Features: Navigating the research maze
14 June 2010
New guidance will help doctors working in research with some of the ethical dilemmas they may face
Research is vital in improving care for and the future health of patients. Following changes to the law, the GMC has published new guidance to help doctors working in this complex regulatory environment to navigate some of the challenges that they face.
The GMC’s new guidance is published in two parts, Good practice in research and Consent to research, and will help doctors apply good medical practice throughout a research project, from design, recruiting participants, seeking consent and the publication and dissemination of research.
The guidance has been carefully designed so that it is applicable to all doctors, regardless of the nature of their research or where in the UK they work. It sets out high level principles and signposts doctors to other, more detailed advice about the legal and governance arrangements applicable to their work.
The draft guidance was finalised following a public consultation in 2009.
Good practice in research
Consent in research
Finding the new guidance
Why the guidance was needed
What does the guidance cover?
This focuses on the high level principles of good research practice. These include the fundamental duties of honesty and integrity and the importance of placing the safety, dignity and well being of participants above the development of treatments and the furthering of knowledge.
One of the concerns highlighted in our consultation before producing these materials was the under-representation in research of certain groups, in particular older people, people with learning disabilities and people from some BME communities.
Good practice in research therefore includes an explicit duty to make sure that decisions from the start of the research onwards are free from discrimination (paragraph 10) and that people are not excluded from research because it is difficult or may take time to explain the issues to them and seek consent. This principle is covered in more detail in Consent to research.
The new guidance also places more emphasis on how doctors conducting research can make sure that they do so honestly and openly, for example by registering details of research projects on an eligible, publicly available database that is kept updated (where such a database exists).
There is also a reminder of the importance of making the results of research available to those who may benefit from it, which may include other researchers, participants and the public.
This second part to the guidance explains how the principles in the GMC’s guidance, Consent: patients and doctors making decisions together (2008) apply in research.
It also provides advice on involving children and young people, vulnerable adults and those who lack capacity in research and highlights the importance of sharing information with participants in a way that they can understand. For example meeting people’s language, communication or other needs to make sure that they are not excluded from research or from the potential benefits research can offer them and the wider groups to which they belong.
It is in these areas that the complexity of the law governing research is most apparent. The requirements for undertaking research involving these groups varies depending on the nature of the research (with different laws governing clinical trials of investigational medicinal products and other forms of research) and where in the UK the research is conducted.
Consent in research covers some of the most difficult decisions doctors face when seeking to conduct research involving adults who lack capacity. It reflects the legal and ethical principle that research can only involve adults who lack capacity if the same or similar research could not be undertaken only with people who have capacity. It includes advice on:
- when adults who lack capacity can be involved in research
- what to do when patients lose capacity during a research project
- research into treatments in emergencies.
The advice on research involving children and young people builds on that provided in 0-18 years: guidance for all doctors, focusing on the challenges of seeking and acting on consent from children and young people or their parents.
It sets out when consent is required and reminds doctors of the importance of trying to reach consensus with parents about a child or young person’s participation in research.
The guidance published by the Medical Research Council, the Royal College of Paediatrics and Child Health and the BMA are also signposted, which each provide a useful guide to the complex legal requirements governing research in this area.
Both documents are published on this website and include clear links to (and, where relevant, extracts from) other GMC guidance, including Confidentiality and 0-18 years: guidance for all doctors. This will enable researchers to see all of the GMC’s advice on research in one place.
We have also produced two legal annexes, which are published with the guidance:
- Annex A includes a general overview of the key legal principles and requirements governing research
- Annex B highlights the key legal requirements governing clinical trials
of investigational medical products.
All the guidance and supporting annexes can be read online or downloaded as PDF documents from our research guidance pages.
GMC’s Director of Standards Jane O’Brien explains
Changes to the law and governance arrangements, such as the Clinical Trials regulations or the Mental Capacity Act meant that existing GMC guidance on research published in 2002 needed to be reviewed.
When beginning this review, we were conscious of the large amount of other guidance and information on research that has already been published by other organisations.
We held an initial consultation to ask research, medical and patient organisations whether they felt guidance from the GMC would be helpful. The overwhelming response was that it would. Some of the reasons given were that:
- the GMC was uniquely placed to give guidance applicable to all doctors
involved in research, regardless of whether they worked in the NHS, universities or private industry
- it was important that, as the regulator, the GMC made clear what was expected of doctors it registers and licenses
- the GMC guidance will be the first reference point for many doctors and could act as a portal to other guidance on ethical issues and highlight those issues of specific relevance to doctors.
The draft guidance was finalised following a further consultation in 2009 in which the majority of respondents supported the principles in the guidance.