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Journal of Immigrant and Minority Health

, Volume 17, Issue 5, pp 1504–1508 | Cite as

Evaluating the Effectiveness of an Illustrated Permission/Assent Form

  • Susan M. Abdel-Rahman
Original Paper
  • 182 Downloads

Abstract

Issues of language and literacy represent a significant barrier to participation in clinical research. This study was designed to explore whether illustrating the permission/assent (P/A) document offers an alternative strategy for communicating study related information to underserved populations. Participants were verbally introduced to a mock study and asked to review the corresponding P/A form with companion pictorials. Questionnaires were used to examine whether the form addressed essential elements of a P/A (as defined under the Code of Federal Regulations) and evaluate the effectiveness of the companion pictures. Over 93 % of participants agreed that the form addressed the required basic elements of a P/A. Pictures depicting study procedures were highly effective while images depicting nebulous concepts such as research and voluntariness were deemed less effective. The medical research community can expand enrollment opportunities to underserved populations by using visual aids to complement the informed consent process.

Keywords

Pictures Illustrations Consent Families Research 

Notes

Acknowledgments

Sincere appreciation is extended to Mike Venneman, Linda Taloney, and Gabriela Flores who assisted with the coordination of this study; Rebecca Ballard for her thoughtful review of the project; and Dee Jo Miller for thoughtful discussions about the concept.

References

  1. 1.
    Bourgeois FT, Murthy S, Ioannidis JPA, et al. Clinical drug trials: a paucity of pediatric representation mismatched to global disease burden [abs]. Boston, MA: PAS meeting; 2012.Google Scholar
  2. 2.
    Schmucker DL, Vesel ES. Are the elderly underrepresented in clinical drug trials. J Clin Pharmacol. 1999;39:1103–8.PubMedGoogle Scholar
  3. 3.
    Lang TA, White NJ, Hien TT, et al. Clinical research in resource-limited settings: enhancing research capacity and working together to make trials less complicated. PLoS Negl Trop Dis. 2010;4:e619.PubMedCentralCrossRefPubMedGoogle Scholar
  4. 4.
    Hussain-Gambles M, Atkin K, Leese B. Why ethnic minority groups are under-represented in clinical trials: a review of the literature. Health Soc Care Commun. 2004;12:382–8.CrossRefGoogle Scholar
  5. 5.
    Wendler D, Kington R, Madans J, et al. Are racial and ethnic minorities less willing to participate in health research? PLoS Med. 2006;3:e19.PubMedCentralCrossRefPubMedGoogle Scholar
  6. 6.
    Lipton LR, Santoro N, Taylor H, et al. Assessing comprehension of clinical research. Contemp Clin Trials. 2011;32:608–13.CrossRefPubMedGoogle Scholar
  7. 7.
    Nundy S, Gulhati CM. A new colonialism? Conducting clinical trials in India. NEJM. 2005;352:1633–6.CrossRefPubMedGoogle Scholar
  8. 8.
    Travaline JM, Ruchinskas R, D’Alonzo GE. Patient–physician communication: why and how. J Am Osteopat Assoc Clin Practice. 2000;105:13–7.Google Scholar
  9. 9.
    Minnies D, Hawkridge T, Hanekom W, et al. Evaluation of the quality of informed consent in a vaccine field trial in a developing country setting. BMC Medical Ethics. 2008;9:15.PubMedCentralCrossRefPubMedGoogle Scholar
  10. 10.
    Fitzgerald DW, Marotte C, Verdier RI, et al. Comprehension during informed consent in a less-developed country. Lancet. 2000;360:1301–2.CrossRefGoogle Scholar
  11. 11.
    Chappuy H, Baruchel A, Leverger G, et al. Parental comprehension and satisfaction in informed consent in paediatric clinical trials: a prospective study on childhood leukaemia. Arch Dis Child. 2010;95:800–4.CrossRefPubMedGoogle Scholar
  12. 12.
    Erraguntla V, De la Huerta I, Vohra S, et al. Parental comprehension following informed consent for pediatric cataract surgery. Can J Ophthalmol. 2012;47:107–12.CrossRefPubMedGoogle Scholar
  13. 13.
    Schenker Y, Wang F, Selig SJ, et al. The impact of language barriers on documentation of informed consent at a hospital with on-site interpreter services. J Gen Intern Med. 2007;22(Suppl 2):294–9.PubMedCentralCrossRefPubMedGoogle Scholar
  14. 14.
    Hunt LM, de Voogd KB. Are good intentions good enough? Informed consent without trained interpreters. J Gen Intern Med. 2007;22:598–605.PubMedCentralCrossRefPubMedGoogle Scholar
  15. 15.
    Resnik DB, Jones CW. Research subjects with limited English proficiency: ethical and legal issues. Account Res. 2006;13:157–77.PubMedCentralCrossRefPubMedGoogle Scholar
  16. 16.
    Lang T, Siribaddana S. Clinical trials have gone global: is this a good thing? PLoS Med. 2012;9:e1001228.PubMedCentralCrossRefPubMedGoogle Scholar
  17. 17.
    Ryan C. Language use in the United States: 2011. U.S. Census Bureau. August 2013. https://www.census.gov/prod/2013pubs/acs-22.pdf. Accessed 5 Aug 2014.
  18. 18.
    Kirsch IS, Jungeblut A, Jenkins L, et al. Adult literacy in America. National Center for Education Statistics, U.S. Department of Education. April 2002. https://nces.ed.gov/pubs93/93275.pdf. Accessed 5 Aug 2014.
  19. 19.
    National Research Council. Responsible research: a systems approach to protecting research participants. Washington, DC: The National Academies Press; 2002. p. 123–7.Google Scholar
  20. 20.
    Protection of Human Subjects—Elements of Informed Consent, 21 C.F.R. pt. 50.25 (2011).Google Scholar
  21. 21.
    Davis S, Wright PW, Schulman SF, et al. Participants in prospective, randomized clinical trials for resected non-small cell lung cancer have improved survival compared with nonparticipants in such trials. Cancer. 1985;56:1710–8.CrossRefPubMedGoogle Scholar
  22. 22.
    Karjalainen S, Palva I. Do treatment protocols improve end results? A study of survival of patients with multiple myeloma in Finland. BMJ. 1989;299:1069–72.PubMedCentralCrossRefPubMedGoogle Scholar
  23. 23.
    Heiat A, Gross C, Krumholz H. Representation of the elderly, women, and minorities in heart failure clinical trials. Arch Intern Med. 2002;162:1682–8.CrossRefPubMedGoogle Scholar
  24. 24.
    Flory J, Emanuel E. Interventions to improve research participants’ understanding in informed consent for research: a systematic review. JAMA. 2004;292:1593–601.CrossRefPubMedGoogle Scholar
  25. 25.
    Ryan RE, Prictor MJ, McLaughlin KJ, et al. Audio-visual presentation of information for informed consent for participation in clinical trials. Cochrane Database of Systematic Reviews 2008; 1:CD00371.Google Scholar

Copyright information

© Springer Science+Business Media New York 2014

Authors and Affiliations

  1. 1.Division of Clinical Pharmacology and Therapeutic InnovationChildren’s Mercy HospitalKansas CityUSA

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