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Multicenter Study
. 2010 Sep;5(3):17-30.
doi: 10.1525/jer.2010.5.3.17.

Returning individual research results: development of a cancer genetics education and risk communication protocol

J Scott Roberts  1 , David I Shalowitz, Kurt D Christensen, Jessica N Everett, Scott Y H Kim, Leon Raskin, Stephen B Gruber
Affiliations
Multicenter Study

Returning individual research results: development of a cancer genetics education and risk communication protocol

J Scott Roberts et al. J Empir Res Hum Res Ethics. 2010 Sep.

Abstract

The obligations of researchers to disclose clinically and/or personally significant individual research results are highly debated, but few empirical studies have addressed this topic. We describe the development of a protocol for returning research results to participants at one site of a multicenter study of the genetic epidemiology of melanoma. Protocol development involved numerous challenges: (1) deciding whether genotype results merited disclosure; (2) achieving an appropriate format for communicating results; (3) developing education materials; (4) deciding whether to retest samples for additional laboratory validation; (5) identifying and notifying selected participants; and (6) assessing the impact of disclosure. Our experience suggests potential obstacles depending on researcher resources and the design of the parent study, but offers a process by which researchers can responsibly return individual study results and evaluate the impact of disclosure.

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Figures

Fig. 1
Fig. 1
Study Flowchart.
Fig. 2
Fig. 2
Sample Risk Communication Tool Used in Educational Materials.
See this image and copyright information in PMC

References

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