Returning individual research results: development of a cancer genetics education and risk communication protocol.
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.
Roberts
J Scott
JS
Department of Health Behavior and Health Education, University of Michigan School of Public Health, Ann Arbor, MI 48109-2029, USA. jscottr@umich.edu
Shalowitz
David I
DI
Christensen
Kurt D
KD
Everett
Jessica N
JN
Kim
Scott Y H
SY
Raskin
Leon
L
Gruber
Stephen B
SB
D002985:Clinical Protocols; D003657:Decision Making; D030881:Disclosure / Q000941:ethics; D019942:Genes, p16; D020022:Genetic Predisposition to Disease / Q000453:epidemiology; D005820:Genetic Testing / Q000941:ethics; D006801:Humans; D008545:Melanoma / Q000453:epidemiology / Q000235:genetics; D008824:Michigan; D017720:Molecular Epidemiology / Q000941:ethics; D010353:Patient Education as Topic