The composition, duties and authority of research ethics committees
To help ensure uniformity and rigour in review, national policies provide specific guidance on the composition, duties and authority of research ethics committees [RECs]. In the next section you will find out more about RECs.
Research ethics committees
Research ethics committees [RECs] review research protocols that involve human participants in order to make sure that risks to these participants are minimised and that they are treated fairly and with respect.
Procedure
Research ethics committees meet regularly. Some RECs invite researchers to present their protocols at their meetings; others deliberately use only the information submitted in writing. Larger institutions may have several RECs to keep up with the workload. Some RECs have a fast-track approval system for straightforward cases.
Membership
REC membership requirements vary. Normally, RECs have a membership with 'backgrounds that will ensure complete and adequate review of research activities commonly conducted by the institution. In addition, it is common for a number of lay persons to be members of such committees in order to provide a different perspective and voice societal concerns.
Regulations
Regulations differ from country to country. In the EU, there is a common Directive and national legislation at the member states' level. Other countries have their own national legislation and regulations. In addition, you need to be aware of and follow the rules set out by agencies – in the UK, for example, those of the National Health Service and funding agencies. It is important to follow the policies/procedures for ethical review that apply to a particular project.
What are they looking for?
In brief, the REC will be looking at the key questions we have identified in relation to human participants:
- Are risks to participants minimised and reasonable in relation to anticipated benefits? [See the 'Key terms' box at the end of this section.]
- Is the selection of participants equitable?
- Will informed consent be obtained?
- Are there adequate provisions to protect the privacy of participants?
- Are there provisions to allow participants to withdraw from the study?
Continuing Review
Federal regulations [45 CFR 46.109[e]] mandate that ongoing Expedited or Full Board human research studies be reviewed at intervals appropriate to the degree of risk, but not less than once per year from the previous date of approval.
All Expedited and Full Board studies require annual re-approval in order to continue with research.
Studies which are not re-approved by the expiration date are no longer in compliance with IRB regulations and will be terminated. Once the study has expired, no research activities can be conducted.