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

J Empir Res Hum Res Ethics. 2010 Sep;5(3):17-30. doi: 10.1525/jer.2010.5.3.17.


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.

Publication types

  • Multicenter Study
  • Research Support, N.I.H., Extramural

MeSH terms

  • Clinical Protocols*
  • Decision Making
  • Disclosure* / ethics
  • Genes, p16
  • Genetic Predisposition to Disease / epidemiology
  • Genetic Testing* / ethics
  • Humans
  • Melanoma / epidemiology
  • Melanoma / genetics
  • Michigan
  • Molecular Epidemiology* / ethics
  • Patient Education as Topic