ALL research needs to be carried out in a manner which minimises risks to participants, their carers and the researcher. The research should be capable of answering the intended question(s), be carried out in a way that is judged by others to be ethical, whilst at the same time, make effective use of what is often public money. European and UK legislation has been introduced to help this process. There are also mandatory directives operating in health and social care sectors, which need to be followed.
Some of the most important laws and regulations directly imposing on research activity relate to:
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Is it Audit or is it Research? Click Here to use a decision tree designed by a research ethics committee |
The regulations can appear daunting, particularly for those carrying out clinical trials of medicinal products. Many of the regulations are new to health & social care. Information to support the application of these regulations and their interpretation is emerging.
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Don't Worry - Help is Here!!! |
As always, we advise any one who is involved or intending to become involved in carrying out research, to contact appropriate departments within their own organisation as an initial source of advice - including research governance and management. Staff in these departments are responsible for the appropriate implementation of the regulations and will be able to help develop your research with respect to these. There is also help available through regional and national groups and through the Department of Health and the Central Office for Research Ethics. Try some of the links on the right for further information.
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 | Don't forget to visit the link to Guides & Support as this includes a range of useful websites and manuals to help with these and other aspects. | |
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Research Management & Governance
Since April 2003, NHS organisations became responsible for all research undertaken in their population following the Research Governance Framework for Health and Social Care (2000). This builds on previous government documents including the NHS Plan (2000) Research and Development for a First Class Service – R&D Funding (2000) and An Organisation with a Memory (2000). It is mandatory that all NHS organisations have a system in place to ensure that research is
- Is appropriate to and for the population being studied;
- Has the approval of the NHS organisation (including primary care) involved in the study;
- Meets certain criteria to ensure safety of patients or staff who are asked to participate in studies;
- Encourages consumer/user involvement in the reseach.
Data Protection
The Data Protection Act (1998), building on previous legislation includes legislation relevant to some areas of research, alongside health & social care in general. Many health and social care organisations employ data protection officers (Caldicott Guardians) able to provide advice about how the legislation may relate to your area of research. Further information can also be obtained from the links shown here. Data Protection is a consideration of the Research Management & Governance process and you will need to provide information on any data protection issues when applying to conduct research in health & social care organisations.
