At the heart of every trial involving human subjects, there’s a conflict. The investigators design their study to find the most accurate answer to a particular scientific question, be it the efficacy of a new drug or the incidence of disease in a city or state. But the participants in that research likely have different goals: finding a cure for their illness, aiding a good cause (whether its the same cause as the researchers’ or not), or obtaining free medical testing and information. Juggling these competing interests is the mission of institutional review boards, or IRBs, panels of scientists and non-scientists charged with protecting the interests of research subjects in human trials.
But how does an IRB located in the United States make decisions about studies conducted in different countries, with different ethical and cultural standards? That was the central question asked by John Schneider, director of global health programs for the Section of Infectious Diseases at the University of Chicago Medical Center, at this week’s MacLean Center for Clinical Medical Ethics seminar. Schneider’s primary area of research is HIV transmission and prevention in India, a country where attitudes about the disease are profoundly different from those found in the United States. That has a dramatic impact on the researcher-subject (or as Schneider prefers, “researcher-participant”) relationship and raises additional ethics questions about how study results should be handled.
Schneider’s presentation focused on disclosure of HIV test results to study participants, a trickier issue than one might expect. Typically, the medical information obtained from a subject is made anonymous, usually by assigning it a number rather than a name. This process is meant to protect both the privacy of the patient and any bias that might occur when the results are analyzed by a researcher – it’s a conversion of a subject’s complex medical status into pure data.
But say an HIV test comes back positive for a test subject who is unaware that they have the disease? Is the researcher then obligated to inform the subject of the positive test? In the United States, the National Bioethics Advisory Commission says Yes, so long as the test results have “significant implications for a patient’s health concerns” or “a course of action to ameliorate the condition is readily available.” A JAMA paper from 2005 highlighted by Schneider reasoned that “It would be disrespectful to treat research volunteers as conduits for generating scientific data without giving due consideration to their interest in receiving information about themselves derived from their participation in research.”
As a result, the NIH requires results disclosure in any study that employs HIV testing, unless the patient chooses to opt out of receiving those results. But that’s not so simple in India, where the news of HIV infection can be life-or-death for reasons beyond the direct effects of the disease. Schneider, who spends about 3 months a year living in India and conducting research, said he often sees news stories in Indian newspapers about people being thrown out of their homes or committing suicide after learning of an HIV infection.
“Every day or every other day there’s somebody killing themselves based on HIV,” Schneider said. “Someone finds out they’re infected and they’ve infected somebody else in their family, or somebody else in their family is infected and has infected their kids…there’s still a tremendous stigma.”
With that in mind, researchers in India are far less likely to disclose HIV test results to study participants, Schneider found. In a survey of HIV studies conducted in India, less than 35 percent provided test results and counseling to participants who tested HIV positive – though the trend over the last 5 years was shifting towards more disclosure. Currently, Schneider and his colleagues are following up with the researchers behind those studies to record their rationale for releasing or not releasing HIV test results. But the current stance of India’s NIH equivalent – the Indian Council of Medical Research – leaves it to investigators to decide whether subjects should informed of their results, Schneider said.
Perhaps those different standards would be inconsequential if researchers only conducted studies within their own borders. But with international collaborations becoming increasingly common, the gap between the guidelines becomes significant. An American-Indian partnership – such as Schneider’s work in India – presents a problem: should the IRB of the country where the research is conducted determine proper procedure? And if the conclusion of that IRB disagrees with American standards, what should the American investigator involved in the project do?
As with most ethical discussions, no easy answer could be reached in an hour. Schneider said that, in his own work, he has pushed his Indian collaborators to allow subjects to access their test results when they begin a 2nd round of testing later this year. But others in the audience thought that attempting to push aside the rulings of a foreign IRB in favor of American standards risked a paternalistic attitude toward other countries’ ethical systems. Whatever the resolution, Schneider’s talk suggested that investigators need to not only acknowledge the conflict inherent in all human studies, but the fact that the rules of that conflict change from society to society.