Ethical Review Process by Ethics Committees

The REC must be properly constituted and function according to applicable guidelines and regulations. It must also perform its functions according to its own written operating procedures.

Minimally, the following elements of any REC should be clearly established:

• The authority which established the REC (Terms of Reference).
  
• The REC’s mandate, i.e. its function and duties (Standard Operating Procedures - SOP).
  
• The REC composition, minimum ‘quorum’ requirements, i.e. the minimum number of people required to attend and vote in order to make a valid decision.
  
• The procedure for appointing members.
  

Guidelines, and in some countries regulations, specify that REC operating procedures should cover at least the following aspects:

• How meetings will be conducted, including scheduling and notifying members - this should also include the need to keep detailed minutes of meetings.
  
  
• How to submit an application to have a proposal reviewed, including the submission form.
  
  
• That the REC will make its decisions at announced meetings, a minimum number of people must be present in order for a decision to be made.
  
  
• Process for ethics review, including:
  
• initial review and continuing review of studies,
• expedited (rapid) review procedures,
  
• target time for notification of the decision to investigators (in the EU, timelines are mandated by 2001/20/EC).
  
  
• A rule that no participant should be signed up before the REC has issued its written favourable opinion of the trial.
  
  
• The investigator’s duty to promptly report to the REC:
  
• deviations from the protocol to remove immediate hazards to participants,
• changes that affect the initial balance of risks and benefits,
  
• serious and unexpected adverse drug reactions (ADRs),
  
• any new information that may have an impact on safety of participants or the conduct of the study.
  

RECs need to ensure their written procedures comply with their national, local or institutional legislation and requirements.