What do human research subjects have the right to know?

An interdisciplinary group of researchers from around the world converged at Northeastern last week to discuss the challenges of and best practices for navigating the new era for informed consent when using humans as research subjects.

Speaking at the Third Annual Workshop in Applied Ethics, Ron Sandler, associate professor of philosophy and director of the Northeastern University Ethics Institute, noted that factors such as community-based research, big data and genomics research, online research, and emergency medicine are changing the landscape of ethics oversight in research involving human subjects.

“There are a lot of areas of research now where it’s not clear how the standard model of informed consent works in those contexts,” he said.

Research using human subjects in America underwent a significant ethics overhaul after revelations surfaced in the mid 1970s that a 40-year syphilis study on black men in rural Alabama followed blatantly unethical practices by deliberately failing to treat sick people. The ensuing Belmont Report provided guidelines for researchers and established Institutional Review Boards to ensure research subjects are protected and best practices are followed.

But researchers at last week’s workshop noted that in the near half-century that has followed since the infamous Tuskeegee case, research itself has changed, rendering the current ethical standards insufficient for some studies.

For example, if a patient is unconscious when he arrives at the emergency department, he doesn’t have the ability to be informed about a study and can’t give consent to participate. Nevertheless, research in those situations is needed to improve emergency medicine practices in the future.

“Everybody agrees that we need to protect research subjects,” Sandler said. “The issue is how we do that effectively with all these new areas.”

Hosted by the Ethics Institute and Northeastern’s Social Science Environmental Health Research Institute, the workshop provided a platform for discussion of so-called “post-Belmont ethics.” The institute’s director, Phil Brown, University Distinguished Professor of Sociology and Health Sciences,  helped coin that term, which points to the need for an expanded view of informed consent.

Brown uses biomonitoring and air and dust monitoring to measure personal and household chemical exposures. Under the current guidelines, informed consent merely requires his team to inform research subjects of the risks and benefits of participating in the study and then non-coercively gain their consent to participate.

But Brown’s particular work generates significant amounts of data on research subjects’ personal exposure levels. Reporting those levels back to the subject—many of whom consider the data to be their “property”—infringes on practices of some IRB’s, which fear the data will scare people.

“We need to support peoples’ right to know about the results of the study, not just make sure that they aren’t exploited by the study,” he said.

In nine months, the national Institutional Review Board guidelines will be updated. Many of the participants at last week’s event, which included staff from the National Institutes of Health, hope the way forward will include new ethical assurances for the changing face of human-subjects research.