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National Code of Health Research Ethics
August, 2007
National Health Research Ethics Committee of Nigeria (NHREC)
Table of Contents
Frontispiece
Foreward
Acknowledgments
About NHREC
Statutory authority
To whom does this code apply?
Definition of Research and Coverage of Code
Exemption
Who determines exemption?
Registration of Health Research Ethics Committees
HREC membership
HREC functions and operations
Process for regular research approval
Process for continuing oversight of research
Process for expedited review
Process for amendment of research
Process for exemption
Process for suspension of research
Process for revision of suspension
Process for termination of research
Process for appeal of HREC's decision to terminate research
Process for review of multi-institutional research
Process for NHREC review of research
Fees
Rights of researchers
Ethical principles and guidelines
HREC's Education and Training Responsibility
Independent Educational and Training Activities in Research Ethics
HREC Research Ethics Consultation and Clinics
Independent Research Ethics Consultation and Clinics
HREC Records and Reports
NHREC oversight of HREC functions
HREC Compliance and Disciplinary Powers
NHREC Compliance and Disciplinary Powers
Continuing Review of the National Code of Health Research Ethics and sub-codes
Members of Technical Consultation Com
Forward
The National Code of Health Research Ethics represents the collective concern of the government and the people of Nigeria to ensure the protection of human participants in scientific research to the highest ethical standard that is possible.
The Accra Ministerial meeting on Health Research, a meeting I initiated, highlighted various challenges inhibiting African and other developing countries in harnessing the full benefits of research and made recommendations on the way forward. One such recommendation was to establish systems for the protection of human participants in research.
There is now increased global, regional and local commitment to strengthening health research in developing countries in order to provide evidence that will serve as the quintessential driver to strengthen health systems, achieve the Millennium Development Goals (MDG) and improve overall health status at all levels. As a result, we are witnessing massive investments from multilateral agencies, global philanthropies and foundations in the development of new tools and methods for the control of our major diseases such as malaria, HIV/AIDS and vaccine-preventable diseases of childhood. It is expected that this trend of increased investment in research that is relevant to our National health issues will continue.
However it is common knowledge that despite the potential of research to contribute to improvements in health care services and training, it also carries a risk that participants, communities, local researchers and even the country may be exploited and exposed to egregious harm. A system of ethical regulation of research ensures that research is conducted in a manner that will maximize the benefits of research while limiting its potential harms and exploitation of research participants.
Nations have statutory responsibility of ensuring the protection of its people from exploitation. As we continue to promote health research in order to contribute towards improving the health status of Nigerians, we have taken it upon ourselves to strengthen our National Health Research Ethics Committee, to provide and ensure adherence to a regulation for protection of human participants in research – The National Code of Health Research Ethics.
This code clearly defines the roles and responsibilities of the National Health Research Ethics Committee, Institutional Health Research Ethics Committees; Healthcare Professionals; Universities; Health Researchers and Research Sponsors in the protection of human research subjects.
As a national code, all stakeholders in health research including our partners in the international community are expected to respect and abide by its tenets, in the spirit of promoting and defending human rights.
I therefore, wish to emphasize the need for all stakeholders to collaborate with my ministry and health authorities at the state and local government levels to ensure the successful implementation of this code. This will promote best practices, maintain public trust and result in improvement in the performance of our health system.
I recommend this document as an indispensable companion for all stakeholders in health and health research, health researchers, the Nigerian public as well as the international community.
Prof. Eyitayo Lambo
Hon. Minister of Health
This document is the property of the Federal Ministry of Health, and was developed by the National Health Research Ethics Committee (NHREC) with technical support of the West African Bioethics Training Programme (WAB).
The National Health Research Ethics Committee (NHREC) is the apex body responsible for the provision of and ensuring adherence to guidelines that govern ethical research practice in order to ensure the protection of human research participants in Nigeria.
The committee was inaugurated in October 2005 by the Hon. Minister of Health in line with Mr. President’s directive for the strengthening of a mechanism that will ensure the protection of Nigerians as they participate in researches.
The committee was an offshoot of the dormant Health Research Ethics Committee which had been in existence since early 1980’s.
The terms of reference for the committee are to:
(a) Determine guidelines for the functioning of health research ethics committees;
(b) Register and audit health research ethics committees;
(c) Set norms and standards for conducting research on humans and animals, including norms and standards for conducting clinical trials;
(d) Adjudicate in complaints about the functioning of health research ethics committees (HREC) and hear any complaint by a researcher who believes that he has been discriminated against by a health research ethics committee;
(e) Refer to the relevant statutory health professional council matters involving the violation or potential violation of an ethical or professional rule by a health care provider;
(f) Institute such disciplinary action as may be prescribed against any person found to be in violation of any norms and standards, or guidelines, set for the conduct of research under this Bill; and
(g) Advise the Federal Ministry of Health and State Ministries on any ethical issues concerning research.
SECTION A
This code applies to all health research involving human participants, conducted, supported or otherwise subject to regulation by any institution in Nigeria.
Definition of Research and Coverage of Code:
Research here is defined as systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this code, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
Health research that is conducted anywhere in Nigeria must comply with all sections of this code.
SECTION B
Research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from health research ethics committee oversight:
(a) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
(1) Research on regular and special education instructional strategies, or
(2) Research on the effectiveness of or comparison among instructional techniques, curricula, or classroom management methods.
(b) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behaviour, unless:
(1) Information obtained is recorded in such a manner that human participants can be identified, directly or through identifiers linked to the participants; and
(2) Any disclosure of the human participants' responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants' financial standing, employability, or reputation.
(c) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available (note that this refers to availability of data and not the status of the custodian of the information/data) or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
(d) Studies that are meant to evaluate the outcome of procedures, programs and services are exempt because they are designed to produce information leading to improvement in delivery of procedures, programs and services. Such studies usually evaluate measures that are already in use and considered part of standard practice. They may include collection and analysis of data or collection of new data but they do not involve allocation into groups or randomisation.
(e) Studies that are designed to evaluate or assess quality of services, programs and procedures and formulate guidelines leading to their improvement are exempt. Such studies may involve the collection and analysis of some data.
(f) Innovative or non-validated medical treatment - treatment that is designed solely for the benefit of the patient but in which the ability of the treatment to result in the desired result is to some degree not proven. Such activities are exempt while recommending that they should be subjected to research in order to generate information about their efficacy as soon as possible.
(g) Clinical audit, where the study is designed and conducted solely to define or judge only current care, without reference to a standard. It may involve the collection and analysis of data but there is no allocation to intervention groups or randomisation and the services have been delivered before the audit is initiated.
All exemptions shall be determined by the Health Research Ethics Committee (HREC) - vide infra. In summary, applicants conducting research that may be exempt shall submit the proposal or a written summary that contains enough information for judgement to be made, to the HREC. The HREC Chairperson or his designee, in consultation with HREC Administrative Officer - where one exists, shall decide whether the research is exempt. Where the Chairperson is uncertain and the uncertainty is unresolved after request for and provision of more information by the applicant, the proposal or summary should be referred to HREC. All applications for exemption must be brought to the notice of HREC at its regular meeting for discussion as may be deemed necessary by members of HREC.
SECTION C
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:
(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.
(f) In lieu of an institution being able to constitute a health research ethics committee and where such institution desires to engage in research:
(1) Such institution shall establish a cooperative agreement with a registered HREC located within the
same state of the federation as the institution.
(2) Where there is no registered HREC within the same state of the federation, agreement can be established
with any HREC within the same geopolitical zone of the country as the institution.
(3) In the eventuality that there is no registered HREC within the same geopolitical zone, the institution should
consult the NHREC for guidance.
(4) Where a registered HREC agrees to review proposals emanating from another institution, this arrangement
shall last only for the period covered by the collaborative agreement and this cannot extend beyond the period of
registration of the HREC by the NHREC.
(5) Institutions seeking to establish collaborative agreements with a registered HREC must submit an application
to the NHREC.
(6) The reviewing HREC must be currently registered and must attest that it will maintain its registration status for
the period covered by the proposed collaborative agreement.
(7) The applicant institution can have collaborative agreement with only one HREC at any given time, while the
reviewing HREC can have multiple collaborative agreements subject to NHREC approval.
(g) Categories of HREC. The NHREC shall establish categories of HRECs on the basis of the size of the committee, qualifications, training and experience of its members in research ethics and science, history of the committee (when established, past review activities, record keeping and compliance with requirements of the Code), resources available to the committee, supporting personnel and infrastructure of both the committee and the proposing institution.
(1) NHREC shall outline from time to time detailed criteria for categorization of HRECs.
(2) Categorization of HRECs shall be done during regularly scheduled meetings of the NHREC.
(3) NHREC shall outline the types of research that different categories of HREC shall review.
SECTION D
(a) The authority to establish a HREC and the procedure of selecting members is vested in the Headship of the proposing institution.
(b) Each HREC shall have at least five members and if more, then the total membership must always be an odd number.
(c) The HREC shall be sufficiently qualified through the experience, expertise and diversity of its members, including consideration of age, gender, socio-cultural backgrounds, religion and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of researchers and research participants. Members should have varying academic and professional backgrounds to promote complete and adequate review of health research conducted by the promoting institution.
(d) In addition to possessing the professional competence necessary to review specific research activities, the HREC shall be able to ascertain the acceptability of proposed research in terms of institutional regulations, applicable laws, and standards of professional conduct and practice. The HREC shall therefore include persons knowledgeable in these areas and whenever feasible, a lawyer.
(e) Each HREC shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in non-scientific areas.
(f) Each HREC shall include at least one member who is not affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.
(g) No HREC may have a member participate in the HREC's initial or continuing review of any project in which the member has a conflicting interest.
(h) If HREC wishes to review research that involves vulnerable participants, such as children, prisoners, pregnant women, physically and psychologically disabled persons, the HREC shall co-opt one or more individuals knowledgeable about and experienced in working with these participants for the review process. These individuals may not vote during the HREC meeting.
(i) Each HREC member must pledge to maintain confidentiality regarding all meetings, deliberations, applications, information on research participants and related matters that shall come to his/her knowledge during service on HREC even after leaving the HREC assignment. There is no time limit for this prohibition.
In order to fulfil the requirements of this code, each HREC shall:
(a) Operate in accordance with the provisions of the current version of the National Code of Health Research Ethics issued by the NHREC. Additional guidance may be obtained from the Standard Operating Procedure (SOP) issued by the NHREC.
(b) Except when an expedited review procedure is used, research proposals shall be considered at regularly convened ordinary meetings of HREC at which a majority of the members are present, including at least one member whose primary concerns are in non-scientific areas.
(c) Where a member cannot physically attend a meeting, the member shall be accounted as being present if he/she can participate electronically, for example by teleconferencing for the majority of the duration of the meeting.
(d) Process for regular research approval
(1) HREC shall review prescribed application materials and have authority to approve, require modifications
in (to secure approval) or disapprove all health research activities covered by this code.
(2) In order for research to be approved, the decision shall ordinarily be arrived at by discussion and consensus or
it shall receive the support of a simple majority of those members present at the meeting.
(3) HREC may, at its own discretion, invite representations from the applicant(s), sponsor(s), institution(s) or any
other person(s) that it may consider relevant to provide information pertinent to the research during the review
process.
(4) HREC shall notify investigator(s) in writing of its decision to approve, disapprove or require modifications of the
research activity.
(5) HREC shall have a maximum of 3 months from the date of receipt of a valid application to give its decision to
the applicant. An application shall be considered valid only after receipt of all materials required by HREC to give
a determination.
6) Where HREC considers an application of such complexity that it cannot conclude the review, the application
shall be referred to NHREC and the applicant duly informed within the stipulated 3 months.
(7) Where HREC does not conclude its review in 3 months and has not referred the case to the NHREC, the
applicant shall have the right to complain to NHREC with the possibility of re-allocation of the proposal to another
HREC and sanction of the concerned HREC
(8) Where HREC decides to disapprove a health research activity, it shall include in its written notification, a
statement of the reason(s) for its decision and give the applicant an opportunity to respond in person or in writing
within 3 months of receipt of the notification.
(9) Where HREC has received representation from the applicant in response to an existing decision, HREC may
decide to uphold or modify its previous decision and shall communicate this decision to the applicant within 3
months of the representation.
(10) HREC is mandated to keep all records related to its decision(s) for a minimum of 10 years after completion of
the research activity.
(e) Process for continuing oversight of research
(1) HREC shall conduct continuing oversight of research covered by this code at intervals adjudged by
HREC as being appropriate to degree of risk involved in participation in the research.
(2) HREC shall have authority to examine all aspects and documents including consent forms, questionnaires,
case report forms etc. that are related to the research and necessary for the HREC to conduct its oversight
function.
(3) This shall be at least once a year or at least once during the lifetime of the research where the duration of the
research is less than a year.
(4) HREC shall have authority to observe or cause to be observed on its behalf, the research and its consent
process to ensure compliance with the highest scientific and ethical standards.
(5) HREC may initiate process of oversight of research in the event of receipt of complaints, information or data
relevant to the research from any source.
(f) Process for expedited review
(1) HREC may expedite review of research in the following circumstances:
(a) Research is found to involve no more than minimal risk or
(b) Minor changes in previously approved research during the period for which approval is authorized.
(2) Expedited review may be carried out by the HREC chairperson or his designee from among members of
HREC. In reviewing the research, the reviewer(s) shall exercise all of the authorities of HREC except that the
reviewer(s) may not disapprove the research.
(3) The Chairman of HREC shall bring all research reviewed expeditiously to the next meeting of HREC for notice,
discussion and ratification.
(g) Process for amendment of research
(1) HREC shall require that applicants apply for permission to amend protocols in any of the following
circumstances:
(a) Where there are changes in any part of the research protocol that alters the risk benefit ratio of the
research.
(b) Where there are changes in the named members of the team conducting the research.
(c) Where there are changes in research sites.
(c) Where there are changes in sponsorship, institutional guidelines, institutional structure, HREC requirements, national laws or exigencies that impact on the ethical conduct of research.
(2) HREC shall require that researcher submit an application for original research approval where in its opinion,
the proposed amendments are substantial, such as but not limited to, change(s) in inclusion or exclusion criteria,
randomization, interventions and outcome measures.
(3) Under no circumstances shall a researcher deviate from approved protocol, except such as is necessary to
eliminate immediate hazard to research participants. The researcher shall notify the Chairman of HREC within 24
hours of such changes.
(4) In such circumstances as described in section (3) above, the researcher shall stop the research and the
HREC shall conduct a thorough review of the research before authorizing suspension, continuation or
modifications to the research.
(h) Process for exemption
(1) HREC may grant exemption from review in any of the conditions enumerated above (vide supra).
(2) Applicants seeking exemption shall submit the proposed research or adequate information about it to the
HREC, sufficient, in HREC judgement, to make a determination.
(3) Exemptions may be granted by the HREC chairperson or his designee from among members of the HREC, in
consultation with the HREC Administrative Officer where one exists.
(4) In granting exemption, the reviewer(s) shall exercise all of the authorities of the HREC except that the
(5) Where the reviewer is uncertain and the uncertainty is unresolved after request for and provision of more
information by the applicant, the proposal or summary should be referred to the HREC.
(6) The Chairman of HREC shall bring all exempted research to the next meeting of HREC for notice, discussion
and ratification.
(i) Process for suspension of research
(1) HREC shall have authority to suspend research that is not being conducted:
(a) In accordance with HREC's requirements or
(b) In accordance with existing legislation or
(c) In accordance with existing institutional guidelines; or
(d) Where research is associated with unexpected serious harm to participants.
(2) Any suspension of research shall include a statement of the reason(s) for the HREC's action and shall be reported
within 14 days to the researcher(s), institution(s), sponsor(s) and the NHREC.
(3) Researcher(s), institution(s) or sponsor(s) shall be entitled to ask for a reconsideration of the decision of HREC to
suspend research within 14 days of receipt of notification.
(j) Process for revision of suspension
(1) HREC may reverse its decision to suspend research if the precipitant(s) of the action is resolved to
HREC's satisfaction
(2) The HREC will determine the case at its next regular meeting and may require that the researcher sign an
agreement with HREC on its finding(s) and agreed remedial measure(s).
(3) Where HREC allows resumption of research, an oversight review of the research shall be carried out within 6
months or at least once during the lifetime of the research if it is shorter than 6 months. days.
(k) Process for termination of research
(1) Where the researcher(s), sponsor(s) or institution(s) is unable to offer or the HREC is unable to ascertain
or enforce satisfactory remediation of the precipitant, HREC shall terminate the research.
(2) HREC shall indicate the reason(s) for the termination of research in writing within 2 weeks to the researcher(s),
institution(s), sponsor(s) and the NHREC.
(3) Researcher(s), institution(s) or sponsor(s) shall be entitled to appeal the decision of HREC to terminate research
to the NHREC within 2 weeks of receipt of notification.
(l) Process for appeal of HREC's decision to terminate research
(1) Upon receipt of an appeal of the decision of a HREC to terminate research, NHREC may, at its
discretion, take up such an appeal.
(2) Where the appeal is sustained,
a. NHREC may with reasons and in consultation with the institutional HREC, direct the institutional HREC to approve the research.
b. NHREC may with reasons and in consultation with the institutional HREC mandate modifications, which if undertaken, can allow the research to proceed or resume as the case may be.
c. Where NHREC mandates restoration of the research, the institutional HREC shall have powers of continuing oversight as outlined in relevant sections of this code