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Review
. 2008 Summer;36(2):249-55, 211.
doi: 10.1111/j.1748-720X.2008.00267.x.

Empirical analysis of current approaches to incidental findings

Frances Lawrenz  1 , Suzanne Sobotka
Affiliations
Review

Empirical analysis of current approaches to incidental findings

Frances Lawrenz et al. J Law Med Ethics. 2008 Summer.

Abstract

This paper presents results found through searching publicly available U.S. data sources for information about how to handle incidental findings (IF) in human subjects research, especially in genetics and genomics research, neuroimaging research, and CT colonography research. We searched the Web sites of 14 federal agencies, 22 professional societies, and 100 universities, as well as used the search engine Google for actual consent forms that had been posted on the Internet. Our analysis of these documents showed that there is very little public guidance available for researchers as to how to deal with incidental findings. Moreover, the guidance available is not consistent.

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References

    1. Wolf SM, Lawrenz F, Nelson CA, et al. Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations. Journal of Law, Medicine & Ethics. 2008;36(2):219–248. - PMC - PubMed
    1. Wolf SM, Sobotka SP, Lawrenz F. Managing Incidental Findings in Human Subjects Research: Empirical Findings. manuscript in progress.
    1. National Institutes of Health. NIH Awards to All Institutions by Rank, FY 2004. 2005. available at < http://grants.nih.gov/grants/award/trends/rnk04all1to500.htm> (last visited February 11, 2008). Note that the list also includes corporations that receive grants from NIH. We excluded those institutions, along with any institution whose web site was not in English.
    1. Department of Veterans Affairs, IRB Guidebook. 2005. [last visited February 11, 2008]. available at < www1.va.gov/oro/apps/compendium/Files/IRB%20Guidebook%20CH5.htm>.
    1. National Institutes of Health Office of Extramural Research. Frequently Asked Questions from Applicants. May 112006. [last visited February 11, 2008]. available at < http://grants2.nih.gov/grants/policy/hs/faqs_aps_hsp.htm>.

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