David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Ezio Di Nucci
Jack Alan Reynolds
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Bioethics 22 (4):203–208 (2008)
To give valid informed consent to participate in clinical research, potential participants should understand the risks, potential benefits, procedures, and alternatives. Potential participants also should understand that they are being invited to participate in research. Yet it is unclear what potential participants need to understand to satisfy this particular requirement. As a result, it is unclear what additional information investigators should disclose about the research; and it is also unclear when failures of understanding in this respect undermine the validity of potential participants' informed consent. An analysis of individuals' interests suggests that potential participants need to understand three additional facts to understand that they are being invited to participate in research: 1) research contribution: those who enroll in the study will be contributing to a project designed to gather generalizable knowledge to benefit others in the future; 2) research relationship: the investigators will rely on participants' efforts to gather the generalizable knowledge to benefit others; and 3) research impact: the extent to which participating in the study will alter what participants do and what happens to them.
|Keywords||clinical research informed consent participation|
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References found in this work BETA
Paul S. Appelbaum, Loren H. Roth, Charles W. Lidz, Paul Benson & William Winslade (1987). False Hopes and Best Data: Consent to Research and the Therapeutic Misconception. Hastings Center Report 17 (2):20-24.
Adnan A. Hyder & Salman A. Wali (2006). Informed Consent and Collaborative Research: Perspectives From the Developing World. Developing World Bioethics 6 (1):33–40.
David Wendler (2002). What Research with Stored Samples Teaches Us About Research with Human Subjects. Bioethics 16 (1):33–54.
Citations of this work BETA
Merryn Ekberg (2012). Reassessing the Role of the Biomedical Research Ethics Committee. Journal of Academic Ethics 10 (4):335-352.
Connie M. Ulrich, Sarah J. Ratcliffe, Gwenyth R. Wallen, Qiuping Zhou, Kathleen Knafl & Christine Grady (2016). Cancer Clinical Trial Participants' Assessment of Risk and Benefit. Ajob Empirical Bioethics 7 (1):8-16.
Eric D. Kodish, Kathleen A. Kassimatis & Tsiao Yi Yap (2011). Both Sides of the Coin: Randomization From the Perspectives of Physician-Investigators and Patient-Subjects. Ethics and Behavior 20 (5):380-386.
David Wendler (2009). Response to Open Peer Commentaries on “Must Research Participants Understand Randomization?”. American Journal of Bioethics 9 (2):W1 – W2.
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