Research Ethics: Navigating a Changing Policy Landscape

Susan Wolf at Research Ethics Conference

Across the country, researchers and research participants are facing big changes in the rules governing the ethical conduct of research.

This month, researchers from the basic sciences, biomedical research, the social sciences, and many other fields came together at the University of Minnesota to discuss and debate these changes and their impact. Major Changes in Research Rules & Oversight: Making Progress or Creating Problems?, the University’s fourth Annual Research Ethics Conference, was presented by the Consortium on Law and Values in Health, Environment & the Life Sciences; the Office of the Vice President for Research; and the Masonic Cancer Center.

Susan Wolf, J.D., chair of the Consortium, said some of the most pressing subjects of the day were new guidelines in oversight of emerging technologies, in the Common Rule that governs research with human participants, and in the federal definition of “clinical trials.”

“We’re looking at new governance and policy changes that will have an impact on many areas of research, including bench science, biomedical research, the social sciences, and research with human participants,” she said.

Making Sure Policy Keeps Pace

Among the event’s speakers was Carrie Wolinetz, Ph.D., associate director for science policy with the National Institutes of Health (NIH), who discussed how federal oversight must adapt to keep pace with rapidly emerging technologies, such as gene editing and synthetic biology. As one example of such a technology, the powerful and flexible CRISPR genome-editing technique, which has stirred controversy for its use in genetically editing human babies.

New and updated policies can feel like “knee-jerk” reactions that lack the deliberation and time needed, Wolinetz said. However, NIH must work to proactively monitor the scientific community’s concerns, consider ethical and safety issues, and figure out the next steps in policy and regulation earlier.

“At the end of the day, one of the exciting things about the rapidity at which we are seeing these new technologies and approaches emerge is they present huge promise to solve some of our most intractable problems in science and medicine,” she said. “But we have to also recognize that a lot of these modern-day applications of biotechnologies are not without some pretty major challenges.”

More Work Needed on Common Rule

Pearl O’Rourke, MD, director of human research affairs at Partners HealthCare Systems in Boston and an associate professor of pediatrics at Harvard Medical School, addressed the recent, long-awaited update to the Common Rule—the set of federal policies meant to protect human participants in research.

A lot has changed since the Common Rule was first introduced in 1991. The revised Common Rule, which went into effect last summer, aimed to address many of the challenges that researchers, research participants, and institutional review board members faced over the years. The general consensus is that the changes mostly fall short of addressing these challenges, O’Rourke said, noting there are gaps between the goals of the policies and real-world situations—but it is a step in the right direction.

“Is there hope?” she said. “I think there may be.”

Changing the Definition of Clinical Trials

Jeremy Wolfe, Ph.D., professor of ophthalmology and radiology at Harvard Medical School and director of the Visual Attention Lab at Brigham and Women’s Hospital, discussed how broadening the definition of what constitutes a clinical trial has created confusion for basic and social scientists

The change created time-consuming new requirements for researchers, such as registering their studies in the federal clinical trials database, There has been a lot of discussion between NIH and the research community to try to fix the policies so they are more suited to the noninvasive studies performed by many social scientists, for example, and some progress has been made. Going forward, Wolfe said, it’s important for a collaborative dialogue to continue.

“We’re getting closer to a place that we can all live with,” he said.

Research Ethics Week

The Research Ethics Conference took place as part of the U of M’s Research Ethics Week, an annual series of educational opportunities for the U community focused on professional development and best practices to promote, maintain, and model high standards of ethics and integrity in research.

More than a dozen academic programs, departments, and colleges from the Twin Cities and Duluth campuses offered trainings and workshops to their research ethics faculty and staff during Research Ethics Week. Subjects ranged from the complexities of collaborating and traveling internationally for research to ethical considerations around sharing and storing data.

Chris Cramer, Ph.D., the U’s vice president for research, said the events provide a foundation for researchers to explore the themes most relevant to their academic disciplines.

“As a University, our goal is to promote and sustain research integrity in a shared culture of compliance,” Cramer said. “I’m pleased that Research Ethics Week continues to grow and offer opportunities to reinforce our research practices. It represents an impressive commitment across the institution.”

Watch Sessions from the Conference

Watch this year’s Annual Research Ethics Conference from the beginning in the video below, or choose a session to watch.