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Participant views on consent in cancer genetics research: preparing for the precision medicine era

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Abstract

The Precision Medicine Initiative (PMI) has created considerable discussions about research participant issues including re-consent and how and when to incorporate the patient experience into clinical trials. Within the changing landscape of genetic and genomic research, the preferences of participants are lacking yet are needed to inform policy. With the growing use of biobanks intended to support studies, including the national research cohort proposed under the PMI, understanding participant preferences, including re-consent, is a pressing concern. The Participant Issues Project (PIP) addresses this gap, and here we present data on participant attitudes regarding re-consent and broad consent in research studies. PIP study participants came from the Northwest Cancer Genetics Registry and included cancer patients, relatives, and controls. Thirty telephone interviews were conducted and analyzed using content and thematic analysis. Results indicate that in some scenarios, re-consent is needed. Most participants agreed that re-consent was necessary when the study direction changed significantly or a child participant became an adult, but not if the genetic variant changed. Most participants’ willingness to participate in research would not be affected if the researcher or institution profited or if a broad consent form were used. Participants emphasized re-consent to provide information and control of the use of their data, now relevant for tailored treatment, while also prioritizing research as important. In the era of precision medicine, it is essential that policy makers consider participant preferences with regard to use of their materials and that participants understand genetic and genomic research and its harms and benefits as well as what broad consent entails, including privacy and re-identification risks.

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Acknowledgments

This study involved multiple collaborators, including our valued colleagues enrolled in the Northwest Cancer Genetics Registry for their ongoing participation in and contribution to cancer research; the University of Washington (UW) Department of Epidemiology, the Institute for Public Health Genetics, and the Department of Biomedical Informatics and Medical Education; Boston University, Department of Community Health Sciences; University of Georgia, Department of Communication Studies; Johns Hopkins University, Genetics and Public Policy Center; the National Coalition for Health Professional Education in Genetics; and the University of California, Irvine. The authors also wish to also acknowledge and thank Nirupama Schridhar, Katherine W. Snapinn, Joan Scott, and David Kaufmann for their work contributing to the earlier stages of this project.

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Author notes

  1. Deborah J. Bowen

    Present address: University of Washington, Seattle, WA, USA

Authors and Affiliations

  1. Epidemiology, University of California, Irvine, 224 Irvine Hall, Mail Code: 7550, Irvine, CA, 92697, USA

    Karen L. Edwards & Deborah Goodman

  2. Biomedical Informatics and Medical Education, University of Washington, Seattle, WA, USA

    Diane M. Korngiebel

  3. Epidemiology, University of Washington, Seattle, WA, USA

    Karen L. Edwards & Lesley Pfeifer

  4. Group Health Research Institute, Seattle, WA, USA

    Anne Renz

  5. Medicine and Public Health, University of California, Irvine, Irvine, CA, USA

    Lari Wenzel

  6. Community Health Sciences, Boston University, Boston, MA, USA

    Deborah J. Bowen

  7. Communication Studies, University of Georgia, Athens, GA, USA

    Celeste M. Condit

Authors
  1. Karen L. Edwards
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  2. Diane M. Korngiebel
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  3. Lesley Pfeifer
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  4. Deborah Goodman
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  7. Deborah J. Bowen
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  8. Celeste M. Condit
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Corresponding author

Correspondence to Karen L. Edwards.

Ethics declarations

This study was funded by the National Cancer Institute (grant 1R01CA149051-01A1; KL Edwards, PI.)

Conflict of interest

The authors declare no conflicts of interest.

Ethical approval

All procedures performed were in accordance with the ethical standards of the institutional research boards and with the 1964 Helsinki declaration and its later amendments.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Edwards, K.L., Korngiebel, D.M., Pfeifer, L. et al. Participant views on consent in cancer genetics research: preparing for the precision medicine era. J Community Genet 7, 133–143 (2016). https://doi.org/10.1007/s12687-015-0259-8

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  • DOI: https://doi.org/10.1007/s12687-015-0259-8

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