Common Rule: New year, new legislation in the works

Will Frist’s support make the difference this time?

One of the major changes promoted in the Institute of Medicine (IOM) report Responsible Research: A Systems Approach to Protecting Research Participants, is a call for federal legislation expanding protections to all human subjects involved in research, regardless of funding or setting.

David Korn, MD, senior vice president for biomedical and health sciences research for the Washington, DC-based Association of American Medical Colleges, says his organization supports the expansion of the Common Rule to studies that are not federally funded or currently subject to federal regulation.

"We agree that would require legislation," he says. "That really is a statutory issue that cannot be done simply by regulation."

Robyn S. Shapiro, JD, a partner specializing in health care at the law firm Michael Best and Friedrich in Milwaukee, says the public is watching to see how Congress reconciles the competing interests in the area of human subjects research.

"What’s at stake is the trust of the public in participating in research," says Shapiro, who is also director of the Bioethics Center at the Medical College of Wisconsin in Milwaukee. "We desperately need their involvement and their support in order for research to proceed and for this country to remain at the cutting edge of development and advances."

Last year, two bills introduced in Congress addressed improvements to human subjects protection. Both bills went nowhere. This year, the sponsor of the House bill, U.S. Rep. Diana DeGette (D-CO), will try again, says Dawn Jackson, legislative assistant. Jackson says an updated version of last year’s Human Research Subject Protections Act could be introduced as early as March.

On the Senate side, the issue may have a more powerful ally in newly minted Senate Majority Leader Sen. Bill Frist, MD (R-TN). The Senate’s only practicing physician, Frist said last year that he planned to introduce legislation in this Congress promoting several components of the IOM report, including:

  • consistent and effective protection for all research subjects;
  • effective federal oversight;
  • additional resources to ensure that necessary safeguards are in place.

Shapiro says she believes Frist will stay involved in this issue despite his expanded responsibilities.

"Having testified before one of his committees, I tend to think that he really has a passion for these issues," she says. "He really knows that he has special insight into them, and I’d be really surprised if he were not also extremely motivated to make a mark in this way."

Many research institutions aren’t waiting for the government to make the change. Anne Dougherty, MD, IRB chair at the University of Texas-Houston Health Science Center, says her university already approaches all protocols under the Common Rule, regardless of funding source.