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

TitleReturning individual research results: development of a cancer genetics education and risk communication protocol
Publication TypeJournal Article
Year of Publication2010
AuthorsRoberts, J. S., Shalowitz, D. I., Christensen, K. D., Everett, J. N., Kim, S. Y. H., Raskin, L., & Gruber, S. B.
JournalJournal of empirical research on human research ethics : JERHRE
Volume5
Issue3
Pagination17-30
Date Published2010 Sep
ISSN1556-2646
KeywordsClinical Protocols, Decision Making, Disclosure, Genes, p16, Genetic Predisposition to Disease, Genetic Testing, Humans, Melanoma, Michigan, Molecular Epidemiology, Patient Education as Topic
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.

Alternate JournalJ Empir Res Hum Res Ethics