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  1. Henry Beecher and Consent to Research: a critical re-examination.Franklin G. Miller - 2016 - Perspectives in Biology and Medicine 59 (1):78-94.
    Henry Beecher was a distinguished professor of anesthesia and clinical investigator at Harvard Medical School. He became an iconic figure in bioethics, best known for his 1966 article describing 22 examples of unethical clinical research. This is one of the most frequently cited articles on ethics in the medical literature. Indeed, it may be seen as marking a watershed in the moral climate of medical research. In his history of bioethics, Albert Jonsen characterized Beecher as one of the “stars in (...)
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  • Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials. [REVIEW]Adam Nishimura, Jantey Carey, Patricia J. Erwin, Jon C. Tilburt, M. Hassan Murad & Jennifer B. McCormick - 2013 - BMC Medical Ethics 14 (1):28.
    Obtaining informed consent is a cornerstone of biomedical research, yet participants comprehension of presented information is often low. The most effective interventions to improve understanding rates have not been identified.
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  • The clinician-investigator: Unavoidable but manageable tension.Howard Brody & Franklin G. Miller - 2003 - Kennedy Institute of Ethics Journal 13 (4):329-346.
    : The "difference position" holds that clinical research and therapeutic medical practice are sufficiently distinct activities to require different ethical rules and principles. The "similarity position" holds instead that clinical investigators ought to be bound by the same fundamental principles that govern therapeutic medicine—specifically, a duty to provide the optimal therapeutic benefit to each patient or subject. Some defenders of the similarity position defend it because of the overlap between the role of attending physician and the role of investigator in (...)
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  • The Emergence of Clinical Research Ethics Consultation: Insights From a National Collaborative.Kathryn M. Porter, Marion Danis, Holly A. Taylor, Mildred K. Cho & Benjamin S. Wilfond - 2018 - American Journal of Bioethics 18 (1):39-45.
    The increasing complexity of human subjects research and its oversight has prompted researchers, as well as institutional review boards, to have a forum in which to discuss challenging or novel ethical issues not fully addressed by regulations. Research ethics consultation services provide such a forum. In this article, we rely on the experiences of a national Research Ethics Consultation Collaborative that collected more than 350 research ethics consultations in a repository and published 18 challenging cases with accompanying ethical commentaries to (...)
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  • What information and the extent of information research participants need in informed consent forms: a multi-country survey.Juntra Karbwang, Nut Koonrungsesomboon, Cristina E. Torres, Edlyn B. Jimenez, Gurpreet Kaur, Roli Mathur, Eti N. Sholikhah, Chandanie Wanigatunge, Chih-Shung Wong, Kwanchanok Yimtae, Murnilina Abdul Malek, Liyana Ahamad Fouzi, Aisyah Ali, Beng Z. Chan, Madawa Chandratilake, Shoen C. Chiew, Melvyn Y. C. Chin, Manori Gamage, Irene Gitek, Mohammad Hakimi, Narwani Hussin, Mohd F. A. Jamil, Pavithra Janarsan, Madarina Julia, Suman Kanungo, Panduka Karunanayake, Sattian Kollanthavelu, Kian K. Kong, Bing-Ling Kueh, Ragini Kulkarni, Paul P. Kumaran, Ranjith Kumarasiri, Wei H. Lim, Xin J. Lim, Fatihah Mahmud, Jacinto B. V. Mantaring, Siti M. Md Ali, Nurain Mohd Noor, Kopalasuntharam Muhunthan, Elanngovan Nagandran, Maisarah Noor, Kim H. Ooi, Jebananthy A. Pradeepan, Ahmad H. Sadewa, Nilakshi Samaranayake, Shalini Sri Ranganathan, Wasanthi Subasingha, Sivasangari Subramaniam, Nadirah Sulaiman, Ju F. Tay, Leh H. Teng, Mei M. Tew, Thipaporn Tharavanij, Peter S. K. Tok, Jayanie Weeratna & T. Wibawa - 2018 - BMC Medical Ethics 19 (1):1-11.
    Background The use of lengthy, detailed, and complex informed consent forms is of paramount concern in biomedical research as it may not truly promote the rights and interests of research participants. The extent of information in ICFs has been the subject of debates for decades; however, no clear guidance is given. Thus, the objective of this study was to determine the perspectives of research participants about the type and extent of information they need when they are invited to participate in (...)
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  • Clinical research and the physician–patient relationship: the dual roles of physician and researcher.Nancy Mp King & Larry R. Churchill - 2008 - In Peter A. Singer & A. M. Viens (eds.), The Cambridge textbook of bioethics. New York: Cambridge University Press.
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  • Supporting positive experiences and sustained participation in clinical trials: looking beyond information provision.Kate Gillies & Vikki A. Entwistle - 2012 - Journal of Medical Ethics 38 (12):751-756.
    Recruitment processes for clinical trials are governed by guidelines and regulatory systems intended to ensure participation is informed and voluntary. Although the guidelines and systems provide some protection to potential participants, current recruitment processes often result in limited understanding and experiences of inadequate decision support. Many trials also have high drop-out rates among participants, which are ethically troubling because they can be indicative of poor experiences and they limit the usefulness of the knowledge the trials were designed to generate. Drawing (...)
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  • The IRB paradox: Could the protectors also encourage deceit?Patricia Keith-Spiegel & Gerald P. Koocher - 2005 - Ethics and Behavior 15 (4):339 – 349.
    The efforts of some institutional review boards (IRBs) to exercise what is viewed as appropriate oversight may contribute to deceit on the part of investigators who feel unjustly treated. An organizational justice paradigm provides a useful context for exploring why certain IRB behaviors may lead investigators to believe that they have not received fair treatment. These feelings may, in turn, lead to intentional deception by investigators that IRBs will rarely detect. Paradoxically, excessive protective zeal by IRBs may actually encourage misconduct (...)
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  • Does Informed Consent to Research Require Comprehension?Gopal Sreenivasan - 2007 - The Proceedings of the Twenty-First World Congress of Philosophy 1:85-93.
    According to the standard view of informed consent, a prospective subject's consent to participate in a research study is invalid if the individual fails to comprehend the information about the study standardly disclosed to him. I argue that this involves three mistakes. First, the standard view confuses an ethical aspiration with a minimum ethical standard. Second, it assigns the entire responsibility for producing comprehension in study participants to the investigators. Most importantly, the standard view requires the termination of many otherwise (...)
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