Protection Money: Human Subjects Research Legislation

Quick, name the largest group dedicated to protecting human subjects in research…

Okay, time’s up. Does ‘the United States Government’ ring a bell?

The federal government has thousands of pages in legislation and regulations aimed at the protection of human subjects. Most of the protections are laid out in 45 CFR 46, or “the Common Rule.” Yet there have been no significant changes to the laws for human subjects protection in over twenty years. Agreement is widespread among virtually everyone involved – scientists, academic research administrators, federal agency officials – that revisions are necessary. But where do we begin?

ENTER CONGRESSWOMAN DIANA DEGETTE

Last year, in the 106th Congress, Rep. DeGette (D-CO) introduced legislation (H.R. 4605, “The Human Research Subject Protections Act”) that would update the existing system. As happens with most of the thousands of bills introduced each session, DeGette’s bill died in committee. She plans to reintroduce the legislation in the 107th Congress with some changes.

“We cannot unleash science without concerns for ethics,” said the Congresswoman at a recent meeting of the National Human Research Protection Advisory Council (NHRPC), which oversees the activities of the leading federal office for human subjects protection.

DeGette’s legislation will include strict informed consent requirements, new federal standards for institutional review boards (IRB), and plans for establishing a commission that would oversee the new standards.

THE COMMON RULE

In 1974, the then-Department of Health, Education and Welfare (now known as the Department of Health and Human Services, or DHHS) set forth the first published regulations pertaining to human subjects in research. ‘The Common Rule,” as it came to be known (45 CFR 46), applied only to research sponsored by the department. Pieces of these regulations were adopted by 16 other federal agencies in 1991, and now apply to any research these agencies conduct or sponsor. Rep. DeGette seeks to apply the Common Rule to all research, regardless of the funding source. This means that private sector, commercial research would now come under the human subjects protection requirements.

The major provisions of the legislation address the issues of informed consent, institutional review board reform, and the creation of a new body to oversee the proposed changes.

The section on informed consent would require an understanding of the research by the participants, consent forms, and written disclosure of the investigator’s financial interests in the experiment. All of these factors would be defined in detail by the legislation.

Perhaps the most interesting and potentially controversial aspect of the legislation is the attempt at IRB reform. Rep. DeGette wants to legislate the membership composition of all IRBs, and will seek funding for IRB member training. In HR 4605, DeGette sought to place three types of people on every IRB: those with expertise in the science being reviewed, those with no expertise in the science being reviewed, and those who have no affiliation with the institution housing the IRB.

Investigators appearing before an IRB would be required to disclose any conflicts of interest, perceived or potential. IRB members would also be required to disclose such conflicts, such as ownership interests in the research being reviewed, financial relationships with private sponsors of research projects, and other similar conflicts.

HR 4605 also sought to establish the creation of a National Bioethics Advisory Commission, which would “provide advice and make recommendations to the President, Federal agencies…and the public on bioethical issues arising from the delivery of health care, research on human biology and behavior, and the applications, including the clinical applications, of that research.” The legislation would require that at least one social or behavioral scientist sit on the commission.

APS is hopeful that we can work with Rep. DeGette to ensure that the legislation she plans to reintroduce is appropriate for behavioral and social science research. Among other things, we will provide input on such topics as the treatment of human subjects involved in non-medical research and how IRBs can function more efficiently and effectively. The protection of human subjects is central to the advancement of science and psychology, and APS remains dedicated to reform and advancement in this area.

For additional information on IRBs and human subjects protection, go to www.psychologicalscience.org/newsresearch/irb.

A Call for IRB ‘Best Practices’ for Psychology Research

Everyone has an IRB story. We want to hear the positive ones. Tell us about your IRB successes. Send us examples of forms, procedures, policies, proposal language, committee structures, informal approaches, you name it. We’ll put your messages online so that your colleagues can benefit from your experience, and you can benefit from theirs.

Send your IRB comments to:

[email protected]

Fax: 202-783-2083 (Attn: Sarah Brookhart, Editor)