Reducing Clinical Research Risks
For Publication, NY Times, August 1, 2001
Dear Editor,
Drs. Shaywitz and Ausiello thoughtful essay (NYT
Week in Review 7/29/01) reminds us that while all clinical research
involves some risk, it is also possible to inform subjects of risks
and to protect subjects from unnecessary risks. In order for subjects
to be protected and to knowingly accept risks, not just clinical
investigators and institutions but also the sponsoring pharmaceutical
company must be considered as potentially jointly responsible. The
requirement to meaningfully inform patients who are clinical research
subjects is central not only by way of respecting their autonomy
but also by way of protecting subjects from unnecessary risks and
early intervention and damage control to reduce the level of necessary
risk. A well informed research subject can not only make a meaningful
choice as to clinical research trail participation but can also alert
the clinical investigator earlier and more effectively as to emergent
side effects. This is why an informed consent process including the
assessment and enhancement of patient competency to communicate even
unexpected side effects is important. However such an informed consent
process involves sponsors allocating sufficient funds and to allow
for the training of clinical investigators and disclosing sufficient
information in a meaningful manner to allow for meaningful informed
consent.
According to the Nuremberg Code and its progeny codes for clinical research,
in addition to clinical investigators, sponsors are accountable for protecting
human subjects from unnecessary risks. Support of such codes via a reasonable
and fair policy delineating sponsoring pharmaceutical company responsibility
is essential to avoid putting especially vulnerable patients at risk
for sponsors shopping for the most compliant and cheapest clinical investigators
and Institutional Review Boards. Without any sponsor accountability it
is foreseeable that an atmosphere will be created where diligent clinical
investigators and institutions who emphasize that informed consent is
not a mere pro forma exercise but a process will be pressured by the
clinical research market to lower their standards for informing and thus
protecting vulnerable human subjects.
Yours very truly,
Harold J. Bursztajn, M.D.
Associate Professor of Psychiatry
Harvard Medical School
co-Founder, Program in Psychiatry and the Law
Harvard Medical School @ Massachusetts Mental Health Center