Reflections from the Front: Conflicts of Interest
Conflicts of interest are an ever present concern in scientific and medical research. One cannot listen to any CME lecture at your local hospital without being informed as to the speaker’s potential financial conflicts of interest.
Oncology research, in particular, poses some unusual risks. We long for breakthroughs in cancer treatment, but we sometimes forget the inherent conflicts of interest that arise when a treating physician also functions as a principle investigator.
I recently heard of an institution that was planning to compensate oncologists for each new person they were able to accrue into a protocol study. Dubious as to the ethics of this decision, I contacted several ethicist friends of mine, who each were equally concerned. A brief internet search revealed two pertinent documents.
A white paper from Seton Hall Law School suggests, “In order to avoid a disincentive for physicians to conduct research, compensation for clinical trial work should include delineated reimbursement for expenses, such as screening interviews or tests and data monitoring and reporting, that do not arise in the clinical context.” In the next paragraph, however, it states, “The federal government should bar the following: …any payment methodology that conditions payment for expenses attendant to screening potential participants on the individual enrolling in the trial, and all bonuses for recruiting or retaining a certain number of participants.” [http://law.shu.edu/programscenters/healthtechIP/upload/health_center_whitepaper_nov2009.pdf]
“Informed Consent of Research Subjects,” by Partners Human Research Committee reads, “If subjects are to be enrolled from the investigator’s own patients, consent procedures must be put in place to ensure that subjects do not feel obligated to participate because the investigator is their treating physician. There is always concern about the possibility of patients feeling obligated to participate because it is their physician who is doing the asking…Researchers are asked to think about this issue and address it.” [http://healthcare.partners.org/phsirb/infcons.htm]
Here are two, of many, ways to address the conflict of interest associated with compensating physicians for accruing patients to study protocols:
1) By including in the consent documentation a statement such as, “Physicians enrolling and managing patients under this protocol receive compensation to cover their additional duties.” While this will not eliminate all conflict of interest, it will achieve transparency, as in the CME lecture scenario, above.
2) By having the treating physician neutrally inform patients about possible studies when appropriate. If interested, patients would be referred to another independent professional who would review the protocol with the patient, and then having this second person sign off on having them enter the protocol. This would limit the degree of coercion currently possible under the typical consent procedure. The second physician could bill under a counseling or education code, or be nominally paid for their work by the parent organization. Thus, this would remove a disincentive for having the discussion—extra uncompensated work—and would allow for unbiased risk and benefit counseling. If the patient then enters the study, management could be performed by the original oncologist.
While it will never be possible to remove all hints of conflict of interest, we should strive to provide our patients with clean, un-coerced and non-coercive information on which to base difficult clinical choices.