Classification of proposed research: Routine or Non-Routine?

Staff members in the first instance are responsible for assessing the ethical status of their research and the research for those whom they supervise (see below for student projects) with reference to peers and appropriate ethical and professional codes. Staff must ensure that full records are kept of their assessment and they should complete one of the forms listed on the 'Proposal Procedure' page.

Each project or piece of new research should be classified into one of two categories, as below:

Routine:

This includes research projects which so closely follow previous research already given ethical approval that the ethical issues are identical, and ESRC funded projects which meet the ESRC’s definition of having less than 2 minimal potential risk of harm to participants and others affected by the proposed research. The ESRC’s guidance on what would normally be considered more than minimal risk is given in Section 1.2.3 of their Framework for Research Ethics. Such routine or minimal risk projects do not need to go through the ethics committee for approval, but should be signed off by the supervisor (ideally with the reference number of the project which had previously received ethical approval) and sent to the Ethics Committee administrator for record keeping.(Note that routine projects funded by the ESRC must be reviewed by a Departmental Research Ethics Officer from outside of the applicant’s department [where appropriate this could be from a different School]. This referral will be managed by the Departmental Research Ethics Officer, who will ensure that full records are kept of the referral and decision made.)

Non-routine:

Research which has not previously been scrutinised by the School Ethics Committee and which cannot be classified as Routine. This also includes circumstances where:

• participants are to be subjected to questions, or other procedures which carry a risk of being harmful to their physical or mental well being
• specific advice is needed on the nature of ethical problems and their solution
• during peer review or complying with the ethical principles outlined in this document unresolved ethical issues are apparent
• vulnerable populations are involved
• research involving groups where permission of a gatekeeper is normally required for initial access to members
• research which might appear to involve deception or which is conducted without participants’ full and informed consent at the time when the study is carried out
• research involving access to personal information or confidential information on identifiable living individuals
• all cases of predictable media interest or sensitivity
• all cases where there is a conflict of interest
• an external agency requires certification of ethical approval
• ESRC funded projects that are considered as involving more than minimal risk.

The Proposal Form for Ethical Review and supporting documentation should then be submitted as early as possible before the intended start date of the project. Proposal forms for research assistants’ projects must be countersigned by the supervisor(s).

Student projects

Undergraduate and taught postgraduate projects should be reviewed by the student’s supervisor, who can approve routine projects (inc. ESRC ‘minimal risk’), taking advice from the Departmental Research Ethics Officer, where necessary. The School Ethics Committee will select a small number of the projects for review each year to ensure that ethical principles are being consistently applied and adhered to.

Proposal forms for student projects must be countersigned by the supervisor(s) and the outcome of their review clearly recorded. In cases where the supervisor cannot classify the project as routine, then these projects must be referred to the School Ethics Committee, for review.

All non-routine research should be submitted to the School Ethics Committee for approval prior to commencement. Where there is any doubt about whether a proposal is routine or new, then the proposal should be considered anew by the School Ethics Committee.

Projects that were reviewed between more than 3 years ago (2 during 2010-11) need to be submitted for review again to ensure that ethical approval remains valid.

A note about 'clinical' projects

By clinical, we mean projects which would require getting NHS ethics approval (now referred to as NRES) for research on patients or NHS staff. Procedures for gaining NRES approval have become much more onerous, time consuming and complex in recent years and the effort required for such approval regularly has meant a delay of between 6-12 months in starting data collection. For this reason we strongly advise against embarking on a project requiring NRES approval and students at Masters level are not allowed to embark on projects requiring NRES. The only exception to this will be if a student, through their existing employed work, is already doing research on a project which has received NRES approval for the work that individual is doing- i.e. no new NRES application would be required.

However, if NRES approval has been obtained to work with NHS patients, facilities and staff Birkbeck’s ethics approval is NOT required, but correspondence confirming ethical NHS approval should be copied to the School Ethics Committee.