Procedures for the Ethical Approval of Research Projects
Who do I contact?
- The Ethics Committee is serviced by the Academic Office and all administrative process relating to ethical approval will be handled by its officers.
- The form PG2/E1 should be used by all students and staff undertaking research regardless of level of study or size of research project. http://www.uwtsd.ac.uk/academic-office/appendices-and-forms/
- The correct contact to use for matters relating to research ethics is: email@example.com
What do I need to do before the research starts?
Applications should be submitted for approval as early as possible. All projects must be signed off from an ethics perspective before that part of the work for which approval is being sought begins.
- If projects are approved research may proceed. The applicant and supervisor[s] will receive a communication to this effect from the Ethics Committee. Projects will be approved for the duration of the research process subject to resubmission should the nature of the research change or on the identification of unforeseen ethical implications that arise during the research process.
- If projects are approved subject to amendments the applicant and supervisor[s] will receive a communication to this effect that indicates the minor points that require clarification. The project should be amended and re-submitted to the Ethics Committee for approval.
- If projects are not approved because they contain major flaws the applicant and supervisor[s] will receive a communication from the Ethics Committee, detailing the issues to be addressed. The project must be substantially revised and re-submitted to the Ethics Committee for approval.
- Staff Research
- Research Degrees
- Taught Undergraduate, Taught Postgraduate Courses and Undergraduate Dissertations
- Taught Postgraduate Dissertation
- Collaborative Research
Do all types of research follow the same process?
The procedures for ethical consent are different for research on the following programmes and levels, principally:
You should follow the processes detailed below.
In principle all researchers should undertake an ethical review of their own research but certain categories of research involving human participants, their tissues or data must be independently reviewed by a properly constituted Research Ethics Committee. Ethics Committee approval must therefore be sought for all research undertaken by members of academic staff within the University that involve human participants in a way that might harm, disturb or upset them (however slight the possibility) or where they can be deemed to be in a vulnerable or disadvantageous situation.
The Table 1 lists the types of research which prima facie should have an independent ethical review but, in general, any research project which has the potential to harm, upset or significantly inconvenience a participant, or seek confidential or sensitive personal information about a participant or where the relationship between the researcher and the participant is unequal, should be reviewed by the Ethics Committee.
This is a requirement for both internal /non-funded research and for research where external funding is granted. In instances where the research is dependent upon external funding being secured, it is not normally expected that the Principal Researcher should seek ethical approval at the application stage, although this is recommended in sensitive cases, such as research dealing with medical or health research, any non-CE marked medical device, research working with children, vulnerable adults, or that which take place in hazardous environments (as set out in Paragraph 7.1). In all cases however, externally funded research projects must have ethical approval before the research commences. The Application for Ethical Approval form (PG2/E1) should be completed and submitted to the Ethics Committee.
All prospective research projects, whether at MPhil or Doctoral levels, should be referred to the Ethics Committee by the student and supervisory team for approval after the proposal form (PG1) has been approved by the Research Degrees Committee. The standard PG2/E1 Application for Ethical Approval Form should be completed in these cases and submitted to the Ethics Committee. All research students are required to complete this form. If the research does not include the collection of primary data then some sections do not need to be completed (see guidance notes on form). A copy of the form shall be retained in the Academic Office.
Taught Postgraduate Dissertation
In the case of dissertations carried out on taught postgraduate courses the responsibility for ethical considerations should be with the research supervisor, and module leader, who should advise the student in line with standard ethical practices and the guidance contained on these pages. For all cases where the School is able to provide ethical approval an annual report shall be forwarded to the Ethics Committee detailing dissertation titles, student names and short statement confirming that no ethical issues have been identified. This will be held by the Academic Office.
Taught Undergraduate, Taught Postgraduate Courses and Undergraduate Dissertations
The Ethics Committee does not, under normal circumstances, review and approve research projects and related research activities conducted as part of taught undergraduate, taught postgraduate, taught short course programmes, or undergraduate dissertations. It does however provide advice, guidance and support to academic staff supervising such teaching, assessment, projects and activities. Each Faculty has its own procedures for ensuring that research conducted in their respective programmes does not breach ethical standards and these are appended to this Code of Practice. These procedures will be reviewed and updated as required and no-less often than is this Code of Practice. Faculty procedures will be reviewed and updated annually and reported to the University Ethics Committee.
In cases where ethical issues are identified by the supervisor, and module leader, then the Ethics form should first be referred to the Faculty Ethics Committee and if necessary these could subsequently be referred to the University Ethics Committee. Instances needing referral include, but are not limited to, research that implicates the involvement of others (human or animal) or has the capacity to interfere with or make a difference to their lives, that which involves extensive travel abroad to areas associated with safety risks and access to websites or other media which deal with particularly sensitive topics. Due regard shall also be made for the risks identified in Sections H. If any such circumstances are identified the Ethics Committee may refer the application to the University’s Health and Safety Officers (care of the Operations Department) for advice or a full risk-assessment.
Research is increasingly conducted on a collaborative basis with a range of public, private and third sector organisations, at national, European and International levels. In such instances the Ethics Committee shall consider the proposed programme of research in its entirety, rather than just those work packages pertaining to UWTSD staff. Consistent with the guidelines in this Code, each organisation shall submit the research proposal to its own governance systems and research shall not commence until each body is satisfied that all ethical issues have been addressed.
Continuing Ethical Review
What do I need to do once the research has started?
All postgraduate research conducted for research degrees shall be reviewed for on-going and unforeseen ethical issues during the various points of a research degree candidature:
- Progress reviews with the supervisory team
- Submission of full research proposal
- Upgrade from MPhil / PhD (where applicable)
- Successful completion of Probationary Period (where applicable)
- Annual review
Staff research will be continually monitored on a self-regulatory basis.
If projects which have initially been judged not to have ethical implications change and do subsequently have ethical dimensions it is the responsibility of project supervisors for all supervised research, or in other cases the staff responsible for the research, to ensure that ethical scrutiny procedures are invoked and followed through. Such instances must be raised immediately with the Ethics Committee.
Unforeseen ethical implications
In all cases any adverse events occurring during the conduct of research projects must be reported to the Ethics Committee. In such cases the researcher, whether staff or student, shall withdraw from the research process with immediate effect until notified by the Ethics Committee that the University is satisfied that the research design has been modified in such a way as to mitigate further harm.