REGISTRATION
FORM FOR HEALTH RESEARCH ETHICS COMMITTEES IN NIGERIA
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.
