David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Jack Alan Reynolds
Learn more about PhilPapers
The clinical trial is the major investigational tool of clinical medicine. Two recent reports highlight the fact that the most often quoted mechanisms for the protection of research subjects, viz., research ethics board review and eligibility criteria, are insufficient to achieve this end. In this paper, we argue that the prime mechanism for the protection of persons in clinical trials should be the clinical judgement of the physician-investigator. The clinical investigator has a duty to protect subjects from both harm and undue risk. It is argued that the clinical investigator has a duty to screen for, and exclude, potential research subjects who may be unduly vulnerable to the risks of a particular clinical trial. In order to fulfill this obligation, the investigator should personally screen each potential research subject at the time of accrual. In larger trials in which this is not feasible, this task could be delegated to another appropriately qualified health care professional, with the principal investigator retaining personal responsibility. To reinforce and make explicit this legal and moral duty, we propose that the investigator sign a statement, appended to each subject's consent form, to attest that this duty has been responsibly discharged
|Keywords||No keywords specified (fix it)|
|Categories||categorize this paper)|
Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
|Through your library||
References found in this work BETA
No references found.
Citations of this work BETA
No citations found.
Similar books and articles
Mark Sheehan & Steve Clarke (2009). The Duty to Disclose Adverse Clinical Trial Results. American Journal of Bioethics 9 (8):24 - 32.
S. Matthew Liao, Mark Sheehan & Steve Clarke (2009). The Duty to Disclose Adverse Clinical Trial Results. American Journal of Bioethics 9 (8):24-32.
Charles Weijer, Characterizing the Population in Clinical Trials: Barriers, Comparability, and Implications for Review.
David Wendler & Emily Abdoler (2011). Does It Matter Whether Investigators Intend to Benefit Research Subjects? Kennedy Institute of Ethics Journal 20 (4):353-370.
Angela Ballantyne (2008). Benefits to Research Subjects in International Trials: Do They Reduce Exploitation or Increase Undue Inducement? Developing World Bioethics 8 (3):178-191.
Jacquelyn Slomka (2009). Manufacturing Mistrust: Issues in the Controversy Regarding Foster Children in the Pediatric Hiv/Aids Clinical Trials. Science and Engineering Ethics 15 (4):503-516.
Charles Weijer (1999). Selecting Subjects for Participation in Clinical Research: One Sphere of Justice. Journal of Medical Ethics 25 (1):31-36.
James A. Anderson & Jonathan Kimmelman (2014). Are Phase 1 Trials Therapeutic? Risk, Ethics, and Division of Labor. Bioethics 28 (3):138-146.
Jonathan Kimmelman (2004). Valuing Risk: The Ethical Review of Clinical Trial Safety. Kennedy Institute of Ethics Journal 14 (4):369-393.
Howard Brody & Franklin G. Miller (2003). The Clinician-Investigator: Unavoidable but Manageable Tension. Kennedy Institute of Ethics Journal 13 (4):329-346.
Charles Weijer, Selecting Subjects for Participation in Clinical Research: An Empirical Inquiry and Ethical Analysis.
Kenneth de Ville (2011). The Case Against Contract: Participant and Investigator Duty in Clinical Trials. American Journal of Bioethics 11 (4):16-18.
Roy G. Spece, David S. Shimm & Allen E. Buchanan (eds.) (1996). Conflicts of Interest in Clinical Practice and Research. Oxford University Press.
Added to index2010-09-08
Total downloads5 ( #249,187 of 1,413,402 )
Recent downloads (6 months)2 ( #94,438 of 1,413,402 )
How can I increase my downloads?