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Research and Finance Office

Department of Engineering

Studying at Cambridge

 

Ethics and Experiments Involving Animals and Tissue Samples

Ethical review of research with human participants

Research in the Department of Engineering may involve various kinds of users, experimental volunteers and others. This ranges from the trivial, such as asking colleagues to assist with the evaluation of new software, through to the complex, such as putting subjects in stressful situations and monitoring their responses. In all cases, it is important to plan the research carefully, not least to ensure scientific validity, and to consider any ethical issues.

The Department adopts a lightweight ethical review model, informed by current practice and in consultation with other Schools and Universities.  Research Ethics Committee Terms of Reference can be found here.  Further guidance is available in the research guidance wiki.

The review process

The review process may involve up to four stages:

  1. Self-assessment, which may lead to
  2. Light-touch review by Divisional Representative, which may be referred for
  3. Departmental review, which may require guidance from a
  4. Specialist panel

Stage 1: Self-assessment

Every research project in the Department should be preceded by consideration of ethical issues, including general issues of research governance, plagiarism, and whether or not the research involves human participants.

The Ethics Committee recommend that individual self-assessment is carried out by the researcher who will undertake the research. This may be done in consultation with the PI/Supervisor or the divisional representative (see table below).  The aim of this assessment is for the researcher concerned to consider whether any ethical concerns are raised. If there are no ethical concerns, then the researcher may proceed with their research work. However, if the researcher has any doubts concerning the ethics of their proposed research work, or whenever the research involves human subjects, the researcher should proceed to Stages 2 or 3 (see below).

University policy statements and guidelines may be useful when undertaking self-assessment:

Stage 2: Light-touch review by Divisional Representative

If the research project involves human participation but the researcher considers the potential risk of harm to the participants to be minimal, then it may be appropriate to seek light-touch review from the respective Divisional Representative (see list below) who can give guidance on whether the application should go on to Stage 3 Departmental review (see below for examples of these types of projects) or can confirm that the research may proceed without further review.  Many student projects may require only light-touch review, but this cannot be assumed.  Projects, including student projects, which involve more than minimal risk should receive a full Departmental review.

If you would like your application to be considered under the light-touch review process, please complete this form and email it to your Divisional Representative, stating "Light-Touch Application" in the subject header.  Your Divisional Representative will review your application and discuss any concerns with you directly.  Should they consider it to be low-risk, they will then sign off the form to confirm that you have sought light-touch review and that approval has been given to proceed. The authorised form and all of the application documents must then be emailed to research-ethics@eng.cam.ac.uk.  You will subsequently receive a letter confirming ethics approval for your project.  Please do not proceed with your project until you have received this approval letter.

However, should your Divisional Representative decide that your application warrants review by the full Research Ethics Committee, the application papers will be forwarded to the REC secretary at research-ethics@eng.cam.ac.uk who will initiate a full review process. You will be notified if this happens.

Stage 3: Departmental review

For all studies involving human participants, self-assessment is not sufficient, and the applicant should inform the Ethics Committee of the nature of the study. This should be done using the review form.  This form should be completed with reference to the research guidance wiki and sent to  together with an example participant information sheet and participant consent form.  Any other documentation that you may have, such as questionnaires or user manuals, should also be submitted.

NHS National Research Ethics Service (NRES) review is required for most research involving NHS patients, staff or facilities, as well as certain other forms of clinical and social science research.  The University has some central guidance on when NHS REC review is required, which is available here http://www.research-integrity.admin.cam.ac.uk/research-ethics/guidance/nres-review.

To help you decide whether your project requires NRES approval the Health Research Authority has created two decision trees that will guide you as to:

  1. Whether your study classifies as research
  2. If so, whether you need NHS REC approval

If researchers are engaged in a Clinical Trial, an investigation or series of investigations conducted on any persons for a medicinal purpose, the researchers must ensure that Clinical Trials Insurance is in place through the University's Insurance office in addition to gaining National Research Ethics Services.  Details of insurance, together with the definition of what constitutes a Clinical Trial for this purpose, can be found at http://www.admin.cam.ac.uk/offices/insurance/clinical/.  Applications to the NHS Research Ethics Committee are managed by your clinical partner and in consultation with your Divisional Representative.  Please note that in the case that NRES/NHS R&D approval has been obtained, a copy of the approval letter should be sent to the Department's Ethics Committee and this will serve as Departmental approval.

The Ethics Committee will consider your application and will offer pragmatic guidance on likely risks and legal constraints, as well as assessing the adequacy of problematic research proposals. In the vast majority of cases, the Ethics Committee is able to approve the proposal and the research can go ahead. In the majority of cases a decision will be given within 7 days, but please allow longer over holiday periods.  Problematic cases will proceed to Stage 4 (see below).

Important note:  The University Research Ethics Committee (UREC) will periodically review the Department's Ethics Committee decisions relating to ESRC-funded projects and may select, at random, individual reviews for audit purposes.  If selected for audit, PIs will be asked to provide relevant documentation on their project.  This may include consent documents and any necessary permissions, information on data storage/gathering, details of changes made following the initial Ethics Committee review and any additional information the UREC judges necessary.  For this reason PIs and supervisors must make their researchers aware of the importance of maintaining adequate records throughout the course of the project.

Stage 4: Specialist panel review

If the Ethics Committee believes further guidance is required, your research proposal will be referred to a specialist panel within the University.

The panel may request further information from applicants before either agreeing that the study can proceed, possibly with specific precautions, or recommending modifications to the study.

Experiments Involving animals and tissue samples

i.  The Academic Committee approved a proposal for a policy on the use of animals and tissue samples in experiments in the Department of Engineering on 3 June 2016. Drs Timothy O'Leary and Michael Sutcliffe are the contacts regarding this policy.
ii. Research involving animals must be referred to University Biomedical Support Services (UBSS), keeping the informed. Drs Timothy O'Leary and Michael Sutcliffe can provide advice.
ii.  Because the Department does not hold an HTA license, NRES approval must be obtained before human tissue can be stored here.  Please send a copy of the appropriate approval to the before commencing the project.

Division

Representative

Energy, Fluid Mechanics and Turbomachinery

Stewart Cant

Electrical Engineering

Andrew Flewitt

Mechanics, Materials and Design

Pat Langdon

Shery Huang

Civil Engineering

Giovanna Biscontin   Dongfang Liang

Manufacturing and Management

Rob Phaal

Alexandra Brintrup

Information Engineering

Daniel Wolpert

Joan Lasenby