Grady urges reform in human research
The way clinical studies inform patients about what they are getting involved with works no better in the U.S. than elsewhere in the world, one expert said.
Patients from both developed and third world countries exhibited a similar lack of understanding of the medical research process, which limits their discernible rights, said Christine Grady, the chief of the department of bioethics at the National Institutes of Health Clinical Center. She discussed her work on subject recruitment for clinical trials at a lecture Wednesday. The lack of subjects’ understanding translates to complications in the volunteering process, especially when giving informed consent—a patient’s commitment to participation in a medical trial with an understanding of what it entails.
“Informed consent is not as good as we would like it to be anywhere,” Grady said. “[It] can be improved everywhere, but there is no logical reason to insist that informed consent be identical in all places.”
Drawing data from 49 quantitative studies that measured participants’ understanding of the research process, Grady said that the socioeconomic background of participants, literacy and familiarity with research did not make a difference in their overall comprehension of their participation.
“Voluntary participation depends on the person’s ability to understand not just the meaning of the research, but the impact that it may have on their life,” Grady said. “We need more clarity about the purposes of informed consent in research.”
Grady’s research demonstrated the need for a more patient-centric approach to consent, said Michael Merson, director of the Duke Global Health Institute.
“It’s not necessarily the perception of the researcher but the perception of the patient—what does the patient think when the patient signs a form of consent?” he noted. “Our procedures we thought have been the best for years clearly [have] issues.”
In studies that assessed whether patients understood the aspects of what a clinical trial entailed—risks, side effects, study design and purpose of the study—patients from developed and developing countries exhibited similar ranges of overall knowledge. In the U.S. and in Mali, for instance, there was a similar percentage of patients in clinical trials who understood what their trials entailed.
These data show that there are issues in relaying information to volunteers, Grady added. Many participants lacked knowledge on the treatment they were receiving—only 44 to 50 percent knew that they were free to withdraw from the voluntary trial before its completion.
Participants struggled in understanding the study design and randomization in particular, Grady said. Despite being told they might receive a placebo, more than 50 percent of patients believed they were receiving medicine and were not part of a control group.
Grady noted a need for greater discussion on the ethics of research and the information made available to patients.
“We should be cognizant in the difference between assessing control and assessing options,” she said. “Instead of asking of people, ‘do you know you have the right to refuse,’ we might want to ask, ‘are you free to refuse or withdraw and if not, why not?’”
Susan Baker, a lab director for Social and Scientific Systems, Inc., noted the importance of questioning the manner of communicating informed consent.
“We’ve exported our model to the developing world and that may not be so appropriate,” Baker said. “There are other ways to impart the information other than to fill out a form and sign at the bottom—that is a very Western concept.”
The lecture Wednesday was sponsored by the Trent Center for Bioethics, Humanities and History of Medicine at the Nasher Museum of Art.