Science and Technology CommitteeWritten evidence submitted by the General Medical Council

Introduction

1. The General Medical Council is the independent regulator for doctors in the UK. Our role is to protect patients by ensuring proper standards in the practice of medicine.

2. We do this by controlling entry to the medical register and setting the standards for medical schools and postgraduate education and training. We also determine the principles and values that underpin good medical practice and we take firm but fair action where those standards have not been met—if necessary, by removing the doctor from the register and removing their right to practise medicine.

3. We have a statutory duty to set standards for doctors on medical ethics. Our core guidance, Good medical practice, defines what it means to be a good doctor in the UK. But we also provide more detailed guidance on a wide range of issues, including Good practice in research and Consent to research.1

4. This memorandum provides information on this guidance for doctors and how we help doctors to meet the standards expected of them.

Providing Guidance on Research to the Profession

5. Research involving people directly or indirectly is vital in improving care and reducing uncertainty for patients now and in the future, and improving the health of the population as a whole.

6. Our guidance, Good practice in research and Consent to research, sets out the good practice principles that doctors are expected to understand and follow if they are involved in research, including clinical trials. It brings together all the GMC’s advice to doctors involved in research including Confidentiality,2 which covers, for example secondary uses of data; and 0–18 years,3 which covers involving children and young people in research.

7. The guidance provides a framework to guide doctors’ decisions throughout all stages of a research project, from research design, recruiting participants, seeking consent and the publication and dissemination of research. The guidance acknowledges the complexity of research work and that it is essential for improving care for patients now and in the future.

8. It reminds doctors that they must put the protection of participants’ interests first, act with honesty and integrity and follow the appropriate national research governance guidelines. It includes advice about avoiding conflicts of interest, doctors’ responsibilities to ensure that research is free from discrimination and about involving vulnerable patients or those who lack capacity.

9. The guidance is also clear on the importance of openness to protect participants and maintain public confidence in research. On publishing research results Good practice in research says:

Whenever possible, you should publish research results, including adverse findings, through peer-reviewed journals.”17 (Paragraph 24). This references more detailed advice from the UK Research Integrity Office, Code of Practice for Research: Promoting good practice and preventing misconduct.

10. On openness in the conduct of research it says:

“You should make sure that details of a research project are registered on an eligible, publicly available database that is kept updated, where such a database exists.” (Paragraph 11)

“You should make sure that commercial and other interests do not stop or adversely affect the completion of research. If you are concerned about this you should follow the guidance on raising your concerns in paragraph 19.” (Paragraph 14)

“You must report adverse findings as soon as possible to the affected participants, to those responsible for their medical care, to the research ethics committee, and to the research sponsor or primary funder where relevant. You must make sure that bodies responsible for protecting the public, for example, the Medicines and Healthcare products Regulatory Agency, are informed.” (Paragraph 16)

11. We would investigate any allegations against a doctor of fraud or misconduct in research and serious or persistent failure to follow this guidance will put a doctor’s registration at risk.

Helping Doctors to meet our Standards

12. We are committed to being a proactive regulator and this means we want to make sure doctors are supported in meeting our standards.

13. A new system of checks for doctors, called revalidation, will put the UK at the forefront of making sure medical practice is of a high quality and that doctors are supported in their professional development. It will also mean that all licensed doctors, including those involved in research, are regularly checked against the professional standards that we and the public expect them to meet.

14. We have three local liaison services which work across the UK to meet face-to-face with doctors, employers, patients and educators to help explain our guidance and to work with employers to manage any concerns about doctors’ fitness to practise.

15. We intend to follow up on the Health Select Committee’s recommendation in its recent report on NICE that the GMC “reiterates its guidance on drug trials to its members, and reminds them that failure to abide by these principles could lead to fitness to practise proceedings being taken against them”. We will include an item in GMC News, our monthly e-bulletin which goes to over 200,000 registered doctors, on Good Practice in Research; and this message will also be cascaded to the profession locally via our liaison services.

16. We are always looking for new ways we can help make sure doctors know what is expected of them and have the support to meet those expectations. We have launched a mobile version of our website so doctors can access our guidance from their phones and other devices and have started piloting induction training to help doctors new to UK practice understand the standards expected of them.

February 2013

1 http://www.gmc-uk.org/static/documents/content/Research_guidance_FINAL.pdf

2 http://www.gmc-uk.org/static/documents/content/Confidentiality_0910.pdf

3 http://www.gmc-uk.org/static/documents/content/0-18_0510.pdf

Prepared 16th September 2013