By Ashley Mooney

Patients giving consent for medical research often do not know what they are getting into, said Christine Grady, chief of the department of bioethics at the National Institutes of Health Clinical Center.

In a March 28 lecture entitled “Ethics in Global Health Research: New Data on Enhancing Informed Consent,” Grady presented the results of her quantitative study on informed consent in the developed and developing countries. As low as 10 percent of patients understood the studies they were participating in, she said, adding that patients in the first and third worlds showed no statistical difference in understanding.

Hospital Corpsman 1st Class Dennis Gamad from Leaitle, Wash., questions a patient who is waiting to see a doctor from the 31st Expeditionary Unit (31st MEU). U.S. Navy photo by Photographer's Mate 1st Class Winston C. Pitman, via Wikimedia Commons.

Using results of 49 studies of the quality of consent—31 in developing countries and 18 in developing countries, Grady compared the quality of informed consent based on patient understanding and voluntariness.

“Informed consent is an ethical, a legal and a regulatory requirement in most healthcare and research with human subjects, but it’s not the only thing that makes research ethical,” Grady said. “There should be a lot of attention to the purpose of doing it, the value of doing it, how the studies are constructed [and] what the risks and benefits are.”

She noted that literacy rates, lack of familiarity with research, cultural-specific patterns of decision making and socioeconomic factors did not prevent informed and independent consent.

“Written documents are increasingly becoming longer and more legalistic, making it impossible for people to understand what they’re getting into,” she said.

Several patients did not understand the use of placebos in research trials, or that they might be randomly selected as members of a control group and not actually receive the treatment.

To improve informed consent, Grady noted that researchers can use tests and feedback, multimedia, enhanced consent forms and extended discussion with a research team member or neutral educator. These methods, however, are based on Western models that do not work in developing countries, she said.

“Informed consent can be improved everywhere. There’s no logical reason to insist that informed consent be identical in countries with different cultures,” Grady said. “We need to be creative in terms of our methods of giving people information, asking them about their understanding [and] enhancing their ability to make decisions.”

CITATION: “The quality of informed consent: mapping the landscape. A review of empirical data from developing and developed countries,” Amulya Mandava, Christine Pace, Benjamin Campbell, Ezekiel Emanuel, Christine Grady. Journal of Medical Ethics, online Feb. 7, 2012. DOI: 10.1136/medethics-2011-100178. Full text.