Across all the group working on Beyond Compliance there has been a desire to make it all as simple and slick as possible. Many of us have been involved with the introduction of a new implant, clinical trials including RCT's, etc. applications to ethics committees etc. We know how time consuming, and indeed sometimes costly, this can be.
We have taken the BC process to the various authorities who decide at which level to describe BC as to whether it embraces research, audit or any other description. We have been to the PROMs group at the Department of Health, National Research Ethics Service (NRES) and the Health and Social Care Information Centre (HSCIC).
We can confirm we have agreement from the DH Inforamtion Governance Compliance Officer that our patient consent model is in order. The process has been defined by NRES and the regulating bodies as a “Service Evaluation”. Thus, unless our BC process is altered there is no need for individual hospitals to approach ethics committees etc.
Consent forms to be administered locally therefore comprise:
The BC consent form covers both the collection of data, analysis and sharing it with appropriate parties in the BC process once it has been anonymised.etc.
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