INFORMED CONSENT IN RESEARCH ENGAGEMENT
both prior to and throughout the project.Researchers must inform participants, in writing or verbally, as appropriate, of all pertinent information regarding the project, including potential physical and psychological risks, however minimal, to the participant. This information must include procedures for ensuring:
1. Confidentiality and anonymity, the use to which participants' responses or data will be put, and who will have access to this information.
2. Such consent must be obtained from participants in writing, unless cultural ormethodological considerations deem otherwise. In such cases, the researcher must document how free and informed consent was obtained.
3. This consent must be unforced. Threats of penalties for refusal to participate orwithdrawal part way through a project are unacceptable. Rewards for participation must not provide undue inducement or influence on a participant's decision to participate or withdraw.
ABUCUHSR may approve a project, which does not include free and informed consent if all of the following criteria are met:
1. the research involves no, or minimal, risk to participants
2. the lack of free and informed consent is unlikely to adversely affect the rights and well-being of the participants
3. the research could not be reasonably or effectively carried out if free and informed consent were obtained
4. participants will, whenever possible, be given full disclosure of pertinent information after participating, including any debriefing, reassurance, reestablishment of trust, and other follow-up as necessary to protect their welfare and their rights
The concept of an informed Consent should take into cognizance:
1. Areas where community consent may be required.
2. Feedback on research findings
3. Non exploitation
4. Privacy, anonymity and confidentiality
5. Full release of necessary information
6. Minimization of risk and maximization of benefits
7. The obligation to compensate for research related injuries and costs
8. Distributive justice.
9. Inclusion/exclusion criteria.
10. Conflict of interest
11. Safety monitoring.
12. Ownership, storage and transfer of biological materials in collaborative research.