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Jul-Sep2002-10(3)
REPORT
Report on a workshop on ethics
in biomedical research, Trivandrum
The workshop (January 19-20, 2002) was jointly
organised by the Kerala Health Studies and Research Centre (KHSRC), Trivandrum,
the Department of Community Medicine at the Medical College, Trivandrum, and the
Forum for Medical Ethics Society, Mumbai. Participants came from all over the
state, representing community medicine, pharmacology and forensic medicine and
various other specialities in private and public practice.
Dr Joy Elamon, Executive Director
of the KHSRC said the workshop had been organised in the light of recent
research controversies, in order to discuss some central ethical questions in
the conduct of research.
Dr Uma, Head of the Department of
Community Medicine at the Medical College, noted that though the public
displayed a keen interest in ethical issues, students had only a vague
understanding of these concepts.
In his inaugural address,Dr C R
Soman, director of Health Action for the People, noted that the setting
in which medicine is practised has become more controversial over the years,
calling into question the very foundation of medical practice. The medical
profession is corrupt and bereft of concern for human welfare. Ethics was an
integral part of practice in the traditional systems of medicine. Doctors need
to take the principles of traditional practice to western science. Finally,
collaborative research had grown exponentially since the 1970s, bringing with it
a host of potentially exploitative situations.
Dr B Ekbal, vice chancellor of
Kerala University, said though Kerala is a progressive state and the majority of
doctors practice ethically, they are often insensitive when discussing medical
practice. There is little discussion on ethical questions related to various
aspects of medical practice. Even as the profession is reluctant to confront
long-standing ethical dilemmas, new challenges are posed every day by advances
in medical science.
Presentations were made on recent unethical trials
and other research controversies, principles governing medical research, the
role of ethics committees, issues in collaborative research, informed consent,
the ICMR's work in developing ethical guidelines, and fraud in medical research.
Small group discussions were held on case studies.
Among the presentations which led to animated
discussion wasMs Neha Madhiwalla'son informed consent,
particularly in relation to contraceptive research. Ms Madhiwalla noted that
written consent is often seen as a requirement to protect the researcher,
instead of a way to ensure that researchers follow the protocol. It is important
to see the ethos in which we see informed consent. It might be good to get
researchers to sign a commitment to undertake to do their duty.
Dr G Sujatan, member of the ethics
committee at the Medical College, discussed some consent forms submitted to the
committee. Consent forms are often confused with patient information sheets, and
both are often incomplete.
Communication and consent: Dr Sujatan reported that a poorly communicated consent request for emergency surgery resulted in a suspicion of negligence/malpractice allegation that the patient had been submitted to a nephrectomy under the pretext of another surgical procedure. Dr M Nair stated that poor communication is the reason for many allegations of malpractice or negligence. Dr Nair stated that when he knows an operation involves many risks, he explains everything to the patient, writes it out in Malayalam, and asks for written consent. However, there may be situations where there is no time to take consent.
Communication and consent: Dr Sujatan reported that a poorly communicated consent request for emergency surgery resulted in a suspicion of negligence/malpractice allegation that the patient had been submitted to a nephrectomy under the pretext of another surgical procedure. Dr M Nair stated that poor communication is the reason for many allegations of malpractice or negligence. Dr Nair stated that when he knows an operation involves many risks, he explains everything to the patient, writes it out in Malayalam, and asks for written consent. However, there may be situations where there is no time to take consent.
Dr Amar Jesanistated that both consent form and patient information sheet should be in the local language. While the former is partly to protect doctors, the latter is something to which participants can always refer later. Ethics committees must demand that patient information sheets are in the vernacular language and understandable to the patients. Second, researchers could sign the information sheet to take responsibility for the information given. Third, the information sheet should contain the contact details of the ethics committee chairperson who reviewed the proposal. The ethics committee must expand its work to include grievance redressal.
What is the procedure for obtaining consent for
screening procedures?A participant observed that family planning clinics
do not take consent for post-partum cervical screening since it is not an
invasive technique and can be included in the clinical examination.
Another stated that treatment policies should be given when obtaining consent
for screening. Another asked: should consent be obtained for 'opportunistic'
screening?
Should research organisations reimburse
patients for travel/expenses?This is going to be a concern if
reimbursement - particularly when research is done in poor populations - acts as
an incentive to participate in a trial.
HIV testing.Why should the doctor take
consent for testing blood for HIV, which after all is a diagnostic procedure?
The response was: since HIV has a social stigma, testing must be done in the
context of counselling.
Retrospective (medical records) studies need
consent only from the institutional head.
Other questions:What are the legal
implications of informed consent? Why insist on equality in research
alone?
Dr Jesani commented that most of the questions were
concerned with legal problems and how to protect the doctor. We should first
think of the patient. We should always take consent, even for physical
examination; the issue is the form in which this consent expressed. There are
certain conditions where it is important to document consent, for example, when
invasive procedures are involved. The problem of communication must be
addressed. We need a culture of giving patients information.