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The School of Pharmacy & Pharmaceutical Sciences Research Ethics Committee

The School of Pharmacy and Pharmaceutical Sciences Research Ethics Committee (SoPPS REC) is a Level 1 committee, i.e. it may provide ethical approval for low risk research. Further information on the type of research that falls within the scope of this committee may be found in the guidance document.

Documentation

Application process

All potential applicants should first read Trinity College’s Policy on Good Research Practice and should check that the proposed research falls within the scope of the SoPPS REC, as outlined in the guidance document.
The application form should be downloaded and completed in full. 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. A hard copy is not required.
Applications will be rejected without further consideration if:

  • The form used is not the current version as posted on the website;
  • The application form is incomplete in any respect (including incomplete checklists or missing signatures);
  • Appropriate documentation referred to in the application form has not been appended;
  • The application form and any appendices have not been collated into a single Word or pdf file;
  • In the case of a student applicant, the research supervisor is not identified in the application or has not completed the requisite sections.

Review and decisions
The initial review and the associated administrative processes will typically take four weeks. This timeline may be extended where the nature of the application necessitates external advice to the REC. Applicants should also note that a maximum of 10 applications will be reviewed 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.
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 SoPPS REC decisions on Level 1 Applications are intended to be binding. However, should an applicant wish, he/she may submit a subsequent application to the Faculty Research Ethics Committee for separate review, disclosing the prior application to the SoPPS REC.
Notification of the committee’s decision will be by email to the applicant (and supervisor if applicable) at the email address(es) supplied in the application form. Where ethical approval has been granted, a letter to this effect will be provided by email. A hard copy can also be provided upon request.

Where an application requires revision prior to approval, the required changes will be communicated to the applicant (and supervisor if applicable) by email.  Tabulated responses to the reviewers’ comments plus the revised version of the full application documentation incorporating the required changes should be submitted by email to pharmacy.ethics@tcd.ie, 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 by email.

Amendment of an approved study
Following approval, it is essential that the research undertaken is as described in the application and approved by the SoPPS REC. Any significant alteration requires approval from the SoPPS REC before implementation. Significant alterations include changes to personnel, study design/methodology (including recruitment methods and consent procedures), duration, and participant information leaflets. Applications for amendment should be on the form linked above, accompanied by a copy of the full application documentation showing the proposed differences from the current approved version as tracked changes.

Reporting
Investigators will be required to provide annual and end of project reports to the SoPPS REC. Further information is provided in the guidance document and the report templates are available above. The SoPPS REC must also be notified of the date when a project concludes, within 90 days of the conclusion date. The conclusion date is defined as the last data collection timepoint. If the project is terminated prematurely, the SoPPS REC must be informed of the reason(s) for premature termination.
If any substantive adverse events occur during the study, it is also the applicant’s responsibility (and the supervisor’s responsibility in the case of a student applicant) to ensure that these are reported immediately by email to pharmacy.ethics@tcd.ie as well as to any other appropriate authorities.

Further information
For further information, please contact pharmacy.ethics@tcd.ie.