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Biomedical & Scientific Research Ethics Committee (BSREC)

* Please note there have been significant changes to the BSREC application process and review structure as of October 2018*

If you are making an application to BSREC for ethical review, please ensure that you are using the latest versions of the BSREC forms (see right hand links) and familiarise yourself with the remit of the Committee below. Any applications requiring a full review received after Friday 7 December 2018, will be reviewed at Committee meetings going forward. BSREC meeting dates can be found here.

Please see 'How to apply' for further details.

Scope & Remit of BSREC

All studies that involve human participants, their tissue, and/or their data, are required to obtain approval from an appropriate research ethics committee.

For the majority of medical and social care research in the NHS that involves patients or their identifiable data, approval by the NHS National Research Ethics Service (NRES) is required. This service is provided by the Health Research Authority (HRA). Further information can be found on the 'NHS Research Ethics Committee' webpage and associated subpages.

BSREC considers applications for research ethical review for projects involving human participants in the Faculty of Science, Engineering and Medicine (excluding the Department of Psychology) that do not fall within the remit of NRES.

Ethics approval should be sought before the project begins. Please note BSREC does not issue retrospective approval.

BSREC grants ethical approval for projects. The seeking and obtaining of all other necessary approvals is the responsibility of the investigator. This includes obtaining HRA approval (NHS permissions) for research projects in the NHS, where this is required in addition to BSREC approval.

BSREC will not review or approve amendments for studies it did not originally review and approve i.e. studies originally awarded approval by an NHS REC or HSSREC. For such studies, applicants should refer to the original approving REC.

Applicants who wish to discuss their research and/or the application process before submission should contact the Research Governance Office (tel: 024 765 73961 or email: BSREC at warwick dot ac dot uk).

BSREC Project/Study Triaging

BSREC undertakes ethical review of all projects on a proportionate basis according to a risk-assessed triage process. Please click the following links for more information on each process:

No ethics review

Departmental Course Delegated Ethics review

Light Touch review

Full review

Chair's action

Public Engagement and Pre-Protocol work

Projects predominantly involving animals

No ethical review

Projects that involve secondary analysis of publicly available data e.g. systematic reviews do not require research ethics review. Please note this does not extend to the use of social media or forums in research. Although these data may appear ‘publicly available’ for researchers to access, there are ethical implications that need to be considered when using these data in research. If it doubt, please contact the BSREC Secretary who will be able to advise whether research ethics review is required.

Delegated to Departments for ethics review

BSREC has approval from the Research Governance & Ethics Committee (RG&EC), to whom it reports, to support departments to set up delegated processes for the ethical review of low risk undergraduate and taught postgraduate student research projects.

This is often referred to as Course Delegated approval and is for research projects that:

  • are limited to interviews, focus groups, and questionnaire completion, or the evaluation of software and e-Learning materials;

  • are with participants who are not vulnerable and not dependent (including, but not limited to those not receiving health or social care, primary or secondary education, or criminal justice services);

  • do not investigate sensitive or intrusive matters (e.g. health status, criminal activity, or sexual history);

OR are:

  • NHS clinical audit projects;

  • NHS health/social care service evaluation and development projects.

Please note this process is only available to undergraduate and taught post-graduate student projects, not masters by research, doctoral student, or staff projects.

These processes must be approved by BSREC and the RG&EC before they can be implemented in departments. These are currently in place for: WMS MB ChB, WMS PGT, Computer Science UG & PGT, Engineering UG & PGT and WMG PGT. If you are interested in setting up a delegated process for your department, please contact the BSREC Secretary: BSREC at warwick dot ac dot uk.

If you are an undergraduate or taught post-graduate student in one of the above departments and are eligible for course delegated review, then please contact your course administrator for details on how to apply as this will vary depending on the department.

For details on how to determine whether your project is a service evaluation or clinical audit, please refer to the study classification tool.

Light Touch

Applications eligible for a light touch review are examined by circulation by one independent reviewer. There are no deadlines for receipt of light touch applications as these are reviewed on a continuum but it is the responsibility of the BSREC Secretary, in conjunction with the Chair, where necessary, to determine whether the study is eligible for light touch review. Where light touch applications are deemed to require a full review, they will be referred for review at the next BSREC meeting.

Projects eligible for a light touch review are as follows:

1. Research involving the secondary analysis of existing, previously collected data (that is not publicly available) e.g.:

  • Research using routinely collected patient data within a clinical care team, or outside a clinical care team where the data has been anonymised prior to its passing to the researcher(s);

  • Research using routinely collected student assessment data within a course or Department/School where the data has been anonymised prior to its passing to the researcher/s;

2. Research involving the secondary analysis of previously collected human samples, with consent for use in research;

3. Staff or Doctoral Student research projects that are limited to interviews, focus groups, and questionnaire completion, or the evaluation of software and e-Learning materials, with participants who are not vulnerable and not dependent (e.g. not receiving health or social care, primary or secondary education, or criminal justice services), where the research does not investigate sensitive or intrusive matters (e.g. health status, criminal activity, or sexual history);

4. Clinical audit projects undertaken by MRes or Doctoral students or members of staff;

5. Health/social care service evaluation and development projects undertaken by research students or members of staff;

6. Substantial amendments to previously approved projects.

BSREC operates to a target of providing a research ethical opinion on new light touch applications within 30 working days. Please ensure you factor this into the timescales for your project.

The application form for light touch and full review is the same.

Full review

Applications are reviewed by the full Committee at BSREC Committee meetings. The Committee meets every six weeks and applications must be submitted two weeks ahead of the meeting date. Late submissions will not be accepted and will be deferred to the following meeting.

The BSREC secretary will provide initial feedback on the application once this has been received and will advise if the application is valid and of sufficient quality for review at the meeting.

Applications requiring a full review are as follows:

Research with human participants that:

  • investigate sensitive or intrusive matters;

  • involve vulnerable participants (including, but not limited to those receiving health or social care, primary or secondary education, or criminal justice services);

  • involve an intervention or experiment (including but not limited to taking human samples, the use of simulators or driving studies, the gait lab, computer/visualisation experiments etc.).

Applicants can expected to receive an outcome within 5 working days of the meeting.

It is the decision of the BSREC Secretary and the Chair, where neccesary, to determine whether a project requires a full or light touch review. The application form for both review processes is the same, the only difference being that applications for a full review need to meet the meeting dates. It is the responsibility of the researcher to familiarise themselves with the remit and the meeting dates to allow sufficient time for ethics review.

Please note all applications received after Friday 7 December 2018 will be reviewed at the January meeting, to accomodate the Christmas Period.

Chair’s Action

Chair’s Action may be taken (with the advice of other Committee members if appropriate) to:

  • determine whether or not an application falls within the remit of the Committee;

  • confirm the approval of conditionally approved protocols when the conditions have been met;

  • review research applications outside of standard BSREC processes where time/funding constraints apply, in conjunction with the BSREC Secretary, or two other members of the Committee*.

*Please note this process is for exceptional circumstances only. Applicants should ensure sufficient time is factored into the research process to ensure ethics approval is sought in a timely manner. Review by Chair’s action will be at the discretion of the Chair.

Public Engagement and Pre protocol work

It is important for researchers to understand the difference between 'public and patient involvement (PPI)' in research and 'participation' in research.

Public and patient involvement in research is where key informants/service users are involved in the planning of what research should be done (what do the public see as a priority) and how this should be carried out or set up. This may involve consultation with patients/members of the public/key stakeholders to discuss feasibility and recruitment methods, review participant information leaflets or drafting/piloting of a questionnaire. Whilst researchers are always required to work ‘ethically’, this pre-protocol work does not require research ethics review.

Where a patient or a member of the public becomes a 'participant' in a research study and data collected from these individuals will be analysed and form part of research report, this is research and does require research ethics review.

Pathways to Impact is an essential component of a research proposal and often a condition of funding. Public engagement is a popular form of impact activity but for it to be as effective as possible it should be two-way engagement activity and not just outreach. Pathways to Impact should be considered early on in the research proposal and where possible details should be included in the research ethics application. If this is to be determined later on, this can be submitted as an amendment to the existing ethics approval.

Projects predominantly involving animals

Researchers should, in the the first instance, seek advice concerning approval from the University's Animal Welfare and Ethical Review Body (AWERB), formerly the Biological Research Ethics Committee.

However, certain animal projects may also involve human participants, particularly those conducted on farms, or at slaughterhouses. BSREC will consider such projects on a case by case basis.

Examples may include:

  • A study on a farm investigating mastitis in cows, for which farmers are asked to take milk samples for the project. BSREC would be likely to deem such a project as out of remit.
  • A study on a farm investigating the feeding schedules for herds, which involves collecting samples from animals, data from farmers, and interviews with the farmers regarding their practices. BSREC may consider such a project to require ethical review for the aspects of the study which involve human particpants, i.e. the interviews with the farmers.

In all instances, please contact the BSREC Secretary for further advice BSREC at warwick dot ac dot uk.

Accountability

The Biomedical and Scientific Research Ethics Committee (BSREC) is accountable to the University Research Governance & Ethics Committee (RG&EC), and is required to report regularly to the University Senate and Council through this Committee.

Advice & Support

The Research Governance Office is dedicated to aiding you with your application; our resource email account is monitored regularly, so please contact BSREC at Warwick dot ac dot uk in the first instance with any queries. Please do not approach the Chair of BSREC directly.