Protocol for Ethical Approval of Student work
UNIVERSITY OF LEICESTER NON-CLINICAL ETHICS REVIEW
PROTOCOL FOR RESEARCH ETHICS REVIEW OF STUDENT PROJECTS:
MAY 2007
All students- whether undergraduate or postgraduate- who undertake non-clinical projects concerning human subjects, using human material or data must obtain ethical approval for the conduct of their projects from 1st October 2007. Projects which would prior to the coming into force of this protocol have been referred to an NHS Research Ethics Committee as required by the NHS Research Governance Framework will continue to be so referred[i]. In addition those topics excluded from review under the University Research Ethics Code of Practice already issued will be excluded from the review of student projects. It should be noted that review of student projects is something which is envisaged in the ESRC Research Ethics guidelines.
I. RESEARCH ETHICS TRAINING
Where students are likely to undertake non-clinical research concerning human subjects as part of their undergraduate/postgraduate degree they must receive appropriate discipline-specific research ethics training during their degree programme[ii]. Reference is made to the need for such training for undergraduates and postgraduates where appropriate in the ESRC Research Ethics Framework[iii]. Such training should also be supported by appropriate direction by the dissertation supervisor. Such students must be made aware of the subject of research ethics and the need to comply with the University’s Research Ethics Code of Practice. In the case of overseas based students it is envisaged that the provision of ethics training e.g. using on-line resources may be appropriate.
Supervisors of undergraduate/postgraduate students undertaking such research will also need to undertake appropriate training in research ethics to ensure that they are aware of the issues and can advise students. In situations in which the supervisors are not members of staff of the University of Leicester and who may operate away from University of Leicester premises Course Directors must ensure that all supervisors are aware of the ethical review process and must ensure that there is formal compliance with this process.
II. PROCEDURE FOR APPROVAL OF STUDENT PROJECTS
(i) Role of the Supervisor
Students shall submit their project for consideration to their supervisor. Where this is a non-clinical project concerning human subjects the supervisor must advise them of the need to obtain appropriate ethical approval and should give initial advice regarding the research ethics issues which may arise as a result of the project. Students and supervisors should also discuss the need for resources to securely store personal data.
(ii) Submission of proposal for research ethics review
At a reasonable period before data collection begins the student must complete an ethics approval form which should be submitted to the Departmental ethics officer for review[iv].
The review of student projects should be undertaken within a reasonable time and not more than four weeks after submission of the form.
The basic process for review of student projects is as set out in the University Research Ethics Code of Practice previously circulated. As with staff projects the initial review of projects will be undertaken by a departmental/school research ethics officer and there will be reference to a departmental/school/faculty research ethics committee where this is required under the Code.
It is proposed that the form for review of student projects should be aligned with that of staff projects with reference being made to the same general criteria and to the factors set out in the ESRC checklist as incorporated in the University Code of Practice.
(iii) Application of criteria
The same criteria will be applied in assessing student and staff research projects as in the University Of Leicester Research Ethics Code of Practice. In the case of student projects reviewed by Departmental Ethics Officers it is envisaged that “light touch” approval will usually be appropriate. Departmental Research Ethics Officers may determine that a project should be referred back to a student to amend and resubmit at this stage.
However it may be the case that because the project involves more than “minimal risk” and in a situation where re-submission/redrafting of the protocol may not be appropriate it may require reference to a departmental/school/faculty research ethics committee for full consideration. Research Ethics Committees must publish a schedule of their proposed meetings at the start of the academic year and these meetings should be set at appropriate times to facilitate the effective and speedy review of student projects.
(iv) Documentation
Clear documentation of all projects considered as part of this process is to be collated and retained by the department. It is envisaged that collation and retention of such information should be undertaken electronically as far as possible. It is also proposed that the University should ensure that mechanisms are in place for electronic submission of documentation for research ethics review[v].
(v) Decisions regarding Student Projects
The decision made by the committee for research ethics as to whether to approve a project must be in accordance with the existing University of Leicester Research Ethics Code of Practice decision-making options.
(vi) Appeal Structure
Students will have a right of appeal to the University Committee for Research Ethics. Where such appeals are heard the procedure will be in accordance with that set out in the University of Leicester Research Ethics Code of Practice. A student has the right to have the support of a friend at the appeal.
III. DISTANCE LEARNING STUDENTS
The protocol for students will apply both to campus and distance learning students[vi] Training should be equally available to campus and DL students. This may be achieved either by training being delivered during teaching sessions when DL students attend campus as part of e.g. DL weekends. Alternatively training may be delivered through on-line materials being made available with use e.g. of Blackboard as appropriate. The latter may be particularly appropriate in relation to overseas students who visit the UK infrequently.
IV. “EXCEPTIONAL GENERAL APPROVAL” PROCESS
It is envisaged that in some exceptional situations in which it is routine practice within a module to undertake some basic research on an annual basis within a UG/PGT module then an “Exceptional General Approval” may be given. A Course Director/Head of Department may make an application to a Faculty Committee for Research Ethics for an “Exceptional General Approval[vii]. The Course Director/Head of Department will be required to fill in an “Exceptional General Approval” application form. This will include the “research ethics” checklist and will require the Course Director/HOD to show why such an approval should be given for this particular course. It is envisaged that approval will be given in situations in which such research would be assessed as below minimal risk. Any such “Exceptional General Approval” cannot be given by a Research Ethics Officer and must be submitted to a Faculty Committee for Research Ethics. Once given the approval would continue for a period of 3 years and then would require renewal. In a situation in which there were modifications to the UG/PGT module then the Course Director would be required to make a fresh application for a “General Approval”.
[i] Department of Health Research Governance Framework for Health and Social Care ( 2nd ed) London: DOH (2005).
[ii] Some ethics training already exists in the context of some PGR programmes e.g. in the Faculty of Medicine and Biological Sciences.
[iii] ESRC Research Ethics Framework Swindon: ESRC, (2005), para 1.10.4.
[iv] This affords some flexibility for departments as in some instances differential time periods may be appropriate.
[v] Dr Richard Mobbs in the Computer Centre is currently developing an electronic form for submission.
[vi] While it was recognised that in responses to the original consultation document that DL students may give rise to additional challenges it has been decided that no one area of student activity can be seen to be exempt from ethics and governance compliance.
[vii] Such applications cannot be made to a department/school committee.
