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The School of Pharmacy & Pharmaceutical Sciences Ethics Policy

The School of Pharmacy & Pharmaceutical Sciences’ research is guided by the principles described in the Policy on Good Research Practice. As our research is intended to have some impact on society, by its nature it will potentially have an ethical dimension that should be considered and addressed prior to commencing this work. This is particularly pertinent in research that directly involves human participants or animal subjects. It is the responsibility of all of those engaged in such research to ensure that the dignity, rights and welfare of these participants and subjects are fully protected.

Research risk level

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.

Approval pathways

Ethics review 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). Details of these categories can be found in Section 2 of the College's background guidance document.

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 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 and does 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 approval

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 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. (See above.)

Level 3 (moderate to high risk) research approval

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

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 also be required from the Ethics Committee(s) of relevant hospital(s), health authorities or other bodies.

Mechanism for application

The College is currently transitioning to an online Research Ethics Application Management System (REAMS). Extensive documentation and training materials can be found on the main REAMS website at https://www.tcd.ie/research/support/ethics-approval.php.

The direct link to the REAMS application interface is https://ethics.tcd.ie, and an access link can also be found on the main REAMS website linked above.Currently, the REAMS system should be used for all applications to the SoPPS REC (Level 2). The Faculty of Health Sciences REC (Level 3) is not currently using REAMS, and applicants to that committee should continue to use the pre-existing application process (Word application form, submitted by email).

For further clarification, as relevant, please contact:

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