Procedures

Procedures for ethical review and approval of research

Summary:

The policy outlines the mechanisms within the College of Science & Engineering for the identification, review and approval of research with ethical implications that are not covered by existing procedures for biomedical and animal research. The procedures outlined here comply with those of the University, please refer to:

Introduction

  1. The ethical implications of a research project are primarily the responsibility of the researcher. However, many research funders require all research proposals submitted to them to provide evidence of University procedures to provide ethical approval for the research.
  2. While some areas of research within the College of Science & Engineering (e.g. biomedical research on human subjects or tissue; research using animals) are already covered by formal review procedures and external ethics committees (see Appendix - link at bottom of page), other research areas, where hitherto ethical considerations may not have been apparent, do not have access to any formal approval system.
  3. The University therefore requires clear mechanisms for dealing with the ethics of research involving human subjects or data that is not covered by already established mechanisms; or covering other areas of potential ethical concern such as environmental issues.
  4. Internal discussions have indicated that research of this type (for instance observation or interviewing of subjects or use of personal data) is most likely to take place in the Schools of GeoSciences (human geography), Informatics, and Engineering & Electronics.

Mechanisms

  1. Each School should take responsibility for ethical review and approval of all research within the School, while the College Office is required to ensure that procedures exist in each School.
  2. All research proposals should be screened for ethical implications. In most cases 'self-audit' by the researcher (or the researcher's supervisor, in the case of undergraduate and postgraduate students) will be sufficient to confirm that there are no ethical implications arising from the research. This confirmation is already included on the IRG-1 form:
  1. ERI's research support team keep the design the IRG-1 form under review and the ethics section has been expanded to provide a straightforward (tick-box) means of identifying areas where ethical review may be necessary.
  2. For student projects or other research that is not externally funded (and therefore does not use an IRG-1 form) a proforma will be used for self-audit. see for example:
  1. Where self-audit identifies a need for review, the research must be referred to a suitably-constituted Ethics Committee or nominated individual within the School (each School has a formally appointed academic contact for ethical issues, and who is a member of the College Ethical Committee).
  2. Those Schools in which a relatively high volume of research using human subjects takes place have set up an Ethics Committee to handle such proposals. Guidelines are provided for committee operation. Schools should use a pro forma approach to the review process to facilitate proper documentation. The below flow chart may be helpful when considering whether there are ethical implications to a particular piece of research (with thanks to the University of Surrey Ethics Committee).
  1. In all other Schools within CSE that do not anticipate a significant amount of work with human subjects, the identification of a named individual, nominated by the Head of School, is deemed sufficient. That individual takes responsibility for ethics in research and provides advice where necessary. Suitable guidelines are provided (see Appendix).
  2. Schools can also refer proposals to another School's Ethics Committee, if that committee contains more appropriate expertise to assess the proposal (for instance a relevant School Ethics Committee within CHSS). Where this is done, a School nominee (e.g. the HoS, the ethics representative as nominated in 10 above, or the Convenor of the School's Ethics Committee) remains responsible within the School for ensuring the research proposal has been reviewed and approved. In practice, no research project requiring ethical approval should start before written approval is received.

Timescales for Review

  1. It is anticipated that relatively few proposals will require full ethical review. In many cases this will be identified by the researcher and the proposal referred for appropriate approval at an early stage.
  2. In most cases it is expected that review by committee will be possible by remote, properly documented feedback (i.e. will not require a meeting of the committee). Committees should have fairly rapid turnaround times for such review under normal circumstances.
  3. Where the need for ethical review is only identified at the stage of completion of an IRG-1 there is currently potential for delay to submission of a proposal while review is completed. This is clearly undesirable and awareness-raising of the process should help to avoid such problems. As the Joint Electronic Submission system (Je-S) is used widely be the Research Councils for proposal submission the IRG-1 form is an integral part of proposal preparation; thus last-minute delays due to late identification of ethical implications should not now be an issue.

Publication of Ethical Review Procedures

  1. Each School should have a written statement of its ethical review procedures. These should be published on the School's website. Under the Freedom of Information Act these may form part of the School's Publication Scheme.

Raising awareness

  1. The College Office, Schools and the University's Research Ethics Committee will work together to raise awareness of ethical issues in research. This can be done through the new staff induction programme, a series of workshops for existing staff, and/or information published on the web.

Reporting

  1. Convenors of School Ethics Committees and nominated individuals from other Schools should meet at least once a year to review procedures and issues, and to prepare a report to the College.
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