Journal of Cancer Education

, Volume 32, Issue 4, pp 836–844 | Cite as

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

  • Bettina F. Drake
  • Katherine M. Brown
  • Sarah Gehlert
  • Leslie E. Wolf
  • Joann Seo
  • Hannah Perkins
  • Melody S. Goodman
  • Kimberly A. Kaphingst
Article

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.

Keywords

Plain language Consent models Biorepository Cancer Minority 

References

  1. 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. 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
  3. 3.
    Cambon-Thomsen A (2004) The social and ethical issues of post-genomic human biobanks. Nat Rev Genet 5(11):866–873CrossRefPubMedGoogle Scholar
  4. 4.
    Hansson MG et al (2006) Should donors be allowed to give broad consent to future biobank research? Lancet Oncol 7(3):266–269CrossRefPubMedGoogle Scholar
  5. 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
  6. 6.
    Falagas ME et al (2009) Informed consent: how much and what do patients understand? Am J Surg 198(3):420–435CrossRefPubMedGoogle Scholar
  7. 7.
    Paasche-Orlow MK, Taylor HA, Brancati FL (2003) Readability standards for informed-consent forms as compared with actual readability. N Engl J Med 348(8):721–726CrossRefPubMedGoogle Scholar
  8. 8.
    Davis TC et al (1998) Informed consent for clinical trials: a comparative study of standard versus simplified forms. J Natl Cancer Inst 90(9):668–674CrossRefPubMedGoogle Scholar
  9. 9.
    Sheridan SL et al (2011) Interventions for individuals with low health literacy: a systematic review. J Health Commun 16(Suppl 3):30–54CrossRefPubMedGoogle Scholar
  10. 10.
    Nielsen-Bohlman L, Panzer A, Kindig D (eds) (2004) Health literacy: a prescription to end confusion. National Academies Press, Washington, DCGoogle Scholar
  11. 11.
    Chen DT et al (2005) Research with stored biological samples: what do research participants want? Arch Intern Med 165(6):652–655CrossRefPubMedGoogle Scholar
  12. 12.
    Helft PR et al (2007) Cancer patients’ attitudes toward future research uses of stored human biological materials. J Empir Res Hum Res Ethics 2(3):15–22CrossRefPubMedGoogle Scholar
  13. 13.
    Huber J et al (2013) Two decades’ experience with a prospective biobank for urologic oncology: research, clinical care, and the patients’ view. Urol Oncol 31(7):990–996CrossRefPubMedGoogle Scholar
  14. 14.
    Pentz RD, Billot L, Wendler D (2006) Research on stored biological samples: views of African American and White American cancer patients. Am J Med Genet A 140(7):733–739CrossRefPubMedGoogle Scholar
  15. 15.
    Luque JS et al (2012) Formative research on perceptions of biobanking: what community members think. J Cancer Educ 27(1):91–99CrossRefPubMedPubMedCentralGoogle Scholar
  16. 16.
    Donovan-Kicken E et al (2012) Health literacy, self-efficacy, and patients’ assessment of medical disclosure and consent documentation. Health Commun 27(6):581–590CrossRefPubMedGoogle Scholar
  17. 17.
    U.S. Department of Health and Human Services (2000) Healthy people 2010 Retrieved from http://www.healthypeople.gov/2010/
  18. 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
  19. 19.
    Jefford M, Moore R (2008) Improvement of informed consent and the quality of consent documents. Lancet Oncol 9(5):485–493CrossRefPubMedGoogle Scholar
  20. 20.
    Ridpath JR, Wiese CJ, Greene SM (2009) Looking at research consent forms through a participant-centered lens: the PRISM readability toolkit. Am J Health Promot 23(6):371–375CrossRefPubMedGoogle Scholar
  21. 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
  22. 22.
    Schnitzer A, Rosenzweig M, Harris B (2011) Health literacy: a survey of the issues and solutions. Journal of Consumer Health on the Internet 15(2):164–179CrossRefGoogle Scholar
  23. 23.
    Walters K, Hamrell M (2008) Consent forms, lower reading levels, and using Flesch-Kincaid readability software. Drug Inf J 42(4):385–394CrossRefGoogle Scholar
  24. 24.
    Tait A et al (2013) Informing the uninformed: optimizing the consent message using a fractional factorial design. JAMA pediatrics 167(7):640–646CrossRefPubMedPubMedCentralGoogle Scholar
  25. 25.
    Enama ME et al (2012) Randomization to standard and concise informed consent forms: development of evidence-based consent practices. Contemp Clin Trials 33(5):895–902CrossRefPubMedPubMedCentralGoogle Scholar
  26. 26.
    Coyne CA et al (2003) Randomized, controlled trial of an easy-to-read informed consent statement for clinical trial participation: a study of the Eastern Cooperative Oncology Group. J Clin Oncol 21(5):836–842CrossRefPubMedGoogle Scholar
  27. 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. 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
  29. 29.
    Juraskova I et al (2008) Improving informed consent: pilot of a decision aid for women invited to participate in a breast cancer prevention trial (IBIS-II DCIS). Health Expect 11(3):252–262CrossRefPubMedPubMedCentralGoogle Scholar
  30. 30.
    Kass NE et al (2015) A pilot study of simple interventions to improve informed consent in clinical research: feasibility, approach, and results. Clin Trials 12(1):54–66CrossRefPubMedGoogle Scholar
  31. 31.
    Mancini J et al (2011) Consent for biobanking: assessing the understanding and views of cancer patients. J Natl Cancer Inst 103(2):154–157CrossRefPubMedGoogle Scholar
  32. 32.
    Robinson JO et al (2013) Participants’ recall and understanding of genomic research and large-scale data sharing. J Empir Res Hum Res Ethics 8(4):42–52CrossRefPubMedPubMedCentralGoogle Scholar
  33. 33.
    Ormond KE et al (2009) Assessing the understanding of biobank participants. Am J Med Genet A 149A(2):188–198CrossRefPubMedGoogle Scholar
  34. 34.
    Klima J et al (2014) Understanding of informed consent by parents of children enrolled in a genetic biobank. Genet Med 16(2):141–148CrossRefPubMedGoogle Scholar
  35. 35.
    Beskow LM et al (2010) Developing a simplified consent form for biobanking. PLoS One 5(10), e13302CrossRefPubMedPubMedCentralGoogle Scholar
  36. 36.
    Mello MM, Wolf LE (2010) The Havasupai Indian tribe case—lessons for research involving stored biologic samples. N Engl J Med 363(3):204–207CrossRefPubMedGoogle Scholar
  37. 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. 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. 39.
    Doak CC, Doak LG, Root JH (1996) Teaching patients with low literacy skills, 2nd edn. J.B. Lippincott Company, PhiladelphiaGoogle Scholar
  40. 40.
    Institute', N.C. (2003) Clear & simple: developing effective print materials for low-literate readersGoogle Scholar
  41. 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. 42.
    Strauss A, C. J (1998) Basics of qualitative research: Second edition: techniques and procedures for developing grounded theory. Sage Publications, IncGoogle Scholar
  43. 43.
    Schillinger D et al (2003) Closing the loop: physician communication with diabetic patients who have low health literacy. Arch Intern Med 163(1):83–90CrossRefPubMedGoogle Scholar
  44. 44.
    Delp C, Jones J (1996) Communicating information to patients: the use of cartoon illustrations to improve comprehension of instructions. Acad Emerg Med 3(3):264–270CrossRefPubMedGoogle Scholar
  45. 45.
    Houts PS et al (2006) The role of pictures in improving health communication: a review of research on attention, comprehension, recall, and adherence. Patient Educ Couns 61(2):173–190CrossRefPubMedGoogle Scholar
  46. 46.
    Mansoor LE, Dowse R (2003) Effect of pictograms on readability of patient information materials. Ann Pharmacother 37(7–8):1003–1009CrossRefPubMedGoogle Scholar
  47. 47.
    Pentz RD, Theriault RL (2001) Research ethics: clinical trial abuse and the public trust. Breast diseases: A year book quarterly 12:141–144CrossRefGoogle Scholar
  48. 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
  49. 49.
    Branson RD, Davis K Jr, Butler KL (2007) African Americans’ participation in clinical research: importance, barriers, and solutions. Am J Surg 193(1):32–39, discussion 40CrossRefPubMedGoogle Scholar
  50. 50.
    Field LA et al (2012) Identification of differentially expressed genes in breast tumors from African American compared with Caucasian women. Cancer 118(5):1334–1344CrossRefPubMedGoogle Scholar
  51. 51.
    Murphy J et al (2009) Public perspectives on informed consent for biobanking. Am J Public Health 99(12):2128–2134CrossRefPubMedPubMedCentralGoogle Scholar
  52. 52.
    Platt J et al (2014) Public preferences regarding informed consent models for participation in population-based genomic research. Genet Med 16(1):11–18CrossRefPubMedGoogle Scholar

Copyright information

© American Association for Cancer Education 2016

Authors and Affiliations

  • Bettina F. Drake
    • 1
    • 2
  • Katherine M. Brown
    • 1
  • Sarah Gehlert
    • 1
    • 2
  • Leslie E. Wolf
    • 3
  • Joann Seo
    • 1
  • Hannah Perkins
    • 1
  • Melody S. Goodman
    • 1
    • 2
  • Kimberly A. Kaphingst
    • 4
    • 5
  1. 1.Division of Public Health SciencesWashington University in St. Louis School of MedicineSt. LouisUSA
  2. 2.Alvin J. Siteman Cancer CenterSt. LouisUSA
  3. 3.Center for Law Health and SocietyGeorgia State University College of LawAtlantaUSA
  4. 4.Department of CommunicationUniversity of UtahSalt Lake CityUSA
  5. 5.Huntsman Cancer InstituteSalt Lake CityUSA

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