Hostname: page-component-586b7cd67f-t7czq Total loading time: 0 Render date: 2024-11-28T15:05:48.705Z Has data issue: false hasContentIssue false
  • English
  • Français

Empirical Analysis of Current Approaches to Incidental Findings

Published online by Cambridge University Press:  01 January 2021

Frances Lawrenz  and
Suzanne Sobotka
Get access Rights & Permissions [Opens in a new window]

Extract

Researchers in the health sciences regularly discover information of potential health importance unrelated to their object of study in the course of their research. However, there appears to be little guidance available on what researchers should do with this information, known in the scientific literature as incidental findings (IFs). The study described here was designed to determine the extent of guidance available to researchers from public sources. This empirical study was part of a larger two-year project funded by the National Human Genome Research Institute (NHGRI) to generate guidance on how incidental findings should be managed in human subjects research, especially genetics, genomics, and imaging research. We generated empirical analysis of publicly available guidance and consent forms to help guide a multidisciplinary Working Group of experts in their formulation of normative recommendations reported in this symposium.

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 36 , Issue 2 , Summer 2008 , pp. 249 - 255
Copyright
Copyright © American Society of Law, Medicine and Ethics 2008

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Wolf, S. M., Lawrenz, F., and Nelson, C. A. et al, “Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations,” Journal of Law, Medicine & Ethics 36, no. 2 (2008): 219–248.CrossRefGoogle Scholar
Wolf, S. M., Sobotka, S. P., and Lawrenz, F., “Managing Incidental Findings in Human Subjects Research: Empirical Findings,” manuscript in progress.Google Scholar
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.+(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.>Google Scholar
Department of Veterans Affairs, IRB Guidebook 2005, available at <www1.va.gov/oro/apps/compendium/Files/IRB%20Guidebook%20CH5.htm> (last visited February 11, 2008).+(last+visited+February+11,+2008).>Google Scholar
National Institutes of Health Office of Extramural Research, Frequently Asked Questions from Applicants (May 11, 2006), available at <http://grants2.nih.gov/grants/policy/hs/faqs_aps_hsp.htm> (last visited February 11, 2008).+(last+visited+February+11,+2008).>Google Scholar
American Society for Human Genetics, ASHG Report: Statement on Informed Consent for Genetic Research, 1996, available at <http://www.ashg.org/genetics/ashg/pubs/policy/pol-25.htm> (last visited February 11, 2008).+(last+visited+February+11,+2008).>Google Scholar
University of Wisconsin-Madison, Consent Form Template and Tips, 2004, available at <http://info.gradsch.wisc.edu/research/compliance/humansubjects/hsirbs/forms/consent-formdoc> (last visited October 18, 2005; copy on file with author).+(last+visited+October+18,+2005;+copy+on+file+with+author).>Google Scholar
Oregon Health Sciences University, IRB Policy/Procedure Manual, 2002, available at <www.ohsu.edu/research/rda/irb/docs/policies/irbpolicy2002.pdf> (last visited October 25, 2005; copy on file with author).+(last+visited+October+25,+2005;+copy+on+file+with+author).>Google Scholar
Stanford University, Consent Form for Adult Brain Function Imaging with MR, (1.5T and 3.0T) 2002, available at <rsl.stanford.edu/sawyer/pdf_files/Consent_15T3TAdult_fMRI.pdf> (last visited February 11, 2008).+(last+visited+February+11,+2008).>Google Scholar