Special Coverage: 2003 PRIM&R/ARENA Conference

Legislation, community education on research radar screen for 2004

Senior policy fellow offers projections on big issues in upcoming year

With the changes that have occurred for IRBs and the research industry in recent years, it’s a safe bet that the trend will continue in 2004.

For some ideas of the challenges that IRBs may face in coming months, Felix A. Khin-Maung-Gyi, PharmD, MBA, CIP, chief executive officer of the Chesapeake Research Review Inc. of Columbia, MD, provides a look at some of the more important issues. Khin-Maung-Gyi is a senior policy fellow with the Center for Drugs and Public Policy at the University of Maryland in Baltimore, and the Chesapeake Research Review, which recently celebrated its 10th anniversary, is one of the nation’s largest independent IRBs with a staff of about 50 and an IRB board consisting of 20 members.

Here are some of the issues he believes will be important to follow this year:

Recruiting women and minorities: "The National Institutes of Health [NIH] has long addressed the issue of recruiting women and minorities into research, and both the Food and Drug Administration [FDA] and the NIH have guidelines posed in the 1993-94 Federal Register encouraging enrollment of women and minorities in research," says Khin-Maung-Gyi. "But here is the dilemma that we as a society are facing: Overall, fewer than 10% of the eligible population participates in research. When we look at critical issues like cancer, the participation of women and minorities falls drastically to less than 5% and less than 3%."

Research must continue to take a systematic approach to evaluating safety and effectiveness prior to FDA or other regulatory approval, yet there must be some effort made to reach greater numbers of the populations that will use these drugs and products, Khin-Maung-Gyi says.

"We have to go into the community," he says. By making greater efforts to include minorities in studies, researchers also could help to improve the long-standing lack of trust that exists between some minority communities and the research community.

"If we take a look at minority communities, there is a huge gap in understanding what the research enterprise might be, and this gap is fueled by a lack of trust in the research enterprise," Khin-Maung-Gyi says. "It’s a lack of trust that is well founded, by the way."

There have been many examples of government research that has violated basic ethical principles of justice, autonomy, and beneficence, he notes. "But other basic principles, like permission and respect, also were violated, and people remember those things."

Examples include the Tuskegee syphilis study, prisoner research in the 1960s, and radiation experiments of the 1960s and 1970s.

"There is a good reason for them to feel skittish about research," Khin-Maung-Gyi says. "They already are feeling as though they don’t have access to good health care and other societal benefits that nonminorities have, and so we can’t ignore that."

NIH road map and education: "I have long believed that education is a critical component in identifying and recruiting and retaining subjects for appropriate identification, appropriate inclusion, and appropriate retention," Khin-Maung-Gyi says.

Three sectors of the public need additional education about research, including the public, legislators, and researchers, Khin-Maung-Gyi notes. Although the NIH road map promotes further education, IRBs and the research community cannot hold NIH solely responsible and accountable for education, he says.

"They are entrusted with public funds to forward public agendas, and the industry also has to share in that responsibility," he says. "We have a burden in training and assuming that level of investment."

It also is important to have the right legislation in place, as well as voluntary accreditation. "Things like accreditation are steps in the right direction to help us assure each other that there are minimum standards being met," Khin-Maung-Gyi says. "But it’s a costly venture."

Health Insurance Portability and Accounta-bility Act (HIPAA): "Clearly HIPAA has had a huge impact on all of us," Khin-Maung-Gyi says.

"I think we need to remind each other that HIPAA is a regulatory constraint that was implemented to protect clinical issues," he adds. "It wasn’t drafted with research in mind as a primary focus." However, now that it’s implemented, it must be a top priority for IRBs.

"Whenever we get to protecting rights and welfare of subjects in any kind of peripheral way, all eyes turn to the IRB," Khin-Maung-Gyi notes. "Administration, researchers, and regulators all turn to the IRB, and the IRB is woefully understaffed to address all of those issues, and it’s not really fair."

Potential legislation: "The IRB community needs to be aware of pending or potential legislation," Khin-Maung-Gyi says. "There are a couple of bills proposed on the Hill that should be re-viewed by IRBs and research communities, and they should educate their own legislators in terms of what’s going on."

Specifically, the bills are as follows:

H.R. 3594: Protection of Human Subjects; Uniform National Applicability of Common Rule and Provisions Protecting Vulnerable Populations.

This bill would require IRBs to review all human subject research, and boards would have to consist of 25% or no fewer than two members who have primary expertise in scientific areas, 20% or no fewer than two members who have an expertise in nonscientific areas, and 20% or no fewer than two members who are not affiliated with the institution served by the IRB and who are not immediate family members of anyone affiliated with the institution and who do not have a significant conflict of interest.

The bill also specifies a list of other requirements for IRBs, including requiring an orientation program and continuing education program for members and the disclosure of significant financial interests.

Sponsored by U.S. Rep. Diana DeGette (D-CO), the bill was referred to the House Energy and Commerce committee as of Nov. 21, 2003.

H.R. 1585: Establishes an office to oversee research compliance and assurance within the Veterans Health Administration of the Depart-ment of Veterans Affairs.

The bill establishes an office of research compliance and assurance to promote responsible conduct and ensure ethical treatment and safety of research subjects. The office will investigate allegations of research impropriety and misconduct and suspend, restrict, or modify research as determined appropriate.

Sponsored by U.S. Rep. Steve Buyer (R-IN), the bill has 19 co-sponsors and, in October 2003, was forwarded by the House Subcommittee on Health to the House Committee on Veterans’ Affairs in the nature of a substitute by voice vote.

— S. 3060: A bill to amend the Public Health Service Act to provide protections for human participants in research.

The bill, also called the Research Revitalization Act of 2002, amends the Public Health Service Act to require research involving human subjects in America, funded by the U.S. government, to meet specific criteria, including prohibiting investigators from conducting the covered research without IRB approval.

Sponsored by Sen. Edward Kennedy (D-MA, the bill was introduced Oct. 4, 2002, and referred to the Senate Health, Education, Labor, and Pensions committee, where it has remained.

"My position is that legislation that is going to be considered should be pretty inclusive to include not only IRBs, but researchers and institutions and sponsors because human subjects protection issues don’t reside only on the IRB level," Khin-Maung-Gyi says. "Other people seeing subjects have to have some shared responsibility for human subjects protection, and it must be fair, inclusive, and consistent."