Feds consider legislation that would tighten research, IRB regulations
Spotlight is on what IRBs do
The spate of highly publicized problems at research institutions in the past few years has contributed to an environment in which the public and Congress are less willing to trust the adequacy of current laws and regulations governing IRBs and human subjects research. In an attempt to ensure that adequate guidelines are in place to protect those volunteering for clinical trials, H.R. 4697, the Human Research Subject Protections Act (HRSPA), was introduced in the House of Representatives. The bill, introduced by Rep. Diana DeGette (D-CO) and cosponsored by Rep. James C. Greenwood (R-PA), would make important changes, including a mandate that all research involving human subjects, whether federally funded or not, be subject to IRB approval.
"The research industry has been growing and growing, and the system for human subjects protection has not kept pace," says Jeanne Sears, MS, RN, program operations manager at Harborview Medical Center of Seattle. "It is in need of a lot of additional support and resources, and a lot of IRBs are feeling the pressure of that disparity," Sears says. "People are more aware of IRBs and their limitations because of the media coverage and patient rights groups and advocacy groups." Also, the American public is less trusting of clinical trials and medical research than previous generations, Sears notes.
Both the recent bill and a 2000 version that went nowhere were drafted in response to a 1998 report about IRBs and research, published by the Office of Inspector General (OIG), says Ralph G. Glover II, JD, an associate attorney who specializes in health care, including clinical research, with Michael Best and Friedrich in Chicago. "Basically, the OIG makes recommendations for several clinical research reforms involving IRBs," he notes. "Only two of them have occurred to date, and so Congress has taken it upon itself to statutorily impose these changes that none of the agencies have made."
While there already has been some recognition of recent research problems, resulting in the formation of the Office of Human Research Protections (OHRP) and voluntary quality and accreditation programs, it would appear that these measures have not been enough to satisfy Congress that enough checks and balances are in place. HRSPA would make several important changes to how IRBs are managed and research is conducted:
• First, it would expand the types of human subject research to be conducted in accordance with the Common Rule. It also would include many studies that are not federally funded or subject to federal regulations. This would, of course, have no impact on institutions that have assurances receiving federal research funding, but it could have considerable impact on other institutions.
"It looks like the bill is applying the Common Rule to all research involving human subjects, and it doesn’t matter whether it’s federally funded or not," says Julie Simpson, MPA, regulatory compliance manager of the Office of Sponsored Research at the University of New Hampshire (UNH) in Durham. The institution’s IRB reviews main social-behavioral research. UNH already signs an Assurance with the federal government to follow those regulations. The institution applies the same rules to all research, including those studies that do not receive federal funds, she adds. "So that provision probably wouldn’t affect us because we already do that anyway."
Sears says that this requirement could be positive. "It will help plug some loopholes where some research wasn’t being reviewed at all, where the research didn’t have any required oversight, and that is a good thing," she says.
• Board membership would have to include specific percentages of people who have scientific and nonscientific expertise and no affiliations with the institution served by the board. Plus, the board would need to include at least one member who is an expert in the issues involving vulnerable populations when the research is designed to include subjects who are part of a vulnerable population. This particular member would have full voting rights. And when research involves a significant number of minority individuals, then the board would need to include minority members who would have the same voting rights as other members.
The bill even includes a provision that a quorum cannot be established for a meeting unless at least one member from these additional categories is present. Many smaller IRBs have a difficult time finding even one person in the community who is willing to devote time and energy, without compensation, to an IRB. This bill would require them to find at least two such community members, Simpson says.
This could be a difficult regulation to follow for smaller IRBs and institutions, Sears notes. "A lot of IRBs would like to have a membership that more reflects these populations, and it’s a very good goal and very important to have more members from the community on the board," she says. "But I think it’s going to be quite a challenge to do that."
Simpson agrees. "We are a relatively small institution and any additional regulations like that, which impose additional membership requirements, do impose an added burden."
"I don’t know how IRBs are expected to handle that provision other than to place permanent minority members," Glover says. "You can’t always have an expert [on] a vulnerable population on an IRB if you study several different vulnerable populations."
On the other hand, Simpson points out, if such legislation were passed, it could force institutions to put more resources into IRBs, and that would be a positive outcome.
• Another potential bureaucratic problem: the requirement that the Secretary of the Department of Health and Human Services develop mechanisms for data safety monitoring boards (DSMBs) to be involved with monitoring high-risk protocols, Glover says. "I don’t know how controversial this would be," he says. "Basically, DSMBs are independent entities, and this would require them to be involved with high-risk research, to add an extra layer of supervision."
• The bill would have some positive effects on IRBs as well, Glover notes. For example, there are provisions in which an investigator is required to let an IRB know if he or she has previously submitted a research protocol to another board, Glover says. "And an investigator also has to notify the board if the investigator has been disqualified or restricted by any federal agency," Glover adds. Also, the educational requirements in the bill would give IRBs added incentive to train IRB members about research. The bill would require investigators to provide a written statement certifying that they will uphold federal rules regarding human research protections, Glover says.
Although it speaks well of Congress’ intentions to concentrate on legislation that is intended to improve human subjects protection, this won’t prevent accidents from happening or eliminate all shoddy research, Simpson says.
"Even research by investigators who have a stellar record might result in a subject’s death, not due to incompetencies or inefficiencies in the system, but due to tragic accidents," Simpson says. "All the regulations in place won’t stop accidents or researchers who don’t care about rules and regulations, or people who don’t conduct research in a responsible and ethical manner."
Ultimately, it’s up to each research institution to inform investigators and the IRB that the institution takes its responsibility to protect the welfare of human research subjects seriously, and that the institution needs to do all within its power to make sure the IRB has the authority and resources it needs to protect research subjects, Simpson adds. "The institution has to have the philosophy of We will not tolerate any misconduct, whether it’s a failure in protecting human subjects or not following the rules,’" Simpson says. "Regulations are one step, but they alone cannot protect human subjects."
The current bill has generated little interest from Congress, as it has only one cosponsor. The 2000 bill had support from members of the research community and still it went nowhere, Glover says. "So I don’t expect a lot to happen, at least not right away," he adds.
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