2. What Research Requires Ethics Evaluation?

Generally speaking, all research that involves humans must be evaluated by a REC. This must happen before the research begins or, more precisely, before any prospective participants are contacted for recruitment. This is often referred to as the ‘ethics review requirement’.

  • The ethics review requirement also applies to research conducted with personal information found, for example, in medical files, or with human tissue and products such as genetic material.

  • Research with gametes (mature male or female sexual reproductive cells, i.e. sperm or egg), embryos and foetal tissue also requires prior ethics review in addition to a number of other requirements.
In some countries, certain types of research may be exempt from the ethics review requirement under certain conditions. Some examples of this are:
  • When research ‘involves only negligible risk’ - i.e. there is no foreseeable risk of harm or discomfort to participants and any foreseeable risk involves no more than inconvenience to participants.

  • When research ‘involves the use of existing collections of data or records that contain only non-identifiable data about people, e.g. publicly accessible records, archives or publications’.
The REC will assess if research qualifies for one of these exemptions. A researcher cannot issue their own exemption for a study. An exemption must be issued by an REC.

Clinical trials are a good example of a type of research that has additional requirements. In Europe, sponsors of clinical trials for medicines must ask the National Competent Authority (NCA) for authorisation to use an investigational medicine in a trial. Investigators are legally required to have both the NCA approval for use of an investigational medicine and REC favourable opinion before a trial can start.

It is particularly important to note that research that is not scientifically sound is not ethically acceptable. This is because it will expose participants to the burden and potential harms of research without having the possibility of yielding benefits to the participants and/or to society. Thus, the REC must ensure that appropriate scientific evaluation has occurred even if it does not conduct the scientific assessment itself. If research does not pass scientific evaluation, then it should be denied a favourable ethics opinion as well.