NATIONAL COUNCIL FOR SCIENCE AND TECHNOLOGY Guidelines for Accreditation of Ethics Review Committees in Kenya National Bioethics Committee February, 2011
1.0 Introduction These Guidelines provide ethics committees and their appointing authorities with the requirements for accreditation. The National Council for Science and Technology (NCST), in fulfilling its mandate, established the National Bioethics Committee (NBC) under section 6 of the requirements of the Science and Technology Act (Rev.1980), to spearhead the development of ethics committees in Kenya. The number of applications received for ethical review has gone up following the growth of the national research and innovation system and thus the need to delegate authority to other ethics committees to act on its behalf while ensuring that all applications are appropriately reviewed and proper ethical consideration given to each. The NBC will concentrate on setting standards and procedures for resolving disputes. The Guidelines indicate the processes that committees are expected to maintain and provide a basis for standardization of ethics review in the country. Compliant committees will have similar basic structures, capacities and operational framework so that uniformity is maintained throughout the country. Reporting and monitoring requirements have been introduced along with standard application timelines for first accreditation and subsequent renewal of accreditation. 1.1 Definition of Terms 1.1.1 Accreditation means; giving approval and delegated authority to an ethics committee to conduct ethics review on behalf of the NBC. 1.1.2 National Bioethics Committee is the national committee established by the NCST and empowered to promote and monitor ethical practices in Kenya. The role of the NBC is to provide advice to institutional ethics committees, policy formulation and dispute resolution. 1.1.3 Institutional Ethics Review Committee (IERC) is a committee responsible for ethical review of research protocols at an institution. 1.1.4 Lay member means a member of an ethics committee who is not: a) Currently, nor has recently been, a registered health practitioner (for example, a doctor, nurse, midwife, dentist or pharmacist) ; b) An officer of, or someone otherwise employed by, any health board, health authority, the ministry of Health, or medical school; c) involved in conducting health research or who is employed by a health research agency and who is in a sector of that agency which undertakes health research; or d) construed by virtue of their employment, profession or relationship, to have a potential conflict or professional bias in a majority of protocols reviewed. National Bioethics Committee Page 2
1.2 Types of Ethics Review Committees Two types of Institutional Ethics Review Committees herein after referred to as IERC, are recognized for the purposes of accreditation. These may be defined according to the subjects of the research, and are: a) human ethics committees; b) animal ethics committees. The human ethics committee deals with protection of human subjects while animal ethics committees are committees associated with a institution that use animals in its research projects. 1.3 Objectives of Accreditation Accreditation will focus on the following: a) Uphold the standards of ethics review in the country; b) Develop public confidence and trust for the national research system; c) Facilitate equitable access to research and human health records in health facilities; d) Standardize the constitution and operations of ethics review committees; e) Facilitate coordination and collaboration in ethics review; f) Highlight areas of weakness and facilitate support; g) Ensure that research using animals takes into account animal welfare. National Bioethics Committee Page 3
2.0 Requirements for Accreditation 2.1 Application Requirements a) Application Form b) A list of the committee members; c) The categorization of each member on the committee (e.g. Chair, lay, health professional or others); d) The areas of expertise or experience which each member brings to the committee (e.g. ethics, law, theology, community involvement, medical practice, health research or others); e) The gender of each appointed member; f) The date of appointment of each member to the committee; g) The professional affiliation (if any) of each member; h) How the member was appointed (e.g. Nomination and interview by committee member(s), nomination by a professional body (state which), nomination by institution or others); i) Copy of the SOPs (see annex I for guidelines) 2.2 Membership requirements for ethics committees a) The Chairperson must have some basic training and/or experience in bioethics and leadership; b) A committee must comprise at of least seven members and if more, the total membership must be an odd number; c) At least one member of the committee should possess knowledge and understanding of Kenyan law; d) Appointments to an ethics committee shall be the responsibility of the administrative head of the institution; e) Where a committee serves more than one institution, the institution providing office space for the secretariat shall be the responsible institution for the functioning of the IRB in all aspects. Where multiple institutions are involved, the appointing authority shall make the appointments in consultation with the heads of relevant institutions f) At least one third of the members of the committee shall be of either gender; g) At least one member shall be from outside the institution; h) At least two members shall have research expertise and experience, one of whom should be in the health field; i) At least one member shall be a lay member; j) For ethics committees reviewing clinical research, at least two members shall be clinicians, one of whom is currently in active practice or clinical research. National Bioethics Committee Page 4
3.0 Procedures for Accreditation 3.1 Duration of Accreditation The duration of accreditation shall be three years from the date of notification by the NBC. Accreditation by the NBC is not retrospective. 3.2 Annual Reporting All accredited IERCs shall submit their annual reports by the 1 st of June each year for review and monitoring. The report should comprise the following: 3.2.1 A list of all protocols reviewed during the year. It should include the following information: - a) research title, b) principal investigator and his/her qualifications, c) co-investigators and their qualifications, d) institution where the research is to be/has been undertaken, e) date of approval. 3.2.2 Any changes in the ethics committee membership or guidelines for operation, or other substantive changes which the committee or its Chair feels should be noted. 3.2.3 A summary of other activities of the committee including training, monitoring and evaluation of approved research projects. 3.2.4 Any areas of review which caused difficulty for the committee in making a decision on any particular protocol(s), and any questions on policy or other matters which the committee may wish to put to the NBC. 3.3 Procedures for Renewal of accreditation Applications for renewal of accreditation should be made 6 months before expiry of accreditation period. The NBC will review the documentation provided and communicate its decision to the applicant. The renewal of accreditation shall not be provided retrospectively. 3.3.1 Applicants will submit all documents listed in 2.1 including the latest report. 3.4 Failure to Renew Accreditation Failure to renew accreditation or failure to maintain the appropriate standards for continuity of accreditation will mean that the accredited status of the ethics committee will lapse at the end of the current accreditation period and the committee shall cease to function henceforth. 3.5 Termination of Accreditation Accreditation shall be terminated if in the opinion o f the NBC the accredited committee fails to maintain the required standards. 3.6 Accredited Committees A list of accredited ethics committees is available from the NBC. National Bioethics Committee Page 5
Annex 1 Guidelines for Development of Standard Operating Procedures for IERCs For accreditation review purposes ethics committees shall provide the standard operating procedures (SOPs) under which the ethics committee will operate. The SOPs are not required as part of the annual reporting process, unless they have been amended, but are required to be stated/included for the three-yearly reaccreditation review process. The NBC will explicitly approve the SOPs and may request revisions if necessary for accreditation to proceed. The NBC recommends that SOPs should include but will not be limited to the following: a) Scope and responsibility of the IERC; institutions served b) Objectives of the committee; streamlining research, safeguarding dignity and rights of research participants, facilitating correction and registration of research protocols; c) Functions of the committee d) Appointment and terms of appointment for members; appointing authority, responsibility to the authority, e) Conduct of business; procedures, decision making, notification, types of review, meetings, confidentiality f) Documentation; record keeping, archiving g) Responsibility of the principal investigator h) Complaints; handling procedures, dispute resolution, appeals and reports to the NBC i) Application procedures j) Monitoring of approved procedures k) Linkages with other ethics review committees. National Bioethics Committee Page 6
Annex II Summary and Checklist Summary a. All ethics committees wishing to provide ethical approval for research protocols must be accredited. Only those ethics committees which are accredited can provide ethical approval for clinical trials, and research involving human subjects and/ or animals. Approval by an accredited ethics committee is also required for research authorization where the methodology includes access to health data. b. Accreditation is for three years, from the date notification occurs. The provision of ethical approvals as an accredited committee commences from the date of notification by the NBC and is not retrospective. c. Annual reports are required by the NBC by 1 st June of each year. d. Requests for renewal of accreditation are required 6 months before the expiry date. e. The role of the NBC is policy development, guidelines, accreditation, dispute resolution, monitoring and evaluation. Checklist of attachments for accreditation The following documentation is required for accreditation review: a) A list of members of the committee, descriptions of their responsibilities in the committee, areas of categorization (Chair, lay, and associated responsibilities.), professional affiliation (if any), areas of expertise, gender, and nominating body and others. b) Any Amendments and/or Extensions to the Standard Operational Procedures where applicable. c) Relevant additional documents, such as a description of the committee s complaints procedure and a summary of other activities of the committee including monitoring and evaluation and training. National Bioethics Committee Page 7