After a quarter century, the Belmont Report holds up as ethical framework

One challenge: Report needs to be used more widely

Despite its relative brevity, 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.

"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 to write the National Research Act. Rogers also chaired the committee on health and environment in the House of Representatives.

While experts in research ethics roundly acknowledge the improvements that have occurred as a result of the Belmont Report, they also note some problems that still prevent the research community from meeting the report’s ideals.

One challenge cited by experts involves disparities in how the report is used.

For instance, the FDA does not promote the Belmont Report, 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.

"So problems come when we have federally funded research, and the community doctors are doing FDA-related research," Bigby explains.

"Our federally funded doctors are very well aware of the Belmont Report because it’s part of their federalwide assurance, and they say, When we accept federal funding, we accept the Belmont Report,’" Bigby says. "But on the other hand, the FDA has a statement of, I will follow good clinical practice,’ which is terribly important, but is not an ethical framework."

Also, while human subjects protections are improved for federally funded research and research conducted at major research institutions, there remains an ethical gray area with regard to research that is privately funded and conducted at small facilities, notes Elizabeth E. Hill, RN, MS, DNSc, director of clinical research management program and assistant professor at Duke University School of Nursing in Durham, NC.

"If you don’t have studies that are funded federally, what are the protections for people who don’t follow the guidelines recommended in the Belmont Report?" Hill asks. "I teach a research methods class and have students from all different places, and some are from small hospitals, and they’ll say, So and so is doing a study and it hasn’t been through the IRB, but it’s not a federally funded study.’"

Another challenge that remains is that clinicians who conduct research still have trouble understanding the differences between their clinical practice and research, says Hill.

For example, she learned of a situation at another institution in which a hospital physician had submitted a protocol to the IRB for the study of different treatment methods of a vulnerable population. When his protocol was deferred until he met further requirements, the physician ignored the IRB procedure and conducted the research as he had initially planned.

Although no patients were harmed, the IRB investigated the physician’s actions, assigning a fellow physician to head the investigation, Hill recalls.

At first the investigator was skeptical that the researcher’s actions amounted to improper conduct, but he quickly changed his perspective, she adds.

"He said, When I first started this I saw it as ridiculous because no one was hurt, but now when I look at the regulations and read the Belmont Report, I can see that what he did was very wrong,’" Hill says.

Issue of informed consent

While the Belmont Report established sound criteria for informed consent, including the three elements of information, comprehension, and voluntariness, there continue to be problems today with how informed consent is carried out, says Camille Nebeker, assistant vice president for research at San Diego State University.

"I’m a principal investigator on a National Institutes of Health-funded grant, and I’m an IRB administrator and I oversee research administration, and the only role I haven’t played is the federal one," she says. "So I can look at the informed consent process from different vantage points, and I can see that it looks good on paper and in practice we all think it’s working, but there are some challenges in the application of the process."

More needs to be done to identify whether the process results in an informed participant, Nebeker says.

The informed consent process could benefit from considerable improvements, suggests Michael Kalichman, PhD, director of the research ethics program at the University of California-San Diego in La Jolla.

"It may be an unrealistic goal, and yet the whole system is based on a premise that our subjects will understand what it is they’re risking by being involved in a study and that they’ll understand what the benefits are," he says.

Nebeker has both participated as a healthy subject in a clinical research study and she has conducted focus groups with key personnel involved in the conduct of the research protocol. Based on her experience, she has found that the informed consent process has the potential to be compromised.

Preliminary findings from focus groups indicate that the process may rely more on the form than the process of describing the study in a manner that is conducive to good decision making, she notes.

"This may be promoted by the IRB review process where the principal investigator is somewhat focused on getting a consent document put together that will be approved by the IRB," Nebeker says. "The IRB may assume that the document submitted by the PI takes into account the appropriate language and reading level and is appropriate for the target group."

When Nebeker volunteered to participate in a clinical study, she was presented with a 13-page consent form. While the nurse practitioner who presented it had done the type of job Nebeker would have expected, there was a great deal more information in the form than what was discussed in the one-on-one, she recalls.

Nebeker knew enough to read the form thoroughly and from that careful read, she discovered the form was written in a way that provided legal protection to the institution conducting the research, but did not provide a clear discussion about what Nebeker’s rights were as a human subject in the event of injury.

"If I became injured as a result of participating in the study, it was very vague on what would happen, almost to the point that I wouldn’t sign it," Nebeker says.

"I have asked study coordinators about the consent process and found that their understanding of what the participants’ rights are if injured vary, and most tend to assume, from reading the text within the consent form, that the institution will cover costs associated with injury," she adds.

If study coordinators are confused, it’s likely participants are not provided with accurate information at the onset, Nebeker notes. This is just one example of how information given to participants might be compromised during the process, Nebeker says.

Another Belmont Report principle that remains a challenge involves the third principle of justice, Kalichman says.

"Some questions have been raised about whether trials should be done in countries where citizens might not be able to take advantage of very costly treatment," he says. "The other side of it is why don’t we ask the same question about trials that include those who are underinsured in this country."

The ethical question of justice concerns whether the outcomes of new therapeutics or approaches to understanding disease have sufficient benefit to outweigh the risks of testing a population that might not, under normal circumstances, benefit from the treatment, Kalichman adds.

"It’s not that the principle is flawed, but we need to find clarity in some new way about how that principle needs to be applied," he says.