Lay people should in future make up at least one-third of the membership of research-ethics committees in hospitals, universities and community settings, according to new guidelines published yesterday.
The guidelines, from the Irish Council for Bioethics, also stress the need to get informed consent from people before involving them in research, and allowing them the freedom to withdraw from the research process at any time. Furthermore, they stress, if there are any risks resulting from participation, such as being involved in the trial of a new drug, there must also be benefits.
The guidelines also require investigators to report adverse events immediately to the research-ethics committee which approved the research.
These committees, which are charged with deciding whether research involving human participants should or should not take place, have up to now operated under clinical-trials legislation dating back to 1987.
But given the number of scientific advancements in recent years, the Irish Council for Bioethics decided to look at devising up-to-date national guidelines.
The chairwoman of the working group which devised the guidelines, Prof Cecily Kelleher, said until now Ireland lacked comprehensive guidance with respect to the ethical review of research involving human participants.
"I think it is of the utmost importance that we have a set of national best-practice guidelines in relation to the operation of research-ethics committees. The existing framework has served Ireland well, but at this time of change and innovation we need the highest quality standards of research," she said.
The guide does not give guidance on stem cell or other specific types of research.