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Memorandum submitted by the Wellcome Trust, the
Medical Research Council and the
Summary
We welcome the intention behind the Coroners and Justice Bill - to clarify and streamline processes for data sharing. However, it is essential to ensure that appropriate safeguards are in place to facilitate beneficial data sharing while maintaining public confidence.
· We are concerned that the current draft threatens to undermine public trust in the framework for data sharing by not including adequate safeguards, and by providing too broad a scope for order-making powers for data sharing, while not giving the Information Commissioner sufficient authority.
· In relation to medical research, the introduction of order-making powers - necessary to remove genuine legal barriers in precisely defined circumstances - should not be seen as an appropriate mechanism to facilitate access to personal information for research on a day-to-day basis. Separate processes are needed to achieve this, as set out in the Thomas-Walport Data Sharing Review (recommendations 15-17).
Clause 151
We welcome this provision but question why it is limited to public bodies. In order to facilitate the objectives of the Bill, we would recommend that this is extended to include private bodies.
Clause 152
We welcome the intention behind Clause 152 - to clarify and streamline processes for data sharing. In order to be beneficial, however, data sharing must be underpinned by appropriate and robust safeguards, and the public benefit must be clearly apparent.
The order-making power described in this clause is based on recommendations 8 (a) and (b) in the Thomas-Walport Data Sharing Review[1], which argued the need for a new statutory fast-track procedure "where there is a genuine case for removing or modifying an existing legal barrier to data sharing". However, these recommendations did not relate to data sharing for medical and other research uses, which were dealt with separately in recommendations 15-17. The Government has accepted these recommendations, which we understand can be implemented without the need to introduce new legislation. We therefore urge Government to ensure that appropriate mechanisms are introduced as soon as possible to allow researchers to access patient information for ethically-approved research. These mechanisms should be viewed as separate to the order-making power included in the Coroners and Justice Bill.
Research using health records
Individual patient records held by the NHS are an extremely valuable resource for research for public benefit. The information offers huge potential to advance understanding of disease, to evaluate interventions and to improve patient care. However, we recognise that patient records are both sensitive and personal, and therefore should be protected by robust safeguards. The research benefits will only be realised if there are appropriate mechanisms in place so that the public, patients and doctors are able to trust that their data will be kept secure and confidential.
Any process for allowing access to patient records for research must instil confidence. In response to other submissions made to the Committee, we would like to emphasise that we do not consider that the order-making power set out in this draft legislation would be an appropriate or workable process for medical research on a day-to-day basis.
In recommendations 15-17, the Data Sharing Review developed the idea of an "approved researcher", who would be "bound by the same duty of confidentiality as the clinical team providing care, and face similar penalties in the case of any breach of confidentiality". The Government made a strong commitment, in response to the Data Sharing Review, to ensure such a mechanism was introduced[2]. While we do not want to introduce unnecessary layers of additional bureaucracy, we do stress the need to ensure clear mechanisms of accreditation and accountability for researchers working with personal information. We are working with the Department of Health and the Research Capability Programme of Connecting for Health to ensure that appropriate processes, with proportionate levels of scrutiny, are developed.
We also highlight the importance of additional safeguards already in place, for example, any proposal to use identifiable data for research, where it is not possible or practical to seek consent, must be reviewed by an NHS Research Ethics Committee. Patients must also be given the opportunity to opt-out of the use of their identifiable information for research.
Role of Information Commissioner
Regarding paragraph 50D, we are concerned that the role of the Information Commissioner is not sufficiently robust. In the interests of preserving public trust, the Information Commissioner should be entitled to produce a full privacy impact assessment, rather than only addressing the matters set out in clause 50A(4)(b) and (c) in any report to Parliament. We also suggest that the timescale for submission of a report - 21 days - may in some circumstances be insufficient to ensure proper scrutiny.
Conclusion
We are concerned that, if this legislation is seen to disregard necessary safeguards around data sharing it will undermine public confidence and serve as a backward step. We urge the Committee to ensure that the Coroners and Justice Bill facilitates beneficial data sharing, but with adequate safeguards to maintain public trust. Separate and specific processes should be introduced by the Department of Health to facilitate access to patient information for medical research.
February 2009 [1] Data Sharing Review, Richard Thomas and Mark Walport. July 2008 [2] Response to the Data Sharing Review Report. Ministry of Justice, November 2008 |