Patient Comprehension Should be Assessed as ‘Routine’ Part of Informed Consent Process for Studies in Developing Countries, Researchers Say
"Formal assessment of research participants' comprehension of the consent form should be considered as a routine step in the informed consent process in less-developed countries," Daniel Fitzgerald and colleagues from the Haitian Study Group on Kaposi's Sarcoma and Immunodeficiency Disorders state in a "Research Letter" to the Lancet. The researchers, working on a case-control study on HIV-1 transmission in Haiti, developed a true/false, 15-question survey to assess participants' comprehension of the informed consent process. The survey included questions on "key elements" of the consent form, such as study purpose, voluntary participation, risks and benefits and knowledge of HIV prevention. The questionnaire was verbally administered by a physician to 15 patients after they had received information about the consent form, had the opportunity to ask questions and were invited to join the study. Of the participants, 12 were women, the median age was 40 and six were unable to read or write. Only three of the 15 participants received a passing score of 80%. The informed consent process was then modified to include three 30- to 40-minute information sessions over a seven- to 10-day period with a counselor instead of a physician. The information was again communicated verbally with the help of visual aids. Thirty patients took part in the modified process. Of the participants, 25 were women, the median age was 37 and 13 could not read or write. Twenty-four of the 30 participants passed the modified assessment.
Reasons for Better Comprehension
The improved comprehension demonstrated by the second group proves that "research participants in a less-developed country can comprehend a complex consent form if sufficient care is taken to provide them with information," the researchers state. However, they note that their findings demonstrate that the standard single-meeting process currently used "might be insufficient" to garner complete comprehension. They state that by spreading the information out over three sessions so that "only a few messages" are communicated at a time, patients are able to better comprehend the information. They write that this style is "generally followed in primary health care education in less-developed countries" but is neglected in the informed consent process. The researchers add that participants in the single, physician-facilitated meeting may have been "intimidated by the authority of a physician, and ... afraid to ask questions, or to state their unwillingness to participate" and may be more receptive to counselors (Fitzgerald et al., Lancet, 10/26).
Further Steps Need to Be Taken to Make Research Ethical
In an accompanying commentary, Paul Farmer of Harvard Medical School and Partners in Health, a group providing HIV/AIDS care in Haiti, states that the study by Fitzgerald and colleagues "suggests that modest investments in better communication can improve participants' understanding of the process in which they are being engaged." Noting that most research projects in developing nations are sponsored by "affluent" universities, Farmer states that counseling sessions before signing informed consent forms do not "change the social conditions that structure the growing gap, cognitive and social, between those who do research and those who are participants." Such gaps "underpin the growing 'outcome gap' that characterizes transnational research projects," and empirical research on the "process of informed consent across this gap is urgently needed," he writes. Farmer notes that transnational research serves as a "reminder that some populations are not really developing, but rather being left behind" by the global economy. In-depth social analyses of inequalities between countries, as well as "plans to remedy them" will assist in making research more ethical, he states, noting that in AIDS studies, research "might have to be linked to access to the best treatment available, rather than to local standards of care." He concludes, "All medical and public health researchers would like a magic bullet that would make research undeniably ethical. But there is no magic bullet. There is only the complex and difficult process of linking research in resource-poor settings to the services demanded by poor people. The alternative prospect -- a world in which medical research is dedicated wholly to the diseases of the affluent -- is too painful to contemplate" (Farmer, Lancet, 10/26).