The UK’s General Medical Council (GMC) has launched a preliminary consultation as an initial step towards revising its guidance for doctors on obtaining consent for research.

A steering group, comprising medical and lay members of the GMC’s Standards & Ethics Committee, has been set up to oversee the development of the new guidance and ensure there is a consistent approach to research issues across all of the Council’s guidance.

This includes Research: The Role and Responsibilities of Doctors, published in 2002 and setting out the principles governing research practice as well as detailed advice on how to put those principles to use. This guidance covers the three main ethical issues pertinent to good research practice: confidentiality, probity and consent.

More recently, the GMC published new guidance on consent issues, Consent: patients and doctors making decisions together. While this document concentrates on decision-making in the context of investigations or treatment by doctors, the intention is that the principles laid out should apply across a range of practice situations, including decisions on taking part in research.

Accordingly, the aim of the current consultation is to produce a shorter, more focused research guidance document to supplement the Consent booklet. The steering group is looking for input from organisations with an interest in medical research issues, which “will help clarify the main issues facing doctors involved in obtaining consent to research, and identify the areas where guidance from the GMC would be most helpful”, the Council says.

The preliminary consultation runs until 11 August 2008. Depending on the response, the GMC plans to prepare draft guidance on consent to research and hold a full public consultation on this document later in the year or in early 2009. Guidance on issues relating to confidentiality and probity in research is being developed separately. There will be a formal consultation on these issues towards the end of 2008 or in early 2009.

The GMC has identified a number of issues that “might warrant careful consideration in the review and/or should be addressed in any revised guidance”. These include:

- The participation in research of children and young people, patients who lack capacity and other vulnerable groups
- Changes in the law affecting consent to research, such as:

- The Mental Capacity Act 2005 and the Adults with Incapacity (Scotland) Act 2000, which clarified the circumstances in which incapacitated adults may lawfully be involved in research (the exception being clinical trials of investigational medicinal products)
- The European Union’s clinical trials directive, 2001/20/EC, which came into force in May 2004 and was transposed into UK law by the Medicines for Human Use (Clinical Trials) Regulations 2004.
- The Human Tissue Act 2004 and the Human Tissue (Scotland) Act 2006, which specified the consent/authorisation needed before a person’s organs and tissue could be stored or used for research purposes.