DRAFT GUIDELINES FOR ETHICAL RESEARCH
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
1.1 Researchers should ask relevant patient/consumer
suggest topics that need investigation
or questions that need answers.
suggest outcome measures for those
advise on the research design and
on the draft proposals.
advise on the recruitment of patients.
advise on the information to be offered
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.
2.1 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,
*2.2 Enrolment in a relevant local trial
should sometimes be a treatment option.
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
*3.1 Consent is not just agreement to the
research proposals; it is informed, willing and uncoerced commitment
to take part in the research.
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,
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.
*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
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
*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.
Patients should be asked to give permission for the possible use
of direct quotes from what they say, even though such quotes will
*4.3 The system for securing the anonymisation
of data should be explained to the patient and agreed by him or
*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
and the retention of any tissue, including blood samples, apart
from that normally removed as part of the therapeutic procedure.
*4.5 Patients' consent to the use of their
medical record and notes must be sought for every new research
*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.
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.
*5.1 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.
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.
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
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.
*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
*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,
*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
*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
*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
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.
6.1 The name and telephone number of a person
who can be contacted easily if the patient has a query or clinical
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.,,
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
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.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
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.
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
StatementResearch 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.
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
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 statementResearch 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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