“In the clinic, the consent form largely focuses on things that are common or important,” says Arthur Kavanaugh, MD, professor of medicine at the University of California, San Diego. “In clinical trials, they may include a laundry list of things that a reasonable person may not understand. It becomes a balancing act to communicate what are important risks while allowing the potential research subject to see the entire breadth of what the company’s lawyers think needs to be said.”
In community settings, the researchers may have little control over the content of the informed consent. The IRB for a particular study gives approval for the form and there is little an individual researcher can do to change it. Thus, one of the important early decisions is whether the researcher is comfortable with the form.
“The informed consent form, in one sense, should be viewed as documenting the important elements of the conversation that you had with the potential subject, reminding the investigator of details that they might have otherwise forgotten and giving the subject a record of those details both before and after they sign,” says Dr. Romain.
All of the experts interviewed agreed that informed consent first requires assessment of the potential subject and their ability to consent. “Informed consent begins with the assessment of the patient’s ability to understand before they are even offered the opportunity to become a research participant,” says Dr. Kavanaugh. “There must be freedom from coercion, competence, and the ability to understand the ramifications of entering the study.”
There must also be equitable access to the study by populations such as the elderly, those who are pregnant, and ethnic minorities.
“One of the more challenging ethical challenges faced by IRBs is to ensure that investigators adhere to the principle of justice, specifically equitable access,” says Dr. Czeisler. “The investigator should make every effort to distribute the benefits associated with clinical research in an equitable manner and to not exclude people simply because they are non-English speakers or educationally or economically disadvantaged.”
Time may be the best way to assure that informed consent is both fully informed and valid consent. Personal contact—taking the time to explain the terminology and the goals of the study—makes it possible to fulfill the requirements of informed consent. This process is even more important for potential subjects with poor educational achievement.
Regulations require that all forms used in trials be written to a sixth- or eighth-grade reading level. However, that may not be clear enough for patients to comprehend fully, and the researchers should also make sure the subject understands the jargon being used.
