Standard 2. Composition of research ethics committees

The research ethics committee (REC) is constituted according to a charter or other document that establishes the manner in which members and the Chair will be appointed. The appointing entity ensures that the REC has a multidisciplinary and multisectoral membership, that its composition is gender balanced, that it reflects the social and cultural diversity of the communities from which research participants are most likely to be drawn, and that it includes individuals with backgrounds relevant to the areas of research the committee is most likely to review.

The entity establishing the REC takes the following factors into consideration when appointing members.

1. Members include individuals with scientific expertise, including expertise in behavioural or social sciences; health care providers; members who have expertise in legal matters and/or ethics; and lay people whose primary role is to share their insights about the communities from which participants are likely to be drawn.
2. Lay people and other members, whose primary background is not in health research with human participants, are appointed in sufficient numbers to ensure that they feel comfortable voicing their views.
3. In order to enhance independence, committee membership includes members who are not affiliated with organizations that sponsor, fund, or conduct research reviewed by the REC (see also Standard 4).
4. Committees are large enough to ensure that multiple perspectives are brought into the discussion. To this end, quorum requirements provide that at least five people, including at least one lay member and one non-affiliated member, are present to make decisions about the proposed research.

Standard 3. Research ethics committee resources

The entity establishing the REC supports it with adequate resources, including staffing, facilities, and financial resources to allow the REC to effectively carry out its responsibilities.

As an integral part of a health research institution or health system, an REC receives:

1. support staff, adequate in number and training to enable the REC to carry out its technical and administrative responsibilities;
2. adequate resources for the staff to fulfil its assigned functions, including office space and equipment and supplies (e.g. computers, stationery, telephones, photocopying machines, shredding machine) to conduct administrative business, to store committee files, and to keep documents secure and confidential;
3. access to appropriate space for the committee to meet and adequate means for members to communicate as needed between meetings;
4. adequate financial resources to permit the committee to produce high-quality work;
5. if considered necessary by the entity establishing the REC, resources necessary to compensate REC members, unless they are already being compensated for their time and effort on the REC through other means.

Standard 4. Independence of research ethics committees

Policies governing the REC include mechanisms to ensure independence of the REC's operations, in order to protect decision-making from influence by any individual or entity that sponsors, conducts, or hosts the research it reviews. Such policies provide at a minimum that REC members (including the Chair) remove themselves from the review of any research in which they or close family members have a conflicting interest.

To ensure that the REC cannot be pressured to approve or disapprove particular protocols, the charter, by-laws, policies and/or procedural rules of the REC provide that:

1. the REC's membership includes at least one person with no connection to the organization that sponsors or conducts the research under review;
2. researchers, sponsors, and funders may attend an REC meeting to answer questions about their research protocols and associated documents, but they are not present when the REC reaches decisions about their proposed research;
3. senior decision-makers of the entity creating the REC, or of any organization that sponsors or conducts the research reviewed by the REC (such as the director of an institution, or his or her agent), do not serve as members of the REC or its Chair;
4. the entity that establishes the REC ensures that REC members are protected from retaliation based on positions taken with respect to REC-related matters or review of research projects.

Standard 5. Training the research ethics committee

Training on the ethical aspects of health-related research with human participants, how ethical considerations apply to different types of research, and how the REC conducts its review of research, is provided to REC members when they join the committee and periodically during their committee service.

The training provided to REC members, either directly by the appointing entity or through cooperative arrangements with other RECs and/or organizations that provide education on research ethics, focuses on:

1. the role and responsibilities of the REC, and its role vis-à-vis other relevant entities, according to relevant international guidelines (e.g. the Council for International Organizations of Medical Societies [CIOMS] International Ethical Guidelines for Biomedical Research, CIOMS International Ethical Guidelines for Epidemiological Research, International Council on Harmonization [ICH] Good Clinical Practice [GCP] guidelines in the case of clinical trials), national laws, and institutional policies;
2. the full range of ethical considerations relevant to research with human participants;
3. the application of such ethical considerations to different types of research;
4. basic aspects of research methodology and design (for members who lack such background);
5. the impact of different scientific designs and objectives on the ethics of a research study;
6. the various approaches for recognizing and resolving the tensions that can arise among different ethical considerations and modes of ethical reasoning.

When training is supported by research sponsors, mechanisms are in place to ensure that the sponsor has no control, direct or indirect, over the content of the training.

Standard 6. Transparency, accountability, and quality of the research ethics committee

Mechanisms exist to make REC operations transparent, accountable, consistent, and of high quality.

The entity establishing the REC employs reliable means to evaluate whether the staff and members of the REC routinely follow the REC's policies, rules, and written procedures (see Standard 9), with special attention to whether the ethical considerations articulated in international guidelines and national standards are being considered and applied consistently and coherently.

1. Such evaluations are conducted by knowledgeable and unbiased people at regular, pre-defined intervals using a pre-defined format; internal assessments are supplemented periodically by independent external evaluations.
2. The entity establishing the REC is committed to consider and, when appropriate, follow up on the findings and recommendations of the internal and external evaluations.
3. The results of the evaluation are of a type that can aid the REC in reviewing its practice and appraising performance (rather than apportioning blame), while also assuring the public that research is being reviewed according to established standards.
4. Researchers, research participants, and other interested parties have a means of lodging complaints about the REC; such complaints should be reviewed by an entity other than the REC itself, and appropriate follow-up actions should be taken.
5. Researchers have a means of discussing concerns with REC members, both on general matters and in response to REC decisions on particular research studies.
6. REC decisions, excluding confidential information, are made publicly available, through mechanisms such as clinical trial registries, web sites, newsletters, and bulletin boards.