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Science in Focus: Michael Leary

Behind Closed Doors, Part 1

A crisis of conscience in research ethics.

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In 1972, several journalists broke the story that federally funded scientists had been withholding penicillin from hundreds of male subjects with syphilis since the late 1940s in order to observe the natural history of the disease. Up to 28 participants died from lack of treatment. Whistleblower accounts of the infamous Tuskegee Experiment generated enough public vitriol that Congress was moved to pass the National Research Act in 1974.

Now mandated by the 1974 Act, any federally funded research that involves human participants requires review by committees we call Institutional Review Boards (IRBs), which apply a specific set of regulations designed to protect the safety and welfare of human research participants. IRBs use these regulations to evaluate the risks and benefits of proposed research, ensure that participants will be adequately informed about the nature of the research, and address related concerns. Laura Stark's Behind Closed Doors is a fascinatingly readable account of her observations of IRB practice and the various social, ethical, and historical forces that make them tick.

The regulations created after the 1974 Act mean that IRBs have the authority to disapprove proposed research or require changes to a research study prior to approving it, which theoretically makes another Tuskegee improbable. However, as Laura Stark points out in Behind Closed Doors, 35 years worth of IRB influence on the research process has led many to question the scope of their authority. If an IRB is able to change research proposals, how do they affect the advancement of science?

Because science does advance, even if our ability to regulate it has trouble keeping up. It is often said that our scope of knowledge about the human body and society increases at a geometric rather than linear pace, but this is somewhat inaccurate in that biomedical advances actually occur in leaps bookended by lengthy periods of bench and clinical research. These leaps, the paradigm shifters, pose "square peg in round hole" problems to research ethics. Genomics, new surgical methods, high-risk cancer treatments—how do we ethically evaluate ideas and practices we have only just discovered?

This question is why the "IRB problem," as Stark poses it, is a key component of what science will look like in the future. Emerging sciences challenge our ethics in that they revise our fundamental concepts about the human body. But this requires revising the boundaries of what we ethically permit researchers to do to people in the pursuit of biological facts about the human condition. As the IRB sets these boundaries, they may periodically halt the progress of science.

Prior to the 1974 Act and its mid-'50s DHEW template, researchers generally made ad hoc decisions about the ethics of a given human subjects protocol. Now, as Stark demonstrates, these ethical decisions are made by communities of physicians and laypersons necessarily uninvolved with a specific research proposal. Here is the point at which Stark's book is sure to energize discourse in the echo-chamber of IRB scholarship.

Which strategy for ethical decision-making is the most effective for meeting the needs of clinical and social sciences? The IRB model presupposes the decisions should be made in diverse moral communities, but these communities are forced to make decisions based on personal experience and are tied to regulations that have not been revised in three decades. The alternative is a system that puts these decisions back in the hands of researchers operating under the rubric of virtue, guided by whatever ethics seem to fit the matter at hand.

The current crisis of conscience in research ethics is not primarily a matter of ethic and application, but rather centers on where this conscience should be located. Stark's book is the first of a wave of evidence-based reflections that will push regulators to reconstruct the system.

Michael Leary researches and administrates research ethics at Washington University in St. Louis. He holds faculty appointments in Biblical and Religious Studies at Fontbonne University and Sydney College of Divinity.

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