Academic journal article
By Kripalani, Sunil; Bengtzen, Rachel; Henderson, Laura E.; Jacobson, Terry A.
IRB: Ethics & Human Research , Vol. 30, No. 2
Ensuring informed consent of participants in clinical research is a significant challenge. (1) During the consent process, prospective participants must be provided with adequate information in order to make an educated decision about whether to enroll in the study, including details on the purpose, risks, benefits, and procedures involved in the study, as well as the confidentiality of personal health information. However, prospective participants may understand only 30% to 81% of information in standard consent forms. (2)
A major reason for such poor comprehension is the complexity of most consent and privacy documents, which often are written at too advanced a level for their intended audience. (3) In addition, a wide range of factors such as older age, (4) cognitive impairment, low educational attainment, (5) and poor literacy skills (6) can adversely affect consent comprehension. The National Assessment of Adult Literacy estimated that only 13% of Americans have proficient literacy skills, the level that would be required for understanding of typical informed consent materials. (7) Low literacy therefore presents a widespread and important barrier to informed participation in clinical research studies.
The National Cancer Institute, National Quality Forum, and other leading groups have recommended steps to improve the informed consent process for all prospective participants, particularly those with limited literacy skills. (8) They suggest providing enhanced consent documents written at an eighth grade reading level or lower. In addition, materials should be relatively short, clearly organized with subheadings, illustrated, and written in active voice with straightforward vocabulary. Individuals prefer material that is presented in a simplified format, (9) and several prior studies of enhanced consent forms have demonstrated improved understanding. 10 Other research has shown that providing both written and verbal information leads to better information recall than written or verbal information alone. (11)
Few studies in which the consent process was modified have examined the role of literacy level on consent comprehension. (12) Moreover, we are not aware of any such studies which included comprehension of privacy information that must be provided as required under the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA Privacy Rule). In the context of a randomized controlled trial to improve medication adherence, we provided patients eligible to enroll in the trial with simplified written documents, a short verbal description of the study, and a visual aid to describe the randomization process. We examined the independent association of patients' age, cognition, years of education, and literacy level with comprehension of informed consent and HIPAA Privacy Rule requirements regarding authorization for use and disclosure of protected health information.
* Setting and Population. The study was conducted in the primary care clinics at an inner-city teaching hospital in Atlanta, Georgia, that serves a predominately low-income, African American population. The study design and materials were approved by the university Institutional Review Board (IRB) and hospital Research Oversight Committee.
Subjects for this analysis were among the 435 participants in a larger randomized controlled trial--the Improving Medication Adherence through Graphically Enhanced interventions in Coronary Heart Disease (IMAGE-CHD) study. (13) The trial followed a 2x2 factorial design; participants were assigned to receive usual care, an illustrated medication schedule ("pill card"), refill reminder postcards, or both interventions for a period of one year. (14) The primary outcome was cardiovascular medication adherence.
Enrollment took place from March 2004 to March 2005. Patients were eligible for the study if they had a history of CHD, as determined by documentation in their medical chart of previous myocardial infarction, percutaneous transluminal coronary angioplasty, coronary artery bypass surgery, or greater than 30% stenosis on prior cardiac catheterization. …