Ethical Review Process by Ethics Committees

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

1.1. Independence of RECs and Committee Members

In order to properly perform their protective function, RECs must be independent from research sponsors, investigators and from any undue influence, such as political, institutional, professional or commercial.

REC independence is critical to ensuring that research participants’ interests always come first and are not secondary to other interests such as scientific advancement or economic gain. REC independence is one of the four requirements for standardised ethical review. The others are constitution, competence and standard operating procedures - these are described later in this lesson.

Achieving REC independence is a challenge in many situations and is often a question of ensuring the following: • Proper accountability (i.e. making sure the right people are responsible) • Balanced membership (i.e. making sure the right mix of people are involved). RECs’ independence is promoted when they are made accountable as will be discussed below. In many countries, it is standard practice to exclude persons of authority within an institution or research centre from being a member of the REC.

A common example of a potential conflict of interest is when an international institution wishes to conduct a collaborative research project, e.g. with institutions in other countries. The foreign collaborating institution typically discusses the issue with the head of the local institution. It might be that the local institution will gain from participation in a trial sponsored by the foreign institution (e.g. a laboratory, equipment, employment). This could be a potential conflict of interest, i.e. if the head of the local institution was to sit on an ethics committee they would not appear to be objective. It is for this reason that many countries in such case do not allow heads of local institutions to sit on RECs.

REC members must also be in a position to conduct independent reviews of protocols. This means that they must be free from, or have declared and properly managed, any conflicts of interest.

If members have particular links with a given protocol, they should not participate in decisions concerning that protocol. Current practice requires them to declare the conflict of interest and they may be asked to leave the meeting room when that protocol is being discussed.