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What impact will Obama administration have on human subjects research?
Experts cite several possibilities
President Barack Obama's long-stated goal for universal health insurance could have a ripple effect on the human subjects research field, possibly removing an incentive for people to enter clinical trails. That is one of several possible changes on the horizon as a new administration takes the helm, experts tell IRB Advisor.
"The major issue is affordable medical care insurance for all," says Paul W. Goebel, Jr., CIP, president of Paul W. Goebel Consulting Inc. of Monrovia, MD. "If something passes there might be small changes to the regulations affecting research."
Moreover, if more Americans have access to affordable health care then there might be an indirect impact on human subjects research recruiting, Goebel suggests.
"There are people now taking part in studies because they can get access to health care during the study when they might not have access otherwise," Goebel says. "I don't know if this [incentive] will go away -- it all depends on the details of what they finally come up with."
From an IRB perspective, recruitment for the purpose of obtaining health care would not be a hidden motive to consider if potential subjects already have access to health care, Goebel adds.
Some other possible changes can be seen from bills that have repeatedly been introduced in Congress only to go nowhere in a Republican administration. These might gain support in the next year.
For example, U.S. Rep Diana DeGette (D-CO) introduced in September, 2008, an amendment to the Public Health Service Act. DeGette has introduced this amendment numerous times with the purpose of reforming the U.S. human protections system to plug-in some of its holes, says Jerry A. Menikoff, MD, JD, director of the Office for Human Subjects Protections (OHRP). (See story on potential federal bills.)
Current human subjects protection regulations have jurisdictional triggers, Menikoff says.
"You have to be federally financed, or you have to be dealing with an FDA-regulated product," Menikoff says. "So you could be doing substantial and risky research and not be federally financed and not be subject to any of these rules."
Many regulatory review bodies have voiced complaints over this gap.
"One of the goals of the DeGette bill is to plug in the holes in the system in terms of having the rules cover more research," Menikoff says.
"So basically, if you were doing human subjects research in this country you would be subject to federal regulations regardless of whether or not it was federally funded or dealing with an FDA-regulated product," Menikoff explains.
If the new Congress and president decide to support this bill, then it could possibly pass and eliminate human subjects research protection loopholes, he notes.
Such a change would not add a tremendous amount to OHRP's workload, but it finally supplies an answer to the ethical question of "Why shouldn't people who aren't being protected now be subjects with some protections?" Menikoff says.
"The issue is whether you should or should not be providing protections to people," he adds.
Stem cell research on way?
Another possible change would be the lifting of the ban on federal funding of stem cell research, says J. Mark Waxman, JD, a partner with Foley & Lardner in Boston, MA.
"This would lead to an increase in the number of stem cell trials," Waxman says.
DeGette in the fall of 2008 sponsored an amendment to the Public Health Service Act to provide for human embryonic stem cell research and to direct NIH to issue guidelines for stem cell research. Nothing has happened on the bill so far, but this could soon change since Presdent-elect. Obama has said that he supports lifting the ban on federal funding of stem cell research.
"If Obama lifts the federal ban on stem cell research funding, then that will open the door to more stem cell research," Goebel says. "I think as it becomes more common, there will be a lot of extra work [for IRBs] right at the start."
But as IRBs think through the ethical issues and the human subjects protection community reaches consensus on how to handle these studies, then there will be less uncertainty, he adds.
"Someone will come up with a flow chart of what to do when you're presented with these issues," Goebel says.
One change could be that research institutions are required to have a special oversight committee look at stem cell research proposals, which may or may not be sent to the IRB.
"A lot of this depends on how the studies are conducted," Menikoff says. "But it's certainly true now and it could be true in the future, depending on how it's done, that this type of research may not come under 45 CFR 46."
Some research on stem cell lines might involve a human subject, and others may not, Menikoff says.
"If you are asking somebody to donate some of their materials to create a new fertilized egg, for example, then that part would probably involve human subjects research," he explains.
In other cases, stem cell research might be handled in a similar way to how studies using tissue samples are handled, Menikoff adds.
"Therefore, you get into the same issues that you do with tissues right now, and that doesn't necessarily end up going under IRB review," Menikoff says.
Another bill to watch is the Fair Access to Clinical Trials Act, which would strengthen a national data base of clinical trials information, Waxman says.
But the bill that could have a significant impact on IRBs is the Physician Payments Sunshine Act of 2008, which calls for transparency in physician relationships with pharmaceutical and device companies, Waxman says.
"It's been pending in Congress for the last couple of years," Waxman says. "A number of states are looking at the relationship between physicians and drug/device companies, so IRBs may want to take another look at conflicts of interest policies."
This bill highlights the need for IRBs to focus on conflicts of interest again, Waxman adds.