Failures at three levels equal a loss of momentum

GAO: More work could be done to fill the gaps

Three parties — the federal agencies, the research institutions, and the investigators themselves — are not doing enough to ensure that human research participants are adequately protected. That’s how Janet Heinrich, director of Health Care and Public Health Issues for the United States General Accounting Office (GAO) summarizes the current levels of oversight for human research protections, starting with the U.S. Department of Health and Human Services (HHS) regarding human research protections. Heinrich’s statement appears in a GAO report: HHS Takes Steps to Strengthen Protections, but Concerns Remain (GAO-01-775T).

Heinrich’s testimony before the Senate Subcommittee on Public Health was scheduled for late May, but the Senate instead focused on the tax cut legislation before the Memorial Day recess. The GAO is an oversight agency created by Congress to identify inadequate governmental safeguards or excessive spending. For IRB administrators, however, the report offers little insight into improving the system.

Heinrich’s statement says that there are gaps within research protection at three levels:

• the federal agencies, such as HHS and the U.S. Food and Drug Administration (FDA);

• the institutional level, which includes research institutions, universities, and academic medical centers;

• the individual investigator level, which includes physicians, scientists, and other professionals.

The federal government’s loss of momentum may have restricted rather than expanded the independence of the Office of Human Research Protections (OHRP), she noted. The OHRP was created in part to increase oversight of clinical trials through on-site reviews of research programs. However, no on-site reviews have been made since last October, states Heinrich.

Facing an administrative backlog

Heinrich notes that on the federal level, the slowdown is attributable to finances and staffing. HHS did not increase the OHRP budget in proportion to the increased amount of work it would be facing in its new mission, she points out. Additionally, the office is unable to hire additional staff due to a federal hiring freeze that went into effect at the beginning of 2001. The problem is compounded when the backlog of compliance cases is added to the equation.

Heinrich’s testimony also includes the following examples of government inaction:

• the National Institutes of Health (NIH) reduced its site visits, and in fact, has not made any random site visits during the first two-thirds of fiscal 2001;

• the FDA still is waiting on HHS efforts to get legislative approval to broaden its authority to levy civil monetary penalties for investigator violations;

• the FDA has not been granted additional resources for its monitoring and inspection programs, and inspected fewer than 2% of the estimated 35,000 trials in 2000; the agency’s request for additional resources to inspect 275 more sites would extend the inspections by less than one percentage point.

HHS’ attempts to support IRBs first appear promising, says Heinrich, but questions still remain over the issue of financing. While institutions must supply the necessary resources for IRBs, HHS has failed to assist by providing resource benchmarks. The benchmarks would help institutions determine the appropriate level of funding, notes Heinrich.

Officials within HHS admit that little information is available on appropriate levels of funding, and there still is debate over what sources of funding are considered unacceptable. Heinrich notes that HHS has started to investigate the issue of financial conflicts of interest at research institutions, but is not clear on when it can begin addressing the issue.

As for investigators, HHS has taken little action to improve the informed consent process for research participants or to educate investigators on improving the process, adds Heinrich. Further, HHS has not clarified the requirements for adverse event reporting. HHS failed to issue new guidance on informed consent as it said it would a year ago, she states.

When asked by GAO officials, staff at OHRP stated that informed consent guidance has a low priority compared to implementing the new assurance process and educational programs. IRB administrators contend, however, that the new assurance process is burdensome and places higher workload demands on HSS and OHRP staff who instead should be focused on other requirements, such as informed consent guidance.

OHRP staff also told GAO investigators that they still need time to get expert and public input on the informed consent process and how to improve it.