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