Medical research involving human subjects raises complex ethical, legal and social issues. Investigators sometimes find that their obligations with respect to a research project come into conflict with their obligations to individual patients. The ethical conduct of research rests on 3 guiding principles: respect for persons, beneficience, and justice. Respect for persons underlies the duty to obtain informed consent from study participants. Beneficence demands a favourable balance between the potential benefits and harms of participation. Justice requires that vulnerable people not be exploited and that eligible candidates who may benefit from participation not be excluded without good cause. Studies must be designed in a way that ensures the validity of findings and must address questions of sufficient importance to justify the risks of participation. In any clinical trial there must be genuine uncertainty as to which treatment arm offers the most benefit, and placebo controls should not be used if effective standard therapies exist. Researchers have a responsibility to inform themselves about the ethical, legal and policy standards that govern their activities. When difficulties arise, they should consult the existing literature and seek the advice of experts in research ethics
|Keywords||No keywords specified (fix it)|
|Categories||categorize this paper)|
References found in this work BETA
No references found.
Citations of this work BETA
No citations found.
Similar books and articles
Undesirable Implications of Disclosing Individual Genetic Results to Research Participants.Leslie Meltzer Henry - unknown
What Should Research Participants Understand to Understand They Are Participants in Research?David Wendler & Christine Grady - 2008 - Bioethics 22 (4):203–208.
Which Benefits of Research Participation Count as 'Direct'?Alexander Friedman, Emily Robbins & David Wendler - 2012 - Bioethics 26 (2):60-67.
Regulatory and Ethical Principles in Research Involving Children and Individuals with Developmental Disabilities.Eric G. Yan & Kerim M. Munir - 2004 - Ethics and Behavior 14 (1):31 – 49.
Lessons From Everyday Lives: A Moral Justification for Acute Care Research.Andrew D. McRae & Charles Weijer - unknown
A Framework to Link International Clinical Research to the Promotion of Justice in Global Health.Bridget Pratt & Bebe Loff - 2013 - Bioethics 27 (3):387-396.
Ethical Issues in Psychosocial Interventions Research Involving Controls.Elyn R. Saks, Dilip V. Jeste, Eric Granholm, Barton W. Palmer & Lawrence Schneiderman - 2002 - Ethics and Behavior 12 (1):87 – 101.
Refuting the Net Risks Test: A Response to Wendler and Miller's "Assessing Research Risks Systematically".Charles Weijer & Paul B. Miller - 2007 - Journal of Medical Ethics 33 (8):487-490.
Going From Principles to Rules in Research Ethics.Benjamin Sachs - 2011 - Bioethics 25 (1):9-20.
Review of The Oxford Textbook of Clinical Research Ethics, by D. Wendler, C. Grady, R. Crouch, R. Lie, F. Miller, and E. Emanuel.Roger Stanev - 2012 - Theoretical Medicine and Bioethics 33 (3):221-226.
Evaluating the Therapeutic Misconception.Franklin G. Miller & Steven Joffe - 2006 - Kennedy Institute of Ethics Journal 16 (4):353-366.
Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary.Ezekiel J. Emanuel (ed.) - 2003 - Johns Hopkins University Press.
Added to index2010-09-08
Total downloads7 ( #525,898 of 2,171,972 )
Recent downloads (6 months)1 ( #326,556 of 2,171,972 )
How can I increase my downloads?