Registration of Health Research Ethics Committees
Before you proceed, please Find below the Section of the National Code for Health Research Ethics relating to Registration of Health Research Ethics Committees
In order for an institution to be able to conduct health research, the institution must have a registered health research ethics committee (HREC). The following are the guidelines for registration:
(a) Registration with National Health Research Ethics Committee (NHREC) shall require:
(1) An application by the authorized head of the institution or their authorized designee which among other things should include that the line of reporting authority of the Chairman of the HREC is directly to the Chief Executive of the proposing institution.
(2) A list of members of the proposed health research ethics committee identified by:
i. Name
ii. Qualifications
iii. Representative capacity
iv. Indications of experience such as trainings, certifications, licenses, etc., sufficient to describe
each member’s chief anticipated contributions to HREC deliberations.
v. Any employment or any other relationships (including stock ownership, receipt of grants,
honorariums or support from potential research sponsors) that may be construed as conflict of
interest within the context of membership of the HREC.
(3) All members of the proposed HREC must have completed NHREC approved training programs in research ethics. Additional training in research methodology and research administration is recommended. Copies of the certificates of completion of such programs must be submitted along with the application. The institution setting up the HREC must provide resources for such training.
(4) Statement of agreement to comply with the Nigerian Code of Health Research Ethics subsequently referred to as “the code”, governing HREC in the discharge of its responsibilities for protecting the rights and welfare of human participants of research conducted at or sponsored by the institution.
(5) Statement of commitment to provide meeting space of sufficient quality, office and storage space, sufficient staff and funds to support the HREC’s review and recordkeeping duties in order to guarantee that these duties can be accomplished with sensitivity and confidentiality.
(6) A statement of commitment to take full responsibility for all actions of each member of HREC in the course of performance of duties related to membership. The institution shall provide coverage for any liability of any member arising from service on HRECs.
(b) The lifespan of any HREC shall be two years, after which the institution shall apply for re-registration. The application for re-registration must be submitted within the last 6 months of the expiry of the current registration. During the re-registration process, the institution shall submit:
(1) A current list of members of the health research ethics committee identified by:
i. Name
ii. Qualifications
iii. Representative capacity
iv. Indications of experience such as trainings, certifications, licenses, etc., sufficient to describe
each member’s chief anticipated contributions to HREC deliberations.
v. Any employment or any other relationships (including stock ownership, receipt of grants,
honorariums or support from potential research sponsors) that may be construed as conflict of
interest within the context of membership of the HREC.
(2) Certificates of completion of National Health Research Ethics Committee approved training programs in research ethics completed within 6 months of the expected start date of the registration of the HREC. Additional training in research methodology and research administration is recommended. Copies of the certificates of completion of such programs must be submitted along with the application.
(3) Copy of the primary statement of agreement to comply with the Nigerian Code of Health Research Ethics previously endorsed by the institution and the NHREC.
(4) Report of fulfilment of previously stated commitment to provide infrastructure and logistics to support the HREC’s review and recordkeeping duties.
(5) Complete record of the activities of the committee, including financial records, attendance register at statutory meetings, complaints, litigations, number, and titles of protocols received, reviewed, approved, rejected and pending, and the mean time from protocol submission to approval in each of the preceding 2 years.
(c) Where a registered HREC does not apply for re-registration during the life of its current registration, the HREC shall be considered de-registered and may apply anew to NHREC. No research may be conducted in the institution during this period of de-registration.
(d) Institutions may propose to have more than one HREC. In such instances, the jurisdiction of each of the HRECs should be clearly defined and there should be open channels of communications between them that will allow transfer of proposals to the HREC with appropriate expertise. Researchers must not submit the same protocol simultaneously to more than one HREC within the same institution.
(e) The authority of HREC shall be limited to the boundary of the proposing institution or the activities of its permanent members of staff, unless otherwise specified by the NHREC. Where a permanent member of staff is the principal investigator of a study taking place outside the boundaries of the proposing institution, the researcher shall seek ethical oversight only from the institution in which he/she is a permanent member of staff. This provision does not preclude co-investigator(s) from seeking ethical oversight from their institution(s) where there is more than one study site.
