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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 EthicsRon 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.

– By Angela Herring

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