Biomedical & Scientific Research Ethics Committee (BSREC)
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. It is appreciated that study designs vary greatly, and that further information may be required to determine whether ethical approval is required. Detailed guidance on whether your research requires ethical approval can be found on the below page.
A useful flowchart to determine what approvals you will require can be accessed here.
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 or their data 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.
For some student research, BSREC has delegated the ethical review to the department. For more information please see the Delegated Student Research page.
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.
If the University of Warwick is not the sole lead organisation for the research and another Higher Education institution (such as the lead or co-lead) has granted formal research ethics approval, it may not be necessary to also gain BSREC ethics approval. However, BSREC will require a record of this external approval along with confirmation that Warwick's role in the project is covered by this. Please submit a copy of the ethics approval granted to BSREC@warwick.ac.uk before the research commences. The BSREC Secretary will advise as to whether further ethical review is required. Where Warwick is the lead institution, ethical review is expected to be conducted by BSREC.
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.
The Committee will normally only accept applications for ethical approval after funding has been awarded (in the instances where external funding is sought), except when ethics approval forms part of the requirements of a grant application.
Applicants who wish to discuss their research and/or the application process before submission should contact the BSREC Secretary (tel: 024 765 73123 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:
Full review
All projects involving the collection of primary data, or that are deemed high risk, are reviewed by the full Committee at BSREC Committee meetings.
The Committee meets seven times per academic year and applications must be submitted two weeks and two days ahead of the meeting date. Late submissions will not be accepted and will be deferred to the following meeting.
The BSREC secretariat 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.
Applicants can expect to receive an outcome within 10 working days of the meeting.
Light Touch
There are no deadlines for receipt of Light Touch applications as these are reviewed outside of full meetings. It is the responsibility of the BSREC Secretary, in conjunction with the Chair where necessary, to determine whether a 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.
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.
Any studies falling under all the following criteria may be eligible for review through the Light Touch process (reviewed by one reviewer via email):
Projects which do NOT:
- Cover sensitive topics (e.g. topics which participants may find difficult, distressing or cause anxiety, topics which could lead to negative consequences for the participant);
- Recruit vulnerable participants (e.g. children, adults who by nature of the topic are vulnerable, adults unable to provide informed consent);
- Involve any dangerous/risky locations (e.g. countries with travel warnings in place, dangerous locations within or outside the UK, lone working where the researcher may be at any risk outside of usual activities);
- Involve any invasive procedures or physical risk (e.g. studies involving taking samples from participants, studies requiring participants to test new or existing technologies);
- Involve risks of possible disclosures or reporting obligations (e.g. research that covers topics where participants may reveal sensitive information such as risk of harm to themselves or others, professional malpractice or insecure migration status that would need to be reported to relevant authorities);
- Involve data processes which may pose a challenge to individual data security;
- Involve any reasonably perceived conflicts of interest.
Examples of studies which may fall under the ‘low risk’ remit are:
- Module/teaching evaluation projects undertaking evaluation work but with the intention to turn the results into publishable research. If the researcher has any direct involvement with the students’ education, this should be acknowledged within the application and participant-facing documents. It should be clearly outlined that no coercion or pressure will be placed on students and that their education will not be affected in any way by the research;
- Anonymous online surveys which do not cover any sensitive topics or recruit vulnerable participants. (e.g. non-sensitive anonymous surveys recruiting participants through MTurk, Prolific);
- Studies which only involve limited numbers of participants who will be taking part in their professional capacity and discussing only professional topics (e.g. interviews with authors/artists on their bodies of work, given the topics are not sensitive or contentious);
- Studies gathering basic company information which could be gained through FOI requests but where the researcher would prefer to contact participants with a polite request to take part in research and offer the information freely rather than through an FOI request.
The Committee Secretariat will make the decision on whether a project meets these criteria and is therefore eligible for review through the Light Touch process. This decision may be made in conjunction with the Chair where necessary. Applicants cannot request that a project be reviewed through the Light Touch process, and it will be determined by the Secretariat if there are any additional risks which need to be considered by the Committee. Please note that applications considered under the Light Touch remit may still be escalated by the reviewer to the Chair or Committee if additional risks are identified and if they believe that the application requires further scrutiny.
Low risk studies still need to complete the full BSREC application form and submit this to BSREC@warwick.ac.uk
Secondary Data
Most applications involving only the collection and analysis of secondary data will be eligible for review through the Light Touch remit. These may be referred for Full Review if the topic is particularly sensitive or contentious or if any further risks are identified by the Secretariat or reviewer.
Amendments
Substantial amendments to previously approved projects are reviewed by light touch.
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.
Do I Need Ethical Approval
Full Application Form and Supporting Documents
BSREC Data Guidance NoteLink opens in a new window
BSREC Substantial Amendment application formLink opens in a new window
Template Research Data Flow Chart