The origin of the Tool Kit

Over the last 10 years the research environment has changed considerably with the advent of new legislative and good practice requirements. One area that has created much discussion is the use of identifiable personal information for healthcare research.

In order to establish balanced guidance of practical benefit on the research use of personal information, the MRC set up the Consent and Confidentiality project. Experienced researchers, patient representatives, and members of research ethics committees and PIAG were involved in workshops and working groups. The following working groups were established to develop guidance:

  • Consent led by David Strachan and Michael Wadsworth
  • Recruitment led by Jenny Hewison
  • Confidentiality led by Dipak Kalra
  • Risks and benefits led by Rory Collins
  • Communication led by Peter Singleton

The products of the Consent and Confidentiality project can be found within this Tool Kit and in the BMJ, where a suite of 4 papers were published in 2006.

  • 'Confidentiality of personal health information used for research' Dipak Kalra et al, BMJ 2006;333:196-198 (22 July)
  • 'Consent for the use of personal medical data in research' Peter Singleton and Michael Wadsworth, BMJ 2006;333:255-258 (29 July)
  • 'Overcoming barriers to recruitment in health research' Jenny Hewison and Andy Haines, BMJ 2006;333:300-302 (5 August)
  • 'Balancing potential risks and benefits of using confidential data' Christina Davies, Rory Collins et al, BMJ 2006;333:349-351 (12 August)

At the same time the Academy of Medical Sciences called for evidence for their report Personal date for public good: using health information in medical research. The report, published in 2006, also highlighted the need for practical guidance in this area (see linked file below).

During this project, new primary legislation covering the use of human tissue samples in research was enacted in the UK, which placed consent/authorisation as the fundamental principle governing the research use of tissue samples.

The MRC Regulatory Support Centre assumed leadership of the project, modelling its outputs on the Clinical Trials Toolkit (developed by MRC in 2004 to disseminate the work of the MRC/Department of Health Joint Project on EU Clinical Trials Directive). This Toolkit, now the responsiblity of the National Institute for Health Research (NIHR), continues to receive positive feedback on the practical nature of the information and usefulness of the Route Map concept. And so the Data and Tissues Tool Kit was born.

More information on the aims of the Data and Tissues Tool Kit and the organisations and individuals involved in its production can be found in Scope of the Tool Kit and Contributors pages.

Linked files

Adobe Portable Document Format file (pdf) AMS: Personal data for public good [0kb]