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Research Ethics Committee

Overview of Research Ethics Review

The School of Medicine Research Ethics Committee reviews applications from staff and students from the School of Medicine TCD.

All applicants must register their application using their TCD email address and supply their TCD Staff Number on the Application Form.

Applications from person’s not affiliated with TCD will not be considered.

Applications involving research on vulnerable groups such as service users, patients, children under 18 years of age, etc, are not appropriate for review at Level 1 and should be sent to the Faculty Level 2 Research Ethics Committee, or if appropriate the Joint Research Ethics Committee (JREC). Any patient related research being undertaken on the St James/ Tallaght hospital sites which requires ethical approval requires a submission to be made via Joint Research Ethics Committee (JREC)……or apply to the appropriate hospital/HSE or other relevant ethics review board.

All members of staff or students undertaking research should do so with cognisance of the Trinity College Guidelines for Good Research Practice  no matter what their research project entails.

If your project involves the recruitment of students from the School of Medicine, a letter of support, must be sought from the Director of Undergraduate Teaching and Learning in the School of Medicine before making an application to any research ethics committee. To seek such a letter please email a brief outline of your study and a copy of your application to: : Director of Undergraduate Teaching & Learning for School of Medicine

Research Ethics Committees & Process

Level 1 School of Medicine Research Ethics Application for Review
The School of Medicine Research Ethics Committee reviews applications from staff and students from the School of Medicine TCD. These applications must match the Level 1 Research Ethics checklist as set out here:  All applicants must register their application using their TCD email address and supply their TCD Staff Number on the Application Form.

If your study does not meet the Level 1 Research Ethics checklist criteria, you must apply to the relevant Research Ethics Committee listed below;

Level 2 Research Ethics Applications for Review
All research ethics applications matching the Level 2 criteria must be submitted to the Faculty Research Ethics Committee.

Animal Research Ethics Applications
All research ethics applications involving animals must be approved by the TCD Bioresource Research Ethics Committee Email: Bioresources@tcd.ie.

Hospital Research Ethics Applications
Any patient related research being undertaken on the St James/ Tallaght hospital site which requires ethical approval requires a submission to be made via Joint Research Ethics Committee (JREC): Claire.Hartin@tuh.ie

Should you be unsure of whether your application meets the criteria for the School of Medicine Level 1 Committee review please send an email to somrec@tcd.ie providing a short description of the research you wish to undertake, and advice will be provided.

 

Application Process for School of Medicine Research Ethics Committee

*Please note that all applications from September 2016 to School of Medicine Research Ethics committee are to be made via the online ethics application system detailed below*

Step 1: Registering and accessing the online system.

If this is your first time submitting an application, please register with our online submission system here. This is a queued system so please do not generate an application number until you have your application ready to be uploaded. You can download the application form and the templates for the PIL and Consent form and work on these offline. Only generate a new application number when you are ready to submit the application online.

Please note that registration can take some time before access to the system is fully approved, so please ensure that you register well in advance of the submission deadline dates (if you are a new registrant).

For subsequent access once registration is completed click here.

Step 2: Complete the application form.

  • APPLICATION FORM. Use this form for Level 1, School of Medicine, Research Ethics Application.

  • Please complete all the required sections on the form. Any sections that you consider not applicable to your study can be answered as N/A, however, you MUST provide an explanation as to why this particular requirement does not apply to your study for SoM REC consideration.

  • Application Form must be signed by ALL listed researchers and supervisor.

  • PARTICIPANT INFORMATION LETTER (PIL). Please use the GDPR Compliant PIL. All applications submitted to SoM REC for review must include a PIL. (New Participant Information Leaflet (Word 269 KB)

  • CONSENT FORM. If a consent form is required then please complete the GDPR Compliant Consent Form. (A Consent Form may not be required if you are using an anonymous survey where consent is assumed on submission of the completed anonymous survey, but this needs to be explicitly stated in the PIL). Consent Form (Word 84 KB). (consent form template is embedded within this document) Please refer to Explicit Consent Checklist here.

  • SUPPORTING DOCUMENTATION. Supply all relevant supporting documentation such as; questionnaires, interview guides, and all other data collection tools to be used in your study. If required, please supply any access/permissions letters, and a DUTL letter if your study involves students as participants.

  • Please name your SoM REC application in the following format only:
    [ApplicantNameMonthYear] and as a single PDF file. e.g. MaryByrneMay2021.pdf

Step 3: Submit your application online.

  • The application must be printed by the applicant and signed by the supervisor as listed. The file must be submitted via the online ethics application system before 5pm on the relevant deadline date.

  • Before uploading your application on the system, please merge the completed application form and all supporting documentation (PIL, consent form, questionnaires, interview schedule etc) into one complete document. Then save the word document for your files, as you may need to revise your application following SoM REC review. Now save the complete application as a pdf file and submit this single pdf document through the online system.

  • The submission is sent to the Academic Supervisor/lead researcher automatically within the online application system for approval before it can be submitted to the Research Ethics Committee for review. If this is the supervisors first time using the online system, they will need to register as a new user. If you are a staff member conducting a piece of research you can act as your own supervisor and will need complete both steps of the submission process.

  • This is a queued system so please do not generate an application number until you have your application ready to be uploaded. You can download the application form and the templates for the PIL and Consent form and work on these offline. Only generate a new application number when you are ready to submit the application online.

Notes.

  • All applications are marked with time and date of submission via the online system.

  • Any application not meeting the deadline for submission will automatically be queued for the next SoM REC meeting.

  • A cap on the number of new applications to be reviewed at any meeting will be 10.

Revisions.

  • Following the SoM REC meeting you will be notified by the online system via email as to the outcome of the review of your application.

  • If revisions are required please do not generate a new application number. You should upload the revised version of your application to the existing application number.

  • Applicants are requested to address the required revisions in a timely manner. Any application that remains ‘inactive’ after a three-month period, where the required revisions have not been addressed, will automatically be rejected (not approved). If the applicant wishes to continue with their study thereafter, the application must be re-submitted as a NEW application and will be queued for full review by the committee at the next available meeting.

Disclaimer.

  • It is essential that applicants carry out their research study exactly as indicated on the application as approved by the School of Medicine Research Ethics Committee.

  • If any new information comes to light after ethical approval has been received and the study cannot be carried out using the methods as per the approved application, you must contact the School of Medicine Research Ethics Committee to seek approval for any subsequent amendments as necessary, until approval is granted your study must be suspended.
Guidance Documents.

Women of Childbearing Potential
Declaration of Helsinki

School of Medicine Research Ethics Committee deadlines and meeting dates

 

DEADLINE
Online Submission
5PM

MEETING DATES

Thursday 9th September 2021
Thursday 7th October 2021
Thursday 4th November 2021
Thursday 2nd December 2021
Thursday 6th January 2022
Thursday 3rd February 2022
Thursday 3rd March 2022
Thursday 7th April 2022
Thursday 5th May 2022
Thursday 9th June 2022

**No meetings in July and August

Wednesday 22nd September 2021
Wednesday 20th October 2021
Wednesday 17th November 2021
Wednesday 15th December 2021
Wednesday 19th January 2022
Wednesday 16th February 2022
Wednesday 16th March 2022
Wednesday 20th April 2022
Wednesday 18th May 2022
Wednesday 22nd June 2022

 

 

Decision Process for School of Medicine Decision Process for School of Medicine Research Ethics Committee

  • Each applicant / supervisor will receive notification stating the decision as per the School of Medicine Research Ethics Committee.
  • Each applicant will be provided with sufficient time to submit any revisions to their application, but this time should not exceed a period of one calendar month.
  • Revisions are submitted electronically, using the same application number, via the online ethics application system.
  • Applicants should note that when they submit revisions to their application, they will be placed in a queue and will be reviewed as soon as possible.

Failure of an applicant to adhere to the re-submission timeframe for revisions of 30 days may incur a penalty whereby the application may expire and may need to be re-submitted.

 

Amendments to Approved Studies

Once an ethics application has been approved by SoM REC, the researcher(s) is responsible for ensuring that the study is conducted in adherence to the protocols outlined in their ethics application.

Amendment requests to approved studies may be considered where the amendment request constitutes a minor change to the original application that does not materially change the previously approved study. Examples of the type of change that may be submitted as an amendment request include:

  • Extension to the end date of the study where there is no change to methods of the approved study (no change to the study methods, recruitment, or data collection).
  • Extension of recruitment to the study (for example accessing a wider sample/participants) with no change to the study methods or data collection.

Any alterations to an approved study that involve a change in study methods (for example introducing a new methodology such as the inclusion of a qualitative component, recruitment of a new sample/participants where the study methods are also changing), needs to be submitted as a new and separate REC application and will be queued for full review by the committee at the next available meeting.

When submitting an Amendment Request we ask that you: 

(1) Precede your study title with the mention: **Amendment request**
(2) Complete and upload this  form  (MS Word 20 kB) summarising the amendments that are being requested.
(3) Upload a copy of your original ethics application form with the requested amendments highlighted in red font in the appropriate sections of the application form, and in any of the supporting documentation.

School of Medicine Research Ethics Committee Contact

For all queries related to your application to the School of Medicine Research Ethics Committee, please email SOMREC@tcd.ie