Theoretical Medicine and Bioethics 33 (2):137-149 (2012)

Authors
Abstract
Healthy volunteers in biomedical research often face significant risks in studies that offer them no medical benefits. The U.S. federal research regulations and laws adopted by other countries place no limits on the risks that these participants face. In this essay, I argue that there should be some limits on the risks for biomedical research involving healthy volunteers. Limits on risk are necessary to protect human participants, institutions, and the scientific community from harm. With the exception of self-experimentation, limits on research risks faced by healthy volunteers constitute a type of soft, impure paternalism because participants usually do not fully understand the risks they are taking. I consider some approaches to limiting research risks and propose that healthy volunteers in biomedical research should not be exposed to greater than a 1% chance of serious harm, such as death, permanent disability, or severe illness or injury. While this guideline would restrict research risks, the limits would not be so low that they would prevent investigators from conducting valuable research. They would, however, set a clear upper boundary for investigators and signal to the scientific community and the public that there are limits on the risks that healthy participants may face in research. This standard provides guidance for decisions made by oversight bodies, but it is not an absolute rule. Investigators can enroll healthy volunteers in studies involving a greater than 1% chance of serious harm if they show that the research addresses a compelling public health or social problem and that the risk of serious harm is only slightly more than 1%. The committee reviewing the research should use outside experts to assess these risks
Keywords Human participant research  Risk  Ethics  Regulations  Paternalism  Healthy volunteers
Categories (categorize this paper)
ISBN(s)
DOI 10.1007/s11017-011-9201-1
Options
Edit this record
Mark as duplicate
Export citation
Find it on Scholar
Request removal from index
Revision history

Download options

PhilArchive copy


Upload a copy of this paper     Check publisher's policy     Papers currently archived: 62,388
Through your library

References found in this work BETA

Paternalism.Gerald Dworkin - 1972 - The Monist 56 (1):64-84.
Paternalism.Gerald Dworkin - 1972 - The Monist.
A Framework for Risk-Benefit Evaluations in Biomedical Research.Wendler Annette Rid David - 2011 - Kennedy Institute of Ethics Journal 21 (2):141-179.

View all 12 references / Add more references

Citations of this work BETA

View all 10 citations / Add more citations

Similar books and articles

The Responsible Conduct of Basic and Clinical Research.Andrzej Górski - 2006 - Science and Engineering Ethics 12 (1):3-4.
Limits to Research Risks.F. G. Miller & S. Joffe - 2009 - Journal of Medical Ethics 35 (7):445-449.

Analytics

Added to PP index
2013-10-31

Total views
65 ( #163,084 of 2,445,551 )

Recent downloads (6 months)
1 ( #457,182 of 2,445,551 )

How can I increase my downloads?

Downloads

My notes