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Lost in Translation

Lost in Translation. The Art of Writing Useful Consent Forms. Valerie Smith OHRP IRB Program Manager 327-2370/valeries@unr.edu. Nancy Moody, JD, MA Director, RIO (de Janeiro) 327-2368/nmoody@unr.edu. The Problem?. The Farside , by Gary Larson . The Issues?. Health literacy

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Lost in Translation

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  1. Lost in Translation The Art of Writing Useful Consent Forms Valerie Smith OHRP IRB Program Manager 327-2370/valeries@unr.edu Nancy Moody, JD, MA Director, RIO (de Janeiro) 327-2368/nmoody@unr.edu

  2. The Problem? The Farside, by Gary Larson

  3. The Issues? Health literacy Scientific jargon/medical terminology Readability – Language barriers Document format

  4. What is heath literacy? The degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions. US DHHS. Health Communication. In: Healthy People 2010. 2nd ed. Washington, DC: US Government Printing Office; 2000

  5. Research on Health Literacy Research conducted by the Institute of Medicine, the Agency for Healthcare Research and Quality, and the AMA notes that nearly 50% of all adults lack the literacy skills needed to function in a health care environment. Examples: Not able to reliably and consistently determine the proper dose of cold medication for a child Not able to read and understand informed consent documents. Rudd, R, et al. The Literacy Proficiencies of GED Examinees: Results from GED –Nals Comparison Study Session 4182. 1. Washington, DC, American Public Health Association; 2003. Paasche-Orlow MK, et al. Readability standards for informed consent forms, as compared with actual readability. N Engl J Med. 2003; 348:721-726

  6. Consider these facts – General language literacy 337 languages are spoken/signed in the US More than 32.5 million foreign-born people live in the US (2000) 21 million Americans speak a language other than English at home 21 million Americans have LEP (Limited English Proficiency)

  7. Consider these facts – on the consent process from a 2002 CenterWatch Study In a survey of 1600 past human research subjects 14% stated they did not read the consent form “A high %” admitted to not fully understanding the risks Many did not know what questions to ask

  8. The Solutions?

  9. Consider your audience Use plain language which is simple, clear, direct and uses common words. No scientific or highly medical jargon – unless explained. Use translations/translators where necessary when a large portion of the subject pool will be ESL

  10. Consider your audience Readability: Use a clean, uncluttered design, with consistent formatting and fonts (San Serif, 12-point) Check readability statistics: Standard is 8th grade, but is moving toward 6th grade level Create a jargon to plain words “Translation” table

  11. Consider your audience

  12. Consider your audience Document Format = Ease in Readability Provide white space to offer visual relief and contrast to highlight words, sentences, phrases Layout: Consider your margins, use of grids/tables, bulleted lists

  13. Consider your audience Have a non-college student or family member not familiar with the research read the consent document. During the study, have a dialogue with the subjects about consent. Remember consent is a process that continues throughout the life cycle of the study.

  14. Let’s Try Everyday Vocabulary: Pick the Best in the following slides to offer information to the participant in language that is understandable.

  15. Choice #1 The purpose of this study is to determine the nature and characteristics of immune cells and tumor cells in patients treated with concomitant cisplatin-based chemotherapy regimens and high dose radiotherapy.

  16. Choice #2 We want to study people who will get both chemotherapy and radiation. We want to see what the treatment does to their tumors and their immune system.

  17. Choice #1 We are asking you to participate in this study, which is evaluating pregnant women’s attitudes about birth control by asking them to complete a 1 hour interview during which they will be asked about their attitudes toward different birth control methods, as well as their past contraceptive choices.

  18. Choice #2 This research study is evaluating pregnant women’s attitudes about birth control. If you participate, the study researcher will interview you for about 1 hour. She will ask how you feel about different types of birth control. She also will ask what kind of birth control you used in the past.

  19. Use Acronyms Sparingly Participants with PTSD (Posttraumatic Stress Disorder) who enroll in this study will receive a cognitive-behavioral therapy (CBT) known as Stress-Inoculation Training (SIT) or an SSRI (selective serotonin reuptake inhibitor). This study is being done because doctors want to know whether SIT CBT or an FDA-approved SSRI is more effective in treating PTSD.

  20. Resources for more information:NEW WEBSITEhttps://www.unr.edu/research-integrity Rebecca Thomas (775) 327-2372rebeccat@unr.edu Gwenn Snow, MS, RD, CIP (775) 784-3506gwenns@unr.edu Nancy Moody, JD, MA, Director(775) 327-2367NMoody@unr.edu Valerie Smith, CIP(775) 327-2370valeries@unr.edu

  21. Q & A THANK YOU! Valerie Smith OHRP IRB Program Manager 327-2370/valeries@unr.edu Nancy Moody, JD, MA Director, RIO (de Janeiro) 327-2368/nmoody@unr.edu

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