Experts discuss Belmont Report’s impact on research since the 1970s

Report recently celebrated 25 years

The Belmont Report has withstood the test of time as a framework for ethical decision making about human subjects research, experts in research ethics say.

The Belmont Report resulted from the National Research Act of 1974, which created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The commission met monthly from 1974 to 1979, the group’s tenure, culminating in the creation of one of the most influential human subjects research documents in the United States.

As federal officials celebrated the Belmont Report’s 25th anniversary in late 2004, research ethics experts, including Bernard Schwetz, DVM, PhD, director of the Office of Human Research Protections (OHRP), from across the country discussed its successes and challenges.

"The big benefit of the Belmont Report was that it put proper emphasis on the importance of the ethical handling of human research," says former U.S. Rep. Paul G. Rogers, JD, a partner in Hogan & Hartson in Washington, DC. Rogers had been a Democratic congressman from Florida for 24 years and helped write the National Research Act. He also chaired the committee on health and environment in the House of Representatives.

"The big disappointment is we still have had occurrences that have not followed the guidelines as basically set forth in the Belmont Report," Rogers says.

The Belmont Report has tremendously changed the process of obtaining informed consent and the protection of subjects in research, including IRB monitoring, says Elizabeth E. Hill, RN, MS, DNSc, director of clinical research management program and assistant professor at Duke University School of Nursing in Durham, NC.

The report also provides research reviewers a way of thinking about the risks and benefits of the research they’re reviewing, says Michael Kalichman, PhD, director of the research ethics program at the University of California-San Diego in La Jolla.

From the perspective of people working in the research community 40 years ago, the Belmont Report was as fundamental a document for the protection of human subjects as the Declaration of Independence is a fundamental document for the establishment of a democratic republic, says Anthony T. Dren, PhD, a consulting professor at Duke University School of Nursing.

Dren observed prison research in the 1960s before the Belmont Report specifically addressed this population with the words, "On the other hand, under prison conditions they may be subtly coerced or unduly influenced to engage in research activities, for which they would not otherwise volunteer."

From Dren’s perspective, subtle coercion was the rule rather than a rare occurrence.

"As an outsider, I realized this research wasn’t right," he recalls. "You’d walk through the prison and see people in cells, and then you’d see the [research] clinic with nice beds and padded mattresses, pool tables, and a kitchen."

The fact that the clinic was available to any prisoner who participated in Phase 1 clinical trials was coercive because the prisoners would do anything to be in that setting rather than in the general prison areas, Dren says.

"Instead of spending all day punching out license plates, they’d get $3 a day to spend time in the clinic; and in a prison, that’s coercion," he says. "They’d accept any kind of treatment, anything, and that bothered me."

Thanks to the Belmont Report, there are more clearly defined standards in research practices that provide increased protection to human subjects, says Camille Nebeker, assistant vice president for research at San Diego State University.

Although the report has resulted in an ethical structure that’s more clearly understood by research stakeholders, there are challenges in the application of these principles to ethical decision making, she adds.

"I think the structure is in place, and it all looks good, but what happens in practice and how people interpret the standards and regulations and guidance vary," Nebeker says.

"The Belmont Report really is an ethical framework, and for me, that makes it so much more useful," says Barbara Bigby, MA, CIP, director of the Scripps Office for the Protection of Research Subjects and an IRB administrator at Scripps Clinic in La Jolla, CA.

"You can apply the Belmont Report principles in so many different ways," she says. "There’s no real right or wrong in ethics; it’s an exploration of the gray that is important because what’s appropriate in one place and time may not be appropriate in another place and time."

Despite the improvements that have been brought about in large part because of the Belmont Report, there remain challenges in the goal of providing optimal protection to human subjects, the experts say.

"We clearly think there’s room for improvement," Bigby says. "In 2000, when I took over this role [as director of the Scripps Office for the Protection of Research Subjects], we decided one of the most important things I could do was hold a research ethics series at the clinic to show we felt this was terribly important."

Later, the clinic sponsored a three-part series on Bringing Belmont to Life, she adds.

"The Belmont report provides principles and what they mean, and it’s a very easy way to get people to walk into ethical decision making," Bigby says. "We do ethical decision making in everything we do, and that’s why it’s so useful."

After 25 years of providing ethical principles for research, the Belmont Report might need a little refurbishing, some experts say.

"It really might be timely now after these 25 years to have another commission look at what has happened to see where there is weakness in our whole research system as far as research on human subjects," Rogers says.

For instance, technology has created situations and potential that could not be adequately imagined or addressed 25 years ago, including the use of nanotechnology, genetic research, and other advances, Rogers notes.

"So this would be an appropriate time, I would think to have another commission," Rogers says. "Not that the commission report is not solid and enduring — I think it is, but we might want to see what other emphases should be given."

Genetics research has the potential for risks that might not be understood for years or even generations, experts say.

"It wouldn’t hurt to have people come together and look at the Belmont Report again and see if it still meets our needs," Hill says. "The thing that concerns a lot of us right now are the issues around genetics and genetic research and what a huge responsibility and risk this is for people that maybe they don’t even think about."

It’s the unknown factors that may keep research ethicists awake at night.

"When you talk about gene therapy and pharmacogenetics and genomics, you don’t know what the results are, and you may not know for generations," Dren says.

"I think with all of the controversy about Vioxx and the long-term studies there has to be a greater concern that when you are introducing a chemical or device into a human system, you really don’t know what is going to happen," he adds.

With Vioxx, the one-year studies and even some two-year studies showed positive results, but now it’s known that the problems with Vioxx did not occur until after 18 months, so how long should a gene therapy before studied before it’s considered long enough, Dren notes.

However, even if the Belmont Report is not updated or revised, it remains the gold standard for the ethical treatment of human subjects, say experts.

"I’m astounded at how well it holds up with the 25th anniversary of the publication of the report," Bigby says. "It holds up amazingly well."