Protection of Research Participants, Communities & Local Researchers. Ben Faneye, OP, DHCE West African Bioethics Training Program

Protection of Research Subjects  Whose duty to protect?  Legislators?  Judiciary?  Law enforcement bodies?  HREC?  Protection of the various stakeholders in research is of the essence of research enterprise. HREC’s responsibility!

Common Misconception  HREC  is not the “ethics police”  does not seek to suppress  does not go searching for faults  HREC’s primary aim is to enhance good scientific research studies. Good Vs. bad science!

Who is Protected?  Research participants, i.e., human subjects  Communities, i.e., host communities of study (e.g., Kano in Trovan study)  Local researchers, i.e., co-investigators in instances of research studies with multiple locations internationally

HREC’s Mode of Operation  Review of research studies, with authority to approve, modify or disapprove(E/d/1)  Ongoing oversight of research(E/e/1)  Targeted review of consent forms, questionnaires, case report forms(E/e/2)  Seeks strict compliance with scientific and ethical standards (E/e/4)

Protection of Subjects  Conformity with ethical principles  Respect for autonomy  Informed consent  Inclusion/exclusion criteria  Risk/benefit analysis of research

Protection of Local Researchers  Administering Materials Transfer Agreement-MTA (E/n)  For protecting the interests of local researchers  For protecting the community’s human and natural resources  Safeguards against exploitation & harm in the use of such resources.

Protection of Local Researchers  For effective protection of all research participants, HREC exercises the authority to communicate with other ethics regulatory bodies of relevance to review of research.  Essence of such communication is to enhance safety of participants by ensuring strict compliance with scientific and ethical standards. (E/o)

Protection of Local Researchers  HREC shall protect researchers’ right to:  Publish their research  Ownership of, and access to data  Intellectual property (E/r/1&2)

Protection of Communities  HREC seeks to protect communities participating in research from exploitation thru:  Community consultation & assent  No assent, no research  Documentation of community engagement  Community Advisory Board – CAB (E/r/3)

Protection of Communities  HREC ensures that:  CAB is established by investigators in consultation with the community  CAB must represent all interest groups in community  CAB is informed of the progress of research and it also serves in an advisory role to investigators.

HREC’s Ultimate Duty  Power to review, approve, monitor, suspend, exempt and/or disapprove a research lies with HREC  It’s a power to enhance good scientific research  As well as upholding ethical standards, i.e., safeguarding research participants from undue harm.