When "Minimal Risk" Research Yields Clinically-Significant Data, Maybe the Risks Aren't So Minimal

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)
DOI 10.1162/152651604323097970
 Save to my reading list
Follow the author(s)
My bibliography
Export citation
Find it on Scholar
Edit this record
Mark as duplicate
Revision history Request removal from index
Download options
PhilPapers Archive

Upload a copy of this paper     Check publisher's policy on self-archival     Papers currently archived: 23,305
External links
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.

Add more references

Citations of this work BETA
Nancy L. Jones (2007). A Code of Ethics for the Life Sciences. Science and Engineering Ethics 13 (1):25-43.

Add more citations

Similar books and articles

Monthly downloads

Added to index


Total downloads

6 ( #538,766 of 1,932,585 )

Recent downloads (6 months)

1 ( #456,397 of 1,932,585 )

How can I increase my downloads?

My notes
Sign in to use this feature

Start a new thread
There  are no threads in this forum
Nothing in this forum yet.