Changes to COREC Application Form

COREC are expecting to release a new version of the ethics application at the end of October - there are changes relating to research tissue banks, indemnity, co-sponsorship, sponsor declaration...

COREC are expecting to release version 5.2 of the REC application form on 21-22 October.

The main change will be the provision of a distinct form for applicants requesting ethical review of licensed research tissue banks (although there are a number of other amendments, see below). There is no statutory requirement for ethical review of research tissue banks. Applications will be made on a voluntary basis.

The review process will complement rather than duplicate the licensing scheme operated by the Human Tissue Authority. In particular, it aims to facilitate research sourcing tissue from licensed research tissue banks by allowing for generic ethical approval.

The main issues addressed in the ethics review will be:

• Arrangements for collecting tissue and, where appropriate, seeking broad consent to the use of tissue in future research.
• Information sheets and consent forms used by research tissue banks and their collaborators.
• Plans for future research using stored tissue.
• Arrangements for releasing tissue to researchers.
• Feedback of significant research findings to donors, where appropriate.

Research tissue banks will be able to seek generic ethical approval to conduct research using stored tissue or to release anonymised samples to researchers - subject to certain conditions, without a requirement for further applications for ethical review on a project-specific basis. 

This type of generic ethical approval will satisfy the requirement of the Human Tissue Act for the researcher to have ethical approval where storing and using tissue without a licence.

Detailed guidance on the process will be available from COREC in due course.

There are also a number of other changes to the application form, as outlined below:

• Revised wording of questions on indemnity to, for example, distinguish between liabilities of sponsor and Investigators (A35 and A36)
• Revision to question on statistical review (A45-2)
• More information about co-sponsorship and division of responsibilities (A59)
• Addition of signed declaration by lead sponsor (part B, section 7) i.e. Clinical Research Office will need to sign off ethics forms.
• More specific information requested on anonymisation and consent for collection of new tissue for research (part B, section 5)

For further information on these and other planned changes to the application form, please see http://www.corec.org.uk/applicants/docs/Changes_form_v5-2.pdf.