Ethical Review Process by Ethics Committees

1. Authority, Role and Mandate of Research Ethics Committees (RECs)

1.4. Ethical Deliberation and Decision-Making

Ethical Deliberation
For members of the REC, ethical deliberation refers to reflection (careful consideration) and discussion of research projects. This process should take into account the ethical principles and values of research ethics from relevant local and international guidelines. During the discussion, all members present should contribute and provide their expertise and perspectives. In order for each member of the committee to do this in a meaningful way, all documentation relevant to the review must be received and reviewed by all members before the discussion. Members must have enough time to communicate their points of view during the discussion. Sometimes different ethical norms and concepts appear relevant but lead to contradictory conclusions, in these cases a significant amount of reflection is required.

Reaching a Decision

Reaching a decision is the second phase of decision-making.

In conducting their review, RECs usually evaluate aspects of the project:
  • Scientific validity.
  • Ethical and financial aspects.
  • Consent documentation.
  • Expected benefit vs burden/risk.
  • Any other documents to be provided to participants.
These are described in the following sections. The REC has the authority to make the following decisions about research under their jurisdiction (authority) according to whether it meets ethical requirements:
  • Provide favourable opinion.
  • Provide negative opinion.
  • Request modifications.
This applies to both proposed and ongoing research.


Ideally, the REC deliberates and eventually comes to a collective opinion (or consensus) that all members find ethically satisfactory. Consensus reached by a REC is valid as long as it emerges out of deliberations that are honest, fair, and factually well-informed and follow standard operating procedures. However, in reality it doesn’t always work this way. Sometimes a decision is not ‘thoroughly acceptable’ to some members, but those members agree their concerns were heard and discussed, and they regard the process of deliberation and decision-making fair.


Making decisions by vote, as opposed to consensus, should be restricted to exceptional circumstances. This is because voting gives priority to the number of people who hold a certain opinion but does not take into account the reasoning behind the opinions held. A minimum quorum is required (and should be defined in the SOP) for voting in order to make a valid decision.