Ethics review is a process whereby your research is reviewed by a team of reviewers and/or researchers in your (or a related) discipline to make sure that it conforms to a set of ethical standards.
An ethics review is a process, which means it takes time. It’s important to be patient and leave yourself time (typically 2-3 months) from the time you submit for your study application to completion of the process; some ethically complex or sensitive studies can take up to six months or more to get approval (although the average three months).
The REC meets once every two months to conduct full reviews. A full list of meetings and application deadlines is available below.
Applications must be submitted in time for the deadline if they are to be reviewed at the following month’s meeting.
Principal investigators are strongly advised to prepare and submit their application well before the deadline to allow the REC sufficient time to review. Applications received after the submission deadline will be reviewed by the REC at the next meeting.
Any applications involving RCSI staff and/or students which include research surveys, will automatically be reviewed by the RCSI Evaluation Working Group (EWG) and/or the Students’ Union.
2021 REC submission deadlines and meeting dates
|Submission deadline||HREC meeting date||AREC meeting date|
|29 January||24 February||23 February|
||28 April||27 April|
||9 June||8 June|
The typical review process is as follows:
- Following the REC meeting, comments from REC members are collated and returned to the applicant, via email and hardcopy. We try to ensure that all letters are sent out within two weeks’ following a meeting.
- Applications can receive ethical approval straight away, or the applicant may be requested to clarify some points for the REC or make some changes to the application in order to adhere to ethical guidelines. Should clarifications be requested, a revised submission, consisting of the requested amended documentation and a cover letter responding point-by-point to the comments raised by the committee, should be sent via email to the convenor at firstname.lastname@example.org. The revised submission will then be considered as soon as possible (the timing determined by the number of applications received at the same time). Revised submissions do not (typically) need to be reviewed at a further REC meeting. This process usually takes around 2-3 weeks, depending on the suitability of the revisions.
- Once comments by the REC have been adequately addressed, the convenor will contact the corresponding applicant notifying them in writing that approval has been granted and a formal letter (signed by the Convenor of the REC) will be sent to the corresponding applicant.
If you have any further questions on the ethical process please send your query to email@example.com.
REC approval is always made on the basis of a number of important conditions:
- Research must not commence until the RCSI REC has granted full and final ethics approval.
- The research must be conducted in compliance with the approved protocol and any deviation from the original protocol must not be implemented without prior approval from the REC.
- Any unforeseen events that may affect the continued ethical acceptability of the research project must be reported immediately to the REC via the convenor.
- The REC must be notified of, and approve, any changes to the original (approved) protocol.
- The REC must be notified of any changes in names of the principal research team.
- Research data arising from a research study must be held securely for a period of five years in line with best practice and data protection guidelines.
- Information for participants must include the name and contact details for both the researcher and of the academic supervisor/principal investigator.
- Approval is for the period stated on the letter of approval. Researchers must make a request for an extension should the collection of data exceed the study approval period.
- Arrangements are in place to ensure that indemnity and/or compensation are available to cover all possible claims from participants.
- Research is carried out in full compliance with all regulatory and legal requirements currently in existence and in accordance with the ethical principles that have been outlined in the Declaration of Helsinki.
You may request that your application is considered under the fast track review process.
This means that your application would receive an expedited review outside of the normal ethics committee meeting cycle.
Should a fast track be granted, the time from submission to approval is approximately one month, depending on the time taken to resolve amendments and clarifications.
To apply for a fast track review you must contact the convenor and provide justification in writing for the fast track consideration. As a fast track requires considerable extra time for the convenor and REC members it should not be undertaken without good reason. Possible justifiable reasons include:
- Tight time frames (e.g. summer studentships, student-selected component)
- Funding reasons
- Ethical approval necessary for grant application or grant registration
Once the request is received the convenor will notify the chair who decides if a fast track is justified.
- A full online application should be completed as per the normal application process.
- All associated documentation, including written confirmation that the supervisor has reviewed the (well-written) protocol, must be uploaded with the submitted application. This will be checked by the convenor and will get back to the applicant if necessary.
The convenor assigns a minimum of four reviewers to each fast track application and notifies the reviewers of their assigned review as soon as possible. A response from the four committee reviewer should be provided within one week if possible. The convenor then combines the reviews.
Applicants will receive feedback from the convenor within 10 working days of submission.