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Protection of Research Participants, Communities & Local Researchers.

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?

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Protection of Research Participants, Communities & Local Researchers.

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

  2. 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!

  3. 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!

  4. 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

  5. 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)

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

  7. 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.

  8. 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)

  9. 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)

  10. 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)

  11. 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.

  12. 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.

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