CASE STUDY RESPONSE
Protecting psychiatric
patients in research
Susan
Pilon
Renu Addlakha (RA) discusses a number of pertinent
ethical issues in the summary of her research (1). These issues could be
generally divided into three categories: confidentiality, freedom of
participation and consent, and the therapeutic
misconception.
Confidentiality
RA stated that
she had been given permission by the institution to review patient charts.
She correctly noted that while this permission may have given her legal access
to the charts it did not absolve her from the ethical need to obtain explicit
consent from patients and/or their families to use the files.
RA assured
study subjects that information provided to her would be kept strictly
confidential. Is it possible that in some instances, for example, if a
subject were to indicate that she had abused a child, there would be specific
legal requirements to report such information to the appropriate
authorities? In Canada we can rarely promise absolute confidentiality and
a similar constraint may apply to researchers in
India.
Freedom of participation and
consent
The research study was made possible through the
co-operation of the department of psychiatry. In addition to conducting
the research, RA was invited to participate in various departmental activities
like medical consultations, rounds and case conferences. Patients then
correctly identified RA as being part of the hospital establishment and were
placed in the position of feeling obligated to participate in her study in order
to ensure the continuation of their treatment. RA sensibly handled this
potentially coercive situation by ensuring that patients were reminded that the
study and their treatment were independent and by providing them the time to
think about participation and to ask questions. In North America, as in Asia,
patients may feel obligated to participate in research because of authority,
education and class factors. Perceived coercion may be subtle but very
real.
In Canada many psychiatric patients would be considered competent to
provide their own consent to participate in research rather than having their
families consent. No doubt there are cultural differences in this. For
example, patients may be hospitalised at different levels of disease in
different countries. If there is doubt about a patient's competency, it is best
to have a formal competency assessment conducted by a psychiatrist who is not
involved in the research study. This assessment would supplement any
advice provided by the attending staff.
Therapeutic misconception
RA
notes that patients' families often believe that "participation in research
might lead to additional privileges at the treatment level". I suspect the
problem is actually a deeper one in that patients and their families may confuse
research with treatment and may feel that those in authority in the hospital
would not ask them to participate in an activity that would not have a direct
treatment benefit for them.
Conclusion
It would appear that
RA conducted a thoughtful and ethical study. One might suggest that in
future studies of this kind, resources permitting, provision be made to
reimburse research participants for their time and expenses (if any). This
would fall within the principle of non-exploitation (2).
References
1. Addlakha
Renu. Ethical quandaries in anthropological fieldwork in psychiatric settings.
IJME 2005; 2: 55-56.
2. Indian Council of Medical Research. Ethical
guidelines for biomedical research on human subjects. New Delhi: ICMR;
2000.
SUSAN PILON, Centre for Addiction and Mental
Health, 33 Russell Street, Toronto, M5S 2S1 CANADA. e-mail:susan_pilon@camh.net 
