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Obtaining other approvals

BSREC grants ethical approval for projects. The seeking and obtaining of all other necessary approvals is the responsibility of the investigator.

These other approvals may include, but are not limited to:

1. Any necessary agreements, approvals, or permissions required in order to comply with the University of Warwick’s Financial Regulations and Procedures. This includes collaboration agreements and data sharing agreements etc.

2. Any necessary approval or permission required in order to comply with the University of Warwick’s Quality Management System and Standard Operating Procedures for the governance, acquisition, storage, use, and disposal of human samples for research.

3. All relevant University, Faculty, and Divisional/Departmental approvals, if an employee or student of the University of Warwick.

4. Approval from the applicant’s academic supervisor and course/module leader (as appropriate), if a student of the University of Warwick.

5. NHS Trust R&D Management (HRA) Approval, for research studies undertaken in NHS Trusts.

6. NHS Trust Clinical Audit Approval, for clinical audit studies undertaken in NHS Trusts.

7. Approval from Departmental or Divisional Heads, as required under local procedures, within Health and Social Care organisations hosting the study.

8. Local ethical approval for studies undertaken overseas, or in other HE institutions in the UK.

9. Approval from Heads (or delegates thereof) of UK Medical Schools, for studies involving medical students as participants.

10. Permission from Warwick Medical School to access medical students or medical student data for research or evaluation purposes.

11. NHS Trust Caldicott Guardian Approval, for studies where identifiable data is being transferred outside of the direct clinical care team. Individual NHS Trust procedures vary in their implementation of Caldicott guidance, and local guidance must be sought.

11. Completion of relevant Information Security Workbooks and subsequent approval from the Information Data Compliance team where appropriate for the use of external services that will be hosting personal data on behalf of the University.

12. Any other approval required by the institution hosting the study, or by the applicant’s employer.

There is no requirement to supply documentary evidence of any of the above to BSREC unless requested, but applicants should hold such evidence in their Study Master File for University of Warwick auditing and monitoring purposes. You may be required to supply evidence of any necessary approvals to other University functions, e.g. The Finance Office, Research & Impact Services (R&IS), or your Department/School.

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