Human Research Ethics Committees in Australia review all research proposals involving human participants to ensure that they are ethically acceptable. According to the National Health and Medical Research Council, there are more than 200 ethics committees across Australia. Each ethics committee reviews study documentation to ensure the proposed research meets ethical standards and guidelines, including the National Statement on Ethical Conduct in Human Research 2007. Many people who have been a part of the clinical research industry, are likely to have been involved in preparing part of an ethics submission, experiencing the ‘rush’ to meet critical submission dates, followed by a waiting period until the ethics committee meeting is held and a decision is communicated to the Investigator. Have you ever wondered though, what actually happens to a submission package at the ethics committee meeting? For the preparation of this blog, I interviewed several members of different ethics committee to find out more.
The Ethics Committee Members
On paper, the National Statement provides clear guidance on the required composition of an ethics committee. In reality, each ethics committee is more than a collection of people who met the required structure, it is a group of members with great respect for each other as each committee members input is valued (scientific, lay, pastoral, lawyer, specific area experts). Indeed, over the years, friendships grow amongst the members as the core membership tends to be stable. All committee members that I interviewed found working on an ethics committee to be a rewarding experience and their involvement was between 10 and 25 hours each month (depending on their role on the ethics committee) which included reviewing submissions and attending the ethics meeting.
What Happens at Each Meeting?
There is a lot to get through at each meeting including a declaration for any conflicts of interest, general updates, a brief update on the status of previously reviewed submissions, then review of any new submissions (several are planned for each meeting) and substantial protocol amendments.
Each ethics committee has a process for managing minor protocol amendments, annual updates and safety updates; these may be reviewed within the ethics meeting or outside of meetings by the Chairperson or appropriate reviewers.
Process for New Submissions
Prior to the meeting, all attending ethics committee members will have access to, and will review an entire submission from their unique perspective, sharing any comments/concerns they have with other committee members. A presenter may be nominated for a new submission.
At the meeting the Chairperson or the nominated presenter will summarise the submission and provide some context for the comments/concerns raised prior to the meeting. All members will speak about any of their concerns/comments, and a discussion of these will follow. The Chairperson will prompt for all opinions to be raised, and ultimately for an agreement on each comment/concern to be reached, either that the submission needs to be adjusted or further detail will be requested from the Investigator, or that the issue can be dismissed. Each issue, regardless of how big or small, is considered on its merits. Any change that would result in improvements to the submission or that relates to the interests of participants may be included in the feedback to the Investigator. Only after all issues have been discussed, is a decision made to either approve, request amendment of, or reject the research proposal. In the instance that further feedback or amendment to the submission is required, a process will be defined for how the response will be reviewed by the ethics committee.
Being a Member of an Ethics Committee
All ethics committee members that I spoke with were very pleased to share their experiences. For some, working on an ethics committee has given them an opportunity to be involved and to help make a difference, for others it has supported their career experience and shaped their career aspirations. All have found it to be personally satisfying and rewarding as they bring their individual expertise and experience to each review.
Thank you to all the ethics committee members that helped me pull together this summary. Thank you also to all ethics committee members across Australia that ensure that the rights of research participants are protected, and that research involving human participants has sufficient scientific merit to justify the risks to those participants.
Written by Monique Anderson, Principal Medical Writer at Delve Medical Writing