Ethical Review Process by Ethics Committees

2. What Research Requires Ethics Evaluation?

2.2. Levels of Evaluation

It is generally accepted that RECs can adopt a proportionate approach to ethics evaluation. In other words, the greater the burden of research, the greater the scrutiny. In practice this means that RECs can use two approaches to ethics evaluation:

  1. Evaluation by the full committee.

  2. Evaluation by a sub-committee, which is also called ‘expedited review’.
If the operating procedures of a given REC allow, research that poses only minimal burden can have an expedited review. Minimal burden in this context is when the amount of harm expected in the research is less than that ordinarily encountered in daily life, or in routine medical, dental, or psychological exams. Research that poses greater burden deserves attention by the full REC to ensure proper safeguards are in place.

Full committee evaluation will involve all members’ comments and discussion of all ethical issues arising from the proposed research. Deliberations will take place and members will aim to reach a consensus on the REC decision. This will take place in an ordinary REC meeting, scheduled according to the standard operating procedures.

RECs should establish standard operating procedures for expedited review of research proposals. These procedures should specify the following:
  • The nature of the applications, amendments and other considerations that will be eligible for expedited review.

  • The quorum requirements for expedited review.

  • The status of opinion - i.e. whether or not the opinion still needs to be confirmed by the full committee.
In some countries national regulations establish categories of research that pose no more than minimal burden that can receive expedited review.