Clinical verification of genetic results returned to research participants: findings from a Colon Cancer Family Registry

Mercy Y. Laurino, Anjali R. Truitt, Lederle Tenney, Douglass Fisher, Noralane Morey Lindor, David Veenstra, Gail P. Jarvik, Polly A. Newcomb, Stephanie M. Fullerton

Research output: Contribution to journalArticle

Abstract

Background: The extent to which participants act to clinically verify research results is largely unknown. This study examined whether participants who received Lynch syndrome (LS)-related findings pursued researchers’ recommendation to clinically verify results with testing performed by a CLIA-certified laboratory. Methods: The Fred Hutchinson Cancer Research Center site of the multinational Colon Cancer Family Registry offered non-CLIA individual genetic research results to select registry participants (cases and their enrolled relatives) from 2011 to 2013. Participants who elected to receive results were counseled on the importance of verifying results at a CLIA-certified laboratory. Twenty-six (76.5%) of the 34 participants who received genetic results completed 2- and 12-month postdisclosure surveys; 42.3% of these (11/26) participated in a semistructured follow-up interview. Results: Within 12 months of result disclosure, only 4 (15.4%) of 26 participants reported having verified their results in a CLIA-certified laboratory; of these four cases, all research and clinical results were concordant. Reasons for pursuing clinical verification included acting on the recommendation of the research team and informing future clinical care. Those who did not verify results cited lack of insurance coverage and limited perceived personal benefit of clinical verification as reasons for inaction. Conclusion: These findings suggest researchers will need to address barriers to seeking clinical verification in order to ensure that the intended benefits of returning genetic research results are realized.

Original languageEnglish (US)
Pages (from-to)700-708
Number of pages9
JournalMolecular Genetics and Genomic Medicine
Volume5
Issue number6
DOIs
StatePublished - Jan 1 2017

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Colonic Neoplasms
Registries
Genetic Research
Research
Research Personnel
Hereditary Nonpolyposis Colorectal Neoplasms
Insurance Coverage
Disclosure
Interviews
Neoplasms

Keywords

  • Cancer registry
  • CLIA verification
  • genetic research
  • Lynch syndrome
  • return of research results

ASJC Scopus subject areas

  • Genetics
  • Genetics(clinical)
  • Molecular Biology
  • Medicine(all)

Cite this

Clinical verification of genetic results returned to research participants : findings from a Colon Cancer Family Registry. / Laurino, Mercy Y.; Truitt, Anjali R.; Tenney, Lederle; Fisher, Douglass; Lindor, Noralane Morey; Veenstra, David; Jarvik, Gail P.; Newcomb, Polly A.; Fullerton, Stephanie M.

In: Molecular Genetics and Genomic Medicine, Vol. 5, No. 6, 01.01.2017, p. 700-708.

Research output: Contribution to journalArticle

Laurino, MY, Truitt, AR, Tenney, L, Fisher, D, Lindor, NM, Veenstra, D, Jarvik, GP, Newcomb, PA & Fullerton, SM 2017, 'Clinical verification of genetic results returned to research participants: findings from a Colon Cancer Family Registry', Molecular Genetics and Genomic Medicine, vol. 5, no. 6, pp. 700-708. https://doi.org/10.1002/mgg3.328
Laurino, Mercy Y. ; Truitt, Anjali R. ; Tenney, Lederle ; Fisher, Douglass ; Lindor, Noralane Morey ; Veenstra, David ; Jarvik, Gail P. ; Newcomb, Polly A. ; Fullerton, Stephanie M. / Clinical verification of genetic results returned to research participants : findings from a Colon Cancer Family Registry. In: Molecular Genetics and Genomic Medicine. 2017 ; Vol. 5, No. 6. pp. 700-708.
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abstract = "Background: The extent to which participants act to clinically verify research results is largely unknown. This study examined whether participants who received Lynch syndrome (LS)-related findings pursued researchers’ recommendation to clinically verify results with testing performed by a CLIA-certified laboratory. Methods: The Fred Hutchinson Cancer Research Center site of the multinational Colon Cancer Family Registry offered non-CLIA individual genetic research results to select registry participants (cases and their enrolled relatives) from 2011 to 2013. Participants who elected to receive results were counseled on the importance of verifying results at a CLIA-certified laboratory. Twenty-six (76.5{\%}) of the 34 participants who received genetic results completed 2- and 12-month postdisclosure surveys; 42.3{\%} of these (11/26) participated in a semistructured follow-up interview. Results: Within 12 months of result disclosure, only 4 (15.4{\%}) of 26 participants reported having verified their results in a CLIA-certified laboratory; of these four cases, all research and clinical results were concordant. Reasons for pursuing clinical verification included acting on the recommendation of the research team and informing future clinical care. Those who did not verify results cited lack of insurance coverage and limited perceived personal benefit of clinical verification as reasons for inaction. Conclusion: These findings suggest researchers will need to address barriers to seeking clinical verification in order to ensure that the intended benefits of returning genetic research results are realized.",
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