Ethical review and approval

 

In order to conduct a biomedical research study involving human subjects and their data, approval is required from an ethics committee (known in the United States as an Institutional Review Board). This committee may act at an institutional level (for example a University Committee), or at a national level (such as The National Research Ethics Service in the UK).

Regardless of level, the role of these committees is the same: to review proposals for research projects and, through discussion amongst the group as a whole, determine whether these projects conform to the ethical norms within that society and do not contravene any legal requirements. Ethical norms vary across cultures, and what is deemed acceptable in one country may not be in another – even if they are close neighbours. 

What is an ethics committee?

Within the European Union, an ethics committee can be defined as:

 "an independent body in a member state of the European Union, consisting of healthcare professionals and non-medical members, whose responsibility is to protect the rights, safety and well being of human subjects..."

(Definition from the EU Clinical trials directive - Directive 2001/20/EC)

Ethical review

An ethics committee will review all aspects of a research study, including the full study protocol, participant information leaflets and consent forms, how data will be stored and used and how results will be disseminated post study.  

For collection of new primary data, whether as a component of a project or the sole purpose, ethical approval will generally be required and informed consent will be sought from individuals to collect their data.

In the case of data that has been collected as part of a previous study, ethical approval may not be required. However, if the data is to be used for a different purpose from that originally agreed, it may be necessary to obtain additional informed consent from the individuals who provided the data in the original study. This additional consent may require new ethical approval.