Development of Plain Language Supplemental Materials for the Biobank Informed Consent Process
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.
KeywordsPlain language Consent models Biorepository Cancer Minority
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.
Compliance with Ethical Standards
All study procedures were approved by the Washington University Institutional Review Board.
- 1.Servies', U.D.o.H.a.H. (2011) Human subjects research protection: enhancing protections for research subjects and reducing burden, delay and ambiguity for investigatorsGoogle Scholar
- 2.Services', U.D.o.H.a.H. (2009) Code of Federal Regulations: 45 C.F.R. § 46 Retrieved from http://www.hhs.gov/ohrp/policy/ohrpregulations.pdf
- 5.Services', U.D.o.H.a.H. (2015) Federal policy for the protection of human subjects. Docket Number: HHS-OPHS-2015-0008. Federal Register. 80(173)Google Scholar
- 10.Nielsen-Bohlman L, Panzer A, Kindig D (eds) (2004) Health literacy: a prescription to end confusion. National Academies Press, Washington, DCGoogle Scholar
- 17.U.S. Department of Health and Human Services (2000) Healthy people 2010 Retrieved from http://www.healthypeople.gov/2010/
- 18.Eagleson R (2014) Short definition of plain language. Improving communication from the federal government to the public. from http://www.plainlanguage.gov/whatisPL/definitions/eagleson.cfm
- 21.Services', U.D.o.H.a.H. (2013) Guidelines for the conduct of research involving human subjects at the National Institutes of Health. Washington DC: Retrieved from http://ohsr.od.nih.gov/ohsr/public/SOP_12_v3_3-12-14_508.pdf
- 27.McGraw S et al (2012) Clarity and appeal of a multimedia informed consent tool for biobanking. IRB: A Review of Human Subjects Reserach 34(1):9–19Google Scholar
- 28.Campbell H et al (2008) Impact of a clinical trials information handbook on patient knowledge, perceptions, and likelihood of participation. IRB: Ethics & Human Research 30:6–14Google Scholar
- 37.Brown KM et al (2015) Differences in preferences for models of consent for biobanks between Black and White women. J Community GenetGoogle Scholar
- 38.The Plain Language Action and Information Network (PLAIN)(2011) federal plain language guidelines. Washington D.C.: Retrieved from http://www.plainlanguage.gov/howto/guidelines/bigdoc/fullbigdoc.pdf
- 39.Doak CC, Doak LG, Root JH (1996) Teaching patients with low literacy skills, 2nd edn. J.B. Lippincott Company, PhiladelphiaGoogle Scholar
- 40.Institute', N.C. (2003) Clear & simple: developing effective print materials for low-literate readersGoogle Scholar
- 41.Prevention', C.f.D.C.a. (2009) Simply put: a guide for creating easy-to-understand materials. Atlanta, Georgia: Strategic and Proactive Communication Branch Retrieved from http://www.cdc.gov/healthliteracy/pdf/Simply_Put.pdf
- 42.Strauss A, C. J (1998) Basics of qualitative research: Second edition: techniques and procedures for developing grounded theory. Sage Publications, IncGoogle Scholar
- 48.Randall V (1995) Slavery, segregation and racism: trusting the health care system ain’t always easy—an African American perspective on bioethics. St Louis University Public Law Review 15:191Google Scholar