Communtiy concerns about ethical conduct of research - informed consent

Between June and September, 2012, the New HIV Vaccine and MIcrobicide Research Advocacy Society conducted 3 community consultations and 2 researcher-community interface to discuss and deliberate on concerns. The groups came up with issues that can be categorised into four (i) informed consent (ii) community engagement (iii)standard of care (iv) specific community related concerns. This first piece will share with you their concerns with the informed consent process in research conduct in Nigeria

1.0 Informed consent and other ethical considerations in research
1.1. Observations
• A number of researches conducted in the country either do not consent research participants or do not conduct the consent process properly when there are attempts to do so even though protocol approved by the IRB included the need to obtain informed consent form.

• Inadequate details of research purpose in the background of the consent form.

• Use of highly technical words to present research purpose in consent form.

• Overemphasis of benefits over risks when discussing research with study participants. This happens too often in the field.

• Ethics committees do not provide proper oversight function for the researches they approve.

• Negotiation of research reimbursements often takes place at the time of research implementation.

• Poor information dissemination about the research to the research community and individuals involved with a research.

1.2 Recommendations
• Informed consent forms should be available in local languages for easy understanding. Verbal translation of English to local language is not acceptable.

• Researchers should discontinue overemphasis of benefits over risks when discussing research with study participants.

• There are persons who truly want to withdraw consent and participation in researches and programmes but do not know how to do this. Also, when participants withdraw from studies, there must assurance that all the data related to the individual is withdrawn from the data collected. While it may be important to withdraw quantitative data collected, it may be important to identify how qualitative data collected are withdrawn from the pool of data.

• HRECs must ensure that the eight (8) minimum requirements of informed consent are addressed in all informed consent they approve. The 8 minimum requirements include: The goal of the research, procedures and schedules, Study duration, Compensation, Confidentiality and anonymity, the risks and benefits associated with study participation, the study product and voluntary nature of the research.

• There is the need to have a platform that facilitates communities and researcher interaction dialogue. This will also help ethics committee identify what to address with respect to community concerns when they review research protocols.

• Ethics committees should monitor all the researches they approve including monitoring of the informed consent process. The community considers it unethical not to do so. The current level of research monitoring is extremely low and very unacceptable. This gives room for research participants’ abuse. Unfortunately the vulnerable - including those that do not understand their rights when it comes to research - are preys to multiple unethical practices including paying for research related investigations in disguise for treatment.

• Ethics committees have the responsibility to educate their communities about their role and responsibility in research. This is a responsibility identified already in the national ethics code. Ethics committees need to be alive to this responsibility

• All ethics committees should have an online database of all researches approved and a summary of the research outcome so as to reduce duplication of research.

• Research protocols should include timelines for planned project implementations so as to ensure appropriate time is allocated for study implementation. This will reduce the tendency to compromise on proper study implementation processes when they are faced with pressure of time for project completion.

• All negotiations including adequacy of reimbursement should take place prior to ethics committee approval of studies.

• For HIV treatment research, study participants must be assured of continued access to ARV drugs even after completing or voluntarily withdrawing from the research.