10 In order to fulfil WHO's responsibilities and oversee its involvement in research involving human participants, the Director-General has established a WHO Research Ethics Review Committee (ERC or the Committee) to provide an ethical review of research involving human participants funded or otherwise supported by WHO, and has designated a WHO staff member as Secretary to the Committee (the Secretary).
20 Equivalent committees, and secretaries, may be established in regional offices and in WHO centres and agencies where warranted by the Organization's involvement at the regional level in research involving human participants. In the absence of an equivalent committee at the regional level or in WHO centres and agencies functioning in accordance with these provisions, all research proposals involving human participants shall be submitted to the ERC as provided herein.
30 The Committee's function shall be to provide ethical review of research projects involving human participants funded or otherwise supported by WHO and to approve, reject, or modify research proposals submitted to it.
40 The Committee shall be guided by the Declaration of Helsinki, the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects, and supplemented by other internationally accepted statements of ethical guidance adopted by the Committee.
50 The Committee may also consider and provide advice to the Organization on any matter of general policy relating to ethical aspects of research involving human participants. The Committee shall, subject to approval by the Director-General, adopt such rules and procedures as are necessary and consistent with its terms of reference. It shall hold such meetings as are required to fulfil its responsibilities.
60 The Committee shall consist of members appointed by the Director-General, including a Chair and two Vice-Chairs. Membership of the Committee shall consist of WHO staff members, including at least one person not being technically qualified in medicine or public health, as well as at least one person not employed by WHO.
70 Members shall be appointed for terms of three years, renewable for a maximum of two consecutive terms. Members should be drawn from all clusters within the Organization, should include both males and females, and should include persons with experience in and knowledge of all WHO regions and from the full range of scientific, medical and other disciplines relevant to the work of the Committee. Additional persons, either WHO staff members or outside experts may be co-opted by the Chair to provide the Committee with relevant expertise as necessary.
80 The Secretary's function shall be to provide technical and administrative support to the Committee.
90 All research proposals involving human participants which are foreseen to be funded or otherwise supported by WHO shall be submitted to the Committee for review.
100 All research involving human participants funded or supported by WHO shall conform to the requirements set forth in the ERC operating rules and procedures. No research involving human participants shall be funded or otherwise supported or endorsed by WHO until it has been reviewed and approved by the Committee. Consequently, the responsible WHO unit may not commence or allow others to commence such research until notified by the Secretary that the research has been approved.
110 For this purpose, research shall be defined as "any social science, biomedical, behavioural, or epidemiological activity that entails systematic collection or analysis of data, with the intent to develop or contribute to generalizable knowledge. Generalizable knowledge consists of theories, principles or relationships, or the accumulation of information on which they are based, that can be corroborated by accepted scientific methods of observation and inference", and human participants shall be defined as (i) human beings whose biological material or medical or other records are collected or used by investigators and/or (ii) who are exposed to manipulation, intervention, observation, or other interaction with investigators either directly or through alteration of their environment as part of a research activity.
120 Before submitting to the Secretary a research proposal for review by the Committee, the WHO staff member responsible for the research shall ensure that:
- The proposal conforms to the ethical requirements established by ERC and by any other applicable ethical review body convened by the Organization;
- Such research has been authorized by the relevant health authorities in all the countries where the research will be undertaken and conforms to national ethical and legal requirements of such countries, when so required in the countries concerned;
- Such research has been approved by an appropriate research ethics committee at the institutional or national level which will be responsible for ensuring that the ethical principles involved and any other relevant requirements are followed carefully; and
- The Principal Investigator and the Institution under whose auspices the research will be conducted have agreed to safeguard the rights and welfare of the research participants in accordance with all local and national ethical and legal requirements and the standards for research ethics adopted by the ERC.
130 Any changes to approved research proposals which might in any way be reasonably considered to alter the balance of risk and benefits or otherwise have ethical implications on the research shall be reported and resubmitted to the ERC and to any other applicable ethical review body having previously reviewed the research proposal.
140 The Committee shall also be notified immediately, through the Secretary, of any serious and unexpected adverse event that was not identified in the research proposal and of any development in the project which suggests that the research exposes participants to any risk not foreseen in the research proposal.
150 The responsible WHO staff member for each research project approved by the ERC shall submit a progress report to the committee on an annual basis, highlighting any developments in the project that might have ethical implications.
