American Journal of Bioethics 4 (2):32-36 (2004)
Surveys and routine clinical procedures applied in research protocols are typically considered only minimally risky to participants. The apparent benign nature of "minimal risk" tasks increases the chance that investigators and Institutional Review Boards (IRBs) will overlook the probability that clinical tools will identify signs, symptoms, or definitive test results that are clinically-relevant to subjects' welfare. "Minimal risk" procedures may also pose a particular hazard to participants in clinical research by increasing the therapeutic misconception because the tasks mimic clinical care and are often conducted in clinical settings. Investigators should anticipate which measures could yield clinically-important findings and should describe explicit plans for data monitoring, disclosure, and follow-up. Protocols that include reliable and valid clinical measures should prompt a more detailed risk assessment by the IRB, even when the tasks meet the regulatory criteria for minimal physical, psychological, or emotional risk
|Keywords||No keywords specified (fix it)|
|Categories||categorize this paper)|
References found in this work BETA
No references found.
Citations of this work BETA
Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations.Susan M. Wolf, Frances P. Lawrenz, Charles A. Nelson, Jeffrey P. Kahn, Mildred K. Cho, Ellen Wright Clayton, Joel G. Fletcher, Michael K. Georgieff, Dale Hammerschmidt, Kathy Hudson, Judy Illes, Vivek Kapur, Moira A. Keane, Barbara A. Koenig, Bonnie S. LeRoy, Elizabeth G. McFarland, Jordan Paradise, Lisa S. Parker, Sharon F. Terry, Brian van Ness & Benjamin S. Wilfond - 2008 - Journal of Law, Medicine & Ethics 36 (2):219-248.
A Code of Ethics for the Life Sciences.Nancy L. Jones - 2007 - Science and Engineering Ethics 13 (1):25-43.
Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations.Susan M. Wolf, Frances P. Lawrenz, Charles A. Nelson, Jeffrey P. Kahn, Mildred K. Cho, Ellen Wright Clayton, Joel G. Fletcher, Michael K. Georgieff, Dale Hammerschmidt, Kathy Hudson, Judy Illes, Vivek Kapur, Moira A. Keane, Barbara A. Koenig, Bonnie S. LeRoy, Elizabeth G. McFarland, Jordan Paradise, Lisa S. Parker, Sharon F. Terry, Brian Van Ness & Benjamin S. Wilfond - 2008 - Journal of Law, Medicine and Ethics 36 (2):219-248.
The Concept of Risk and Responsible Conduct of Research.Eugenijus Gefenas - 2006 - Science and Engineering Ethics 12 (1):75-83.
Similar books and articles
Risk in Emergency Research Using a Waiver of/Exception From Consent: Implications of a Structured Approach for Institutional Review Board Review.Andrew D. McRae, Stacy Ackroyd-Stolarz & Charles Weijer - unknown
Minimal Risk in Research Involving Pregnant Women and Fetuses.Carson Strong - 2011 - Journal of Law, Medicine & Ethics 39 (3):529-538.
Statistical Power, the Belmont Report, and the Ethics of Clinical Trials.Sara Vollmer & George Howard - 2010 - Science and Engineering Ethics 16 (4):675-691.
Valuing Risk: The Ethical Review of Clinical Trial Safety.Jonathan Kimmelman - 2004 - Kennedy Institute of Ethics Journal 14 (4):369-393.
What's the Risk in Asking? Participant Reaction to Trauma History Questions Compared with Reaction to Other Personal Questions.Lisa DeMarni Cromer, Jennifer J. Freyd, Angela K. Binder, Anne P. DePrince & Kathryn Becker-Blease - 2006 - Ethics and Behavior 16 (4):347 – 362.
Relative Versus Absolute Standards for Everyday Risk in Adolescent HIV Prevention Trials: Expanding the Debate.Jeremy Snyder, Cari L. Miller & Glenda Gray - 2011 - American Journal of Bioethics 11 (6):5 - 13.
Human Participants Challenges in Youth-Focused Research: Perspectives and Practices of IRB Administrators.Diane K. Wagener, Amy K. Sporer, Mary Simmerling, Jennifer L. Flome, Christina An & Susan J. Curry - 2004 - Ethics and Behavior 14 (4):335 – 349.
Protecting Subjects Who Cannot Give Consent: Toward a Better Standard for "Minimal" Risks.David Wendler - 2005 - Hastings Center Report 35 (5):37-43.
Familial Communication of Research Results: A Need to Know?Lee Black & Kelly A. McClellan - 2011 - Journal of Law, Medicine & Ethics 39 (4):605-613.
Conflict and Convergence: The Ethics Review of Action Research. [REVIEW]Michael Owen - 2006 - Journal of Academic Ethics 4 (1-4):61-75.
Added to index2010-09-14
Total downloads6 ( #542,263 of 2,143,563 )
Recent downloads (6 months)1 ( #386,855 of 2,143,563 )
How can I increase my downloads?
There are no threads in this forum
Nothing in this forum yet.