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Ethics in Clinical Research

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Ethics in Clinical Research Healthcare Management Ethics Ethics in Clinical The ethical principle that most prominently figured in the Belmont Research Report was that of respect for persons. This premise has been a driving force in contemporary bioethics and Executives must ensure trial participants’ is defined as the obligation of the protection and the public’s best interest. organization and the executive to Richard Culbertson, protect and preserve individual PhD autonomy (self-determination) of participants in clinical research studies. In this regard, it parallels Clinical research is no longer the exclu- of “first do no harm” has been vio- the drive toward protection of sive domain of the academic health sci- lated by some studies in the past such patient self-determination in the ences center but has extended into the as the infamous Tuskegee syphilis clinical setting that is embodied in everyday world of the healthcare execu- experiment begun in 1932 in which ACHE’s Code of Ethics. According to tive in a wide range of organizational participants were not informed of the the code, the healthcare executive and clinical settings. This trend is a nature of the study and in which commits to, “Work to provide a pro- beneficial one in many respects, for therapy for treatment of the disease cess that ensures the autonomy and clinical research is the R&D of the was withheld. In response to public self-determination of patients or oth- healthcare world in applying and vali- outrage, the study was terminated in ers served.” dating discoveries from the realm of 1972, and a formal presidential apol- basic science (the bench) to the care of ogy by President Clinton on behalf of the patient (the bedside). Healthcare the nation followed in 1997. Within Clinical research is no longer organizations have engaged in clinical the conduct of the study, informed the exclusive domain of the research at a variety of levels as direct consent by the participants was sponsors of research investigators or impossible because the study’s objec- academic health sciences as part of a broader research network tives and a detailed explanation of center but has extended into engaged in the conduct of clinical trials. relative risks and benefits (if any) of participation had not been disclosed the everyday world of the Total spending on health-related to them. healthcare executive. research and development from public and private sources in the United The Belmont Report of 1979, which States reached $49.3 billion annually was prompted in part by the Protection of Subjects by 2010, according to ACHE’s Key Tuskegee incident, led to the adop- Federal regulation for protection of Industry Facts: 2012. This source of tion of recommendations to avert clinical trial volunteers in federally opportunity to advance the research future ethical lapses in clinical sponsored research projects has been dimension of one’s organizational mis- research as official U.S. Department highly developed through the sion while opening new sources of rev- of Health, Education and Welfare Institutional Review Board mecha- enue in a world of diminishing policy. These policy directives were nism of the U.S. Department of resources has proven attractive to cli- based on specific ethical principles Health and Human Services. Many nicians in private practice settings and and were directed primarily toward healthcare executives are part of to community institutions, attracting protection of participants. The organizations sponsoring their own new entrants to clinical research. directives were specifically applied IRBs or are members of research through policies of informed con- networks that assume IRB responsi- Ethical issues have always had a sent, assessment of risks and bene- bilities. In the work of IRBs, the prominent place in discussion of clin- fits, and responsible selection of attainment of participants’ informed ical research. The ethical imperative study participants. consent is a central value, much as 60 Reprinted from Healthcare Executive maY/JUNE 2013 ache.org informed consent is essential to necessary in the successful involve- The National Institutes of Health patient safety and self-determination ment of minority and underserved promulgated regulations in 2011 to in the clinical setting. populations in studies. The literature provide added barriers to conflicts demonstrates that variation in success of interest through investigator dis- In their 2002 “Clinical Trial of treatments exists across these lines closure and formal institutional Volunteer’s Bill of Rights,” Kenneth and that generalizable results cannot review. This intensified interest on Getz and Deborah Borfitz summa- be attained without the voluntary the part of NIH requires certifica- rize the gist of these regulations for involvement of these individuals. In tion of all investigators to meet protection of subjects. Key elements this regard, the ethical obligation of stringent financial conflict of inter- involve informing the participant of the executive in the conduct of clini- est requirements. This was in part the purpose of the clinical trial; all cal research is again no different than prompted by public revelations risks, side effects or discomforts that in the therapeutic setting. highlighted in the media of investi- might be reasonably expected; and gators profiting from the distortion any expected benefits. The partici- Conflicts of Interest of clinical trial results for the bene- pant must be told what will happen With the increasing fiscal attractive- fit of commercial interests from in the study and whether interven- ness of clinical research has come an which they stand to profit. tions such as drugs and devices differ intensified focus on the obligation to from those used in standard medical minimize conflicts of interest—on Also of interest is the improper treatment. Available options should the part of researchers and their provision of information regarding be discussed and assessed as better or organizations—resulting from the probable outcome of trials to worse than being a participant. financial interests that could affect investors who will profit if a drug the design, conduct or reporting of or device can be successfully mar- Throughout the clinical trial process, research results. In his 2011 book keted. Significant interest is con- prevention of coercion, which dimin- Ethics in Health Services sidered to be compensation or ishes patient freedom and detracts Management, Kurt Darr defines equity interest exceeding $5,000, from the respect for persons tenet, is conflict of interest as “a duality of intellectual property rights and essential. The participant is to be competing interest when duties are reimbursed travel to a researcher allowed to ask questions about the owed to two or more persons or by a sponsoring entity. trial prior to giving consent and at organizations and meeting the duty any time during the trial. She or he to one makes it impossible to fulfill For healthcare executives, clinical must have ample time to decide to the duty to the other.” research is a new but vital mission consent free of pressure. The partici- essential to the financial and social pant may refuse to participate for any Further, without full disclosure of vitality of the organization and soci- reason before and after the trial has conflicts to participants, the respect ety in general. The ethical imperative commenced and must be told of any for persons principle is undermined, for executives is to ensure research is medical treatments available if com- as the participant is giving consent conducted within policies that pro- plications occur. All of the above pro- based on incomplete information. tect participants in research and that visions must be addressed in an Just as the American Medical are for the good of the public. s informed consent form that is signed, Association’s Code of Medical Ethics dated and given to the participant. mandates that if a conflict develops Richard Culbertson, PhD, is professor, between a physician’s financial inter- health policy systems management, in Protection of study participants has est and the interest of the patient the School of Public Health at LSU proven crucial in gaining the public’s that the conflict must be resolved to Health Sciences Center in New confidence regarding the integrity of the benefit of the patient (Standard Orleans. He also heads the ethics research studies and the absence of 8.03), so must a conflict in the resource for the Louisiana Clinical exploitation of their essential partici- research world be resolved in favor Trials Consortium. He can be reached pants. This protection is especially of the public. at [email protected]. Reprinted from 61 Healthcare Executive maY/JUNE 2013 ache.org.
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