Regulators increase scrutiny of clinical research
Circa 2008, IRBs face more pressures
Considering the question of whether there are new challenges, new laws, or new ways of looking at ethical decisions for institutional review boards, one major organization chair responsible for IRBs, responds: "I think it's kind of ratcheted up over the years, that's for sure."
Elizabeth L. Hohmann, MD, chair and director, Partners Human Research Committees, Brigham and Women's Hospital and Massachusetts General Hospital, says that regulations that mandate IRBS for clinical research studies that receive federal funding have been in place since the mid-70s, when the National Research Act was passed by the then-U.S. Department of Health, Education, and Welfare on July 12, 1974.
"But I think it's fair to say that there hasn't in the past been a lot of oversight," Hohmann notes. "[Now], there's more federal oversight, and there's more public interest, I think, in all aspects of this."
As an example, the Associated Press reported in mid-September that the National Institute of Mental Health released a statement that the government agency had dropped plans for what had been a study for a treatment for autism because critics had called it an unethical experiment on children.
Hohmann oversees about seven panels of institutional review boards ranging in size from eight to 10 people to the largest panel, which consists of about 40 people. These IRBs pore over and evaluate clinical research projects that range from a simple questionnaire to neurosurgical implants, she notes.
For example, currently, there is an accrediting body for institutions that conduct clinical research, called the Association for the Accreditation of Human Research Protection Programs in Washington, DC, similar, Hohmann says, to The Joint Commission's program for accreditation for hospitals, a seal of approval pursued relentlessly by many hospitals'leaders.
The Office of Human Research Protection, part of the Department of Health and Human Services, oversees clinical research programs and the institutions where they are conducted.
There also have been relatively recent problems that were "well publicized" and led to enforcement actions, she says — problems that "sent some shock waves through the research oversight community. . ." and which put the work of IRBs in the spotlight.
As a result of that spotlight, ". . . people are evaluating their programs, making sure they have the right processes, policies, or approach in place," Hohmann says. "I guess what I'm trying to say is that there are not necessarily news laws, but more specific guidance, clearer expectations of what's required."
Another organization, Public Responsibility in Medicine and Research (PRIM&R), Hohmann says is "the leading national membership group interested in research oversight and research ethics."
Cornerstone of clinical research
A paper called The Belmont Report, adopted by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research on April 18, 1979, is "the cornerstone of clinical research oversight in the U.S.," Hohmann says. She calls it a "seminal document" that provides the framework for ethical decision making regarding clinical research.1
According to the summary of The Belmont Report, one of the charges of the commission was "to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles."1
The report states that it was directed to consider:
- the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine;
- the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects;
- appropriate guidelines for the selection of human subjects for participation in such research;
- the nature and definition of informed consent in various research settings.
"The Belmont Report is sort of an overall framework, but it's a very lofty document that doesn't deal with the day-to-day kind of things that we encounter in medicine and research," Hohmann notes. "And sometimes, it's really easy to read through that and understand it, but implementing it can be a real challenge.
Difficulty in recruiting board members
"You know, there's the ethics, and always sort of the right thing to do, and then there's the things you'd like to do, and then, of course that's where the rubber meets the road – reality," she says. "What actually can you do? What is somebody who's funding the research going to pay for?"
According to federal regulations, there are specific guidelines as to the individuals that comprise an institutional review board. For example, IRBs must have at least one physician and one non-scientist, as well as at least one person who is in no way affiliated with the institution.
Each IRB must have at least five members.
Hohmann says that she looks for diverse membership for her institution's IRBs, as well as people who have formal training in medical ethics — not always an easy combination to find.
"Because in our IRBs, we see the entire breadth of biomedical research . . . we need a very broad expertise," Hohmann says. "And so, we'll go after, for members, everyone from the neurosurgeons to the physical therapists to the nurses to the patients, PhDs, and then our community members . . ."
"It can be a real challenge to find people who are interested and capable of the work that we ask of them," she says.
Reference
- The Belmont Report, April 18, 1979.
Sources
For more information, contact:
- Elizabeth L. Hohmann, MD, Associate Professor of Medicine/Infectious Diseases; Chair and Director, Partners Human Research Committees; Brigham and Women's Hospital and Massachusetts General Hospital, Boston.
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