Scope of the Tool Kit
On this site you will find practical help with the legislative and good practice requirements relating to the use of personal information and human tissue samples in healthcare research in the UK, including the following:
- Data Protection Act 1998
- Common law of Confidentiality
- Health and Social Care Act 2001
- Human Tissue Act 2004
- Human Tissue (Scotland) Act 2006
- Human Fertilisation and Embryology Act 1990
- Adults With Incapacity (Scotland) Act 2000
- Mental Capacity Act 2005
- UK Health Departments’ Research Governance Frameworks
Much of the information is held in Route Maps, which provide an overall picture of the issues to consider, you can then drill down for more information by clicking on each station. For most research projects it will not be necessary to visit every station, for example if using anonymised information or robustly pseudonymised/linked anonymised information, confidentiality arrangements will not be an issue.
The Route Maps focus on the Planning and Approvals stages of setting up a research project. The importance of considering all relevant issues before securing funding has been highlighted to ensure that all the required expenses are planned. Funders, like the MRC, require that studies are ethical, meet regulatory requirements, are well managed and can be delivered on time; and accept that additional funds may be needed to meet these objectives. At the same time, such funders would expect that host organisations have systems in place to support their research activity promoting quality and ensuring that the necessary standards are met.
Within this Tool Kit, information that is relevant to research managers in the NHS, universities, and research units has been extracted from the stations and displayed in the Organisations & Policies section.
The site has been developed for the UK research community in its widest sense, including researchers, research managers, research ethics committee members and interested members of the public. It was developed by the MRC, in close collaboration with many UKCRC partners, including the following organisations:
- NHS R&D Forum
- Patient Information Advisory Group
- Human Tissue Authority
- National Research Ethics Service
- Academy of Medical Sciences
For a full list of contributors please see the Contributors page.