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Development of Plain Language Supplemental Materials for the Biobank Informed Consent Process

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Abstract

The US Department of Health and Human Services addresses clear communication in the informed consent process as part of the Notice of Proposed Rulemaking for revisions to the Common Rule. However, prior research has shown that participants may not fully comprehend research studies despite completion of an informed consent process. Our main goal was to provide plain language information about donation processes to a cancer biobank to supplement an informed consent form. We developed and conducted cognitive testing with supplemental brochures that clearly communicated information about three different models for consent (notice, broad and study-specific) to future use of biospecimens. During the brochure development process, we conducted qualitative, semi-structured, individual, in-person cognitive interviews among 14 women to examine participants’ perceptions of the brochures. Each participant provided feedback regarding the understandability, graphics and layout, and cultural appropriateness of the brochures. Our findings demonstrate that these methods may be used to tailor consent form brochures, such as the ones developed here, to other populations. This study therefore adds to our understanding of how best to present content to help women from two different racial groups make informed decisions about participation in a cancer biobank.

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Acknowledgments

This project was supported by grant number U54CA153460-03S1, a supplement to the Program for the Elimination of Cancer Disparities grant from the National Cancer Institute, Washington University School of Medicine, the Barnes-Jewish Hospital Foundation, and Siteman Cancer Center. We thank all of our community partners, The Breakfast Club, Inc., Siteman Cancer Center and Women’s Health Repository. We thank the 60 women who participated in the study and shared their opinions.

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Authors and Affiliations

  1. Division of Public Health Sciences, Washington University in St. Louis School of Medicine, St. Louis, MO, 63110, USA

    Bettina F. Drake, Katherine M. Brown, Sarah Gehlert, Joann Seo, Hannah Perkins & Melody S. Goodman

  2. Alvin J. Siteman Cancer Center, St. Louis, MO, 63110, USA

    Bettina F. Drake, Sarah Gehlert & Melody S. Goodman

  3. Center for Law Health and Society, Georgia State University College of Law, 85 Park Place NE, Atlanta, GA, 30303, USA

    Leslie E. Wolf

  4. Department of Communication, University of Utah, 255 S. Central Campus Dr., Salt Lake City, UT, 84112-0491, USA

    Kimberly A. Kaphingst

  5. Huntsman Cancer Institute, 2000 Circle of Hope Drive, Salt Lake City, UT, 84112, USA

    Kimberly A. Kaphingst

Authors
  1. Bettina F. Drake
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  2. Katherine M. Brown
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  3. Sarah Gehlert
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  4. Leslie E. Wolf
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  5. Joann Seo
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  6. Hannah Perkins
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  7. Melody S. Goodman
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  8. Kimberly A. Kaphingst
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Correspondence to Bettina F. Drake.

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All study procedures were approved by the Washington University Institutional Review Board.

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Drake, B.F., Brown, K.M., Gehlert, S. et al. Development of Plain Language Supplemental Materials for the Biobank Informed Consent Process. J Canc Educ 32, 836–844 (2017). https://doi.org/10.1007/s13187-016-1029-y

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