How to apply for BSREC ethical approval
From 1st October 2012, BSREC simplified the application process for ethical review by the Committee. The process is as follows:
- Develop a study protocol/proposal
; - Complete the BSREC application form
and produce all associated documents (e.g. Participant Information Leaflet(s) (PIL)
, questionnaire(s), consent form(s)
, interview schedule(s), interview topic guide(s)); - Sign the application form (wet ink signature) and if you are a student, ask your Academic Supervisor to either sign the form, or to send an e-mail to BSREC at warwick dot ac dot uk confirming that they agree to abide by the statements made in part 4.2 of the application form;
- Post the wet ink signed copy of the application form to: Amy Ismay- BSREC Administrator, Research Ethics and Governance Team, A010, Medical School Building, Warwick Medical School, University of Warwick, Coventry, CV4 7AL;
- E-mail two pdfs of your documents to the BSREC Administrator via BSREC at warwick dot ac dot uk: the first pdf should just contain the completed application form, the second pdf should contain all other documents associated with your study (protocol, participant information leaflet(s), consent form(s), questionnaire(s), interview schedule(s), interview topic guide(s));
- The review of your study will take up to 20 working days from when you are issued with your BSREC reference number via an e-mail from Amy Ismay, BSREC Administrator, or Emily Dight, Governance and HTA Administrator. If your study raises significant ethical concerns, you may be asked to attend a meeting of the Committee to answer any queries;
- Your study will either be awarded full approval or conditional approval. If you are awarded conditional approval, you will be required to meet all of the conditions set out in the letter and resubmit your study to the BSREC Administrator via BSREC at warwick dot ac dot uk, highlighting all of the amends you have made in a different colour so that they are easy to locate. You should receive a final decision from BSREC for all resubmitted documents that meet all of the conditions within 10 working days. You cannot start your study until you have received full approval from the BSREC Chair in writing;
- If you receive full approval from BSREC and you find that you need to make a change to your study, you may need to apply to BSREC for ethical approval of the changes that you would like to make (find out if that is the case for the amends that you would like to make by reading the BSREC study amendment and application guidance
). You will need to complete the BSREC application form for substantial amendment requests for previously approved studies
and submit your documents as per points 2-5 above, but highlighting in a different colour any changes that you have made so that they are easy to locate. The review of an amendment request will take up to 20 working days.