.000038: Regardless of this requirement, participants who are at
p.000039: 39
p.000039:
p.000039: excessively increased risk of harm should be excluded. Children, pregnant women, socially, culturally, economically,
p.000039: politically, educationally, physically and psychologically disadvantaged groups, groups with constrained autonomy and
p.000039: other vulnerable populations should not be excluded from research without explicit reasons for doing so; particularly
p.000039: from studies that can advance their health and well being. However specific safeguards should be included to protect
p.000039: the vulnerable, appropriate to degree of risk. Groups, communities, participants and researchers who bear the burden of
p.000039: research should share in the benefits.
p.000039: d. All research involve risks; to be ethical therefore, there must be valid attempts to minimize risks and
p.000039: maximize health related benefits (as distinguished from risks and benefits of therapies that participants would be
p.000039: exposed to even if they were not participating in research or incidental risks or benefits) to participants in order to
p.000039: engender favourable risk benefit ratio within the context of where the research is being conducted.
p.000039:
p.000039: (1) Where the risks outweigh the benefits to the participants, other criteria outlined in this code must justify such
p.000039: risks.
p.000039:
...
p.000042:
p.000042: (6) Research participants are entitled to retain a copy of the consent form.
p.000042:
p.000042: (7) Where appropriate, researcher(s) may be required to undertake a re-consenting process during the course of research
p.000042: as determined by the HREC.
p.000042:
p.000042: (8) Where, in ordinary circumstances, participant(s) are unable to provide written consent, researcher(s) must propose
p.000042: a process of consent that adequately records participants’ informed decision such as witnessed thumb- printing or
p.000042: witnessed audio recording. The process proposed must be approved by the HREC before the research commences.
p.000042:
p.000042: (9) HREC may require that all or some types of consent process be witnessed.
p.000042:
p.000042: (10) Researcher(s) must keep all copies of consent form and make them available for examination by participant(s),
p.000042: sponsor(s), institution(s), HREC and NHREC.
p.000042:
p.000042: (11) Where appropriate, HREC may require researchers to provide translations of consent processes appropriate to the
p.000042: socio-cultural characteristics of the population to be studied.
p.000042:
p.000042: (12) All consent activities must be documented.
p.000042:
p.000042: (13) Consent in other situations, including research involving children, persons with diminished autonomy, vulnerable
p.000042: populations and other extraordinary situations, including waiver of consent, are described in other guidance documents
p.000042: issued by NHREC.
p.000042:
p.000042: (g) For research to be ethical there must be respect for potential and enrolled participants. This implies that
p.000042: potential participants be treated with respect from the
p.000043: 43
p.000043:
p.000043: moment that they are approached to the conclusion of the research should they choose to participate. Their right to
p.000043: privacy may not be needlessly compromised. Participants must know that their involvement is voluntary and that they can
p.000043: withdraw at any time without penalties. However, data, samples, etc. already contributed to the research up to that
p.000043: point may not needlessly be withdrawn as this may jeopardise the scientific validity of the research, unjust to those
p.000043: who remain in the study and all or part of their sample or data may have been used or modified into different form(s),
p.000043: including presentation at meetings or publications by the researchers.
p.000043:
p.000043: Respect entails that participants must be treated as partners in the research enterprise with every opportunity taken
p.000043: to inform them of the progress of the research and any new finding that may have potential impact on their health and
p.000043: well being, and on their continued participation in the research. It also entails protection of the welfare of research
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000049:
p.000049: (1) Attendance at the meetings.
p.000049:
p.000049: (2) Actions taken by the HREC.
p.000049:
p.000049: (3) The vote on these actions including the number of members voting for, against, and abstaining.
p.000049:
p.000049: (4) The basis for requiring changes in or disapproving research.
p.000049:
p.000050: 50
p.000050:
p.000050: (5) A written summary of the discussion of controversial issues and their resolution.
p.000050:
p.000050: (c) Records of continuing oversight activities.
p.000050:
p.000050: (d) Copies of all correspondence between the HREC and applicants, researchers, sponsors, and any other agent consulted
p.000050: by HREC in the discharge of its duties.
p.000050:
p.000050: (e) Statements of complaints or information/data used to determine decision(s) on research.
p.000050:
p.000050: (f) The applicant applying for ethics review must submit the following:
p.000050:
p.000050: (1) Copy of the research proposal.
p.000050:
p.000050: (2) Copy of all materials to be used for the consent process such as consent forms and advertisements, including but
p.000050: not limited to promotional materials, advertisements, notices in newspapers, trade publications, audio, video and web
p.000050: advertisements.
p.000050:
p.000050: (3) Copy of brief curriculum vitae (2 – 3 pages) of the principal investigator(s) sufficient to judge ability to carry
p.000050: out the proposed research.
p.000050:
p.000050: (4) Copy of letter(s) of support from co- investigator(s), laboratories and sources of required resources.
p.000050:
p.000050: (5) Where applicable, letter of sponsorship.
p.000050:
p.000050: (6) One page plain language summary of the research.
p.000050:
p.000050: (7) Copies of all questionnaires and instruments to be used for the study.
p.000050:
p.000050: (8) Other ethics committee(s)’ review of the study and their decisions, where applicable.
p.000050:
p.000051: 51
p.000051:
p.000051: (9) Evidence of NHREC certified informed consent training by applicant and co-investigator(s) undertaken within 2 years
p.000051: of the date of submission of a valid application to HREC.
p.000051:
p.000051: (10) Copies of all agreements such as the MTA etc. where indicated.
p.000051:
p.000051: (g) Investigator(s) must submit an annual report on their research to HREC within 3 months of expiry of their current
p.000051: research approval. This report shall contain brief summary statistics about the research – number of participants
p.000051: recruited and their breakdown, number of adverse events, complaints and their resolution, any ongoing investigation or
p.000051: review and copies of any publications, reports or abstracts arising from the research. Failure to submit annual report
p.000051: within the stipulated period shall lead to termination of research by HREC. HREC may issue letters of notification
p.000051: advising researchers of the need to submit annual reports.
p.000051:
p.000051: (h) HREC shall determine the form and number of copies of materials to be submitted by applicants for research review.
p.000051:
p.000051: (i) All HREC records shall be accessible for inspection and copying by NHREC and through NHREC by other agencies at the
p.000051: discretion of NHREC and in a reasonable manner.
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000052: 52
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.000029: can allow the research to proceed or resume as the case may be.
p.000029: c. Where NHREC mandates restoration of the research, the institutional HREC shall have powers of continuing oversight
p.000029: as outlined in relevant sections of this code
p.000029:
p.000029: (3) NHREC may sustain the decision of the HREC and dismiss the appeal.
p.000029:
p.000029: (m) Process for review of multi-institutional research
p.000029:
p.000029: In the conduct of multi-institutional research, each institution is responsible for safeguarding the rights and welfare
p.000029: of human participants in its institution and for complying with this code.
p.000029:
p.000029:
p.000030: 30
p.000030:
p.000030: (1) Where there are no more than 3 Nigerian research
p.000030: sites:
p.000030:
p.000030: (a) The principal investigator at each research site may apply to the institutional HREC for review.
p.000030:
p.000030: (b) HREC may, at its own discretion, adopt the approval of research by another HREC rather than conduct a fresh review
p.000030: and approve the research.
p.000030:
p.000030: (c) Where the outcome of review is discordant (that is, some HREC approve while others disapprove the research), the
p.000030: applicant shall submit the comments from the different HREC to their institutional HREC for consideration and possible
p.000030: reconciliation.
p.000030:
p.000030: (d) Where the outcome of review by different institutional HREC is favourable but different modifications are
p.000030: requested, the applicant shall submit the comments their institutional HREC for reconciliation.
p.000030:
p.000030: (e) HREC shall, as much as possible, consult with each other in order to resolve discordant reviews and generate
p.000030: consistent single response to multi-site research.
p.000030:
p.000030: (2) Where there are more than 3 Nigerian research
p.000030: sites:
p.000030:
p.000030: (a) Applicant(s) may follow the steps outlined
p.000030: above or
p.000030:
p.000030: (b) Applicant(s) may apply to NHREC directly.
p.000030:
p.000030: (3) In international collaborative research
p.000030:
p.000030: (a) Only applicant(s) with qualification(s) and background sufficient to serve as principal investigator(s) and based
p.000030: in a registered institution in
p.000030:
p.000031: 31
p.000031:
p.000031: Nigeria that is capable of carrying out the proposed research shall apply for review of research.
p.000031:
p.000031: (b) HREC may adopt the approval of another HREC or that of any other local or international ethics review committee (to
p.000031: the degree that such approvals comply with the requirements of the code and take account of local circumstances) and
p.000031: approve the research.
p.000031:
p.000031: (c) Where the outcome of review is discordant, the applicant shall submit the comments from the different HREC or
p.000031: ethics committees their institutional HREC for consideration and possible reconciliation.
p.000031:
p.000031: (d) Where the outcome of review is favourable but different modifications are requested, the applicant shall submit the
p.000031: comments from the different HREC or ethics committees their institutional HREC for consideration and possible
p.000031: reconciliation.
p.000031:
p.000031: (e) HREC and ethics committees shall, as much as possible, consult with each other in order to resolve discordant
p.000031: reviews and generate consistent single response to multi-site research.
p.000031:
p.000031:
p.000031:
p.000031: (n) Materials Transfer Agreement
p.000031:
p.000031: Transfer of samples and biological materials such as animals, herbs and plants out of Nigeria shall require a Materials
p.000031: Transfer Agreement (MTA) detailing the type of materials, anticipated use, location of storage outside Nigeria,
p.000031: duration of such storage, limitations on use, transfer and termination of use of such materials subject to any law,
p.000031: regulations and enactment in Nigeria.
p.000031:
p.000031: The purpose of MTA is to protect the interests of local researchers and Nigeria’s human and natural resources in all
p.000031: its biodiversity as well as how they can be legitimately used. It ensures that the interests of all relevant parties,
p.000031: human
p.000032: 32
p.000032:
p.000032: and community participants in research and the Nigerian nation are protected from exploitation and egregious harm.
p.000032:
p.000032: (a) The MTA shall be signed by all parties involved in the research including local and international principal
p.000032: investigators, heads of local institutions, research sponsors and other relevant parties.
p.000032:
p.000032: (b) HREC shall review the MTA to ensure consistency with the stated objectives of the research, the contents of the
p.000032: informed consent documents and the principles enumerated above. The HREC shall grant provisional approval pending the
p.000032: submission of MTA to NHREC and receipt of acknowledgement from the NHREC.
p.000032:
p.000032: (c) The applicant for research review shall file a copy of the MTA and provisional approval by the institutional HREC
...
Social / Police Officer
Searching for indicator officer:
(return to top)
p.000013: and analysis of data or collection of new data but they do not involve allocation into groups or randomisation.
p.000013:
p.000013: (e) Studies that are designed to evaluate or assess quality of services, programs and procedures and formulate
p.000013: guidelines leading to their improvement are exempt. Such studies may involve the collection and analysis of some data.
p.000013:
p.000013: (f) Innovative or non-validated medical treatment – treatment that is designed solely for the benefit of the patient
p.000013: but in which the ability of the treatment to result in the desired result is to some degree not proven. Such activities
p.000013: are exempt while recommending that they should be subjected to research in order to generate information about their
p.000013: efficacy as soon as possible.
p.000013:
p.000013: (g) Clinical audit, where the study is designed and conducted solely to define or judge only current care, without
p.000013: reference to a standard. It may involve the collection and analysis of data but there is no allocation to intervention
p.000013: groups or randomisation and the services have been delivered before the audit is initiated.
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: Who determines exemption?
p.000014:
p.000014: All exemptions shall be determined by the Health Research Ethics Committee (HREC) - vide infra. In summary, applicants
p.000014: conducting research that may be exempt shall submit the proposal or a written summary that contains enough information
p.000014: for judgement to be made, to the HREC. The HREC Chairperson or his designee, in consultation with HREC Administrative
p.000014: Officer – where one exists, shall decide whether the research is exempt. Where the Chairperson is uncertain and the
p.000014: uncertainty is unresolved after request for and provision of more information by the applicant, the proposal or summary
p.000014: should be referred to HREC. All applications for exemption must be brought to the notice of HREC at its regular meeting
p.000014: for discussion as may be deemed necessary by members of HREC.
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000015: 15
p.000015:
p.000015: Section C
p.000015:
p.000015: Registration of Health Research Ethics Committees
p.000015:
p.000015: In order for an institution to be able to conduct health research, the institution must have a registered health
p.000015: research ethics committee (HREC). The following are the guidelines for registration:
p.000015:
p.000015: (a) Registration with National Health Research Ethics Committee (NHREC) shall require:
p.000015:
p.000015: (1) An application by the authorized head of the institution or their authorized designee which among other things
p.000015: should include that the line of reporting authority of the Chairman of the HREC is directly to the Chief Executive of
p.000015: the proposing institution.
p.000015:
p.000015: (2) A list of members of the proposed health research ethics committee identified by:
p.000015:
p.000015: i. Name
p.000015:
...
p.000026:
p.000026: (c) Where there are changes in research sites.
p.000026:
p.000026: (c) Where there are changes in sponsorship, institutional guidelines, institutional structure, HREC requirements,
p.000026: national laws or exigencies that impact on the ethical conduct of research.
p.000026:
p.000026: (2) HREC shall require that researcher submit an application for original research approval where in its opinion, the
p.000026: proposed amendments are substantial, such as but not limited to, change(s) in inclusion or exclusion criteria,
p.000026: randomization, interventions and outcome measures.
p.000027: 27
p.000027:
p.000027: (3) Under no circumstance shall a researcher deviate from approved protocol, except such as is necessary to eliminate
p.000027: immediate hazard to research participants. The researcher shall notify the Chairman of HREC within 24 hours of such
p.000027: changes.
p.000027:
p.000027: (4) In such circumstances as described in section (3) above, the researcher shall stop the research and the HREC shall
p.000027: conduct a thorough review of the research before authorizing suspension, continuation or modifications to the research.
p.000027:
p.000027: (h) Process for exemption
p.000027:
p.000027: (1) HREC may grant exemption from review in any of the conditions enumerated above (vide supra).
p.000027:
p.000027: (2) Applicants seeking exemption shall submit the proposed research or adequate information about it to the HREC,
p.000027: sufficient, in HREC judgement, to make a determination.
p.000027:
p.000027: (3) Exemptions may be granted by the HREC chairperson or his designee from among members of the HREC, in consultation
p.000027: with the HREC Administrative Officer – where one exists.
p.000027:
p.000027: (4) In granting exemption, the reviewer(s) shall exercise all of the authorities of the HREC except that the
p.000027: reviewer(s) may not disapprove the research.
p.000027:
p.000027: (5) Where the reviewer is uncertain and the uncertainty is unresolved after request for and provision of more
p.000027: information by the applicant, the proposal or summary should be referred to the HREC.
p.000027:
p.000027: (6) The Chairman of HREC shall bring all exempted research to the next meeting of HREC for notice, discussion and
p.000027: ratification.
p.000027:
p.000027: (i) Process for suspension of research
p.000027:
p.000028: 28
p.000028:
p.000028: (1) HREC shall have authority to suspend research that is not being conducted:
p.000028:
p.000028: (a) In accordance with HREC requirements or
p.000028: (b) In accordance with existing legislation or
p.000028: (c) In accordance with existing institutional guidelines; or
p.000028: (d) Where research is associated with unexpected serious harm to participants.
p.000028:
p.000028: (2) Any suspension of research shall include a statement of the reason(s) for the HREC action and shall be reported
p.000028: within 2 weeks to the researcher(s), institution(s), sponsor(s) and the NHREC.
p.000028:
p.000028: (3) Researcher(s), institution(s) or sponsor(s) shall be entitled to ask for a reconsideration of the decision of HREC
p.000028: to suspend research within 2 weeks of receipt of notification.
p.000028:
p.000028: (j) Process for revision of suspension
p.000028:
p.000028: (1) HREC may reverse its decision to suspend research if the precipitant(s) of the action is resolved to HREC
p.000028: satisfaction
p.000028:
...
Searching for indicator police:
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p.000053:
p.000053: (a) Such recommendations shall be made after exhaustion of all steps outlined in this code for resolution of problems
p.000053: identified in research.
p.000053:
p.000053: (b) Such recommendations shall be made after the matter is discussed at a regularly convened ordinary meeting of the
p.000053: HREC.
p.000053:
p.000053: (c) All records pertinent to the matter shall be forwarded to the NHREC within 2 weeks of the HREC meeting at which the
p.000053: decision is taken to recommend the matter to NHREC and a formal notice shall be issued to the researcher(s),
p.000053: institution(s) or sponsors(s) by the HREC.
p.000053:
p.000053: (d) Such recommendation shall not preclude the HREC from reporting acts that are clear violations of civil and criminal
p.000053: law such as fraud, assault and battery to constituted authorities or clear violations of institutional rules and
p.000053: guidelines to the institution where the researcher is based.
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000054: 54
p.000054:
p.000054: Section N
p.000054:
p.000054: NHREC Compliance and Disciplinary Powers
p.000054:
p.000054: (a) NHREC may advertise all cases of research misconduct reported to it, its plan of action and the resolution of cases
p.000054: to the public.
p.000054:
p.000054: (b) NHREC shall recommend disciplinary action against researcher(s) to the institutional and legally constituted
p.000054: authorities.
p.000054:
p.000054: (c) NHREC shall report all cases of fraud, deception, infamous conduct, plagiarism, fabrication, falsification to the
p.000054: appropriate regulatory, the police and other relevant authorities.
p.000054:
p.000054: (d) NHREC shall bar researchers from conducting research for variable periods of time depending on the severity of
p.000054: findings of misconduct.
p.000054:
p.000054: (e) NHREC shall cause researchers to make restitution appropriate to the case under consideration to research
p.000054: participants, collaborators, institutions, sponsors or any other persons as may be required by the facts of the case.
p.000054:
p.000054: (f) NHREC shall institute legal action against researchers and institutions found in violation of these guidelines
p.000054:
p.000054: (g) In international collaborative research, NHREC shall report its findings of misconduct against researchers,
p.000054: sponsors and collaborators to the national ethics regulatory agency of the country of origin of the researcher. This
p.000054: does not preclude the institution of appropriate legal action, where indicated, against such researchers, his/her
p.000054: representatives, collaborators or agents in Nigeria.
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000055: 55
p.000055:
p.000055: Section O
p.000055:
p.000055: Continuing Review of the National Code of Health Research Ethics and sub-codes
p.000055:
p.000055: The NHREC shall regularly update, revise, edit and modify the National Code of Health Research Ethics in accordance
p.000055: with new developments in international research ethics, local laws and enactments and at its discretion.
p.000055:
p.000055: The most recent version shall always be posted on the index page of the web site of the NHREC (http://www.nhrec.net)
...
Social / Property Ownership
Searching for indicator property:
(return to top)
p.000002: Federal Secretariat Complex Shehu Shagari Way
p.000002: P.M.B. 083, Garki – Abuja, Abuja, Nigeria
p.000002: E-mail: secretary@nhrec.net, deskofficer@nhrec.net Website: http://www.nhrec.net
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
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p.000003: 3
p.000003:
p.000003: Foreword
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p.000004: 4
p.000004:
p.000004: Acknowledgement
p.000004:
p.000004: This document is the property of the Federal Ministry of Health, and was developed with technical support of the West
p.000004: African Bioethics Training Programme (WAB).
p.000004:
p.000004: We thank the members of the WAB team which included
p.000004: Ven. Dr. Adefolarin Obanishola Malomo MB,BS, FWACS, FICS; Dr Emmanuel Babatunde Omobowale Ph.D (English), M.A
p.000004: (Bioethics; Dr. (Mrs.) Jane Roli Adebusuyi PhD (Social Welfare); Dr. (Mrs.) Bolatito Asiata Lanre-Abass, PhD
p.000004: (Philosophy); Dr. John Oluwole A. Akintayo LL.B, LL.M, PhD (Law); Dr Adebayo Olayiwola Adejumo BSc (Nursing), MHSc
p.000004: (Bioethics), PhD (Psychology); Dr. Ademola J. Ajuwon BSc, MPH, PhD; Professor (Mrs.) Olaitan Soyannwo MBBS, DA, M.Med,
p.000004: FWACS, FAS; Arc. Mrs. Eugenious Adebamowo BSc, MSc; Dr. Ayodele Samuel Jegede BSc, MSc, MHSc (Bioethics), PhD; Mrs.
p.000004: Oluwatoyin Siminsola Akintola LLM; Dr. Christopher Agulanna, B.A., M.A. (Lagos); PhD (Ibadan)
p.000004:
p.000004: The following members of the Federal Ministry of Health; Dr. Jonathan Jiya, Dr. A. Nasidi, Dr. J. M. Adekeye, and Mr.
p.000004: Aminu Yakubu; also made significant contributions to the development of the code.
p.000004:
p.000004: Special thanks to Professor Clement Adebamowo BM, ChB Hons (Jos), FWACS, FACS, Sc.D. (Harvard) who developed the
p.000004: preliminary draft code, coordinated and supported the entire technical consultation process with his NIH Research Grant
p.000004: No. D43 TW007091 funded by the Fogarty International Center and the National Human Genome Research Institute.
p.000004:
p.000004: Thanks also to Mr. M. L. Oladejo and Mr. Ali Gubio for providing support towards the final editing and printing of the
p.000004: code.
p.000004:
...
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000035: 35
p.000035:
p.000035: (q) Fees
p.000035:
p.000035: HREC may charge fees for any or all of its activities, at its discretion and in consultation with the principal
p.000035: officers of the institution.
p.000035:
p.000035: (1) Fees may vary depending on the size, complexity, duration, status of researcher and sponsor of the researcher.
p.000035:
p.000035: (2) Fees must be commensurate with anticipated expenses required for adequate oversight of research.
p.000035:
p.000035: (r) Protection of participants in the research enterprise
p.000035:
p.000035: HREC must protect the rights of researcher(s)
p.000035:
p.000035: (1) HREC shall protect the right of researcher(s) to publish their research.
p.000035:
p.000035: (a) In certain situations, this will require the submission of an agreement between sponsor(s), institution(s) and
p.000035: researcher(s) allowing researcher(s) to use the outcome of research in manner consistent with current practice within
p.000035: the research community.
p.000035:
p.000035: (b) HREC shall evaluate whether such agreement is necessary when the research is being reviewed and if found necessary,
p.000035: request same before approval is given.
p.000035:
p.000035: (2) HREC shall protect researchers from exploitation.
p.000035:
p.000035: (a) In certain situations, this will require the submission of an agreement between sponsor(s), institution(s) and
p.000035: researcher(s) indicating rights to, ownership of and rights of access to data, resources, intellectual property and
p.000035: infrastructure generated in the course of the research.
p.000035:
p.000035: (b) HREC should evaluate whether such agreement is necessary when the research is being
p.000035:
p.000036: 36
p.000036:
p.000036: reviewed and if found necessary, request same before approval is given.
p.000036:
p.000036: (3) HREC shall protect communities participating in research from exploitation.
p.000036:
p.000036: (a) In certain situations, this will require the submission of an agreement between sponsor(s), institution(s),
p.000036: researcher(s) and the community indicating adequate community consultation and agreement with the proposed research.
p.000036:
p.000036: (b) HREC should evaluate whether such agreement is necessary when the research is being reviewed and if found
p.000036: necessary, request same before approval is given. This implies that the HREC has ordinarily found the study approvable
p.000036: but requires that the community should be engaged and their assent sought before research is allowed to proceed. In
p.000036: this circumstance, the HREC cannot change its decision on the approval status of the research once the community
p.000036: engagement process has commenced. If the community engagement fails, then the research cannot proceed in that community
p.000036:
p.000036: (c) Where applicable, such community assent or engagement efforts shall be documented and evidence of same submitted to
p.000036: HREC during the research review process.
p.000036:
p.000036: (d) In some instances, it will be necessary to set up a community advisory board (CAB). Such boards may be established
p.000036: by the study investigators in consultation with the community.
p.000036:
p.000036: (e) Members of CAG shall be selected by the community through their usual consultative process and it shall include
...
p.000043: outcome of the research.
p.000043:
p.000043: (h) For research to be ethical, nothing must be done to undermine the trust relationship that is at the heart of
p.000043: the researcher(s)-participant(s) relationships. This requires that
p.000044: 44
p.000044:
p.000044: there is transparency in all matters relating to the research enterprise including clear description of goals, risks,
p.000044: benefits, alternatives to participation and voluntariness. It is also necessary to determine the social value of the
p.000044: research and engage in creative approaches for effective representations and involvement of researchers and communities
p.000044: in the entire enterprise. Strategies for dynamic and reciprocal collaboration that leads to transformation of essential
p.000044: relationships based on reciprocity are also essential. This trust principle encourages the engagement of individual
p.000044: participants and communities, respects local socio-cultural values and encourages the provision of relevant and timely
p.000044: feedback to communities.
p.000044:
p.000044: (i) For research to be ethical, the interest of participants, researchers, sponsors and communities must be
p.000044: protected. This will ensure that the research has lasting impact, transfers technology where appropriate, contributes
p.000044: to capacity building and demonstrates respect for socio-cultural and other differences. Risks, benefits and
p.000044: responsibilities of research must be shared during the development, planning, conduct, dissemination of results.
p.000044: Intellectual property, indigenous knowledge and contributions of all parties must be taken into consideration,
p.000044: adequately protected and compensated particularly where research leads to tangible or intangible benefits. Satisfactory
p.000044: parameter(s) that shall determine sharing of commercial and other benefits should be clearly articulated and where
p.000044: indicated, benefit sharing agreements, materials transfer agreements, patent rights, intellectual property and
p.000044: royalties’ distribution agreements should be signed before initiation of research.
p.000044:
p.000044: (j) For research to be ethical, it must be conducted in accordance with the principles of good clinical and laboratory
p.000044: practices. These are international standards for designing, conducting, and reporting clinical trials that involve
p.000044: human participants. Compliance with these standards is additional assurance that the rights, safety and well-being of
p.000044: trial participants are protected in a manner that is consistent with the highest ethical and scientific standards.
p.000044:
p.000044: Section G
p.000044:
p.000045: 45
p.000045:
p.000045: HREC Education and Training Responsibility
p.000045:
p.000045: (a) HREC shall organise, cause to be organized on its behalf, sponsor, support or associate with training and
p.000045: educational programs for biomedical, social and behavioural sciences’ researchers.
p.000045:
p.000045: (b) In order for such programs to be accepted for purposes of membership of HREC and as evidence of satisfactory
p.000045: training of biomedical researchers for purposes of research review, the curriculum must be certified by NHREC.
p.000045:
p.000045: (c) Suitable educational programs must contain modules on national code of health research ethics, principles of
p.000045: research ethics, functions of HREC, research integrity and misconduct. Additional training in research methodology and
p.000045: research administration may also be provided.
p.000045:
...
Social / Racial Minority
Searching for indicator minority:
(return to top)
p.000039: from studies that can advance their health and well being. However specific safeguards should be included to protect
p.000039: the vulnerable, appropriate to degree of risk. Groups, communities, participants and researchers who bear the burden of
p.000039: research should share in the benefits.
p.000039: d. All research involve risks; to be ethical therefore, there must be valid attempts to minimize risks and
p.000039: maximize health related benefits (as distinguished from risks and benefits of therapies that participants would be
p.000039: exposed to even if they were not participating in research or incidental risks or benefits) to participants in order to
p.000039: engender favourable risk benefit ratio within the context of where the research is being conducted.
p.000039:
p.000039: (1) Where the risks outweigh the benefits to the participants, other criteria outlined in this code must justify such
p.000039: risks.
p.000039:
p.000039: (2) Risks and benefits should be considered at the level of individual research participants and at the community,
p.000039: whenever appropriate.
p.000039:
p.000039: (3) Comprehensive delineation of risks and benefits should be done for participants during the research, the population
p.000039: hosting the research and for both participants and population after completion of research
p.000039:
p.000039: (3) Therapeutic procedures must fulfil requirements of clinical equipoise – there must be genuine uncertainty, among at
p.000039: least a significant minority of unbiased acknowledged experts who are not associated with the study under
p.000039: consideration, about preferred treatment.
p.000039:
p.000039: (4) The risks associated with non-therapeutic procedures must be minimized by:
p.000039:
p.000039: (a) Procedures consistent with sound research designs
p.000040: 40
p.000040:
p.000040: (b) Procedures that do not expose participants to undue risk
p.000040:
p.000040: (c) Using procedures already being performed on participants for diagnostic or therapeutic purposes, whenever
p.000040: appropriate
p.000040:
p.000040: (d) Applying risk-knowledge calculus to ensure that risks are reasonable compared to the knowledge to be gained from
p.000040: the study.
p.000040:
p.000040: e. For research to be ethical, it must undergo independent review. Research participants, researcher(s),
p.000040: sponsor(s) and institution(s) have multiple and overlapping interests which can generate conflicts and distort
p.000040: judgements. Independent review, through a system of ethical review and oversight of such systems assures society that
p.000040: reasonable attempts have been made to minimize the potential impacts of these conflicting interests and ensure balanced
p.000040: judgements.
p.000040: f. Informed consent is a sine qua non for ethical conduct of research. In order for consent to be valid, it must
p.000040: have the following components
p.000040:
p.000040: (1) Adequate information must be provided at the educational level no higher than that of individuals with at most 9
p.000040: years of education in Nigeria.
...
Social / Religion
Searching for indicator religion:
(return to top)
p.000019: to the committee, supporting personnel and infrastructure of both the committee and the proposing institution.
p.000019:
p.000019: (1) NHREC shall outline from time to time detailed criteria for categorization of HREC.
p.000019:
p.000019: (2) Categorization of HREC shall be approved during regularly scheduled meetings of the NHREC.
p.000019:
p.000020: 20
p.000020:
p.000020: (3) NHREC shall outline the types of research that different categories of HREC shall review.
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
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p.000020:
p.000020:
p.000021: 21
p.000021:
p.000021: Section D
p.000021:
p.000021: HREC membership
p.000021:
p.000021: (a) The authority to establish a HREC and the procedure of selecting members is vested in the Headship of the proposing
p.000021: institution.
p.000021: (b) Each HREC shall have at least five members and if more, then the total membership must always be an odd number.
p.000021: (c) The HREC shall be sufficiently qualified through the experience, expertise and diversity of its members, including
p.000021: consideration of age, gender, socio-cultural backgrounds, religion and sensitivity to such issues as community
p.000021: attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of researchers and
p.000021: research participants. Members should have varying academic and professional backgrounds to promote complete and
p.000021: adequate review of health research conducted by the promoting institution.
p.000021: (d) In addition to possessing the professional competence necessary to review specific research activities, the HREC
p.000021: shall be able to ascertain the acceptability of proposed research in terms of institutional regulations, applicable
p.000021: laws, and standards of professional conduct and practice. The HREC shall therefore include persons knowledgeable in
p.000021: these areas and whenever feasible, a lawyer.
p.000021: (e) Each HREC shall include at least one member whose primary concerns are in scientific areas and at least one member
p.000021: whose primary concerns are in non-scientific areas.
p.000021: (f) Each HREC shall include at least one member who is not affiliated with the institution and who is not part of the
p.000021: immediate family of a person who is affiliated with the institution.
p.000021: (g) No HREC may have a member participate in the HREC initial or continuing review of any project in which the member
p.000021: has a conflicting interest.
p.000021: (h) If HREC wishes to review research that involves vulnerable participants, such as children, prisoners, pregnant
...
p.000035:
p.000036: 36
p.000036:
p.000036: reviewed and if found necessary, request same before approval is given.
p.000036:
p.000036: (3) HREC shall protect communities participating in research from exploitation.
p.000036:
p.000036: (a) In certain situations, this will require the submission of an agreement between sponsor(s), institution(s),
p.000036: researcher(s) and the community indicating adequate community consultation and agreement with the proposed research.
p.000036:
p.000036: (b) HREC should evaluate whether such agreement is necessary when the research is being reviewed and if found
p.000036: necessary, request same before approval is given. This implies that the HREC has ordinarily found the study approvable
p.000036: but requires that the community should be engaged and their assent sought before research is allowed to proceed. In
p.000036: this circumstance, the HREC cannot change its decision on the approval status of the research once the community
p.000036: engagement process has commenced. If the community engagement fails, then the research cannot proceed in that community
p.000036:
p.000036: (c) Where applicable, such community assent or engagement efforts shall be documented and evidence of same submitted to
p.000036: HREC during the research review process.
p.000036:
p.000036: (d) In some instances, it will be necessary to set up a community advisory board (CAB). Such boards may be established
p.000036: by the study investigators in consultation with the community.
p.000036:
p.000036: (e) Members of CAG shall be selected by the community through their usual consultative process and it shall include
p.000036: broad representation of community members based on age, sex, religion and other community parameters that may be
p.000036: relevant to the study. It may include relatively more representation from population of interest to the study. It may
p.000036: include representatives from the research group and
p.000037: 37
p.000037:
p.000037: other non-community members whose special knowledge or expertise may be considered necessary for effective functioning
p.000037: of the community advisory group. In all instances, members of the community must constitute a simple majority of the
p.000037: CAB.
p.000037:
p.000037: (f) The function of the CAB is to provide community members opportunity to share their views about ethical issues that
p.000037: proposed research raises for individual community members, community as a whole, neighbouring communities and their
p.000037: region/nation. The CAB also provides a forum for dissemination of pre, intra and post-research information to the
p.000037: community. Members of CAB may provide advice and support as needed for the successful implementation of research.
p.000037:
p.000037: (g) The definition of community shall vary with research and shall be based on application of the best scientific
p.000037: principles.
p.000037:
p.000037: (4) HREC must protect researcher(s) from undue pressure from sponsor(s), institution(s), participant(s) or any other
p.000037: source by ensuring that no researcher enters into an agreement or is subjected to circumstances that limits his/her
p.000037: legal rights, freedoms and obligations under Nigerian law to pursue his/her research activities.
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000038: 38
p.000038:
p.000038: Section F
p.000038:
...
Social / Women
Searching for indicator women:
(return to top)
p.000021: attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of researchers and
p.000021: research participants. Members should have varying academic and professional backgrounds to promote complete and
p.000021: adequate review of health research conducted by the promoting institution.
p.000021: (d) In addition to possessing the professional competence necessary to review specific research activities, the HREC
p.000021: shall be able to ascertain the acceptability of proposed research in terms of institutional regulations, applicable
p.000021: laws, and standards of professional conduct and practice. The HREC shall therefore include persons knowledgeable in
p.000021: these areas and whenever feasible, a lawyer.
p.000021: (e) Each HREC shall include at least one member whose primary concerns are in scientific areas and at least one member
p.000021: whose primary concerns are in non-scientific areas.
p.000021: (f) Each HREC shall include at least one member who is not affiliated with the institution and who is not part of the
p.000021: immediate family of a person who is affiliated with the institution.
p.000021: (g) No HREC may have a member participate in the HREC initial or continuing review of any project in which the member
p.000021: has a conflicting interest.
p.000021: (h) If HREC wishes to review research that involves vulnerable participants, such as children, prisoners, pregnant
p.000021: women, physically and psychologically disabled persons, the HREC shall co-opt one or more individuals knowledgeable
p.000021: about and experienced in working with
p.000022: 22
p.000022:
p.000022: these participants for the review process. These individuals may not vote during the HREC meeting.
p.000022: (i) Each HREC member must pledge to maintain confidentiality regarding all meetings, deliberations, applications,
p.000022: information on research participants and related matters that shall come to his/her knowledge during service on HREC
p.000022: even after leaving the HREC assignment. There is no time limit for this prohibition.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000023: 23
p.000023:
p.000023: Section E
p.000023:
p.000023: HREC functions and operations
p.000023:
p.000023: In order to fulfil the requirements of this code, each HREC shall:
p.000023:
p.000023: (a) Operate in accordance with the provisions of the current version of the National Code of Health Research Ethics
p.000023: issued by the NHREC. Additional guidance may be obtained from the Standard Operating Procedure (SOP) issued by the
p.000023: NHREC.
p.000023:
p.000023: (b) Except when an expedited review procedure is used, research proposals shall be considered at regularly convened
...
p.000025:
p.000025: (3) This shall be at least once a year or at least once during the lifetime of the research where the duration of the
p.000025: research is less than a year.
p.000025:
p.000025: (4) HREC shall have authority to observe or cause to be observed on its behalf, the research and its consent process to
p.000025: ensure compliance with the highest scientific and ethical standards.
p.000025:
p.000025: (5) HREC may initiate process of oversight of research in the event of receipt of complaints, information or data
p.000025: relevant to the research from any source.
p.000025:
p.000025: (f) Process for expedited review
p.000025:
p.000025: (1) HREC may expedite review of research in the following circumstances:
p.000025:
p.000025: (a) Research is found to involve no more than minimal risk – meaning that the probability and magnitude of harm is no
p.000025: greater than that encountered in the daily lives of all (or the great majority) persons in the population (under normal
p.000025: circumstances) from which research participants are to be recruited. Note that minimal risk is applicable in
p.000025: non-therapeutic research only.
p.000025:
p.000025: (b) Research does not involve vulnerable populations such as children, prisoners, pregnant women etc.
p.000025:
p.000025:
p.000026: 26
p.000026:
p.000026: (c) Research does not contain serious methodological or ethical flaws
p.000026:
p.000026: (d) Minor changes in previously approved research during the period for which approval is authorized.
p.000026:
p.000026: (2) Expedited review may be carried out by the HREC chairperson or his designee from among members of HREC. In
p.000026: reviewing the research, the reviewer(s) shall exercise all of the authorities of HREC except that the reviewer(s) may
p.000026: not disapprove the research.
p.000026:
p.000026: (3) The Chairman of HREC shall bring all research reviewed expeditiously to the next meeting of HREC for notice,
p.000026: discussion and ratification.
p.000026:
p.000026: (g) Process for amendment of research
p.000026:
p.000026: (1) HREC shall require that applicants apply for permission to amend protocols in any of the following circumstances:
p.000026:
p.000026: (a) Where there are changes in any part of the research protocol that alters the risk benefit ratio of the research.
p.000026:
p.000026: (b) Where there are changes in the named members of the team conducting the research.
p.000026:
p.000026: (c) Where there are changes in research sites.
p.000026:
p.000026: (c) Where there are changes in sponsorship, institutional guidelines, institutional structure, HREC requirements,
p.000026: national laws or exigencies that impact on the ethical conduct of research.
p.000026:
p.000026: (2) HREC shall require that researcher submit an application for original research approval where in its opinion, the
p.000026: proposed amendments are substantial, such as but not limited to, change(s) in inclusion or exclusion criteria,
...
p.000038: of research. In certain instances, for example in some international collaborative studies, research should be
p.000038: integrated with comprehensive capacity building, technology transfer and health care delivery strategies that address
p.000038: significant local health problems and add value to local participants of research, including researchers, institutions,
p.000038: communities and the country.
p.000038: b. For research to be ethical, it must be have scientific validity. Research lacking clear scientific
p.000038: objective(s); using invalid methodology; that is underpowered; lacking equipoise (for clinical studies); whose
p.000038: operationalizing plans are inadequate within the context of the environment where research would be conducted; lacks
p.000038: plausible data analysis plan (including a specific role for a Data and Safety Monitoring Board [DSMB] in clinical
p.000038: trials) and research with biased measurement(s) of outcome(s) is unethical.
p.000038: c. Ethical research must ensure fair selection of participants based on the scientific objective(s) of the
p.000038: research while minimizing risk. This requirement refers to both who is included and who is excluded from recruitment
p.000038: and the strategies employed for participants’ recruitment (including choice of research sites and communities).
p.000038: Regardless of this requirement, participants who are at
p.000039: 39
p.000039:
p.000039: excessively increased risk of harm should be excluded. Children, pregnant women, socially, culturally, economically,
p.000039: politically, educationally, physically and psychologically disadvantaged groups, groups with constrained autonomy and
p.000039: other vulnerable populations should not be excluded from research without explicit reasons for doing so; particularly
p.000039: from studies that can advance their health and well being. However specific safeguards should be included to protect
p.000039: the vulnerable, appropriate to degree of risk. Groups, communities, participants and researchers who bear the burden of
p.000039: research should share in the benefits.
p.000039: d. All research involve risks; to be ethical therefore, there must be valid attempts to minimize risks and
p.000039: maximize health related benefits (as distinguished from risks and benefits of therapies that participants would be
p.000039: exposed to even if they were not participating in research or incidental risks or benefits) to participants in order to
p.000039: engender favourable risk benefit ratio within the context of where the research is being conducted.
p.000039:
p.000039: (1) Where the risks outweigh the benefits to the participants, other criteria outlined in this code must justify such
p.000039: risks.
p.000039:
p.000039: (2) Risks and benefits should be considered at the level of individual research participants and at the community,
p.000039: whenever appropriate.
p.000039:
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000025: research is less than a year.
p.000025:
p.000025: (4) HREC shall have authority to observe or cause to be observed on its behalf, the research and its consent process to
p.000025: ensure compliance with the highest scientific and ethical standards.
p.000025:
p.000025: (5) HREC may initiate process of oversight of research in the event of receipt of complaints, information or data
p.000025: relevant to the research from any source.
p.000025:
p.000025: (f) Process for expedited review
p.000025:
p.000025: (1) HREC may expedite review of research in the following circumstances:
p.000025:
p.000025: (a) Research is found to involve no more than minimal risk – meaning that the probability and magnitude of harm is no
p.000025: greater than that encountered in the daily lives of all (or the great majority) persons in the population (under normal
p.000025: circumstances) from which research participants are to be recruited. Note that minimal risk is applicable in
p.000025: non-therapeutic research only.
p.000025:
p.000025: (b) Research does not involve vulnerable populations such as children, prisoners, pregnant women etc.
p.000025:
p.000025:
p.000026: 26
p.000026:
p.000026: (c) Research does not contain serious methodological or ethical flaws
p.000026:
p.000026: (d) Minor changes in previously approved research during the period for which approval is authorized.
p.000026:
p.000026: (2) Expedited review may be carried out by the HREC chairperson or his designee from among members of HREC. In
p.000026: reviewing the research, the reviewer(s) shall exercise all of the authorities of HREC except that the reviewer(s) may
p.000026: not disapprove the research.
p.000026:
p.000026: (3) The Chairman of HREC shall bring all research reviewed expeditiously to the next meeting of HREC for notice,
p.000026: discussion and ratification.
p.000026:
p.000026: (g) Process for amendment of research
p.000026:
p.000026: (1) HREC shall require that applicants apply for permission to amend protocols in any of the following circumstances:
p.000026:
p.000026: (a) Where there are changes in any part of the research protocol that alters the risk benefit ratio of the research.
p.000026:
p.000026: (b) Where there are changes in the named members of the team conducting the research.
p.000026:
p.000026: (c) Where there are changes in research sites.
p.000026:
p.000026: (c) Where there are changes in sponsorship, institutional guidelines, institutional structure, HREC requirements,
p.000026: national laws or exigencies that impact on the ethical conduct of research.
p.000026:
p.000026: (2) HREC shall require that researcher submit an application for original research approval where in its opinion, the
p.000026: proposed amendments are substantial, such as but not limited to, change(s) in inclusion or exclusion criteria,
p.000026: randomization, interventions and outcome measures.
p.000027: 27
p.000027:
p.000027: (3) Under no circumstance shall a researcher deviate from approved protocol, except such as is necessary to eliminate
...
Social / education
Searching for indicator education:
(return to top)
p.000006: of Code 12
p.000006: Exemption 13
p.000006: Who determines exemption? 15
p.000006: Registration of Health Research
p.000006: Ethics Committees 16
p.000006: HREC membership 22
p.000006: HREC functions and operations 24
p.000006: Process for regular research 24
p.000006: approval
p.000006: Process for continuing oversight 26
p.000006: of research
p.000006: Process for expedited review 26
p.000006: Process for amendment of 27
p.000006: research
p.000007: 7
p.000007:
p.000007: Process for exemption 28
p.000007: Process for suspension of 29
p.000007: research
p.000007: Process for revision of 29
p.000007: suspension
p.000007: Process for termination of 30
p.000007: research
p.000007: Process for appeal of HREC 30
p.000007: decision to terminate research
p.000007: Process for review of multi- 31
p.000007: institutional research
p.000007: Materials Transfer Agreement 33
p.000007: Communication with other agencies 34
p.000007: Process for NHREC review of 34
p.000007: research
p.000007: Fees 36
p.000007: Protection of participants in the 36
p.000007: research enterprise
p.000007: Ethical principles and guidelines 39
p.000007: HREC Education and Training
p.000007: Responsibility 46
p.000008: 8
p.000008:
p.000008: Independent Educational and 47
p.000008: Training Activities in Research
p.000008: Ethics
p.000008: HREC Research Ethics Consultation 48
p.000008: and Clinics
p.000008: Independent Research Ethics 49
p.000008: Consultation and Clinics
p.000008: HREC Records and Reports 49
p.000008: NHREC oversight of HREC functions 53
p.000008: HREC Compliance and Disciplinary 54
p.000008: Powers
p.000008: NHREC Compliance and Disciplinary 55
p.000008: Powers
p.000008: Continuing Review of the National 56
p.000008: Code of Health Research Ethics and
p.000008: sub-codes
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: About NHREC
p.000009:
p.000009: The National Health Research Ethics Committee (NHREC) is the apex body responsible for the provision of and ensuring
p.000009: adherence to guidelines that govern ethical research practice in order to ensure the protection of human research
p.000009: participants in Nigeria.
p.000009:
p.000009: The committee was inaugurated in October 2005 by the Hon. Minister of Health in line with Mr. President’s directive for
...
p.000011:
p.000011: Research here is defined as systematic investigation, including research development, testing and evaluation, designed
p.000011: to develop or contribute to generalizable knowledge. It may consist of:
p.000011:
p.000011: (a) Therapeutic procedures – interventions administered with the intent of providing direct benefit to the research
p.000011: participant
p.000011: (b) Non-therapeutic procedures – interventions that are not administered with therapeutic intent and are only intended
p.000011: to answer the scientific question of the study
p.000011:
p.000011: Activities which meet this definition constitute research for purposes of this code, whether or not they are conducted
p.000011: or supported under a program which is considered research for other purposes. For example, some demonstration and
p.000011: service programs may include research activities.
p.000011:
p.000011: Health research that is conducted anywhere in Nigeria must comply with all sections of this code.
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000012: 12
p.000012:
p.000012: Section B Exemption
p.000012: Research activities in which the only involvement of human participants will be in one or more of the following
p.000012: categories are exempt from health research ethics committee oversight:
p.000012:
p.000012: (a) Research conducted in established or commonly accepted educational settings, involving normal educational
p.000012: practices, such as:
p.000012:
p.000012: (1) Research on regular and special education instructional strategies, or
p.000012:
p.000012: (2) Research on the effectiveness of or comparison among instructional techniques, curricula, or classroom management
p.000012: methods.
p.000012:
p.000012: (b) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures,
p.000012: interview procedures or observation of public behaviour, unless:
p.000012:
p.000012: (1) Information obtained is recorded in such a manner that human participants can be identified, directly or through
p.000012: identifiers linked to the participants; and
p.000012:
p.000012: (2) Any disclosure of the human participants' responses outside the research could reasonably place the participants at
p.000012: risk of criminal or civil liability or be damaging to the participants' financial standing, employability, or
p.000012: reputation.
p.000012:
p.000012: (c) Research involving the collection or study of existing data, documents, records, pathological specimens, or
p.000012: diagnostic specimens, if these sources are publicly available (note that this refers to availability of data and not
p.000012: the status of the custodian
p.000013: 13
p.000013:
p.000013: of the information/data) or if the information is recorded by the investigator in such a manner that participants
p.000013: cannot be identified, directly or through identifiers linked to the participants.
p.000013:
p.000013: (d) Studies that are meant to evaluate the outcome of procedures, programs and services are exempt because they are
...
p.000039: consideration, about preferred treatment.
p.000039:
p.000039: (4) The risks associated with non-therapeutic procedures must be minimized by:
p.000039:
p.000039: (a) Procedures consistent with sound research designs
p.000040: 40
p.000040:
p.000040: (b) Procedures that do not expose participants to undue risk
p.000040:
p.000040: (c) Using procedures already being performed on participants for diagnostic or therapeutic purposes, whenever
p.000040: appropriate
p.000040:
p.000040: (d) Applying risk-knowledge calculus to ensure that risks are reasonable compared to the knowledge to be gained from
p.000040: the study.
p.000040:
p.000040: e. For research to be ethical, it must undergo independent review. Research participants, researcher(s),
p.000040: sponsor(s) and institution(s) have multiple and overlapping interests which can generate conflicts and distort
p.000040: judgements. Independent review, through a system of ethical review and oversight of such systems assures society that
p.000040: reasonable attempts have been made to minimize the potential impacts of these conflicting interests and ensure balanced
p.000040: judgements.
p.000040: f. Informed consent is a sine qua non for ethical conduct of research. In order for consent to be valid, it must
p.000040: have the following components
p.000040:
p.000040: (1) Adequate information must be provided at the educational level no higher than that of individuals with at most 9
p.000040: years of education in Nigeria.
p.000040:
p.000040: (2) The design of the consent process must be appropriate for the type of research, expected participants, risks
p.000040: anticipated and the research context.
p.000040:
p.000040: (3) Consent forms shall not be longer than 8 pages in order to ensure comprehensibility and enhance recall of pertinent
p.000040: information. Unnecessary verbiage, legalisms, jargons and truth-dumping are to be avoided. The recommended format for
p.000040: each page of the consent form is as follows:
p.000040:
p.000040: i. Paper size – A4
p.000040: ii. Font – Times New Roman or similar
p.000040: iii. Font Size – 12
p.000041: 41
p.000041:
p.000041: iv. Spacing – 1.5
p.000041: v. Margins – 2.5 cm, no gutter
p.000041:
p.000041: (4) Where indicated, additional information can be provided on supplementary information sheets.
p.000041:
p.000041: (5) The informed consent document shall contain the following aspects:
p.000041:
p.000041: i. Title of the research
p.000041: ii. Name(s) and affiliation(s) of researcher(s) of applicant(s)
p.000041: iii. Sponsor(s) of research
p.000041: iv. Purpose(s) of research
p.000041: v. Procedure of the research, what shall be required of each participant and approximate total number of participants
p.000041: that would be involved in the research.
p.000041: vi. Expected duration of research and of participant(s)’ involvement.
p.000041: vii. Risk(s)
p.000041: viii. Costs to the participants, if any, of joining the research
p.000041: ix. Benefit(s)
p.000041: x. Confidentiality
p.000041: xi. Voluntariness
p.000041: xii. Alternatives to participation
...
p.000044: protected. This will ensure that the research has lasting impact, transfers technology where appropriate, contributes
p.000044: to capacity building and demonstrates respect for socio-cultural and other differences. Risks, benefits and
p.000044: responsibilities of research must be shared during the development, planning, conduct, dissemination of results.
p.000044: Intellectual property, indigenous knowledge and contributions of all parties must be taken into consideration,
p.000044: adequately protected and compensated particularly where research leads to tangible or intangible benefits. Satisfactory
p.000044: parameter(s) that shall determine sharing of commercial and other benefits should be clearly articulated and where
p.000044: indicated, benefit sharing agreements, materials transfer agreements, patent rights, intellectual property and
p.000044: royalties’ distribution agreements should be signed before initiation of research.
p.000044:
p.000044: (j) For research to be ethical, it must be conducted in accordance with the principles of good clinical and laboratory
p.000044: practices. These are international standards for designing, conducting, and reporting clinical trials that involve
p.000044: human participants. Compliance with these standards is additional assurance that the rights, safety and well-being of
p.000044: trial participants are protected in a manner that is consistent with the highest ethical and scientific standards.
p.000044:
p.000044: Section G
p.000044:
p.000045: 45
p.000045:
p.000045: HREC Education and Training Responsibility
p.000045:
p.000045: (a) HREC shall organise, cause to be organized on its behalf, sponsor, support or associate with training and
p.000045: educational programs for biomedical, social and behavioural sciences’ researchers.
p.000045:
p.000045: (b) In order for such programs to be accepted for purposes of membership of HREC and as evidence of satisfactory
p.000045: training of biomedical researchers for purposes of research review, the curriculum must be certified by NHREC.
p.000045:
p.000045: (c) Suitable educational programs must contain modules on national code of health research ethics, principles of
p.000045: research ethics, functions of HREC, research integrity and misconduct. Additional training in research methodology and
p.000045: research administration may also be provided.
p.000045:
p.000045: (d) NHREC may from time to time certify short courses and diplomas in health research ethics in Nigeria
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000046: 46
p.000046:
p.000046: Section H
p.000046:
p.000046: Independent Educational and Training Activities in Research Ethics
p.000046:
...
Searching for indicator educational:
(return to top)
p.000006: Ethics Committees 16
p.000006: HREC membership 22
p.000006: HREC functions and operations 24
p.000006: Process for regular research 24
p.000006: approval
p.000006: Process for continuing oversight 26
p.000006: of research
p.000006: Process for expedited review 26
p.000006: Process for amendment of 27
p.000006: research
p.000007: 7
p.000007:
p.000007: Process for exemption 28
p.000007: Process for suspension of 29
p.000007: research
p.000007: Process for revision of 29
p.000007: suspension
p.000007: Process for termination of 30
p.000007: research
p.000007: Process for appeal of HREC 30
p.000007: decision to terminate research
p.000007: Process for review of multi- 31
p.000007: institutional research
p.000007: Materials Transfer Agreement 33
p.000007: Communication with other agencies 34
p.000007: Process for NHREC review of 34
p.000007: research
p.000007: Fees 36
p.000007: Protection of participants in the 36
p.000007: research enterprise
p.000007: Ethical principles and guidelines 39
p.000007: HREC Education and Training
p.000007: Responsibility 46
p.000008: 8
p.000008:
p.000008: Independent Educational and 47
p.000008: Training Activities in Research
p.000008: Ethics
p.000008: HREC Research Ethics Consultation 48
p.000008: and Clinics
p.000008: Independent Research Ethics 49
p.000008: Consultation and Clinics
p.000008: HREC Records and Reports 49
p.000008: NHREC oversight of HREC functions 53
p.000008: HREC Compliance and Disciplinary 54
p.000008: Powers
p.000008: NHREC Compliance and Disciplinary 55
p.000008: Powers
p.000008: Continuing Review of the National 56
p.000008: Code of Health Research Ethics and
p.000008: sub-codes
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: About NHREC
p.000009:
p.000009: The National Health Research Ethics Committee (NHREC) is the apex body responsible for the provision of and ensuring
p.000009: adherence to guidelines that govern ethical research practice in order to ensure the protection of human research
p.000009: participants in Nigeria.
p.000009:
p.000009: The committee was inaugurated in October 2005 by the Hon. Minister of Health in line with Mr. President’s directive for
p.000009: the strengthening of a mechanism that will ensure the protection of Nigerians as they participate in researches.
p.000009:
...
p.000010:
p.000011: 11
p.000011:
p.000011: Section A
p.000011:
p.000011: To whom does this code apply?
p.000011:
p.000011: This code applies to all health research involving human participants, conducted, supported or otherwise subject to
p.000011: regulation by any institution in Nigeria.
p.000011:
p.000011: Definition of Research and Coverage of Code:
p.000011:
p.000011: Research here is defined as systematic investigation, including research development, testing and evaluation, designed
p.000011: to develop or contribute to generalizable knowledge. It may consist of:
p.000011:
p.000011: (a) Therapeutic procedures – interventions administered with the intent of providing direct benefit to the research
p.000011: participant
p.000011: (b) Non-therapeutic procedures – interventions that are not administered with therapeutic intent and are only intended
p.000011: to answer the scientific question of the study
p.000011:
p.000011: Activities which meet this definition constitute research for purposes of this code, whether or not they are conducted
p.000011: or supported under a program which is considered research for other purposes. For example, some demonstration and
p.000011: service programs may include research activities.
p.000011:
p.000011: Health research that is conducted anywhere in Nigeria must comply with all sections of this code.
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000012: 12
p.000012:
p.000012: Section B Exemption
p.000012: Research activities in which the only involvement of human participants will be in one or more of the following
p.000012: categories are exempt from health research ethics committee oversight:
p.000012:
p.000012: (a) Research conducted in established or commonly accepted educational settings, involving normal educational
p.000012: practices, such as:
p.000012:
p.000012: (1) Research on regular and special education instructional strategies, or
p.000012:
p.000012: (2) Research on the effectiveness of or comparison among instructional techniques, curricula, or classroom management
p.000012: methods.
p.000012:
p.000012: (b) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures,
p.000012: interview procedures or observation of public behaviour, unless:
p.000012:
p.000012: (1) Information obtained is recorded in such a manner that human participants can be identified, directly or through
p.000012: identifiers linked to the participants; and
p.000012:
p.000012: (2) Any disclosure of the human participants' responses outside the research could reasonably place the participants at
p.000012: risk of criminal or civil liability or be damaging to the participants' financial standing, employability, or
p.000012: reputation.
p.000012:
p.000012: (c) Research involving the collection or study of existing data, documents, records, pathological specimens, or
p.000012: diagnostic specimens, if these sources are publicly available (note that this refers to availability of data and not
p.000012: the status of the custodian
p.000013: 13
p.000013:
p.000013: of the information/data) or if the information is recorded by the investigator in such a manner that participants
p.000013: cannot be identified, directly or through identifiers linked to the participants.
p.000013:
p.000013: (d) Studies that are meant to evaluate the outcome of procedures, programs and services are exempt because they are
p.000013: designed to produce information leading to improvement in delivery of procedures, programs and services. Such studies
p.000013: usually evaluate measures that are already in use and considered part of standard practice. They may include collection
p.000013: and analysis of data or collection of new data but they do not involve allocation into groups or randomisation.
p.000013:
...
p.000039: least a significant minority of unbiased acknowledged experts who are not associated with the study under
p.000039: consideration, about preferred treatment.
p.000039:
p.000039: (4) The risks associated with non-therapeutic procedures must be minimized by:
p.000039:
p.000039: (a) Procedures consistent with sound research designs
p.000040: 40
p.000040:
p.000040: (b) Procedures that do not expose participants to undue risk
p.000040:
p.000040: (c) Using procedures already being performed on participants for diagnostic or therapeutic purposes, whenever
p.000040: appropriate
p.000040:
p.000040: (d) Applying risk-knowledge calculus to ensure that risks are reasonable compared to the knowledge to be gained from
p.000040: the study.
p.000040:
p.000040: e. For research to be ethical, it must undergo independent review. Research participants, researcher(s),
p.000040: sponsor(s) and institution(s) have multiple and overlapping interests which can generate conflicts and distort
p.000040: judgements. Independent review, through a system of ethical review and oversight of such systems assures society that
p.000040: reasonable attempts have been made to minimize the potential impacts of these conflicting interests and ensure balanced
p.000040: judgements.
p.000040: f. Informed consent is a sine qua non for ethical conduct of research. In order for consent to be valid, it must
p.000040: have the following components
p.000040:
p.000040: (1) Adequate information must be provided at the educational level no higher than that of individuals with at most 9
p.000040: years of education in Nigeria.
p.000040:
p.000040: (2) The design of the consent process must be appropriate for the type of research, expected participants, risks
p.000040: anticipated and the research context.
p.000040:
p.000040: (3) Consent forms shall not be longer than 8 pages in order to ensure comprehensibility and enhance recall of pertinent
p.000040: information. Unnecessary verbiage, legalisms, jargons and truth-dumping are to be avoided. The recommended format for
p.000040: each page of the consent form is as follows:
p.000040:
p.000040: i. Paper size – A4
p.000040: ii. Font – Times New Roman or similar
p.000040: iii. Font Size – 12
p.000041: 41
p.000041:
p.000041: iv. Spacing – 1.5
p.000041: v. Margins – 2.5 cm, no gutter
p.000041:
p.000041: (4) Where indicated, additional information can be provided on supplementary information sheets.
p.000041:
p.000041: (5) The informed consent document shall contain the following aspects:
p.000041:
p.000041: i. Title of the research
p.000041: ii. Name(s) and affiliation(s) of researcher(s) of applicant(s)
p.000041: iii. Sponsor(s) of research
p.000041: iv. Purpose(s) of research
p.000041: v. Procedure of the research, what shall be required of each participant and approximate total number of participants
p.000041: that would be involved in the research.
p.000041: vi. Expected duration of research and of participant(s)’ involvement.
p.000041: vii. Risk(s)
...
p.000044: responsibilities of research must be shared during the development, planning, conduct, dissemination of results.
p.000044: Intellectual property, indigenous knowledge and contributions of all parties must be taken into consideration,
p.000044: adequately protected and compensated particularly where research leads to tangible or intangible benefits. Satisfactory
p.000044: parameter(s) that shall determine sharing of commercial and other benefits should be clearly articulated and where
p.000044: indicated, benefit sharing agreements, materials transfer agreements, patent rights, intellectual property and
p.000044: royalties’ distribution agreements should be signed before initiation of research.
p.000044:
p.000044: (j) For research to be ethical, it must be conducted in accordance with the principles of good clinical and laboratory
p.000044: practices. These are international standards for designing, conducting, and reporting clinical trials that involve
p.000044: human participants. Compliance with these standards is additional assurance that the rights, safety and well-being of
p.000044: trial participants are protected in a manner that is consistent with the highest ethical and scientific standards.
p.000044:
p.000044: Section G
p.000044:
p.000045: 45
p.000045:
p.000045: HREC Education and Training Responsibility
p.000045:
p.000045: (a) HREC shall organise, cause to be organized on its behalf, sponsor, support or associate with training and
p.000045: educational programs for biomedical, social and behavioural sciences’ researchers.
p.000045:
p.000045: (b) In order for such programs to be accepted for purposes of membership of HREC and as evidence of satisfactory
p.000045: training of biomedical researchers for purposes of research review, the curriculum must be certified by NHREC.
p.000045:
p.000045: (c) Suitable educational programs must contain modules on national code of health research ethics, principles of
p.000045: research ethics, functions of HREC, research integrity and misconduct. Additional training in research methodology and
p.000045: research administration may also be provided.
p.000045:
p.000045: (d) NHREC may from time to time certify short courses and diplomas in health research ethics in Nigeria
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000046: 46
p.000046:
p.000046: Section H
p.000046:
p.000046: Independent Educational and Training Activities in Research Ethics
p.000046:
p.000046: (a) Suitably qualified individuals and organizations shall have the right to provide training programs in research
p.000046: ethics for biomedical, social and behavioural sciences’ researchers.
p.000046: (b) For such programs to be acceptable for the purposes of membership of HREC and considered adequate training of
p.000046: biomedical researchers applying for review of research, the curriculum must be certified by the NHREC.
p.000046: (c) Suitable educational programs must contain modules on national code of health research ethics, principles of
p.000046: research ethics, functions of HREC, research integrity and misconduct. Additional training in research methodology and
p.000046: administration may also be provided.
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000047: 47
p.000047:
p.000047: Section I
p.000047:
p.000047: HREC Research Ethics Consultation and Clinics
p.000047:
p.000047: (a) HREC may conduct ethics’ clinics and consultations, at its own discretion, and upon payment of fees, as it may
p.000047: determine, for the purposes of providing advice to researchers during the development of research protocols or during
p.000047: the conduct of research.
p.000047: (b) Such clinics and consultations shall be rigidly separated from the process of ethical review of research and shall
p.000047: not have any effect on HREC review or oversight functions.
p.000047: (c) NHREC shall certify and maintain a record of all individuals authorized to provide ethics consultation and run
p.000047: ethics consultation clinic in Nigeria
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
...
Social / gender
Searching for indicator gender:
(return to top)
p.000019: established, past review activities, record keeping and compliance with requirements of the Code), resources available
p.000019: to the committee, supporting personnel and infrastructure of both the committee and the proposing institution.
p.000019:
p.000019: (1) NHREC shall outline from time to time detailed criteria for categorization of HREC.
p.000019:
p.000019: (2) Categorization of HREC shall be approved during regularly scheduled meetings of the NHREC.
p.000019:
p.000020: 20
p.000020:
p.000020: (3) NHREC shall outline the types of research that different categories of HREC shall review.
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000021: 21
p.000021:
p.000021: Section D
p.000021:
p.000021: HREC membership
p.000021:
p.000021: (a) The authority to establish a HREC and the procedure of selecting members is vested in the Headship of the proposing
p.000021: institution.
p.000021: (b) Each HREC shall have at least five members and if more, then the total membership must always be an odd number.
p.000021: (c) The HREC shall be sufficiently qualified through the experience, expertise and diversity of its members, including
p.000021: consideration of age, gender, socio-cultural backgrounds, religion and sensitivity to such issues as community
p.000021: attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of researchers and
p.000021: research participants. Members should have varying academic and professional backgrounds to promote complete and
p.000021: adequate review of health research conducted by the promoting institution.
p.000021: (d) In addition to possessing the professional competence necessary to review specific research activities, the HREC
p.000021: shall be able to ascertain the acceptability of proposed research in terms of institutional regulations, applicable
p.000021: laws, and standards of professional conduct and practice. The HREC shall therefore include persons knowledgeable in
p.000021: these areas and whenever feasible, a lawyer.
p.000021: (e) Each HREC shall include at least one member whose primary concerns are in scientific areas and at least one member
p.000021: whose primary concerns are in non-scientific areas.
p.000021: (f) Each HREC shall include at least one member who is not affiliated with the institution and who is not part of the
p.000021: immediate family of a person who is affiliated with the institution.
p.000021: (g) No HREC may have a member participate in the HREC initial or continuing review of any project in which the member
p.000021: has a conflicting interest.
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000025:
p.000025:
p.000026: 26
p.000026:
p.000026: (c) Research does not contain serious methodological or ethical flaws
p.000026:
p.000026: (d) Minor changes in previously approved research during the period for which approval is authorized.
p.000026:
p.000026: (2) Expedited review may be carried out by the HREC chairperson or his designee from among members of HREC. In
p.000026: reviewing the research, the reviewer(s) shall exercise all of the authorities of HREC except that the reviewer(s) may
p.000026: not disapprove the research.
p.000026:
p.000026: (3) The Chairman of HREC shall bring all research reviewed expeditiously to the next meeting of HREC for notice,
p.000026: discussion and ratification.
p.000026:
p.000026: (g) Process for amendment of research
p.000026:
p.000026: (1) HREC shall require that applicants apply for permission to amend protocols in any of the following circumstances:
p.000026:
p.000026: (a) Where there are changes in any part of the research protocol that alters the risk benefit ratio of the research.
p.000026:
p.000026: (b) Where there are changes in the named members of the team conducting the research.
p.000026:
p.000026: (c) Where there are changes in research sites.
p.000026:
p.000026: (c) Where there are changes in sponsorship, institutional guidelines, institutional structure, HREC requirements,
p.000026: national laws or exigencies that impact on the ethical conduct of research.
p.000026:
p.000026: (2) HREC shall require that researcher submit an application for original research approval where in its opinion, the
p.000026: proposed amendments are substantial, such as but not limited to, change(s) in inclusion or exclusion criteria,
p.000026: randomization, interventions and outcome measures.
p.000027: 27
p.000027:
p.000027: (3) Under no circumstance shall a researcher deviate from approved protocol, except such as is necessary to eliminate
p.000027: immediate hazard to research participants. The researcher shall notify the Chairman of HREC within 24 hours of such
p.000027: changes.
p.000027:
p.000027: (4) In such circumstances as described in section (3) above, the researcher shall stop the research and the HREC shall
p.000027: conduct a thorough review of the research before authorizing suspension, continuation or modifications to the research.
p.000027:
p.000027: (h) Process for exemption
p.000027:
p.000027: (1) HREC may grant exemption from review in any of the conditions enumerated above (vide supra).
p.000027:
p.000027: (2) Applicants seeking exemption shall submit the proposed research or adequate information about it to the HREC,
p.000027: sufficient, in HREC judgement, to make a determination.
p.000027:
p.000027: (3) Exemptions may be granted by the HREC chairperson or his designee from among members of the HREC, in consultation
p.000027: with the HREC Administrative Officer – where one exists.
p.000027:
p.000027: (4) In granting exemption, the reviewer(s) shall exercise all of the authorities of the HREC except that the
p.000027: reviewer(s) may not disapprove the research.
p.000027:
p.000027: (5) Where the reviewer is uncertain and the uncertainty is unresolved after request for and provision of more
p.000027: information by the applicant, the proposal or summary should be referred to the HREC.
p.000027:
...
Searching for indicator philosophy:
(return to top)
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: 2
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: Foreword
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: Acknowledgement
p.000004:
p.000004: This document is the property of the Federal Ministry of Health, and was developed with technical support of the West
p.000004: African Bioethics Training Programme (WAB).
p.000004:
p.000004: We thank the members of the WAB team which included
p.000004: Ven. Dr. Adefolarin Obanishola Malomo MB,BS, FWACS, FICS; Dr Emmanuel Babatunde Omobowale Ph.D (English), M.A
p.000004: (Bioethics; Dr. (Mrs.) Jane Roli Adebusuyi PhD (Social Welfare); Dr. (Mrs.) Bolatito Asiata Lanre-Abass, PhD
p.000004: (Philosophy); Dr. John Oluwole A. Akintayo LL.B, LL.M, PhD (Law); Dr Adebayo Olayiwola Adejumo BSc (Nursing), MHSc
p.000004: (Bioethics), PhD (Psychology); Dr. Ademola J. Ajuwon BSc, MPH, PhD; Professor (Mrs.) Olaitan Soyannwo MBBS, DA, M.Med,
p.000004: FWACS, FAS; Arc. Mrs. Eugenious Adebamowo BSc, MSc; Dr. Ayodele Samuel Jegede BSc, MSc, MHSc (Bioethics), PhD; Mrs.
p.000004: Oluwatoyin Siminsola Akintola LLM; Dr. Christopher Agulanna, B.A., M.A. (Lagos); PhD (Ibadan)
p.000004:
p.000004: The following members of the Federal Ministry of Health; Dr. Jonathan Jiya, Dr. A. Nasidi, Dr. J. M. Adekeye, and Mr.
p.000004: Aminu Yakubu; also made significant contributions to the development of the code.
p.000004:
p.000004: Special thanks to Professor Clement Adebamowo BM, ChB Hons (Jos), FWACS, FACS, Sc.D. (Harvard) who developed the
p.000004: preliminary draft code, coordinated and supported the entire technical consultation process with his NIH Research Grant
p.000004: No. D43 TW007091 funded by the Fogarty International Center and the National Human Genome Research Institute.
p.000004:
p.000004: Thanks also to Mr. M. L. Oladejo and Mr. Ali Gubio for providing support towards the final editing and printing of the
p.000004: code.
p.000004:
p.000004: Thanks are also due to the all the departments of the Federal Ministry of Health and the various stakeholders for their
p.000004: contributions during the consultation process.
p.000004:
p.000005: 5
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
...
General/Other / Diminished Autonomy
Searching for indicator diminished:
(return to top)
p.000042: (6) Research participants are entitled to retain a copy of the consent form.
p.000042:
p.000042: (7) Where appropriate, researcher(s) may be required to undertake a re-consenting process during the course of research
p.000042: as determined by the HREC.
p.000042:
p.000042: (8) Where, in ordinary circumstances, participant(s) are unable to provide written consent, researcher(s) must propose
p.000042: a process of consent that adequately records participants’ informed decision such as witnessed thumb- printing or
p.000042: witnessed audio recording. The process proposed must be approved by the HREC before the research commences.
p.000042:
p.000042: (9) HREC may require that all or some types of consent process be witnessed.
p.000042:
p.000042: (10) Researcher(s) must keep all copies of consent form and make them available for examination by participant(s),
p.000042: sponsor(s), institution(s), HREC and NHREC.
p.000042:
p.000042: (11) Where appropriate, HREC may require researchers to provide translations of consent processes appropriate to the
p.000042: socio-cultural characteristics of the population to be studied.
p.000042:
p.000042: (12) All consent activities must be documented.
p.000042:
p.000042: (13) Consent in other situations, including research involving children, persons with diminished autonomy, vulnerable
p.000042: populations and other extraordinary situations, including waiver of consent, are described in other guidance documents
p.000042: issued by NHREC.
p.000042:
p.000042: (g) For research to be ethical there must be respect for potential and enrolled participants. This implies that
p.000042: potential participants be treated with respect from the
p.000043: 43
p.000043:
p.000043: moment that they are approached to the conclusion of the research should they choose to participate. Their right to
p.000043: privacy may not be needlessly compromised. Participants must know that their involvement is voluntary and that they can
p.000043: withdraw at any time without penalties. However, data, samples, etc. already contributed to the research up to that
p.000043: point may not needlessly be withdrawn as this may jeopardise the scientific validity of the research, unjust to those
p.000043: who remain in the study and all or part of their sample or data may have been used or modified into different form(s),
p.000043: including presentation at meetings or publications by the researchers.
p.000043:
p.000043: Respect entails that participants must be treated as partners in the research enterprise with every opportunity taken
p.000043: to inform them of the progress of the research and any new finding that may have potential impact on their health and
p.000043: well being, and on their continued participation in the research. It also entails protection of the welfare of research
p.000043: participants. This means that the process of research must be carefully monitored to ensure that participants are not
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
(return to top)
p.000038: communities and the country.
p.000038: b. For research to be ethical, it must be have scientific validity. Research lacking clear scientific
p.000038: objective(s); using invalid methodology; that is underpowered; lacking equipoise (for clinical studies); whose
p.000038: operationalizing plans are inadequate within the context of the environment where research would be conducted; lacks
p.000038: plausible data analysis plan (including a specific role for a Data and Safety Monitoring Board [DSMB] in clinical
p.000038: trials) and research with biased measurement(s) of outcome(s) is unethical.
p.000038: c. Ethical research must ensure fair selection of participants based on the scientific objective(s) of the
p.000038: research while minimizing risk. This requirement refers to both who is included and who is excluded from recruitment
p.000038: and the strategies employed for participants’ recruitment (including choice of research sites and communities).
p.000038: Regardless of this requirement, participants who are at
p.000039: 39
p.000039:
p.000039: excessively increased risk of harm should be excluded. Children, pregnant women, socially, culturally, economically,
p.000039: politically, educationally, physically and psychologically disadvantaged groups, groups with constrained autonomy and
p.000039: other vulnerable populations should not be excluded from research without explicit reasons for doing so; particularly
p.000039: from studies that can advance their health and well being. However specific safeguards should be included to protect
p.000039: the vulnerable, appropriate to degree of risk. Groups, communities, participants and researchers who bear the burden of
p.000039: research should share in the benefits.
p.000039: d. All research involve risks; to be ethical therefore, there must be valid attempts to minimize risks and
p.000039: maximize health related benefits (as distinguished from risks and benefits of therapies that participants would be
p.000039: exposed to even if they were not participating in research or incidental risks or benefits) to participants in order to
p.000039: engender favourable risk benefit ratio within the context of where the research is being conducted.
p.000039:
p.000039: (1) Where the risks outweigh the benefits to the participants, other criteria outlined in this code must justify such
p.000039: risks.
p.000039:
p.000039: (2) Risks and benefits should be considered at the level of individual research participants and at the community,
p.000039: whenever appropriate.
p.000039:
p.000039: (3) Comprehensive delineation of risks and benefits should be done for participants during the research, the population
p.000039: hosting the research and for both participants and population after completion of research
p.000039:
p.000039: (3) Therapeutic procedures must fulfil requirements of clinical equipoise – there must be genuine uncertainty, among at
...
p.000042:
p.000042: (7) Where appropriate, researcher(s) may be required to undertake a re-consenting process during the course of research
p.000042: as determined by the HREC.
p.000042:
p.000042: (8) Where, in ordinary circumstances, participant(s) are unable to provide written consent, researcher(s) must propose
p.000042: a process of consent that adequately records participants’ informed decision such as witnessed thumb- printing or
p.000042: witnessed audio recording. The process proposed must be approved by the HREC before the research commences.
p.000042:
p.000042: (9) HREC may require that all or some types of consent process be witnessed.
p.000042:
p.000042: (10) Researcher(s) must keep all copies of consent form and make them available for examination by participant(s),
p.000042: sponsor(s), institution(s), HREC and NHREC.
p.000042:
p.000042: (11) Where appropriate, HREC may require researchers to provide translations of consent processes appropriate to the
p.000042: socio-cultural characteristics of the population to be studied.
p.000042:
p.000042: (12) All consent activities must be documented.
p.000042:
p.000042: (13) Consent in other situations, including research involving children, persons with diminished autonomy, vulnerable
p.000042: populations and other extraordinary situations, including waiver of consent, are described in other guidance documents
p.000042: issued by NHREC.
p.000042:
p.000042: (g) For research to be ethical there must be respect for potential and enrolled participants. This implies that
p.000042: potential participants be treated with respect from the
p.000043: 43
p.000043:
p.000043: moment that they are approached to the conclusion of the research should they choose to participate. Their right to
p.000043: privacy may not be needlessly compromised. Participants must know that their involvement is voluntary and that they can
p.000043: withdraw at any time without penalties. However, data, samples, etc. already contributed to the research up to that
p.000043: point may not needlessly be withdrawn as this may jeopardise the scientific validity of the research, unjust to those
p.000043: who remain in the study and all or part of their sample or data may have been used or modified into different form(s),
p.000043: including presentation at meetings or publications by the researchers.
p.000043:
p.000043: Respect entails that participants must be treated as partners in the research enterprise with every opportunity taken
p.000043: to inform them of the progress of the research and any new finding that may have potential impact on their health and
p.000043: well being, and on their continued participation in the research. It also entails protection of the welfare of research
p.000043: participants. This means that the process of research must be carefully monitored to ensure that participants are not
...
General/Other / Natural Hazards
Searching for indicator hazard:
(return to top)
p.000026:
p.000026: (2) Expedited review may be carried out by the HREC chairperson or his designee from among members of HREC. In
p.000026: reviewing the research, the reviewer(s) shall exercise all of the authorities of HREC except that the reviewer(s) may
p.000026: not disapprove the research.
p.000026:
p.000026: (3) The Chairman of HREC shall bring all research reviewed expeditiously to the next meeting of HREC for notice,
p.000026: discussion and ratification.
p.000026:
p.000026: (g) Process for amendment of research
p.000026:
p.000026: (1) HREC shall require that applicants apply for permission to amend protocols in any of the following circumstances:
p.000026:
p.000026: (a) Where there are changes in any part of the research protocol that alters the risk benefit ratio of the research.
p.000026:
p.000026: (b) Where there are changes in the named members of the team conducting the research.
p.000026:
p.000026: (c) Where there are changes in research sites.
p.000026:
p.000026: (c) Where there are changes in sponsorship, institutional guidelines, institutional structure, HREC requirements,
p.000026: national laws or exigencies that impact on the ethical conduct of research.
p.000026:
p.000026: (2) HREC shall require that researcher submit an application for original research approval where in its opinion, the
p.000026: proposed amendments are substantial, such as but not limited to, change(s) in inclusion or exclusion criteria,
p.000026: randomization, interventions and outcome measures.
p.000027: 27
p.000027:
p.000027: (3) Under no circumstance shall a researcher deviate from approved protocol, except such as is necessary to eliminate
p.000027: immediate hazard to research participants. The researcher shall notify the Chairman of HREC within 24 hours of such
p.000027: changes.
p.000027:
p.000027: (4) In such circumstances as described in section (3) above, the researcher shall stop the research and the HREC shall
p.000027: conduct a thorough review of the research before authorizing suspension, continuation or modifications to the research.
p.000027:
p.000027: (h) Process for exemption
p.000027:
p.000027: (1) HREC may grant exemption from review in any of the conditions enumerated above (vide supra).
p.000027:
p.000027: (2) Applicants seeking exemption shall submit the proposed research or adequate information about it to the HREC,
p.000027: sufficient, in HREC judgement, to make a determination.
p.000027:
p.000027: (3) Exemptions may be granted by the HREC chairperson or his designee from among members of the HREC, in consultation
p.000027: with the HREC Administrative Officer – where one exists.
p.000027:
p.000027: (4) In granting exemption, the reviewer(s) shall exercise all of the authorities of the HREC except that the
p.000027: reviewer(s) may not disapprove the research.
p.000027:
p.000027: (5) Where the reviewer is uncertain and the uncertainty is unresolved after request for and provision of more
p.000027: information by the applicant, the proposal or summary should be referred to the HREC.
p.000027:
p.000027: (6) The Chairman of HREC shall bring all exempted research to the next meeting of HREC for notice, discussion and
p.000027: ratification.
p.000027:
p.000027: (i) Process for suspension of research
p.000027:
p.000028: 28
p.000028:
p.000028: (1) HREC shall have authority to suspend research that is not being conducted:
p.000028:
p.000028: (a) In accordance with HREC requirements or
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000014: conducting research that may be exempt shall submit the proposal or a written summary that contains enough information
p.000014: for judgement to be made, to the HREC. The HREC Chairperson or his designee, in consultation with HREC Administrative
p.000014: Officer – where one exists, shall decide whether the research is exempt. Where the Chairperson is uncertain and the
p.000014: uncertainty is unresolved after request for and provision of more information by the applicant, the proposal or summary
p.000014: should be referred to HREC. All applications for exemption must be brought to the notice of HREC at its regular meeting
p.000014: for discussion as may be deemed necessary by members of HREC.
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000015: 15
p.000015:
p.000015: Section C
p.000015:
p.000015: Registration of Health Research Ethics Committees
p.000015:
p.000015: In order for an institution to be able to conduct health research, the institution must have a registered health
p.000015: research ethics committee (HREC). The following are the guidelines for registration:
p.000015:
p.000015: (a) Registration with National Health Research Ethics Committee (NHREC) shall require:
p.000015:
p.000015: (1) An application by the authorized head of the institution or their authorized designee which among other things
p.000015: should include that the line of reporting authority of the Chairman of the HREC is directly to the Chief Executive of
p.000015: the proposing institution.
p.000015:
p.000015: (2) A list of members of the proposed health research ethics committee identified by:
p.000015:
p.000015: i. Name
p.000015:
p.000015: ii. Qualifications
p.000015:
p.000015: iii. Representative capacity
p.000015:
p.000015: iv. Indications of experience such as trainings, certifications, licenses, etc., sufficient to describe each member's
p.000015: chief anticipated contributions to HREC deliberations.
p.000015:
p.000015: v. Any employment or any other relationships (including stock ownership, receipt of grants, honorariums or support from
p.000015: potential research sponsors) that may be construed as conflict of interest within the context of membership of the
p.000015: HREC.
p.000015:
p.000015:
p.000016: 16
p.000016:
p.000016: (3) All members of the proposed HREC must have completed NHREC approved training programs in research ethics.
p.000016: Additional training in research methodology and research administration is recommended. Copies of the certificates of
p.000016: completion of such programs must be submitted along with the application. The institution setting up the HREC must
p.000016: provide resources for such training.
p.000016:
p.000016: (4) Statement of agreement to comply with the Nigerian Code of Health Research Ethics subsequently referred to as “the
p.000016: code”, governing HREC in the discharge of its responsibilities for protecting the rights and welfare of human
p.000016: participants of research conducted at or sponsored by the institution.
p.000016:
...
p.000017: research methodology and research administration is recommended. Copies of the certificates of completion of such
p.000017: programs must be submitted along with the application.
p.000017:
p.000017: (3) Copy of the primary statement of agreement to comply with the National Code of Health Research Ethics previously
p.000017: endorsed by the institution and the NHREC.
p.000017:
p.000017: (4) Report of fulfilment of previously stated commitment to provide infrastructure and logistics to support the HREC
p.000017: review and recordkeeping duties.
p.000017:
p.000017: (5) Complete record of the activities of the committee, including financial records, attendance register at statutory
p.000017: meetings, complaints, litigations, number, and titles of protocols received, reviewed, approved, rejected and pending,
p.000017: and the mean time from protocol submission to approval in each of the preceding 2 years.
p.000018: 18
p.000018:
p.000018: (c) Where a registered HREC does not apply for re-registration during the life of its current registration, the HREC
p.000018: shall be considered de- registered and may apply anew to NHREC. No research may be conducted in the institution during
p.000018: this period of de-registration.
p.000018:
p.000018: (d) Institutions may propose to have more than one HREC. In such instances, the jurisdiction of each of the HREC should
p.000018: be clearly defined and there should be open channels of communications between them that will allow transfer of
p.000018: proposals to the HREC with appropriate expertise. Researchers must not submit the same protocol simultaneously to more
p.000018: than one HREC within the same institution.
p.000018:
p.000018: (e) The authority of HREC shall be limited to the boundary of the proposing institution or the activities of its
p.000018: permanent members of staff, unless otherwise specified by the NHREC. Where a permanent member of staff is the principal
p.000018: investigator of a study taking place outside the boundaries of the proposing institution, the researcher shall seek
p.000018: ethical oversight only from the institution in which he/she is a permanent member of staff. This provision does not
p.000018: preclude co-investigator(s) from seeking ethical oversight from their institution(s) where there is more than one study
p.000018: site.
p.000018:
p.000018: (f) In lieu of an institution being able to constitute a health research ethics committee and where such institution
p.000018: desires to engage in research:
p.000018:
p.000018: (1) Such institution shall establish a cooperative agreement with a registered HREC located within the same state of
p.000018: the federation as the institution.
p.000018:
p.000018: (2) Where there is no registered HREC within the same state of the federation, agreement can be established with any
p.000018: HREC within the same geopolitical zone of the country as the institution.
p.000019: 19
p.000019:
p.000019: (3) In the eventuality that there is no registered HREC within the same geopolitical zone, the institution should
p.000019: consult the NHREC for guidance.
p.000019:
p.000019: (4) Where a registered HREC agrees to review proposals emanating from another institution, this arrangement shall last
p.000019: only for the period covered by the collaborative agreement and this cannot extend beyond the period of registration of
p.000019: the HREC by the NHREC.
p.000019:
p.000019: (5) Institutions seeking to establish collaborative agreements with a registered HREC must submit an application to the
p.000019: NHREC.
p.000019:
...
p.000019: the period covered by the proposed collaborative agreement.
p.000019:
p.000019: (7) The applicant institution can have collaborative agreement with only one HREC at any given time, while the
p.000019: reviewing HREC can have multiple collaborative agreements subject to NHREC approval.
p.000019:
p.000019: (g) Categories of HREC. The NHREC shall establish categories of HREC on the basis of the size of the committee,
p.000019: qualifications, training and experience of its members in research ethics and science, history of the committee (when
p.000019: established, past review activities, record keeping and compliance with requirements of the Code), resources available
p.000019: to the committee, supporting personnel and infrastructure of both the committee and the proposing institution.
p.000019:
p.000019: (1) NHREC shall outline from time to time detailed criteria for categorization of HREC.
p.000019:
p.000019: (2) Categorization of HREC shall be approved during regularly scheduled meetings of the NHREC.
p.000019:
p.000020: 20
p.000020:
p.000020: (3) NHREC shall outline the types of research that different categories of HREC shall review.
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000021: 21
p.000021:
p.000021: Section D
p.000021:
p.000021: HREC membership
p.000021:
p.000021: (a) The authority to establish a HREC and the procedure of selecting members is vested in the Headship of the proposing
p.000021: institution.
p.000021: (b) Each HREC shall have at least five members and if more, then the total membership must always be an odd number.
p.000021: (c) The HREC shall be sufficiently qualified through the experience, expertise and diversity of its members, including
p.000021: consideration of age, gender, socio-cultural backgrounds, religion and sensitivity to such issues as community
p.000021: attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of researchers and
p.000021: research participants. Members should have varying academic and professional backgrounds to promote complete and
p.000021: adequate review of health research conducted by the promoting institution.
p.000021: (d) In addition to possessing the professional competence necessary to review specific research activities, the HREC
p.000021: shall be able to ascertain the acceptability of proposed research in terms of institutional regulations, applicable
p.000021: laws, and standards of professional conduct and practice. The HREC shall therefore include persons knowledgeable in
p.000021: these areas and whenever feasible, a lawyer.
p.000021: (e) Each HREC shall include at least one member whose primary concerns are in scientific areas and at least one member
p.000021: whose primary concerns are in non-scientific areas.
p.000021: (f) Each HREC shall include at least one member who is not affiliated with the institution and who is not part of the
...
p.000022: even after leaving the HREC assignment. There is no time limit for this prohibition.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000023: 23
p.000023:
p.000023: Section E
p.000023:
p.000023: HREC functions and operations
p.000023:
p.000023: In order to fulfil the requirements of this code, each HREC shall:
p.000023:
p.000023: (a) Operate in accordance with the provisions of the current version of the National Code of Health Research Ethics
p.000023: issued by the NHREC. Additional guidance may be obtained from the Standard Operating Procedure (SOP) issued by the
p.000023: NHREC.
p.000023:
p.000023: (b) Except when an expedited review procedure is used, research proposals shall be considered at regularly convened
p.000023: ordinary meetings of HREC at which a majority of the members are present, including at least one member whose primary
p.000023: concerns are in non-scientific areas.
p.000023:
p.000023: (c) Where a member cannot physically attend a meeting, the member shall be accounted as being present if he/she can
p.000023: participate electronically, for example by teleconferencing for the majority of the duration of the meeting.
p.000023:
p.000023: (d) Process for regular research approval
p.000023:
p.000023: (1) HREC shall review prescribed application materials and have authority to approve, require modifications in (to
p.000023: secure approval) or disapprove all health research activities covered by this code.
p.000023:
p.000023: (2) In order for research to be approved, the decision shall ordinarily be arrived at by discussion and consensus or
p.000023: it shall receive the support of a simple majority of those members present at the meeting.
p.000023:
p.000023: (3) HREC may, at its own discretion, invite representations from the applicant(s), sponsor(s), institution(s) or any
p.000023: other person(s) that it may consider relevant to provide information pertinent to the research during the review
p.000023: process.
p.000023:
p.000023:
p.000024: 24
p.000024:
p.000024: (4) HREC shall notify investigator(s) in writing of its decision to approve, disapprove or require modifications of the
p.000024: research activity.
p.000024:
p.000024: (5) HREC shall have a maximum of 3 months from the date of receipt of a valid application to give its decision to the
p.000024: applicant. An application shall be considered valid only after receipt of all materials required by HREC to give a
p.000024: determination.
p.000024:
p.000024: (6) Where HREC considers an application of such complexity that it cannot conclude the review, the application shall be
p.000024: referred to NHREC and the applicant duly informed within the stipulated 3 months.
p.000024:
p.000024: (7) Where HREC does not conclude its review in 3 months and has not referred the case to the NHREC, the applicant shall
p.000024: have the right to complain to NHREC with the possibility of re-allocation of the proposal to another HREC and sanction
p.000024: of the concerned HREC
p.000024:
p.000024: (8) Where HREC decides to disapprove a health research activity, it shall include in its written notification, a
p.000024: statement of the reason(s) for its decision and give the applicant an opportunity to respond in person or in writing
p.000024: within 3 months of receipt of the notification.
p.000024:
p.000024: (9) Where HREC has received representation from the applicant in response to an existing decision, HREC may decide to
p.000024: uphold or modify its previous decision and shall communicate this decision to the applicant within 3 months of the
p.000024: representation.
p.000024:
p.000024: (10) HREC is mandated to keep all records related to its decision(s) for a minimum of 10 years after completion of the
p.000024: research activity.
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024: (e) Process for continuing oversight of research
p.000025: 25
p.000025:
p.000025: (1) HREC shall conduct continuing oversight of research covered by this code at intervals adjudged by HREC as being
p.000025: appropriate to degree of risk involved in participation in the research.
p.000025:
p.000025: (2) HREC shall have authority to examine all aspects and documents including consent forms, questionnaires, case report
p.000025: forms etc. that are related to the research and necessary for the HREC to conduct its oversight function.
p.000025:
p.000025: (3) This shall be at least once a year or at least once during the lifetime of the research where the duration of the
p.000025: research is less than a year.
p.000025:
p.000025: (4) HREC shall have authority to observe or cause to be observed on its behalf, the research and its consent process to
p.000025: ensure compliance with the highest scientific and ethical standards.
p.000025:
p.000025: (5) HREC may initiate process of oversight of research in the event of receipt of complaints, information or data
p.000025: relevant to the research from any source.
p.000025:
p.000025: (f) Process for expedited review
p.000025:
p.000025: (1) HREC may expedite review of research in the following circumstances:
p.000025:
p.000025: (a) Research is found to involve no more than minimal risk – meaning that the probability and magnitude of harm is no
p.000025: greater than that encountered in the daily lives of all (or the great majority) persons in the population (under normal
p.000025: circumstances) from which research participants are to be recruited. Note that minimal risk is applicable in
p.000025: non-therapeutic research only.
p.000025:
p.000025: (b) Research does not involve vulnerable populations such as children, prisoners, pregnant women etc.
p.000025:
p.000025:
p.000026: 26
p.000026:
p.000026: (c) Research does not contain serious methodological or ethical flaws
p.000026:
p.000026: (d) Minor changes in previously approved research during the period for which approval is authorized.
p.000026:
...
p.000027: immediate hazard to research participants. The researcher shall notify the Chairman of HREC within 24 hours of such
p.000027: changes.
p.000027:
p.000027: (4) In such circumstances as described in section (3) above, the researcher shall stop the research and the HREC shall
p.000027: conduct a thorough review of the research before authorizing suspension, continuation or modifications to the research.
p.000027:
p.000027: (h) Process for exemption
p.000027:
p.000027: (1) HREC may grant exemption from review in any of the conditions enumerated above (vide supra).
p.000027:
p.000027: (2) Applicants seeking exemption shall submit the proposed research or adequate information about it to the HREC,
p.000027: sufficient, in HREC judgement, to make a determination.
p.000027:
p.000027: (3) Exemptions may be granted by the HREC chairperson or his designee from among members of the HREC, in consultation
p.000027: with the HREC Administrative Officer – where one exists.
p.000027:
p.000027: (4) In granting exemption, the reviewer(s) shall exercise all of the authorities of the HREC except that the
p.000027: reviewer(s) may not disapprove the research.
p.000027:
p.000027: (5) Where the reviewer is uncertain and the uncertainty is unresolved after request for and provision of more
p.000027: information by the applicant, the proposal or summary should be referred to the HREC.
p.000027:
p.000027: (6) The Chairman of HREC shall bring all exempted research to the next meeting of HREC for notice, discussion and
p.000027: ratification.
p.000027:
p.000027: (i) Process for suspension of research
p.000027:
p.000028: 28
p.000028:
p.000028: (1) HREC shall have authority to suspend research that is not being conducted:
p.000028:
p.000028: (a) In accordance with HREC requirements or
p.000028: (b) In accordance with existing legislation or
p.000028: (c) In accordance with existing institutional guidelines; or
p.000028: (d) Where research is associated with unexpected serious harm to participants.
p.000028:
p.000028: (2) Any suspension of research shall include a statement of the reason(s) for the HREC action and shall be reported
p.000028: within 2 weeks to the researcher(s), institution(s), sponsor(s) and the NHREC.
p.000028:
p.000028: (3) Researcher(s), institution(s) or sponsor(s) shall be entitled to ask for a reconsideration of the decision of HREC
p.000028: to suspend research within 2 weeks of receipt of notification.
p.000028:
p.000028: (j) Process for revision of suspension
p.000028:
p.000028: (1) HREC may reverse its decision to suspend research if the precipitant(s) of the action is resolved to HREC
p.000028: satisfaction
p.000028:
p.000028: (2) The HREC will determine the case at its next regular meeting and may require that the researcher sign an agreement
p.000028: with HREC on its finding(s) and agreed remedial measure(s).
p.000028:
p.000028: (3) Where HREC allows resumption of research, an oversight review of the research shall be carried out within 6 months
p.000028: or at least once during the lifetime of the research if it is shorter than 6 months.
p.000028:
p.000028: (k) Process for termination of research
p.000028:
p.000028: (1) Where the researcher(s), sponsor(s) or institution(s) is unable to offer or the HREC is unable to ascertain or
p.000028: enforce satisfactory remediation of the precipitant, HREC shall terminate the research.
p.000028:
p.000029: 29
p.000029:
...
p.000032: informed consent documents and the principles enumerated above. The HREC shall grant provisional approval pending the
p.000032: submission of MTA to NHREC and receipt of acknowledgement from the NHREC.
p.000032:
p.000032: (c) The applicant for research review shall file a copy of the MTA and provisional approval by the institutional HREC
p.000032: with the NHREC for record purposes only.
p.000032:
p.000032: (d) NHREC shall acknowledge receipt of the MTA to the applicant who shall inform the institutional HREC.
p.000032:
p.000032: (e) Institutional HREC shall grant final approval to research involving international transfer of Nigerian samples
p.000032: after all other criteria stated in this code for approval of research has been met and upon receipt of acknowledgement
p.000032: of MTA.
p.000032:
p.000032: (f) The MTA does not vitiate the right of research participants or communities to request that their samples be
p.000032: withdrawn from research according to the terms of the informed consent process.
p.000032:
p.000032: (g) Where there is any change in the MTA, a request for amendment of protocol shall be submitted to HREC and HREC shall
p.000032: consider this in the usual manner used for amendment of protocol.
p.000032:
p.000033: 33
p.000033:
p.000033: (h) Where there is verifiable proof that the applicant has sent a copy of the MTA to the NHREC and has not received an
p.000033: acknowledgement in 2 weeks, the applicant shall file evidence of this with the institutional HREC who shall proceed to
p.000033: issue the final approval for the research.
p.000033:
p.000033: (o) Communication with other regulatory agencies
p.000033:
p.000033: HREC(s) shall have the authority to communicate with other ethics regulatory agencies and institutions about matters
p.000033: relevant to review of research. In such instances, HREC shall notify researcher(s), sponsor(s) and institution(s) about
p.000033: the communication(s).
p.000033:
p.000033: (p) Process for NHREC review of research
p.000033:
p.000033: (1) The NHREC may decide to review a research
p.000033: where:
p.000033:
p.000033: (a) The research is nation-wide in coverage or
p.000033:
p.000033: (b) The research involves more than 3 sites in Nigeria or
p.000033:
p.000033: (c) The research was referred to NHREC by HREC(s) or
p.000033:
p.000033: (d) There is no HREC in an institution and the institution does not have a HREC cooperative agreement or
p.000033:
p.000033: (e) The researcher considers the researcher of such complexity that there may be inadequate expertise in any one local
p.000033: institution or
p.000033:
p.000033: (f) At its discretion.
p.000033:
p.000033: (2) The NHREC may review research by:
p.000033:
p.000033:
p.000033:
p.000034: 34
p.000034:
p.000034: (a) Mandating review by any HREC in the country to act as a “HREC of record” and review the research on its behalf.
p.000034:
p.000034: (b) Constituting itself into a review committee and exercising all the powers applicable therein as outlined for HREC
p.000034: in this code.
p.000034:
p.000034: (c) Constituting an ad hoc HREC at its discretion.
p.000034:
p.000034: (3) Where NHREC utilizes any of these methods, it shall assign continuing oversight of research to institutional HREC.
p.000034:
p.000034: (4) Where NHREC assigns continuing oversight functions to institutional HREC, the institutional HREC shall have all the
p.000034: authority of oversight function as outlined in relevant sections of this code
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000035: 35
p.000035:
p.000035: (q) Fees
p.000035:
p.000035: HREC may charge fees for any or all of its activities, at its discretion and in consultation with the principal
p.000035: officers of the institution.
p.000035:
p.000035: (1) Fees may vary depending on the size, complexity, duration, status of researcher and sponsor of the researcher.
p.000035:
p.000035: (2) Fees must be commensurate with anticipated expenses required for adequate oversight of research.
p.000035:
p.000035: (r) Protection of participants in the research enterprise
p.000035:
p.000035: HREC must protect the rights of researcher(s)
p.000035:
p.000035: (1) HREC shall protect the right of researcher(s) to publish their research.
p.000035:
p.000035: (a) In certain situations, this will require the submission of an agreement between sponsor(s), institution(s) and
p.000035: researcher(s) allowing researcher(s) to use the outcome of research in manner consistent with current practice within
p.000035: the research community.
p.000035:
p.000035: (b) HREC shall evaluate whether such agreement is necessary when the research is being reviewed and if found necessary,
p.000035: request same before approval is given.
p.000035:
p.000035: (2) HREC shall protect researchers from exploitation.
p.000035:
...
p.000054:
p.000054: (g) In international collaborative research, NHREC shall report its findings of misconduct against researchers,
p.000054: sponsors and collaborators to the national ethics regulatory agency of the country of origin of the researcher. This
p.000054: does not preclude the institution of appropriate legal action, where indicated, against such researchers, his/her
p.000054: representatives, collaborators or agents in Nigeria.
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000055: 55
p.000055:
p.000055: Section O
p.000055:
p.000055: Continuing Review of the National Code of Health Research Ethics and sub-codes
p.000055:
p.000055: The NHREC shall regularly update, revise, edit and modify the National Code of Health Research Ethics in accordance
p.000055: with new developments in international research ethics, local laws and enactments and at its discretion.
p.000055:
p.000055: The most recent version shall always be posted on the index page of the web site of the NHREC (http://www.nhrec.net)
p.000055: and shall be dated. The existence of a code with a more recent date invalidates all the previous codes and their
p.000055: provisions. The new code shall be enforced from the date indicated on it. Its provisions shall not be retroactive.
p.000055:
p.000055: Sub-codes provide additional guidelines and where their provisions appear to conflict with that of the National Code of
p.000055: Health Research Ethics, the latter shall be the superior authority.
p.000055:
p.000055: The National Code of Health Research Ethics shall be available in different Nigerian languages but the English version
p.000055: shall be the only correct interpretation of the provisions of the code.
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
...
General/Other / cultural difference
Searching for indicator culturally:
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p.000038: integrated with comprehensive capacity building, technology transfer and health care delivery strategies that address
p.000038: significant local health problems and add value to local participants of research, including researchers, institutions,
p.000038: communities and the country.
p.000038: b. For research to be ethical, it must be have scientific validity. Research lacking clear scientific
p.000038: objective(s); using invalid methodology; that is underpowered; lacking equipoise (for clinical studies); whose
p.000038: operationalizing plans are inadequate within the context of the environment where research would be conducted; lacks
p.000038: plausible data analysis plan (including a specific role for a Data and Safety Monitoring Board [DSMB] in clinical
p.000038: trials) and research with biased measurement(s) of outcome(s) is unethical.
p.000038: c. Ethical research must ensure fair selection of participants based on the scientific objective(s) of the
p.000038: research while minimizing risk. This requirement refers to both who is included and who is excluded from recruitment
p.000038: and the strategies employed for participants’ recruitment (including choice of research sites and communities).
p.000038: Regardless of this requirement, participants who are at
p.000039: 39
p.000039:
p.000039: excessively increased risk of harm should be excluded. Children, pregnant women, socially, culturally, economically,
p.000039: politically, educationally, physically and psychologically disadvantaged groups, groups with constrained autonomy and
p.000039: other vulnerable populations should not be excluded from research without explicit reasons for doing so; particularly
p.000039: from studies that can advance their health and well being. However specific safeguards should be included to protect
p.000039: the vulnerable, appropriate to degree of risk. Groups, communities, participants and researchers who bear the burden of
p.000039: research should share in the benefits.
p.000039: d. All research involve risks; to be ethical therefore, there must be valid attempts to minimize risks and
p.000039: maximize health related benefits (as distinguished from risks and benefits of therapies that participants would be
p.000039: exposed to even if they were not participating in research or incidental risks or benefits) to participants in order to
p.000039: engender favourable risk benefit ratio within the context of where the research is being conducted.
p.000039:
p.000039: (1) Where the risks outweigh the benefits to the participants, other criteria outlined in this code must justify such
p.000039: risks.
p.000039:
p.000039: (2) Risks and benefits should be considered at the level of individual research participants and at the community,
p.000039: whenever appropriate.
p.000039:
p.000039: (3) Comprehensive delineation of risks and benefits should be done for participants during the research, the population
...
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p.000004: 4
p.000004:
p.000004: Acknowledgement
p.000004:
p.000004: This document is the property of the Federal Ministry of Health, and was developed with technical support of the West
p.000004: African Bioethics Training Programme (WAB).
p.000004:
p.000004: We thank the members of the WAB team which included
p.000004: Ven. Dr. Adefolarin Obanishola Malomo MB,BS, FWACS, FICS; Dr Emmanuel Babatunde Omobowale Ph.D (English), M.A
p.000004: (Bioethics; Dr. (Mrs.) Jane Roli Adebusuyi PhD (SocialXWelfare); Dr. (Mrs.) Bolatito Asiata Lanre-Abass, PhD
p.000004: (Philosophy); Dr. John Oluwole A. Akintayo LL.B, LL.M, PhD (Law); Dr Adebayo Olayiwola Adejumo BSc (Nursing), MHSc
p.000004: (Bioethics), PhD (Psychology); Dr. Ademola J. Ajuwon BSc, MPH, PhD; Professor (Mrs.) Olaitan Soyannwo MBBS, DA, M.Med,
p.000004: FWACS, FAS; Arc. Mrs. Eugenious Adebamowo BSc, MSc; Dr. Ayodele Samuel Jegede BSc, MSc, MHSc (Bioethics), PhD; Mrs.
p.000004: Oluwatoyin Siminsola Akintola LLM; Dr. Christopher Agulanna, B.A., M.A. (Lagos); PhD (Ibadan)
p.000004:
p.000004: The following members of the Federal Ministry of Health; Dr. Jonathan Jiya, Dr. A. Nasidi, Dr. J. M. Adekeye, and Mr.
p.000004: Aminu Yakubu; also made significant contributions to the development of the code.
p.000004:
p.000004: Special thanks to Professor Clement Adebamowo BM, ChB Hons (Jos), FWACS, FACS, Sc.D. (Harvard) who developed the
p.000004: preliminary draft code, coordinated and supported the entire technical consultation process with his NIH Research Grant
p.000004: No. D43 TW007091 funded by the Fogarty International Center and the National Human Genome Research Institute.
p.000004:
p.000004: Thanks also to Mr. M. L. Oladejo and Mr. Ali Gubio for providing support towards the final editing and printing of the
p.000004: code.
p.000004:
p.000004: Thanks are also due to the all the departments of the Federal Ministry of Health and the various stakeholders for their
p.000004: contributions during the consultation process.
p.000004:
p.000005: 5
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p.000006: 6
p.000006:
p.000006: Table of Contents Page No
p.000006: Foreword 4
p.000006: Acknowledgement 5
p.000006: About NHREC 10
p.000006: To whom does this code apply? 12
p.000006: Definition of Research and Coverage
p.000006: of Code 12
p.000006: Exemption 13
p.000006: Who determines exemption? 15
p.000006: Registration of Health Research
p.000006: Ethics Committees 16
p.000006: HREC membership 22
p.000006: HREC functions and operations 24
p.000006: Process for regular research 24
p.000006: approval
p.000006: Process for continuing oversight 26
p.000006: of research
p.000006: Process for expedited review 26
p.000006: Process for amendment of 27
p.000006: research
p.000007: 7
p.000007:
p.000007: Process for exemption 28
p.000007: Process for suspension of 29
p.000007: research
p.000007: Process for revision of 29
p.000007: suspension
p.000007: Process for termination of 30
p.000007: research
p.000007: Process for appeal of HREC 30
p.000007: decision to terminate research
p.000007: Process for review of multi- 31
p.000007: institutional research
p.000007: Materials Transfer Agreement 33
p.000007: Communication with other agencies 34
p.000007: Process for NHREC review of 34
p.000007: research
p.000007: Fees 36
p.000007: Protection of participants in the 36
p.000007: research enterprise
p.000007: Ethical principles and guidelines 39
p.000007: HREC Education and Training
p.000007: Responsibility 46
p.000008: 8
p.000008:
...
p.000011: (b) Non-therapeutic procedures – interventions that are not administered with therapeutic intent and are only intended
p.000011: to answer the scientific question of the study
p.000011:
p.000011: Activities which meet this definition constitute research for purposes of this code, whether or not they are conducted
p.000011: or supported under a program which is considered research for other purposes. For example, some demonstration and
p.000011: service programs may include research activities.
p.000011:
p.000011: Health research that is conducted anywhere in Nigeria must comply with all sections of this code.
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000012: 12
p.000012:
p.000012: Section B Exemption
p.000012: Research activities in which the only involvement of human participants will be in one or more of the following
p.000012: categories are exempt from health research ethics committee oversight:
p.000012:
p.000012: (a) Research conducted in established or commonly accepted educational settings, involving normal educational
p.000012: practices, such as:
p.000012:
p.000012: (1) Research on regular and special education instructional strategies, or
p.000012:
p.000012: (2) Research on the effectiveness of or comparison among instructional techniques, curricula, or classroom management
p.000012: methods.
p.000012:
p.000012: (b) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures,
p.000012: interview procedures or observation of public behaviour, unless:
p.000012:
p.000012: (1) Information obtained is recorded in such a manner that human participants can be identified, directly or through
p.000012: identifiers linked to the participants; and
p.000012:
p.000012: (2) Any disclosure of the human participants' responses outside the research could reasonably place the participants at
p.000012: risk of criminal or civil liability or be damaging to the participants' financial standing, employability, or
p.000012: reputation.
p.000012:
p.000012: (c) Research involving the collection or study of existing data, documents, records, pathological specimens, or
p.000012: diagnostic specimens, if these sources are publicly available (note that this refers to availability of data and not
p.000012: the status of the custodian
p.000013: 13
p.000013:
p.000013: of the information/data) or if the information is recorded by the investigator in such a manner that participants
p.000013: cannot be identified, directly or through identifiers linked to the participants.
p.000013:
p.000013: (d) Studies that are meant to evaluate the outcome of procedures, programs and services are exempt because they are
p.000013: designed to produce information leading to improvement in delivery of procedures, programs and services. Such studies
p.000013: usually evaluate measures that are already in use and considered part of standard practice. They may include collection
p.000013: and analysis of data or collection of new data but they do not involve allocation into groups or randomisation.
p.000013:
p.000013: (e) Studies that are designed to evaluate or assess quality of services, programs and procedures and formulate
p.000013: guidelines leading to their improvement are exempt. Such studies may involve the collection and analysis of some data.
p.000013:
p.000013: (f) Innovative or non-validated medical treatment – treatment that is designed solely for the benefit of the patient
p.000013: but in which the ability of the treatment to result in the desired result is to some degree not proven. Such activities
p.000013: are exempt while recommending that they should be subjected to research in order to generate information about their
p.000013: efficacy as soon as possible.
p.000013:
p.000013: (g) Clinical audit, where the study is designed and conducted solely to define or judge only current care, without
p.000013: reference to a standard. It may involve the collection and analysis of data but there is no allocation to intervention
p.000013: groups or randomisation and the services have been delivered before the audit is initiated.
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: Who determines exemption?
p.000014:
p.000014: All exemptions shall be determined by the Health Research Ethics Committee (HREC) - vide infra. In summary, applicants
p.000014: conducting research that may be exempt shall submit the proposal or a written summary that contains enough information
p.000014: for judgement to be made, to the HREC. The HREC Chairperson or his designee, in consultation with HREC Administrative
p.000014: Officer – where one exists, shall decide whether the research is exempt. Where the Chairperson is uncertain and the
p.000014: uncertainty is unresolved after request for and provision of more information by the applicant, the proposal or summary
p.000014: should be referred to HREC. All applications for exemption must be brought to the notice of HREC at its regular meeting
p.000014: for discussion as may be deemed necessary by members of HREC.
p.000014:
p.000014:
p.000014:
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p.000014:
p.000014:
p.000015: 15
p.000015:
p.000015: Section C
p.000015:
p.000015: Registration of Health Research Ethics Committees
p.000015:
p.000015: In order for an institution to be able to conduct health research, the institution must have a registered health
p.000015: research ethics committee (HREC). The following are the guidelines for registration:
p.000015:
p.000015: (a) Registration with National Health Research Ethics Committee (NHREC) shall require:
p.000015:
p.000015: (1) An application by the authorized head of the institution or their authorized designee which among other things
p.000015: should include that the line of reporting authority of the Chairman of the HREC is directly to the Chief Executive of
p.000015: the proposing institution.
p.000015:
p.000015: (2) A list of members of the proposed health research ethics committee identified by:
p.000015:
p.000015: i. Name
p.000015:
p.000015: ii. Qualifications
p.000015:
p.000015: iii. Representative capacity
p.000015:
p.000015: iv. Indications of experience such as trainings, certifications, licenses, etc., sufficient to describe each member's
p.000015: chief anticipated contributions to HREC deliberations.
p.000015:
p.000015: v. Any employment or any other relationships (including stock ownership, receipt of grants, honorariums or support from
p.000015: potential research sponsors) that may be construed as conflict of interest within the context of membership of the
p.000015: HREC.
p.000015:
p.000015:
p.000016: 16
p.000016:
...
p.000018:
p.000018: (e) The authority of HREC shall be limited to the boundary of the proposing institution or the activities of its
p.000018: permanent members of staff, unless otherwise specified by the NHREC. Where a permanent member of staff is the principal
p.000018: investigator of a study taking place outside the boundaries of the proposing institution, the researcher shall seek
p.000018: ethical oversight only from the institution in which he/she is a permanent member of staff. This provision does not
p.000018: preclude co-investigator(s) from seeking ethical oversight from their institution(s) where there is more than one study
p.000018: site.
p.000018:
p.000018: (f) In lieu of an institution being able to constitute a health research ethics committee and where such institution
p.000018: desires to engage in research:
p.000018:
p.000018: (1) Such institution shall establish a cooperative agreement with a registered HREC located within the same state of
p.000018: the federation as the institution.
p.000018:
p.000018: (2) Where there is no registered HREC within the same state of the federation, agreement can be established with any
p.000018: HREC within the same geopolitical zone of the country as the institution.
p.000019: 19
p.000019:
p.000019: (3) In the eventuality that there is no registered HREC within the same geopolitical zone, the institution should
p.000019: consult the NHREC for guidance.
p.000019:
p.000019: (4) Where a registered HREC agrees to review proposals emanating from another institution, this arrangement shall last
p.000019: only for the period covered by the collaborative agreement and this cannot extend beyond the period of registration of
p.000019: the HREC by the NHREC.
p.000019:
p.000019: (5) Institutions seeking to establish collaborative agreements with a registered HREC must submit an application to the
p.000019: NHREC.
p.000019:
p.000019: (6) The reviewing HREC must be currently registered and must attest that it will maintain its registration status for
p.000019: the period covered by the proposed collaborative agreement.
p.000019:
p.000019: (7) The applicant institution can have collaborative agreement with only one HREC at any given time, while the
p.000019: reviewing HREC can have multiple collaborative agreements subject to NHREC approval.
p.000019:
p.000019: (g) Categories of HREC. The NHREC shall establish categories of HREC on the basis of the size of the committee,
p.000019: qualifications, training and experience of its members in research ethics and science, history of the committee (when
p.000019: established, past review activities, record keeping and compliance with requirements of the Code), resources available
p.000019: to the committee, supporting personnel and infrastructure of both the committee and the proposing institution.
p.000019:
p.000019: (1) NHREC shall outline from time to time detailed criteria for categorization of HREC.
p.000019:
p.000019: (2) Categorization of HREC shall be approved during regularly scheduled meetings of the NHREC.
p.000019:
p.000020: 20
p.000020:
p.000020: (3) NHREC shall outline the types of research that different categories of HREC shall review.
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
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p.000020:
p.000020:
p.000021: 21
p.000021:
p.000021: Section D
p.000021:
p.000021: HREC membership
p.000021:
p.000021: (a) The authority to establish a HREC and the procedure of selecting members is vested in the Headship of the proposing
p.000021: institution.
p.000021: (b) Each HREC shall have at least five members and if more, then the total membership must always be an odd number.
p.000021: (c) The HREC shall be sufficiently qualified through the experience, expertise and diversity of its members, including
p.000021: consideration of age, gender, socio-cultural backgrounds, religion and sensitivity to such issues as community
p.000021: attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of researchers and
p.000021: research participants. Members should have varying academic and professional backgrounds to promote complete and
p.000021: adequate review of health research conducted by the promoting institution.
p.000021: (d) In addition to possessing the professional competence necessary to review specific research activities, the HREC
p.000021: shall be able to ascertain the acceptability of proposed research in terms of institutional regulations, applicable
p.000021: laws, and standards of professional conduct and practice. The HREC shall therefore include persons knowledgeable in
p.000021: these areas and whenever feasible, a lawyer.
p.000021: (e) Each HREC shall include at least one member whose primary concerns are in scientific areas and at least one member
p.000021: whose primary concerns are in non-scientific areas.
p.000021: (f) Each HREC shall include at least one member who is not affiliated with the institution and who is not part of the
p.000021: immediate family of a person who is affiliated with the institution.
p.000021: (g) No HREC may have a member participate in the HREC initial or continuing review of any project in which the member
p.000021: has a conflicting interest.
p.000021: (h) If HREC wishes to review research that involves vulnerable participants, such as children, prisoners, pregnant
p.000021: women, physically and psychologically disabled persons, the HREC shall co-opt one or more individuals knowledgeable
p.000021: about and experienced in working with
p.000022: 22
p.000022:
p.000022: these participants for the review process. These individuals may not vote during the HREC meeting.
p.000022: (i) Each HREC member must pledge to maintain confidentiality regarding all meetings, deliberations, applications,
p.000022: information on research participants and related matters that shall come to his/her knowledge during service on HREC
p.000022: even after leaving the HREC assignment. There is no time limit for this prohibition.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
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p.000022:
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p.000022:
p.000023: 23
p.000023:
p.000023: Section E
p.000023:
p.000023: HREC functions and operations
p.000023:
p.000023: In order to fulfil the requirements of this code, each HREC shall:
p.000023:
p.000023: (a) Operate in accordance with the provisions of the current version of the National Code of Health Research Ethics
p.000023: issued by the NHREC. Additional guidance may be obtained from the Standard Operating Procedure (SOP) issued by the
p.000023: NHREC.
p.000023:
p.000023: (b) Except when an expedited review procedure is used, research proposals shall be considered at regularly convened
p.000023: ordinary meetings of HREC at which a majority of the members are present, including at least one member whose primary
p.000023: concerns are in non-scientific areas.
p.000023:
p.000023: (c) Where a member cannot physically attend a meeting, the member shall be accounted as being present if he/she can
p.000023: participate electronically, for example by teleconferencing for the majority of the duration of the meeting.
p.000023:
p.000023: (d) Process for regular research approval
p.000023:
p.000023: (1) HREC shall review prescribed application materials and have authority to approve, require modifications in (to
p.000023: secure approval) or disapprove all health research activities covered by this code.
p.000023:
p.000023: (2) In order for research to be approved, the decision shall ordinarily be arrived at by discussion and consensus or
p.000023: it shall receive the support of a simple majority of those members present at the meeting.
p.000023:
p.000023: (3) HREC may, at its own discretion, invite representations from the applicant(s), sponsor(s), institution(s) or any
p.000023: other person(s) that it may consider relevant to provide information pertinent to the research during the review
p.000023: process.
p.000023:
p.000023:
p.000024: 24
p.000024:
p.000024: (4) HREC shall notify investigator(s) in writing of its decision to approve, disapprove or require modifications of the
p.000024: research activity.
p.000024:
p.000024: (5) HREC shall have a maximum of 3 months from the date of receipt of a valid application to give its decision to the
p.000024: applicant. An application shall be considered valid only after receipt of all materials required by HREC to give a
p.000024: determination.
p.000024:
p.000024: (6) Where HREC considers an application of such complexity that it cannot conclude the review, the application shall be
p.000024: referred to NHREC and the applicant duly informed within the stipulated 3 months.
p.000024:
p.000024: (7) Where HREC does not conclude its review in 3 months and has not referred the case to the NHREC, the applicant shall
p.000024: have the right to complain to NHREC with the possibility of re-allocation of the proposal to another HREC and sanction
p.000024: of the concerned HREC
p.000024:
p.000024: (8) Where HREC decides to disapprove a health research activity, it shall include in its written notification, a
p.000024: statement of the reason(s) for its decision and give the applicant an opportunity to respond in person or in writing
p.000024: within 3 months of receipt of the notification.
p.000024:
p.000024: (9) Where HREC has received representation from the applicant in response to an existing decision, HREC may decide to
p.000024: uphold or modify its previous decision and shall communicate this decision to the applicant within 3 months of the
p.000024: representation.
p.000024:
p.000024: (10) HREC is mandated to keep all records related to its decision(s) for a minimum of 10 years after completion of the
p.000024: research activity.
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024: (e) Process for continuing oversight of research
p.000025: 25
p.000025:
p.000025: (1) HREC shall conduct continuing oversight of research covered by this code at intervals adjudged by HREC as being
p.000025: appropriate to degree of risk involved in participation in the research.
p.000025:
p.000025: (2) HREC shall have authority to examine all aspects and documents including consent forms, questionnaires, case report
p.000025: forms etc. that are related to the research and necessary for the HREC to conduct its oversight function.
p.000025:
p.000025: (3) This shall be at least once a year or at least once during the lifetime of the research where the duration of the
p.000025: research is less than a year.
p.000025:
p.000025: (4) HREC shall have authority to observe or cause to be observed on its behalf, the research and its consent process to
p.000025: ensure compliance with the highest scientific and ethical standards.
p.000025:
p.000025: (5) HREC may initiate process of oversight of research in the event of receipt of complaints, information or data
p.000025: relevant to the research from any source.
p.000025:
p.000025: (f) Process for expedited review
p.000025:
p.000025: (1) HREC may expedite review of research in the following circumstances:
p.000025:
p.000025: (a) Research is found to involve no more than minimal risk – meaning that the probability and magnitude of harm is no
p.000025: greater than that encountered in the daily lives of all (or the great majority) persons in the population (under normal
p.000025: circumstances) from which research participants are to be recruited. Note that minimal risk is applicable in
p.000025: non-therapeutic research only.
p.000025:
p.000025: (b) Research does not involve vulnerable populations such as children, prisoners, pregnant women etc.
p.000025:
p.000025:
p.000026: 26
p.000026:
p.000026: (c) Research does not contain serious methodological or ethical flaws
p.000026:
p.000026: (d) Minor changes in previously approved research during the period for which approval is authorized.
p.000026:
p.000026: (2) Expedited review may be carried out by the HREC chairperson or his designee from among members of HREC. In
p.000026: reviewing the research, the reviewer(s) shall exercise all of the authorities of HREC except that the reviewer(s) may
p.000026: not disapprove the research.
p.000026:
p.000026: (3) The Chairman of HREC shall bring all research reviewed expeditiously to the next meeting of HREC for notice,
p.000026: discussion and ratification.
p.000026:
p.000026: (g) Process for amendment of research
p.000026:
p.000026: (1) HREC shall require that applicants apply for permission to amend protocols in any of the following circumstances:
p.000026:
p.000026: (a) Where there are changes in any part of the research protocol that alters the risk benefit ratio of the research.
p.000026:
p.000026: (b) Where there are changes in the named members of the team conducting the research.
p.000026:
p.000026: (c) Where there are changes in research sites.
p.000026:
p.000026: (c) Where there are changes in sponsorship, institutional guidelines, institutional structure, HREC requirements,
p.000026: national laws or exigencies that impact on the ethical conduct of research.
p.000026:
p.000026: (2) HREC shall require that researcher submit an application for original research approval where in its opinion, the
p.000026: proposed amendments are substantial, such as but not limited to, change(s) in inclusion or exclusion criteria,
p.000026: randomization, interventions and outcome measures.
p.000027: 27
p.000027:
p.000027: (3) Under no circumstance shall a researcher deviate from approved protocol, except such as is necessary to eliminate
p.000027: immediate hazard to research participants. The researcher shall notify the Chairman of HREC within 24 hours of such
p.000027: changes.
p.000027:
p.000027: (4) In such circumstances as described in section (3) above, the researcher shall stop the research and the HREC shall
p.000027: conduct a thorough review of the research before authorizing suspension, continuation or modifications to the research.
p.000027:
p.000027: (h) Process for exemption
p.000027:
p.000027: (1) HREC may grant exemption from review in any of the conditions enumerated above (vide supra).
p.000027:
p.000027: (2) Applicants seeking exemption shall submit the proposed research or adequate information about it to the HREC,
p.000027: sufficient, in HREC judgement, to make a determination.
p.000027:
p.000027: (3) Exemptions may be granted by the HREC chairperson or his designee from among members of the HREC, in consultation
p.000027: with the HREC Administrative Officer – where one exists.
p.000027:
p.000027: (4) In granting exemption, the reviewer(s) shall exercise all of the authorities of the HREC except that the
p.000027: reviewer(s) may not disapprove the research.
p.000027:
p.000027: (5) Where the reviewer is uncertain and the uncertainty is unresolved after request for and provision of more
p.000027: information by the applicant, the proposal or summary should be referred to the HREC.
p.000027:
p.000027: (6) The Chairman of HREC shall bring all exempted research to the next meeting of HREC for notice, discussion and
p.000027: ratification.
p.000027:
p.000027: (i) Process for suspension of research
p.000027:
p.000028: 28
p.000028:
p.000028: (1) HREC shall have authority to suspend research that is not being conducted:
p.000028:
p.000028: (a) In accordance with HREC requirements or
p.000028: (b) In accordance with existing legislation or
p.000028: (c) In accordance with existing institutional guidelines; or
p.000028: (d) Where research is associated with unexpected serious harm to participants.
p.000028:
p.000028: (2) Any suspension of research shall include a statement of the reason(s) for the HREC action and shall be reported
p.000028: within 2 weeks to the researcher(s), institution(s), sponsor(s) and the NHREC.
p.000028:
p.000028: (3) Researcher(s), institution(s) or sponsor(s) shall be entitled to ask for a reconsideration of the decision of HREC
p.000028: to suspend research within 2 weeks of receipt of notification.
p.000028:
p.000028: (j) Process for revision of suspension
p.000028:
p.000028: (1) HREC may reverse its decision to suspend research if the precipitant(s) of the action is resolved to HREC
p.000028: satisfaction
p.000028:
p.000028: (2) The HREC will determine the case at its next regular meeting and may require that the researcher sign an agreement
p.000028: with HREC on its finding(s) and agreed remedial measure(s).
p.000028:
p.000028: (3) Where HREC allows resumption of research, an oversight review of the research shall be carried out within 6 months
p.000028: or at least once during the lifetime of the research if it is shorter than 6 months.
p.000028:
p.000028: (k) Process for termination of research
p.000028:
p.000028: (1) Where the researcher(s), sponsor(s) or institution(s) is unable to offer or the HREC is unable to ascertain or
p.000028: enforce satisfactory remediation of the precipitant, HREC shall terminate the research.
p.000028:
p.000029: 29
p.000029:
p.000029: (2) HREC shall indicate the reason(s) for the termination of research in writing within 2 weeks to the researcher(s),
p.000029: institution(s), sponsor(s) and the NHREC.
p.000029:
p.000029: (3) Researcher(s), institution(s) or sponsor(s) shall be entitled to appeal the decision of HREC to terminate research
p.000029: to the NHREC within 2 weeks of receipt of notification.
p.000029:
p.000029: (l) Process for appeal of HREC decision to terminate research
p.000029:
p.000029: (1) Upon receipt of an appeal of the decision of a HREC to terminate research, NHREC may, at its discretion, take up
p.000029: such an appeal.
p.000029:
p.000029: (2) Where the appeal is sustained,
p.000029:
p.000029: a. NHREC may with reasons and in consultation with the institutional HREC, direct the institutional HREC to approve
p.000029: the research.
p.000029: b. NHREC may with reasons and in consultation with the institutional HREC mandate modifications, which if undertaken,
p.000029: can allow the research to proceed or resume as the case may be.
p.000029: c. Where NHREC mandates restoration of the research, the institutional HREC shall have powers of continuing oversight
p.000029: as outlined in relevant sections of this code
p.000029:
p.000029: (3) NHREC may sustain the decision of the HREC and dismiss the appeal.
p.000029:
p.000029: (m) Process for review of multi-institutional research
p.000029:
p.000029: In the conduct of multi-institutional research, each institution is responsible for safeguarding the rights and welfare
p.000029: of human participants in its institution and for complying with this code.
p.000029:
p.000029:
p.000030: 30
p.000030:
p.000030: (1) Where there are no more than 3 Nigerian research
p.000030: sites:
p.000030:
p.000030: (a) The principal investigator at each research site may apply to the institutional HREC for review.
p.000030:
p.000030: (b) HREC may, at its own discretion, adopt the approval of research by another HREC rather than conduct a fresh review
p.000030: and approve the research.
p.000030:
p.000030: (c) Where the outcome of review is discordant (that is, some HREC approve while others disapprove the research), the
p.000030: applicant shall submit the comments from the different HREC to their institutional HREC for consideration and possible
p.000030: reconciliation.
p.000030:
p.000030: (d) Where the outcome of review by different institutional HREC is favourable but different modifications are
p.000030: requested, the applicant shall submit the comments their institutional HREC for reconciliation.
p.000030:
p.000030: (e) HREC shall, as much as possible, consult with each other in order to resolve discordant reviews and generate
p.000030: consistent single response to multi-site research.
p.000030:
p.000030: (2) Where there are more than 3 Nigerian research
p.000030: sites:
p.000030:
p.000030: (a) Applicant(s) may follow the steps outlined
p.000030: above or
p.000030:
p.000030: (b) Applicant(s) may apply to NHREC directly.
p.000030:
p.000030: (3) In international collaborative research
p.000030:
p.000030: (a) Only applicant(s) with qualification(s) and background sufficient to serve as principal investigator(s) and based
p.000030: in a registered institution in
p.000030:
p.000031: 31
p.000031:
p.000031: Nigeria that is capable of carrying out the proposed research shall apply for review of research.
p.000031:
p.000031: (b) HREC may adopt the approval of another HREC or that of any other local or international ethics review committee (to
p.000031: the degree that such approvals comply with the requirements of the code and take account of local circumstances) and
p.000031: approve the research.
p.000031:
p.000031: (c) Where the outcome of review is discordant, the applicant shall submit the comments from the different HREC or
p.000031: ethics committees their institutional HREC for consideration and possible reconciliation.
p.000031:
p.000031: (d) Where the outcome of review is favourable but different modifications are requested, the applicant shall submit the
p.000031: comments from the different HREC or ethics committees their institutional HREC for consideration and possible
p.000031: reconciliation.
p.000031:
p.000031: (e) HREC and ethics committees shall, as much as possible, consult with each other in order to resolve discordant
p.000031: reviews and generate consistent single response to multi-site research.
p.000031:
p.000031:
p.000031:
p.000031: (n) Materials Transfer Agreement
p.000031:
p.000031: Transfer of samples and biological materials such as animals, herbs and plants out of Nigeria shall require a Materials
p.000031: Transfer Agreement (MTA) detailing the type of materials, anticipated use, location of storage outside Nigeria,
p.000031: duration of such storage, limitations on use, transfer and termination of use of such materials subject to any law,
p.000031: regulations and enactment in Nigeria.
p.000031:
p.000031: The purpose of MTA is to protect the interests of local researchers and Nigeria’s human and natural resources in all
p.000031: its biodiversity as well as how they can be legitimately used. It ensures that the interests of all relevant parties,
p.000031: human
p.000032: 32
p.000032:
p.000032: and community participants in research and the Nigerian nation are protected from exploitation and egregious harm.
p.000032:
p.000032: (a) The MTA shall be signed by all parties involved in the research including local and international principal
p.000032: investigators, heads of local institutions, research sponsors and other relevant parties.
p.000032:
p.000032: (b) HREC shall review the MTA to ensure consistency with the stated objectives of the research, the contents of the
p.000032: informed consent documents and the principles enumerated above. The HREC shall grant provisional approval pending the
p.000032: submission of MTA to NHREC and receipt of acknowledgement from the NHREC.
p.000032:
p.000032: (c) The applicant for research review shall file a copy of the MTA and provisional approval by the institutional HREC
p.000032: with the NHREC for record purposes only.
p.000032:
p.000032: (d) NHREC shall acknowledge receipt of the MTA to the applicant who shall inform the institutional HREC.
p.000032:
p.000032: (e) Institutional HREC shall grant final approval to research involving international transfer of Nigerian samples
p.000032: after all other criteria stated in this code for approval of research has been met and upon receipt of acknowledgement
p.000032: of MTA.
p.000032:
p.000032: (f) The MTA does not vitiate the right of research participants or communities to request that their samples be
p.000032: withdrawn from research according to the terms of the informed consent process.
p.000032:
p.000032: (g) Where there is any change in the MTA, a request for amendment of protocol shall be submitted to HREC and HREC shall
p.000032: consider this in the usual manner used for amendment of protocol.
p.000032:
p.000033: 33
p.000033:
p.000033: (h) Where there is verifiable proof that the applicant has sent a copy of the MTA to the NHREC and has not received an
p.000033: acknowledgement in 2 weeks, the applicant shall file evidence of this with the institutional HREC who shall proceed to
p.000033: issue the final approval for the research.
p.000033:
p.000033: (o) Communication with other regulatory agencies
p.000033:
p.000033: HREC(s) shall have the authority to communicate with other ethics regulatory agencies and institutions about matters
p.000033: relevant to review of research. In such instances, HREC shall notify researcher(s), sponsor(s) and institution(s) about
p.000033: the communication(s).
p.000033:
p.000033: (p) Process for NHREC review of research
p.000033:
p.000033: (1) The NHREC may decide to review a research
p.000033: where:
p.000033:
p.000033: (a) The research is nation-wide in coverage or
p.000033:
p.000033: (b) The research involves more than 3 sites in Nigeria or
p.000033:
p.000033: (c) The research was referred to NHREC by HREC(s) or
p.000033:
p.000033: (d) There is no HREC in an institution and the institution does not have a HREC cooperative agreement or
p.000033:
p.000033: (e) The researcher considers the researcher of such complexity that there may be inadequate expertise in any one local
p.000033: institution or
p.000033:
p.000033: (f) At its discretion.
p.000033:
p.000033: (2) The NHREC may review research by:
p.000033:
p.000033:
p.000033:
p.000034: 34
p.000034:
p.000034: (a) Mandating review by any HREC in the country to act as a “HREC of record” and review the research on its behalf.
p.000034:
p.000034: (b) Constituting itself into a review committee and exercising all the powers applicable therein as outlined for HREC
p.000034: in this code.
p.000034:
p.000034: (c) Constituting an ad hoc HREC at its discretion.
p.000034:
p.000034: (3) Where NHREC utilizes any of these methods, it shall assign continuing oversight of research to institutional HREC.
p.000034:
p.000034: (4) Where NHREC assigns continuing oversight functions to institutional HREC, the institutional HREC shall have all the
p.000034: authority of oversight function as outlined in relevant sections of this code
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000035: 35
p.000035:
p.000035: (q) Fees
p.000035:
p.000035: HREC may charge fees for any or all of its activities, at its discretion and in consultation with the principal
p.000035: officers of the institution.
p.000035:
p.000035: (1) Fees may vary depending on the size, complexity, duration, status of researcher and sponsor of the researcher.
p.000035:
p.000035: (2) Fees must be commensurate with anticipated expenses required for adequate oversight of research.
p.000035:
p.000035: (r) Protection of participants in the research enterprise
p.000035:
p.000035: HREC must protect the rights of researcher(s)
p.000035:
p.000035: (1) HREC shall protect the right of researcher(s) to publish their research.
p.000035:
p.000035: (a) In certain situations, this will require the submission of an agreement between sponsor(s), institution(s) and
p.000035: researcher(s) allowing researcher(s) to use the outcome of research in manner consistent with current practice within
p.000035: the research community.
p.000035:
p.000035: (b) HREC shall evaluate whether such agreement is necessary when the research is being reviewed and if found necessary,
p.000035: request same before approval is given.
p.000035:
p.000035: (2) HREC shall protect researchers from exploitation.
p.000035:
p.000035: (a) In certain situations, this will require the submission of an agreement between sponsor(s), institution(s) and
p.000035: researcher(s) indicating rights to, ownership of and rights of access to data, resources, intellectual property and
p.000035: infrastructure generated in the course of the research.
p.000035:
p.000035: (b) HREC should evaluate whether such agreement is necessary when the research is being
p.000035:
p.000036: 36
p.000036:
p.000036: reviewed and if found necessary, request same before approval is given.
p.000036:
p.000036: (3) HREC shall protect communities participating in research from exploitation.
p.000036:
p.000036: (a) In certain situations, this will require the submission of an agreement between sponsor(s), institution(s),
p.000036: researcher(s) and the community indicating adequate community consultation and agreement with the proposed research.
p.000036:
p.000036: (b) HREC should evaluate whether such agreement is necessary when the research is being reviewed and if found
p.000036: necessary, request same before approval is given. This implies that the HREC has ordinarily found the study approvable
p.000036: but requires that the community should be engaged and their assent sought before research is allowed to proceed. In
p.000036: this circumstance, the HREC cannot change its decision on the approval status of the research once the community
p.000036: engagement process has commenced. If the community engagement fails, then the research cannot proceed in that community
p.000036:
p.000036: (c) Where applicable, such community assent or engagement efforts shall be documented and evidence of same submitted to
p.000036: HREC during the research review process.
p.000036:
p.000036: (d) In some instances, it will be necessary to set up a community advisory board (CAB). Such boards may be established
p.000036: by the study investigators in consultation with the community.
p.000036:
p.000036: (e) Members of CAG shall be selected by the community through their usual consultative process and it shall include
p.000036: broad representation of community members based on age, sex, religion and other community parameters that may be
p.000036: relevant to the study. It may include relatively more representation from population of interest to the study. It may
p.000036: include representatives from the research group and
p.000037: 37
p.000037:
p.000037: other non-community members whose special knowledge or expertise may be considered necessary for effective functioning
p.000037: of the community advisory group. In all instances, members of the community must constitute a simple majority of the
p.000037: CAB.
p.000037:
p.000037: (f) The function of the CAB is to provide community members opportunity to share their views about ethical issues that
p.000037: proposed research raises for individual community members, community as a whole, neighbouring communities and their
p.000037: region/nation. The CAB also provides a forum for dissemination of pre, intra and post-research information to the
p.000037: community. Members of CAB may provide advice and support as needed for the successful implementation of research.
p.000037:
p.000037: (g) The definition of community shall vary with research and shall be based on application of the best scientific
p.000037: principles.
p.000037:
p.000037: (4) HREC must protect researcher(s) from undue pressure from sponsor(s), institution(s), participant(s) or any other
p.000037: source by ensuring that no researcher enters into an agreement or is subjected to circumstances that limits his/her
p.000037: legal rights, freedoms and obligations under Nigerian law to pursue his/her research activities.
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000038: 38
p.000038:
p.000038: Section F
p.000038:
p.000038: Ethical Principles and Guidelines for HREC approval of research
p.000038:
p.000038: In order to approve research covered by this code the HREC, shall determine a balance between the various principles
p.000038: guiding the ethical conduct of research, some of which are outlined below. Since some of these will inevitably
p.000038: conflict, judgement and consensus are essential in determining whether a research should be conducted.
p.000038:
p.000038: a. Research must have social or scientific value to either participants, the population they represent, the
p.000038: local community, the host country or the world, in order to justify the use of finite resources and risk exposure of
p.000038: some participants to harm. Research should evaluate issues that lead to improvements in health and contribute to
p.000038: meaningful knowledge. Such knowledge should be disseminated to all relevant stakeholders during and after the conduct
p.000038: of research. In certain instances, for example in some international collaborative studies, research should be
p.000038: integrated with comprehensive capacity building, technology transfer and health care delivery strategies that address
p.000038: significant local health problems and add value to local participants of research, including researchers, institutions,
p.000038: communities and the country.
p.000038: b. For research to be ethical, it must be have scientific validity. Research lacking clear scientific
p.000038: objective(s); using invalid methodology; that is underpowered; lacking equipoise (for clinical studies); whose
p.000038: operationalizing plans are inadequate within the context of the environment where research would be conducted; lacks
p.000038: plausible data analysis plan (including a specific role for a Data and Safety Monitoring Board [DSMB] in clinical
p.000038: trials) and research with biased measurement(s) of outcome(s) is unethical.
p.000038: c. Ethical research must ensure fair selection of participants based on the scientific objective(s) of the
p.000038: research while minimizing risk. This requirement refers to both who is included and who is excluded from recruitment
p.000038: and the strategies employed for participants’ recruitment (including choice of research sites and communities).
p.000038: Regardless of this requirement, participants who are at
p.000039: 39
p.000039:
p.000039: excessively increased risk of harm should be excluded. Children, pregnant women, socially, culturally, economically,
p.000039: politically, educationally, physically and psychologically disadvantaged groups, groups with constrained autonomy and
p.000039: other vulnerable populations should not be excluded from research without explicit reasons for doing so; particularly
p.000039: from studies that can advance their health and well being. However specific safeguards should be included to protect
p.000039: the vulnerable, appropriate to degree of risk. Groups, communities, participants and researchers who bear the burden of
p.000039: research should share in the benefits.
p.000039: d. All research involve risks; to be ethical therefore, there must be valid attempts to minimize risks and
p.000039: maximize health related benefits (as distinguished from risks and benefits of therapies that participants would be
p.000039: exposed to even if they were not participating in research or incidental risks or benefits) to participants in order to
p.000039: engender favourable risk benefit ratio within the context of where the research is being conducted.
p.000039:
p.000039: (1) Where the risks outweigh the benefits to the participants, other criteria outlined in this code must justify such
p.000039: risks.
p.000039:
p.000039: (2) Risks and benefits should be considered at the level of individual research participants and at the community,
p.000039: whenever appropriate.
p.000039:
p.000039: (3) Comprehensive delineation of risks and benefits should be done for participants during the research, the population
p.000039: hosting the research and for both participants and population after completion of research
p.000039:
p.000039: (3) Therapeutic procedures must fulfil requirements of clinical equipoise – there must be genuine uncertainty, among at
p.000039: least a significant minority of unbiased acknowledged experts who are not associated with the study under
p.000039: consideration, about preferred treatment.
p.000039:
p.000039: (4) The risks associated with non-therapeutic procedures must be minimized by:
p.000039:
p.000039: (a) Procedures consistent with sound research designs
p.000040: 40
p.000040:
p.000040: (b) Procedures that do not expose participants to undue risk
p.000040:
p.000040: (c) Using procedures already being performed on participants for diagnostic or therapeutic purposes, whenever
p.000040: appropriate
p.000040:
p.000040: (d) Applying risk-knowledge calculus to ensure that risks are reasonable compared to the knowledge to be gained from
p.000040: the study.
p.000040:
p.000040: e. For research to be ethical, it must undergo independent review. Research participants, researcher(s),
p.000040: sponsor(s) and institution(s) have multiple and overlapping interests which can generate conflicts and distort
p.000040: judgements. Independent review, through a system of ethical review and oversight of such systems assures society that
p.000040: reasonable attempts have been made to minimize the potential impacts of these conflicting interests and ensure balanced
p.000040: judgements.
p.000040: f. Informed consent is a sine qua non for ethical conduct of research. In order for consent to be valid, it must
p.000040: have the following components
p.000040:
p.000040: (1) Adequate information must be provided at the educational level no higher than that of individuals with at most 9
p.000040: years of education in Nigeria.
p.000040:
p.000040: (2) The design of the consent process must be appropriate for the type of research, expected participants, risks
p.000040: anticipated and the research context.
p.000040:
p.000040: (3) Consent forms shall not be longer than 8 pages in order to ensure comprehensibility and enhance recall of pertinent
p.000040: information. Unnecessary verbiage, legalisms, jargons and truth-dumping are to be avoided. The recommended format for
p.000040: each page of the consent form is as follows:
p.000040:
p.000040: i. Paper size – A4
p.000040: ii. Font – Times New Roman or similar
p.000040: iii. Font Size – 12
p.000041: 41
p.000041:
p.000041: iv. Spacing – 1.5
p.000041: v. Margins – 2.5 cm, no gutter
p.000041:
p.000041: (4) Where indicated, additional information can be provided on supplementary information sheets.
p.000041:
p.000041: (5) The informed consent document shall contain the following aspects:
p.000041:
p.000041: i. Title of the research
p.000041: ii. Name(s) and affiliation(s) of researcher(s) of applicant(s)
p.000041: iii. Sponsor(s) of research
p.000041: iv. Purpose(s) of research
p.000041: v. Procedure of the research, what shall be required of each participant and approximate total number of participants
p.000041: that would be involved in the research.
p.000041: vi. Expected duration of research and of participant(s)’ involvement.
p.000041: vii. Risk(s)
p.000041: viii. Costs to the participants, if any, of joining the research
p.000041: ix. Benefit(s)
p.000041: x. Confidentiality
p.000041: xi. Voluntariness
p.000041: xii. Alternatives to participation
p.000041: xiii. Incentive (inducement) to participants
p.000041: xiv. Consequences of participants’ decision to withdraw from research and procedure for orderly termination of
p.000041: participation.
p.000041: xv. Modality of providing treatments and action(s) to be taken in case of injury or adverse event(s).
p.000041: xvi. What happens to research participants and communities when the research is over.
p.000041: xvii. Statement about sharing of benefits among researchers and whether this includes or exclude research
p.000041: participants.
p.000041: xviii. Any apparent or potential conflict of interest.
p.000041: xix. Detailed contact information including contact address, telephone, fax, e-mail and
p.000042: 42
p.000042:
p.000042: any other contact information of researcher(s), institutional HREC and head of the institution.
p.000042:
p.000042: (6) Research participants are entitled to retain a copy of the consent form.
p.000042:
p.000042: (7) Where appropriate, researcher(s) may be required to undertake a re-consenting process during the course of research
p.000042: as determined by the HREC.
p.000042:
p.000042: (8) Where, in ordinary circumstances, participant(s) are unable to provide written consent, researcher(s) must propose
p.000042: a process of consent that adequately records participants’ informed decision such as witnessed thumb- printing or
p.000042: witnessed audio recording. The process proposed must be approved by the HREC before the research commences.
p.000042:
p.000042: (9) HREC may require that all or some types of consent process be witnessed.
p.000042:
p.000042: (10) Researcher(s) must keep all copies of consent form and make them available for examination by participant(s),
p.000042: sponsor(s), institution(s), HREC and NHREC.
p.000042:
p.000042: (11) Where appropriate, HREC may require researchers to provide translations of consent processes appropriate to the
p.000042: socio-cultural characteristics of the population to be studied.
p.000042:
p.000042: (12) All consent activities must be documented.
p.000042:
p.000042: (13) Consent in other situations, including research involving children, persons with diminished autonomy, vulnerable
p.000042: populations and other extraordinary situations, including waiver of consent, are described in other guidance documents
p.000042: issued by NHREC.
p.000042:
p.000042: (g) For research to be ethical there must be respect for potential and enrolled participants. This implies that
p.000042: potential participants be treated with respect from the
p.000043: 43
p.000043:
p.000043: moment that they are approached to the conclusion of the research should they choose to participate. Their right to
p.000043: privacy may not be needlessly compromised. Participants must know that their involvement is voluntary and that they can
p.000043: withdraw at any time without penalties. However, data, samples, etc. already contributed to the research up to that
p.000043: point may not needlessly be withdrawn as this may jeopardise the scientific validity of the research, unjust to those
p.000043: who remain in the study and all or part of their sample or data may have been used or modified into different form(s),
p.000043: including presentation at meetings or publications by the researchers.
p.000043:
p.000043: Respect entails that participants must be treated as partners in the research enterprise with every opportunity taken
p.000043: to inform them of the progress of the research and any new finding that may have potential impact on their health and
p.000043: well being, and on their continued participation in the research. It also entails protection of the welfare of research
p.000043: participants. This means that the process of research must be carefully monitored to ensure that participants are not
p.000043: exposed to excessive risk and all adverse events are examined in detail and promptly. Such adverse events must also be
p.000043: reported to HREC and efforts made to prevent future occurrences. Full medical care must be provided to participants who
p.000043: have suffered such adverse events and where warranted compensations paid.
p.000043:
p.000043: The requirement to respect both enrolled and potential participants means that researchers should engage with
p.000043: communities where research is being conducted whenever this is appropriate. In certain instances, community
p.000043: consultation or assent may have to precede research activities in order to engender community buy-in and to respect the
p.000043: socio-cultural values of the community and its institutions. It may also be necessary to inform the community from time
p.000043: to time about the progress of the research, pertinent findings that may influence their health and well being, and the
p.000043: outcome of the research.
p.000043:
p.000043: (h) For research to be ethical, nothing must be done to undermine the trust relationship that is at the heart of
p.000043: the researcher(s)-participant(s) relationships. This requires that
p.000044: 44
p.000044:
p.000044: there is transparency in all matters relating to the research enterprise including clear description of goals, risks,
p.000044: benefits, alternatives to participation and voluntariness. It is also necessary to determine the social value of the
p.000044: research and engage in creative approaches for effective representations and involvement of researchers and communities
p.000044: in the entire enterprise. Strategies for dynamic and reciprocal collaboration that leads to transformation of essential
p.000044: relationships based on reciprocity are also essential. This trust principle encourages the engagement of individual
p.000044: participants and communities, respects local socio-cultural values and encourages the provision of relevant and timely
p.000044: feedback to communities.
p.000044:
p.000044: (i) For research to be ethical, the interest of participants, researchers, sponsors and communities must be
p.000044: protected. This will ensure that the research has lasting impact, transfers technology where appropriate, contributes
p.000044: to capacity building and demonstrates respect for socio-cultural and other differences. Risks, benefits and
p.000044: responsibilities of research must be shared during the development, planning, conduct, dissemination of results.
p.000044: Intellectual property, indigenous knowledge and contributions of all parties must be taken into consideration,
p.000044: adequately protected and compensated particularly where research leads to tangible or intangible benefits. Satisfactory
p.000044: parameter(s) that shall determine sharing of commercial and other benefits should be clearly articulated and where
p.000044: indicated, benefit sharing agreements, materials transfer agreements, patent rights, intellectual property and
p.000044: royalties’ distribution agreements should be signed before initiation of research.
p.000044:
p.000044: (j) For research to be ethical, it must be conducted in accordance with the principles of good clinical and laboratory
p.000044: practices. These are international standards for designing, conducting, and reporting clinical trials that involve
p.000044: human participants. Compliance with these standards is additional assurance that the rights, safety and well-being of
p.000044: trial participants are protected in a manner that is consistent with the highest ethical and scientific standards.
p.000044:
p.000044: Section G
p.000044:
p.000045: 45
p.000045:
p.000045: HREC Education and Training Responsibility
p.000045:
p.000045: (a) HREC shall organise, cause to be organized on its behalf, sponsor, support or associate with training and
p.000045: educational programs for biomedical, social and behavioural sciences’ researchers.
p.000045:
p.000045: (b) In order for such programs to be accepted for purposes of membership of HREC and as evidence of satisfactory
p.000045: training of biomedical researchers for purposes of research review, the curriculum must be certified by NHREC.
p.000045:
p.000045: (c) Suitable educational programs must contain modules on national code of health research ethics, principles of
p.000045: research ethics, functions of HREC, research integrity and misconduct. Additional training in research methodology and
p.000045: research administration may also be provided.
p.000045:
p.000045: (d) NHREC may from time to time certify short courses and diplomas in health research ethics in Nigeria
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000046: 46
p.000046:
p.000046: Section H
p.000046:
p.000046: Independent Educational and Training Activities in Research Ethics
p.000046:
p.000046: (a) Suitably qualified individuals and organizations shall have the right to provide training programs in research
p.000046: ethics for biomedical, social and behavioural sciences’ researchers.
p.000046: (b) For such programs to be acceptable for the purposes of membership of HREC and considered adequate training of
p.000046: biomedical researchers applying for review of research, the curriculum must be certified by the NHREC.
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| children | Child |
| cognitive | Cognitive Impairment |
| criminal | criminal |
| culturally | cultural difference |
| diminished | Diminished Autonomy |
| disabled | Mentally Disabled |
| education | education |
| educational | education |
| family | Motherhood/Family |
| gender | gender |
| hazard | Natural Hazards |
| indigenous | Indigenous |
| influence | Drug Usage |
| language | Linguistic Proficiency |
| minor | Youth/Minors |
| minority | Racial Minority |
| nation | stateless persons |
| officer | Police Officer |
| opinion | philosophical differences/differences of opinion |
| philosophy | philosophical differences/differences of opinion |
| physically | Physically Disabled |
| police | Police Officer |
| pregnant | Pregnant |
| prisoners | Criminal Convictions |
| property | Property Ownership |
| religion | Religion |
| single | Marital Status |
| socialXwelfare | Access to Social Goods |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| access | ['socialXwelfare'] |
| education | ['educational'] |
| educational | ['education'] |
| officer | ['police'] |
| opinion | ['philosophy'] |
| philosophy | ['opinion'] |
| police | ['officer'] |
| socialXwelfare | ['access'] |
Trigger Words
capacity
consent
cultural
ethics
harm
protect
protection
risk
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input