Scope and Remit of the Biomedical & Scientific Research Ethics Committee (BSREC)
All studies undertaken within the Faculties of Medicine and Science 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 research, and research in the NHS, approval by the NHS National Research Ethics Service (NRES) is required. Further information can be found on the Research Support Services (RIS) web page: 'NHS Research Ethics Committees'.
BSREC considers applications for ethical review for research projects involving human participants in the Faculty of Medicine and the Faculty of Science (excluding the Department of Psychology) that do not fall within the remit of NRES.
BSREC undertakes ethical review of all projects on a proportionate basis according to a risk-assessed triage process. Projects are either delegated to taught undergraduate and postgraduate courses for review, subject to BSREC 'Light Touch Review', or BSREC 'Full Review', depending on their nature.
Projects delegated to taught undergraduate and postgraduate courses are subject to the processes of individual courses.
Projects subject to BSREC 'Light Touch Review' are examined by one independent reviewer, while those subject to subject to BSREC 'Full Review' are examined by two independent reviewers. There is no difference in the procedure for making an application for either BSREC Full or a Light Touch Review;
BSREC operates to a target of providing research ethical opinion on new project applications within 30 working days.
Either type of BSREC review can lead to the project being referred to the full Committee, if it raises significant ethical concerns. If necessary, the Committee may request that an applicant attends a Committee meeting in person to answer questions about the proposed study. The applicant will be invited to the next scheduled BSREC meeting, which occur termly.
BSREC Project/Study Triaging
a) BSREC does not require ethical review for:
- Secondary analysis of published or publically available data, e.g. meta-analyses and literature reviews;
- Minor amendments to previously approved BSREC projects;
- Undergraduate projects with primarily an educational purpose, including projects for the purpose of research methods training, provided they do not:
i. Seek to recruit participants beyond the students’ social circle, family, peers, or colleagues
ii. Receive external funding
iii. Include any form of deception or coercion
iv. Involve the administration of any substance
v. Involve participants being subjected to any invasive procedure.
1. The ethical review and approval of undergraduate and taught postgraduate student (but not masters by research, doctoral student, or staff) 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 (e.g. 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);
2. The ethical review and approval of undergraduate and taught postgraduate student (but not masters by research, doctoral student, or staff) clinical audit projects;
3. The ethical review and approval of undergraduate and taught postgraduate student (but not masters by research, doctoral student, or staff) health/social care service evaluation and development projects.
Research projects primarily involving animals, but which also involve human participants. Please contact the BSREC Secretary in the first instance to discuss such projects.
Research using the secondary analysis of existing anonymised collected data, 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;
- 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);
- Clinical audit projects undertaken by research students or members of staff;
- Health/social care service evaluation and development projects undertaken by research students or members of staff;
- Substantial amendments to previously approved projects.
- All other research with human participants
In addition, the Committee would not normally undertake ethical review for:
- Interview/consultation with key informants/service users during the development of research proposals/protocols;
- Stakeholder consultations during the developmental stage of research proposals/protocols.
BSREC grants ethical approval for projects. The seeking and obtaining of all other necessary approvals is the responsibility of the investigator (click this link for further details).
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. 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 Ethics & Governance Office (tel: 024 765 28207 or email: BSREC at warwick dot ac dot uk). Please note: it is very difficult for members of the Research Ethics and Governance Office to provide accurate advice without being provided with, at the very least, an outline protocol.
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;
- In conjunction with the BSREC Secretary, or two other members of the Committee, review research applications outside of standard BSREC processes where time/funding constraints apply.
The Research Ethics & Governance Office (REGO) of Warwick Medical School is dedicated to aiding you with your application; our resource email account is monitored regularly, so please contact WMS REGO in the first instance with any queries. Please do not approach the Chair of BSREC directly.
BSREC at warwick dot ac dot uk.
The Biomedical and Scientific Research Ethics Committee is accountable to the University Research Governance & Ethics Committee, and is required to report regularly to the University Senate and Council through this Committee.