An Australian Based Study on the Readability of HIV/AIDS and Type 2 Diabetes Clinical Trial Informed Consent Documents
David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Jack Alan Reynolds
Learn more about PhilPapers
Journal of Bioethical Inquiry 7 (3):313-319 (2010)
The aims of this study were to measure the readability of Australian based informed consent documents and determine whether informed consent readability guidelines have been established by Australian human research ethics committees (HRECs). A total of 20 informed consent documents, 10 HIV/AIDS and 10 type 2 diabetes, were measured for readability using the Simple Measure of Gobbledygook (SMOG) and Gunning Fog Index (Fog). Published guidelines and policy statements of the two local HREC who approved the 20 clinical trials under study where examined to identify whether they had any formal policies/guidelines on the readability of informed consent documents. The two HRECs were contacted via e-mail to also determine whether they utilised any informal readability standards or rules of thumb that may not have been mentioned in the published documents. The HIV/AIDS and type 2 diabetes informed consent documents were, on average, written at a grade 13 reading level. Formal readability standards had not been established by the two local HRECs, however, they did verify the use of informal rules for assessing readability of informed consent documents. Based on Australian literacy data, the majority of informed consent documents were written well beyond the reading ability of many Australians. Unreadable informed consent documents may result in patients rejecting trial participation altogether or conversely may result in their participating in a trial with inadequate consent. Therefore, a step toward reducing the complexity of informed consent documents may be to implement objective readability assessments into the human research ethics application and review process.
|Keywords||Clinical trials Consent forms Comprehension Diabetes mellitus HIV|
|Categories||categorize this paper)|
Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
|Through your library|
References found in this work BETA
No references found.
Citations of this work BETA
No citations found.
Similar books and articles
Caroline Jones (2010). An Australian Based Study on the Readability of HIV/AIDS and Type 2 Diabetes Clinical Trial Informed Consent Documents. Journal of Bioethical Inquiry 7 (3):313-319.
James R. P. Ogloff & Randy K. Otto (1991). Are Research Participants Truly Informed? Readability of Informed Consent Forms Used in Research. Ethics and Behavior 1 (4):239 – 252.
Robert F. Weir & Jay R. Horton (1995). Genetic Research, Adolescents, and Informed Consent. Theoretical Medicine and Bioethics 16 (4).
Connie K. Varnhagen, Matthew Gushta, Jason Daniels, Tara C. Peters, Neil Parmar, Danielle Law, Rachel Hirsch, Bonnie Sadler Takach & Tom Johnson (2005). How Informed is Online Informed Consent? Ethics and Behavior 15 (1):37 – 48.
Emma Verástegui (2006). Consenting of the Vulnerable: The Informed Consent Procedure in Advanced Cancer Patients in Mexico. [REVIEW] BMC Medical Ethics 7 (1):1-12.
Deborah Bowman (2011). Informed Consent: A Primer for Clinical Practice. Cambridge University Press.
Benedetto Vitiello (2008). Effectively Obtaining Informed Consent for Child and Adolescent Participation in Mental Health Research. Ethics and Behavior 18 (2 & 3):182 – 198.
Shaun D. Pattinson (2009). Consent and Informational Responsibility. Journal of Medical Ethics 35 (3):176-179.
Martin Gunderson, David J. Mayo & Frank S. Rhame (1996). Routine HIV Testing of Hospital Patients and Pregnant Women: Informed Consent in the Real World. Kennedy Institute of Ethics Journal 6 (2):161-182.
Loretta M. Kopelman (1994). Informed Consent and Anonymous Tissue Samples: The Case of Hiv Seroprevalence Studies. Journal of Medicine and Philosophy 19 (6):525-552.
Michelle H. Biros (2007). Research Without Consent: Exception From and Waiver of Informed Consent in Resuscitation Research. Science and Engineering Ethics 13 (3):361-369.
David Shaw (2009). Prescribing Placebos Ethically: The Appeal of Negatively Informed Consent. Journal of Medical Ethics 35 (2):97-99.
Mutsawashe Bwakura-Dangarembizi, Rosemary Musesengwa, Kusum Nathoo, Patrick Takaidza, Tawanda Mhute & Tichaona Vhembo (2012). Ethical and Legal Constraints to Children's Participation in Research in Zimbabwe: Experiences From the Multicenter Pediatric Hiv Arrow Trial. BMC Medical Ethics 13 (1):17-.
Sheila McLean (2010). Autonomy, Consent and the Law. Routledge-Cavendish.
Silvana Ferreira Bento, Ellen Hardy & Maria José Duarte Osis (2008). Process for Obtaining Informed Consent: Women's Opinions. Developing World Bioethics 8 (3):197-206.
Added to index2010-12-04
Total downloads4 ( #267,964 of 1,102,136 )
Recent downloads (6 months)2 ( #192,056 of 1,102,136 )
How can I increase my downloads?