House of Commons - Science and Technology

Select Committee on Science and Technology Minutes of Evidence

Annex 2

DRAFT GUIDELINES FOR ETHICAL RESEARCH WITH PATIENTS

Drawn up by Consumers for Ethics in Research (CERES), and Breast-Cancer Research, Ethics & Advocacy Strategy (BREAST UK), March 2000

Researchers and patients who take part in research should see each other as partners, sharing the search for new knowledge to help medical science and future patients. In that belief, these guidelines aim to promote ethically sound, high quality clinical research. They address practical guidance to clinical researchers. And they let patients know what they should expect when they take part in research.

Some of the guidelines may seem difficult to implement. But making research trustworthy and including patients as partners in the research enterprise are important. They should help raise standards of research, ensure that it is directed to significant questions, and increase the willingness of patients to take part in it.

Essential guidelines, in line with other guidelines and the relevant law, are marked with an asterisk; desirable guidelines reflecting good ethical practice, are left plain.

1. DECIDING WHAT RESEARCH TO DO

1.1 Researchers should ask relevant patient/consumer groups to:

— suggest topics that need investigation or questions that need answers.

— suggest outcome measures for those topics.

— advise on the research design and on the draft proposals.

— advise on the recruitment of patients.

— advise on the information to be offered to patients.

1.2 Funding for the above should be included in the research proposal but patient/consumer group members' expenses should be paid promptly from pre-existing funds.

2. RECRUITMENT

2.1 General information about research taking place locally should be offered to patients well in advance of their being invited to take part in a specific project or programme, whenever possible.[11]

*2.2 Enrolment in a relevant local trial should sometimes be a treatment option.[12] But doctors must offer patients all treatment options, whether or not they are being tested in a trial, even though this may mean that some patients are not eligible for the trial.

2.3 Patients who are not eligible for a relevant local clinical trial should be told of any possibility that they might be eligible for a clinical trial elsewhere in the country or internationally, and helped to put themselves forward to the trialists for consideration for enrolment.

2.4 Patients who are already involved in other medical research should say so; patients should not be asked to take part in research repeatedly.

*2.5 In trials of any therapy, patients must be told in advance what will happen at the end of the trial and if they will be able to continue with a therapy if it benefits them.

3. CONSENT

*3.1 Consent is not just agreement to the research proposals; it is informed, willing and uncoerced commitment to take part in the research.[13] No-one should be part of a research project or programme without his or her knowledge and consent: a breach of this is a breach of the right of patients to know all relevant factors about the situation they are in,[14] as well as a breach of trust between patient and doctor or researcher, and between the medical profession and the public.

*3.2 It must be made clear that patients are not obliged to take part, and reassured that declining to take part will not affect their subsequent treatment.

*3.3 Consent in writing is needed for all clinical research; consent must be given by those who are to be controls as well as by those in experimental treatments.[15]

*3.4 Full written information must be given to all those who are asked to take part in clinical research.

*3.5 Information should be given in plain English and, where relevant, in other languages readily understandable by patients (minority languages, Braille, tape, etc.) and in a form they can keep.1 A glossary of terminology should be included.

*3.6 The proposed research should be discussed with patients in privacy, with patients dressed, and without interruptions.

*3.7 Normally, several days should be allowed for patients to consider the matter thoroughly, and, if they wish, discuss it with their families, friends or family doctor.

*3.8 The consent form must be given or sent to patients while they are considering taking part in the research and a copy of the form must be returned to them after they have signed it.

3.9 Any promises made to a patient during the seeking of consent, eg telling him or her test results during the course of the research, must be made in writing and adhered to.

4. CONFIDENTIALITY AND PROTECTING PERSONAL INFORMATION

*4.1 Confidentiality, and the systems in place to ensure it, need full and honest explanation to patients, and, where necessary, their consent to the transfer of information about them. Health professionals' and patients' understanding of confidentiality are not always the same.

*4.2 If interviews with patients are taped or videoed, in addition to the patient's written consent, his or her oral consent to the recording should be included on the tape. The patient's right to review the tape or video, to withdraw consent to the taping, to know who will have access to it, and to know how long it will be stored before being destroyed, must be made clear.[16] Patients should be asked to give permission for the possible use of direct quotes from what they say, even though such quotes will be anonymous.

*4.3 The system for securing the anonymisation of data should be explained to the patient and agreed by him or her.

*4.4 Who will have access to the patients' medical record and notes must be made clear, and written consent gained for that, as well as for any tests that may be required[17] and the retention of any tissue, including blood samples, apart from that normally removed as part of the therapeutic procedure.[18]

*4.5 Patients' consent to the use of their medical record and notes must be sought for every new research project.

*4.6 If there is any possibility that the patients' anonymised data might be used in future research, permission to do this should be sought at the time of the patient's consent to the initial research. If tissue is to be retained for possible use in future research or teaching, patients' consent should also be sought now.[19]

4.7 If a new research project is started using data from the first project while the data are still being collected from patients, those patients' permission must be sought, with full information as to the purposes, status of the investigator, etc., as if it were a completely new project.

4.8 In blinded trials, patients need to know details of how the intervention the patient is receiving can be uncovered, quickly and reliably, in case of the patient's sudden illness or accident.

5. INFORMATION PATIENTS OUGHT TO HAVE BEFORE DECIDING TO TAKE PART IN RESEARCH

*5.1 Information must be given in as unbiased a way as possible, taking care not to use paternalistic or over-optimistic terms to persuade patients to participate in the research.

*5.2 Information must include things patients ought to know as well as things those giving the information think patients need or want to know.[20] Information should include

5.3 The names, qualifications and status of those conducting the study and information about the organisation under whose auspices the research is to be conducted.[21] If the part or all of the research is to be put towards a qualification or a degree, this must be made plain. If the research is part of a student's project, details about the supervision must also be supplied. Patients are entitled to ask about the experience and competence of individual researchers and must be answered fully.[22]

5.4 Who is funding the research and whether there will be any payments to doctors to enrol patients (if so, how much and to cover what).1

5.5 That the research, if independently-sponsored, is fully insured for harm resulting to patients from known risks of the treatment or treatments, and that there is cover for treating or offering compensation for unexpected side effects or complications. For publicly-sponsored research, patients should be told that sympathetic consideration will be given to any claims that might arise from non-negligent harm.[23]

*5.6 How the results will be given to those who take part. If there is any intention not to publish the results promptly, that must be made clear to patients, since some patients may not wish to take part in research whose results are not intended to be made public, or only made public if regarded by the sponsors as favourable.

*5.7 A brief summary of what is known already about the topic or question, and how patients can get fuller information.

*5.8 An accurate description of the context and purposes of the research (not just a vague "to see which is better"). The information offered should be as full as that supplied to the research ethics committee that approved the proposal. But a shorter version, written in clear language, should be available for patients who do not want detailed information.

*5.9 A clear description of what outcomes are to be measured.

*5.10 Access to the research protocol and a named person who will discuss it if the patient wishes.

*5.11 A clear description of the proposed doses, frequencies, duration of treatment etc. for drug therapies, radiotherapy, etc.

*5.12 A full explanation of any extra clinical requirements over and above those for standard treatment eg extra blood tests. If these extras include any tests or procedures that themselves increase risk eg extra X-rays, these risks must be stated.

*5.13 A list of the consequences of extra clinical requirements eg the number of extra visits to hospital or general practitioner's surgery the patient would have to make, access for disabled people, reimbursement for fares, car parking, baby sitting, the care of elderly relatives, etc. It should make clear what is not covered as well as what is.

*5.14 Full information on, and an accurate assessment of all the known risks and possible benefits of each arm of a trial or alternative treatment.5 Risks include possible side effects or complications ranging from effects that may seem trivial through to serious adverse events and death. For all research, the potential benefits must outweigh the expected risks8 but patients and researchers may assess these differently. It is for patients to decide this balance and what other considerations should influence their decision.

*5.15 For controlled trials, randomisation must be explained in writing or other format (tape, etc) before patients are randomised.8 This explanation must include what randomisation is; how it will be carried out; and what allocation to each arm of the trial would entail ie what all the treatments are and what a placebo is, if one is included. For drug trials, the dosages as well as the scientific and proprietary or popular names of the drugs must be given.

*5.16 Patients must be assured that, if the trial is blinded, they will be told at the end of the trial what treatment, or placebo, they received.1

*5.17 Advice that patients can withdraw from the research at any time, without affecting their treatment and care.1,5

5.18 A promise that, if it seems desirable to withdraw an individual patient, the reasons will be promptly explained and his or her agreement obtained.

*5.19 A promise that the trial will be stopped as soon as it can be shown statistically that one treatment is better than the others.

6. INFORMATION PATIENTS OUGHT TO HAVE DURING AND AFTER THE RESEARCH

6.1 The name and telephone number of a person who can be contacted easily if the patient has a query or clinical problem.

6.2 Patients should have access to the results of the research as soon as it is completed, if they want it. Ideally, this should be before the widespread publication of the results.[24],[25], But in any case, it must be prompt.

6.3 Positive, negative and inconclusive results are all important.

6.4 Patients should be asked at the beginning of the research whether they would want to know if they were in the arm(s) with the worst outcome. If they say they would, that information must be given them.

6.5 If feasible and still relevant, patients in the worse arm should be offered the better treatment when the trial is over.

6.6 If the research is not completed, patients must be told that promptly, with the reasons.

6.7 Patients should be told they can contact the local research ethics (LREC) or multicentre research ethics committee (MREC) that approved the research, if they have any comments or queries on the ethics of the research.

6.8 Patients need to know that they can praise, comment on, or raise concerns about any aspect of the research or make a complaint about it, to some named person not directly involved in the research eg the Chair of the LREC, the Chief Executive of the Trust or Health Authority, whose addresses should be given.

6.9 For chronic or recurrent disease, a summary of current relevant trials and information about how to find out about new clinical developments in the treatment of their disease and new trials should be offered to those patients who wish it.

7. TERMINAL DISEASE

*7.1 Patients who have a terminal disease may be invited to join curative trials. If they accept, special care must be taken to ensure that, when the trial ends, they have easy access to health professionals who know about the trial and what the patient experienced and can continue to offer information and support as part of palliative care.[26]12

*7.2 Patients with terminal disease who are getting worse must be offered the options of continuing the trial, if it has not finished, returning to treatment under their own doctor or moving on to best-practice palliative care.

7.3 Special care should be taken to tell each patient what the trial contributed to knowledge and, if this is the patient's wish, whether patients in the other arms had benefited, especially if the patient himself or herself had not benefited from their arm of the trial.12

8. AUDIT

The general principles that apply to research, the search for new knowledge, apply also to audit, the review of practice against predetermined standards. Patients' consent to the review of their notes should be sought; patients' anonymity should apply throughout the audit process; and some feedback of the conclusions from audit should be offered to patients.

9. END-NOTE

These guidelines are based primarily on professional guidelines like the General Medical Council's guidance for doctors, Seeking patients' consent: the ethical considerations, 1999 and the Senate of Surgery of Great Britain and Ireland's The Surgeon's Duty of Care, Guidance for surgeons on ethical and legal issues, 1997 and on the charters published by patient/consumer groups, especially on A Charter for Ethical Research in Maternity Care by the Association for Improvements in Maternity Services (AIMS) and the National Childbirth Trust (NCT), 1997 and the Policy Statement—Research and Clinical Trials by Breast Cancer Action Group Australia, 1998. They are intended for patients who are able to decide whether or not to take part in research. Patients not in this category require more specialised guidelines.

REFERENCES

1. Association for Improvements in the Maternity Services, the National Childbirth Trust. A Charter for Ethical Research in Maternity Care. London: Association for Improvements in the Maternity Services, the National Childbirth Trust, 1997.

2. Marquis D. How to solve an ethical dilemma concerning randomised clinical trials. New England Journal of Medicine 1993; 341: 691-693.

3. Social Science Research Unit. Consent To Health Treatment & Research, Differing Perspectives. London: Social Science Research Unit, Institute of Education, University of London: 1992.

4. Fried C. Medical Experimentation and Social Policy. Amsterdam: North Holland, 1974.

5. General Medical Council. Seeking patients' consent: the ethical considerations. London: General Medical Council 1990.

6. Royal College of Physicians. Guidelines on the Practice of Ethics Committees in Medical Research Involving Human Subjects. London: Royal College of Physicians, 1996.

7. Baron ND. Ethical Problems in Clinical Pathology. Journal of Applied Philosophy 1992; 9: 189-201.

8. The Senate of Surgery of Great Britain and Ireland. The Surgeon's Duty of Care, Guidance for surgeons on ethical and legal issues. London: the Senate of Surgery of Great Britain and Ireland, 1997.

9. Medical Research Council. Human tissue and biological samples for use in research. Interim guidance. London: MRC, November 1999.

10. NHS Executive. NHS Indemnity, Arrangements for Clinical Negligence Claims in the NHS. [date].

11. Breast Cancer Action Group Australia. Policy statement—Research and Clinical Trials. Fairfield, Victoria: Breast Cancer Action Group, 1998.

12. Cox K. Investigating Psychosocial Aspects of Participation in Phase I and II Anti-cancer Drug Trials, Final Report. Nottingham: University of Nottingham, 1999.

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