The ISAC is a non-statutory expert advisory body was established in 2006 by the Secretary of State to provide advice on research related requests to access data from the Yellow Card Scheme and the General Practice Research Database. Members are appointed by the Appointments Commission.
Terms of reference
To consider and provide advice to MHRA on applications for Yellow Card data which fall outside Freedom of Information provisions, and all research projects which propose the use of data from the General Practice Research Database. In particular, ISAC should consider the following:
- scientific issues
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- medical aspects
- statistical/epidemiological aspects
- methodological aspects
- Other ISAC advice relating to other ethical or confidentiality issues is encouraged. This must be considered alongside input from other Committees such as Ethics and National Information Governance Boards (NIGB).
Members should note that the primary responsibility of the ISAC relates to 1 above.
To provide advice at the request of the MHRA on wider aspects of the release of Yellow Card data.
Meeting dates for 2012
| February | June | October |
|---|---|---|
| 1 | 20 | 16 |
Meeting dates for 2011
| February | June | October |
|---|---|---|
| 1 | 23 | 7 |
Applications for access to data
Applications for Yellow Card and GPRD data should be made using the appropriate form below:
Download GPRD form 
(145Kb)
Download Yellow Card form (194Kb)
The following IT security guidelines will assist you to complete Section H of the application form
Guidelines for safe disposal of electronic Yellow Card data for external users
Please note that the closing date for Yellow Card applications is the Friday four weeks before the next meeting.
GPRD protocols are reviewed electronically, typically within three weeks of the date of receipt, so can be accepted at any time. Applicants should however note that, on occasion following initial electronic review, a protocol may be referred to an ISAC meeting where it is felt that discussion between members is required in order for the Committee to provide a considered opinion on the protocol. In such cases, protocols will be refereed to the next meeting and applicants informed of this referral.
Appeals
If the MHRA accepts the advice of ISAC to turn down an application for data, the unsuccessful applicant will be sent a letter setting out the reasons why. The applicant will be told that he/she has 28 days from the date of the letter to make representations, and that these should be made in writing to the YellowCard/GPRD ISAC Secretary as appropriate. The applicant will be informed that once this 28 day period has expired, he/she will have to make a fresh application. If an appeal is to be carried out then the Licensing Authority will appoint a person or persons to undertake a review of the documentation. A letter will be sent to the applicant with the outcome of the appeal. The decision of the Licensing Authority will be final.
National Research Register
The National Research Register (NRR) is a register of ongoing and recently completed projects funded by, or of interest to, the UK National Health Service.
ISAC strongly recommends that UK researchers using GPRD and Yellow Card data consider registering as NRR data providers, in order that others engaged in research within the UK can be made aware of current works.
Registration with the NRR is entirely voluntary and will not replace information on ISAC approved protocols published in summary minutes or in the ISAC Annual Report.
Contacts for further information
For Yellow Card enquiries please email isacyellowcarddata@mhra.gsi.gov.uk
For GPRD enquiries please email isac@gprd.com.
If you have any general queries about ISAC or are unsure whom you should contact, please contact isac@gprd.com in the first instance.
