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Individual genetic and genomic research results and the tradition of informed consent: exploring US review board guidance
  1. Christian Simon1,2,
  2. Laura A Shinkunas2,
  3. Debra Brandt3,
  4. Janet K Williams3
  1. 1Department of Internal Medicine, University of Iowa, Roy J. and Lucille A. Carver School of Medicine, Iowa City, Iowa, USA
  2. 2Program in Bioethics and Humanities, University of Iowa Carver College of Medicine, Iowa City, Iowa, USA
  3. 3College of Nursing, University of Iowa, Iowa City, Iowa, USA
  1. Correspondence to Dr Christian Simon, Department of Internal Medicine, University of Iowa, Roy J. and Lucille A. Carver School of Medicine, 500 Newton Drive, 1-103 MEB, Iowa City, IA 52242-1190, USA; christian-simon{at}uiowa.edu

Abstract

Background Genomic research is challenging the tradition of informed consent. Genomic researchers in the USA, Canada and parts of Europe are encouraged to use informed consent to address the prospect of disclosing individual research results (IRRs) to study participants. In the USA, no national policy exists to direct this use of informed consent, and it is unclear how local institutional review boards (IRBs) may want researchers to respond.

Objective and methods To explore publicly accessible IRB websites for guidance in this area, using summative content analysis.

Findings Three types of research results were addressed in 45 informed consent templates and instructions from 20 IRBs based at centres conducting genomic research: (1) IRRs in general, (2) incidental findings (IFs) and (3) a broad and unspecified category of ‘significant new findings’ (SNFs). IRRs were more frequently referenced than IFs or SNFs. Most documents stated that access to IRRs would not be an option for research participants. These non-disclosure statements were found to coexist in some documents with statements that SNFs would be disclosed to participants if related to their willingness to participate in research. The median readability of template language on IRRs, IFs and SNFs exceeded a ninth-grade level.

Conclusion IRB guidance may downplay the possibility of IFs and contain conflicting messages on IRR non-disclosure and SNF disclosure. IRBs may need to clarify why separate IRR and SNF language should appear in the same consent document. The extent of these issues, nationally and internationally, needs to be determined.

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Footnotes

  • Funding Funding for this research was provided by an (ARRA) grant from the National Human Genome Institute (RC1HG005786). Support was also provided by Grant Number TL1RR024981 (training support for DB) from the National Center for Research Resources (NCRR), a part of the National Institutes of Health (NIH).

  • Competing interests None.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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