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
