MPS response to GMC consultation on obtaining consent for research

Introduction

The Medical Protection Society (MPS) welcomes the opportunity to comment on the GMC’s guidance on the standards expected of doctors working in research in the NHS, universities; the private sector and other settings.

Consultation questions

1. Given that guidance on ethical issues in research is issued by a number of different bodies (eg the departments of health, the Medical Research Council, the National Patient Safety Agency) is it useful for the GMC to provide guidance to doctors on their obligations when undertaking research?

Given that research is an integral part of professional practice for a significant number of registered doctors it is right that the GMC should provide guidance so that doctors undertaking research are clear about their professional obligations and the expectations and standards of their regulatory body.

2a. Do you agree that the principles set out in 'Consent: patients and doctors making decisions together' are also applicable to research?

The principles set out in the GMC’s guidance on consent are applicable to research. However, there are additional important issues around consent which are unique to research and therefore the guidance should take account of these issues (see 2b).

2b. What, if any, additional principles do you think might apply?

It is important to consider the different circumstances in which research is conducted, particularly where there is no therapeutic benefit for the participant. The GMC guidance, Consent: patients and doctors making decisions together, is constructed solely around diagnosis, treatment and therapeutic interventions. Principles of consent for research should, therefore, be extended and adapted to include non-therapeutic interventions, particularly when dealing with healthy volunteers who may receive a financial benefit to engage in the research.

Consent principles should also be adapted to reflect the unique issues which arise in different research settings such as basic science research, clinically based research including clinical trials research, and pilot studies.

There should be rigorous safeguards in relation to giving information about risks to participants engaging in research for which they will derive no personal health benefit and may have a financial inducement to participate in the research.

As is reflected in GMC guidance elsewhere in relation to clinical practice any present or future financial interests must be declared as part of the consent process.

It is particularly important in the field of research that the activity does not extend beyond the scope of consent which has been obtained. This will involve reviewing and revisiting the consent process during a research project as it progresses and develops for example, consent should be re-taken in molecular/genetic research where the researcher wishes to use samples for DNA/gene/subgene component testing.

As a matter of good practice information given to participants in research must be replicated in information sheets and we would welcome minimum national standards of format and content.

Paragraph 49 should be explicit that patients have the right for their withdrawal of consent to have retrospective effect resulting in the safe disposal and/or destruction of data and samples and any other material obtained during the research.

3a.  What have been the major organisational and other changes relevant to consent to research since 2002?

Guidance on consent to research should include guidance on how principles of confidentiality should apply to who may have access to material or information arising from participants involvement with appropriate safeguards in relation to changes in electronic data management and use of smart cards.

Other major post-2002 changes which will affect consent to research include the Mental Capacity Act 2005 and the Human Tissue Act 2004.

3b. Have these changes affected the way that research, including clinical trials, is conducted?

These changes have affected the way that research is conducted. We particularly want to highlight research involving patients who lack capacity where it is important that the processes for approval safeguard the different interests of vulnerable patients, doctors and the wider public interest.

4. What do you see as the most important research issues relevant to doctors?

There should be clear lines of accountability in research projects. It is important that there is a structure of proper training and formal supervision in research just as in clinical practice. Guidance around managerial issues in research would be welcome.

Issues around the electronic storage of data are increasingly important. We would like to see guidance on the short and long term storage of data obtained from clinical trials and original basic research and where that data or material is held for example should it remain with the researcher or the research laboratory/unit.

5. How might we make our guidance on consent to research useful to doctors?

The guidance should be available in hard copy and online. It is also helpful as tool for understanding to illustrate principles by reference to case scenarios.

The guidance should be consistent with the guidance provided by Ethics Committees and Royal Colleges. As in other recent GMC guidance, it would also be useful to include links to other relevant guidance and information sources.

6. How might we make our guidance on consent to research accessible to patients and the public?

See comments to question 5, some of which may enhance accessibility to patients and the public.

7. Would you be happy for us to contact you in connection with your response, or to discuss any related issues that arise as we develop the guidance?

We would be pleased to discuss any of the issues raised in our consultation response or in relation to the guidance in general.

We also question whether the GMC plans to review and update the guidance on research in its entirety. We would be pleased to assist in any way with a review of this guidance.