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
The College is switching from emailed applications to an online Research Ethics Application Management System (REAMS) on a phased basis.
| Application type | Currently | Future |
| Staff project | REAMS | REAMS |
| Research postgraduate project | REAMS | REAMS |
| Taught postgraduate project | REAMS | |
| Undergraduate project | REAMS |
Key links
- Application (new projects or amendments to approved projects) via REAMS For staff and research postgrads only, until further notice. This is the main REAMS page, which includes guidance. A direct link to the application interface is https://ethics.tcd.ie.
- SoPPS REC Application form for email applications For taught postgraduates and undergraduates only, until further notice.
- SoPPS REC application form for amendment to an approved study (for studies that were approved outside REAMS)
- TCD guidance on background to making an ethics application (labelled for REAMS but also includes information relevant to email applications)
- TCD guidance on completion of the application form (labelled for REAMS but also includes information relevant to email applications)
- 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
- TCD templates for PILs, consent forms, data protection review and DPIA
- SoPPS REC annual report form
- SoPPS REC end of project report form
- TCD Policy on Good Research Practice
- Data protection and research (includes College Data Protection Policy and Handbook)
Application deadlines (academic year 2023-24)
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 8th September 2023 |
Wednesday 27th September 2023 |
Friday 6th October 2023 |
Wednesday 25th October 2023 |
Friday 3rd November 2023 |
Wednesday 29th November 2023 |
Friday 24th November 2023 (note earlier deadline) |
Wednesday 13th December 2023 |
Friday 5th January 2024 |
Wednesday 31st January 2024 |
Friday 2nd February 2024 |
Wednesday 28th February 2023 |
Friday 1st March 2024 |
Wednesday 27th March 2024 |
| Friday 5th April 2024 | Wednesday 24th April 2024 |
| Friday 3rd May 2024 | Wednesday 29th May 2024 |
Friday 7th June 2024 |
Wednesday 26th June 2024 |
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 consent form 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;
- Identify the required application format (email or REAMS; see table above);
- If applying by email, 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. (Applications via REAMS will automatically be assigned to the appropriate REC level.)
- 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. Detailed guidance on interpretation of the questions and completion of the form is available (labelled for REAMS but also relevant to applications by email).
If applying by email, any appendices should be collated with the application form into a single electronic file (Word or pdf format only). The collated application should be submitted by email to pharmacy.ethics@tcd.ie.
If applying by REAMS, appendices should be uploaded at the relevant prompts.
Applications will be rejected without further consideration if:
- The application is not by the correct route (REAMS or email as appropriate; see table above);
- The application is incomplete in any respect (including incomplete checklists or missing appendices);
- In the case of a student applicant, the research supervisor is not identified in the application or has not completed the requisite sections;
- The form used is not the current version as posted on the website (for email applications);
- The application form and any appendices have not been collated into a single Word or pdf file (for email applications).
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. Where ethics approval has been granted, a letter to this effect will be issued electronically, via REAMS or email depending on the manner of application. 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 electronically to the applicant. Tabulated responses to the reviewers’ comments plus the revised version of the full application documentation incorporating the required clarifications/changes should be submitted via REAMS (staff and research postgraduate projects) or by email to pharmacy.ethics@tcd.ie (taught postgraduate or undergraduate projects), ensuring that revisions are highlighted using the tracked changes facility in Word. 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. 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 Research Ethics Committee for separate review, disclosing the prior application to the SoPPS REC.