In Plain Sight: A Solution to a Fundamental Challenge in Human Research

Abstract:     
The conflict of interest created when physician-researchers combine medical research and treatment is a long-standing and widely recognized ethical challenge of clinical research that has thus far eluded satisfactory solution. A researcher’s obligation to the scientific enterprise not only provides the temptation to ignore the medical needs of subjects in a study, it may provide an obligation, short of actually endangering subjects, to override their medical needs or preferences. Expecting research subjects to protect themselves through informed consent processes is unrealistic, as is expecting physician-researchers to internally navigate this conflict simply by being virtuous. The problem is a structural one that requires a structural solution. People who are receiving medical treatment need a doctor devoted to their care to provide the independent, individualized judgment and advice expected of a physician outside of research. Reliance on other, existing protective mechanisms — institutional review boards, data safety monitoring boards, medical monitors or even the new research subject advocacy programs — falls short, as indeed each of those mechanisms assumes that the subject will be protected and advised by the local investigators, a role they cannot fulfill. For these reasons, we propose that in much clinical research, each research subject should have a doctor independent from the research study.

Number of Pages in PDF File: 24

Keywords: conflict of interest, research, physician, investigator, medical monitors, institutional review boards, research ethics, research subject advocate, clinical research, biomedical research, clinical trials, therapeutic misconception, informed consent, patient-subject, Belmont Report, risk/benefit

Accepted Paper Series