A patient participating in a clinical trial has the right to know
all the information regarding the trial, including its potential benefits and
risks, so that he can make an informed decision
Clinical trials are
scientific research experiments, conducted on human volunteers in order to find
new ways to prevent, detect and cure diseases. Medical science has grown leaps
and bounds on the back of such biomedical research. When done properly, such
studies are very useful in improving our medical knowledge base.
However, not all clinical
trials are conducted ethically. This is especially true in India, which is fast
becoming an attractive destination for carrying out clinical trials, primarily
because we have a huge and diverse pool of patients on whom these trials can be
conducted fairly inexpensively. Many of the patients chosen are uneducated, who
can easily be exploited by doctors, researchers and pharmaceutical companies,
alike. Unethical researchers (who get paid huge sums for signing up as many
participants as possible) may exaggerate the benefits of a treatment, offer
financial sweeteners, or attempt to play down the risks of the trial.
In 1997, the oncology division of the Indian Council of Medical
Research (ICMR) carried out an observational study on cervical cancer in Indian
women. The study did not have any ethical clearance from the All India
Institute of Medical Sciences (AIIMS) from where the subjects were drawn; nor
did the researchers get informed consent from the subjects themselves. Under
the ICMR study, 1100 uneducated urban women from Delhi with pre-cancerous
lesions were studied between 1976 and 1988. The objective was to study the
natural progression of cervical dysplasia to cervical cancer (the most
prevalent cancer amongst Indian women) without any medical intervention. So
despite the fact that a simple surgery would have removed the cervical lesions,
before they could turn cancerous, the women were wantonly left untreated. The
outcome was that 62 of these women needlessly developed cancer; and in nine the
disease had already spread to other parts of their body.
In
another equally scandalous incident, an Indian scientist attempted to inject
the bovine HIV strain into a human subject. This research was also not approved
by any ethical body. Likewise there have been reports of a pig’s heart
transplant into humans; and controversial trials with mepacrine, an
anti-malarial drug that is injected into a woman’s uterus for contraceptive
purposes, although some doctors suspect it causes cancer. Although every
hospital unit is supposed to have its own ethical committee, in our country
most are defunct bodies. The National Human Rights Commission (NHRC) guidelines
propose that a research group must provide human subjects with printed
literature, explaining in simple, non-technical language, the purpose of the
study; details of the procedure; the risks involved; the financial or other
interests of the researcher; and a commitment to treat, completely and
free-of-cost, any complication that may arise during the course of the trial.
The
subject too has to certify in writing that she has understood the document and
is volunteering to participate in the research, without the promise of any
monetary inducement that is not permitted under the Indian law. There are a few
other government bodies that monitor clinical trials such as the Drug
Controller of India and the Clinical Trial Registry in India (CTRI).
Nonetheless, the Supreme Court recently expressed reservations about the
unethical way in which most clinical trials are being conducted in the country,
and has directed the Ministry of Health to formulate proper guidelines on this,
to protect patients’ interests. According to existing rules, an ethically sound
clinical trial:
Will
aim for the enhancement of medical knowledge
Will
have strong scientific validity
Will
recruit participants fairly
Will
have a favourable risk-benefit ratio
Will
have people who independently review, approve, amend or terminate it
Will
obtain informed consent from its participants
Will
respect the participants privacy and will strive hard to protect their wellness
and rights
Role of patient advocates in clinical trials
Patient-advocates
can play an extremely important role in clinical trials. Among other things
they are required to:
Make
sure whether the information about the trial is presented in a format which is
easily understandable to the patient
Assist
the research team in developing relevant educational materials about the trial
in lay-friendly terms that is simple and easy to understand
Identify
and address potential ethical issues in the trial
Promote
patient safety and confidentiality
Assist
the research team in obtaining valid informed consent from the patients,
recruited in the trial
QUIZ TIME: Informed Consent
Quality Assessment Questionnaire
Use this
form to gauge patient’s understanding of their participation in clinical trials
Do
you feel that you have been informed how long your participation in this
clinical trial will last?
Do
you think that all the treatments and procedures that the investigator proposed
for you are the best for your disease?
Do
you understand what “randomisation” means?
Do
you know that no direct medical benefit will derive to you from your
participation in this clinical trial?
Are
you sure that your participation in this trial will not involve any additional
risk or discomforts?
Do
you know that because you are participating in a clinical trial, it is possible
that the study sponsor, various government agencies, or others not directly involved
in your health care could have access to your medical records?
Do
you know that the consent form you signed lists the names of the contact
persons, who must answer any of your questions or concerns about the clinical
trial?
Do
you know that the consent form you signed describes how you will be covered by
insurance if you are injured or become ill as a result of participation in the
clinical trial?
Do
you understand that if you do not want to participate in the clinical trial you
are free to refuse to sign the consent form? This will not affect the quality
of medical care you receive, so you do not need to be scared that your doctor
will get angry or upset if you refuse to participate.
Do
you understand that you are not obliged to remain in the clinical trial if you
decide to withdraw at any point of time?
Explain
in your words the purpose of the clinical trial to which you have consented to
be a subject.
A patient-advocate who uses
such questionnaires with patients who have been recruited to participate in a
clinical trial will help to protect the patients; and will also ensure that the
research team is never caught on the wrong side of the fence.
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