Abstract
The aim of clinical trials is to obtain generalizable knowledge that can be used to advance healthcare. The ethical issues in clinical trials arise when human subjects, who may not directly benefit from the research, are faced with the risk of being exploited or harmed. Additional ethical challenges pertain to informed consent of subjects and conflicts of interest of physician-investigators. The current ethical standards for research are based on guidelines and laws which were a necessary response to historical abuses of participants in the name of science. In this chapter, a framework for evaluating clinical research for ethical deficits is discussed, as are challenges in upholding ethical principles, including in obtaining informed consent from research participants as well as in navigating conflicts of interest.
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References
Trials of war criminals before the Nuremberg Military tribunals under control council law no. 10. Washington, DC: US Government Printing Office; 1949. p. 181–182.
Declaration of Helsinki: recommendations guiding doctors in clinical research. Finland: 18th World Medical Assembly; June 1964.
Declaration of Helsinki: recommendations guiding medical doctors in biomedical research involving human subjects. Japan: 29th World Medical Assembly; October 1975.
Brandt AM. Racism and research: the case of the Tuskegee syphilis study. Hast Cent Rep. 1978;8(6):21–9.
Beecher HK. Ethics and clinical research. N Engl J Med. 1966;274(24):1354–60.
Sparks J. Timeline of laws related to the protection of human subjects. National Institutes of Health Office of History; June 2002. https://history.nih.gov/about/timelines_laws_human.html.
Menikoff J. Rules and regulations. Fed Regist. 2017;82(12):7149–62.
Menikoff J, Kaneshiro J, Pritchard I. The common rule, updated. N Engl J Med. 2017;376(7):613–5.
Electronic Code of Federal Regulations. In: Services UDoHaH, editor. Title 45: public welfare; part 46—protection of human subjects. Online 2018.
Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA. 2000;283(20):2701–11.
Barondess JA. Medicine against society. Lessons from the Third Reich. JAMA. 1996;276(20):1657–61.
Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 1987;317(3):141–5.
Berry MF, Zeyer-Brunner J, Castleberry AW, Martin JT, Gloor B, Pietrobon R, et al. Treatment modalities for T1N0 esophageal cancers: a comparative analysis of local therapy versus surgical resection. J Thorac Oncol. 2013;8(6):796–802.
Ell C, May A, Gossner L, Pech O, Gunter E, Mayer G, et al. Endoscopic mucosal resection of early cancer and high-grade dysplasia in Barrett’s esophagus. Gastroenterology. 2000;118(4):670–7.
Omae M, Fujisaki J, Horiuchi Y, Yoshizawa N, Matsuo Y, Kubota M, et al. Safety, efficacy, and long-term outcomes for endoscopic submucosal dissection of early esophagogastric junction cancer. Gastric Cancer. 2013;16(2):147–54.
Ioannidis JPA, Stuart ME, Brownlee S, Strite SA. How to survive the medical misinformation mess. Eur J Clin Investig. 2017;47(11):795–802.
Rice TW. The historical, ethical, and legal background of human-subjects research. Respir Care. 2008;53(10):1325–9.
Barker AD, Sigman CC, Kelloff GJ, Hylton NM, Berry DA, Esserman LJ. I-SPY 2: an adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy. Clin Pharmacol Ther. 2009;86(1):97–100.
Behrendt C, Golz T, Roesler C, Bertz H, Wunsch A. What do our patients understand about their trial participation? Assessing patients’ understanding of their informed consent consultation about randomised clinical trials. J Med Ethics. 2011;37(2):74–80.
Robinson EJ, Kerr CE, Stevens AJ, Lilford RJ, Braunholtz DA, Edwards SJ, et al. Lay public’s understanding of equipoise and randomisation in randomised controlled trials. Health Technol Assess. 2005;9(8):1–192, iii-iv.
Falagas ME, Korbila IP, Giannopoulou KP, Kondilis BK, Peppas G. Informed consent: how much and what do patients understand? Am J Surg. 2009;198(3):420–35.
Dellson P, Nilsson K, Jernstrom H, Carlsson C. Patients’ reasoning regarding the decision to participate in clinical cancer trials: an interview study. Trials. 2018;19(1):528.
Angelos P. Ethical issues of participant recruitment in surgical clinical trials. Ann Surg Oncol. 2013;20(10):3184–7.
Bossert S, Strech D. An integrated conceptual framework for evaluating and improving ‘understanding’ in informed consent. Trials. 2017;18(1):482.
Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of informed consent: a new measure of understanding among research subjects. J Natl Cancer Inst. 2001;93(2):139–47.
Cohn EG, Jia H, Smith WC, Erwin K, Larson EL. Measuring the process and quality of informed consent for clinical research: development and testing. Oncol Nurs Forum. 2011;38(4):417–22.
Gillies K, Elwyn G, Cook J. Making a decision about trial participation: the feasibility of measuring deliberation during the informed consent process for clinical trials. Trials. 2014;15:307.
Stryker JE, Wray RJ, Emmons KM, Winer E, Demetri G. Understanding the decisions of cancer clinical trial participants to enter research studies: factors associated with informed consent, patient satisfaction, and decisional regret. Patient Educ Couns. 2006;63(1–2):104–9.
Wade J, Elliott D, Avery KNL, Gaunt D, Young GJ, Barnes R, et al. Informed consent in randomised controlled trials: development and preliminary evaluation of a measure of participatory and informed consent (PIC). Trials. 2017;18(1):327.
Childers R, Lipsett PA, Pawlik TM. Informed consent and the surgeon. J Am Coll Surg. 2009;208(4):627–34.
Synnot A, Ryan R, Prictor M, Fetherstonhaugh D, Parker B. Audio-visual presentation of information for informed consent for participation in clinical trials. Cochrane Database Syst Rev. 2014(5):CD003717.
Agre P, Rapkin B. Improving informed consent: a comparison of four consent tools. IRB. 2003;25(6):1–7.
Grady C, Cummings SR, Rowbotham MC, McConnell MV, Ashley EA, Kang G. Informed consent. N Engl J Med. 2017;376(9):856–67.
Wendler D. The assent requirement in pediatric research. In: Emanuel EJ, editor. New York: Oxford University Press; 2008.
Gilbert T, Bosquet A, Thomas-Anterion C, Bonnefoy M, Le Saux O. Assessing capacity to consent for research in cognitively impaired older patients. Clin Interv Aging. 2017;12:1553–63.
Karlawish J. Emergency research. In: Emanuel EJ, editor. New York: Oxford University Press; 2008.
Capron A. Legal and regulatory standards of informed consent in research. In: Emanuel EJ, editor. New York: Oxford University Press; 2008.
Angelos P. Surgical ethics and the challenge of surgical innovation. Am J Surg. 2014;208(6):881–5.
Stead WW. The complex and multifaceted aspects of conflicts of interest. JAMA. 2017;317(17):1765–7.
Thompson DF. Understanding financial conflicts of interest. N Engl J Med. 1993;329(8):573–6.
Lo B, Field MJ, editors. Conflict of interest in medical research, education, and practice. The National Academies Collection: Reports funded by National Institutes of Health. Washington, DC: National Academies Press; 2009.
Agrawal S, Brennan N, Budetti P. The sunshine act—effects on physicians. N Engl J Med. 2013;368(22):2054–7.
Cherla DV, Olavarria OA, Holihan JL, Viso CP, Hannon C, Kao LS, et al. Discordance of conflict of interest self-disclosure and the centers of Medicare and Medicaid services. J Surg Res. 2017;218:18–22.
Jacmon H. Disclosure is inadequate as a solution to managing conflicts of interest in human research. J Bioeth Inq. 2018;15(1):71–80.
Lichter AS. Conflict of interest and the integrity of the medical profession. JAMA. 2017;317(17):1725–6.
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We appreciate the outstanding work of Jukes Namm and Peter Angelos for authoring the first edition of this chapter.
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Rossfeld, K.K., Cloyd, J.M., Palmer, E., Pawlik, T.M. (2020). Ethics (Informed Consent and Conflicts of Interest). In: Pawlik, T., Sosa, J. (eds) Clinical Trials. Success in Academic Surgery. Springer, Cham. https://doi.org/10.1007/978-3-030-35488-6_2
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