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Dealing with Ethical Conflicts in Clinical Research

      Ever since the horrors of Nazi human experimentation were revealed following World War II, the clinical research community has been continuously re-examining and strengthening ethical control measures employed in medical experimentation. Human subjects committees, informed consent procedures employing easily understood language, local and national clinical research review entities, and considerable media attention have all led to a safer, more enlightened, and more equitable clinical research environment. Having been personally involved in many of these processes, I can attest to the serious nature with which these experimental protocols are planned and implemented.
      The remarkable advances in clinical therapeutics seen over the last 50 years are largely the result of such carefully designed and carefully performed clinical trials. In the world of human experimentation, every clinical investigator with whom I have ever worked accepted the premise that physicians should encourage their patients to enter clinical research protocols as volunteers when the correct therapeutic intervention in a particular setting was unknown. In addition, there has always been universal agreement that physician-investigators should be completely forthright with patients recruited into clinical trials concerning potential financial and non-financial conflicts of the investigator. For example, does the doctor stand to profit personally from the patient's participation in the trial that has been suggested?
      Recently, there have been reports in the national media concerning potential problems in the ethical environment of clinical studies that involve the recruitment of so-called normal subjects as well as patients destined to participate in specific pharmaceutical drug trials. In the January 7, 2008 issue of The New Yorker, Carl Elliott, a faculty member at the University of Minnesota who teaches philosophy and ethics, describes in frightening detail some of the more egregious examples where ethical concerns seemed to have been conveniently overlooked in a world of hastily performed drug trials.
      • Elliott C.
      Guinea-pigging.
      Elliott points out something that is well known in academic centers these days, ie, experimental pharmaceutical studies in human beings which were formerly carried out at teaching and research hospitals and medical schools are now largely performed by for-profit clinical research entities in the community. These centers function as high output testing units evaluating new drugs that are undergoing initial and subsequent clinical development.
      Many of the test subjects employed by these for-profit testing entities are “professional patients” including impoverished students for whom the honoraria paid to participate in the research project are an important component of their income. Even more sinister is Elliott's description of the use of homeless individuals, prisoners, and illegal immigrants in drug trials for whom the income derived is essential for their well-being.
      • Elliott C.
      Guinea-pigging.
      The ethical failure of such activities is obvious. The Nuremburg and Helsinki codes, developed following the human experimental atrocities of World War II, strongly advocate for voluntary participation on the part of research subjects. The substantial sums of money paid to the human “guinea pigs” described by Elliott clearly obfuscate any volunteerism on the part of the individuals involved in these clinical experiments.
      Unfortunately, the overworked and under-funded Food and Drug Administration of our federal government has been unable to develop a system for satisfactory oversight of the for-profit research test centers. Although some of these entities are owned and operated by non-physicians, many of them are, unfortunately, the property of practicing and non-practicing physicians who profit handsomely from this activity. The potential conflict of interest for these doctors, and the possibility of exploitation of the research subjects involved raises, at least, the specter of the horrible misdeeds carried out in the name of research by Nazi physicians.
      I am a great believer in clinical research and its obvious benefits and have personally participated in such activities for more than 40 years. However, the article by Elliott in The New Yorker has sent chills down my spine. Lives saved and disease suffering lessened at the expense of individuals who are lured and perhaps even coerced into clinical trial participation cannot be allowed to continue in an open and equitable democracy. Clearly, the article by Elliott should be widely disseminated among academic and community physicians and governmental authorities. The topic should be openly discussed leading to corrective actions. Steps must be taken in the near future to protect the lives and the civil rights of individuals participating in clinical research studies.

      Reference

        • Elliott C.
        Guinea-pigging.
        (The New Yorker)in: 2008: 36-41 (January 7)