The School of Pharmacy & Pharmaceutical Sciences Ethics Policy and Procedures

Trinity College currently recognizes three levels of research risk:

• Level 1: Research that carries very low risk (no risk to participants);
• Level 2: Low-risk research, i.e. research that carries no greater risk or discomfort to participants than would usually be encountered during normal daily life.
• Level 3: Moderate to high-risk research, i.e. research where the risk or discomfort is greater than that usually encountered during normal daily life.

Further information on the type of research that is classified at each level may be found in Section 2 of the College's background guidance document.

Where ethics review and approval are required, they must take place before the research is undertaken. Retrospective approval is not possible. The pathway depends on the level of risk: Level 1 (very low risk), Level 2 (low risk) or Level 3 (moderate to high risk).

Research that does not usually require ethics approval

Some study types (including quality assurance studies, clinical audits and service evaluation studies that are not designed to produce generalisable and transferable findings) do not usually require ethics approval. Details can be found here. However, if the QA study/ audit/ service evaluation is to be published or used in a M.Sc./Ph.D. thesis, this is perceived as presenting generalisable/ transferable findings and is considered to be research, so TCD ethics approval will be required. This is the case even if another institution (e.g. the hospital where an audit is taking place) treats it solely as an audit from their perspective and they do not require ethics approval.

A useful decision-making tool to help in distinguishing between research, audit, service evaluation and health surveillance can be found here: https://www.hra-decisiontools.org.uk/research/index.html.

If it is anticipated that formal ethics approval will be required (e.g. for publication/thesis), then a study that would not otherwise require ethics approval project may be submitted for review by a Level 2 committee such as the School of Pharmacy and Pharmaceutical Sciences Research Ethics Committee (SoPPS REC). Please note that this must take place before the research is undertaken. It is not possible for the REC to provide ethics approval retrospectively for research that has already been conducted.

Level 1 (very low risk) and Level 2 (low risk) research ethics approval

Research ethics applications for Level 1 and Level 2 research should be directed to the School of Pharmacy and Pharmaceutical Sciences Research Ethics Committee (SoPPS REC), which is a Level 2 committee. Details of how to apply to the SoPPS REC are provided below.

Level 3 (moderate to high risk) research ethics approval

The Faculty of Health Sciences Research Ethics Committee (FHS REC) is a Level 3 committee, i.e. it may provide ethics approval for moderate to high risk research.

Please note that the FHS REC is not currently using the College’s online Research Ethics Application Management System (REAMS). It has its own Word application form (submitted by email), and the questions on that form differ somewhat from those on REAMS. Therefore applicants are strongly advised to determine at an early stage whether their application should be directed to the FHS Level 3 REC. You can do this by (1) reading Section 2 of the College's background guidance document, and (2) looking at the REAMS questions that cause an application to be classified as Level 3 in this file: Level 3 REC

Approval for animal research

Animal research will require ethics approval from TCD's Animal Research Ethics Committee.

Approval from external bodies

Depending on the nature of the research, ethics approval may be required from the Ethics Committee(s) of relevant hospitals, health authorities or other bodies. In almost all cases, such approval is in addition to approval from the relevant TCD REC, must be obtained before applying to the TCD REC, and must be submitted as an appendix to the TCD ethics application. Therefore this should be factored into the time you allocate for approval of your research project.

Because of Trinity’s association with the Joint Research Ethics Committee (JREC) of St James’s Hospital and Tallaght University Hospital, projects with JREC approval do not usually require separate, additional Trinity REC approval unless the project also involves other sites. However, if any such projects require a hospital Data Protection Impact Assessment (DPIA), this must be submitted to the Trinity Data Protection Officer (DPO) for review.

For further clarification, as relevant, please contact:

• School of Pharmacy and Pharmaceutical Sciences Research Ethics Committee (Level 2): pharmacy.ethics@tcd.ie
• Faculty of Health Sciences Research Ethics Committee (Level 3): ethicscommittee@tcd.ie
• Trinity Animal Research Ethics Committee, School Representative - Dr Oliviero Gobbo: ogobbo@tcd.ie

The School of Pharmacy and Pharmaceutical Sciences Research Ethics Committee is a Level 2 committee, i.e., it may provide ethics approval for Level 1 and Level 2 research (where the level of risk/discomfort is no greater than that usually encountered in normal daily life). It may also provide ethics approval for projects that would not typically need ethics approval but for the fact that publication is planned, in advance of that research being undertaken, as outlined above.

All new applications to the SoPPS REC must be made via the College’s Research Ethics Application Management System (REAMS). 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 provided in the key links below, for information only.

Extensive documentation and training materials can be found on the main REAMS website at https://www.tcd.ie/research/support/ethics-approval.php.

IMPORTANT: Since the Faculty of Health Sciences 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 in the key links below.

Classifying your project

• 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

Making a new application

• REAMS. This is the main REAMS page, which includes guidance, FAQs
  A direct link to the application interface is https://ethics.tcd.ie.
• 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.

Templates for study documentation

• TCD templates for participant information leaflets (PILs), consent forms, data protection review and DPIA. Please take note of the separate templates for health research and non-health research. See next link for template if your project involves anonymous research.
• DPO guidance on anonymous research studies including sample/template PIL for an anonymous project

Amending a previously approved application

• Summary form required when applying for an amendment to an approved study on REAMS
• SoPPS REC application form for amendment to an approved study (ONLY for studies that were previously approved outside REAMS).

Report forms

• SoPPS_REC_annual_report_form
• SoPPS_REC_end_of_project_report_form
• For adverse event reporting procedures and documentation, see REAMS website

Other guidance and policies

• HSE guidance on data protection and research (if a HSE site is involved)
• Guidance on retrospective chart review
• Data Protection Commission guidance on anonymisation and pseudonymisation
• European Data Protection Board guidelines on pseudonymisation
• TCD DPO guidance on data retention periods
• Health research definition and guidance
• Rules for emails to all TCD staff/students or emails to selected TCD mailing lists
• Policy on access to Trinity College staff and students for research purposes by external organisations
• Trinity Policy on Good Research Practice
• Data protection and research (includes College Data Protection Policy and Handbook)
• College research policies
• University lone working policy and guidance

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 will need to be considered no later than the June REC meeting (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.

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 Data Protection Officer signoff on study documentation (using the College templates where applicable), and obtain letters of approval/access if your study involves external sites or resources. (Note that only data protection training undertaken within the last 24 months is recognised.) 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;
• IMPORTANT – As soon as possible, 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 that your project will not be directed to the FHS Level 3 REC, which has a different application form and process.
• IMPORTANT – As soon as possible, check whether DPO review is required based on the six questions in the College guidance. It is essential to check this at an early stage, 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.
• Check whether your research involves another data controller besides TCD (e.g. where data from a hospital or other organisation will be used for a TCD postgraduate project). If so, you are likely to need a joint data controller agreement. A template for this can be obtained by emailing pharmacy.ethics@tcd.ie. Any such agreement will need to be approved by relevant personnel in both TCD and the other organisation and this process is likely to add significantly to your timeline. The agreement must be included in your application to the REC.
• If your project involves a Health Service Executive (HSE) site (e.g. hospital), ensure that it will comply with HSE requirements regarding data protection and research.
• If your project involves retrospective chart review, liaise with appropriate personnel in the healthcare organisation(s) holding these records, to ensure that the relevant legal requirements will be satisfied in advance of your project.
• Check what appendices are likely to be required, since some of these (e.g. letters of access/support) may take some time to obtain. You may find it helpful to review the Word copy of the REAMS application form, which shows (in green) many of the appendices triggered by individual REAMS questions.
• Familiarise yourself with the other key links above, identifying those of relevance to your project.

To apply to the SoPPS REC, the ethics application form must be completed in full on REAMS, including attachment of all appendices. Detailed guidance on interpretation of the questions and completion of the form is available. All applicants are advised to consult this question by question guidance when working on the application. Applications will be rejected without further consideration if they are incomplete in any respect.

The initial REC review and the associated administrative processes will typically yield an outcome within 5-10 working days of the relevant REC meeting date. This timeline may be extended where the nature of the application necessitates engagement beyond 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.

An applicant to the SoPPS REC 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 brief tabulated responses to the reviewers’ comments (uploaded to REAMS as an attachment). Revised applications will be reviewed for satisfactory responses to queries and 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.

Following approval, it is essential that the research is undertaken 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. Depending on the nature of the alteration, it may be possible to seek approval via an amendment to the original application or it may require a new application. Some guidance on this is available in Section 3.4 of the REAMS background guidance manual and Section 3.4 of the REAMS guidance on making an application.

If the project was originally approved via REAMS, an application for amendment should be via REAMS. The SoPPS_REC_REAMS_amendment_summary_form should be completed and uploaded as an attachment to the REAMS amendment application.

If the project was originally approved outside REAMS (this will apply only to a small number of historic projects), an amendment application should be made using the Word_non-REAMS_amendment_application_form, accompanied by a copy of the full application documentation showing the proposed differences from the current approved version as tracked changes. These should be emailed to pharmacy.ethics@tcd.ie.

Investigators will be required to provide annual and end of project reports to the SoPPS REC. The report templates are available in the key links 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. Details on adverse event reporting procedures and documentation are available on the REAMS website: https://www.tcd.ie/research/support/ethics-approval.php.