Other important Information

Ethical review for CPRD Protocols

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The CPRD Group has obtained ethical approval from a National Research Ethics Service Committee (NRES) for all purely observational research using anonymised CPRD data; namely, studies which do not include patient involvement (which is the vast majority of CPRD studies). ISAC is responsible for reviewing protocols for scientific quality, but may recommend that study-specific ethical approval is sought if ethical issues arise in relation to an individual study. Separate ethical approval will be required for any study which includes any form of direct patient involvement.

Voluntary registration of ISAC approved studies

Epidemiological studies are increasingly being included in registries of research around the world, including those primarily set up for clinical trials. To increase awareness amongst researchers of ongoing research, ISAC encourages voluntary registration of epidemiological research conducted using MHRA databases. This will not replace information on ISAC approved protocols that may be published in its summary minutes or annual report. It is for the applicant to determine the most appropriate registry for their study. Please inform the ISAC secretariat that you have registered a protocol and provide the location.

Guidance on resubmissions to ISAC

About 60% of protocols submitted to ISAC require resubmission before approval is given. Feedback will be provided by ISAC on the points to be addressed upon resubmission. Applicants should use the feedback form provided to respond to the points made by the reviewers and should highlight all changes they have made to the protocol (please do not use "track changes").

Research using Yellow Card data

In addition to CPRD research protocols, ISAC is responsible for the scientific review of research protocols seeking to use data from the Yellow Card Scheme*. We are conscious of the importance of keeping the nature and content of CPRD research protocols confidential within the CPRD Group, which is separate from the regulatory function of the MHRA.

Although the same committee reviews the protocols for both CPRD and Yellow Card data sources, administrative/Secretariat support for the two aspects of ISAC’s work is provided by entirely distinct groups of staff within the MHRA. Staff of the CPRD Group form the Secretariat support for CPRD protocols, with responsibility for receiving, logging, and distributing protocols for review. They also liaise with applicants and forward feedback from the committee. ISAC discusses CPRD and Yellow Card protocol-related issues separately and the only MHRA staff permitted to attend the sessions for CPRD protocol-related matters are staff from the CPRD Group. This ensures that knowledge of the nature of research that applicants propose to conduct using CPRD remains confidential to the CPRD Group and to ISAC members, who are required to sign confidentiality agreements.

The MHRA’s Vigilance and Risk Management of Medicines (VRMM) division provides equivalent support to ISAC for Yellow Card protocols which remain confidential to relevant staff in VRMM and to ISAC members

On occasion, it is possible that a research protocol proposal will propose the use of data from both the Yellow Card Scheme and from CPRD. Such protocols are seen by relevant staff from both the CPRD Group and the VRMM Division, and remain confidential to these staff and to ISAC members

*The Yellow Card Scheme is the UK’s spontaneous reporting scheme to which notifications of suspected adverse drug reactions can be made by healthcare professionals and, more recently, patients. The MHRA is responsible for the operation of this Scheme.