When reviewing research proposals, an NREC’s top priority is to protect the safety, dignity and well-being of research participants. NRECs expect researchers to adhere to good clinical practice principles in research studies, and the review process makes reference to best practices that represent the highest standard in research ethics (an overview of this guidance can be viewed on the Procedures and Guidance page of our website).
By modelling these best practices, the NRECs will help shape a national system of ethics review in a way that will safeguard the interests of research participants while making Ireland a more attractive place to conduct clinical trials – enabling access for Irish patients to innovative medicines and services.
You can read more below on the rights of research participants, which form the cornerstone of any NREC decision-making process.
Your rights as a research participant
Both patients and healthy volunteers may be approached to participate in a research study. Participation in research studies will always be voluntary. Even when you agree to be part of a research study, you should be able to withdraw at any point from the study while the study is running.
You may not directly benefit from being involved in a study, but your involvement may lead to new knowledge in a particular area of research, such as prevent a disease or benefit those with a particular disease.
If you are approached to be involved in a study, you will likely be provided with a Participant Information Leaflet. The Participant Information Leaflet should provide you with information on the essential elements of the specific study:
- what the research is about,
- the condition or treatment under study,
- the voluntary nature of involvement, what will happen during and after the research has taken place,
- what treatment (if applicable) will be withheld,
- the participants responsibilities, the potential risks, inconvenience or restrictions balanced against any possible benefits and the alternatives,
- how to withdraw from a study,
- how your data might be used.
If you are considering participating in a research study, it is important that you carefully read the Participant Information Leaflet before deciding whether to participate or not.
Ethics Committees play a key role in protecting the interests of research participants. Although Research Ethics Committees value new knowledge and scientific progress obtained from research, the safety and well-being of participants takes precedence in the review process.
The REC will pay close attention to whether the participant is being adequately informed about the research study before participating.