3. University Ethics Review Procedure (University Procedure)
The University Procedure has been designed to take into account the differences between disciplines, and aims to achieve an appropriate balance between carrying out the ethical review of research projects in a sufficiently rigorous way to effectively protect the welfare, dignity and rights of human participants, whilst also being risk-aware, flexible and as user-friendly as possible in order to facilitate research within departments.
The University Procedure is based on the following guiding principles:
- Quality: competent and consistent decision-making by ethics reviewers within, and across, departments should be enabled and encouraged.
- Effectiveness: the welfare, dignity and rights of participants and researchers must be protected.
- Devolution: applications should be reviewed at department level, enabling researchers to 'own' their own research ethics, thereby raising awareness and allowing research to be ethically reviewed by those with close knowledge of the particular ethical challenges raised by their departments' research activities.
- Flexibility: departments should, within the minimum requirements set by the University Research Ethics Committee (UREC), be able to tailor the procedure to fit their particular needs in a number of ways, such as modifying the University's standard research ethics application form to add discipline-relevant questions, managing the reviewing process in the most appropriate way (e.g. via an email system, or face-to-face), or creating discipline-specific guidance.
- Ease of application: the procedure is designed to be as simple and prompt as possible, while maintaining high standards. For example, when successive cohorts of undergraduate or postgraduate-taught students are required to undertake sufficiently similar research projects, a single ‘generic’ research ethics application can be submitted.
- Efficiency: on average, departments should provide a decision on an ethics application within 10 working days.
- Independence: ethics reviewers must not have any conflict of interest with respect to an application they review (other than in the case of undergraduate or postgraduate-taught student research, for which the supervisor may be a reviewer).
- Proportionality: the detail and depth of the ethics review of any particular project should be in proportion to the estimated level of risk posed to prospective participants. This is not a straightforward matter; where possible researchers should take into account potential participants’ likely perceptions of risk.
- Transparency: applicants should receive sufficiently detailed, critical and constructive feedback from reviewers to explain the decision made; this should also be able to satisfy the requirements of external scrutiny, if ever required.
Although ethical approval is required before any data collection involving human participants commences, applicants are expected to consider the ethical implications of their research at all stages of the project. Even the most well thought-out project may come across unexpected ethical challenges after approval has been obtained, and researchers should constantly reflect on the ethics of their research. If changes are made to the project after approval has been obtained, it may be necessary to obtain re-approval in certain circumstances, which are explained in Section 3.1.8 of this document.
Since academic departments have considerable flexibility in how they operate the University Procedure, applicants will need to refer to their own department for details of the specific process they are required to follow. The following section outlines the minimum requirements set by the UREC within which departments must operate the procedure.