The School of Pharmacy & Pharmaceutical Sciences Research Ethics Committee
The School of Pharmacy and Pharmaceutical Sciences Research Ethics Committee (SoPPS REC) is a Level 2 committee, i.e. it may provide ethics approval for very low or low risk research. It may also provide ethics approval for projects that would not ordinarily require REC approval but for the fact that publication is intended, but only before the research has been conducted. It is not possible to provide retrospective approval for research that has already been undertaken. See Section 2 of the College's background guidance document for further information on research risk level.
Application format
All applications to the SoPPS REC (Level 2) should be made via the College’s Research Ethics Application Management System (REAMS), as should applications for amendments to projects that were previously approved via REAMS. Applications for amendments to older projects that were previously approved outside REAMS should be made by email, using the Word amendment application form linked below.
REAMS is a dynamic online interface that presents relevant sections of the application form to applicants, depending on their response to certain filter questions. Because of this, when an applicant first logs in to REAMS, only a small subset of questions is initially visible. If you wish to see all the potential questions to facilitate planning your application, a Word copy of the REAMS application form has been linked below, for information only.
IMPORTANT: Since the Faculty of Health Sciences(FHS) REC (Level 3) does not use REAMS and its application form has a different set of questions, it is important to identify at an early stage whether your application should be directed to the SoPPS Level 2 REC or to the FHS Level 3 REC. Guidance on this is linked below.
Key links
- REAMS. This is the main REAMS page, which includes guidance, FAQs etc..
A direct link to the application interface is https://ethics.tcd.ie. - Word version of REAMS application form, for information only
- TCD guidance on background to making an ethics application
- TCD guidance on completion of the REAMS application form Please follow this question by question guidance carefully as you complete your ethics application.
- TCD guidance on research that does not usually require REC approval
- Tool to assist in distinguishing between research, audit, service evaluation and health surveillance
- TCD guidance on research that will require review by the TCD Data Protection Officer
- Research to be approved by the Faculty of Health Sciences (Level 3) REC
- TCD templates for PILs, consent forms, data protection review and DPIA
- SoPPS REC annual report form
- SoPPS REC end of project report form
- SoPPS REC application form for amendment to an approved study (Word form for studies that were previously approved outside REAMS)
- TCD Policy on Good Research Practice
- Data protection and research (includes College Data Protection Policy and Handbook)
Application deadlines (academic year 2024-25)
Applications must be received by 17.00 on the specified dates (first Friday of the month except for December meeting; see details below). The committee will not meet in July or August; hence applications should be made no later than June (earlier is recommended) for research that is intended to commence in September.
Note: A maximum of 10 applications will be reviewed by the SoPPS REC in any calendar month. If more than 10 applications are received in a given month, preference may be given to undergraduate and taught postgraduate applications over postgraduate research degree applications.
| Submission deadline | Expected meeting date |
Friday 6th September 2024 |
Wednesday 25th September 2024 |
Friday 4th October 2024 |
Wednesday 23rd October 2024 |
Friday 1st November 2024 |
Wednesday 27th November 2024 |
Friday 22nd November 2024 (note earlier deadline) |
Wednesday 11th December 2024 |
Friday 3rd January 2025 |
Wednesday 29th January 2025 |
Friday 7th February 2025 |
Wednesday 26th February 2025 |
Friday 7th March 2025 |
Wednesday 26th March 2025 |
| Friday 4th April 2025 | Wednesday 23rd April 2025 |
| Friday 2nd May 2025 | Wednesday 28th May 2025 |
Friday 6th June 2025 |
Wednesday 25th June 2025 |
No meetings in July and August. |
|
SoPPS REC application process
When planning a research project you should allow sufficient time to prepare your ethics application. This will potentially take weeks rather than days, as you may need to undertake training and/or obtain training certificates, prepare and obtain DPO signoff on study documentation (using the College templates where applicable), and obtain letters of approval/access if your study involves external sites. You should also allow sufficient time for the REC approval process itself: at least a month from the relevant REC meeting date, as it is likely that the initial review process will trigger revisions and further review.
All potential applicants should first:
- Read Trinity College’s Policy on Good Research Practice;
- Check that the proposed research falls within the scope of the SoPPS REC (Level 2 committee), as outlined in Section 2 of the College's background guidance document. In particular, please check as soon as possible that your project will not be directed to the FHS Level 3 REC, which has a different application form and process.
- Check whether DPO review is required based on the six questions in the College guidance. It is important to check this as soon as possible, because the need for DPO review will potentially add months to the approval process that you will need to factor into your timeline. If DPO review is required, complete the DPO review template and email both it and the data protection training certificate(s) for research team members to dataprotection@tcd.ie with the email subject line ‘Data Protection Review’. Arising from this initial screening review, it is likely that you will need to supply further documentation to the DPO for review (e.g. information for study participants, consent forms, data protection impact assessment). The DPO will provide feedback and you may need to revise your documentation. You can therefore expect several emails back and forth with the DPO over an extended period before you receive a DPO Review Letter of Completion. This letter must be included in your application to the REC, so you will not be able to submit your ethics application until you have received it
The ethics application form must be completed in full, including upload of all appendices. Detailed guidance on interpretation of the questions and completion of the form is available. Applications will be rejected without further consideration if they are incomplete in any respect.
Review and decisions
The initial REC review and the associated administrative processes will typically yield an outcome within a week of the relevant REC meeting date. This timeline may be extended where the nature of the application necessitates engagement beyond to the REC. Applicants should also note that a maximum of 10 applications will be reviewed by the SoPPS REC in any calendar month. If more than 10 applications are received in a given month, an application may be assigned for review in a later month despite having been received by the submission deadline. Preference may be given to undergraduate and taught postgraduate applications over postgraduate research degree applications.
Review of applications will include consideration of the scientific justification for the study, the characteristics of research participants and their recruitment (including consent), ethical aspects of research methodology including the care and protection of research participants throughout the study and the risk/benefit ratio, confidentiality and data protection.
The applicant will be notified electronically of the review's outcome via REAMS. Where ethics approval has been granted, a letter to this effect will be issued electronically, via REAMS. A hard copy can also be provided upon request.
The most likely initial outcome is that queries or issues raised by the REC will need to be addressed by the applicant through revisions before approval can be granted. Where an application requires revision prior to approval, the required clarifications/changes will be communicated to the applicant via REAMS. The original application on REAMS should be revised (please do NOT start a new application) and should be accompanied by tabulated responses to the reviewers’ comments (uploaded to REAMS as an attachment). Revised applications will be reviewed for satisfactory completion of the specified alterations. If the revisions are satisfactory a formal letter of approval will be issued electronically via REAMS. It is likely that the revision and additional review process will take up to a month, though this may vary depending on the nature of any revisions sought.
The SoPPS REC decisions on applications are intended to be binding. However, should an applicant wish, a subsequent application may be submitted to the Faculty of Health Sciences Research Ethics Committee for separate review, disclosing the prior application to the SoPPS REC.