79C3C34C52B45572883A05D425EB0F82
National Guidelines for Ethical Conduct of Research Involving Human Subjects
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This file was generated: 2020-12-01 07:57:13
| 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 / person under arrest
Searching for indicator arrest:
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p.000056:
p.000056: 1- Groups or communities to be subjects of research should be selected so that the burdens and benefits of the
p.000056: research will be equitably distributed. The exclusion of groups or communities that might benefit from study
p.000056: participation must be justified.
p.000056:
p.000056: 2- Members of vulnerable groups also have the same entitlement to access to the benefits of investigational
p.000056: interventions that show promise of therapeutic benefit as non vulnerable groups particularly when no superior
p.000056: or equivalent approaches to therapy are available.
p.000056:
p.000056: 3- Overuse of certain groups, such as the poor or the administratively available, is unjustified.
p.000056:
p.000056: 5.17 Exception to the requirement for informed consent in studies of emergencies in which the researcher
p.000056: anticipates that many subjects will be unable to consent:
p.000056:
p.000056: Research protocols are sometimes designed to address conditions occurring suddenly and rendering the
p.000056: patients/subjects incapable of giving informed consent. Examples are head trauma, cardiopulmonary arrest and
p.000056: stroke. The investigation cannot be done with patients who can give informed consent in time and there
p.000056: may not be time to locate a person having the authority to give permission.
p.000056:
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p.000057: In such circumstances it is often necessary to precede with the research interventions very soon after the onset of the
p.000057: condition in order to evaluate an investigational treatment or develop the desired knowledge. Consent should be
p.000057: taken from the guardian if available or from an authorized body in the health facility. As this class of emergency
p.000057: exception can be anticipated, the researcher must secure the review and approval of an ethical review
p.000057: committee before initiating the study. If possible, an attempt should be made to identify a population that is likely
p.000057: to develop the condition to be studied. This can be done readily, for example, if the condition is one that
p.000057: recurs periodically in individuals; examples include grand mal seizures and alcohol binges. In such cases, prospective
p.000057: subjects should be contacted while fully capable of informed consent, and invited to consent to their involvement as
p.000057: research subjects during future periods of incapacitation. If they are patients of an independent physician who is
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Political / political affiliation
Searching for indicator party:
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p.000054: and hence invalidate results. In most such cases, the prospective subjects are asked to consent to remain uninformed of
p.000054: the purpose of some procedures until the research is completed and after the conclusion of the study they
p.000054: are given the omitted information.
p.000054: In other cases, because a request for permission to withhold some information would jeopardize the validity
p.000054: of the research, subjects are not told that some information has been withheld until the research has been
p.000054: completed. Any such procedure must receive the explicit approval of the ethical review committee.
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p.000055: Intimidation in any form invalidates informed consent. Prospective subjects who are patients often
p.000055: depend for medical care upon the physician/investigator, who consequently has certain credibility in
p.000055: their eyes, and whose influence over them may be considerable, particularly if the study protocol has a
p.000055: therapeutic component. They may fear, for example, that refusal to participate would damage the therapeutic
p.000055: relationship or result in the withholding of health services. The physician/investigator must assure them that
p.000055: their decision on whether to participate will not affect the therapeutic relationship or other benefits
p.000055: to which they are entitled. In this situation the ethical review committee should consider whether a
p.000055: neutral third party should seek informed consent.
p.000055: The prospective subject must not be exposed to undue influence. The borderline between justifiable
p.000055: persuasion and undue influence is imprecise, however. The researcher should give justifiable assurances
p.000055: about the benefits, risks or inconveniences of the research, for example, or induce a close
p.000055: relative or a community leader to influence a prospective subject's decision.
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p.000056:
p.000056: 5.16 Equitable distribution of burdens and benefits in the selection of groups of subjects in research:
p.000056:
p.000056: 1- Groups or communities to be subjects of research should be selected so that the burdens and benefits of the
p.000056: research will be equitably distributed. The exclusion of groups or communities that might benefit from study
p.000056: participation must be justified.
p.000056:
p.000056: 2- Members of vulnerable groups also have the same entitlement to access to the benefits of investigational
p.000056: interventions that show promise of therapeutic benefit as non vulnerable groups particularly when no superior
p.000056: or equivalent approaches to therapy are available.
p.000056:
p.000056: 3- Overuse of certain groups, such as the poor or the administratively available, is unjustified.
...
Political / vulnerable
Searching for indicator vulnerable:
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p.000020: consent requirement 48
p.000020: 5.8 Renewing consent 48
p.000020: 5.9 Cultural considerations 49
p.000020: 5.10 Use of biological materials from subjects in clinical trials 50
p.000020: 5.11 Use of medical records and biological specimens 50
p.000020: 5.12 Secondary use of research records or biological specimens 51
p.000020: 5.13 Obligations of sponsors and investigators 52
p.000020: 5.14 Withholding information and deception 53
p.000020: 5.15 Intimidation and undue influence 54
p.000020: 5.16 Equitable distribution of burdens and benefits in the selection of groups of subjects in research
p.000055: 55
p.000055: 5.17 Exception to the requirement for informed consent in studies of emergencies
p.000056: 56
p.000056: 5.18 Inducement to participate 57
p.000056: 5.19 Incompetent persons 57
p.000056: 5.20 Withdrawal from a study 58
p.000056: 5.21 Research involving vulnerable persons 58
p.000056: 5.22 Research involving vulnerable groups include 59
p.000056: 5.22.1 Research involving children 59
p.000056: 5.22.2 Women as research subjects 59
p.000056: 5.22.3 Pregnant women as research participants 60
p.000056: 5.23References 62
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p.000056: D
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p.000056: 12. Annexes 63
p.000056: 6.1 National Application Form For Ethical Approval of a Research Project
p.000067: 67
p.000067: 6.2 National Application Form For Ethical Approval of a Research Proposal
p.000069: 69
p.000069: 6.2.1 Form A: Part 1: Technical proposal form 69
p.000069: 6.2.2 Form B: Part Two: Ethical Considerations 77
p.000069: 1- Minimization of Harm 77
p.000069: 2- Privacy and Confidentiality 79
p.000069: 6.3 Form C 80 1- Informed
p.000069: Consent 80 2- Declarations
p.000081: 81
p.000081: 6.4 The Participant's Acceptance Form ( كر¹ a²ا و= ²ا ¾ب ا9a ةر¹aäذإ جذ9a: A:⁄ ب9:i ýa وأ #⁄ş²ا y )
p.000082: 82
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p.000085: requirement, renewing consent and other cultural considerations.
p.000085:
p.000085: It also goes through the regulations of the use of biological materials from subjects in clinical trials, the
p.000085: use of medical records and biological specimens. It explains some of the basic principles about the secondary
p.000085: use of research records or biological specimens together with some obligations to be followed by both sponsors
p.000085: and investigators. It covers the issues related to the possible influence on the research subject like
p.000085: withholding information and deception, intimidation and undue influence. It also aims at assuring the equitable
p.000085: distribution of burdens and benefits in the selection of groups of subjects in research.
p.000085:
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p.000085: N
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p.000085: The regulation by which an exception to the requirement for informed consent in studies of emergencies
p.000085: in which the researcher anticipates that many subjects will be unable to give consent is also included in this
p.000085: chapter. Special interest is given to the inducement of research subjects to participate and the consent taken from
p.000085: incompetent persons or vulnerable persons. It also emphasizes the right of withdrawal from a study.
p.000085:
p.000085: The annexes include the, the National Application Form for ethical committee (A & B), and the
p.000085: Informed Consent form guidelines (form c), and the list of the National Research Ethic Committee members.
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p.000085: Milestones of preparing the guidelines:
p.000085:
p.000085: • In 2002, The Ministerial Decision No. 11 / 2002 was issued for the formation of Health Research Council (HRC).
p.000085: • The first meeting of Health Research Council was held in March 2003 with the recommendations of
p.000085: formation of the National Rechearch Ethics Review Committee (NHREC).
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p.000010: 10
p.000010:
p.000010: 2.1 The major principles:
p.000010:
p.000010: All research involving human subjects should be conducted in accordance with three basic ethical principles, namely
p.000010: respect for persons, beneficence and non-malificence and justice. It is generally agreed that these principles, which
p.000010: in the abstract have equal moral force, guide the conscientious preparation of proposals for scientific studies (1,4).
p.000010: • Respect for persons incorporates at least two fundamental ethical considerations, namely:
p.000010: a. Respect for autonomy which requires that those who are capable of deliberation about their personal choices should
p.000010: be treated with respect for their capacity for self- determination.
p.000010: b. Protection of persons with impaired or diminished autonomy, which requires that those who are dependent or
p.000010: vulnerable be afforded full security against harm or abuse.
p.000010: • Beneficence and non-malificence refers to the ethical obligation to maximize benefits and to minimize harms,
p.000010: respectively. This gives rise to norms requiring that the risks of research to be reasonable in the light of the
p.000010: expected benefits, that the research design to be sound, and that the investigators to be competent to conduct the
p.000010: research and to safeguard the welfare of the research subjects.
p.000010: • Justice refers to the ethical obligation to treat each person in accordance with what is morally
p.000010: right and proper; to give each person what is due to him or her. In the ethics of research involving human
p.000010: subjects the principle refers primarily to distributive justice,
p.000010:
p.000011: 11
p.000011:
p.000011: which requires equitable distribution of both the burdens and the benefits of participation in research.
p.000011:
p.000011: Table (1): Ethical Principles of Research
p.000011:
p.000011:
p.000011:
p.000011: Major Principles
p.000011: 1. Autonomy
p.000011: 2. Beneficence and non-maleficence
p.000011: 3. Justice
p.000011: Others
p.000011: 1. Accepted Scientifically
p.000011: 2. Accepted qualified researchers
p.000011: 3. Ethics committee review
p.000011: 4. Accuracy of published results……etc
p.000011:
...
p.000055: therapeutic component. They may fear, for example, that refusal to participate would damage the therapeutic
p.000055: relationship or result in the withholding of health services. The physician/investigator must assure them that
p.000055: their decision on whether to participate will not affect the therapeutic relationship or other benefits
p.000055: to which they are entitled. In this situation the ethical review committee should consider whether a
p.000055: neutral third party should seek informed consent.
p.000055: The prospective subject must not be exposed to undue influence. The borderline between justifiable
p.000055: persuasion and undue influence is imprecise, however. The researcher should give justifiable assurances
p.000055: about the benefits, risks or inconveniences of the research, for example, or induce a close
p.000055: relative or a community leader to influence a prospective subject's decision.
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000056: 56
p.000056:
p.000056: 5.16 Equitable distribution of burdens and benefits in the selection of groups of subjects in research:
p.000056:
p.000056: 1- Groups or communities to be subjects of research should be selected so that the burdens and benefits of the
p.000056: research will be equitably distributed. The exclusion of groups or communities that might benefit from study
p.000056: participation must be justified.
p.000056:
p.000056: 2- Members of vulnerable groups also have the same entitlement to access to the benefits of investigational
p.000056: interventions that show promise of therapeutic benefit as non vulnerable groups particularly when no superior
p.000056: or equivalent approaches to therapy are available.
p.000056:
p.000056: 3- Overuse of certain groups, such as the poor or the administratively available, is unjustified.
p.000056:
p.000056: 5.17 Exception to the requirement for informed consent in studies of emergencies in which the researcher
p.000056: anticipates that many subjects will be unable to consent:
p.000056:
p.000056: Research protocols are sometimes designed to address conditions occurring suddenly and rendering the
p.000056: patients/subjects incapable of giving informed consent. Examples are head trauma, cardiopulmonary arrest and
p.000056: stroke. The investigation cannot be done with patients who can give informed consent in time and there
p.000056: may not be time to locate a person having the authority to give permission.
p.000056:
p.000056:
p.000056:
p.000056:
p.000057: 57
p.000057:
p.000057: In such circumstances it is often necessary to precede with the research interventions very soon after the onset of the
p.000057: condition in order to evaluate an investigational treatment or develop the desired knowledge. Consent should be
...
p.000057: informed consent.
p.000057:
p.000057: In all cases in which approved research has begun without prior consent of patients/subjects incapable of
p.000057: giving informed consent because of suddenly occurring conditions, they should be given all relevant information
p.000057: as soon as they are in a state to receive it, and their consent to continued participation should be
p.000057: obtained as soon as is reasonably possible.
p.000057:
p.000057: 5.18 Inducement to participate:
p.000057:
p.000057: Subjects may be reimbursed for lost earnings, travel costs and other expenses incurred in taking part in
p.000057: a study; and may receive free medical services. Subjects, particularly those who receive no direct
p.000057: benefit from
p.000058: 58
p.000058:
p.000058: research, may be paid or otherwise compensated for inconvenience and time spent. The payments should not be so
p.000058: large, however, or the medical services so extensive as to induce prospective subjects to consent to
p.000058: participate in the research against their better judgment ("undue inducement"). An ethical
p.000058: review committee must have approved all payments, reimbursement and medical services provided to
p.000058: research subjects.
p.000058:
p.000058:
p.000058:
p.000058: 5.19 Incompetent persons
p.000058:
p.000058:
p.000058: Incompetent persons may be vulnerable to exploitation for financial gain by guardians. A guardian asked to give
p.000058: permission on behalf of an incompetent person should be offered no recompense other than a refund of
p.000058: travel and related expenses.
p.000058:
p.000058: 5.20 Withdrawal from a study:
p.000058:
p.000058: A subject who withdraws from research for reasons related to the study,
p.000058: e.g. side-effects of a study drug, or who is withdrawn on health grounds, should be paid or recompensed as if
p.000058: full participation had taken place. A subject who withdraws for any other reason should be paid in proportion to
p.000058: the amount of participation. An investigator who must remove a subject from the study for wilful
p.000058: non-compliance is entitled to withhold part or all of the payment.
p.000058:
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p.000059: 59
p.000059:
p.000059: 5.21 Research involving vulnerable persons
p.000059:
p.000059: Special justification is required for inviting vulnerable individuals to serve as research subjects and, if they are
p.000059: selected, the means of protecting their rights and welfare must be strictly applied.
p.000059: Individuals conventionally considered vulnerable are those with limited capacity or freedom to consent or to decline to
p.000059: consent. They include children, and persons who because of mental or behavioural disorders are incapable of giving
p.000059: informed consent.
p.000059:
p.000059: Ethical justification of their involvement usually requires the investigators to satisfy the ethical review committees
p.000059: that:
p.000059:
p.000059: a. The research could not be carried out equally well with less vulnerable subjects.
p.000059:
p.000059: b. The research is intended to obtain knowledge that will lead to improved diagnosis, prevention or treatment of
p.000059: diseases or other health problems characteristic.
p.000059:
p.000059: c. Research subjects and other members of the vulnerable class from which subjects are recruited will ordinarily
p.000059: be assured reasonable access to any diagnostic, preventive or therapeutic products that will become available as a
p.000059: consequence of the research;
p.000059:
p.000059: d. The risks attached to interventions or procedures will not exceed those associated with routine
p.000059: medical or psychological examination of such persons unless an ethical review committee authorizes a slight
p.000059: increase over this level of risk.
p.000060: 60
p.000060:
p.000060: e. When the prospective subjects are either incompetent or otherwise substantially unable to give informed
p.000060: consent, their agreement will be supplemented by the permission of their legal guardians or other appropriate
p.000060: representatives.
p.000060:
p.000060:
p.000060:
p.000060: 5.22 Research involving vulnerable groups includes:
p.000060:
p.000060:
p.000060:
p.000060: 5.22.1 Research involving children:
p.000060: Before undertaking research involving children, the investigator must ensure that:
p.000060: * The research might not equally well be carried out with adults;
p.000060: * The purpose of the research is to obtain knowledge relevant to the health needs of children;
p.000060: * A parent or legal representative of each child has given permission;
p.000060: * The agreement (assent) of each child has been obtained to the extent of the child’s capabilities;
p.000060: * A child’s refusal to participate or continue in the research will be respected.
p.000060: 5.22.2 Women as research subjects:
p.000060: Investigators, sponsors or ethical review committees should not exclude women of reproductive age
p.000060: from biomedical
p.000060:
p.000061: 61
p.000061:
p.000061: research. The potential for becoming pregnant during a study should not be used as a reason for
p.000061: precluding or limiting participation. However, a thorough discussion of risks to the pregnant woman and to
...
Health / Cognitive Impairment
Searching for indicator impaired:
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p.000010: 10
p.000010:
p.000010: 2.1 The major principles:
p.000010:
p.000010: All research involving human subjects should be conducted in accordance with three basic ethical principles, namely
p.000010: respect for persons, beneficence and non-malificence and justice. It is generally agreed that these principles, which
p.000010: in the abstract have equal moral force, guide the conscientious preparation of proposals for scientific studies (1,4).
p.000010: • Respect for persons incorporates at least two fundamental ethical considerations, namely:
p.000010: a. Respect for autonomy which requires that those who are capable of deliberation about their personal choices should
p.000010: be treated with respect for their capacity for self- determination.
p.000010: b. Protection of persons with impaired or diminished autonomy, which requires that those who are dependent or
p.000010: vulnerable be afforded full security against harm or abuse.
p.000010: • Beneficence and non-malificence refers to the ethical obligation to maximize benefits and to minimize harms,
p.000010: respectively. This gives rise to norms requiring that the risks of research to be reasonable in the light of the
p.000010: expected benefits, that the research design to be sound, and that the investigators to be competent to conduct the
p.000010: research and to safeguard the welfare of the research subjects.
p.000010: • Justice refers to the ethical obligation to treat each person in accordance with what is morally
p.000010: right and proper; to give each person what is due to him or her. In the ethics of research involving human
p.000010: subjects the principle refers primarily to distributive justice,
p.000010:
p.000011: 11
p.000011:
p.000011: which requires equitable distribution of both the burdens and the benefits of participation in research.
p.000011:
p.000011: Table (1): Ethical Principles of Research
p.000011:
p.000011:
p.000011:
p.000011: Major Principles
p.000011: 1. Autonomy
p.000011: 2. Beneficence and non-maleficence
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Health / Drug Usage
Searching for indicator drug:
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p.000002: new knowledge, in which human being are involved”.
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p.000003: 3
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p.000003: 1.1 Research involving human subjects includes:
p.000003: • Studies of physiological, biochemical or pathological processes or of the response to a specific
p.000003: intervention-whether physical, chemical or psychological- in healthy subjects or patients.
p.000003: • Controlled trials of diagnostic, preventive or therapeutic measures in larger groups of persons, designed
p.000003: to demonstrate a specific generalizable response to these measures against a background of individual
p.000003: biological variation.
p.000003: • Studies designed to determine the consequences for individuals and communities of specific preventive or
p.000003: therapeutic measures.
p.000003: • Studies concerning human health-related behaviour in a variety of circumstances and environments (1).
p.000003:
p.000003: The research may be concerned with the social environment, manipulating environmental factors in a way
p.000003: that could affect incidentally- exposed individuals. It is defined in broad terms in order to embrace field studies of
p.000003: pathogenic organisms and toxic chemicals under investigation for health-related purposes.
p.000003:
p.000003: Biomedical research involving human subjects is to be distinguished from the practice of medicine, public
p.000003: health and other forms of health care, which is designed to contribute directly to the health of individuals
p.000003: or communities. Prospective subjects may find it confusing when research and practice are to be conducted
p.000003: simultaneously, as when research is designed to obtain new information about the efficacy of a drug or other
p.000003: therapeutic, diagnostic or preventive modality.
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p.000004: 4
p.000004:
p.000004: 1.2 What is ethics in research?
p.000004:
p.000004: “Ethics is the study of morality – careful and systematic reflection on analysis of moral decisions and
p.000004: behaviour” (2). Ethics and ethical principles extend to all spheres of human activity (3).
p.000004:
p.000004: The Declaration of Helsinki issued by the World Medical Association in 1964, is the fundamental document in the
p.000004: field of ethics in biomedical research and has influenced the formulation of international, regional and
p.000004: national legislation and codes of conduct. The declaration, amended several times, most recently in 2002, is a
p.000004: comprehensive international statement of the ethics of research involving human subjects. It sets out ethical
p.000004: guidelines for physicians engaged in both clinical and non-clinical biomedical research(4).
p.000004:
p.000004: Research involving human subjects should be carried out only by, or strictly supervised by, suitably
p.000004: qualified and experienced investigators and in accordance with a protocol that clearly states: the aim of the research;
p.000004: the reasons for proposing involvement of human subjects; the nature and degree of any known risks to the subjects; the
p.000004: sources from which it is proposed to recruit subjects; and the means proposed for ensuring that subjects' consent will
...
p.000057: as soon as they are in a state to receive it, and their consent to continued participation should be
p.000057: obtained as soon as is reasonably possible.
p.000057:
p.000057: 5.18 Inducement to participate:
p.000057:
p.000057: Subjects may be reimbursed for lost earnings, travel costs and other expenses incurred in taking part in
p.000057: a study; and may receive free medical services. Subjects, particularly those who receive no direct
p.000057: benefit from
p.000058: 58
p.000058:
p.000058: research, may be paid or otherwise compensated for inconvenience and time spent. The payments should not be so
p.000058: large, however, or the medical services so extensive as to induce prospective subjects to consent to
p.000058: participate in the research against their better judgment ("undue inducement"). An ethical
p.000058: review committee must have approved all payments, reimbursement and medical services provided to
p.000058: research subjects.
p.000058:
p.000058:
p.000058:
p.000058: 5.19 Incompetent persons
p.000058:
p.000058:
p.000058: Incompetent persons may be vulnerable to exploitation for financial gain by guardians. A guardian asked to give
p.000058: permission on behalf of an incompetent person should be offered no recompense other than a refund of
p.000058: travel and related expenses.
p.000058:
p.000058: 5.20 Withdrawal from a study:
p.000058:
p.000058: A subject who withdraws from research for reasons related to the study,
p.000058: e.g. side-effects of a study drug, or who is withdrawn on health grounds, should be paid or recompensed as if
p.000058: full participation had taken place. A subject who withdraws for any other reason should be paid in proportion to
p.000058: the amount of participation. An investigator who must remove a subject from the study for wilful
p.000058: non-compliance is entitled to withhold part or all of the payment.
p.000058:
p.000058:
p.000058:
p.000059: 59
p.000059:
p.000059: 5.21 Research involving vulnerable persons
p.000059:
p.000059: Special justification is required for inviting vulnerable individuals to serve as research subjects and, if they are
p.000059: selected, the means of protecting their rights and welfare must be strictly applied.
p.000059: Individuals conventionally considered vulnerable are those with limited capacity or freedom to consent or to decline to
p.000059: consent. They include children, and persons who because of mental or behavioural disorders are incapable of giving
p.000059: informed consent.
p.000059:
p.000059: Ethical justification of their involvement usually requires the investigators to satisfy the ethical review committees
p.000059: that:
p.000059:
p.000059: a. The research could not be carried out equally well with less vulnerable subjects.
p.000059:
...
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070: Æ You can use extra paper.
p.000070:
p.000070:
p.000070:
p.000070: 6. Objectives
p.000070: • General objective:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070: • Specific objectives:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000071: 71
p.000071:
p.000071: 8. Methodology
p.000071: • Study design:
p.000071:
p.000071:
p.000071:
p.000071: • Study area:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071: • Study population:( demographic profile, sampling frame, inclusion and exclusion criteria)
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071: • Sampling: (sample size , calculation, selection, stratification…..etc ,)
p.000071:
p.000071:
p.000071:
p.000071: .
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
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p.000071:
p.000072: 72
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: • Data collection technique ( interviews, observation, review of secondary data, focus group discussion…etc)
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: • Data collection tools(including questionnaire ,details of laboratory tests, detailed sample taking procedures,
p.000072: drug dosage, clinical case sheet, check list……etc.)
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: 9. Data analysis
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000073: 73
p.000073:
p.000073: 9. Work plan:
p.000073: • Place (include institutional technical facilities available)
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073: • Time (include when study to commence, duration, if in stages the time schedule for each part)
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073: • Collaborating individuals / institutions:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
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p.000073:
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p.000073:
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p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000074: 74
p.000074:
p.000074: 10. Budget: :( Personnel/ consumable items/ transportation/ field expenses…..etc.)
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
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p.000074:
p.000075: 75
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075: 11. References:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
...
p.000076:
p.000076: 11. How do the research procedures differ from standard treatment procedures?
p.000076:
p.000076: 12. What are the benefits to research participants taking part?
p.000076:
p.000076: 13. What are the physical or psychological risks, or side effects to participants or third
p.000076: parties? Describe what action will be taken to minimize any such risks or side effects.
p.000076:
p.000076:
p.000076:
p.000077: 77
p.000077:
p.000077: 14. What facilities/procedures and personnel are there for dealing with emergencies?
p.000077:
p.000077: 15. What arrangements will be made for monitoring and detecting adverse outcomes?
p.000077:
p.000077: 16. Is the trial being reviewed by a data safety monitoring board (DSMB)?
p.000077: 17. If yes, who will fund of the DSMB?
p.000077:
p.000077: 18. What are the criteria for terminating the study?
p.000077:
p.000077: 19. Will any potential toxins, mutagens or teratogens be used?
p.000077:
p.000077: 20. If yes, specify and outline the justification for their use
p.000077:
p.000077: 21. Will any radiation or radioactive substances be used?
p.000077:
p.000077: 22. Has the National Committee for atomic energy completed risk assessment?
p.000077:
p.000077: 23. If yes, please enclose a copy of the risk assessment, and the contact name and phone number
p.000077:
p.000077: 24. If no, please explain why
p.000077:
p.000077: 25. Will any drugs be administered for the purposes of this study?
p.000077:
p.000077: 26. If yes:
p.000077: a. is approval of the concerned authorities required?
p.000077:
p.000077: b. trade name of drug
p.000077:
p.000077: c. Chemical name of drug
p.000077:
p.000077: d. Pharmacological class:
p.000077:
p.000077: e. Pharmacological class, e.g., long half life, receptor selectivity.
p.000077:
p.000077: f. Recommended dose range
p.000077:
p.000078: 78
p.000078:
p.000078: g. Form of administration in the study
p.000078:
p.000078: h. Known or possible interactions with non-trial drugs the participants may be taking
p.000078: i. Side effects and adverse reactions
p.000078: 27. Does the study involve the use of healthcare resources?
p.000078:
p.000078: 28. If yes, please specify:
p.000078:
p.000078: 29. What effect will this use of resources have on waiting list times for patients i.e. for diagnostic
p.000078: tests or for standard treatments?
p.000078:
p.000078: 2- Privacy and Confidentiality
p.000078:
p.000078: 30. How will participants be recruited? (e.g. advertisements, notices)
p.000078:
p.000078: 31. Where will potential participants be approached? (e.g. outpatient clinic) If appropriate describe by type (eg
p.000078: students)
p.000078:
p.000078: 32. Who will make the initial approach to potential participants?
p.000078:
p.000078: 33. How will data including audio and video tapes be handled and stored to safeguard confidentiality (both during and
p.000078: after completion of the research project)?
p.000078:
p.000078: 34. What will be done with the raw data when the study is finished?
p.000078:
p.000078: 35. How long will the data from the study be kept and who will be responsible for its safe keeping?
p.000078:
p.000078: 36. Who will have access to the raw data and/or clinical records during, or after, the study?
p.000078:
p.000078: 37. Describe any arrangements to make results available to participants, including whether they will be
p.000078: offered their audio tapes or videos.
p.000078:
p.000078:
p.000078:
...
Searching for indicator influence:
(return to top)
p.000085: obtaining the ethical clearance in a simplified flowchart and detailed steps of what to prepare, ethical
p.000085: elements review, how to apply, review procedures and decision making.
p.000085:
p.000085: The fifth chapter is about the Informed Consent, its definition, importance, and components. It explains the
p.000085: information that the research subject should know and understand before being involved in the study. The
p.000085: chapter explains the procedure and process by which the informed consent should be obtained from the subjects
p.000085: included in the research. Other principles about the informed consent were included and explained in this
p.000085: chapter. This includes the language, comprehension, documentation of consent, waiver of the consent
p.000085: requirement, renewing consent and other cultural considerations.
p.000085:
p.000085: It also goes through the regulations of the use of biological materials from subjects in clinical trials, the
p.000085: use of medical records and biological specimens. It explains some of the basic principles about the secondary
p.000085: use of research records or biological specimens together with some obligations to be followed by both sponsors
p.000085: and investigators. It covers the issues related to the possible influence on the research subject like
p.000085: withholding information and deception, intimidation and undue influence. It also aims at assuring the equitable
p.000085: distribution of burdens and benefits in the selection of groups of subjects in research.
p.000085:
p.000085:
p.000085:
p.000085: N
p.000085:
p.000085: The regulation by which an exception to the requirement for informed consent in studies of emergencies
p.000085: in which the researcher anticipates that many subjects will be unable to give consent is also included in this
p.000085: chapter. Special interest is given to the inducement of research subjects to participate and the consent taken from
p.000085: incompetent persons or vulnerable persons. It also emphasizes the right of withdrawal from a study.
p.000085:
p.000085: The annexes include the, the National Application Form for ethical committee (A & B), and the
p.000085: Informed Consent form guidelines (form c), and the list of the National Research Ethic Committee members.
p.000085:
p.000085:
p.000085:
p.000085:
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p.000085:
p.000085:
p.000085: O
p.000085:
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p.000085:
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p.000085:
p.000085:
p.000085:
p.000085:
...
p.000040: Chapter 5
p.000040: Informed Consent
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
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p.000041: 41
p.000041:
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p.000042: 42
p.000042:
p.000042: 5.1 What is ‘Informed Consent’?
p.000042:
p.000042: The Council for International Organizations of Medical Sciences (CIOMS) Guidelines has defined informed
p.000042: consent as:
p.000042:
p.000042: Approval to participate in a study or trial given by a competent individual who:
p.000042:
p.000042: • Has received the necessary information (verbally and in writing).
p.000042: • Has adequately understood the information.
p.000042: • After considering the information, has arrived at a decision without having been subjected to compulsion,
p.000042: undue influence, incentive, or pressure.
p.000042: • In the case of those who are not capable, has the legal authorization to approve on behalf of the incompetent.
p.000042:
p.000042: Informed consent is based on the principle that competent individuals are entitled to choose freely whether to
p.000042: participate in research. It protects the individual's freedom of choice and respects the individual's autonomy.
p.000042: As an additional safeguard, it must always be complemented by the approval of an independent review of an ethical
p.000042: research committee.
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
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p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000043: 43
p.000043:
p.000043:
p.000043: 5.2 Obtaining informed consent:
p.000043:
p.000043:
p.000043: Before requesting an individual's consent to participate in research, the investigator must
p.000043: provide the following information, in language or another form of communication that the individual can
p.000043: understand to the research subject:
p.000043: 1. The individual is invited to participate voluntarily in the research, explaining the reasons for
p.000043: considering him/her suitable for the research.
p.000043: 2. The individual is free to refuse to participate and will be free to withdraw from the research at any time without
p.000043: penalty or loss of benefits to which he or she would otherwise be entitled.
p.000043: 3. The purpose of the research, the procedures to be carried out by the investigator and the subject, and an
...
p.000052: the original collection or use of such records or specimens for research purposes, secondary uses are generally
p.000052: constrained by the conditions specified in the original consent.
p.000052: Consequently, it is essential that the original consent process anticipate, to the extent that this is feasible, any
p.000052: foreseeable plans for future use of the records or specimens for research. Thus, in the original process of seeking
p.000052: informed consent a member of the research team should discuss with, and, when indicated, request the permission of,
p.000052: prospective subjects as to:
p.000052: i. Whether there will or could be any secondary use and, if so, whether such
p.000052:
p.000053: 53
p.000053:
p.000053: secondary use will be limited with regard to the type of study that may be performed on such materials;
p.000053: ii. The conditions under which investigators will be required to contact the research subjects for additional
p.000053: authorization for secondary use;
p.000053: iii. The investigators' plans, if any, to destroy or to strip off personal identifiers from the records or
p.000053: specimens; and
p.000053: iv. The rights of subjects to request destruction or removal of individual identification of biological
p.000053: specimens or of records or parts of records that they might consider particularly sensitive, such as photographs,
p.000053: videotapes or audiotapes.
p.000053: Sponsors and investigators have a duty to:
p.000053: 1) Refrain from unjustified deception, undue influence, or intimidation;
p.000053: 2) Seek consent only after ascertaining that the prospective subject has adequate understanding of the
p.000053: relevant facts and of the consequences of participation and has had sufficient opportunity to consider
p.000053: whether to participate.
p.000053: 3) As a general rule, obtain from each prospective subject a signed form as evidence of informed consent.
p.000053: 4) Investigators should justify any exceptions to this general rule and obtain the approval of the ethical
p.000053: review committee renew the informed consent of each subject if there are significant changes in the
p.000053: conditions or procedures of the research or if new
p.000053:
p.000053:
p.000053:
p.000053:
p.000054: 54
p.000054:
p.000054: information becomes available that could affect the willingness of subjects to continue to participate.
p.000054: 5) Renew the informed consent of each subject in long-term studies at pre-determined intervals, even if there are no
p.000054: changes in the design or objectives of the research.
p.000054:
p.000054: 5.14 Withholding information and deception:
p.000054:
p.000054: Sometimes, to ensure the validity of research, investigators withhold certain information in the consent
p.000054: process. In biomedical research, this typically takes the form of withholding information about the
p.000054: purpose of specific procedures.
p.000054: For example, subjects in clinical trials are often not told the purpose of tests performed to monitor their compliance
p.000054: with the protocol, since if they knew their compliance was being monitored they might modify their behaviour
p.000054: and hence invalidate results. In most such cases, the prospective subjects are asked to consent to remain uninformed of
p.000054: the purpose of some procedures until the research is completed and after the conclusion of the study they
p.000054: are given the omitted information.
p.000054: In other cases, because a request for permission to withhold some information would jeopardize the validity
p.000054: of the research, subjects are not told that some information has been withheld until the research has been
p.000054: completed. Any such procedure must receive the explicit approval of the ethical review committee.
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000055: 55
p.000055:
p.000055:
p.000055: Intimidation in any form invalidates informed consent. Prospective subjects who are patients often
p.000055: depend for medical care upon the physician/investigator, who consequently has certain credibility in
p.000055: their eyes, and whose influence over them may be considerable, particularly if the study protocol has a
p.000055: therapeutic component. They may fear, for example, that refusal to participate would damage the therapeutic
p.000055: relationship or result in the withholding of health services. The physician/investigator must assure them that
p.000055: their decision on whether to participate will not affect the therapeutic relationship or other benefits
p.000055: to which they are entitled. In this situation the ethical review committee should consider whether a
p.000055: neutral third party should seek informed consent.
p.000055: The prospective subject must not be exposed to undue influence. The borderline between justifiable
p.000055: persuasion and undue influence is imprecise, however. The researcher should give justifiable assurances
p.000055: about the benefits, risks or inconveniences of the research, for example, or induce a close
p.000055: relative or a community leader to influence a prospective subject's decision.
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000056: 56
p.000056:
p.000056: 5.16 Equitable distribution of burdens and benefits in the selection of groups of subjects in research:
p.000056:
p.000056: 1- Groups or communities to be subjects of research should be selected so that the burdens and benefits of the
p.000056: research will be equitably distributed. The exclusion of groups or communities that might benefit from study
p.000056: participation must be justified.
p.000056:
p.000056: 2- Members of vulnerable groups also have the same entitlement to access to the benefits of investigational
p.000056: interventions that show promise of therapeutic benefit as non vulnerable groups particularly when no superior
p.000056: or equivalent approaches to therapy are available.
p.000056:
p.000056: 3- Overuse of certain groups, such as the poor or the administratively available, is unjustified.
p.000056:
p.000056: 5.17 Exception to the requirement for informed consent in studies of emergencies in which the researcher
p.000056: anticipates that many subjects will be unable to consent:
p.000056:
p.000056: Research protocols are sometimes designed to address conditions occurring suddenly and rendering the
...
Health / HIV/AIDS
Searching for indicator HIV:
(return to top)
p.000023:
p.000023: The members, the chair person and the deputy will be selected by the Minister of Health. The term of the member
p.000023: can end by resignation, death, termination or completing three years.
p.000023:
p.000024: 24
p.000024:
p.000024: Organogram of the ethics committee
p.000024:
p.000024: Federal Minister of Health
p.000024:
p.000024:
p.000024: Under secretary of FMOH
p.000024:
p.000024:
p.000024: Director DOR
p.000024:
p.000024:
p.000024: Chairman of NHREC
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024: State & IECs
p.000024: Members of NHREC
p.000024:
p.000024: 3.1.3 Meetings:
p.000024:
p.000024: 1-The committee will hold a regular meeting every two months, and it may hold an extra meeting if need arises.
p.000024: 2-The committee chairman or his deputy chairs the meeting, and in case of the absence of the chairman and his/her
p.000024: deputy the members choose the one who heads the meeting.
p.000024:
p.000024:
p.000024: 3.1.3.1 Quorum:
p.000024:
p.000024: The meeting shall be legal with the attendance of half of the members. In case of the lack of quorum, a following
p.000024: meeting must be determined during one week and it shall be legal by any number of members.
p.000024:
p.000025: 25
p.000025:
p.000025: 3.1.4 Independent consultants:
p.000025:
p.000025: a. NHREC may call upon subject experts as independent consultants who may provide special review of selected research
p.000025: protocols, if needed.
p.000025: b. These experts may be specialists in ethics or specific diseases, or methodologies, or represent
p.000025: specific communities, or patient groups e. g. cancer patients, HIV/ Aids positive persons or ethnic minority.
p.000025: c. They are required to give their specialized views but do not take part in the decision-making process, which
p.000025: will be made by the members of the NHREC.
p.000025: 3.1.5 Operational cost:
p.000025:
p.000025: The MOH will avail the budget for the operational cost of the committee. The committee will prepare an annual budget
p.000025: covering all the expenses for the meetings, reviewers, consultations……etc. Fees for application will be decided
p.000025: annually.
p.000025: 3.1.6 Record keeping and Archiving:
p.000025:
p.000025: 1. Curriculum Vitae (CV) of all members of NHREC.
p.000025:
p.000025: 2. Copy of all study protocols with enclosed documents, progress reports, and SAEs.
p.000025: 3. Minutes of all meetings duly signed by the Chairperson.
p.000025: 4. Copy of all existing relevant national and international guidelines on research ethics and laws along
p.000025: with amendments.
p.000025: 5. Copy of all correspondence with members, researchers and other regulatory bodies.
p.000025: 6. Final report of the approved projects.
p.000025: All documents should be archived for a prescribed period.
p.000026: 26
p.000026:
p.000026:
p.000026:
p.000026: 3.1.7. Updating NHREC members
p.000026:
p.000026: a. All relevant new guidelines should be brought to the attention of the members.
p.000026: b. Members should be encouraged to attend national and international training programs in research ethics for
p.000026: maintaining quality in ethical review and be aware of the latest developments in this area.
p.000026:
p.000026:
p.000026:
...
Health / Mentally Disabled
Searching for indicator disability:
(return to top)
p.000013: that of the subject in accordance with national legislation.
p.000013: 12. In any study, every patient- including those of a control group, if any- should be assured of the best
p.000013: proven diagnostic and therapeutic method. This does not exclude the use of inert placebo in studies
p.000013: where no proven diagnostic or therapeutic method exists.
p.000013: 13. The refusal of the patient to participate in a study must never interfere with the physician-patient
p.000013: relationship.
p.000013: 14. The physician can combine medical research with professional care, the objective being the acquisition of
p.000013: new knowledge, only to the extent that medical research is justified by its potential diagnostic or
p.000013: therapeutic value for the patient.
p.000013: 15. It is necessary for the researcher to demonstrate that the risks to the research subjects are not unreasonable or
p.000013: disproportionate to the expected benefits of the research, which may not even go to the research subjects. A risk
p.000013: is the potential for an adverse outcome (harm) to occur. It has two components: (1) the
p.000013: likelihood of the occurrence of harm (from highly unlikely to
p.000013:
p.000014: 14
p.000014:
p.000014: very likely), and (2) the severity of the harm (from trivial to permanent severe disability or death). A
p.000014: highly unlikely risk of a trivial harm would not be problematic for a good research project. At the other
p.000014: end of the spectrum, a likely risk of a serious harm would be unacceptable unless the project provided the only
p.000014: hope of treatment for terminally ill research subjects. In between these two extremes, paragraph 17 of the DOH requires
p.000014: researchers to adequately assess the risks and be sure that they can be managed. If the risk is entirely
p.000014: unknown, then the researcher should not proceed with the project until some reliable data are
p.000014: available, for example, from laboratory studies or experiments on animals.
p.000014: 16. Paragraph 11 of the declaration of Helsinki (DoH) requires that medical research involving human subjects must
p.000014: be justifiable on scientific grounds. This requirement is meant to eliminate projects that are unlikely to
p.000014: succeed, for example, because they are methodologically inadequate, or that, even if successful, will likely produce
p.000014: trivial results.
p.000014: 17. In the purely scientific application of medical research carried out on a human being, it is the duty of
p.000014: the physician to remain the protector of the life and health well-being of that person on whom biomedical research is
p.000014: being carried out.
...
p.000045: sources of funding for the research.
p.000045: 18. The possible research uses, direct or secondary, of the subject’s medical records and of biological
p.000045: specimens taken in the course of clinical care.
p.000045: 19. Whether it is planned that biological specimens collected in the research will be destroyed at its
p.000045: conclusion, and, if not,
p.000045:
p.000046: 46
p.000046:
p.000046: details about their storage (where, how, for how long, and final disposition) and possible future use, and that
p.000046: subjects have the right to decide about such future use, to refuse storage, and to have the material
p.000046: destroyed.
p.000046: 20. Whether commercial products may be developed from biological specimens, and whether the
p.000046: participant will receive money or other benefits from the development of such products.
p.000046: 21. Whether the investigator is serving only as an investigator or as both investigator and subject’s physician.
p.000046: 22. The extent of the investigator's responsibility to provide medical services to the participant.
p.000046: 23. The treatment will be provided free of charge for specified types of research-related injury or for
p.000046: complications associated with the research, the nature and duration of such care, the name of the organization or
p.000046: individual that will provide the treatment, and whether there is any uncertainty regarding funding of such
p.000046: treatment.
p.000046: 24. In what way, and by what organization, the subject or the subject’s family or dependants will be
p.000046: compensated for disability or death resulting from such injury (or, when indicated, that there are no plans to provide
p.000046: such compensation).
p.000046:
p.000046:
p.000046:
p.000046:
p.000047: 47
p.000047:
p.000047: 25. Whether or not, in the country in which the prospective subject is invited to participate in
p.000047: research, the right to compensation is legally guaranteed.
p.000047: 26. An ethical review committee has approved or cleared the research protocol.
p.000047:
p.000047: 5.3 Process:
p.000047:
p.000047: Obtaining informed consent is a process that is begun when initial contact is made with a prospective
p.000047: subject and continues throughout the course of the study. By informing the prospective subjects, by repetition and
p.000047: explanation, by answering their questions as they arise, and by ensuring that each individual understands each
p.000047: procedure, investigators have to elicit the informed consent from their subjects. By doing so the investigator
p.000047: manifests respect for their dignity and autonomy.
p.000047:
p.000047: Each individual must be given as much time as is needed to reach a decision, including time for
p.000047: consultation with family members or others. Adequate time and resources should be set aside for
p.000047: informed-consent procedures.
p.000047:
p.000047: 5.4 Language:
p.000047:
p.000047: Informing the individual subject must not be simply a ritual recitation of the contents of a written document. Rather,
...
Health / Mentally Incapacitated
Searching for indicator incapable:
(return to top)
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000056: 56
p.000056:
p.000056: 5.16 Equitable distribution of burdens and benefits in the selection of groups of subjects in research:
p.000056:
p.000056: 1- Groups or communities to be subjects of research should be selected so that the burdens and benefits of the
p.000056: research will be equitably distributed. The exclusion of groups or communities that might benefit from study
p.000056: participation must be justified.
p.000056:
p.000056: 2- Members of vulnerable groups also have the same entitlement to access to the benefits of investigational
p.000056: interventions that show promise of therapeutic benefit as non vulnerable groups particularly when no superior
p.000056: or equivalent approaches to therapy are available.
p.000056:
p.000056: 3- Overuse of certain groups, such as the poor or the administratively available, is unjustified.
p.000056:
p.000056: 5.17 Exception to the requirement for informed consent in studies of emergencies in which the researcher
p.000056: anticipates that many subjects will be unable to consent:
p.000056:
p.000056: Research protocols are sometimes designed to address conditions occurring suddenly and rendering the
p.000056: patients/subjects incapable of giving informed consent. Examples are head trauma, cardiopulmonary arrest and
p.000056: stroke. The investigation cannot be done with patients who can give informed consent in time and there
p.000056: may not be time to locate a person having the authority to give permission.
p.000056:
p.000056:
p.000056:
p.000056:
p.000057: 57
p.000057:
p.000057: In such circumstances it is often necessary to precede with the research interventions very soon after the onset of the
p.000057: condition in order to evaluate an investigational treatment or develop the desired knowledge. Consent should be
p.000057: taken from the guardian if available or from an authorized body in the health facility. As this class of emergency
p.000057: exception can be anticipated, the researcher must secure the review and approval of an ethical review
p.000057: committee before initiating the study. If possible, an attempt should be made to identify a population that is likely
p.000057: to develop the condition to be studied. This can be done readily, for example, if the condition is one that
p.000057: recurs periodically in individuals; examples include grand mal seizures and alcohol binges. In such cases, prospective
p.000057: subjects should be contacted while fully capable of informed consent, and invited to consent to their involvement as
p.000057: research subjects during future periods of incapacitation. If they are patients of an independent physician who is
p.000057: also the physician-researcher, the physician should likewise seek their consent while they are fully capable of
p.000057: informed consent.
p.000057:
p.000057: In all cases in which approved research has begun without prior consent of patients/subjects incapable of
p.000057: giving informed consent because of suddenly occurring conditions, they should be given all relevant information
p.000057: as soon as they are in a state to receive it, and their consent to continued participation should be
p.000057: obtained as soon as is reasonably possible.
p.000057:
p.000057: 5.18 Inducement to participate:
p.000057:
p.000057: Subjects may be reimbursed for lost earnings, travel costs and other expenses incurred in taking part in
p.000057: a study; and may receive free medical services. Subjects, particularly those who receive no direct
p.000057: benefit from
p.000058: 58
p.000058:
p.000058: research, may be paid or otherwise compensated for inconvenience and time spent. The payments should not be so
p.000058: large, however, or the medical services so extensive as to induce prospective subjects to consent to
p.000058: participate in the research against their better judgment ("undue inducement"). An ethical
p.000058: review committee must have approved all payments, reimbursement and medical services provided to
p.000058: research subjects.
p.000058:
p.000058:
p.000058:
p.000058: 5.19 Incompetent persons
p.000058:
p.000058:
p.000058: Incompetent persons may be vulnerable to exploitation for financial gain by guardians. A guardian asked to give
p.000058: permission on behalf of an incompetent person should be offered no recompense other than a refund of
p.000058: travel and related expenses.
p.000058:
p.000058: 5.20 Withdrawal from a study:
p.000058:
p.000058: A subject who withdraws from research for reasons related to the study,
p.000058: e.g. side-effects of a study drug, or who is withdrawn on health grounds, should be paid or recompensed as if
p.000058: full participation had taken place. A subject who withdraws for any other reason should be paid in proportion to
p.000058: the amount of participation. An investigator who must remove a subject from the study for wilful
p.000058: non-compliance is entitled to withhold part or all of the payment.
p.000058:
p.000058:
p.000058:
p.000059: 59
p.000059:
p.000059: 5.21 Research involving vulnerable persons
p.000059:
p.000059: Special justification is required for inviting vulnerable individuals to serve as research subjects and, if they are
p.000059: selected, the means of protecting their rights and welfare must be strictly applied.
p.000059: Individuals conventionally considered vulnerable are those with limited capacity or freedom to consent or to decline to
p.000059: consent. They include children, and persons who because of mental or behavioural disorders are incapable of giving
p.000059: informed consent.
p.000059:
p.000059: Ethical justification of their involvement usually requires the investigators to satisfy the ethical review committees
p.000059: that:
p.000059:
p.000059: a. The research could not be carried out equally well with less vulnerable subjects.
p.000059:
p.000059: b. The research is intended to obtain knowledge that will lead to improved diagnosis, prevention or treatment of
p.000059: diseases or other health problems characteristic.
p.000059:
p.000059: c. Research subjects and other members of the vulnerable class from which subjects are recruited will ordinarily
p.000059: be assured reasonable access to any diagnostic, preventive or therapeutic products that will become available as a
p.000059: consequence of the research;
p.000059:
p.000059: d. The risks attached to interventions or procedures will not exceed those associated with routine
p.000059: medical or psychological examination of such persons unless an ethical review committee authorizes a slight
p.000059: increase over this level of risk.
p.000060: 60
p.000060:
p.000060: e. When the prospective subjects are either incompetent or otherwise substantially unable to give informed
p.000060: consent, their agreement will be supplemented by the permission of their legal guardians or other appropriate
p.000060: representatives.
p.000060:
p.000060:
p.000060:
p.000060: 5.22 Research involving vulnerable groups includes:
p.000060:
p.000060:
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.000044: utility (unless the ethical review committee has approved temporary or permanent non-disclosure of data, in which
p.000044: case the subject should be informed of, and given, the reasons for such non-disclosure).
p.000044: 9. Any foreseeable risks, pain or discomfort, or inconvenience to the individual (or others) associated with
p.000044: participation in the research, including risks to the health or well-being of a subject’s spouse or partner.
p.000044: 10. The direct benefits, if any, to the subjects from participating in the research
p.000044: 11. The expected benefits of the research to the community or to society at large, or contributions to scientific
p.000044: knowledge.
p.000044: 12. Whether, when and how any products or interventions proven by the research to be safe and effective will be made
p.000044: available to
p.000045: 45
p.000045:
p.000045: subjects after they have completed their participation in the research, and whether they will be expected to
p.000045: pay for them.
p.000045: 13. Any currently available alternative interventions or courses of treatment.
p.000045: 14. The provisions that will be made to ensure respect for the privacy of subjects and for the
p.000045: confidentiality of records in which subjects are identified.
p.000045: 15. The limits, legal or other, to the investigators' ability to safeguard confidentiality, and the
p.000045: possible consequences of breaches of confidentiality.
p.000045: 16. Policy with regard to the use of results of genetic tests and familial genetic information, and the
p.000045: precautions in place to prevent disclosure of the results of a subject's genetic tests to immediate
p.000045: family relatives or to others (e.g., insurance companies or employers) without the consent of the
p.000045: subject.
p.000045: 17. The sponsors of the research, the institutional affiliation of the investigators, and the nature and
p.000045: sources of funding for the research.
p.000045: 18. The possible research uses, direct or secondary, of the subject’s medical records and of biological
p.000045: specimens taken in the course of clinical care.
p.000045: 19. Whether it is planned that biological specimens collected in the research will be destroyed at its
p.000045: conclusion, and, if not,
p.000045:
p.000046: 46
p.000046:
p.000046: details about their storage (where, how, for how long, and final disposition) and possible future use, and that
p.000046: subjects have the right to decide about such future use, to refuse storage, and to have the material
p.000046: destroyed.
p.000046: 20. Whether commercial products may be developed from biological specimens, and whether the
p.000046: participant will receive money or other benefits from the development of such products.
p.000046: 21. Whether the investigator is serving only as an investigator or as both investigator and subject’s physician.
p.000046: 22. The extent of the investigator's responsibility to provide medical services to the participant.
p.000046: 23. The treatment will be provided free of charge for specified types of research-related injury or for
p.000046: complications associated with the research, the nature and duration of such care, the name of the organization or
p.000046: individual that will provide the treatment, and whether there is any uncertainty regarding funding of such
p.000046: treatment.
p.000046: 24. In what way, and by what organization, the subject or the subject’s family or dependants will be
p.000046: compensated for disability or death resulting from such injury (or, when indicated, that there are no plans to provide
p.000046: such compensation).
p.000046:
p.000046:
p.000046:
p.000046:
p.000047: 47
p.000047:
p.000047: 25. Whether or not, in the country in which the prospective subject is invited to participate in
p.000047: research, the right to compensation is legally guaranteed.
p.000047: 26. An ethical review committee has approved or cleared the research protocol.
p.000047:
p.000047: 5.3 Process:
p.000047:
p.000047: Obtaining informed consent is a process that is begun when initial contact is made with a prospective
p.000047: subject and continues throughout the course of the study. By informing the prospective subjects, by repetition and
p.000047: explanation, by answering their questions as they arise, and by ensuring that each individual understands each
p.000047: procedure, investigators have to elicit the informed consent from their subjects. By doing so the investigator
p.000047: manifests respect for their dignity and autonomy.
p.000047:
p.000047: Each individual must be given as much time as is needed to reach a decision, including time for
p.000047: consultation with family members or others. Adequate time and resources should be set aside for
p.000047: informed-consent procedures.
p.000047:
p.000047: 5.4 Language:
p.000047:
p.000047: Informing the individual subject must not be simply a ritual recitation of the contents of a written document. Rather,
p.000047: the investigator must convey the information, whether orally or in writing, in language that suits
p.000047: the individual's level of understanding.
p.000047:
p.000047:
p.000048: 48
p.000048:
p.000048: The investigator must bear in mind that the prospective subject’s ability to understand the information necessary to
p.000048: give informed consent depends on that individual's maturity, intelligence, education and belief system. It
p.000048: depends also on the investigator's ability and willingness to communicate with patience and sensitivity.
p.000048:
p.000048: 5.5 Comprehension:
p.000048:
p.000048: The investigator must then ensure that the prospective subject has adequately understood the information.
p.000048: The investigator should give each one full opportunity to ask questions and should answer them honestly,
p.000048: promptly and completely. In some instances the investigator may administer an oral or a written test or otherwise
p.000048: determine whether the information has been adequately understood.
p.000048:
p.000048:
p.000048:
p.000048:
p.000048: 5.6 Documentation of consent:
p.000048:
p.000048:
p.000048:
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.000020: 5.11 Use of medical records and biological specimens 50
p.000020: 5.12 Secondary use of research records or biological specimens 51
p.000020: 5.13 Obligations of sponsors and investigators 52
p.000020: 5.14 Withholding information and deception 53
p.000020: 5.15 Intimidation and undue influence 54
p.000020: 5.16 Equitable distribution of burdens and benefits in the selection of groups of subjects in research
p.000055: 55
p.000055: 5.17 Exception to the requirement for informed consent in studies of emergencies
p.000056: 56
p.000056: 5.18 Inducement to participate 57
p.000056: 5.19 Incompetent persons 57
p.000056: 5.20 Withdrawal from a study 58
p.000056: 5.21 Research involving vulnerable persons 58
p.000056: 5.22 Research involving vulnerable groups include 59
p.000056: 5.22.1 Research involving children 59
p.000056: 5.22.2 Women as research subjects 59
p.000056: 5.22.3 Pregnant women as research participants 60
p.000056: 5.23References 62
p.000056:
p.000056:
p.000056:
p.000056:
p.000056: D
p.000056:
p.000056: 12. Annexes 63
p.000056: 6.1 National Application Form For Ethical Approval of a Research Project
p.000067: 67
p.000067: 6.2 National Application Form For Ethical Approval of a Research Proposal
p.000069: 69
p.000069: 6.2.1 Form A: Part 1: Technical proposal form 69
p.000069: 6.2.2 Form B: Part Two: Ethical Considerations 77
p.000069: 1- Minimization of Harm 77
p.000069: 2- Privacy and Confidentiality 79
p.000069: 6.3 Form C 80 1- Informed
p.000069: Consent 80 2- Declarations
p.000081: 81
p.000081: 6.4 The Participant's Acceptance Form ( كر¹ a²ا و= ²ا ¾ب ا9a ةر¹aäذإ جذ9a: A:⁄ ب9:i ýa وأ #⁄ş²ا y )
p.000082: 82
p.000082: 6.5 Model of Informed Consent (ً¹ 49a #⁄ş²ا y كر¹ a²ا ¾ب ا9a راك4إ مر9 ) 84
p.000082: 6.6 Members of the National Health Research Ethical Committee (NHREC)
p.000085: 85
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
...
p.000060: representatives.
p.000060:
p.000060:
p.000060:
p.000060: 5.22 Research involving vulnerable groups includes:
p.000060:
p.000060:
p.000060:
p.000060: 5.22.1 Research involving children:
p.000060: Before undertaking research involving children, the investigator must ensure that:
p.000060: * The research might not equally well be carried out with adults;
p.000060: * The purpose of the research is to obtain knowledge relevant to the health needs of children;
p.000060: * A parent or legal representative of each child has given permission;
p.000060: * The agreement (assent) of each child has been obtained to the extent of the child’s capabilities;
p.000060: * A child’s refusal to participate or continue in the research will be respected.
p.000060: 5.22.2 Women as research subjects:
p.000060: Investigators, sponsors or ethical review committees should not exclude women of reproductive age
p.000060: from biomedical
p.000060:
p.000061: 61
p.000061:
p.000061: research. The potential for becoming pregnant during a study should not be used as a reason for
p.000061: precluding or limiting participation. However, a thorough discussion of risks to the pregnant woman and to
p.000061: her foetus is a prerequisite for the woman’s ability to make a rational decision to enroll in a clinical study.
p.000061: In this discussion, if participation in the research might be hazardous to a foetus or a woman if she becomes pregnant,
p.000061: the sponsors/ investigators should guarantee the prospective subject a pregnancy test and access to effective
p.000061: contraceptive methods before the research commences. Where such access is not possible, for legal or religious reasons,
p.000061: investigators should not recruit for such possibly hazardous research women who might become pregnant.
p.000061: 5.22.3 Pregnant women as research participants:
p.000061: Pregnant women should be eligible for participation in biomedical research. Investigators and ethical review committees
p.000061: should ensure that prospective subjects who are pregnant are adequately informed about the risks and benefits to
p.000061: themselves, their pregnancies, the foetus and their subsequent offspring, and their fertility.
p.000061: Research in this population should be performed only if it is relevant to the particular health needs of a pregnant
p.000061: woman or
p.000061:
p.000062: 62
p.000062:
p.000062: her foetus, or to the health needs of pregnant women in general, and, when appropriate, if it is supported by reliable
p.000062: evidence from animal experiments, particularly as to risks of teratogenicity and mutagenicity.
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000063: 63
p.000063:
p.000063: 5.23 References:
p.000063:
p.000063: 1. TDR/PRD/ETHICS/2000."Operational Guidelines for Ethics Committees That Review Biomedical Research"
p.000063:
p.000063: 2. Council for International Organizations of Medical Sciences (CIOMS) International Ethical
p.000063: Guidelines for Biomedical Research Involving Human Subjects. CIOMS, Geneva 2002. ISBN 92 9036 075 5
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000064: 64
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064: Annexes
...
Health / Terminally Ill
Searching for indicator terminally:
(return to top)
p.000013: 13. The refusal of the patient to participate in a study must never interfere with the physician-patient
p.000013: relationship.
p.000013: 14. The physician can combine medical research with professional care, the objective being the acquisition of
p.000013: new knowledge, only to the extent that medical research is justified by its potential diagnostic or
p.000013: therapeutic value for the patient.
p.000013: 15. It is necessary for the researcher to demonstrate that the risks to the research subjects are not unreasonable or
p.000013: disproportionate to the expected benefits of the research, which may not even go to the research subjects. A risk
p.000013: is the potential for an adverse outcome (harm) to occur. It has two components: (1) the
p.000013: likelihood of the occurrence of harm (from highly unlikely to
p.000013:
p.000014: 14
p.000014:
p.000014: very likely), and (2) the severity of the harm (from trivial to permanent severe disability or death). A
p.000014: highly unlikely risk of a trivial harm would not be problematic for a good research project. At the other
p.000014: end of the spectrum, a likely risk of a serious harm would be unacceptable unless the project provided the only
p.000014: hope of treatment for terminally ill research subjects. In between these two extremes, paragraph 17 of the DOH requires
p.000014: researchers to adequately assess the risks and be sure that they can be managed. If the risk is entirely
p.000014: unknown, then the researcher should not proceed with the project until some reliable data are
p.000014: available, for example, from laboratory studies or experiments on animals.
p.000014: 16. Paragraph 11 of the declaration of Helsinki (DoH) requires that medical research involving human subjects must
p.000014: be justifiable on scientific grounds. This requirement is meant to eliminate projects that are unlikely to
p.000014: succeed, for example, because they are methodologically inadequate, or that, even if successful, will likely produce
p.000014: trivial results.
p.000014: 17. In the purely scientific application of medical research carried out on a human being, it is the duty of
p.000014: the physician to remain the protector of the life and health well-being of that person on whom biomedical research is
p.000014: being carried out.
p.000014: 18. Paragraphs 18 and 19 of the DoH clearly favour the consideration of social value in the
p.000014: evaluation of research projects. The importance of the project’s objective, understood
p.000014:
p.000014:
p.000014:
p.000015: 15
p.000015:
p.000015: as both scientific and social importance, should outweigh the risks and burdens to research subjects.
p.000015: 19. In research on humans, the interest of science and society should never take precedence over considerations
p.000015: related to the well- being of the subject.
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
...
Health / ill
Searching for indicator ill:
(return to top)
p.000013: relationship.
p.000013: 14. The physician can combine medical research with professional care, the objective being the acquisition of
p.000013: new knowledge, only to the extent that medical research is justified by its potential diagnostic or
p.000013: therapeutic value for the patient.
p.000013: 15. It is necessary for the researcher to demonstrate that the risks to the research subjects are not unreasonable or
p.000013: disproportionate to the expected benefits of the research, which may not even go to the research subjects. A risk
p.000013: is the potential for an adverse outcome (harm) to occur. It has two components: (1) the
p.000013: likelihood of the occurrence of harm (from highly unlikely to
p.000013:
p.000014: 14
p.000014:
p.000014: very likely), and (2) the severity of the harm (from trivial to permanent severe disability or death). A
p.000014: highly unlikely risk of a trivial harm would not be problematic for a good research project. At the other
p.000014: end of the spectrum, a likely risk of a serious harm would be unacceptable unless the project provided the only
p.000014: hope of treatment for terminally ill research subjects. In between these two extremes, paragraph 17 of the DOH requires
p.000014: researchers to adequately assess the risks and be sure that they can be managed. If the risk is entirely
p.000014: unknown, then the researcher should not proceed with the project until some reliable data are
p.000014: available, for example, from laboratory studies or experiments on animals.
p.000014: 16. Paragraph 11 of the declaration of Helsinki (DoH) requires that medical research involving human subjects must
p.000014: be justifiable on scientific grounds. This requirement is meant to eliminate projects that are unlikely to
p.000014: succeed, for example, because they are methodologically inadequate, or that, even if successful, will likely produce
p.000014: trivial results.
p.000014: 17. In the purely scientific application of medical research carried out on a human being, it is the duty of
p.000014: the physician to remain the protector of the life and health well-being of that person on whom biomedical research is
p.000014: being carried out.
p.000014: 18. Paragraphs 18 and 19 of the DoH clearly favour the consideration of social value in the
p.000014: evaluation of research projects. The importance of the project’s objective, understood
p.000014:
p.000014:
p.000014:
p.000015: 15
p.000015:
p.000015: as both scientific and social importance, should outweigh the risks and burdens to research subjects.
p.000015: 19. In research on humans, the interest of science and society should never take precedence over considerations
p.000015: related to the well- being of the subject.
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
...
Health / patients in emergency situations
Searching for indicator emergencies:
(return to top)
p.000020: 5.4 Language 46
p.000020: 5.5 Comprehension 46
p.000020: 5.6 Documentation of consent 47 5.7 Waiving of the
p.000020: consent requirement 48
p.000020: 5.8 Renewing consent 48
p.000020: 5.9 Cultural considerations 49
p.000020: 5.10 Use of biological materials from subjects in clinical trials 50
p.000020: 5.11 Use of medical records and biological specimens 50
p.000020: 5.12 Secondary use of research records or biological specimens 51
p.000020: 5.13 Obligations of sponsors and investigators 52
p.000020: 5.14 Withholding information and deception 53
p.000020: 5.15 Intimidation and undue influence 54
p.000020: 5.16 Equitable distribution of burdens and benefits in the selection of groups of subjects in research
p.000055: 55
p.000055: 5.17 Exception to the requirement for informed consent in studies of emergencies
p.000056: 56
p.000056: 5.18 Inducement to participate 57
p.000056: 5.19 Incompetent persons 57
p.000056: 5.20 Withdrawal from a study 58
p.000056: 5.21 Research involving vulnerable persons 58
p.000056: 5.22 Research involving vulnerable groups include 59
p.000056: 5.22.1 Research involving children 59
p.000056: 5.22.2 Women as research subjects 59
p.000056: 5.22.3 Pregnant women as research participants 60
p.000056: 5.23References 62
p.000056:
p.000056:
p.000056:
p.000056:
p.000056: D
p.000056:
p.000056: 12. Annexes 63
p.000056: 6.1 National Application Form For Ethical Approval of a Research Project
p.000067: 67
p.000067: 6.2 National Application Form For Ethical Approval of a Research Proposal
p.000069: 69
p.000069: 6.2.1 Form A: Part 1: Technical proposal form 69
p.000069: 6.2.2 Form B: Part Two: Ethical Considerations 77
...
p.000085: included in the research. Other principles about the informed consent were included and explained in this
p.000085: chapter. This includes the language, comprehension, documentation of consent, waiver of the consent
p.000085: requirement, renewing consent and other cultural considerations.
p.000085:
p.000085: It also goes through the regulations of the use of biological materials from subjects in clinical trials, the
p.000085: use of medical records and biological specimens. It explains some of the basic principles about the secondary
p.000085: use of research records or biological specimens together with some obligations to be followed by both sponsors
p.000085: and investigators. It covers the issues related to the possible influence on the research subject like
p.000085: withholding information and deception, intimidation and undue influence. It also aims at assuring the equitable
p.000085: distribution of burdens and benefits in the selection of groups of subjects in research.
p.000085:
p.000085:
p.000085:
p.000085: N
p.000085:
p.000085: The regulation by which an exception to the requirement for informed consent in studies of emergencies
p.000085: in which the researcher anticipates that many subjects will be unable to give consent is also included in this
p.000085: chapter. Special interest is given to the inducement of research subjects to participate and the consent taken from
p.000085: incompetent persons or vulnerable persons. It also emphasizes the right of withdrawal from a study.
p.000085:
p.000085: The annexes include the, the National Application Form for ethical committee (A & B), and the
p.000085: Informed Consent form guidelines (form c), and the list of the National Research Ethic Committee members.
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085: O
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085: P
p.000085:
p.000085: Milestones of preparing the guidelines:
p.000085:
...
p.000051: in some cases (e.g., if investigators are requesting permission to conduct basic research which is not a
p.000051: necessary part of the clinical trial), but not in others (e.g., the clinical trial requires the use of
p.000051: subjects’ biological materials).
p.000051:
p.000051:
p.000051:
p.000051: 5.11 Use of medical records and biological specimens:
p.000051:
p.000051:
p.000051:
p.000051: Medical records and biological specimens taken in the course of clinical care may be used for research without the
p.000051: consent of the patients/subjects. This can only be done if an ethical review committee has determined that:
p.000051: * The research poses minimal risk, that the rights or interests of the patients will not be violated.
p.000051: * Patient privacy and confidentiality or anonymity is assured.
p.000051:
p.000051:
p.000051:
p.000051:
p.000052: 52
p.000052:
p.000052: * The research is designed to answer an important question and would be impracticable if the requirement for informed
p.000052: consent were to be imposed.
p.000052: * Patients have a right to know that their records or specimens may be used for research. Refusal or reluctance of
p.000052: individuals to agree to participate would not be evidence of impracticability sufficient to warrant waiving
p.000052: informed consent. Records and specimens of individuals who have specifically rejected such uses in the
p.000052: past may be used only in the case of public health emergencies.
p.000052:
p.000052: 5.12 Secondary use of research records or biological specimens:
p.000052: Investigators may want to use records or biological specimens that another investigator has used or
p.000052: collected for use in the same or another institution or another country. This raises the issue of whether the
p.000052: records or specimens contain personal identifiers. If informed consent or permission was required to authorize
p.000052: the original collection or use of such records or specimens for research purposes, secondary uses are generally
p.000052: constrained by the conditions specified in the original consent.
p.000052: Consequently, it is essential that the original consent process anticipate, to the extent that this is feasible, any
p.000052: foreseeable plans for future use of the records or specimens for research. Thus, in the original process of seeking
p.000052: informed consent a member of the research team should discuss with, and, when indicated, request the permission of,
p.000052: prospective subjects as to:
p.000052: i. Whether there will or could be any secondary use and, if so, whether such
p.000052:
p.000053: 53
p.000053:
p.000053: secondary use will be limited with regard to the type of study that may be performed on such materials;
p.000053: ii. The conditions under which investigators will be required to contact the research subjects for additional
p.000053: authorization for secondary use;
p.000053: iii. The investigators' plans, if any, to destroy or to strip off personal identifiers from the records or
p.000053: specimens; and
...
p.000055: persuasion and undue influence is imprecise, however. The researcher should give justifiable assurances
p.000055: about the benefits, risks or inconveniences of the research, for example, or induce a close
p.000055: relative or a community leader to influence a prospective subject's decision.
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000056: 56
p.000056:
p.000056: 5.16 Equitable distribution of burdens and benefits in the selection of groups of subjects in research:
p.000056:
p.000056: 1- Groups or communities to be subjects of research should be selected so that the burdens and benefits of the
p.000056: research will be equitably distributed. The exclusion of groups or communities that might benefit from study
p.000056: participation must be justified.
p.000056:
p.000056: 2- Members of vulnerable groups also have the same entitlement to access to the benefits of investigational
p.000056: interventions that show promise of therapeutic benefit as non vulnerable groups particularly when no superior
p.000056: or equivalent approaches to therapy are available.
p.000056:
p.000056: 3- Overuse of certain groups, such as the poor or the administratively available, is unjustified.
p.000056:
p.000056: 5.17 Exception to the requirement for informed consent in studies of emergencies in which the researcher
p.000056: anticipates that many subjects will be unable to consent:
p.000056:
p.000056: Research protocols are sometimes designed to address conditions occurring suddenly and rendering the
p.000056: patients/subjects incapable of giving informed consent. Examples are head trauma, cardiopulmonary arrest and
p.000056: stroke. The investigation cannot be done with patients who can give informed consent in time and there
p.000056: may not be time to locate a person having the authority to give permission.
p.000056:
p.000056:
p.000056:
p.000056:
p.000057: 57
p.000057:
p.000057: In such circumstances it is often necessary to precede with the research interventions very soon after the onset of the
p.000057: condition in order to evaluate an investigational treatment or develop the desired knowledge. Consent should be
p.000057: taken from the guardian if available or from an authorized body in the health facility. As this class of emergency
p.000057: exception can be anticipated, the researcher must secure the review and approval of an ethical review
p.000057: committee before initiating the study. If possible, an attempt should be made to identify a population that is likely
p.000057: to develop the condition to be studied. This can be done readily, for example, if the condition is one that
...
p.000075: 12. Annexes
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000076: 76
p.000076:
p.000076: Form B:
p.000076: Part Two: Ethical Considerations
p.000076: 1. What is an estimate of total time involved for participants in the study?
p.000076: 2. Who will carry out the research procedures?
p.000076:
p.000076: 3. What other research studies is the principal investigator currently involved with?
p.000076:
p.000076: 4. Where will the research procedures take place?
p.000076:
p.000076: 5. Does the project Involve collection or use of human tissue?
p.000076:
p.000076: 6. If yes: will this material be used in further studies?
p.000076:
p.000076: 8. Is it intended to inform the participant’s doctor of individual results of the investigations, and their
p.000076: participation, if the participant consents?
p.000076:
p.000076: 9. If no, outline the reasons
p.000076:
p.000076: 10. Does the researcher, the host department, the host institution, have any financial interest in the outcome of
p.000076: this research? If “yes”, please give details.
p.000076:
p.000076: 1- Minimization of Harm
p.000076:
p.000076: 11. How do the research procedures differ from standard treatment procedures?
p.000076:
p.000076: 12. What are the benefits to research participants taking part?
p.000076:
p.000076: 13. What are the physical or psychological risks, or side effects to participants or third
p.000076: parties? Describe what action will be taken to minimize any such risks or side effects.
p.000076:
p.000076:
p.000076:
p.000077: 77
p.000077:
p.000077: 14. What facilities/procedures and personnel are there for dealing with emergencies?
p.000077:
p.000077: 15. What arrangements will be made for monitoring and detecting adverse outcomes?
p.000077:
p.000077: 16. Is the trial being reviewed by a data safety monitoring board (DSMB)?
p.000077: 17. If yes, who will fund of the DSMB?
p.000077:
p.000077: 18. What are the criteria for terminating the study?
p.000077:
p.000077: 19. Will any potential toxins, mutagens or teratogens be used?
p.000077:
p.000077: 20. If yes, specify and outline the justification for their use
p.000077:
p.000077: 21. Will any radiation or radioactive substances be used?
p.000077:
p.000077: 22. Has the National Committee for atomic energy completed risk assessment?
p.000077:
p.000077: 23. If yes, please enclose a copy of the risk assessment, and the contact name and phone number
p.000077:
p.000077: 24. If no, please explain why
p.000077:
p.000077: 25. Will any drugs be administered for the purposes of this study?
p.000077:
p.000077: 26. If yes:
p.000077: a. is approval of the concerned authorities required?
p.000077:
p.000077: b. trade name of drug
p.000077:
p.000077: c. Chemical name of drug
p.000077:
p.000077: d. Pharmacological class:
p.000077:
p.000077: e. Pharmacological class, e.g., long half life, receptor selectivity.
p.000077:
p.000077: f. Recommended dose range
p.000077:
p.000078: 78
p.000078:
p.000078: g. Form of administration in the study
p.000078:
p.000078: h. Known or possible interactions with non-trial drugs the participants may be taking
p.000078: i. Side effects and adverse reactions
p.000078: 27. Does the study involve the use of healthcare resources?
p.000078:
p.000078: 28. If yes, please specify:
...
Health / visual impairment
Searching for indicator blind:
(return to top)
p.000042: As an additional safeguard, it must always be complemented by the approval of an independent review of an ethical
p.000042: research committee.
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000043: 43
p.000043:
p.000043:
p.000043: 5.2 Obtaining informed consent:
p.000043:
p.000043:
p.000043: Before requesting an individual's consent to participate in research, the investigator must
p.000043: provide the following information, in language or another form of communication that the individual can
p.000043: understand to the research subject:
p.000043: 1. The individual is invited to participate voluntarily in the research, explaining the reasons for
p.000043: considering him/her suitable for the research.
p.000043: 2. The individual is free to refuse to participate and will be free to withdraw from the research at any time without
p.000043: penalty or loss of benefits to which he or she would otherwise be entitled.
p.000043: 3. The purpose of the research, the procedures to be carried out by the investigator and the subject, and an
p.000043: explanation of how the research differs from routine medical care.
p.000043: 4. An explanation of the features of the research design e.g., in controlled trials the method of randomization,
p.000043: double-blinding, and that the subject will not be told of the assigned treatment until the study has
p.000043: been completed and the blind has been broken.
p.000043: 5. The expected duration of the individual's participation (including number and duration of visits
p.000043: to the research centre
p.000043:
p.000043:
p.000044: 44
p.000044:
p.000044: and the total time involved) and the possibility of early termination of the trial or of the
p.000044: individual’s participation in it.
p.000044: 6. Whether money or other forms of material goods will be provided in return for the individual's
p.000044: participation and if so, the kind and amount.
p.000044: 7. The subject will be informed of the findings of the research in general, and individual subjects will be informed of
p.000044: any finding that relates to their particular health status.
p.000044: 8. The subjects have the right of access to their data on demand, even if these data lack immediate clinical
p.000044: utility (unless the ethical review committee has approved temporary or permanent non-disclosure of data, in which
p.000044: case the subject should be informed of, and given, the reasons for such non-disclosure).
p.000044: 9. Any foreseeable risks, pain or discomfort, or inconvenience to the individual (or others) associated with
p.000044: participation in the research, including risks to the health or well-being of a subject’s spouse or partner.
p.000044: 10. The direct benefits, if any, to the subjects from participating in the research
p.000044: 11. The expected benefits of the research to the community or to society at large, or contributions to scientific
p.000044: knowledge.
p.000044: 12. Whether, when and how any products or interventions proven by the research to be safe and effective will be made
p.000044: available to
p.000045: 45
p.000045:
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.000033:
p.000033: Prepare requested documents.
p.000033: Consider all ethical elements.
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033: Apply for ethical clearance
p.000033:
p.000033:
p.000033:
p.000033: 4.2 Flowchart for getting ethical clearance
p.000033:
p.000033:
p.000033:
p.000033:
p.000033: NHREC review procedure will take 1-2 /12
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033: NHREC follow up procedure
p.000033:
p.000033: Communicating the decision
p.000033: Decision of NHREC in two months
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000034: 34
p.000034:
p.000034:
p.000034: 4.3 Prepare
p.000034:
p.000034:
p.000034:
p.000034:
p.000034: 1. Research proposal, copies with name of applicant and institute.
p.000034: 2. Curriculum vitae of the investigator.
p.000034: 3. Approval of head of department or institution.
p.000034: 4. Ethical issues in the study and plan to address them.
p.000034: 5. Informed consent
p.000034: 6. All relevant pre clinical animal data, and clinical trial data from other centers.
p.000034: 7. Any regulatory clearance.
p.000034: 8. Source of funding and financial requirements for the project.
p.000034: 9. Other financial issues including those related to insurance
p.000034: 10. An agreement to report only Serious Adverse Events (SAE) to institutional ethical committee.
p.000034: 11. Statement of conflicts or of interest, if any.
p.000034: 12. Agreement to comply with the relevant national and applicable international guidelines.
p.000034: 13. A statement describing any compensation for study participation (including expenses and access to medical care) to
p.000034: be given to research participants.
p.000034: 14. A description of the arrangements for indemnity, if applicable (in study-related injuries).
p.000034: . A description of the arrangements for insurance coverage for research participants, if applicable.
p.000034: . All significant previous decisions (e.g., those leading to a negative decision or modified
p.000034: protocol) by other ethical committee or regulatory authorities for the proposed study (whether in the
p.000034: same location or elsewhere) and an indication of the modification(s) to the protocol made on that account. The
p.000034: reasons for negative decisions should be provided.
p.000034: . Plans for publication of results – positive or negative- while maintaining the privacy
p.000034: and confidentiality of the study participants.
p.000034: 18. Any other information relevant to the study.
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000035: 35
p.000035:
p.000035:
p.000035: 4.4 Elements of ethical review
p.000035:
p.000035:
p.000035:
p.000035:
p.000035: 1. Ethical issues in the design of the study.
p.000035: 2. Examination of predictable risks/harms.
p.000035: 3. Examination of potential benefits.
p.000035: 4. Procedure for selection of subjects in methodology including inclusion/ exclusion, withdrawal criteria and other
p.000035: issues like advertisement details.
p.000035:
p.000035: 5. Management of research related injuries, adverse events.
p.000035: 6. Compensation provisions.
p.000035: 7. Justification for placebo in control, if any.
p.000035: 8. Availability of products after the study, if applicable.
...
p.000043: understand to the research subject:
p.000043: 1. The individual is invited to participate voluntarily in the research, explaining the reasons for
p.000043: considering him/her suitable for the research.
p.000043: 2. The individual is free to refuse to participate and will be free to withdraw from the research at any time without
p.000043: penalty or loss of benefits to which he or she would otherwise be entitled.
p.000043: 3. The purpose of the research, the procedures to be carried out by the investigator and the subject, and an
p.000043: explanation of how the research differs from routine medical care.
p.000043: 4. An explanation of the features of the research design e.g., in controlled trials the method of randomization,
p.000043: double-blinding, and that the subject will not be told of the assigned treatment until the study has
p.000043: been completed and the blind has been broken.
p.000043: 5. The expected duration of the individual's participation (including number and duration of visits
p.000043: to the research centre
p.000043:
p.000043:
p.000044: 44
p.000044:
p.000044: and the total time involved) and the possibility of early termination of the trial or of the
p.000044: individual’s participation in it.
p.000044: 6. Whether money or other forms of material goods will be provided in return for the individual's
p.000044: participation and if so, the kind and amount.
p.000044: 7. The subject will be informed of the findings of the research in general, and individual subjects will be informed of
p.000044: any finding that relates to their particular health status.
p.000044: 8. The subjects have the right of access to their data on demand, even if these data lack immediate clinical
p.000044: utility (unless the ethical review committee has approved temporary or permanent non-disclosure of data, in which
p.000044: case the subject should be informed of, and given, the reasons for such non-disclosure).
p.000044: 9. Any foreseeable risks, pain or discomfort, or inconvenience to the individual (or others) associated with
p.000044: participation in the research, including risks to the health or well-being of a subject’s spouse or partner.
p.000044: 10. The direct benefits, if any, to the subjects from participating in the research
p.000044: 11. The expected benefits of the research to the community or to society at large, or contributions to scientific
p.000044: knowledge.
p.000044: 12. Whether, when and how any products or interventions proven by the research to be safe and effective will be made
p.000044: available to
p.000045: 45
p.000045:
p.000045: subjects after they have completed their participation in the research, and whether they will be expected to
p.000045: pay for them.
p.000045: 13. Any currently available alternative interventions or courses of treatment.
p.000045: 14. The provisions that will be made to ensure respect for the privacy of subjects and for the
p.000045: confidentiality of records in which subjects are identified.
p.000045: 15. The limits, legal or other, to the investigators' ability to safeguard confidentiality, and the
p.000045: possible consequences of breaches of confidentiality.
p.000045: 16. Policy with regard to the use of results of genetic tests and familial genetic information, and the
p.000045: precautions in place to prevent disclosure of the results of a subject's genetic tests to immediate
...
p.000055: relationship or result in the withholding of health services. The physician/investigator must assure them that
p.000055: their decision on whether to participate will not affect the therapeutic relationship or other benefits
p.000055: to which they are entitled. In this situation the ethical review committee should consider whether a
p.000055: neutral third party should seek informed consent.
p.000055: The prospective subject must not be exposed to undue influence. The borderline between justifiable
p.000055: persuasion and undue influence is imprecise, however. The researcher should give justifiable assurances
p.000055: about the benefits, risks or inconveniences of the research, for example, or induce a close
p.000055: relative or a community leader to influence a prospective subject's decision.
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000056: 56
p.000056:
p.000056: 5.16 Equitable distribution of burdens and benefits in the selection of groups of subjects in research:
p.000056:
p.000056: 1- Groups or communities to be subjects of research should be selected so that the burdens and benefits of the
p.000056: research will be equitably distributed. The exclusion of groups or communities that might benefit from study
p.000056: participation must be justified.
p.000056:
p.000056: 2- Members of vulnerable groups also have the same entitlement to access to the benefits of investigational
p.000056: interventions that show promise of therapeutic benefit as non vulnerable groups particularly when no superior
p.000056: or equivalent approaches to therapy are available.
p.000056:
p.000056: 3- Overuse of certain groups, such as the poor or the administratively available, is unjustified.
p.000056:
p.000056: 5.17 Exception to the requirement for informed consent in studies of emergencies in which the researcher
p.000056: anticipates that many subjects will be unable to consent:
p.000056:
p.000056: Research protocols are sometimes designed to address conditions occurring suddenly and rendering the
p.000056: patients/subjects incapable of giving informed consent. Examples are head trauma, cardiopulmonary arrest and
p.000056: stroke. The investigation cannot be done with patients who can give informed consent in time and there
p.000056: may not be time to locate a person having the authority to give permission.
p.000056:
p.000056:
p.000056:
p.000056:
p.000057: 57
p.000057:
p.000057: In such circumstances it is often necessary to precede with the research interventions very soon after the onset of the
...
p.000059: 5.21 Research involving vulnerable persons
p.000059:
p.000059: Special justification is required for inviting vulnerable individuals to serve as research subjects and, if they are
p.000059: selected, the means of protecting their rights and welfare must be strictly applied.
p.000059: Individuals conventionally considered vulnerable are those with limited capacity or freedom to consent or to decline to
p.000059: consent. They include children, and persons who because of mental or behavioural disorders are incapable of giving
p.000059: informed consent.
p.000059:
p.000059: Ethical justification of their involvement usually requires the investigators to satisfy the ethical review committees
p.000059: that:
p.000059:
p.000059: a. The research could not be carried out equally well with less vulnerable subjects.
p.000059:
p.000059: b. The research is intended to obtain knowledge that will lead to improved diagnosis, prevention or treatment of
p.000059: diseases or other health problems characteristic.
p.000059:
p.000059: c. Research subjects and other members of the vulnerable class from which subjects are recruited will ordinarily
p.000059: be assured reasonable access to any diagnostic, preventive or therapeutic products that will become available as a
p.000059: consequence of the research;
p.000059:
p.000059: d. The risks attached to interventions or procedures will not exceed those associated with routine
p.000059: medical or psychological examination of such persons unless an ethical review committee authorizes a slight
p.000059: increase over this level of risk.
p.000060: 60
p.000060:
p.000060: e. When the prospective subjects are either incompetent or otherwise substantially unable to give informed
p.000060: consent, their agreement will be supplemented by the permission of their legal guardians or other appropriate
p.000060: representatives.
p.000060:
p.000060:
p.000060:
p.000060: 5.22 Research involving vulnerable groups includes:
p.000060:
p.000060:
p.000060:
p.000060: 5.22.1 Research involving children:
p.000060: Before undertaking research involving children, the investigator must ensure that:
p.000060: * The research might not equally well be carried out with adults;
p.000060: * The purpose of the research is to obtain knowledge relevant to the health needs of children;
p.000060: * A parent or legal representative of each child has given permission;
p.000060: * The agreement (assent) of each child has been obtained to the extent of the child’s capabilities;
p.000060: * A child’s refusal to participate or continue in the research will be respected.
p.000060: 5.22.2 Women as research subjects:
p.000060: Investigators, sponsors or ethical review committees should not exclude women of reproductive age
p.000060: from biomedical
p.000060:
p.000061: 61
p.000061:
p.000061: research. The potential for becoming pregnant during a study should not be used as a reason for
p.000061: precluding or limiting participation. However, a thorough discussion of risks to the pregnant woman and to
p.000061: her foetus is a prerequisite for the woman’s ability to make a rational decision to enroll in a clinical study.
p.000061: In this discussion, if participation in the research might be hazardous to a foetus or a woman if she becomes pregnant,
p.000061: the sponsors/ investigators should guarantee the prospective subject a pregnancy test and access to effective
p.000061: contraceptive methods before the research commences. Where such access is not possible, for legal or religious reasons,
p.000061: investigators should not recruit for such possibly hazardous research women who might become pregnant.
p.000061: 5.22.3 Pregnant women as research participants:
p.000061: Pregnant women should be eligible for participation in biomedical research. Investigators and ethical review committees
p.000061: should ensure that prospective subjects who are pregnant are adequately informed about the risks and benefits to
p.000061: themselves, their pregnancies, the foetus and their subsequent offspring, and their fertility.
p.000061: Research in this population should be performed only if it is relevant to the particular health needs of a pregnant
p.000061: woman or
p.000061:
p.000062: 62
p.000062:
p.000062: her foetus, or to the health needs of pregnant women in general, and, when appropriate, if it is supported by reliable
p.000062: evidence from animal experiments, particularly as to risks of teratogenicity and mutagenicity.
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
...
p.000077: 26. If yes:
p.000077: a. is approval of the concerned authorities required?
p.000077:
p.000077: b. trade name of drug
p.000077:
p.000077: c. Chemical name of drug
p.000077:
p.000077: d. Pharmacological class:
p.000077:
p.000077: e. Pharmacological class, e.g., long half life, receptor selectivity.
p.000077:
p.000077: f. Recommended dose range
p.000077:
p.000078: 78
p.000078:
p.000078: g. Form of administration in the study
p.000078:
p.000078: h. Known or possible interactions with non-trial drugs the participants may be taking
p.000078: i. Side effects and adverse reactions
p.000078: 27. Does the study involve the use of healthcare resources?
p.000078:
p.000078: 28. If yes, please specify:
p.000078:
p.000078: 29. What effect will this use of resources have on waiting list times for patients i.e. for diagnostic
p.000078: tests or for standard treatments?
p.000078:
p.000078: 2- Privacy and Confidentiality
p.000078:
p.000078: 30. How will participants be recruited? (e.g. advertisements, notices)
p.000078:
p.000078: 31. Where will potential participants be approached? (e.g. outpatient clinic) If appropriate describe by type (eg
p.000078: students)
p.000078:
p.000078: 32. Who will make the initial approach to potential participants?
p.000078:
p.000078: 33. How will data including audio and video tapes be handled and stored to safeguard confidentiality (both during and
p.000078: after completion of the research project)?
p.000078:
p.000078: 34. What will be done with the raw data when the study is finished?
p.000078:
p.000078: 35. How long will the data from the study be kept and who will be responsible for its safe keeping?
p.000078:
p.000078: 36. Who will have access to the raw data and/or clinical records during, or after, the study?
p.000078:
p.000078: 37. Describe any arrangements to make results available to participants, including whether they will be
p.000078: offered their audio tapes or videos.
p.000078:
p.000078:
p.000078:
p.000079: 79
p.000079:
p.000079: Form C:
p.000079: 1- Informed Consent
p.000079:
p.000079: Consent should be obtained in writing, unless there are good reasons to the contrary. If consent is not to be
p.000079: obtained in writing the justification should be given and the circumstances under which consent is obtained should be
p.000079: recorded. Attach a copy of the information sheet and consent form.
p.000079:
p.000079: 38. By whom, and how, will the project be explained to potential participants?
p.000079:
p.000079: 39. When and where will the explanation be given?
p.000079:
p.000079: 40. Will a competent interpreter be available, if required?
p.000079:
p.000079: 41. How much time will be allowed for the potential participant to decide about taking part?
p.000079: 42. In what form (written or oral) will consent be obtained? If oral consent only, state reasons
p.000079:
p.000079: 43. Are all participants able to consent themselves?
p.000079:
p.000079: 44. If no, explain why, and who will consent for them?
p.000079:
...
Social / Age
Searching for indicator age:
(return to top)
p.000060:
p.000060: e. When the prospective subjects are either incompetent or otherwise substantially unable to give informed
p.000060: consent, their agreement will be supplemented by the permission of their legal guardians or other appropriate
p.000060: representatives.
p.000060:
p.000060:
p.000060:
p.000060: 5.22 Research involving vulnerable groups includes:
p.000060:
p.000060:
p.000060:
p.000060: 5.22.1 Research involving children:
p.000060: Before undertaking research involving children, the investigator must ensure that:
p.000060: * The research might not equally well be carried out with adults;
p.000060: * The purpose of the research is to obtain knowledge relevant to the health needs of children;
p.000060: * A parent or legal representative of each child has given permission;
p.000060: * The agreement (assent) of each child has been obtained to the extent of the child’s capabilities;
p.000060: * A child’s refusal to participate or continue in the research will be respected.
p.000060: 5.22.2 Women as research subjects:
p.000060: Investigators, sponsors or ethical review committees should not exclude women of reproductive age
p.000060: from biomedical
p.000060:
p.000061: 61
p.000061:
p.000061: research. The potential for becoming pregnant during a study should not be used as a reason for
p.000061: precluding or limiting participation. However, a thorough discussion of risks to the pregnant woman and to
p.000061: her foetus is a prerequisite for the woman’s ability to make a rational decision to enroll in a clinical study.
p.000061: In this discussion, if participation in the research might be hazardous to a foetus or a woman if she becomes pregnant,
p.000061: the sponsors/ investigators should guarantee the prospective subject a pregnancy test and access to effective
p.000061: contraceptive methods before the research commences. Where such access is not possible, for legal or religious reasons,
p.000061: investigators should not recruit for such possibly hazardous research women who might become pregnant.
p.000061: 5.22.3 Pregnant women as research participants:
p.000061: Pregnant women should be eligible for participation in biomedical research. Investigators and ethical review committees
...
Social / Child
Searching for indicator child:
(return to top)
p.000059: consequence of the research;
p.000059:
p.000059: d. The risks attached to interventions or procedures will not exceed those associated with routine
p.000059: medical or psychological examination of such persons unless an ethical review committee authorizes a slight
p.000059: increase over this level of risk.
p.000060: 60
p.000060:
p.000060: e. When the prospective subjects are either incompetent or otherwise substantially unable to give informed
p.000060: consent, their agreement will be supplemented by the permission of their legal guardians or other appropriate
p.000060: representatives.
p.000060:
p.000060:
p.000060:
p.000060: 5.22 Research involving vulnerable groups includes:
p.000060:
p.000060:
p.000060:
p.000060: 5.22.1 Research involving children:
p.000060: Before undertaking research involving children, the investigator must ensure that:
p.000060: * The research might not equally well be carried out with adults;
p.000060: * The purpose of the research is to obtain knowledge relevant to the health needs of children;
p.000060: * A parent or legal representative of each child has given permission;
p.000060: * The agreement (assent) of each child has been obtained to the extent of the child’s capabilities;
p.000060: * A child’s refusal to participate or continue in the research will be respected.
p.000060: 5.22.2 Women as research subjects:
p.000060: Investigators, sponsors or ethical review committees should not exclude women of reproductive age
p.000060: from biomedical
p.000060:
p.000061: 61
p.000061:
p.000061: research. The potential for becoming pregnant during a study should not be used as a reason for
p.000061: precluding or limiting participation. However, a thorough discussion of risks to the pregnant woman and to
p.000061: her foetus is a prerequisite for the woman’s ability to make a rational decision to enroll in a clinical study.
p.000061: In this discussion, if participation in the research might be hazardous to a foetus or a woman if she becomes pregnant,
p.000061: the sponsors/ investigators should guarantee the prospective subject a pregnancy test and access to effective
p.000061: contraceptive methods before the research commences. Where such access is not possible, for legal or religious reasons,
p.000061: investigators should not recruit for such possibly hazardous research women who might become pregnant.
...
Searching for indicator children:
(return to top)
p.000020: 5.9 Cultural considerations 49
p.000020: 5.10 Use of biological materials from subjects in clinical trials 50
p.000020: 5.11 Use of medical records and biological specimens 50
p.000020: 5.12 Secondary use of research records or biological specimens 51
p.000020: 5.13 Obligations of sponsors and investigators 52
p.000020: 5.14 Withholding information and deception 53
p.000020: 5.15 Intimidation and undue influence 54
p.000020: 5.16 Equitable distribution of burdens and benefits in the selection of groups of subjects in research
p.000055: 55
p.000055: 5.17 Exception to the requirement for informed consent in studies of emergencies
p.000056: 56
p.000056: 5.18 Inducement to participate 57
p.000056: 5.19 Incompetent persons 57
p.000056: 5.20 Withdrawal from a study 58
p.000056: 5.21 Research involving vulnerable persons 58
p.000056: 5.22 Research involving vulnerable groups include 59
p.000056: 5.22.1 Research involving children 59
p.000056: 5.22.2 Women as research subjects 59
p.000056: 5.22.3 Pregnant women as research participants 60
p.000056: 5.23References 62
p.000056:
p.000056:
p.000056:
p.000056:
p.000056: D
p.000056:
p.000056: 12. Annexes 63
p.000056: 6.1 National Application Form For Ethical Approval of a Research Project
p.000067: 67
p.000067: 6.2 National Application Form For Ethical Approval of a Research Proposal
p.000069: 69
p.000069: 6.2.1 Form A: Part 1: Technical proposal form 69
p.000069: 6.2.2 Form B: Part Two: Ethical Considerations 77
p.000069: 1- Minimization of Harm 77
p.000069: 2- Privacy and Confidentiality 79
p.000069: 6.3 Form C 80 1- Informed
p.000069: Consent 80 2- Declarations
p.000081: 81
p.000081: 6.4 The Participant's Acceptance Form ( كر¹ a²ا و= ²ا ¾ب ا9a ةر¹aäذإ جذ9a: A:⁄ ب9:i ýa وأ #⁄ş²ا y )
p.000082: 82
p.000082: 6.5 Model of Informed Consent (ً¹ 49a #⁄ş²ا y كر¹ a²ا ¾ب ا9a راك4إ مر9 ) 84
...
p.000058: permission on behalf of an incompetent person should be offered no recompense other than a refund of
p.000058: travel and related expenses.
p.000058:
p.000058: 5.20 Withdrawal from a study:
p.000058:
p.000058: A subject who withdraws from research for reasons related to the study,
p.000058: e.g. side-effects of a study drug, or who is withdrawn on health grounds, should be paid or recompensed as if
p.000058: full participation had taken place. A subject who withdraws for any other reason should be paid in proportion to
p.000058: the amount of participation. An investigator who must remove a subject from the study for wilful
p.000058: non-compliance is entitled to withhold part or all of the payment.
p.000058:
p.000058:
p.000058:
p.000059: 59
p.000059:
p.000059: 5.21 Research involving vulnerable persons
p.000059:
p.000059: Special justification is required for inviting vulnerable individuals to serve as research subjects and, if they are
p.000059: selected, the means of protecting their rights and welfare must be strictly applied.
p.000059: Individuals conventionally considered vulnerable are those with limited capacity or freedom to consent or to decline to
p.000059: consent. They include children, and persons who because of mental or behavioural disorders are incapable of giving
p.000059: informed consent.
p.000059:
p.000059: Ethical justification of their involvement usually requires the investigators to satisfy the ethical review committees
p.000059: that:
p.000059:
p.000059: a. The research could not be carried out equally well with less vulnerable subjects.
p.000059:
p.000059: b. The research is intended to obtain knowledge that will lead to improved diagnosis, prevention or treatment of
p.000059: diseases or other health problems characteristic.
p.000059:
p.000059: c. Research subjects and other members of the vulnerable class from which subjects are recruited will ordinarily
p.000059: be assured reasonable access to any diagnostic, preventive or therapeutic products that will become available as a
p.000059: consequence of the research;
p.000059:
p.000059: d. The risks attached to interventions or procedures will not exceed those associated with routine
p.000059: medical or psychological examination of such persons unless an ethical review committee authorizes a slight
p.000059: increase over this level of risk.
p.000060: 60
p.000060:
p.000060: e. When the prospective subjects are either incompetent or otherwise substantially unable to give informed
p.000060: consent, their agreement will be supplemented by the permission of their legal guardians or other appropriate
p.000060: representatives.
p.000060:
p.000060:
p.000060:
p.000060: 5.22 Research involving vulnerable groups includes:
p.000060:
p.000060:
p.000060:
p.000060: 5.22.1 Research involving children:
p.000060: Before undertaking research involving children, the investigator must ensure that:
p.000060: * The research might not equally well be carried out with adults;
p.000060: * The purpose of the research is to obtain knowledge relevant to the health needs of children;
p.000060: * A parent or legal representative of each child has given permission;
p.000060: * The agreement (assent) of each child has been obtained to the extent of the child’s capabilities;
p.000060: * A child’s refusal to participate or continue in the research will be respected.
p.000060: 5.22.2 Women as research subjects:
p.000060: Investigators, sponsors or ethical review committees should not exclude women of reproductive age
p.000060: from biomedical
p.000060:
p.000061: 61
p.000061:
p.000061: research. The potential for becoming pregnant during a study should not be used as a reason for
p.000061: precluding or limiting participation. However, a thorough discussion of risks to the pregnant woman and to
p.000061: her foetus is a prerequisite for the woman’s ability to make a rational decision to enroll in a clinical study.
...
Social / Fetus/Neonate
Searching for indicator foetus:
(return to top)
p.000060:
p.000060:
p.000060:
p.000060: 5.22.1 Research involving children:
p.000060: Before undertaking research involving children, the investigator must ensure that:
p.000060: * The research might not equally well be carried out with adults;
p.000060: * The purpose of the research is to obtain knowledge relevant to the health needs of children;
p.000060: * A parent or legal representative of each child has given permission;
p.000060: * The agreement (assent) of each child has been obtained to the extent of the child’s capabilities;
p.000060: * A child’s refusal to participate or continue in the research will be respected.
p.000060: 5.22.2 Women as research subjects:
p.000060: Investigators, sponsors or ethical review committees should not exclude women of reproductive age
p.000060: from biomedical
p.000060:
p.000061: 61
p.000061:
p.000061: research. The potential for becoming pregnant during a study should not be used as a reason for
p.000061: precluding or limiting participation. However, a thorough discussion of risks to the pregnant woman and to
p.000061: her foetus is a prerequisite for the woman’s ability to make a rational decision to enroll in a clinical study.
p.000061: In this discussion, if participation in the research might be hazardous to a foetus or a woman if she becomes pregnant,
p.000061: the sponsors/ investigators should guarantee the prospective subject a pregnancy test and access to effective
p.000061: contraceptive methods before the research commences. Where such access is not possible, for legal or religious reasons,
p.000061: investigators should not recruit for such possibly hazardous research women who might become pregnant.
p.000061: 5.22.3 Pregnant women as research participants:
p.000061: Pregnant women should be eligible for participation in biomedical research. Investigators and ethical review committees
p.000061: should ensure that prospective subjects who are pregnant are adequately informed about the risks and benefits to
p.000061: themselves, their pregnancies, the foetus and their subsequent offspring, and their fertility.
p.000061: Research in this population should be performed only if it is relevant to the particular health needs of a pregnant
p.000061: woman or
p.000061:
p.000062: 62
p.000062:
p.000062: her foetus, or to the health needs of pregnant women in general, and, when appropriate, if it is supported by reliable
p.000062: evidence from animal experiments, particularly as to risks of teratogenicity and mutagenicity.
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000063: 63
p.000063:
p.000063: 5.23 References:
p.000063:
p.000063: 1. TDR/PRD/ETHICS/2000."Operational Guidelines for Ethics Committees That Review Biomedical Research"
p.000063:
p.000063: 2. Council for International Organizations of Medical Sciences (CIOMS) International Ethical
p.000063: Guidelines for Biomedical Research Involving Human Subjects. CIOMS, Geneva 2002. ISBN 92 9036 075 5
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000064: 64
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
...
Social / Incarcerated
Searching for indicator liberty:
(return to top)
p.000012: 12
p.000012:
p.000012: consideration, comment, guidance and approval of the nationally-recognised research ethics committee.
p.000012: 5. Biomedical research involving human subjects should be conducted only by scientifically qualified
p.000012: persons and under the supervision of a clinically competent medical person as decided by the relevant committee.
p.000012: 6. The responsibility for the human subject must always rest with a medically qualified person and never rest on
p.000012: the subject of the research, even though the subject has given his or her consent.
p.000012: 7. The right of the research subject to safeguard his / her integrity must always be respected. Every precaution
p.000012: should be taken to respect the privacy of the subject and to minimize the impact of the study on the subject's
p.000012: physical and mental health and integrity and on the personality of the subject.
p.000012: 8. Physicians should abstain from engaging in research projects involving human subjects unless they are
p.000012: satisfied that the hazards involved are believed to be predictable. Physicians should cease any
p.000012: investigation if the hazards are found to outweigh the potential benefits.
p.000012: 9. In publication of the results of his or her research, the physician is obliged to preserve the accuracy of the
p.000012: results.
p.000012: 10. In any research on human beings, each potential subject must be adequately informed of the aims, methods,
p.000012: anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should
p.000012: be informed that he or she is at liberty to abstain from participation in the study and that he or she is free
p.000012:
p.000013: 13
p.000013:
p.000013: to withdraw her consent to participation at any time. The physician should then obtain the subject's
p.000013: freely given informed consent, preferably in writing.
p.000013: 11. In case of legal incompetence, informed consent should be obtained from the legal guardian in
p.000013: accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain
p.000013: informed consent, or when the subject is a minor, permission from the legally responsible person/authority replaces
p.000013: that of the subject in accordance with national legislation.
p.000013: 12. In any study, every patient- including those of a control group, if any- should be assured of the best
p.000013: proven diagnostic and therapeutic method. This does not exclude the use of inert placebo in studies
p.000013: where no proven diagnostic or therapeutic method exists.
p.000013: 13. The refusal of the patient to participate in a study must never interfere with the physician-patient
p.000013: relationship.
p.000013: 14. The physician can combine medical research with professional care, the objective being the acquisition of
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000020: 3.3 References 28
p.000020: 10. Chapter 4: Ethical clearance procedure 29
p.000020: 4.1 How to get the ethical clearance? 31
p.000020: C
p.000020:
p.000020: 4.2 Flowchart for getting ethical clearance 32
p.000020: 4.3 Prepare 33
p.000020: 4.4 Elements of ethical review 34
p.000020: 4.5 Application 34
p.000020: 4.6 Review procedures 35
p.000020: 4.7 Expedited review 35
p.000020: 4.8 Decision making 36 4.9 Communicating
p.000020: the decision 37
p.000020: 4.10Follow up procedures 38
p.000020: 11. Chapter 5: Informed Consent 39
p.000020: 5.1 What is ‘Informed Consent’? 41
p.000020: 5.2 Obtaining informed consent 42
p.000020: 5.3 Process 46
p.000020: 5.4 Language 46
p.000020: 5.5 Comprehension 46
p.000020: 5.6 Documentation of consent 47 5.7 Waiving of the
p.000020: consent requirement 48
p.000020: 5.8 Renewing consent 48
p.000020: 5.9 Cultural considerations 49
p.000020: 5.10 Use of biological materials from subjects in clinical trials 50
p.000020: 5.11 Use of medical records and biological specimens 50
p.000020: 5.12 Secondary use of research records or biological specimens 51
p.000020: 5.13 Obligations of sponsors and investigators 52
p.000020: 5.14 Withholding information and deception 53
p.000020: 5.15 Intimidation and undue influence 54
p.000020: 5.16 Equitable distribution of burdens and benefits in the selection of groups of subjects in research
p.000055: 55
p.000055: 5.17 Exception to the requirement for informed consent in studies of emergencies
p.000056: 56
p.000056: 5.18 Inducement to participate 57
...
p.000085: of the structure and functioning technical procedures followed within the National Research Ethics
p.000085: Committee. It includes the authority under which NHREC was constituted, its Membership,
p.000085: meetings, and quorum. It also elaborates on the independent consultants, operational cost, the record keeping and
p.000085: archiving together with updating of NHREC members.
p.000085:
p.000085:
p.000085: M
p.000085:
p.000085: In this chapter the guidelines and procedures for the State and Institutional Ethics Committees, were also explained.
p.000085:
p.000085: Chapter four is the core of the guidelines for the researcher, as it explains all the steps and procedures for
p.000085: obtaining the ethical clearance in a simplified flowchart and detailed steps of what to prepare, ethical
p.000085: elements review, how to apply, review procedures and decision making.
p.000085:
p.000085: The fifth chapter is about the Informed Consent, its definition, importance, and components. It explains the
p.000085: information that the research subject should know and understand before being involved in the study. The
p.000085: chapter explains the procedure and process by which the informed consent should be obtained from the subjects
p.000085: included in the research. Other principles about the informed consent were included and explained in this
p.000085: chapter. This includes the language, comprehension, documentation of consent, waiver of the consent
p.000085: requirement, renewing consent and other cultural considerations.
p.000085:
p.000085: It also goes through the regulations of the use of biological materials from subjects in clinical trials, the
p.000085: use of medical records and biological specimens. It explains some of the basic principles about the secondary
p.000085: use of research records or biological specimens together with some obligations to be followed by both sponsors
p.000085: and investigators. It covers the issues related to the possible influence on the research subject like
p.000085: withholding information and deception, intimidation and undue influence. It also aims at assuring the equitable
p.000085: distribution of burdens and benefits in the selection of groups of subjects in research.
p.000085:
p.000085:
p.000085:
p.000085: N
p.000085:
p.000085: The regulation by which an exception to the requirement for informed consent in studies of emergencies
p.000085: in which the researcher anticipates that many subjects will be unable to give consent is also included in this
p.000085: chapter. Special interest is given to the inducement of research subjects to participate and the consent taken from
...
p.000034: 14. A description of the arrangements for indemnity, if applicable (in study-related injuries).
p.000034: . A description of the arrangements for insurance coverage for research participants, if applicable.
p.000034: . All significant previous decisions (e.g., those leading to a negative decision or modified
p.000034: protocol) by other ethical committee or regulatory authorities for the proposed study (whether in the
p.000034: same location or elsewhere) and an indication of the modification(s) to the protocol made on that account. The
p.000034: reasons for negative decisions should be provided.
p.000034: . Plans for publication of results – positive or negative- while maintaining the privacy
p.000034: and confidentiality of the study participants.
p.000034: 18. Any other information relevant to the study.
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000035: 35
p.000035:
p.000035:
p.000035: 4.4 Elements of ethical review
p.000035:
p.000035:
p.000035:
p.000035:
p.000035: 1. Ethical issues in the design of the study.
p.000035: 2. Examination of predictable risks/harms.
p.000035: 3. Examination of potential benefits.
p.000035: 4. Procedure for selection of subjects in methodology including inclusion/ exclusion, withdrawal criteria and other
p.000035: issues like advertisement details.
p.000035:
p.000035: 5. Management of research related injuries, adverse events.
p.000035: 6. Compensation provisions.
p.000035: 7. Justification for placebo in control, if any.
p.000035: 8. Availability of products after the study, if applicable.
p.000035: 9. Patient information sheet and informed consent form in local language (See chapter 5).
p.000035: 10. Protection of privacy and confidentiality.
p.000035: l1. Involvement of the community, wherever necessary.
p.000035: 12. Plans for data analysis and reporting.
p.000035: 13. Adherence to all regulatory requirements and applicable guidelines.
p.000035: 14. Competence of investigators, research and supporting staff.
p.000035: 15. Facilities and infrastructure of study sites.
p.000035: 16. Criteria for withdrawal of patients, suspending or terminating the study.
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035: 4.5 Application
p.000035:
p.000035:
p.000035: 1. Apply to the NHREC secretariat with all the required documents.
p.000035: 2. Reviewable expenses fees should be paid.
p.000035: 3. Receivable letter accrediting application will be issued.
p.000035: 4. The researcher will be informed about the date of the committee meeting so as to be available for any clarification.
p.000035:
p.000035:
p.000035:
p.000035:
p.000036: 36
p.000036:
p.000036:
p.000036: 4.6 Review procedures
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036: 1. The meeting of the NHREC should be held on scheduled intervals as prescribed and additional meetings may be held as
p.000036: and when the proposals are received for review.
p.000036: 2. The Directorate of Research will submit the research proposals for technical review one month before
p.000036: submission to the ethics committee.
p.000036: 3. Scientific approval will be made according to the technical guidelines.
p.000036: 4. Two members from the national ethics committee will be assigned by the raporteur to review proposals in details.
...
p.000042: consent as:
p.000042:
p.000042: Approval to participate in a study or trial given by a competent individual who:
p.000042:
p.000042: • Has received the necessary information (verbally and in writing).
p.000042: • Has adequately understood the information.
p.000042: • After considering the information, has arrived at a decision without having been subjected to compulsion,
p.000042: undue influence, incentive, or pressure.
p.000042: • In the case of those who are not capable, has the legal authorization to approve on behalf of the incompetent.
p.000042:
p.000042: Informed consent is based on the principle that competent individuals are entitled to choose freely whether to
p.000042: participate in research. It protects the individual's freedom of choice and respects the individual's autonomy.
p.000042: As an additional safeguard, it must always be complemented by the approval of an independent review of an ethical
p.000042: research committee.
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000043: 43
p.000043:
p.000043:
p.000043: 5.2 Obtaining informed consent:
p.000043:
p.000043:
p.000043: Before requesting an individual's consent to participate in research, the investigator must
p.000043: provide the following information, in language or another form of communication that the individual can
p.000043: understand to the research subject:
p.000043: 1. The individual is invited to participate voluntarily in the research, explaining the reasons for
p.000043: considering him/her suitable for the research.
p.000043: 2. The individual is free to refuse to participate and will be free to withdraw from the research at any time without
p.000043: penalty or loss of benefits to which he or she would otherwise be entitled.
p.000043: 3. The purpose of the research, the procedures to be carried out by the investigator and the subject, and an
p.000043: explanation of how the research differs from routine medical care.
p.000043: 4. An explanation of the features of the research design e.g., in controlled trials the method of randomization,
p.000043: double-blinding, and that the subject will not be told of the assigned treatment until the study has
p.000043: been completed and the blind has been broken.
p.000043: 5. The expected duration of the individual's participation (including number and duration of visits
p.000043: to the research centre
p.000043:
p.000043:
p.000044: 44
p.000044:
p.000044: and the total time involved) and the possibility of early termination of the trial or of the
p.000044: individual’s participation in it.
p.000044: 6. Whether money or other forms of material goods will be provided in return for the individual's
p.000044: participation and if so, the kind and amount.
p.000044: 7. The subject will be informed of the findings of the research in general, and individual subjects will be informed of
p.000044: any finding that relates to their particular health status.
...
p.000046: compensated for disability or death resulting from such injury (or, when indicated, that there are no plans to provide
p.000046: such compensation).
p.000046:
p.000046:
p.000046:
p.000046:
p.000047: 47
p.000047:
p.000047: 25. Whether or not, in the country in which the prospective subject is invited to participate in
p.000047: research, the right to compensation is legally guaranteed.
p.000047: 26. An ethical review committee has approved or cleared the research protocol.
p.000047:
p.000047: 5.3 Process:
p.000047:
p.000047: Obtaining informed consent is a process that is begun when initial contact is made with a prospective
p.000047: subject and continues throughout the course of the study. By informing the prospective subjects, by repetition and
p.000047: explanation, by answering their questions as they arise, and by ensuring that each individual understands each
p.000047: procedure, investigators have to elicit the informed consent from their subjects. By doing so the investigator
p.000047: manifests respect for their dignity and autonomy.
p.000047:
p.000047: Each individual must be given as much time as is needed to reach a decision, including time for
p.000047: consultation with family members or others. Adequate time and resources should be set aside for
p.000047: informed-consent procedures.
p.000047:
p.000047: 5.4 Language:
p.000047:
p.000047: Informing the individual subject must not be simply a ritual recitation of the contents of a written document. Rather,
p.000047: the investigator must convey the information, whether orally or in writing, in language that suits
p.000047: the individual's level of understanding.
p.000047:
p.000047:
p.000048: 48
p.000048:
p.000048: The investigator must bear in mind that the prospective subject’s ability to understand the information necessary to
p.000048: give informed consent depends on that individual's maturity, intelligence, education and belief system. It
p.000048: depends also on the investigator's ability and willingness to communicate with patience and sensitivity.
p.000048:
p.000048: 5.5 Comprehension:
p.000048:
p.000048: The investigator must then ensure that the prospective subject has adequately understood the information.
p.000048: The investigator should give each one full opportunity to ask questions and should answer them honestly,
p.000048: promptly and completely. In some instances the investigator may administer an oral or a written test or otherwise
p.000048: determine whether the information has been adequately understood.
p.000048:
p.000048:
p.000048:
p.000048:
p.000048: 5.6 Documentation of consent:
p.000048:
p.000048:
p.000048:
p.000048: Consent may be indicated in a number of ways. The subject may imply consent by voluntary actions, express
p.000048: consent orally, or sign a consent form. Generally, the subject should sign a consent form, or, in the case of
...
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000065: 65
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000066: 66
p.000066:
p.000066: The Republic of Sudan Federal Ministry of Health Health Research Council
p.000066: National Health Research Ethics Committee
p.000066:
p.000066: NATIONAL APPLICATION FORM FOR ETHICAL APPROVAL OF A RESEARCH PROJECT
p.000066:
p.000066: The application technical and ethical guidelines format are to be read before completing this form to ensure that
p.000066: the questions are answered appropriately.
p.000066: You may find it helpful to read both national technical and ethical guidelines and then fill the format. You
p.000066: can add extra pages.
p.000066: Before requesting an individual's consent to participate in research, the investigator must read chapter three in the
p.000066: Guidelines for Ethical Conduct of Research Involving Human Subjects.
p.000066: The Arabic version of the informed consent is the form to be used to take the consent from the Sudanese
p.000066: research participants, so you should fill it in details and in a language or another form of communication that the
p.000066: individual can understand the research subject.
p.000066:
p.000066: Ministry of Health Health Research Council
p.002007: 2007
p.002007:
p.002007: Do not include this page with your application form
p.002007:
p.000067: 67
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
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p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000068: 68
p.000068:
p.000068: Form A
p.000068: Federal Ministry of Health Health Research Council
p.000068:
p.000068: çiع9²ا ýaع9²ا ةا ç~ş
p.000068: Health Research Ethics Committee
p.000068: NATIONAL APPLICATION FORM FOR ETHICAL APPROVAL OF A RESEARCH PROPOSAL
p.000068:
p.000068: For office use only
p.000068:
p.000068: Proposal No.: Date Received:
p.000068:
p.000068: Please read the technical and ethical guidelines thoroughly before filling the form
p.000068: Part 1: Technical proposal form
p.000068: 1. Principal investigator (PI) / Applicant
p.000068: • Name:
p.000068: • Institute:
p.000068:
p.000068: • Current position
p.000068: • Address / e-mail:
p.000068:
p.000068:
p.000068: • Office Tel.
p.000068: • Signature
p.000068: Mobile Tel.
p.000068:
p.000068: 2. Co-investigator (1)
p.000068: • Name:
p.000068: • Institute:
p.000068:
p.000068: • Current position:
p.000069: 69
p.000069:
p.000069: • Address / e-mail:
p.000069:
p.000069:
p.000069: • Office Tel.
...
Searching for indicator linguistic:
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p.000050: designated authority. Such customs must be respected.
p.000050:
p.000050: In no case, however, may the permission of a community leader or other authority substitute for individual informed
p.000050: consent. In some populations the use of a number of local languages may complicate the communication of
p.000050: information to potential subjects and the ability of an investigator to ensure that they truly understand
p.000050: it. Many people in all cultures are unfamiliar with, or do not readily understand, scientific concepts
p.000050: such as those of placebo or randomization.
p.000050:
p.000050: Sponsors and investigators should develop culturally appropriate ways to communicate information that is necessary
p.000050: for adherence to the standard required in the informed consent process. In addition, they should describe and
p.000050: justify in the research protocol the procedure they plan to use in communicating information to subjects.
p.000050:
p.000050: For collaborative research in developing countries the research project should include the provision of
p.000050: resources to ensure that informed consent
p.000050:
p.000050:
p.000050:
p.000051: 51
p.000051:
p.000051: can indeed be obtained legitimately within different linguistic and cultural settings.
p.000051:
p.000051:
p.000051:
p.000051: 5.10 Use of biological materials from subjects in clinical trials:
p.000051:
p.000051: Consent forms for the research protocol should include a separate section for clinical-trial subjects requested to
p.000051: provide their consent for the use of their biological specimens for research. Separate consent may be appropriate
p.000051: in some cases (e.g., if investigators are requesting permission to conduct basic research which is not a
p.000051: necessary part of the clinical trial), but not in others (e.g., the clinical trial requires the use of
p.000051: subjects’ biological materials).
p.000051:
p.000051:
p.000051:
p.000051: 5.11 Use of medical records and biological specimens:
p.000051:
p.000051:
p.000051:
p.000051: Medical records and biological specimens taken in the course of clinical care may be used for research without the
p.000051: consent of the patients/subjects. This can only be done if an ethical review committee has determined that:
p.000051: * The research poses minimal risk, that the rights or interests of the patients will not be violated.
p.000051: * Patient privacy and confidentiality or anonymity is assured.
p.000051:
p.000051:
p.000051:
p.000051:
p.000052: 52
p.000052:
p.000052: * The research is designed to answer an important question and would be impracticable if the requirement for informed
p.000052: consent were to be imposed.
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.000048: In some cases, particularly when the information is complicated, it is advisable to give subjects
p.000048: information sheets to
p.000048:
p.000048:
p.000049: 49
p.000049:
p.000049: retain; these may resemble consent forms in all respects except that subjects are not required to sign
p.000049: them. The ethical review committee should review their wording. When consent has been obtained orally,
p.000049: investigators are responsible for providing documentation or proof of consent.
p.000049:
p.000049: 5.7 Waiving of the consent requirement:
p.000049:
p.000049: Investigators should never initiate research involving human subjects without obtaining each subject's
p.000049: informed consent, unless they have received explicit approval to do so from an ethical review
p.000049: committee. However, when the research design involves no more than a minimal risk and not greater than that expected
p.000049: with routine medical examination and the requirement of individual informed consent would make the conduct of the
p.000049: research impracticable (for example, where the research involves only data from subjects' records), the ethical review
p.000049: committee may waive some or all of the elements of informed consent. Such waiver may also be approved when
p.000049: the existence of a single consent form would be an unjustified threat to the subject’s confidentiality.
p.000049:
p.000049: 5.8 Renewing consent:
p.000049:
p.000049: When material changes occur in the conditions or the procedures of a study, and periodically in
p.000049: long-term studies, the investigator should once again seek informed consent from the subjects. For
p.000049: example, new information may have become known, either from the study or from other sources, about the risks or
p.000049: benefits of products being tested or about alternatives to them. Subjects should be given such information
p.000049: promptly.
p.000050: 50
p.000050:
p.000050: In many clinical trials, results are not disclosed to subjects and investigators until the study is
p.000050: concluded. This is ethically acceptable if an ethical review committee has approved their non-disclosure.
p.000050:
p.000050: 5.9 Cultural considerations:
p.000050:
p.000050: In some cultures an investigator may enter a community to conduct research or approach prospective subjects
p.000050: for their individual consent only after obtaining permission from a community leader, a council of elders, or another
p.000050: designated authority. Such customs must be respected.
p.000050:
p.000050: In no case, however, may the permission of a community leader or other authority substitute for individual informed
...
Social / Religion
Searching for indicator belief:
(return to top)
p.000047: subject and continues throughout the course of the study. By informing the prospective subjects, by repetition and
p.000047: explanation, by answering their questions as they arise, and by ensuring that each individual understands each
p.000047: procedure, investigators have to elicit the informed consent from their subjects. By doing so the investigator
p.000047: manifests respect for their dignity and autonomy.
p.000047:
p.000047: Each individual must be given as much time as is needed to reach a decision, including time for
p.000047: consultation with family members or others. Adequate time and resources should be set aside for
p.000047: informed-consent procedures.
p.000047:
p.000047: 5.4 Language:
p.000047:
p.000047: Informing the individual subject must not be simply a ritual recitation of the contents of a written document. Rather,
p.000047: the investigator must convey the information, whether orally or in writing, in language that suits
p.000047: the individual's level of understanding.
p.000047:
p.000047:
p.000048: 48
p.000048:
p.000048: The investigator must bear in mind that the prospective subject’s ability to understand the information necessary to
p.000048: give informed consent depends on that individual's maturity, intelligence, education and belief system. It
p.000048: depends also on the investigator's ability and willingness to communicate with patience and sensitivity.
p.000048:
p.000048: 5.5 Comprehension:
p.000048:
p.000048: The investigator must then ensure that the prospective subject has adequately understood the information.
p.000048: The investigator should give each one full opportunity to ask questions and should answer them honestly,
p.000048: promptly and completely. In some instances the investigator may administer an oral or a written test or otherwise
p.000048: determine whether the information has been adequately understood.
p.000048:
p.000048:
p.000048:
p.000048:
p.000048: 5.6 Documentation of consent:
p.000048:
p.000048:
p.000048:
p.000048: Consent may be indicated in a number of ways. The subject may imply consent by voluntary actions, express
p.000048: consent orally, or sign a consent form. Generally, the subject should sign a consent form, or, in the case of
p.000048: incompetence, a legal guardian or other duly authorized representative should do so.
p.000048: In some cases, particularly when the information is complicated, it is advisable to give subjects
p.000048: information sheets to
p.000048:
p.000048:
p.000049: 49
p.000049:
p.000049: retain; these may resemble consent forms in all respects except that subjects are not required to sign
...
p.000079: recorded. Attach a copy of the information sheet and consent form.
p.000079:
p.000079: 38. By whom, and how, will the project be explained to potential participants?
p.000079:
p.000079: 39. When and where will the explanation be given?
p.000079:
p.000079: 40. Will a competent interpreter be available, if required?
p.000079:
p.000079: 41. How much time will be allowed for the potential participant to decide about taking part?
p.000079: 42. In what form (written or oral) will consent be obtained? If oral consent only, state reasons
p.000079:
p.000079: 43. Are all participants able to consent themselves?
p.000079:
p.000079: 44. If no, explain why, and who will consent for them?
p.000079:
p.000079: 45. Is there any special relationship between the participants and the researchers? E.g. doctor/patient,
p.000079: student/teacher
p.000079:
p.000079: 46. Will there be any financial cost to the participant, e.g. travel costs? If so, will such cost be reimbursed?
p.000079:
p.000079: 47. Will any payments be made to participants or will they gain materially in other ways from participating in this
p.000079: project?
p.000079:
p.000079: 48. If yes, please supply details
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000080: 80
p.000080:
p.000080: 2- Declarations
p.000080:
p.000080: 1. Declaration by Principal Investigator
p.000080:
p.000080: The information supplied in this application is, to the best of my knowledge and belief, accurate. I have
p.000080: considered the ethical issues involved in this research and believe that I have adequately
p.000080: addressed them in this application. I understand that if the protocol for this research changes in any way I
p.000080: must inform the ethics committee.
p.000080:
p.000080: NAME OF PRINCIPAL INVESTIGATOR:
p.000080:
p.000080: SIGNATURE OF PRINCIPAL INVESTIGATOR:
p.000080:
p.000080: DATE
p.000080:
p.000080: 2. Declaration by Head of Department in which the Principal Investigator is located or appropriate
p.000080: Dean or other Senior Manager
p.000080:
p.000080: I have read the application and it is appropriate for this research to be conducted in this department I give my
p.000080: consent for the application to be forwarded to the concerned ethics committee.
p.000080:
p.000080: NAME AND DESIGNATION:
p.000080:
p.000080: SIGNATURE: INSTITUTION:
p.000080:
p.000080: DATE:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000081: 81
p.000081:
p.000081: çiع9²ا ýaع9²ا ةا ç~ş
p.000081: ªªªاqa ةرأو;nإ جذqو:
p.000081: Aذج بqذş ya وأ رة ¹ا yª كرأ÷و¹ا q=÷¹ا
p.000081:
p.000081: م9¾ä فب²او ىض² çثبä زب²ا ¾~~9a²ا وأ ¾ضş²ا 9آذأ ç# ًيلىآ “a~ىş A)9⁄ä) قعىث²ا ى:أ
p.000081: .( Siكهب²ىş Aeا9=أو قتث²ا نا9:⁄ ح9إş م9¾ä ç# ) ý⁄ ¾~ارد وأ قتثş م9¾: ,(قتث²ىş A² ح9إä ç# )ýiآرىإa²ا ýل 9=” دح⁄ “⁄لو (
p.000081: “²هن وأ ) ÷:أ قتث²ا ا.ه ف) كرىإب² كرىiب=إ çä ح¾²
p.000081: .(ýiآرىإa²ا ýل A⁄ل ýلو 9ه 9iب=أ اذىa² Siكهب²ىş
...
Searching for indicator religious:
(return to top)
p.000020:
p.000020: • Protection of the researchers
p.000020:
p.000020: • Definition of the research priorities
p.000020: In 1980, the research ethics committee was established in the Faculty of Medicine, the University of Khartoum where it
p.000020: reviewed 400 researches. In 1998, the Undersecretary of the Federal Ministry of Health issued Decree No.
p.000020: 60/1998 for forming a committee to review health research ethics. As a result, the committee for review of health
p.000020: research ethics was set up by the Decree No. 31 / 1999
p.000020: In 2002, the Federal Minister of Health issued a Ministerial Decree no 11 / 2002 for the constitution of
p.000020: National Technical (NTC) and National Ethical Committees (NEC). According to this decree a number of tasks were
p.000020: assigned for the NHREC:
p.000020: 1- Formulating guidelines for research ethics.
p.000020:
p.000020:
p.000020:
p.000021: 21
p.000021:
p.000021: 2- Undertaking the ethics approval of the research that takes place at the national level in which it
p.000021: participates or that presented to external bodies.
p.000021: 3- Endorsement and delegation of the powers to the state and institutional research ethics committees.
p.000021: 4- The research ethics committee should include in its membership lawyers, Islamic and Christian religious leaders and
p.000021: the leaders of civil society and should not be confined only to the doctors and scholars in medical and
p.000021: scientific field.
p.000021: * The FMOH would approach WHO EMRO to allocate some funds in the WHO through JPRM.
p.000021: 3.1.2 Regulation of the National Health Research Ethics Committee (NHREC)
p.000021: 3.1.2.1 Authority under which the NHREC will be constituted:
p.000021:
p.000021: The FMOH will approve the authority of the constitution and membership of the NHREC. It will be approved and notified
p.000021: by the Federal Ministry of Health.
p.000021: 3.1.2.2 Responsibilities of (NHREC):
p.000021:
p.000021: The committee shall have the following responsibilities:
p.000021:
p.000021: • Formulating guidelines for the approval of the research ethically.
p.000021:
p.000021: • The approval of health research that take place at the national level, or in more than one state from an ethical
p.000021: point of view.
p.000021: • The ethical approval of the research in which there are external participants or that is presented to
p.000021: external bodies.
p.000021:
p.000022: 22
p.000022:
p.000022: • The ethical approval of the experimental research on human.
p.000022:
p.000022: • Reviewing and approving all types of research proposals involving human participants directing or indirectly,
p.000022: with a view to safe-guard the dignity, rights, safety and well being of all actual and potential research participants
p.000022: and to take care of all the cardinal principles of research ethics i.e. autonomy, beneficence, non maleficience
...
p.000022: • Look into the aspects of informed consent process, risk-benefit ratio, distribution of burden and benefit and
p.000022: provisions for appropriate compensation, wherever required.
p.000022: • Review the proposals before start of the study, as well as monitor the research throughout the study, until and
p.000022: after completion of the study through appropriate well documented procedures for example annual reports, final reports
p.000022: and site visits etc. .
p.000022: • The committee will also examine compliance with all regulatory requirements applicable guideline and laws.
p.000022: 3.1.2.3 Membership of the (NHREC):
p.000022:
p.000022: The NHREC should be multidisciplinary and multisectorial. Independence and competence are the two hall marks for
p.000022: membership.
p.000022: The membership of ( NHRERC) will include 20-25 members:
p.000022:
p.000022: 1. The Chairman of the committee.
p.000022: 2. The legal advisor of the FMOH.
p.000022: 3. Representative of the Government of Southern Sudan.
p.000022: 4. The secretary general of the Health Research Council (Rapporteur).
p.000022:
p.000023: 23
p.000023:
p.000023: 5. Representatives of universities and research institutions.
p.000023: 6. Researchers.
p.000023: 7. Representative of the Medical Council.
p.000023: 8. The representative of the Veterinary Research Council.
p.000023: 9. The representative of the National Health Laboratory
p.000023: I0.The representative of the Sudanese Medical Specializations Board.
p.000023: 11. Representatives of the national civil society organizations
p.000023: 12. The Representative of Press and Publications Council.
p.000023: 13. Representatives of the Islamic and Christian religious men.
p.000023: 14. Community leaders.
p.000023: • Chairperson:
p.000023: The chairperson of the committee should preferably be from outside the Ministry of Health to maintain the independence
p.000023: of the committee.
p.000023: • Deputy chairman if needed:
p.000023: • Secretariat:
p.000023: The Directorate of Research in the Federal Ministry of Health will be the secretariat of the committee. It will
p.000023: take the responsibility of arranging meetings of the committee and implementing its decisions
p.000023: and recommendations. It will coordinate the meetings and keep liaison with states, institutions and
p.000023: international ethics committees. All documents regarding the reviewing process of the proposals received by or
p.000023: sent to the committee are the responsibility of the secretariat.
p.000023: 3.1.2.4 Term of the membership:
p.000023:
p.000023: The members, the chair person and the deputy will be selected by the Minister of Health. The term of the member
p.000023: can end by resignation, death, termination or completing three years.
p.000023:
p.000024: 24
p.000024:
p.000024: Organogram of the ethics committee
p.000024:
p.000024: Federal Minister of Health
p.000024:
p.000024:
p.000024: Under secretary of FMOH
p.000024:
p.000024:
p.000024: Director DOR
p.000024:
p.000024:
p.000024: Chairman of NHREC
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024: State & IECs
p.000024: Members of NHREC
p.000024:
p.000024: 3.1.3 Meetings:
p.000024:
p.000024: 1-The committee will hold a regular meeting every two months, and it may hold an extra meeting if need arises.
...
p.000060: * A child’s refusal to participate or continue in the research will be respected.
p.000060: 5.22.2 Women as research subjects:
p.000060: Investigators, sponsors or ethical review committees should not exclude women of reproductive age
p.000060: from biomedical
p.000060:
p.000061: 61
p.000061:
p.000061: research. The potential for becoming pregnant during a study should not be used as a reason for
p.000061: precluding or limiting participation. However, a thorough discussion of risks to the pregnant woman and to
p.000061: her foetus is a prerequisite for the woman’s ability to make a rational decision to enroll in a clinical study.
p.000061: In this discussion, if participation in the research might be hazardous to a foetus or a woman if she becomes pregnant,
p.000061: the sponsors/ investigators should guarantee the prospective subject a pregnancy test and access to effective
p.000061: contraceptive methods before the research commences. Where such access is not possible, for legal or religious reasons,
p.000061: investigators should not recruit for such possibly hazardous research women who might become pregnant.
p.000061: 5.22.3 Pregnant women as research participants:
p.000061: Pregnant women should be eligible for participation in biomedical research. Investigators and ethical review committees
p.000061: should ensure that prospective subjects who are pregnant are adequately informed about the risks and benefits to
p.000061: themselves, their pregnancies, the foetus and their subsequent offspring, and their fertility.
p.000061: Research in this population should be performed only if it is relevant to the particular health needs of a pregnant
p.000061: woman or
p.000061:
p.000062: 62
p.000062:
p.000062: her foetus, or to the health needs of pregnant women in general, and, when appropriate, if it is supported by reliable
p.000062: evidence from animal experiments, particularly as to risks of teratogenicity and mutagenicity.
p.000062:
p.000062:
p.000062:
p.000062:
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p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
...
Social / Student
Searching for indicator student:
(return to top)
p.000078: offered their audio tapes or videos.
p.000078:
p.000078:
p.000078:
p.000079: 79
p.000079:
p.000079: Form C:
p.000079: 1- Informed Consent
p.000079:
p.000079: Consent should be obtained in writing, unless there are good reasons to the contrary. If consent is not to be
p.000079: obtained in writing the justification should be given and the circumstances under which consent is obtained should be
p.000079: recorded. Attach a copy of the information sheet and consent form.
p.000079:
p.000079: 38. By whom, and how, will the project be explained to potential participants?
p.000079:
p.000079: 39. When and where will the explanation be given?
p.000079:
p.000079: 40. Will a competent interpreter be available, if required?
p.000079:
p.000079: 41. How much time will be allowed for the potential participant to decide about taking part?
p.000079: 42. In what form (written or oral) will consent be obtained? If oral consent only, state reasons
p.000079:
p.000079: 43. Are all participants able to consent themselves?
p.000079:
p.000079: 44. If no, explain why, and who will consent for them?
p.000079:
p.000079: 45. Is there any special relationship between the participants and the researchers? E.g. doctor/patient,
p.000079: student/teacher
p.000079:
p.000079: 46. Will there be any financial cost to the participant, e.g. travel costs? If so, will such cost be reimbursed?
p.000079:
p.000079: 47. Will any payments be made to participants or will they gain materially in other ways from participating in this
p.000079: project?
p.000079:
p.000079: 48. If yes, please supply details
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000080: 80
p.000080:
p.000080: 2- Declarations
p.000080:
p.000080: 1. Declaration by Principal Investigator
p.000080:
p.000080: The information supplied in this application is, to the best of my knowledge and belief, accurate. I have
p.000080: considered the ethical issues involved in this research and believe that I have adequately
p.000080: addressed them in this application. I understand that if the protocol for this research changes in any way I
p.000080: must inform the ethics committee.
p.000080:
p.000080: NAME OF PRINCIPAL INVESTIGATOR:
p.000080:
p.000080: SIGNATURE OF PRINCIPAL INVESTIGATOR:
p.000080:
p.000080: DATE
p.000080:
p.000080: 2. Declaration by Head of Department in which the Principal Investigator is located or appropriate
p.000080: Dean or other Senior Manager
p.000080:
p.000080: I have read the application and it is appropriate for this research to be conducted in this department I give my
p.000080: consent for the application to be forwarded to the concerned ethics committee.
p.000080:
p.000080: NAME AND DESIGNATION:
p.000080:
p.000080: SIGNATURE: INSTITUTION:
p.000080:
p.000080: DATE:
p.000080:
p.000080:
...
Social / Threat of Stigma
Searching for indicator threat:
(return to top)
p.000048: information sheets to
p.000048:
p.000048:
p.000049: 49
p.000049:
p.000049: retain; these may resemble consent forms in all respects except that subjects are not required to sign
p.000049: them. The ethical review committee should review their wording. When consent has been obtained orally,
p.000049: investigators are responsible for providing documentation or proof of consent.
p.000049:
p.000049: 5.7 Waiving of the consent requirement:
p.000049:
p.000049: Investigators should never initiate research involving human subjects without obtaining each subject's
p.000049: informed consent, unless they have received explicit approval to do so from an ethical review
p.000049: committee. However, when the research design involves no more than a minimal risk and not greater than that expected
p.000049: with routine medical examination and the requirement of individual informed consent would make the conduct of the
p.000049: research impracticable (for example, where the research involves only data from subjects' records), the ethical review
p.000049: committee may waive some or all of the elements of informed consent. Such waiver may also be approved when
p.000049: the existence of a single consent form would be an unjustified threat to the subject’s confidentiality.
p.000049:
p.000049: 5.8 Renewing consent:
p.000049:
p.000049: When material changes occur in the conditions or the procedures of a study, and periodically in
p.000049: long-term studies, the investigator should once again seek informed consent from the subjects. For
p.000049: example, new information may have become known, either from the study or from other sources, about the risks or
p.000049: benefits of products being tested or about alternatives to them. Subjects should be given such information
p.000049: promptly.
p.000050: 50
p.000050:
p.000050: In many clinical trials, results are not disclosed to subjects and investigators until the study is
p.000050: concluded. This is ethically acceptable if an ethical review committee has approved their non-disclosure.
p.000050:
p.000050: 5.9 Cultural considerations:
p.000050:
p.000050: In some cultures an investigator may enter a community to conduct research or approach prospective subjects
p.000050: for their individual consent only after obtaining permission from a community leader, a council of elders, or another
p.000050: designated authority. Such customs must be respected.
p.000050:
p.000050: In no case, however, may the permission of a community leader or other authority substitute for individual informed
p.000050: consent. In some populations the use of a number of local languages may complicate the communication of
...
Social / Trade Union Membership
Searching for indicator union:
(return to top)
p.000084: 5. Prof. Osman Khalafalla , University of Gezira/Faculty of Medicine
p.000084: 6. Prof. Abdalhamid Ibrahim, General Directorate of Pharmacy
p.000084: 7. Prof. Faisal Awad Ahmed, Veterinary Research Center
p.000084: 8. Prof. Ahmed Mohammed Elhassan, Institute of Endemic Diseases
p.000084: 9. Prof. Hashim Elgaz, Council of Journalism and Publishing
p.000084: 10. Prof. Abdelrahman Eltom, Sudan Medical Council
p.000084: 11. Mr. Hamad Abdelatti, SCOVA
p.000084: 12. Prof. Zein Alabdin Karar, University of Khartoum /Faculty of Medicine
p.000084: 13. Prof. Mamoun Humida/ University of Medical Sciences and Technology
p.000084: 14. Prof. Assim Farouq, Omderman Islamic University/Faculty of Pharmacy
p.000084: 15. Prof. Abdelrahman Kabashi, Ahfad University for Women/ School of Medicine
p.000084: 16. Prof. Ahmed Hassan Fahal, University of Khartoum/Faculty of Medicine
p.000084: 17. Prof. Awad Mohamed Ahmed/ University of Bahr Elghazal/ Faculty of Medicine
p.000084: 18. Associate Prof. Mustafa Khidir El Niemiri/ International Africa University/ Faculty of Medicine
p.000084: 19. Dr. Maawia Mohammed Mukhtar, Institute of Endemic Diseases
p.000084: 20. Dr. Amnah Elsadeeg Badry, Ahfad University for Women
p.000084: 21. Dr. Abdelgalil Elnazeer Elkaroory, Eliman Research Center
p.000084: 22. Dr. Zidan Abdou Zidan, Sudan Medical Specialization Board
p.000084: 23. Dr. Mohammed Abdelsalam, University of Juba/Faculty of Medicine
p.000084: 24. Dr. Samia Yousif Habbani, community Physician, Ministry of Social Affairs
p.000084:
p.000085: 85
p.000085:
p.000085: 25. Mrs. Afaf Bukhary, Council of Journalism and Publishing
p.000085: 26. The Representative of Pharmacy and Poisons Union Board
p.000085: 27. Dr. Elnajeeb Suliman, National Health Laboratory/FMOH
p.000085: 28. Mrs. Iman Bashir, Legal consultant/FMOH
p.000085: 29. Mr. Hamza Tolah, Health Professions Union/FMOH
p.000085: 30. Dr. Mustafa Salih Mustafa, Directorate General of Health Planning and Development/FMOH
p.000085: 31. Dr. Iman Abdallah Mustafa, Directorate of Health Research/ FMOH
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
...
Social / Victim of Abuse
Searching for indicator trauma:
(return to top)
p.000055:
p.000055:
p.000055:
p.000056: 56
p.000056:
p.000056: 5.16 Equitable distribution of burdens and benefits in the selection of groups of subjects in research:
p.000056:
p.000056: 1- Groups or communities to be subjects of research should be selected so that the burdens and benefits of the
p.000056: research will be equitably distributed. The exclusion of groups or communities that might benefit from study
p.000056: participation must be justified.
p.000056:
p.000056: 2- Members of vulnerable groups also have the same entitlement to access to the benefits of investigational
p.000056: interventions that show promise of therapeutic benefit as non vulnerable groups particularly when no superior
p.000056: or equivalent approaches to therapy are available.
p.000056:
p.000056: 3- Overuse of certain groups, such as the poor or the administratively available, is unjustified.
p.000056:
p.000056: 5.17 Exception to the requirement for informed consent in studies of emergencies in which the researcher
p.000056: anticipates that many subjects will be unable to consent:
p.000056:
p.000056: Research protocols are sometimes designed to address conditions occurring suddenly and rendering the
p.000056: patients/subjects incapable of giving informed consent. Examples are head trauma, cardiopulmonary arrest and
p.000056: stroke. The investigation cannot be done with patients who can give informed consent in time and there
p.000056: may not be time to locate a person having the authority to give permission.
p.000056:
p.000056:
p.000056:
p.000056:
p.000057: 57
p.000057:
p.000057: In such circumstances it is often necessary to precede with the research interventions very soon after the onset of the
p.000057: condition in order to evaluate an investigational treatment or develop the desired knowledge. Consent should be
p.000057: taken from the guardian if available or from an authorized body in the health facility. As this class of emergency
p.000057: exception can be anticipated, the researcher must secure the review and approval of an ethical review
p.000057: committee before initiating the study. If possible, an attempt should be made to identify a population that is likely
p.000057: to develop the condition to be studied. This can be done readily, for example, if the condition is one that
p.000057: recurs periodically in individuals; examples include grand mal seizures and alcohol binges. In such cases, prospective
p.000057: subjects should be contacted while fully capable of informed consent, and invited to consent to their involvement as
p.000057: research subjects during future periods of incapacitation. If they are patients of an independent physician who is
...
Searching for indicator abuse:
(return to top)
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
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p.000009:
p.000009:
p.000009:
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p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: 2.1 The major principles:
p.000010:
p.000010: All research involving human subjects should be conducted in accordance with three basic ethical principles, namely
p.000010: respect for persons, beneficence and non-malificence and justice. It is generally agreed that these principles, which
p.000010: in the abstract have equal moral force, guide the conscientious preparation of proposals for scientific studies (1,4).
p.000010: • Respect for persons incorporates at least two fundamental ethical considerations, namely:
p.000010: a. Respect for autonomy which requires that those who are capable of deliberation about their personal choices should
p.000010: be treated with respect for their capacity for self- determination.
p.000010: b. Protection of persons with impaired or diminished autonomy, which requires that those who are dependent or
p.000010: vulnerable be afforded full security against harm or abuse.
p.000010: • Beneficence and non-malificence refers to the ethical obligation to maximize benefits and to minimize harms,
p.000010: respectively. This gives rise to norms requiring that the risks of research to be reasonable in the light of the
p.000010: expected benefits, that the research design to be sound, and that the investigators to be competent to conduct the
p.000010: research and to safeguard the welfare of the research subjects.
p.000010: • Justice refers to the ethical obligation to treat each person in accordance with what is morally
p.000010: right and proper; to give each person what is due to him or her. In the ethics of research involving human
p.000010: subjects the principle refers primarily to distributive justice,
p.000010:
p.000011: 11
p.000011:
p.000011: which requires equitable distribution of both the burdens and the benefits of participation in research.
p.000011:
p.000011: Table (1): Ethical Principles of Research
p.000011:
p.000011:
p.000011:
p.000011: Major Principles
p.000011: 1. Autonomy
p.000011: 2. Beneficence and non-maleficence
p.000011: 3. Justice
p.000011: Others
p.000011: 1. Accepted Scientifically
p.000011: 2. Accepted qualified researchers
p.000011: 3. Ethics committee review
p.000011: 4. Accuracy of published results……etc
p.000011:
p.000011: 2.2 Other principles: (5-11)
p.000011: 1. Biomedical research involving human subjects must conform to generally accepted scientific principles and should
...
Social / Women
Searching for indicator women:
(return to top)
p.000020: 5.10 Use of biological materials from subjects in clinical trials 50
p.000020: 5.11 Use of medical records and biological specimens 50
p.000020: 5.12 Secondary use of research records or biological specimens 51
p.000020: 5.13 Obligations of sponsors and investigators 52
p.000020: 5.14 Withholding information and deception 53
p.000020: 5.15 Intimidation and undue influence 54
p.000020: 5.16 Equitable distribution of burdens and benefits in the selection of groups of subjects in research
p.000055: 55
p.000055: 5.17 Exception to the requirement for informed consent in studies of emergencies
p.000056: 56
p.000056: 5.18 Inducement to participate 57
p.000056: 5.19 Incompetent persons 57
p.000056: 5.20 Withdrawal from a study 58
p.000056: 5.21 Research involving vulnerable persons 58
p.000056: 5.22 Research involving vulnerable groups include 59
p.000056: 5.22.1 Research involving children 59
p.000056: 5.22.2 Women as research subjects 59
p.000056: 5.22.3 Pregnant women as research participants 60
p.000056: 5.23References 62
p.000056:
p.000056:
p.000056:
p.000056:
p.000056: D
p.000056:
p.000056: 12. Annexes 63
p.000056: 6.1 National Application Form For Ethical Approval of a Research Project
p.000067: 67
p.000067: 6.2 National Application Form For Ethical Approval of a Research Proposal
p.000069: 69
p.000069: 6.2.1 Form A: Part 1: Technical proposal form 69
p.000069: 6.2.2 Form B: Part Two: Ethical Considerations 77
p.000069: 1- Minimization of Harm 77
p.000069: 2- Privacy and Confidentiality 79
p.000069: 6.3 Form C 80 1- Informed
p.000069: Consent 80 2- Declarations
p.000081: 81
p.000081: 6.4 The Participant's Acceptance Form ( كر¹ a²ا و= ²ا ¾ب ا9a ةر¹aäذإ جذ9a: A:⁄ ب9:i ýa وأ #⁄ş²ا y )
p.000082: 82
p.000082: 6.5 Model of Informed Consent (ً¹ 49a #⁄ş²ا y كر¹ a²ا ¾ب ا9a راك4إ مر9 ) 84
p.000082: 6.6 Members of the National Health Research Ethical Committee (NHREC)
p.000085: 85
p.000085:
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...
p.000059: medical or psychological examination of such persons unless an ethical review committee authorizes a slight
p.000059: increase over this level of risk.
p.000060: 60
p.000060:
p.000060: e. When the prospective subjects are either incompetent or otherwise substantially unable to give informed
p.000060: consent, their agreement will be supplemented by the permission of their legal guardians or other appropriate
p.000060: representatives.
p.000060:
p.000060:
p.000060:
p.000060: 5.22 Research involving vulnerable groups includes:
p.000060:
p.000060:
p.000060:
p.000060: 5.22.1 Research involving children:
p.000060: Before undertaking research involving children, the investigator must ensure that:
p.000060: * The research might not equally well be carried out with adults;
p.000060: * The purpose of the research is to obtain knowledge relevant to the health needs of children;
p.000060: * A parent or legal representative of each child has given permission;
p.000060: * The agreement (assent) of each child has been obtained to the extent of the child’s capabilities;
p.000060: * A child’s refusal to participate or continue in the research will be respected.
p.000060: 5.22.2 Women as research subjects:
p.000060: Investigators, sponsors or ethical review committees should not exclude women of reproductive age
p.000060: from biomedical
p.000060:
p.000061: 61
p.000061:
p.000061: research. The potential for becoming pregnant during a study should not be used as a reason for
p.000061: precluding or limiting participation. However, a thorough discussion of risks to the pregnant woman and to
p.000061: her foetus is a prerequisite for the woman’s ability to make a rational decision to enroll in a clinical study.
p.000061: In this discussion, if participation in the research might be hazardous to a foetus or a woman if she becomes pregnant,
p.000061: the sponsors/ investigators should guarantee the prospective subject a pregnancy test and access to effective
p.000061: contraceptive methods before the research commences. Where such access is not possible, for legal or religious reasons,
p.000061: investigators should not recruit for such possibly hazardous research women who might become pregnant.
p.000061: 5.22.3 Pregnant women as research participants:
p.000061: Pregnant women should be eligible for participation in biomedical research. Investigators and ethical review committees
p.000061: should ensure that prospective subjects who are pregnant are adequately informed about the risks and benefits to
p.000061: themselves, their pregnancies, the foetus and their subsequent offspring, and their fertility.
p.000061: Research in this population should be performed only if it is relevant to the particular health needs of a pregnant
p.000061: woman or
p.000061:
p.000062: 62
p.000062:
p.000062: her foetus, or to the health needs of pregnant women in general, and, when appropriate, if it is supported by reliable
p.000062: evidence from animal experiments, particularly as to risks of teratogenicity and mutagenicity.
p.000062:
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p.000062:
p.000062:
p.000063: 63
p.000063:
p.000063: 5.23 References:
p.000063:
p.000063: 1. TDR/PRD/ETHICS/2000."Operational Guidelines for Ethics Committees That Review Biomedical Research"
p.000063:
p.000063: 2. Council for International Organizations of Medical Sciences (CIOMS) International Ethical
p.000063: Guidelines for Biomedical Research Involving Human Subjects. CIOMS, Geneva 2002. ISBN 92 9036 075 5
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
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p.000063:
p.000063:
p.000063:
p.000063:
p.000064: 64
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064: Annexes
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
...
p.000083: : Aح ç.9اi وأ ح9جi ýa .حإ ج¹ا~iو را9¾كا ةءا9¾ .²⁄ كر¹جaحا ةرإ¾ مإ⁄ ل¹ب y(.
p.000083:
p.000083: ......................................................................... (ç.9اaاا )حر¹جحا çمإ
p.000083:
p.000083: .................................................................... :(ç.9اaحا )وأ حر¹جحا نا(ل⁄
p.000083: .................................................................... :(ç.9اaحا )وأ حر¹جحا نi¾(ä
p.000083:
p.000083: ..................................................................................... :;ب¹ حا نi¾(ä
p.000083:
p.000083:
p.000083:
p.000083:
p.000084: 84
p.000084:
p.000084: Members of the National Health Research Ethical Committee (NHREC)
p.000084:
p.000084:
p.000084: 1. Prof. Mohamed Ahmed Elsheikh, University of Khartoum/ Faculty of Medicine
p.000084: 2. Prof. Suad M. Sulaiman, Nile Collage
p.000084: 3. Prof. Omer Abdelaziz Musa, National Ribat University/Faculty of Medicine
p.000084: 4. Prof. Mohamed Siddig Ali ,University of Khartoum/Faculty of Medicine
p.000084: 5. Prof. Osman Khalafalla , University of Gezira/Faculty of Medicine
p.000084: 6. Prof. Abdalhamid Ibrahim, General Directorate of Pharmacy
p.000084: 7. Prof. Faisal Awad Ahmed, Veterinary Research Center
p.000084: 8. Prof. Ahmed Mohammed Elhassan, Institute of Endemic Diseases
p.000084: 9. Prof. Hashim Elgaz, Council of Journalism and Publishing
p.000084: 10. Prof. Abdelrahman Eltom, Sudan Medical Council
p.000084: 11. Mr. Hamad Abdelatti, SCOVA
p.000084: 12. Prof. Zein Alabdin Karar, University of Khartoum /Faculty of Medicine
p.000084: 13. Prof. Mamoun Humida/ University of Medical Sciences and Technology
p.000084: 14. Prof. Assim Farouq, Omderman Islamic University/Faculty of Pharmacy
p.000084: 15. Prof. Abdelrahman Kabashi, Ahfad University for Women/ School of Medicine
p.000084: 16. Prof. Ahmed Hassan Fahal, University of Khartoum/Faculty of Medicine
p.000084: 17. Prof. Awad Mohamed Ahmed/ University of Bahr Elghazal/ Faculty of Medicine
p.000084: 18. Associate Prof. Mustafa Khidir El Niemiri/ International Africa University/ Faculty of Medicine
p.000084: 19. Dr. Maawia Mohammed Mukhtar, Institute of Endemic Diseases
p.000084: 20. Dr. Amnah Elsadeeg Badry, Ahfad University for Women
p.000084: 21. Dr. Abdelgalil Elnazeer Elkaroory, Eliman Research Center
p.000084: 22. Dr. Zidan Abdou Zidan, Sudan Medical Specialization Board
p.000084: 23. Dr. Mohammed Abdelsalam, University of Juba/Faculty of Medicine
p.000084: 24. Dr. Samia Yousif Habbani, community Physician, Ministry of Social Affairs
p.000084:
p.000085: 85
p.000085:
p.000085: 25. Mrs. Afaf Bukhary, Council of Journalism and Publishing
p.000085: 26. The Representative of Pharmacy and Poisons Union Board
p.000085: 27. Dr. Elnajeeb Suliman, National Health Laboratory/FMOH
p.000085: 28. Mrs. Iman Bashir, Legal consultant/FMOH
p.000085: 29. Mr. Hamza Tolah, Health Professions Union/FMOH
p.000085: 30. Dr. Mustafa Salih Mustafa, Directorate General of Health Planning and Development/FMOH
p.000085: 31. Dr. Iman Abdallah Mustafa, Directorate of Health Research/ FMOH
p.000085:
p.000085:
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p.000085:
p.000085:
p.000085:
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000012: physical and mental health and integrity and on the personality of the subject.
p.000012: 8. Physicians should abstain from engaging in research projects involving human subjects unless they are
p.000012: satisfied that the hazards involved are believed to be predictable. Physicians should cease any
p.000012: investigation if the hazards are found to outweigh the potential benefits.
p.000012: 9. In publication of the results of his or her research, the physician is obliged to preserve the accuracy of the
p.000012: results.
p.000012: 10. In any research on human beings, each potential subject must be adequately informed of the aims, methods,
p.000012: anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should
p.000012: be informed that he or she is at liberty to abstain from participation in the study and that he or she is free
p.000012:
p.000013: 13
p.000013:
p.000013: to withdraw her consent to participation at any time. The physician should then obtain the subject's
p.000013: freely given informed consent, preferably in writing.
p.000013: 11. In case of legal incompetence, informed consent should be obtained from the legal guardian in
p.000013: accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain
p.000013: informed consent, or when the subject is a minor, permission from the legally responsible person/authority replaces
p.000013: that of the subject in accordance with national legislation.
p.000013: 12. In any study, every patient- including those of a control group, if any- should be assured of the best
p.000013: proven diagnostic and therapeutic method. This does not exclude the use of inert placebo in studies
p.000013: where no proven diagnostic or therapeutic method exists.
p.000013: 13. The refusal of the patient to participate in a study must never interfere with the physician-patient
p.000013: relationship.
p.000013: 14. The physician can combine medical research with professional care, the objective being the acquisition of
p.000013: new knowledge, only to the extent that medical research is justified by its potential diagnostic or
p.000013: therapeutic value for the patient.
p.000013: 15. It is necessary for the researcher to demonstrate that the risks to the research subjects are not unreasonable or
p.000013: disproportionate to the expected benefits of the research, which may not even go to the research subjects. A risk
p.000013: is the potential for an adverse outcome (harm) to occur. It has two components: (1) the
p.000013: likelihood of the occurrence of harm (from highly unlikely to
p.000013:
p.000014: 14
p.000014:
...
Social / education
Searching for indicator education:
(return to top)
p.000047: subject and continues throughout the course of the study. By informing the prospective subjects, by repetition and
p.000047: explanation, by answering their questions as they arise, and by ensuring that each individual understands each
p.000047: procedure, investigators have to elicit the informed consent from their subjects. By doing so the investigator
p.000047: manifests respect for their dignity and autonomy.
p.000047:
p.000047: Each individual must be given as much time as is needed to reach a decision, including time for
p.000047: consultation with family members or others. Adequate time and resources should be set aside for
p.000047: informed-consent procedures.
p.000047:
p.000047: 5.4 Language:
p.000047:
p.000047: Informing the individual subject must not be simply a ritual recitation of the contents of a written document. Rather,
p.000047: the investigator must convey the information, whether orally or in writing, in language that suits
p.000047: the individual's level of understanding.
p.000047:
p.000047:
p.000048: 48
p.000048:
p.000048: The investigator must bear in mind that the prospective subject’s ability to understand the information necessary to
p.000048: give informed consent depends on that individual's maturity, intelligence, education and belief system. It
p.000048: depends also on the investigator's ability and willingness to communicate with patience and sensitivity.
p.000048:
p.000048: 5.5 Comprehension:
p.000048:
p.000048: The investigator must then ensure that the prospective subject has adequately understood the information.
p.000048: The investigator should give each one full opportunity to ask questions and should answer them honestly,
p.000048: promptly and completely. In some instances the investigator may administer an oral or a written test or otherwise
p.000048: determine whether the information has been adequately understood.
p.000048:
p.000048:
p.000048:
p.000048:
p.000048: 5.6 Documentation of consent:
p.000048:
p.000048:
p.000048:
p.000048: Consent may be indicated in a number of ways. The subject may imply consent by voluntary actions, express
p.000048: consent orally, or sign a consent form. Generally, the subject should sign a consent form, or, in the case of
p.000048: incompetence, a legal guardian or other duly authorized representative should do so.
p.000048: In some cases, particularly when the information is complicated, it is advisable to give subjects
p.000048: information sheets to
p.000048:
p.000048:
p.000049: 49
p.000049:
p.000049: retain; these may resemble consent forms in all respects except that subjects are not required to sign
...
Social / ethnic minority
Searching for indicator ethnic minority:
(return to top)
p.000023: can end by resignation, death, termination or completing three years.
p.000023:
p.000024: 24
p.000024:
p.000024: Organogram of the ethics committee
p.000024:
p.000024: Federal Minister of Health
p.000024:
p.000024:
p.000024: Under secretary of FMOH
p.000024:
p.000024:
p.000024: Director DOR
p.000024:
p.000024:
p.000024: Chairman of NHREC
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024: State & IECs
p.000024: Members of NHREC
p.000024:
p.000024: 3.1.3 Meetings:
p.000024:
p.000024: 1-The committee will hold a regular meeting every two months, and it may hold an extra meeting if need arises.
p.000024: 2-The committee chairman or his deputy chairs the meeting, and in case of the absence of the chairman and his/her
p.000024: deputy the members choose the one who heads the meeting.
p.000024:
p.000024:
p.000024: 3.1.3.1 Quorum:
p.000024:
p.000024: The meeting shall be legal with the attendance of half of the members. In case of the lack of quorum, a following
p.000024: meeting must be determined during one week and it shall be legal by any number of members.
p.000024:
p.000025: 25
p.000025:
p.000025: 3.1.4 Independent consultants:
p.000025:
p.000025: a. NHREC may call upon subject experts as independent consultants who may provide special review of selected research
p.000025: protocols, if needed.
p.000025: b. These experts may be specialists in ethics or specific diseases, or methodologies, or represent
p.000025: specific communities, or patient groups e. g. cancer patients, HIV/ Aids positive persons or ethnic minority.
p.000025: c. They are required to give their specialized views but do not take part in the decision-making process, which
p.000025: will be made by the members of the NHREC.
p.000025: 3.1.5 Operational cost:
p.000025:
p.000025: The MOH will avail the budget for the operational cost of the committee. The committee will prepare an annual budget
p.000025: covering all the expenses for the meetings, reviewers, consultations……etc. Fees for application will be decided
p.000025: annually.
p.000025: 3.1.6 Record keeping and Archiving:
p.000025:
p.000025: 1. Curriculum Vitae (CV) of all members of NHREC.
p.000025:
p.000025: 2. Copy of all study protocols with enclosed documents, progress reports, and SAEs.
p.000025: 3. Minutes of all meetings duly signed by the Chairperson.
p.000025: 4. Copy of all existing relevant national and international guidelines on research ethics and laws along
p.000025: with amendments.
p.000025: 5. Copy of all correspondence with members, researchers and other regulatory bodies.
p.000025: 6. Final report of the approved projects.
p.000025: All documents should be archived for a prescribed period.
p.000026: 26
p.000026:
p.000026:
p.000026:
p.000026: 3.1.7. Updating NHREC members
p.000026:
p.000026: a. All relevant new guidelines should be brought to the attention of the members.
p.000026: b. Members should be encouraged to attend national and international training programs in research ethics for
p.000026: maintaining quality in ethical review and be aware of the latest developments in this area.
p.000026:
p.000026:
p.000026:
p.000026: 3.2 States and Institutional Ethics Committees
p.000026:
p.000026:
...
Social / parents
Searching for indicator parent:
(return to top)
p.000059:
p.000059: c. Research subjects and other members of the vulnerable class from which subjects are recruited will ordinarily
p.000059: be assured reasonable access to any diagnostic, preventive or therapeutic products that will become available as a
p.000059: consequence of the research;
p.000059:
p.000059: d. The risks attached to interventions or procedures will not exceed those associated with routine
p.000059: medical or psychological examination of such persons unless an ethical review committee authorizes a slight
p.000059: increase over this level of risk.
p.000060: 60
p.000060:
p.000060: e. When the prospective subjects are either incompetent or otherwise substantially unable to give informed
p.000060: consent, their agreement will be supplemented by the permission of their legal guardians or other appropriate
p.000060: representatives.
p.000060:
p.000060:
p.000060:
p.000060: 5.22 Research involving vulnerable groups includes:
p.000060:
p.000060:
p.000060:
p.000060: 5.22.1 Research involving children:
p.000060: Before undertaking research involving children, the investigator must ensure that:
p.000060: * The research might not equally well be carried out with adults;
p.000060: * The purpose of the research is to obtain knowledge relevant to the health needs of children;
p.000060: * A parent or legal representative of each child has given permission;
p.000060: * The agreement (assent) of each child has been obtained to the extent of the child’s capabilities;
p.000060: * A child’s refusal to participate or continue in the research will be respected.
p.000060: 5.22.2 Women as research subjects:
p.000060: Investigators, sponsors or ethical review committees should not exclude women of reproductive age
p.000060: from biomedical
p.000060:
p.000061: 61
p.000061:
p.000061: research. The potential for becoming pregnant during a study should not be used as a reason for
p.000061: precluding or limiting participation. However, a thorough discussion of risks to the pregnant woman and to
p.000061: her foetus is a prerequisite for the woman’s ability to make a rational decision to enroll in a clinical study.
p.000061: In this discussion, if participation in the research might be hazardous to a foetus or a woman if she becomes pregnant,
p.000061: the sponsors/ investigators should guarantee the prospective subject a pregnancy test and access to effective
...
Economic / Economic/Poverty
Searching for indicator poor:
(return to top)
p.000055: The prospective subject must not be exposed to undue influence. The borderline between justifiable
p.000055: persuasion and undue influence is imprecise, however. The researcher should give justifiable assurances
p.000055: about the benefits, risks or inconveniences of the research, for example, or induce a close
p.000055: relative or a community leader to influence a prospective subject's decision.
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000056: 56
p.000056:
p.000056: 5.16 Equitable distribution of burdens and benefits in the selection of groups of subjects in research:
p.000056:
p.000056: 1- Groups or communities to be subjects of research should be selected so that the burdens and benefits of the
p.000056: research will be equitably distributed. The exclusion of groups or communities that might benefit from study
p.000056: participation must be justified.
p.000056:
p.000056: 2- Members of vulnerable groups also have the same entitlement to access to the benefits of investigational
p.000056: interventions that show promise of therapeutic benefit as non vulnerable groups particularly when no superior
p.000056: or equivalent approaches to therapy are available.
p.000056:
p.000056: 3- Overuse of certain groups, such as the poor or the administratively available, is unjustified.
p.000056:
p.000056: 5.17 Exception to the requirement for informed consent in studies of emergencies in which the researcher
p.000056: anticipates that many subjects will be unable to consent:
p.000056:
p.000056: Research protocols are sometimes designed to address conditions occurring suddenly and rendering the
p.000056: patients/subjects incapable of giving informed consent. Examples are head trauma, cardiopulmonary arrest and
p.000056: stroke. The investigation cannot be done with patients who can give informed consent in time and there
p.000056: may not be time to locate a person having the authority to give permission.
p.000056:
p.000056:
p.000056:
p.000056:
p.000057: 57
p.000057:
p.000057: In such circumstances it is often necessary to precede with the research interventions very soon after the onset of the
p.000057: condition in order to evaluate an investigational treatment or develop the desired knowledge. Consent should be
p.000057: taken from the guardian if available or from an authorized body in the health facility. As this class of emergency
p.000057: exception can be anticipated, the researcher must secure the review and approval of an ethical review
...
General/Other / Dependent
Searching for indicator dependent:
(return to top)
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
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p.000009:
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p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
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p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: 2.1 The major principles:
p.000010:
p.000010: All research involving human subjects should be conducted in accordance with three basic ethical principles, namely
p.000010: respect for persons, beneficence and non-malificence and justice. It is generally agreed that these principles, which
p.000010: in the abstract have equal moral force, guide the conscientious preparation of proposals for scientific studies (1,4).
p.000010: • Respect for persons incorporates at least two fundamental ethical considerations, namely:
p.000010: a. Respect for autonomy which requires that those who are capable of deliberation about their personal choices should
p.000010: be treated with respect for their capacity for self- determination.
p.000010: b. Protection of persons with impaired or diminished autonomy, which requires that those who are dependent or
p.000010: vulnerable be afforded full security against harm or abuse.
p.000010: • Beneficence and non-malificence refers to the ethical obligation to maximize benefits and to minimize harms,
p.000010: respectively. This gives rise to norms requiring that the risks of research to be reasonable in the light of the
p.000010: expected benefits, that the research design to be sound, and that the investigators to be competent to conduct the
p.000010: research and to safeguard the welfare of the research subjects.
p.000010: • Justice refers to the ethical obligation to treat each person in accordance with what is morally
p.000010: right and proper; to give each person what is due to him or her. In the ethics of research involving human
p.000010: subjects the principle refers primarily to distributive justice,
p.000010:
p.000011: 11
p.000011:
p.000011: which requires equitable distribution of both the burdens and the benefits of participation in research.
p.000011:
p.000011: Table (1): Ethical Principles of Research
p.000011:
p.000011:
p.000011:
p.000011: Major Principles
p.000011: 1. Autonomy
p.000011: 2. Beneficence and non-maleficence
p.000011: 3. Justice
p.000011: Others
p.000011: 1. Accepted Scientifically
p.000011: 2. Accepted qualified researchers
p.000011: 3. Ethics committee review
...
General/Other / Diminished Autonomy
Searching for indicator diminished:
(return to top)
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p.000009: 9
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p.000010: 10
p.000010:
p.000010: 2.1 The major principles:
p.000010:
p.000010: All research involving human subjects should be conducted in accordance with three basic ethical principles, namely
p.000010: respect for persons, beneficence and non-malificence and justice. It is generally agreed that these principles, which
p.000010: in the abstract have equal moral force, guide the conscientious preparation of proposals for scientific studies (1,4).
p.000010: • Respect for persons incorporates at least two fundamental ethical considerations, namely:
p.000010: a. Respect for autonomy which requires that those who are capable of deliberation about their personal choices should
p.000010: be treated with respect for their capacity for self- determination.
p.000010: b. Protection of persons with impaired or diminished autonomy, which requires that those who are dependent or
p.000010: vulnerable be afforded full security against harm or abuse.
p.000010: • Beneficence and non-malificence refers to the ethical obligation to maximize benefits and to minimize harms,
p.000010: respectively. This gives rise to norms requiring that the risks of research to be reasonable in the light of the
p.000010: expected benefits, that the research design to be sound, and that the investigators to be competent to conduct the
p.000010: research and to safeguard the welfare of the research subjects.
p.000010: • Justice refers to the ethical obligation to treat each person in accordance with what is morally
p.000010: right and proper; to give each person what is due to him or her. In the ethics of research involving human
p.000010: subjects the principle refers primarily to distributive justice,
p.000010:
p.000011: 11
p.000011:
p.000011: which requires equitable distribution of both the burdens and the benefits of participation in research.
p.000011:
p.000011: Table (1): Ethical Principles of Research
p.000011:
p.000011:
p.000011:
p.000011: Major Principles
p.000011: 1. Autonomy
p.000011: 2. Beneficence and non-maleficence
p.000011: 3. Justice
p.000011: Others
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
(return to top)
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008:
p.000008:
p.000008: Chapter 2
p.000008: Principles of Ethics for Research Involving Human Subjects
p.000008:
p.000008:
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p.000009: 9
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p.000010: 10
p.000010:
p.000010: 2.1 The major principles:
p.000010:
p.000010: All research involving human subjects should be conducted in accordance with three basic ethical principles, namely
p.000010: respect for persons, beneficence and non-malificence and justice. It is generally agreed that these principles, which
p.000010: in the abstract have equal moral force, guide the conscientious preparation of proposals for scientific studies (1,4).
p.000010: • Respect for persons incorporates at least two fundamental ethical considerations, namely:
p.000010: a. Respect for autonomy which requires that those who are capable of deliberation about their personal choices should
p.000010: be treated with respect for their capacity for self- determination.
p.000010: b. Protection of persons with impaired or diminished autonomy, which requires that those who are dependent or
p.000010: vulnerable be afforded full security against harm or abuse.
p.000010: • Beneficence and non-malificence refers to the ethical obligation to maximize benefits and to minimize harms,
p.000010: respectively. This gives rise to norms requiring that the risks of research to be reasonable in the light of the
p.000010: expected benefits, that the research design to be sound, and that the investigators to be competent to conduct the
p.000010: research and to safeguard the welfare of the research subjects.
p.000010: • Justice refers to the ethical obligation to treat each person in accordance with what is morally
p.000010: right and proper; to give each person what is due to him or her. In the ethics of research involving human
p.000010: subjects the principle refers primarily to distributive justice,
p.000010:
p.000011: 11
p.000011:
p.000011: which requires equitable distribution of both the burdens and the benefits of participation in research.
p.000011:
p.000011: Table (1): Ethical Principles of Research
p.000011:
p.000011:
p.000011:
p.000011: Major Principles
p.000011: 1. Autonomy
p.000011: 2. Beneficence and non-maleficence
p.000011: 3. Justice
p.000011: Others
p.000011: 1. Accepted Scientifically
p.000011: 2. Accepted qualified researchers
p.000011: 3. Ethics committee review
p.000011: 4. Accuracy of published results……etc
p.000011:
p.000011: 2.2 Other principles: (5-11)
p.000011: 1. Biomedical research involving human subjects must conform to generally accepted scientific principles and should
p.000011: be based on adequately performed laboratory and animal experimentation and on a knowledge of the related
p.000011: scientific literature.
p.000011: 2. Every proposal for health and medical research on human subjects must be reviewed and
p.000011: approved by an independent nationally-recognised ethics committee before it can proceed.
p.000011: 3. The research ethics committee may approve the project as presented, require changes before it can start,
p.000011: or refuse approval altogether.
p.000011: 4. The design and performance of each experimental procedure involving human subjects should be clearly
p.000011: formulated in an experimental protocol, which should be transmitted for
p.000012: 12
p.000012:
p.000012: consideration, comment, guidance and approval of the nationally-recognised research ethics committee.
p.000012: 5. Biomedical research involving human subjects should be conducted only by scientifically qualified
p.000012: persons and under the supervision of a clinically competent medical person as decided by the relevant committee.
...
p.000021: the leaders of civil society and should not be confined only to the doctors and scholars in medical and
p.000021: scientific field.
p.000021: * The FMOH would approach WHO EMRO to allocate some funds in the WHO through JPRM.
p.000021: 3.1.2 Regulation of the National Health Research Ethics Committee (NHREC)
p.000021: 3.1.2.1 Authority under which the NHREC will be constituted:
p.000021:
p.000021: The FMOH will approve the authority of the constitution and membership of the NHREC. It will be approved and notified
p.000021: by the Federal Ministry of Health.
p.000021: 3.1.2.2 Responsibilities of (NHREC):
p.000021:
p.000021: The committee shall have the following responsibilities:
p.000021:
p.000021: • Formulating guidelines for the approval of the research ethically.
p.000021:
p.000021: • The approval of health research that take place at the national level, or in more than one state from an ethical
p.000021: point of view.
p.000021: • The ethical approval of the research in which there are external participants or that is presented to
p.000021: external bodies.
p.000021:
p.000022: 22
p.000022:
p.000022: • The ethical approval of the experimental research on human.
p.000022:
p.000022: • Reviewing and approving all types of research proposals involving human participants directing or indirectly,
p.000022: with a view to safe-guard the dignity, rights, safety and well being of all actual and potential research participants
p.000022: and to take care of all the cardinal principles of research ethics i.e. autonomy, beneficence, non maleficience
p.000022: and Justice, in planning, conduct and reporting of the proposed research.
p.000022: • Look into the aspects of informed consent process, risk-benefit ratio, distribution of burden and benefit and
p.000022: provisions for appropriate compensation, wherever required.
p.000022: • Review the proposals before start of the study, as well as monitor the research throughout the study, until and
p.000022: after completion of the study through appropriate well documented procedures for example annual reports, final reports
p.000022: and site visits etc. .
p.000022: • The committee will also examine compliance with all regulatory requirements applicable guideline and laws.
p.000022: 3.1.2.3 Membership of the (NHREC):
p.000022:
p.000022: The NHREC should be multidisciplinary and multisectorial. Independence and competence are the two hall marks for
p.000022: membership.
p.000022: The membership of ( NHRERC) will include 20-25 members:
p.000022:
p.000022: 1. The Chairman of the committee.
p.000022: 2. The legal advisor of the FMOH.
p.000022: 3. Representative of the Government of Southern Sudan.
p.000022: 4. The secretary general of the Health Research Council (Rapporteur).
p.000022:
p.000023: 23
p.000023:
p.000023: 5. Representatives of universities and research institutions.
p.000023: 6. Researchers.
p.000023: 7. Representative of the Medical Council.
p.000023: 8. The representative of the Veterinary Research Council.
p.000023: 9. The representative of the National Health Laboratory
p.000023: I0.The representative of the Sudanese Medical Specializations Board.
p.000023: 11. Representatives of the national civil society organizations
...
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p.000042: 42
p.000042:
p.000042: 5.1 What is ‘Informed Consent’?
p.000042:
p.000042: The Council for International Organizations of Medical Sciences (CIOMS) Guidelines has defined informed
p.000042: consent as:
p.000042:
p.000042: Approval to participate in a study or trial given by a competent individual who:
p.000042:
p.000042: • Has received the necessary information (verbally and in writing).
p.000042: • Has adequately understood the information.
p.000042: • After considering the information, has arrived at a decision without having been subjected to compulsion,
p.000042: undue influence, incentive, or pressure.
p.000042: • In the case of those who are not capable, has the legal authorization to approve on behalf of the incompetent.
p.000042:
p.000042: Informed consent is based on the principle that competent individuals are entitled to choose freely whether to
p.000042: participate in research. It protects the individual's freedom of choice and respects the individual's autonomy.
p.000042: As an additional safeguard, it must always be complemented by the approval of an independent review of an ethical
p.000042: research committee.
p.000042:
p.000042:
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p.000043: 43
p.000043:
p.000043:
p.000043: 5.2 Obtaining informed consent:
p.000043:
p.000043:
p.000043: Before requesting an individual's consent to participate in research, the investigator must
p.000043: provide the following information, in language or another form of communication that the individual can
p.000043: understand to the research subject:
p.000043: 1. The individual is invited to participate voluntarily in the research, explaining the reasons for
p.000043: considering him/her suitable for the research.
p.000043: 2. The individual is free to refuse to participate and will be free to withdraw from the research at any time without
p.000043: penalty or loss of benefits to which he or she would otherwise be entitled.
p.000043: 3. The purpose of the research, the procedures to be carried out by the investigator and the subject, and an
p.000043: explanation of how the research differs from routine medical care.
p.000043: 4. An explanation of the features of the research design e.g., in controlled trials the method of randomization,
p.000043: double-blinding, and that the subject will not be told of the assigned treatment until the study has
p.000043: been completed and the blind has been broken.
...
p.000046: 23. The treatment will be provided free of charge for specified types of research-related injury or for
p.000046: complications associated with the research, the nature and duration of such care, the name of the organization or
p.000046: individual that will provide the treatment, and whether there is any uncertainty regarding funding of such
p.000046: treatment.
p.000046: 24. In what way, and by what organization, the subject or the subject’s family or dependants will be
p.000046: compensated for disability or death resulting from such injury (or, when indicated, that there are no plans to provide
p.000046: such compensation).
p.000046:
p.000046:
p.000046:
p.000046:
p.000047: 47
p.000047:
p.000047: 25. Whether or not, in the country in which the prospective subject is invited to participate in
p.000047: research, the right to compensation is legally guaranteed.
p.000047: 26. An ethical review committee has approved or cleared the research protocol.
p.000047:
p.000047: 5.3 Process:
p.000047:
p.000047: Obtaining informed consent is a process that is begun when initial contact is made with a prospective
p.000047: subject and continues throughout the course of the study. By informing the prospective subjects, by repetition and
p.000047: explanation, by answering their questions as they arise, and by ensuring that each individual understands each
p.000047: procedure, investigators have to elicit the informed consent from their subjects. By doing so the investigator
p.000047: manifests respect for their dignity and autonomy.
p.000047:
p.000047: Each individual must be given as much time as is needed to reach a decision, including time for
p.000047: consultation with family members or others. Adequate time and resources should be set aside for
p.000047: informed-consent procedures.
p.000047:
p.000047: 5.4 Language:
p.000047:
p.000047: Informing the individual subject must not be simply a ritual recitation of the contents of a written document. Rather,
p.000047: the investigator must convey the information, whether orally or in writing, in language that suits
p.000047: the individual's level of understanding.
p.000047:
p.000047:
p.000048: 48
p.000048:
p.000048: The investigator must bear in mind that the prospective subject’s ability to understand the information necessary to
p.000048: give informed consent depends on that individual's maturity, intelligence, education and belief system. It
p.000048: depends also on the investigator's ability and willingness to communicate with patience and sensitivity.
p.000048:
p.000048: 5.5 Comprehension:
p.000048:
p.000048: The investigator must then ensure that the prospective subject has adequately understood the information.
p.000048: The investigator should give each one full opportunity to ask questions and should answer them honestly,
p.000048: promptly and completely. In some instances the investigator may administer an oral or a written test or otherwise
...
General/Other / Incapacitated
Searching for indicator incapacity:
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p.000012: 7. The right of the research subject to safeguard his / her integrity must always be respected. Every precaution
p.000012: should be taken to respect the privacy of the subject and to minimize the impact of the study on the subject's
p.000012: physical and mental health and integrity and on the personality of the subject.
p.000012: 8. Physicians should abstain from engaging in research projects involving human subjects unless they are
p.000012: satisfied that the hazards involved are believed to be predictable. Physicians should cease any
p.000012: investigation if the hazards are found to outweigh the potential benefits.
p.000012: 9. In publication of the results of his or her research, the physician is obliged to preserve the accuracy of the
p.000012: results.
p.000012: 10. In any research on human beings, each potential subject must be adequately informed of the aims, methods,
p.000012: anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should
p.000012: be informed that he or she is at liberty to abstain from participation in the study and that he or she is free
p.000012:
p.000013: 13
p.000013:
p.000013: to withdraw her consent to participation at any time. The physician should then obtain the subject's
p.000013: freely given informed consent, preferably in writing.
p.000013: 11. In case of legal incompetence, informed consent should be obtained from the legal guardian in
p.000013: accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain
p.000013: informed consent, or when the subject is a minor, permission from the legally responsible person/authority replaces
p.000013: that of the subject in accordance with national legislation.
p.000013: 12. In any study, every patient- including those of a control group, if any- should be assured of the best
p.000013: proven diagnostic and therapeutic method. This does not exclude the use of inert placebo in studies
p.000013: where no proven diagnostic or therapeutic method exists.
p.000013: 13. The refusal of the patient to participate in a study must never interfere with the physician-patient
p.000013: relationship.
p.000013: 14. The physician can combine medical research with professional care, the objective being the acquisition of
p.000013: new knowledge, only to the extent that medical research is justified by its potential diagnostic or
p.000013: therapeutic value for the patient.
p.000013: 15. It is necessary for the researcher to demonstrate that the risks to the research subjects are not unreasonable or
p.000013: disproportionate to the expected benefits of the research, which may not even go to the research subjects. A risk
p.000013: is the potential for an adverse outcome (harm) to occur. It has two components: (1) the
p.000013: likelihood of the occurrence of harm (from highly unlikely to
p.000013:
p.000014: 14
...
General/Other / Other Country
Searching for indicator another country:
(return to top)
p.000051: subjects’ biological materials).
p.000051:
p.000051:
p.000051:
p.000051: 5.11 Use of medical records and biological specimens:
p.000051:
p.000051:
p.000051:
p.000051: Medical records and biological specimens taken in the course of clinical care may be used for research without the
p.000051: consent of the patients/subjects. This can only be done if an ethical review committee has determined that:
p.000051: * The research poses minimal risk, that the rights or interests of the patients will not be violated.
p.000051: * Patient privacy and confidentiality or anonymity is assured.
p.000051:
p.000051:
p.000051:
p.000051:
p.000052: 52
p.000052:
p.000052: * The research is designed to answer an important question and would be impracticable if the requirement for informed
p.000052: consent were to be imposed.
p.000052: * Patients have a right to know that their records or specimens may be used for research. Refusal or reluctance of
p.000052: individuals to agree to participate would not be evidence of impracticability sufficient to warrant waiving
p.000052: informed consent. Records and specimens of individuals who have specifically rejected such uses in the
p.000052: past may be used only in the case of public health emergencies.
p.000052:
p.000052: 5.12 Secondary use of research records or biological specimens:
p.000052: Investigators may want to use records or biological specimens that another investigator has used or
p.000052: collected for use in the same or another institution or another country. This raises the issue of whether the
p.000052: records or specimens contain personal identifiers. If informed consent or permission was required to authorize
p.000052: the original collection or use of such records or specimens for research purposes, secondary uses are generally
p.000052: constrained by the conditions specified in the original consent.
p.000052: Consequently, it is essential that the original consent process anticipate, to the extent that this is feasible, any
p.000052: foreseeable plans for future use of the records or specimens for research. Thus, in the original process of seeking
p.000052: informed consent a member of the research team should discuss with, and, when indicated, request the permission of,
p.000052: prospective subjects as to:
p.000052: i. Whether there will or could be any secondary use and, if so, whether such
p.000052:
p.000053: 53
p.000053:
p.000053: secondary use will be limited with regard to the type of study that may be performed on such materials;
p.000053: ii. The conditions under which investigators will be required to contact the research subjects for additional
p.000053: authorization for secondary use;
p.000053: iii. The investigators' plans, if any, to destroy or to strip off personal identifiers from the records or
p.000053: specimens; and
p.000053: iv. The rights of subjects to request destruction or removal of individual identification of biological
p.000053: specimens or of records or parts of records that they might consider particularly sensitive, such as photographs,
p.000053: videotapes or audiotapes.
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000056:
p.000056: 3- Overuse of certain groups, such as the poor or the administratively available, is unjustified.
p.000056:
p.000056: 5.17 Exception to the requirement for informed consent in studies of emergencies in which the researcher
p.000056: anticipates that many subjects will be unable to consent:
p.000056:
p.000056: Research protocols are sometimes designed to address conditions occurring suddenly and rendering the
p.000056: patients/subjects incapable of giving informed consent. Examples are head trauma, cardiopulmonary arrest and
p.000056: stroke. The investigation cannot be done with patients who can give informed consent in time and there
p.000056: may not be time to locate a person having the authority to give permission.
p.000056:
p.000056:
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p.000056:
p.000057: 57
p.000057:
p.000057: In such circumstances it is often necessary to precede with the research interventions very soon after the onset of the
p.000057: condition in order to evaluate an investigational treatment or develop the desired knowledge. Consent should be
p.000057: taken from the guardian if available or from an authorized body in the health facility. As this class of emergency
p.000057: exception can be anticipated, the researcher must secure the review and approval of an ethical review
p.000057: committee before initiating the study. If possible, an attempt should be made to identify a population that is likely
p.000057: to develop the condition to be studied. This can be done readily, for example, if the condition is one that
p.000057: recurs periodically in individuals; examples include grand mal seizures and alcohol binges. In such cases, prospective
p.000057: subjects should be contacted while fully capable of informed consent, and invited to consent to their involvement as
p.000057: research subjects during future periods of incapacitation. If they are patients of an independent physician who is
p.000057: also the physician-researcher, the physician should likewise seek their consent while they are fully capable of
p.000057: informed consent.
p.000057:
p.000057: In all cases in which approved research has begun without prior consent of patients/subjects incapable of
p.000057: giving informed consent because of suddenly occurring conditions, they should be given all relevant information
p.000057: as soon as they are in a state to receive it, and their consent to continued participation should be
p.000057: obtained as soon as is reasonably possible.
p.000057:
p.000057: 5.18 Inducement to participate:
p.000057:
...
General/Other / Relationship to Authority
Searching for indicator authority:
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p.000008: 5. Preamble M
p.000008: 6. Milestones of preparing the guidelines Q
p.000008: 7. Chapter 1: Introduction 1
p.000008: 1. Introduction 3
p.000008: 1.1 Research involving human subjects 4
p.000008: 1.2 What is ethics in research? 5
p.000008: 2. References 7
p.000008: 8. Chapter 2: Principles of ethics for research involving Human Subjects
p.000008: 8
p.000008: 2.1 The major principles 10
p.000008: 2.2 Other principles 12
p.000008: 2.3 References 15
p.000008: 9. Chapter 3: Research Ethics Committees 16
p.000008: 3.1 National Research Health Ethics Committee (NHREC) 18
p.000008: 3. 1.1 Historical background 18
p.000008: 3.1.2 Regulation of the National Health Research Ethics Committee (NHREC)
p.000020: 20
p.000020: 3.1.2.1 Authority under which NHREC will be constituted 20
p.000020: 3.1.2.2 Responsibilities of (NHREC) 20
p.000020: 3.1.2.3 Membership of the (HREC) 21
p.000020: 3.1. 2.4 Term of the membership 23
p.000020: 3.1.3 Meetings 24
p.000020: 3.1.3.1 Quorum 24
p.000020: 3.1.4 Independent consultants 25
p.000020: 3.1.5 Operational costs 25 3.1.6 Record
p.000020: keeping and Archiving 25
p.000020: 3.1.7 Updating NHREC members 26
p.000020: 3.2 State and Institutional Ethics Committees guidelines 27
p.000020: 3.3 References 28
p.000020: 10. Chapter 4: Ethical clearance procedure 29
p.000020: 4.1 How to get the ethical clearance? 31
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p.000020: 4.2 Flowchart for getting ethical clearance 32
p.000020: 4.3 Prepare 33
p.000020: 4.4 Elements of ethical review 34
p.000020: 4.5 Application 34
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p.000085: L
p.000085:
p.000085: Preamble:
p.000085: This document entitled "Guidelines for Ethical Conduct of Research Involving Human Subjects" is the
p.000085: national document for the guidelines that regulate the conduct of research related to health, with special emphasis on
p.000085: those involving human subjects in Sudan. It was developed by the National Health Research Ethics Committee (NHREC)
p.000085: through a long process as a continuation of important historical efforts by the pioneers of
p.000085: health research in Sudan, which had started as early as 1913.
p.000085:
p.000085: It is composed of five main chapters followed by the annexes. The introduction goes through the main
p.000085: concepts of research, types of research and research ethics.
p.000085:
p.000085: The second chapter explains the principles of ethics for research involving human subjects. This includes detailed
p.000085: explanation of all the three basic ethical principles, namely respect for persons, beneficence and justice in any
p.000085: research involving human subjects. It also enlists about other 20 principles that regulate and guide the research
p.000085: conduction.
p.000085:
p.000085: The third chapter is about the National Research Ethics Committee. This includes a thorough explanation
p.000085: of the structure and functioning technical procedures followed within the National Research Ethics
p.000085: Committee. It includes the authority under which NHREC was constituted, its Membership,
p.000085: meetings, and quorum. It also elaborates on the independent consultants, operational cost, the record keeping and
p.000085: archiving together with updating of NHREC members.
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p.000085:
p.000085: In this chapter the guidelines and procedures for the State and Institutional Ethics Committees, were also explained.
p.000085:
p.000085: Chapter four is the core of the guidelines for the researcher, as it explains all the steps and procedures for
p.000085: obtaining the ethical clearance in a simplified flowchart and detailed steps of what to prepare, ethical
p.000085: elements review, how to apply, review procedures and decision making.
p.000085:
p.000085: The fifth chapter is about the Informed Consent, its definition, importance, and components. It explains the
p.000085: information that the research subject should know and understand before being involved in the study. The
p.000085: chapter explains the procedure and process by which the informed consent should be obtained from the subjects
p.000085: included in the research. Other principles about the informed consent were included and explained in this
p.000085: chapter. This includes the language, comprehension, documentation of consent, waiver of the consent
...
p.000012: 8. Physicians should abstain from engaging in research projects involving human subjects unless they are
p.000012: satisfied that the hazards involved are believed to be predictable. Physicians should cease any
p.000012: investigation if the hazards are found to outweigh the potential benefits.
p.000012: 9. In publication of the results of his or her research, the physician is obliged to preserve the accuracy of the
p.000012: results.
p.000012: 10. In any research on human beings, each potential subject must be adequately informed of the aims, methods,
p.000012: anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should
p.000012: be informed that he or she is at liberty to abstain from participation in the study and that he or she is free
p.000012:
p.000013: 13
p.000013:
p.000013: to withdraw her consent to participation at any time. The physician should then obtain the subject's
p.000013: freely given informed consent, preferably in writing.
p.000013: 11. In case of legal incompetence, informed consent should be obtained from the legal guardian in
p.000013: accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain
p.000013: informed consent, or when the subject is a minor, permission from the legally responsible person/authority replaces
p.000013: that of the subject in accordance with national legislation.
p.000013: 12. In any study, every patient- including those of a control group, if any- should be assured of the best
p.000013: proven diagnostic and therapeutic method. This does not exclude the use of inert placebo in studies
p.000013: where no proven diagnostic or therapeutic method exists.
p.000013: 13. The refusal of the patient to participate in a study must never interfere with the physician-patient
p.000013: relationship.
p.000013: 14. The physician can combine medical research with professional care, the objective being the acquisition of
p.000013: new knowledge, only to the extent that medical research is justified by its potential diagnostic or
p.000013: therapeutic value for the patient.
p.000013: 15. It is necessary for the researcher to demonstrate that the risks to the research subjects are not unreasonable or
p.000013: disproportionate to the expected benefits of the research, which may not even go to the research subjects. A risk
p.000013: is the potential for an adverse outcome (harm) to occur. It has two components: (1) the
p.000013: likelihood of the occurrence of harm (from highly unlikely to
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p.000014: very likely), and (2) the severity of the harm (from trivial to permanent severe disability or death). A
...
p.000020: 60/1998 for forming a committee to review health research ethics. As a result, the committee for review of health
p.000020: research ethics was set up by the Decree No. 31 / 1999
p.000020: In 2002, the Federal Minister of Health issued a Ministerial Decree no 11 / 2002 for the constitution of
p.000020: National Technical (NTC) and National Ethical Committees (NEC). According to this decree a number of tasks were
p.000020: assigned for the NHREC:
p.000020: 1- Formulating guidelines for research ethics.
p.000020:
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p.000021: 2- Undertaking the ethics approval of the research that takes place at the national level in which it
p.000021: participates or that presented to external bodies.
p.000021: 3- Endorsement and delegation of the powers to the state and institutional research ethics committees.
p.000021: 4- The research ethics committee should include in its membership lawyers, Islamic and Christian religious leaders and
p.000021: the leaders of civil society and should not be confined only to the doctors and scholars in medical and
p.000021: scientific field.
p.000021: * The FMOH would approach WHO EMRO to allocate some funds in the WHO through JPRM.
p.000021: 3.1.2 Regulation of the National Health Research Ethics Committee (NHREC)
p.000021: 3.1.2.1 Authority under which the NHREC will be constituted:
p.000021:
p.000021: The FMOH will approve the authority of the constitution and membership of the NHREC. It will be approved and notified
p.000021: by the Federal Ministry of Health.
p.000021: 3.1.2.2 Responsibilities of (NHREC):
p.000021:
p.000021: The committee shall have the following responsibilities:
p.000021:
p.000021: • Formulating guidelines for the approval of the research ethically.
p.000021:
p.000021: • The approval of health research that take place at the national level, or in more than one state from an ethical
p.000021: point of view.
p.000021: • The ethical approval of the research in which there are external participants or that is presented to
p.000021: external bodies.
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p.000022: • The ethical approval of the experimental research on human.
p.000022:
p.000022: • Reviewing and approving all types of research proposals involving human participants directing or indirectly,
p.000022: with a view to safe-guard the dignity, rights, safety and well being of all actual and potential research participants
p.000022: and to take care of all the cardinal principles of research ethics i.e. autonomy, beneficence, non maleficience
p.000022: and Justice, in planning, conduct and reporting of the proposed research.
p.000022: • Look into the aspects of informed consent process, risk-benefit ratio, distribution of burden and benefit and
p.000022: provisions for appropriate compensation, wherever required.
p.000022: • Review the proposals before start of the study, as well as monitor the research throughout the study, until and
...
p.000026: b. Members should be encouraged to attend national and international training programs in research ethics for
p.000026: maintaining quality in ethical review and be aware of the latest developments in this area.
p.000026:
p.000026:
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p.000026: 3.2 States and Institutional Ethics Committees
p.000026:
p.000026:
p.000026: I. In 2002, the Federal Minister of Health issued a ministerial decree no. 11/2002 for the constitution of
p.000026: National Technical and Advisory ( NTAC) and National Health Research Ethics Committees( NHREC). According to this
p.000026: decree, the NHREC has been assigned to take the task of:
p.000026: 1. Endorsement and delegation of its powers to the state and institutional research ethics committees.
p.000026: 2. The State Ministries of Health and Head of the research institutions should constitute research ethics
p.000026: committees to approve research proposals conducted by their own researchers and/or that are conducted in the
p.000026: state only.
p.000026: 3. State and research institutions ethics committee should not start their functions and tasks of ethical
p.000026: reviewing unless their constitution has been approved and endorsed by the NHREC.
p.000026:
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p.000027: 4. State and research institutions ethics committees have the authority to issue ethical approval for all
p.000027: health research that takes place inside the state excluding the following researches:
p.000027: i. The experimental research on the human subjects.
p.000027:
p.000027: ii. Researches linked to external bodies (i.e. out side Sudan).
p.000027:
p.000027: iii. Researches that take place in more than one state (Interstate).
p.000027:
p.000027: 5. The State and institutional ethics committees work under the supervision of the NHREC.
p.000027: 6. The State and institutional ethics committees should present regular biannual reports of their research
p.000027: reviewing activities and the research proposals that have been approved ethically to the NHREC.
p.000027: 7. A copy of approved research proposals and copies of the ethical certificates should be enclosed with
p.000027: the report.
p.000027: 8. The NHREC discusses the research proposals and the reports of the State and institutions ethics committees in their
p.000027: regular meetings.
p.000027: II. The state and institution ethics committees should follow the same guidelines, relevant to the research
p.000027: proposal submitted to them.
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p.000028: 3.9 References:
p.000028:
p.000028: 1. Council for International Organizations of Medical Sciences International Ethical Guidelines for
p.000028: Biomedical Research Involving Human Subjects
p.000028: (CIOMS) Geneva 2002.ISBN 92 9036 075 5
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p.000049: committee may waive some or all of the elements of informed consent. Such waiver may also be approved when
p.000049: the existence of a single consent form would be an unjustified threat to the subject’s confidentiality.
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p.000049: 5.8 Renewing consent:
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p.000049: When material changes occur in the conditions or the procedures of a study, and periodically in
p.000049: long-term studies, the investigator should once again seek informed consent from the subjects. For
p.000049: example, new information may have become known, either from the study or from other sources, about the risks or
p.000049: benefits of products being tested or about alternatives to them. Subjects should be given such information
p.000049: promptly.
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p.000050: In many clinical trials, results are not disclosed to subjects and investigators until the study is
p.000050: concluded. This is ethically acceptable if an ethical review committee has approved their non-disclosure.
p.000050:
p.000050: 5.9 Cultural considerations:
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p.000050: In some cultures an investigator may enter a community to conduct research or approach prospective subjects
p.000050: for their individual consent only after obtaining permission from a community leader, a council of elders, or another
p.000050: designated authority. Such customs must be respected.
p.000050:
p.000050: In no case, however, may the permission of a community leader or other authority substitute for individual informed
p.000050: consent. In some populations the use of a number of local languages may complicate the communication of
p.000050: information to potential subjects and the ability of an investigator to ensure that they truly understand
p.000050: it. Many people in all cultures are unfamiliar with, or do not readily understand, scientific concepts
p.000050: such as those of placebo or randomization.
p.000050:
p.000050: Sponsors and investigators should develop culturally appropriate ways to communicate information that is necessary
p.000050: for adherence to the standard required in the informed consent process. In addition, they should describe and
p.000050: justify in the research protocol the procedure they plan to use in communicating information to subjects.
p.000050:
p.000050: For collaborative research in developing countries the research project should include the provision of
p.000050: resources to ensure that informed consent
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p.000051: can indeed be obtained legitimately within different linguistic and cultural settings.
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p.000051: 5.10 Use of biological materials from subjects in clinical trials:
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p.000056: participation must be justified.
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p.000056: 2- Members of vulnerable groups also have the same entitlement to access to the benefits of investigational
p.000056: interventions that show promise of therapeutic benefit as non vulnerable groups particularly when no superior
p.000056: or equivalent approaches to therapy are available.
p.000056:
p.000056: 3- Overuse of certain groups, such as the poor or the administratively available, is unjustified.
p.000056:
p.000056: 5.17 Exception to the requirement for informed consent in studies of emergencies in which the researcher
p.000056: anticipates that many subjects will be unable to consent:
p.000056:
p.000056: Research protocols are sometimes designed to address conditions occurring suddenly and rendering the
p.000056: patients/subjects incapable of giving informed consent. Examples are head trauma, cardiopulmonary arrest and
p.000056: stroke. The investigation cannot be done with patients who can give informed consent in time and there
p.000056: may not be time to locate a person having the authority to give permission.
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p.000057: In such circumstances it is often necessary to precede with the research interventions very soon after the onset of the
p.000057: condition in order to evaluate an investigational treatment or develop the desired knowledge. Consent should be
p.000057: taken from the guardian if available or from an authorized body in the health facility. As this class of emergency
p.000057: exception can be anticipated, the researcher must secure the review and approval of an ethical review
p.000057: committee before initiating the study. If possible, an attempt should be made to identify a population that is likely
p.000057: to develop the condition to be studied. This can be done readily, for example, if the condition is one that
p.000057: recurs periodically in individuals; examples include grand mal seizures and alcohol binges. In such cases, prospective
p.000057: subjects should be contacted while fully capable of informed consent, and invited to consent to their involvement as
p.000057: research subjects during future periods of incapacitation. If they are patients of an independent physician who is
p.000057: also the physician-researcher, the physician should likewise seek their consent while they are fully capable of
p.000057: informed consent.
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General/Other / Undue Influence
Searching for indicator undue influence:
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p.000020: 5.1 What is ‘Informed Consent’? 41
p.000020: 5.2 Obtaining informed consent 42
p.000020: 5.3 Process 46
p.000020: 5.4 Language 46
p.000020: 5.5 Comprehension 46
p.000020: 5.6 Documentation of consent 47 5.7 Waiving of the
p.000020: consent requirement 48
p.000020: 5.8 Renewing consent 48
p.000020: 5.9 Cultural considerations 49
p.000020: 5.10 Use of biological materials from subjects in clinical trials 50
p.000020: 5.11 Use of medical records and biological specimens 50
p.000020: 5.12 Secondary use of research records or biological specimens 51
p.000020: 5.13 Obligations of sponsors and investigators 52
p.000020: 5.14 Withholding information and deception 53
p.000020: 5.15 Intimidation and undue influence 54
p.000020: 5.16 Equitable distribution of burdens and benefits in the selection of groups of subjects in research
p.000055: 55
p.000055: 5.17 Exception to the requirement for informed consent in studies of emergencies
p.000056: 56
p.000056: 5.18 Inducement to participate 57
p.000056: 5.19 Incompetent persons 57
p.000056: 5.20 Withdrawal from a study 58
p.000056: 5.21 Research involving vulnerable persons 58
p.000056: 5.22 Research involving vulnerable groups include 59
p.000056: 5.22.1 Research involving children 59
p.000056: 5.22.2 Women as research subjects 59
p.000056: 5.22.3 Pregnant women as research participants 60
p.000056: 5.23References 62
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p.000056: 12. Annexes 63
p.000056: 6.1 National Application Form For Ethical Approval of a Research Project
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p.000085: elements review, how to apply, review procedures and decision making.
p.000085:
p.000085: The fifth chapter is about the Informed Consent, its definition, importance, and components. It explains the
p.000085: information that the research subject should know and understand before being involved in the study. The
p.000085: chapter explains the procedure and process by which the informed consent should be obtained from the subjects
p.000085: included in the research. Other principles about the informed consent were included and explained in this
p.000085: chapter. This includes the language, comprehension, documentation of consent, waiver of the consent
p.000085: requirement, renewing consent and other cultural considerations.
p.000085:
p.000085: It also goes through the regulations of the use of biological materials from subjects in clinical trials, the
p.000085: use of medical records and biological specimens. It explains some of the basic principles about the secondary
p.000085: use of research records or biological specimens together with some obligations to be followed by both sponsors
p.000085: and investigators. It covers the issues related to the possible influence on the research subject like
p.000085: withholding information and deception, intimidation and undue influence. It also aims at assuring the equitable
p.000085: distribution of burdens and benefits in the selection of groups of subjects in research.
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p.000085: The regulation by which an exception to the requirement for informed consent in studies of emergencies
p.000085: in which the researcher anticipates that many subjects will be unable to give consent is also included in this
p.000085: chapter. Special interest is given to the inducement of research subjects to participate and the consent taken from
p.000085: incompetent persons or vulnerable persons. It also emphasizes the right of withdrawal from a study.
p.000085:
p.000085: The annexes include the, the National Application Form for ethical committee (A & B), and the
p.000085: Informed Consent form guidelines (form c), and the list of the National Research Ethic Committee members.
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p.000054: the purpose of some procedures until the research is completed and after the conclusion of the study they
p.000054: are given the omitted information.
p.000054: In other cases, because a request for permission to withhold some information would jeopardize the validity
p.000054: of the research, subjects are not told that some information has been withheld until the research has been
p.000054: completed. Any such procedure must receive the explicit approval of the ethical review committee.
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p.000055: Intimidation in any form invalidates informed consent. Prospective subjects who are patients often
p.000055: depend for medical care upon the physician/investigator, who consequently has certain credibility in
p.000055: their eyes, and whose influence over them may be considerable, particularly if the study protocol has a
p.000055: therapeutic component. They may fear, for example, that refusal to participate would damage the therapeutic
p.000055: relationship or result in the withholding of health services. The physician/investigator must assure them that
p.000055: their decision on whether to participate will not affect the therapeutic relationship or other benefits
p.000055: to which they are entitled. In this situation the ethical review committee should consider whether a
p.000055: neutral third party should seek informed consent.
p.000055: The prospective subject must not be exposed to undue influence. The borderline between justifiable
p.000055: persuasion and undue influence is imprecise, however. The researcher should give justifiable assurances
p.000055: about the benefits, risks or inconveniences of the research, for example, or induce a close
p.000055: relative or a community leader to influence a prospective subject's decision.
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p.000056: 5.16 Equitable distribution of burdens and benefits in the selection of groups of subjects in research:
p.000056:
p.000056: 1- Groups or communities to be subjects of research should be selected so that the burdens and benefits of the
p.000056: research will be equitably distributed. The exclusion of groups or communities that might benefit from study
p.000056: participation must be justified.
p.000056:
p.000056: 2- Members of vulnerable groups also have the same entitlement to access to the benefits of investigational
p.000056: interventions that show promise of therapeutic benefit as non vulnerable groups particularly when no superior
p.000056: or equivalent approaches to therapy are available.
p.000056:
p.000056: 3- Overuse of certain groups, such as the poor or the administratively available, is unjustified.
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General/Other / cioms guidelines
Searching for indicator cioms:
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p.000085: to its representative Dr. Mohammed Abdu Arub, for his encouragement and deep concern.
p.000085: If not for the hard work of Prof. Suad Sulaiman, Dr. Mustafa Khidir El Niemiri, Dr. Samia Habbani and the
p.000085: invaluable advice from Prof. Abd Alhamid Ibrahim, this work would have not been prepared. The DoR is
p.000085: indebted and grateful to them.
p.000085: Our thanks are due to all the research ethics committee members and special thanks to Prof. Omer
p.000085: AbdAlaziz –Ribat University for his continuous technical and moral support for these guidelines to see light.
p.000085: Lastly, but not least, our thanks to the former Director of DoR, Dr. Ahmed Eltigani, for his
p.000085: contribution in the initial preparation of this guidelines; and to all the secretarate members.
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p.000085: Dr. Iman Abdalla Mustafa
p.000085: Director, Directorate of Health Research
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p.000085: Abbreviations
p.000085: CIOMS : Council for International Organization of Medical Sciences DOH : Declaration of Helsinki.
p.000085: DOR : Directorate of Research.
p.000085: DSMB : Data and Safety Monitoring Board FMOH : Federal Ministry of Health
p.000085: HRC : Health Research Council
p.000085: IEC : Institutional Ethics Committee.
p.000085: IERC : Institution Ethical Review Committee IOMS : Islamic Organization of Medical Sciences JPRM
p.000085: : Joined Programmes Review Mission
p.000085: NTAC : National Technical and Advisory Committee NHREC : National Health Research Ethics Committee. PI
p.000085: : Principal investigator.
p.000085: SERC : State Ethical Review Committee SAEs : Serious Adverse Events.
p.000085: TOR : Terms of Reference
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p.000085: J
p.000085:
p.000085: Minister Preface
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p.000004: the reasons for proposing involvement of human subjects; the nature and degree of any known risks to the subjects; the
p.000004: sources from which it is proposed to recruit subjects; and the means proposed for ensuring that subjects' consent will
p.000004: be adequately informed and voluntary. The protocol should be scientifically and ethically appraised
p.000004: by one or more suitably constituted review bodies, independent of the investigators.
p.000004:
p.000004: The mere formulation of ethical guidelines for biomedical research involving human subjects will hardly resolve
p.000004: all the moral doubts that can
p.000004:
p.000005: 5
p.000005:
p.000005: arise in association with much research, but the guidelines can at least draw the attention of sponsors, investigators
p.000005: and ethical review committees to the need to consider carefully the ethical implications of research protocols and the
p.000005: conduct of research, and thus conduct of high scientific and ethical standards of biomedical research.
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p.000006: 6
p.000006:
p.000006: References:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: 1- Council for International Organizations of Medical Sciences (CIOMS): Ethical Guidelines for
p.000006: Biomedical Research Involving Human Subjects, World Health Organization, Geneva, Switzerland 2002.
p.000006: 2- World Medical Association: WMA declaration of Helsinki, Adopted by the 18th World Medical Assembly,
p.000006: Helsinki, Finland, June 1964.
p.000006: 3- World Medical Association (2005): Medical Ethics Manual, The World Medical Association, B.P. 63, 01212
p.000006: Ferney-Voltaire Cedex, France.
p.000006: 4- National Health and Medical Research Council: National Statement on Ethical Conduct in Research
p.000006: Involving Preamble: 28 June 1999.
p.000006:
p.000006:
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p.000007:
p.000008: 8
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p.000008:
p.000008:
p.000008: Chapter 2
p.000008: Principles of Ethics for Research Involving Human Subjects
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...
p.000014: be justifiable on scientific grounds. This requirement is meant to eliminate projects that are unlikely to
p.000014: succeed, for example, because they are methodologically inadequate, or that, even if successful, will likely produce
p.000014: trivial results.
p.000014: 17. In the purely scientific application of medical research carried out on a human being, it is the duty of
p.000014: the physician to remain the protector of the life and health well-being of that person on whom biomedical research is
p.000014: being carried out.
p.000014: 18. Paragraphs 18 and 19 of the DoH clearly favour the consideration of social value in the
p.000014: evaluation of research projects. The importance of the project’s objective, understood
p.000014:
p.000014:
p.000014:
p.000015: 15
p.000015:
p.000015: as both scientific and social importance, should outweigh the risks and burdens to research subjects.
p.000015: 19. In research on humans, the interest of science and society should never take precedence over considerations
p.000015: related to the well- being of the subject.
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p.000016: 16
p.000016:
p.000016: References:
p.000016: http://www.nhmrc.gov.au/issues/humanlpreamble.htm. Produced by NHMRC
p.000016: 1- Council for International Organizations of Medical Sciences (CIOMS): Ethical Guidelines for
p.000016: Biomedical Research Involving Human Subjects, World Health Organization, Geneva, Switzerland 2002.
p.000016: 2- World Medical Association: WMA declaration of Helsinki, Adopted by the 18th World Medical Assembly,
p.000016: Helsinki, Finland, June 1964.
p.000016: 3- World Medical Association (2005): Medical Ethics Manual, The World Medical Association, B.P. 63, 01212
p.000016: Ferney-Voltaire Cedex, France.
p.000016: 4- National Health and Medical Research Council: National Statement on Ethical Conduct in Research
p.000016: Involving Preamble: 28 June 1999.
p.000016: Date created by NHMRC. Accessed May 2005.
p.000016: 5- Operational Guidelines for Ethics Committees That Review Biomedical Research, WHO 2000.
p.000016: 6- International guidelines for Ethical Review of Epidemiological Studies, CIOMS, 1991
p.000016: 7- Serour G I, Implementation of ethics Review Committee in WHO Workshop [on Ethical Issues in Research in
p.000016: Reproductive Health], Cairo 2001.
p.000016:
p.000016:
p.000016:
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p.000016:
p.000017: 17
p.000017:
p.000017: 8- Langat S K, The role of Ethics Review in Health Research, in The Africa Malaria Vaccine Testing Network
p.000017: Workshop on Ethics in Health Research in Africa, Kisumu, Kenya 2001.
p.000017: 9- Botha J, the Role of Ethical Review in Health Research, Workshop on Ethics in Health Research in
p.000017: Africa, Kisumu, Kenya 2001.
p.000017: 10- World Association Declaration of Helsinki, Ethical Principle for Medical Research Involving Human Subjects, 2000
p.000017: 11- TDR, WHO, Scientific and Ethical Review group Terms of Reference and Procedures, 1999.
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p.000018: 18
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p.000018:
p.000018: Chapter 3
p.000018:
p.000018: Research Ethics Committee
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p.000027: health research that takes place inside the state excluding the following researches:
p.000027: i. The experimental research on the human subjects.
p.000027:
p.000027: ii. Researches linked to external bodies (i.e. out side Sudan).
p.000027:
p.000027: iii. Researches that take place in more than one state (Interstate).
p.000027:
p.000027: 5. The State and institutional ethics committees work under the supervision of the NHREC.
p.000027: 6. The State and institutional ethics committees should present regular biannual reports of their research
p.000027: reviewing activities and the research proposals that have been approved ethically to the NHREC.
p.000027: 7. A copy of approved research proposals and copies of the ethical certificates should be enclosed with
p.000027: the report.
p.000027: 8. The NHREC discusses the research proposals and the reports of the State and institutions ethics committees in their
p.000027: regular meetings.
p.000027: II. The state and institution ethics committees should follow the same guidelines, relevant to the research
p.000027: proposal submitted to them.
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p.000028: 28
p.000028:
p.000028: 3.9 References:
p.000028:
p.000028: 1. Council for International Organizations of Medical Sciences International Ethical Guidelines for
p.000028: Biomedical Research Involving Human Subjects
p.000028: (CIOMS) Geneva 2002.ISBN 92 9036 075 5
p.000028: 2. Council for International Organizations of Medical Sciences International Ethical Guidelines for
p.000028: Biomedical Research Involving Human Subjects (An Islamic Perspective):
p.000028: 3. Indian Council of Medical Research. Guidelines for preparing Standard Operating Procedures (SOP) for
p.000028: Institutional Ethics Committee for Human Research. URL: http://www.icmr.org.ind/ Produced by ICMR. Date
p.000028: created by ICMR. Accessed May 2006.
p.000028: 4. Pakistan Medical Research Council. National Bioethics Committee. URL:http://www.pmrc.org.pk/ Produced by PMRC.
p.000028: Date created by ICMR. Accessed
p.000028: May 2006.
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p.000029: 29
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p.000030: 30
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p.000030:
p.000030: Chapter 4
p.000030: Ethical Clearance Procedure
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p.000039: 6. Any new information related to the study should be communicated.
p.000039: 7. Premature termination of study should be notified with reasons along with summary of the data obtained
p.000039: so far.
p.000039: 8. Change of investigators / sites should be informed.
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p.000040: 40
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p.000040: Chapter 5
p.000040: Informed Consent
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p.000042: 42
p.000042:
p.000042: 5.1 What is ‘Informed Consent’?
p.000042:
p.000042: The Council for International Organizations of Medical Sciences (CIOMS) Guidelines has defined informed
p.000042: consent as:
p.000042:
p.000042: Approval to participate in a study or trial given by a competent individual who:
p.000042:
p.000042: • Has received the necessary information (verbally and in writing).
p.000042: • Has adequately understood the information.
p.000042: • After considering the information, has arrived at a decision without having been subjected to compulsion,
p.000042: undue influence, incentive, or pressure.
p.000042: • In the case of those who are not capable, has the legal authorization to approve on behalf of the incompetent.
p.000042:
p.000042: Informed consent is based on the principle that competent individuals are entitled to choose freely whether to
p.000042: participate in research. It protects the individual's freedom of choice and respects the individual's autonomy.
p.000042: As an additional safeguard, it must always be complemented by the approval of an independent review of an ethical
p.000042: research committee.
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p.000043: 43
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p.000043: 5.2 Obtaining informed consent:
p.000043:
p.000043:
p.000043: Before requesting an individual's consent to participate in research, the investigator must
...
p.000061: should ensure that prospective subjects who are pregnant are adequately informed about the risks and benefits to
p.000061: themselves, their pregnancies, the foetus and their subsequent offspring, and their fertility.
p.000061: Research in this population should be performed only if it is relevant to the particular health needs of a pregnant
p.000061: woman or
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p.000062: 62
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p.000062: her foetus, or to the health needs of pregnant women in general, and, when appropriate, if it is supported by reliable
p.000062: evidence from animal experiments, particularly as to risks of teratogenicity and mutagenicity.
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p.000063: 63
p.000063:
p.000063: 5.23 References:
p.000063:
p.000063: 1. TDR/PRD/ETHICS/2000."Operational Guidelines for Ethics Committees That Review Biomedical Research"
p.000063:
p.000063: 2. Council for International Organizations of Medical Sciences (CIOMS) International Ethical
p.000063: Guidelines for Biomedical Research Involving Human Subjects. CIOMS, Geneva 2002. ISBN 92 9036 075 5
p.000063:
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p.000064: Annexes
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p.000066:
p.000066: The Republic of Sudan Federal Ministry of Health Health Research Council
p.000066: National Health Research Ethics Committee
p.000066:
p.000066: NATIONAL APPLICATION FORM FOR ETHICAL APPROVAL OF A RESEARCH PROJECT
p.000066:
...
General/Other / cultural difference
Searching for indicator culturally:
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p.000049: benefits of products being tested or about alternatives to them. Subjects should be given such information
p.000049: promptly.
p.000050: 50
p.000050:
p.000050: In many clinical trials, results are not disclosed to subjects and investigators until the study is
p.000050: concluded. This is ethically acceptable if an ethical review committee has approved their non-disclosure.
p.000050:
p.000050: 5.9 Cultural considerations:
p.000050:
p.000050: In some cultures an investigator may enter a community to conduct research or approach prospective subjects
p.000050: for their individual consent only after obtaining permission from a community leader, a council of elders, or another
p.000050: designated authority. Such customs must be respected.
p.000050:
p.000050: In no case, however, may the permission of a community leader or other authority substitute for individual informed
p.000050: consent. In some populations the use of a number of local languages may complicate the communication of
p.000050: information to potential subjects and the ability of an investigator to ensure that they truly understand
p.000050: it. Many people in all cultures are unfamiliar with, or do not readily understand, scientific concepts
p.000050: such as those of placebo or randomization.
p.000050:
p.000050: Sponsors and investigators should develop culturally appropriate ways to communicate information that is necessary
p.000050: for adherence to the standard required in the informed consent process. In addition, they should describe and
p.000050: justify in the research protocol the procedure they plan to use in communicating information to subjects.
p.000050:
p.000050: For collaborative research in developing countries the research project should include the provision of
p.000050: resources to ensure that informed consent
p.000050:
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p.000050:
p.000051: 51
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p.000051: can indeed be obtained legitimately within different linguistic and cultural settings.
p.000051:
p.000051:
p.000051:
p.000051: 5.10 Use of biological materials from subjects in clinical trials:
p.000051:
p.000051: Consent forms for the research protocol should include a separate section for clinical-trial subjects requested to
p.000051: provide their consent for the use of their biological specimens for research. Separate consent may be appropriate
p.000051: in some cases (e.g., if investigators are requesting permission to conduct basic research which is not a
p.000051: necessary part of the clinical trial), but not in others (e.g., the clinical trial requires the use of
p.000051: subjects’ biological materials).
p.000051:
p.000051:
p.000051:
p.000051: 5.11 Use of medical records and biological specimens:
p.000051:
p.000051:
p.000051:
...
General/Other / declaration of helsinki
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p.000085: If not for the hard work of Prof. Suad Sulaiman, Dr. Mustafa Khidir El Niemiri, Dr. Samia Habbani and the
p.000085: invaluable advice from Prof. Abd Alhamid Ibrahim, this work would have not been prepared. The DoR is
p.000085: indebted and grateful to them.
p.000085: Our thanks are due to all the research ethics committee members and special thanks to Prof. Omer
p.000085: AbdAlaziz –Ribat University for his continuous technical and moral support for these guidelines to see light.
p.000085: Lastly, but not least, our thanks to the former Director of DoR, Dr. Ahmed Eltigani, for his
p.000085: contribution in the initial preparation of this guidelines; and to all the secretarate members.
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p.000085: Dr. Iman Abdalla Mustafa
p.000085: Director, Directorate of Health Research
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p.000085: Abbreviations
p.000085: CIOMS : Council for International Organization of Medical Sciences DOH : Declaration of Helsinki.
p.000085: DOR : Directorate of Research.
p.000085: DSMB : Data and Safety Monitoring Board FMOH : Federal Ministry of Health
p.000085: HRC : Health Research Council
p.000085: IEC : Institutional Ethics Committee.
p.000085: IERC : Institution Ethical Review Committee IOMS : Islamic Organization of Medical Sciences JPRM
p.000085: : Joined Programmes Review Mission
p.000085: NTAC : National Technical and Advisory Committee NHREC : National Health Research Ethics Committee. PI
p.000085: : Principal investigator.
p.000085: SERC : State Ethical Review Committee SAEs : Serious Adverse Events.
p.000085: TOR : Terms of Reference
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p.000085: Minister Preface
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p.000003: biological variation.
p.000003: • Studies designed to determine the consequences for individuals and communities of specific preventive or
p.000003: therapeutic measures.
p.000003: • Studies concerning human health-related behaviour in a variety of circumstances and environments (1).
p.000003:
p.000003: The research may be concerned with the social environment, manipulating environmental factors in a way
p.000003: that could affect incidentally- exposed individuals. It is defined in broad terms in order to embrace field studies of
p.000003: pathogenic organisms and toxic chemicals under investigation for health-related purposes.
p.000003:
p.000003: Biomedical research involving human subjects is to be distinguished from the practice of medicine, public
p.000003: health and other forms of health care, which is designed to contribute directly to the health of individuals
p.000003: or communities. Prospective subjects may find it confusing when research and practice are to be conducted
p.000003: simultaneously, as when research is designed to obtain new information about the efficacy of a drug or other
p.000003: therapeutic, diagnostic or preventive modality.
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p.000004: 4
p.000004:
p.000004: 1.2 What is ethics in research?
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p.000004: “Ethics is the study of morality – careful and systematic reflection on analysis of moral decisions and
p.000004: behaviour” (2). Ethics and ethical principles extend to all spheres of human activity (3).
p.000004:
p.000004: The Declaration of Helsinki issued by the World Medical Association in 1964, is the fundamental document in the
p.000004: field of ethics in biomedical research and has influenced the formulation of international, regional and
p.000004: national legislation and codes of conduct. The declaration, amended several times, most recently in 2002, is a
p.000004: comprehensive international statement of the ethics of research involving human subjects. It sets out ethical
p.000004: guidelines for physicians engaged in both clinical and non-clinical biomedical research(4).
p.000004:
p.000004: Research involving human subjects should be carried out only by, or strictly supervised by, suitably
p.000004: qualified and experienced investigators and in accordance with a protocol that clearly states: the aim of the research;
p.000004: the reasons for proposing involvement of human subjects; the nature and degree of any known risks to the subjects; the
p.000004: sources from which it is proposed to recruit subjects; and the means proposed for ensuring that subjects' consent will
p.000004: be adequately informed and voluntary. The protocol should be scientifically and ethically appraised
p.000004: by one or more suitably constituted review bodies, independent of the investigators.
p.000004:
p.000004: The mere formulation of ethical guidelines for biomedical research involving human subjects will hardly resolve
p.000004: all the moral doubts that can
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p.000005: 5
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p.000005: arise in association with much research, but the guidelines can at least draw the attention of sponsors, investigators
p.000005: and ethical review committees to the need to consider carefully the ethical implications of research protocols and the
p.000005: conduct of research, and thus conduct of high scientific and ethical standards of biomedical research.
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p.000006: References:
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p.000006:
p.000006:
p.000006: 1- Council for International Organizations of Medical Sciences (CIOMS): Ethical Guidelines for
p.000006: Biomedical Research Involving Human Subjects, World Health Organization, Geneva, Switzerland 2002.
p.000006: 2- World Medical Association: WMA declaration of Helsinki, Adopted by the 18th World Medical Assembly,
p.000006: Helsinki, Finland, June 1964.
p.000006: 3- World Medical Association (2005): Medical Ethics Manual, The World Medical Association, B.P. 63, 01212
p.000006: Ferney-Voltaire Cedex, France.
p.000006: 4- National Health and Medical Research Council: National Statement on Ethical Conduct in Research
p.000006: Involving Preamble: 28 June 1999.
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p.000008: 8
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p.000008: Chapter 2
p.000008: Principles of Ethics for Research Involving Human Subjects
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p.000013: is the potential for an adverse outcome (harm) to occur. It has two components: (1) the
p.000013: likelihood of the occurrence of harm (from highly unlikely to
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p.000014: very likely), and (2) the severity of the harm (from trivial to permanent severe disability or death). A
p.000014: highly unlikely risk of a trivial harm would not be problematic for a good research project. At the other
p.000014: end of the spectrum, a likely risk of a serious harm would be unacceptable unless the project provided the only
p.000014: hope of treatment for terminally ill research subjects. In between these two extremes, paragraph 17 of the DOH requires
p.000014: researchers to adequately assess the risks and be sure that they can be managed. If the risk is entirely
p.000014: unknown, then the researcher should not proceed with the project until some reliable data are
p.000014: available, for example, from laboratory studies or experiments on animals.
p.000014: 16. Paragraph 11 of the declaration of Helsinki (DoH) requires that medical research involving human subjects must
p.000014: be justifiable on scientific grounds. This requirement is meant to eliminate projects that are unlikely to
p.000014: succeed, for example, because they are methodologically inadequate, or that, even if successful, will likely produce
p.000014: trivial results.
p.000014: 17. In the purely scientific application of medical research carried out on a human being, it is the duty of
p.000014: the physician to remain the protector of the life and health well-being of that person on whom biomedical research is
p.000014: being carried out.
p.000014: 18. Paragraphs 18 and 19 of the DoH clearly favour the consideration of social value in the
p.000014: evaluation of research projects. The importance of the project’s objective, understood
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p.000015: as both scientific and social importance, should outweigh the risks and burdens to research subjects.
p.000015: 19. In research on humans, the interest of science and society should never take precedence over considerations
p.000015: related to the well- being of the subject.
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p.000016: 16
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p.000016: References:
p.000016: http://www.nhmrc.gov.au/issues/humanlpreamble.htm. Produced by NHMRC
p.000016: 1- Council for International Organizations of Medical Sciences (CIOMS): Ethical Guidelines for
p.000016: Biomedical Research Involving Human Subjects, World Health Organization, Geneva, Switzerland 2002.
p.000016: 2- World Medical Association: WMA declaration of Helsinki, Adopted by the 18th World Medical Assembly,
p.000016: Helsinki, Finland, June 1964.
p.000016: 3- World Medical Association (2005): Medical Ethics Manual, The World Medical Association, B.P. 63, 01212
p.000016: Ferney-Voltaire Cedex, France.
p.000016: 4- National Health and Medical Research Council: National Statement on Ethical Conduct in Research
p.000016: Involving Preamble: 28 June 1999.
p.000016: Date created by NHMRC. Accessed May 2005.
p.000016: 5- Operational Guidelines for Ethics Committees That Review Biomedical Research, WHO 2000.
p.000016: 6- International guidelines for Ethical Review of Epidemiological Studies, CIOMS, 1991
p.000016: 7- Serour G I, Implementation of ethics Review Committee in WHO Workshop [on Ethical Issues in Research in
p.000016: Reproductive Health], Cairo 2001.
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p.000017: 8- Langat S K, The role of Ethics Review in Health Research, in The Africa Malaria Vaccine Testing Network
p.000017: Workshop on Ethics in Health Research in Africa, Kisumu, Kenya 2001.
p.000017: 9- Botha J, the Role of Ethical Review in Health Research, Workshop on Ethics in Health Research in
p.000017: Africa, Kisumu, Kenya 2001.
p.000017: 10- World Association Declaration of Helsinki, Ethical Principle for Medical Research Involving Human Subjects, 2000
p.000017: 11- TDR, WHO, Scientific and Ethical Review group Terms of Reference and Procedures, 1999.
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p.000018: Research Ethics Committee
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p.000020: 3.1 National Research Health Ethics Committee (NRHEC)
p.000020: 3.1.1 Historical background:
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General/Other / participants in a control group
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p.000012: investigation if the hazards are found to outweigh the potential benefits.
p.000012: 9. In publication of the results of his or her research, the physician is obliged to preserve the accuracy of the
p.000012: results.
p.000012: 10. In any research on human beings, each potential subject must be adequately informed of the aims, methods,
p.000012: anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should
p.000012: be informed that he or she is at liberty to abstain from participation in the study and that he or she is free
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p.000013: to withdraw her consent to participation at any time. The physician should then obtain the subject's
p.000013: freely given informed consent, preferably in writing.
p.000013: 11. In case of legal incompetence, informed consent should be obtained from the legal guardian in
p.000013: accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain
p.000013: informed consent, or when the subject is a minor, permission from the legally responsible person/authority replaces
p.000013: that of the subject in accordance with national legislation.
p.000013: 12. In any study, every patient- including those of a control group, if any- should be assured of the best
p.000013: proven diagnostic and therapeutic method. This does not exclude the use of inert placebo in studies
p.000013: where no proven diagnostic or therapeutic method exists.
p.000013: 13. The refusal of the patient to participate in a study must never interfere with the physician-patient
p.000013: relationship.
p.000013: 14. The physician can combine medical research with professional care, the objective being the acquisition of
p.000013: new knowledge, only to the extent that medical research is justified by its potential diagnostic or
p.000013: therapeutic value for the patient.
p.000013: 15. It is necessary for the researcher to demonstrate that the risks to the research subjects are not unreasonable or
p.000013: disproportionate to the expected benefits of the research, which may not even go to the research subjects. A risk
p.000013: is the potential for an adverse outcome (harm) to occur. It has two components: (1) the
p.000013: likelihood of the occurrence of harm (from highly unlikely to
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p.000014: very likely), and (2) the severity of the harm (from trivial to permanent severe disability or death). A
p.000014: highly unlikely risk of a trivial harm would not be problematic for a good research project. At the other
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p.000012: results.
p.000012: 10. In any research on human beings, each potential subject must be adequately informed of the aims, methods,
p.000012: anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should
p.000012: be informed that he or she is at liberty to abstain from participation in the study and that he or she is free
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p.000013: to withdraw her consent to participation at any time. The physician should then obtain the subject's
p.000013: freely given informed consent, preferably in writing.
p.000013: 11. In case of legal incompetence, informed consent should be obtained from the legal guardian in
p.000013: accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain
p.000013: informed consent, or when the subject is a minor, permission from the legally responsible person/authority replaces
p.000013: that of the subject in accordance with national legislation.
p.000013: 12. In any study, every patient- including those of a control group, if any- should be assured of the best
p.000013: proven diagnostic and therapeutic method. This does not exclude the use of inert placebo in studies
p.000013: where no proven diagnostic or therapeutic method exists.
p.000013: 13. The refusal of the patient to participate in a study must never interfere with the physician-patient
p.000013: relationship.
p.000013: 14. The physician can combine medical research with professional care, the objective being the acquisition of
p.000013: new knowledge, only to the extent that medical research is justified by its potential diagnostic or
p.000013: therapeutic value for the patient.
p.000013: 15. It is necessary for the researcher to demonstrate that the risks to the research subjects are not unreasonable or
p.000013: disproportionate to the expected benefits of the research, which may not even go to the research subjects. A risk
p.000013: is the potential for an adverse outcome (harm) to occur. It has two components: (1) the
p.000013: likelihood of the occurrence of harm (from highly unlikely to
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p.000014: very likely), and (2) the severity of the harm (from trivial to permanent severe disability or death). A
p.000014: highly unlikely risk of a trivial harm would not be problematic for a good research project. At the other
p.000014: end of the spectrum, a likely risk of a serious harm would be unacceptable unless the project provided the only
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p.000034: 13. A statement describing any compensation for study participation (including expenses and access to medical care) to
p.000034: be given to research participants.
p.000034: 14. A description of the arrangements for indemnity, if applicable (in study-related injuries).
p.000034: . A description of the arrangements for insurance coverage for research participants, if applicable.
p.000034: . All significant previous decisions (e.g., those leading to a negative decision or modified
p.000034: protocol) by other ethical committee or regulatory authorities for the proposed study (whether in the
p.000034: same location or elsewhere) and an indication of the modification(s) to the protocol made on that account. The
p.000034: reasons for negative decisions should be provided.
p.000034: . Plans for publication of results – positive or negative- while maintaining the privacy
p.000034: and confidentiality of the study participants.
p.000034: 18. Any other information relevant to the study.
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p.000035: 4.4 Elements of ethical review
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p.000035: 1. Ethical issues in the design of the study.
p.000035: 2. Examination of predictable risks/harms.
p.000035: 3. Examination of potential benefits.
p.000035: 4. Procedure for selection of subjects in methodology including inclusion/ exclusion, withdrawal criteria and other
p.000035: issues like advertisement details.
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p.000035: 5. Management of research related injuries, adverse events.
p.000035: 6. Compensation provisions.
p.000035: 7. Justification for placebo in control, if any.
p.000035: 8. Availability of products after the study, if applicable.
p.000035: 9. Patient information sheet and informed consent form in local language (See chapter 5).
p.000035: 10. Protection of privacy and confidentiality.
p.000035: l1. Involvement of the community, wherever necessary.
p.000035: 12. Plans for data analysis and reporting.
p.000035: 13. Adherence to all regulatory requirements and applicable guidelines.
p.000035: 14. Competence of investigators, research and supporting staff.
p.000035: 15. Facilities and infrastructure of study sites.
p.000035: 16. Criteria for withdrawal of patients, suspending or terminating the study.
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p.000035: 4.5 Application
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p.000035: 1. Apply to the NHREC secretariat with all the required documents.
p.000035: 2. Reviewable expenses fees should be paid.
p.000035: 3. Receivable letter accrediting application will be issued.
p.000035: 4. The researcher will be informed about the date of the committee meeting so as to be available for any clarification.
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p.000036: 4.6 Review procedures
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p.000036: 1. The meeting of the NHREC should be held on scheduled intervals as prescribed and additional meetings may be held as
p.000036: and when the proposals are received for review.
p.000036: 2. The Directorate of Research will submit the research proposals for technical review one month before
p.000036: submission to the ethics committee.
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p.000049: example, new information may have become known, either from the study or from other sources, about the risks or
p.000049: benefits of products being tested or about alternatives to them. Subjects should be given such information
p.000049: promptly.
p.000050: 50
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p.000050: In many clinical trials, results are not disclosed to subjects and investigators until the study is
p.000050: concluded. This is ethically acceptable if an ethical review committee has approved their non-disclosure.
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p.000050: 5.9 Cultural considerations:
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p.000050: In some cultures an investigator may enter a community to conduct research or approach prospective subjects
p.000050: for their individual consent only after obtaining permission from a community leader, a council of elders, or another
p.000050: designated authority. Such customs must be respected.
p.000050:
p.000050: In no case, however, may the permission of a community leader or other authority substitute for individual informed
p.000050: consent. In some populations the use of a number of local languages may complicate the communication of
p.000050: information to potential subjects and the ability of an investigator to ensure that they truly understand
p.000050: it. Many people in all cultures are unfamiliar with, or do not readily understand, scientific concepts
p.000050: such as those of placebo or randomization.
p.000050:
p.000050: Sponsors and investigators should develop culturally appropriate ways to communicate information that is necessary
p.000050: for adherence to the standard required in the informed consent process. In addition, they should describe and
p.000050: justify in the research protocol the procedure they plan to use in communicating information to subjects.
p.000050:
p.000050: For collaborative research in developing countries the research project should include the provision of
p.000050: resources to ensure that informed consent
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p.000051: can indeed be obtained legitimately within different linguistic and cultural settings.
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p.000051: 5.10 Use of biological materials from subjects in clinical trials:
p.000051:
p.000051: Consent forms for the research protocol should include a separate section for clinical-trial subjects requested to
p.000051: provide their consent for the use of their biological specimens for research. Separate consent may be appropriate
p.000051: in some cases (e.g., if investigators are requesting permission to conduct basic research which is not a
p.000051: necessary part of the clinical trial), but not in others (e.g., the clinical trial requires the use of
p.000051: subjects’ biological materials).
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Orphaned Trigger Words
p.000008: 8. Chapter 2: Principles of ethics for research involving Human Subjects
p.000008: 8
p.000008: 2.1 The major principles 10
p.000008: 2.2 Other principles 12
p.000008: 2.3 References 15
p.000008: 9. Chapter 3: Research Ethics Committees 16
p.000008: 3.1 National Research Health Ethics Committee (NHREC) 18
p.000008: 3. 1.1 Historical background 18
p.000008: 3.1.2 Regulation of the National Health Research Ethics Committee (NHREC)
p.000020: 20
p.000020: 3.1.2.1 Authority under which NHREC will be constituted 20
p.000020: 3.1.2.2 Responsibilities of (NHREC) 20
p.000020: 3.1.2.3 Membership of the (HREC) 21
p.000020: 3.1. 2.4 Term of the membership 23
p.000020: 3.1.3 Meetings 24
p.000020: 3.1.3.1 Quorum 24
p.000020: 3.1.4 Independent consultants 25
p.000020: 3.1.5 Operational costs 25 3.1.6 Record
p.000020: keeping and Archiving 25
p.000020: 3.1.7 Updating NHREC members 26
p.000020: 3.2 State and Institutional Ethics Committees guidelines 27
p.000020: 3.3 References 28
p.000020: 10. Chapter 4: Ethical clearance procedure 29
p.000020: 4.1 How to get the ethical clearance? 31
p.000020: C
p.000020:
p.000020: 4.2 Flowchart for getting ethical clearance 32
p.000020: 4.3 Prepare 33
p.000020: 4.4 Elements of ethical review 34
p.000020: 4.5 Application 34
p.000020: 4.6 Review procedures 35
p.000020: 4.7 Expedited review 35
p.000020: 4.8 Decision making 36 4.9 Communicating
p.000020: the decision 37
p.000020: 4.10Follow up procedures 38
p.000020: 11. Chapter 5: Informed Consent 39
p.000020: 5.1 What is ‘Informed Consent’? 41
p.000020: 5.2 Obtaining informed consent 42
p.000020: 5.3 Process 46
p.000020: 5.4 Language 46
p.000020: 5.5 Comprehension 46
p.000020: 5.6 Documentation of consent 47 5.7 Waiving of the
p.000020: consent requirement 48
p.000020: 5.8 Renewing consent 48
p.000020: 5.9 Cultural considerations 49
p.000020: 5.10 Use of biological materials from subjects in clinical trials 50
p.000020: 5.11 Use of medical records and biological specimens 50
p.000020: 5.12 Secondary use of research records or biological specimens 51
p.000020: 5.13 Obligations of sponsors and investigators 52
p.000020: 5.14 Withholding information and deception 53
p.000020: 5.15 Intimidation and undueXinfluence 54
p.000020: 5.16 Equitable distribution of burdens and benefits in the selection of groups of subjects in research
p.000055: 55
p.000055: 5.17 Exception to the requirement for informed consent in studies of emergencies
p.000056: 56
p.000056: 5.18 Inducement to participate 57
p.000056: 5.19 Incompetent persons 57
p.000056: 5.20 Withdrawal from a study 58
p.000056: 5.21 Research involving vulnerable persons 58
p.000056: 5.22 Research involving vulnerable groups include 59
p.000056: 5.22.1 Research involving children 59
p.000056: 5.22.2 Women as research subjects 59
p.000056: 5.22.3 Pregnant women as research participants 60
p.000056: 5.23References 62
p.000056:
p.000056:
p.000056:
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p.000056: D
p.000056:
p.000056: 12. Annexes 63
p.000056: 6.1 National Application Form For Ethical Approval of a Research Project
p.000067: 67
p.000067: 6.2 National Application Form For Ethical Approval of a Research Proposal
p.000069: 69
p.000069: 6.2.1 Form A: Part 1: Technical proposal form 69
p.000069: 6.2.2 Form B: Part Two: Ethical Considerations 77
p.000069: 1- Minimization of Harm 77
p.000069: 2- Privacy and Confidentiality 79
p.000069: 6.3 Form C 80 1- Informed
p.000069: Consent 80 2- Declarations
p.000081: 81
p.000081: 6.4 The Participant's Acceptance Form ( كر¹ a²ا و= ²ا ¾ب ا9a ةر¹aäذإ جذ9a: A:⁄ ب9:i ýa وأ #⁄ş²ا y )
p.000082: 82
p.000082: 6.5 Model of Informed Consent (ً¹ 49a #⁄ş²ا y كر¹ a²ا ¾ب ا9a راك4إ مر9 ) 84
p.000082: 6.6 Members of the National Health Research Ethical Committee (NHREC)
p.000085: 85
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p.000085: Acknowledgement:
p.000085: The Directorate of Research – National Ministry of Health (DOR – NMOH) would like to thank Her
p.000085: Excellence the Minister of Health Dr. Tabita Botrous and the under secretary of the NMOH for their
p.000085: concern, encouragement and continuous support for this work. Our gratitude is extended to The WHO Country
p.000085: Office for the technical and financial support provided to produce this document. Special thanks are due
p.000085: to its representative Dr. Mohammed Abdu Arub, for his encouragement and deep concern.
p.000085: If not for the hard work of Prof. Suad Sulaiman, Dr. Mustafa Khidir El Niemiri, Dr. Samia Habbani and the
p.000085: invaluable advice from Prof. Abd Alhamid Ibrahim, this work would have not been prepared. The DoR is
p.000085: indebted and grateful to them.
p.000085: Our thanks are due to all the research ethics committee members and special thanks to Prof. Omer
p.000085: AbdAlaziz –Ribat University for his continuous technical and moral support for these guidelines to see light.
p.000085: Lastly, but not least, our thanks to the former Director of DoR, Dr. Ahmed Eltigani, for his
p.000085: contribution in the initial preparation of this guidelines; and to all the secretarate members.
p.000085:
p.000085:
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p.000085: Dr. Iman Abdalla Mustafa
p.000085: Director, Directorate of Health Research
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p.000085: Abbreviations
p.000085: CIOMS : Council for International Organization of Medical Sciences DOH : Declaration of Helsinki.
p.000085: DOR : Directorate of Research.
p.000085: DSMB : Data and Safety Monitoring Board FMOH : Federal Ministry of Health
p.000085: HRC : Health Research Council
p.000085: IEC : Institutional Ethics Committee.
p.000085: IERC : Institution Ethical Review Committee IOMS : Islamic Organization of Medical Sciences JPRM
p.000085: : Joined Programmes Review Mission
p.000085: NTAC : National Technical and Advisory Committee NHREC : National Health Research Ethics Committee. PI
p.000085: : Principal investigator.
p.000085: SERC : State Ethical Review Committee SAEs : Serious Adverse Events.
p.000085: TOR : Terms of Reference
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p.000085: J
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p.000085: Minister Preface
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p.000085: Preamble:
p.000085: This document entitled "Guidelines for Ethical Conduct of Research Involving Human Subjects" is the
p.000085: national document for the guidelines that regulate the conduct of research related to health, with special emphasis on
p.000085: those involving human subjects in Sudan. It was developed by the National Health Research Ethics Committee (NHREC)
p.000085: through a long process as a continuation of important historical efforts by the pioneers of
p.000085: health research in Sudan, which had started as early as 1913.
p.000085:
p.000085: It is composed of five main chapters followed by the annexes. The introduction goes through the main
p.000085: concepts of research, types of research and research ethics.
p.000085:
p.000085: The second chapter explains the principles of ethics for research involving human subjects. This includes detailed
p.000085: explanation of all the three basic ethical principles, namely respect for persons, beneficence and justice in any
p.000085: research involving human subjects. It also enlists about other 20 principles that regulate and guide the research
p.000085: conduction.
p.000085:
p.000085: The third chapter is about the National Research Ethics Committee. This includes a thorough explanation
p.000085: of the structure and functioning technical procedures followed within the National Research Ethics
p.000085: Committee. It includes the authority under which NHREC was constituted, its Membership,
p.000085: meetings, and quorum. It also elaborates on the independent consultants, operational cost, the record keeping and
p.000085: archiving together with updating of NHREC members.
p.000085:
p.000085:
p.000085: M
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p.000085: In this chapter the guidelines and procedures for the State and Institutional Ethics Committees, were also explained.
p.000085:
p.000085: Chapter four is the core of the guidelines for the researcher, as it explains all the steps and procedures for
p.000085: obtaining the ethical clearance in a simplified flowchart and detailed steps of what to prepare, ethical
p.000085: elements review, how to apply, review procedures and decision making.
p.000085:
p.000085: The fifth chapter is about the Informed Consent, its definition, importance, and components. It explains the
p.000085: information that the research subject should know and understand before being involved in the study. The
p.000085: chapter explains the procedure and process by which the informed consent should be obtained from the subjects
p.000085: included in the research. Other principles about the informed consent were included and explained in this
p.000085: chapter. This includes the language, comprehension, documentation of consent, waiver of the consent
p.000085: requirement, renewing consent and other cultural considerations.
p.000085:
p.000085: It also goes through the regulations of the use of biological materials from subjects in clinical trials, the
p.000085: use of medical records and biological specimens. It explains some of the basic principles about the secondary
p.000085: use of research records or biological specimens together with some obligations to be followed by both sponsors
p.000085: and investigators. It covers the issues related to the possible influence on the research subject like
p.000085: withholding information and deception, intimidation and undueXinfluence. It also aims at assuring the equitable
p.000085: distribution of burdens and benefits in the selection of groups of subjects in research.
p.000085:
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p.000085: N
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p.000085: The regulation by which an exception to the requirement for informed consent in studies of emergencies
p.000085: in which the researcher anticipates that many subjects will be unable to give consent is also included in this
p.000085: chapter. Special interest is given to the inducement of research subjects to participate and the consent taken from
p.000085: incompetent persons or vulnerable persons. It also emphasizes the right of withdrawal from a study.
p.000085:
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p.000002: they are based, that can be corroborated by accepted scientific methods of observation and inference.(1)
p.000002: In the present context, "research" includes both medical and behavioural studies pertaining to human health.
p.000002: Usually "research" is modified by the adjective "biomedical" to indicate its relation to health. In the
p.000002: field of biomedical research a fundamental distinction must be recognized between medical research, in which the
p.000002: aim is essentially diagnostic or therapeutic for a patient, and medical research the essential objective of which
p.000002: is purely scientific and without implying direct diagnostic or therapeutic value to the person subjected to the
p.000002: research (2).
p.000002: Progress in medical care and disease prevention depends upon an understanding of physiological
p.000002: and pathological processes or epidemiological findings, and requires in some cases research
p.000002: involving human subjects. The collection, analysis and interpretation of information obtained from research
p.000002: involving human beings contribute significantly to the improvement of human health.
p.000002: Research involving human participant is defined by WHO as " any social science, biomedical, behavioural or
p.000002: epidemiological act that entails systematic collection or analysis of data with the intent to generate
p.000002: new knowledge, in which human being are involved”.
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p.000003: 3
p.000003:
p.000003: 1.1 Research involving human subjects includes:
p.000003: • Studies of physiological, biochemical or pathological processes or of the response to a specific
p.000003: intervention-whether physical, chemical or psychological- in healthy subjects or patients.
p.000003: • Controlled trials of diagnostic, preventive or therapeutic measures in larger groups of persons, designed
p.000003: to demonstrate a specific generalizable response to these measures against a background of individual
p.000003: biological variation.
p.000003: • Studies designed to determine the consequences for individuals and communities of specific preventive or
p.000003: therapeutic measures.
p.000003: • Studies concerning human health-related behaviour in a variety of circumstances and environments (1).
p.000003:
p.000003: The research may be concerned with the social environment, manipulating environmental factors in a way
p.000003: that could affect incidentally- exposed individuals. It is defined in broad terms in order to embrace field studies of
p.000003: pathogenic organisms and toxic chemicals under investigation for health-related purposes.
p.000003:
p.000003: Biomedical research involving human subjects is to be distinguished from the practice of medicine, public
p.000003: health and other forms of health care, which is designed to contribute directly to the health of individuals
p.000003: or communities. Prospective subjects may find it confusing when research and practice are to be conducted
p.000003: simultaneously, as when research is designed to obtain new information about the efficacy of a drug or other
p.000003: therapeutic, diagnostic or preventive modality.
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p.000004: 4
p.000004:
p.000004: 1.2 What is ethics in research?
p.000004:
p.000004: “Ethics is the study of morality – careful and systematic reflection on analysis of moral decisions and
p.000004: behaviour” (2). Ethics and ethical principles extend to all spheres of human activity (3).
p.000004:
p.000004: The Declaration of Helsinki issued by the World Medical Association in 1964, is the fundamental document in the
p.000004: field of ethics in biomedical research and has influenced the formulation of international, regional and
p.000004: national legislation and codes of conduct. The declaration, amended several times, most recently in 2002, is a
p.000004: comprehensive international statement of the ethics of research involving human subjects. It sets out ethical
p.000004: guidelines for physicians engaged in both clinical and non-clinical biomedical research(4).
p.000004:
p.000004: Research involving human subjects should be carried out only by, or strictly supervised by, suitably
p.000004: qualified and experienced investigators and in accordance with a protocol that clearly states: the aim of the research;
p.000004: the reasons for proposing involvement of human subjects; the nature and degree of any known risks to the subjects; the
p.000004: sources from which it is proposed to recruit subjects; and the means proposed for ensuring that subjects' consent will
p.000004: be adequately informed and voluntary. The protocol should be scientifically and ethically appraised
p.000004: by one or more suitably constituted review bodies, independent of the investigators.
p.000004:
p.000004: The mere formulation of ethical guidelines for biomedical research involving human subjects will hardly resolve
p.000004: all the moral doubts that can
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p.000005: 5
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p.000005: arise in association with much research, but the guidelines can at least draw the attention of sponsors, investigators
p.000005: and ethical review committees to the need to consider carefully the ethical implications of research protocols and the
p.000005: conduct of research, and thus conduct of high scientific and ethical standards of biomedical research.
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p.000006: References:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: 1- Council for International Organizations of Medical Sciences (CIOMS): Ethical Guidelines for
p.000006: Biomedical Research Involving Human Subjects, World Health Organization, Geneva, Switzerland 2002.
p.000006: 2- World Medical Association: WMA declaration of Helsinki, Adopted by the 18th World Medical Assembly,
p.000006: Helsinki, Finland, June 1964.
p.000006: 3- World Medical Association (2005): Medical Ethics Manual, The World Medical Association, B.P. 63, 01212
p.000006: Ferney-Voltaire Cedex, France.
p.000006: 4- National Health and Medical Research Council: National Statement on Ethical Conduct in Research
p.000006: Involving Preamble: 28 June 1999.
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p.000008: Chapter 2
p.000008: Principles of Ethics for Research Involving Human Subjects
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p.000010: 10
p.000010:
p.000010: 2.1 The major principles:
p.000010:
p.000010: All research involving human subjects should be conducted in accordance with three basic ethical principles, namely
p.000010: respect for persons, beneficence and non-malificence and justice. It is generally agreed that these principles, which
p.000010: in the abstract have equal moral force, guide the conscientious preparation of proposals for scientific studies (1,4).
p.000010: • Respect for persons incorporates at least two fundamental ethical considerations, namely:
p.000010: a. Respect for autonomy which requires that those who are capable of deliberation about their personal choices should
p.000010: be treated with respect for their capacity for self- determination.
p.000010: b. Protection of persons with impaired or diminished autonomy, which requires that those who are dependent or
p.000010: vulnerable be afforded full security against harm or abuse.
p.000010: • Beneficence and non-malificence refers to the ethical obligation to maximize benefits and to minimize harms,
p.000010: respectively. This gives rise to norms requiring that the risks of research to be reasonable in the light of the
p.000010: expected benefits, that the research design to be sound, and that the investigators to be competent to conduct the
p.000010: research and to safeguard the welfare of the research subjects.
p.000010: • Justice refers to the ethical obligation to treat each person in accordance with what is morally
p.000010: right and proper; to give each person what is due to him or her. In the ethics of research involving human
p.000010: subjects the principle refers primarily to distributive justice,
p.000010:
p.000011: 11
p.000011:
p.000011: which requires equitable distribution of both the burdens and the benefits of participation in research.
p.000011:
p.000011: Table (1): Ethical Principles of Research
p.000011:
p.000011:
p.000011:
p.000011: Major Principles
p.000011: 1. Autonomy
p.000011: 2. Beneficence and non-maleficence
p.000011: 3. Justice
p.000011: Others
p.000011: 1. Accepted Scientifically
p.000011: 2. Accepted qualified researchers
p.000011: 3. Ethics committee review
p.000011: 4. Accuracy of published results……etc
p.000011:
p.000011: 2.2 Other principles: (5-11)
p.000011: 1. Biomedical research involving human subjects must conform to generally accepted scientific principles and should
p.000011: be based on adequately performed laboratory and animal experimentation and on a knowledge of the related
p.000011: scientific literature.
p.000011: 2. Every proposal for health and medical research on human subjects must be reviewed and
p.000011: approved by an independent nationally-recognised ethics committee before it can proceed.
p.000011: 3. The research ethics committee may approve the project as presented, require changes before it can start,
p.000011: or refuse approval altogether.
p.000011: 4. The design and performance of each experimental procedure involving human subjects should be clearly
p.000011: formulated in an experimental protocol, which should be transmitted for
p.000012: 12
p.000012:
p.000012: consideration, comment, guidance and approval of the nationally-recognised research ethics committee.
p.000012: 5. Biomedical research involving human subjects should be conducted only by scientifically qualified
p.000012: persons and under the supervision of a clinically competent medical person as decided by the relevant committee.
p.000012: 6. The responsibility for the human subject must always rest with a medically qualified person and never rest on
p.000012: the subject of the research, even though the subject has given his or her consent.
p.000012: 7. The right of the research subject to safeguard his / her integrity must always be respected. Every precaution
p.000012: should be taken to respect the privacy of the subject and to minimize the impact of the study on the subject's
p.000012: physical and mental health and integrity and on the personality of the subject.
p.000012: 8. Physicians should abstain from engaging in research projects involving human subjects unless they are
p.000012: satisfied that the hazards involved are believed to be predictable. Physicians should cease any
p.000012: investigation if the hazards are found to outweigh the potential benefits.
p.000012: 9. In publication of the results of his or her research, the physician is obliged to preserve the accuracy of the
p.000012: results.
p.000012: 10. In any research on human beings, each potential subject must be adequately informed of the aims, methods,
p.000012: anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should
p.000012: be informed that he or she is at liberty to abstain from participation in the study and that he or she is free
p.000012:
p.000013: 13
p.000013:
p.000013: to withdraw her consent to participation at any time. The physician should then obtain the subject's
p.000013: freely given informed consent, preferably in writing.
p.000013: 11. In case of legal incompetence, informed consent should be obtained from the legal guardian in
p.000013: accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain
p.000013: informed consent, or when the subject is a minor, permission from the legally responsible person/authority replaces
p.000013: that of the subject in accordance with national legislation.
p.000013: 12. In any study, every patient- including those of a controlXgroup, if any- should be assured of the best
p.000013: proven diagnostic and therapeutic method. This does not exclude the use of inert placebo in studies
p.000013: where no proven diagnostic or therapeutic method exists.
p.000013: 13. The refusal of the patient to participate in a study must never interfere with the physician-patient
p.000013: relationship.
p.000013: 14. The physician can combine medical research with professional care, the objective being the acquisition of
p.000013: new knowledge, only to the extent that medical research is justified by its potential diagnostic or
p.000013: therapeutic value for the patient.
p.000013: 15. It is necessary for the researcher to demonstrate that the risks to the research subjects are not unreasonable or
p.000013: disproportionate to the expected benefits of the research, which may not even go to the research subjects. A risk
p.000013: is the potential for an adverse outcome (harm) to occur. It has two components: (1) the
p.000013: likelihood of the occurrence of harm (from highly unlikely to
p.000013:
p.000014: 14
p.000014:
p.000014: very likely), and (2) the severity of the harm (from trivial to permanent severe disability or death). A
p.000014: highly unlikely risk of a trivial harm would not be problematic for a good research project. At the other
p.000014: end of the spectrum, a likely risk of a serious harm would be unacceptable unless the project provided the only
p.000014: hope of treatment for terminally ill research subjects. In between these two extremes, paragraph 17 of the DOH requires
p.000014: researchers to adequately assess the risks and be sure that they can be managed. If the risk is entirely
p.000014: unknown, then the researcher should not proceed with the project until some reliable data are
p.000014: available, for example, from laboratory studies or experiments on animals.
p.000014: 16. Paragraph 11 of the declaration of Helsinki (DoH) requires that medical research involving human subjects must
p.000014: be justifiable on scientific grounds. This requirement is meant to eliminate projects that are unlikely to
p.000014: succeed, for example, because they are methodologically inadequate, or that, even if successful, will likely produce
p.000014: trivial results.
p.000014: 17. In the purely scientific application of medical research carried out on a human being, it is the duty of
p.000014: the physician to remain the protector of the life and health well-being of that person on whom biomedical research is
p.000014: being carried out.
p.000014: 18. Paragraphs 18 and 19 of the DoH clearly favour the consideration of social value in the
p.000014: evaluation of research projects. The importance of the project’s objective, understood
p.000014:
p.000014:
p.000014:
p.000015: 15
p.000015:
p.000015: as both scientific and social importance, should outweigh the risks and burdens to research subjects.
p.000015: 19. In research on humans, the interest of science and society should never take precedence over considerations
p.000015: related to the well- being of the subject.
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p.000016: 16
p.000016:
p.000016: References:
p.000016: http://www.nhmrc.gov.au/issues/humanlpreamble.htm. Produced by NHMRC
p.000016: 1- Council for International Organizations of Medical Sciences (CIOMS): Ethical Guidelines for
p.000016: Biomedical Research Involving Human Subjects, World Health Organization, Geneva, Switzerland 2002.
p.000016: 2- World Medical Association: WMA declaration of Helsinki, Adopted by the 18th World Medical Assembly,
p.000016: Helsinki, Finland, June 1964.
p.000016: 3- World Medical Association (2005): Medical Ethics Manual, The World Medical Association, B.P. 63, 01212
p.000016: Ferney-Voltaire Cedex, France.
p.000016: 4- National Health and Medical Research Council: National Statement on Ethical Conduct in Research
p.000016: Involving Preamble: 28 June 1999.
p.000016: Date created by NHMRC. Accessed May 2005.
p.000016: 5- Operational Guidelines for Ethics Committees That Review Biomedical Research, WHO 2000.
p.000016: 6- International guidelines for Ethical Review of Epidemiological Studies, CIOMS, 1991
p.000016: 7- Serour G I, Implementation of ethics Review Committee in WHO Workshop [on Ethical Issues in Research in
p.000016: Reproductive Health], Cairo 2001.
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000017: 17
p.000017:
p.000017: 8- Langat S K, The role of Ethics Review in Health Research, in The Africa Malaria Vaccine Testing Network
p.000017: Workshop on Ethics in Health Research in Africa, Kisumu, Kenya 2001.
p.000017: 9- Botha J, the Role of Ethical Review in Health Research, Workshop on Ethics in Health Research in
p.000017: Africa, Kisumu, Kenya 2001.
...
p.000021: the leaders of civil society and should not be confined only to the doctors and scholars in medical and
p.000021: scientific field.
p.000021: * The FMOH would approach WHO EMRO to allocate some funds in the WHO through JPRM.
p.000021: 3.1.2 Regulation of the National Health Research Ethics Committee (NHREC)
p.000021: 3.1.2.1 Authority under which the NHREC will be constituted:
p.000021:
p.000021: The FMOH will approve the authority of the constitution and membership of the NHREC. It will be approved and notified
p.000021: by the Federal Ministry of Health.
p.000021: 3.1.2.2 Responsibilities of (NHREC):
p.000021:
p.000021: The committee shall have the following responsibilities:
p.000021:
p.000021: • Formulating guidelines for the approval of the research ethically.
p.000021:
p.000021: • The approval of health research that take place at the national level, or in more than one state from an ethical
p.000021: point of view.
p.000021: • The ethical approval of the research in which there are external participants or that is presented to
p.000021: external bodies.
p.000021:
p.000022: 22
p.000022:
p.000022: • The ethical approval of the experimental research on human.
p.000022:
p.000022: • Reviewing and approving all types of research proposals involving human participants directing or indirectly,
p.000022: with a view to safe-guard the dignity, rights, safety and well being of all actual and potential research participants
p.000022: and to take care of all the cardinal principles of research ethics i.e. autonomy, beneficence, non maleficience
p.000022: and Justice, in planning, conduct and reporting of the proposed research.
p.000022: • Look into the aspects of informed consent process, risk-benefit ratio, distribution of burden and benefit and
p.000022: provisions for appropriate compensation, wherever required.
p.000022: • Review the proposals before start of the study, as well as monitor the research throughout the study, until and
p.000022: after completion of the study through appropriate well documented procedures for example annual reports, final reports
p.000022: and site visits etc. .
p.000022: • The committee will also examine compliance with all regulatory requirements applicable guideline and laws.
p.000022: 3.1.2.3 Membership of the (NHREC):
p.000022:
p.000022: The NHREC should be multidisciplinary and multisectorial. Independence and competence are the two hall marks for
p.000022: membership.
p.000022: The membership of ( NHRERC) will include 20-25 members:
p.000022:
p.000022: 1. The Chairman of the committee.
p.000022: 2. The legal advisor of the FMOH.
p.000022: 3. Representative of the Government of Southern Sudan.
p.000022: 4. The secretary general of the Health Research Council (Rapporteur).
p.000022:
p.000023: 23
p.000023:
p.000023: 5. Representatives of universities and research institutions.
p.000023: 6. Researchers.
p.000023: 7. Representative of the Medical Council.
p.000023: 8. The representative of the Veterinary Research Council.
p.000023: 9. The representative of the National Health Laboratory
p.000023: I0.The representative of the Sudanese Medical Specializations Board.
p.000023: 11. Representatives of the national civil society organizations
p.000023: 12. The Representative of Press and Publications Council.
p.000023: 13. Representatives of the Islamic and Christian religious men.
p.000023: 14. Community leaders.
p.000023: • Chairperson:
p.000023: The chairperson of the committee should preferably be from outside the Ministry of Health to maintain the independence
p.000023: of the committee.
p.000023: • Deputy chairman if needed:
p.000023: • Secretariat:
p.000023: The Directorate of Research in the Federal Ministry of Health will be the secretariat of the committee. It will
p.000023: take the responsibility of arranging meetings of the committee and implementing its decisions
p.000023: and recommendations. It will coordinate the meetings and keep liaison with states, institutions and
p.000023: international ethics committees. All documents regarding the reviewing process of the proposals received by or
p.000023: sent to the committee are the responsibility of the secretariat.
p.000023: 3.1.2.4 Term of the membership:
p.000023:
p.000023: The members, the chair person and the deputy will be selected by the Minister of Health. The term of the member
p.000023: can end by resignation, death, termination or completing three years.
p.000023:
p.000024: 24
p.000024:
p.000024: Organogram of the ethics committee
p.000024:
p.000024: Federal Minister of Health
p.000024:
p.000024:
p.000024: Under secretary of FMOH
p.000024:
p.000024:
p.000024: Director DOR
p.000024:
p.000024:
p.000024: Chairman of NHREC
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024: State & IECs
p.000024: Members of NHREC
p.000024:
p.000024: 3.1.3 Meetings:
p.000024:
p.000024: 1-The committee will hold a regular meeting every two months, and it may hold an extra meeting if need arises.
p.000024: 2-The committee chairman or his deputy chairs the meeting, and in case of the absence of the chairman and his/her
p.000024: deputy the members choose the one who heads the meeting.
p.000024:
p.000024:
p.000024: 3.1.3.1 Quorum:
p.000024:
p.000024: The meeting shall be legal with the attendance of half of the members. In case of the lack of quorum, a following
p.000024: meeting must be determined during one week and it shall be legal by any number of members.
p.000024:
p.000025: 25
p.000025:
p.000025: 3.1.4 Independent consultants:
p.000025:
p.000025: a. NHREC may call upon subject experts as independent consultants who may provide special review of selected research
p.000025: protocols, if needed.
p.000025: b. These experts may be specialists in ethics or specific diseases, or methodologies, or represent
p.000025: specific communities, or patient groups e. g. cancer patients, HIV/ Aids positive persons or ethnicXminority.
p.000025: c. They are required to give their specialized views but do not take part in the decision-making process, which
p.000025: will be made by the members of the NHREC.
p.000025: 3.1.5 Operational cost:
p.000025:
p.000025: The MOH will avail the budget for the operational cost of the committee. The committee will prepare an annual budget
p.000025: covering all the expenses for the meetings, reviewers, consultations……etc. Fees for application will be decided
p.000025: annually.
p.000025: 3.1.6 Record keeping and Archiving:
p.000025:
p.000025: 1. Curriculum Vitae (CV) of all members of NHREC.
p.000025:
p.000025: 2. Copy of all study protocols with enclosed documents, progress reports, and SAEs.
p.000025: 3. Minutes of all meetings duly signed by the Chairperson.
p.000025: 4. Copy of all existing relevant national and international guidelines on research ethics and laws along
p.000025: with amendments.
p.000025: 5. Copy of all correspondence with members, researchers and other regulatory bodies.
p.000025: 6. Final report of the approved projects.
p.000025: All documents should be archived for a prescribed period.
p.000026: 26
p.000026:
p.000026:
p.000026:
p.000026: 3.1.7. Updating NHREC members
p.000026:
p.000026: a. All relevant new guidelines should be brought to the attention of the members.
p.000026: b. Members should be encouraged to attend national and international training programs in research ethics for
p.000026: maintaining quality in ethical review and be aware of the latest developments in this area.
p.000026:
p.000026:
p.000026:
p.000026: 3.2 States and Institutional Ethics Committees
p.000026:
p.000026:
p.000026: I. In 2002, the Federal Minister of Health issued a ministerial decree no. 11/2002 for the constitution of
p.000026: National Technical and Advisory ( NTAC) and National Health Research Ethics Committees( NHREC). According to this
p.000026: decree, the NHREC has been assigned to take the task of:
p.000026: 1. Endorsement and delegation of its powers to the state and institutional research ethics committees.
p.000026: 2. The State Ministries of Health and Head of the research institutions should constitute research ethics
p.000026: committees to approve research proposals conducted by their own researchers and/or that are conducted in the
p.000026: state only.
p.000026: 3. State and research institutions ethics committee should not start their functions and tasks of ethical
p.000026: reviewing unless their constitution has been approved and endorsed by the NHREC.
p.000026:
p.000026:
p.000027: 27
p.000027:
p.000027: 4. State and research institutions ethics committees have the authority to issue ethical approval for all
p.000027: health research that takes place inside the state excluding the following researches:
p.000027: i. The experimental research on the human subjects.
p.000027:
p.000027: ii. Researches linked to external bodies (i.e. out side Sudan).
p.000027:
p.000027: iii. Researches that take place in more than one state (Interstate).
p.000027:
p.000027: 5. The State and institutional ethics committees work under the supervision of the NHREC.
p.000027: 6. The State and institutional ethics committees should present regular biannual reports of their research
p.000027: reviewing activities and the research proposals that have been approved ethically to the NHREC.
p.000027: 7. A copy of approved research proposals and copies of the ethical certificates should be enclosed with
p.000027: the report.
p.000027: 8. The NHREC discusses the research proposals and the reports of the State and institutions ethics committees in their
p.000027: regular meetings.
p.000027: II. The state and institution ethics committees should follow the same guidelines, relevant to the research
p.000027: proposal submitted to them.
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000028: 28
p.000028:
p.000028: 3.9 References:
p.000028:
p.000028: 1. Council for International Organizations of Medical Sciences International Ethical Guidelines for
p.000028: Biomedical Research Involving Human Subjects
p.000028: (CIOMS) Geneva 2002.ISBN 92 9036 075 5
p.000028: 2. Council for International Organizations of Medical Sciences International Ethical Guidelines for
p.000028: Biomedical Research Involving Human Subjects (An Islamic Perspective):
p.000028: 3. Indian Council of Medical Research. Guidelines for preparing Standard Operating Procedures (SOP) for
p.000028: Institutional Ethics Committee for Human Research. URL: http://www.icmr.org.ind/ Produced by ICMR. Date
p.000028: created by ICMR. Accessed May 2006.
p.000028: 4. Pakistan Medical Research Council. National Bioethics Committee. URL:http://www.pmrc.org.pk/ Produced by PMRC.
p.000028: Date created by ICMR. Accessed
p.000028: May 2006.
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
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p.000034: 10. An agreement to report only Serious Adverse Events (SAE) to institutional ethical committee.
p.000034: 11. Statement of conflicts or of interest, if any.
p.000034: 12. Agreement to comply with the relevant national and applicable international guidelines.
p.000034: 13. A statement describing any compensation for study participation (including expenses and access to medical care) to
p.000034: be given to research participants.
p.000034: 14. A description of the arrangements for indemnity, if applicable (in study-related injuries).
p.000034: . A description of the arrangements for insurance coverage for research participants, if applicable.
p.000034: . All significant previous decisions (e.g., those leading to a negative decision or modified
p.000034: protocol) by other ethical committee or regulatory authorities for the proposed study (whether in the
p.000034: same location or elsewhere) and an indication of the modification(s) to the protocol made on that account. The
p.000034: reasons for negative decisions should be provided.
p.000034: . Plans for publication of results – positive or negative- while maintaining the privacy
p.000034: and confidentiality of the study participants.
p.000034: 18. Any other information relevant to the study.
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000035: 35
p.000035:
p.000035:
p.000035: 4.4 Elements of ethical review
p.000035:
p.000035:
p.000035:
p.000035:
p.000035: 1. Ethical issues in the design of the study.
p.000035: 2. Examination of predictable risks/harms.
p.000035: 3. Examination of potential benefits.
p.000035: 4. Procedure for selection of subjects in methodology including inclusion/ exclusion, withdrawal criteria and other
p.000035: issues like advertisement details.
p.000035:
p.000035: 5. Management of research related injuries, adverse events.
p.000035: 6. Compensation provisions.
p.000035: 7. Justification for placebo in control, if any.
p.000035: 8. Availability of products after the study, if applicable.
p.000035: 9. Patient information sheet and informed consent form in local language (See chapter 5).
p.000035: 10. Protection of privacy and confidentiality.
p.000035: l1. Involvement of the community, wherever necessary.
p.000035: 12. Plans for data analysis and reporting.
p.000035: 13. Adherence to all regulatory requirements and applicable guidelines.
p.000035: 14. Competence of investigators, research and supporting staff.
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| HIV | HIV/AIDS |
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| age | Age |
| another country | Other Country |
| arrest | person under arrest |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| belief | Religion |
| blind | visual impairment |
| child | Child |
| children | Child |
| cioms | cioms guidelines |
| control group | participants in a control group |
| culturally | cultural difference |
| dependent | Dependent |
| diminished | Diminished Autonomy |
| disability | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| emergencies | patients in emergency situations |
| emergency | Public Emergency |
| ethnic minority | ethnic minority |
| family | Motherhood/Family |
| foetus | Fetus/Neonate |
| helsinki | declaration of helsinki |
| ill | ill |
| impaired | Cognitive Impairment |
| incapable | Mentally Incapacitated |
| incapacity | Incapacitated |
| influence | Drug Usage |
| language | Linguistic Proficiency |
| liberty | Incarcerated |
| linguistic | Linguistic Proficiency |
| minor | Youth/Minors |
| parent | parents |
| party | political affiliation |
| placebo | participants in a control group |
| poor | Economic/Poverty |
| pregnant | Pregnant |
| religious | Religion |
| single | Marital Status |
| student | Student |
| terminally | Terminally Ill |
| threat | Threat of Stigma |
| trauma | Victim of Abuse |
| undue influence | Undue Influence |
| union | Trade Union Membership |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| abuse | ['trauma'] |
| belief | ['religious'] |
| child | ['children'] |
| children | ['child'] |
| control group | ['placebo'] |
| drug | ['influence'] |
| influence | ['drug'] |
| language | ['linguistic'] |
| linguistic | ['language'] |
| placebo | ['controlXgroup'] |
| religious | ['belief'] |
| trauma | ['abuse'] |
Trigger Words
capacity
consent
cultural
developing
ethics
harm
justice
protection
risk
sensitive
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input