Ethical approval for non-clinical research: guidance for module level and group application

Introduction

All research involving human participants, their tissue or data requires review and approval by a research ethics committee before the research starts. The ethical review and approval of non-clinical research involving human participants proposed by staff and students is conducted by School Research Ethics Committees (SRECs).

This guidance document is to be used when making module and group applications for Non-Clinical Research Involving Human Participants. For the purposes of this document, a module is defined as a discreet credit bearing element of a programme at either UG or PG level. A group is defined as a grouping of projects which are similar in nature, perhaps originating from extra-curricular projects, where students are from a range of programmes, or for public engagement events not linked to a module.

This document should be considered in addition to all other procedural and guidance materials which should also be read and abided by (including: Guidance for Researchers, Checklist 1 Guidance, Forms A & B Data Management Guidance).

Criteria

In order to be considered for module/group level approval, the application must meet the following criteria:

• Be low risk as determined by checklist 2
• Not collect any personal data
• The various projects within the application must be substantially similar
• There must be a named single point of contact overseeing all the projects (such as module lead, project supervisor, PI etc)

Procedure

The approval procedure will be the same as for individual ethical applications, being that the named researcher should submit Checklists 1 & 2 with Form A, plus all other documents relevant to their application (for example, participant information sheet(s), consent form(s)) by e-mail to the relevant SREC administrator.

Before proceeding with the review, the administrator or reviewer will check to ensure that the above criteria have been met.

For rolling applications (I.e. a module that occurs every year), approval will be given for a maximum of three years, assuming no substantial changes, after which it must be reviewed. The project end date will therefore be three years from the first ethical approval.