Current consultations

NIHR Research Support Services update
The draft guidelines and procedures for the NIHR Research Support Services are now released on the NIHR Portal for feedback, requested by 30 June 2010.

For access to the portal please contact Craig.Biggs@dh.gsi.gov.uk

Clinical Trials Directive
The responses to the public consultation on the assessment of the functioning of the Clinical Trials Directive have been published. The 'roadmap' of the Commission impact assessment, setting out the main structure and the next steps, is also available.

Review of Competency Framework for Clinical Research Nurses
The Competency Framework for Clinical Research Nurses was first published in 2008, the Working Group would now like to undertake a review of this framework, and are seeking opinions. Closing date for responses is 30 June 2010.

National Cancer Research Institute (NCRI) published template for access policy development
Open draft for consultation

The NCRI have created a Samples and Data for Research: Template for Access Policy Development. The aim is to provide a practical instrument which (i) reflects established good practice principles, (ii) can be tailored to particular circumstances, and (iii) helps avoid unnecessary duplication of effort. This version of the document is published as an open draft for consultation and will be updated based on comments received. If you have any comments or suggestions for improving the document please email them to access@ncri.org.uk.

Summary of Responses to the Consultation on the Additional Uses of Patient Data

The Department of Health undertook a consultation on patient consent and confidentiality in relation to using patient information for research at the end of 2008. The report of that consultation has now been published on the DH website. The DH website states: "It is clear that the public expects their consent to be sought if the data used is identifiable. This means we need to test out how best to secure that consent and properly inform patients about the use of their identifiable medical records. We intend to set up a number of pilots in Hampshire, the Isle of Wight, Birmingham and Nottingham which will explore means of patients opting out of having their records viewed for research purposes. We will report back on testing and offer a preferred mechanism by June 2010.”

Responses to NIGB Consultation on Guidance on Requesting Amendments to Health and Social Care Records

The NIGB have now published guidance on requesting amendments to health and social care records. This includes a section on records used for secondary uses which includes research.

EU Directive consultation response

The UK response to the European Commission’s consultation on the Clinical Trials Directive that has been submitted by the MHRA.

Outcome of the consultation on the European Commission's legislative proposal to strengthen patient safety (pharmacovigilance)
This consultation sought comments from stakeholders on the European Commission's legislative proposals to strengthen and rationalise the EU pharmacovigilance systems. The list of responses and the outcome are available on the MHRA website.

NIGB seeks comments for the 2010 Annual Update of the NHS Care Record Guarantee
Deadline for comments: 7 May 2010
The NHS Care Record Guarantee for England sets out the rules that govern how patient information is used in the NHS and what control the patient can have over this. It covers people's access to their own records, controls on others' access, how access will be monitored and policed, options people have to further limit access, access in an emergency, and what happens when someone cannot make decisions for themselves. Details of how to contribute are available on the NIGB website.

NIGB seeks comments for the first revision of the Social Care Record Guarantee
Deadline for comments: 21 May 2010
The Social Care Record Guarantee explains to service users how the information they provide to social care staff is used and what control they can have over this. It complements the NHS Care Record Guarantee for England. Details of how to contribute are available on the NIGB website.

HTA Consultation on licence fees 2011/12
Deadline for comments: 16 June 2010
The HTA invites you to take part in a consultation on the the HTA's licence fee structure for 2011/12.

Last updated: 09 June 2010