Ethical review process
Ethical review is about helping you as a researcher to think through the ethical issues surrounding your research. The principles of good research practice encourage you to consider the wider consequences of your research and engage with the interest of your participants.
Ethics review by a Research Ethics Committee (REC) is typically required when (sensitive) personal data are being collected. The role of a REC is to protect the safety, rights and well-being of research participants and to promote ethically sound research. Among other duties, this involves ensuring that research complies with national and international data protection laws regarding the use of personal information collected in research.
Regardless whether there is a formal requirement, we recommend you to perform an ethical self-assessment. The type of questions which are generally to be answered in an ethical review is shown in the illustration below. These questions are derived from the Research Ethics Checklist by the Norwegian National Research Ethics Committees (2014)
European diversity in ethical review
Ethical guidelines for research involving people are often issued by professional bodies, host institutions and funding organisations. Therefore, these rules and guidelines will differ from country-to-country as well as from research funder to research funder. This wide variation in requirements for ethical review across countries is challenging, especially for multi-national research projects. Usually, when working in more than one country, the strictest regulations typically apply. It is also good practice to engage with any local regimes, where possible.
For examples of local diversity in ethical review, you can click the accordion.
TIP 1. Educate your REC
RECs may be informed and supportive of efforts to share data. However, there is great variation, and some oppose data sharing, fearing (mistakenly) that sharing data violates participants’ confidentiality. As a researcher, you may need to ensure that your REC is fully informed on these subjects. At a minimum, REC members should know that:
- Many research funders and journals expect or require data publication (i.e., data to be made available in an archive or repository);
- Consent forms should allow for participants to opt in or opt out of data sharing, whilst also protecting their confidentiality (see 'Informed consent');
- Data protection laws only apply to personal data, but they do not apply to anonymised data;
- Identifiable information may be exempt from data sharing;
- A combination of gaining consent, anonymising data and controlling access to data can enable the ethical and legal sharing of data; even sensitive data can be shared if suitable procedures and precautions are taken, as is done at major data repositories.
Tip 2. Finding RECs
Find the REC at your own institution or have a look at The European Network of Research Ethics Committees - EURECis (EUREC, n.d.) - which brings together already existing national Research Ethics Committees (RECs) associations, networks or comparable initiatives on the European level.