More on Conflict of Interest: Wearing Two Hats: Clinician and Researcher
For those of my visitors who would like to read more about the ethical conflicts of interest which can occur when the same individual is both a clinician and a clinical investigator, I would recommend reading the article written by KATRINA A. BRAMSTEDT, PhD in
CLEVELAND CLINIC JOURNAL OF MEDICINE VOLUME 71,NUMBER 11 NOVEMBER 2004 titled "A Guide to Informed Consent for Clinician-Investigators". In it she describes the potential conflicts and also provides a guidline to obtain informed consent from the patient-subject. This may help mitigate some of the ethical issues but I think not all of them since it may be difficult for the clinician/investigator to fully divest one responsibility for another. I have excerpted her comments about conflict of the dual role of the physician-investigator below. To read the entire article in pdf format go to Cleveland Clinic Journal of Medicine.
An innate conflict also exists when one person
is both physician and clinical investigator,
especially when subjects are drawn from the
physician’s own pool of patients. In this situation
the physician assumes the dual role of
both caring for patients and performing
research on them, two functions that may
conflict. Several ethical issues may arise as a
result of outlooks of both the physician and
Coercion to enroll or stay in a study.
One danger is that a physician may aggressively
recruit research subjects to the point of
coercion and may not fully inform patients of
the study’s risks or other treatment options.
The potential for a problem is especially great
when the sponsors of a study offer financial
bonuses to investigators for rapid enrollment.
In the case of Guckin v Nagle, a surgeon
who also functioned as a clinical investigator
recommended an experimental intervention
as “the best therapeutic alternative” for a
patient’s occasional fecal incontinence. The
patient’s anal sphincter was permanently
damaged when the radiofrequency device
overheated and failed to shut off automatically.
The consent form did not indicate that the
procedure was part of a clinical trial, nor did it
mention alternative treatments. The patient
argued that she was a victim of “therapeutic
misconception,” that is, she believed that the
intervention would directly benefit her based
on the information provided by the surgeon
and the consent form.
In the case of adverse events occurring
during a study, a physician-investigator may
be tempted to choose an intervention that
keeps the individual enrolled rather than one
that is clinically the most appropriate.
Patient confusion about the dual role. A
patient may feel obliged to enroll in a study to
“help” his or her doctor in return for the care
the doctor provides. Patients may also feel that the doctor would not be offering study
participation unless it were safe or to their
Patients are especially vulnerable when
they are desperate for treatment or if they
lack health insurance. In such cases they may
seek out research studies as a form of health