Research

Overview

We are committed to promoting ethical research and ensuring all research carried out through RCPI is conducted according to best ethical practice

Our Research Ethics Committee ensures that all research carried out through RCPI is conducted according to best ethical practice. It was established in line with the Irish Council for Bioethics’ 2004 guidance document: Operational Procedures for Research Ethics Committees (PDF, 125KB).

The Committee meets quarterly to review research proposals from an ethical perspective.

The RCPI REC reviews research studies that meet one of the following criteria:

• Research studies performed under the governance of the College, predominantly educational studies;
• Studies carried out by RCPI Trainees, Members and Fellows which may be conducted in the absence of an overarching organisational governance structure which provides ethics review;
• Large national public health studies to which a member or fellow of the college is a co-investigator, such as those involving the Department of Health, HIQA or other governmental organisations.

The RCPI REC does not review research defined under the Clinical Trials for the Investigation of Medicinal Products (CTIMP) legislation.

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How to Submit a Research Proposal for Ethical Review

Before you submit a research proposal for ethical review, please take time to:

• understand our Ethics Committee’s operating procedures (PDF, 125KB)
• read our guidelines on how to fill in the ethics review application form (PDF, 483KB).

When you are ready, download the Research Ethics Application Form (Word, 485KB) and include a declaration and signature page.

Make sure you include the following documents with your application:

• application form with a signed declaration
• a participant study/information leaflet
• invitation to participate letter
• informed consent (if applicable)
• questionnaire(s) (if applicable)
• your current CV
• evidence of previous ethical review (if applicable).

Please submit your application to us via email to research@rcpi.ie with any supporting documentation as a single document.

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When to Submit

You should submit your application at least four weeks before the next Research Ethics Committee meeting.

If your research application has been submitted to another research ethics committee, make sure you include a copy of their response with your application.

RCPI Research Ethics Committee Meeting Dates for 2024

• Wednesday, 6 March 2024
• Wednesday, 29 May 2024
• Wednesday, 4 September 2024
• Wednesday, 4 December 2024

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How the Review Process Works

After your application for ethical approval is received, the process is as follows:

1. You will be invited to attend the review
After we’ve checked that your application has been submitted with all the required supplementary documentation, we will invite you to attend a Research Ethics Committee meeting. We encourage all researchers, including supervising researchers, to attend the meeting in person.

2. The review is carried out
Your application will be reviewed by each committee member before the meeting and their questions will be addressed to you on the day of your review.

3. The decision is made
The committee will make its decision. The five possible outcomes are:

• Favourable opinion
• Provisional favourable opinion - Request for further information or for specified conditions to be met. The response will be assessed by the Chair
• No opinion - Request for further information or for specified conditions to be met. The response will be assessed by the full Research Ethics Committee.
• No opinion, pending consultation with an external referee or expert
• Unfavourable opinion

We will let you know the outcome of your review within two weeks of your review date.

Our response to you will include:

• a clear statement of the decision taken
• details of any further information required and/or specified conditions to be met
• reasons for an unfavourable opinion.

Responding to the decision

If the committee has asked for changes and/or additional information, you should submit your reply within 60 days from the date of first Research Ethics Committee response.

• Category B responses (provisional favourable opinion) will be assessed by the Chair and replies will be sent within 15 working days.
• Category C responses (no opinion) will be assessed by the full Research Ethics Committee at the next scheduled meeting and a response will be sent within two weeks of the meeting.
• Category D responses (no opinions pending consultation) will include a time-scale for a response.

Your research should not start until a final communication has been sent by the Research Ethics Committee Chair.

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Members of RCPI's Research Ethics Committee

Our Research Ethics Committee consists of:

• Committee Chair: Dr Una Fallon, Public Health Specialist
• a member with training in ethics (for example, ethicist, philosopher, theologian)
• a member with a qualification in Law
• a member with training in statistics
• one or two lay members
• a member with knowledge of, and current experience in, the professional care, counselling or treatment of people (for example,nurse, medical practitioner, clinical psychologist, as appropriate)

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