Protection of Research Protection of Research Participants, Communities & Participants, Communities &

Local Researchers.Local Researchers.Ben Faneye, OP, DHCEBen Faneye, OP, DHCE

West African Bioethics Training ProgramWest African Bioethics Training Program

Protection of Research SubjectsProtection of Research Subjects

Whose duty to protect?Whose duty to protect? Legislators?Legislators? Judiciary?Judiciary? Law enforcement bodies?Law enforcement bodies? HREC?HREC?

Protection of the various stakeholders in Protection of the various stakeholders in research is of the essence of research research is of the essence of research enterprise. HREC’s responsibility!enterprise. HREC’s responsibility!

Common MisconceptionCommon Misconception

HREC HREC is not the “ethics police”is not the “ethics police” does not seek to suppressdoes not seek to suppress does not go searching for faultsdoes not go searching for faults

HREC’s primary aim is to enhance good HREC’s primary aim is to enhance good scientific research studies. Good Vs. bad scientific research studies. Good Vs. bad science!science!

Who is Protected?Who is Protected?

Research participants, i.e., human Research participants, i.e., human subjectssubjects

Communities, i.e., host communities of Communities, i.e., host communities of study (e.g., Kano in Trovan study)study (e.g., Kano in Trovan study)

Local researchers, i.e., co-investigators in Local researchers, i.e., co-investigators in instances of research studies with multiple instances of research studies with multiple locations internationallylocations internationally

HREC’s Mode of OperationHREC’s Mode of Operation

Review of research studies, with authority Review of research studies, with authority to approve, modify or disapprove(E/d/1)to approve, modify or disapprove(E/d/1)

Ongoing oversight of research(E/e/1)Ongoing oversight of research(E/e/1) Targeted review of consent forms, Targeted review of consent forms,

questionnaires, case report forms(E/e/2)questionnaires, case report forms(E/e/2) Seeks strict compliance with scientific and Seeks strict compliance with scientific and

ethical standards (E/e/4)ethical standards (E/e/4)

Protection of SubjectsProtection of Subjects

Conformity with ethical principles Conformity with ethical principles

Respect for autonomyRespect for autonomy Informed consentInformed consent Inclusion/exclusion criteriaInclusion/exclusion criteria Risk/benefit analysis of researchRisk/benefit analysis of research

Protection of Local ResearchersProtection of Local Researchers

Administering Materials Transfer Administering Materials Transfer Agreement-MTA (E/n) Agreement-MTA (E/n) For protecting the interests of local For protecting the interests of local

researchersresearchers For protecting the community’s human and For protecting the community’s human and

natural resourcesnatural resources Safeguards against exploitation & harm in the Safeguards against exploitation & harm in the

use of such resources.use of such resources.

Protection of Local ResearchersProtection of Local Researchers

For effective protection of all research For effective protection of all research participants, HREC exercises the authority participants, HREC exercises the authority to communicate with other ethics to communicate with other ethics regulatory bodies of relevance to review of regulatory bodies of relevance to review of research.research.

Essence of such communication is to Essence of such communication is to enhance safety of participants by ensuring enhance safety of participants by ensuring strict compliance with scientific and ethical strict compliance with scientific and ethical standards. (E/o)standards. (E/o)

Protection of Local ResearchersProtection of Local Researchers

HREC shall protect researchers’ right to:HREC shall protect researchers’ right to:

Publish their researchPublish their research Ownership of, and access to dataOwnership of, and access to data Intellectual property Intellectual property

(E/r/1&2)(E/r/1&2)

Protection of CommunitiesProtection of Communities

HREC seeks to protect communities HREC seeks to protect communities participating in research from exploitation participating in research from exploitation thru:thru: Community consultation & assentCommunity consultation & assent No assent, no researchNo assent, no research Documentation of community engagementDocumentation of community engagement Community Advisory Board – CABCommunity Advisory Board – CAB

(E/r/3)(E/r/3)

Protection of CommunitiesProtection of Communities

HREC ensures that: HREC ensures that: CAB is established by investigators in CAB is established by investigators in

consultation with the communityconsultation with the community CAB must represent all interest groups in CAB must represent all interest groups in

communitycommunity CAB is informed of the progress of research CAB is informed of the progress of research

and it also serves in an advisory role to and it also serves in an advisory role to investigators.investigators.

HREC’s Ultimate DutyHREC’s Ultimate Duty

Power to review, approve, monitor, Power to review, approve, monitor, suspend, exempt and/or disapprove a suspend, exempt and/or disapprove a research lies with HRECresearch lies with HREC

It’s a power to enhance good scientific It’s a power to enhance good scientific researchresearch

As well as upholding ethical standards, As well as upholding ethical standards, i.e., safeguarding research participants i.e., safeguarding research participants from undue harm.from undue harm.