HHS guidance on financial conflicts puzzles some
Some call it vague
The U.S. Department of Health and Human Services (HHS) has managed to calm some concerns about federal guidance on financial conflicts of interest and research, but new issues have arisen.
Unlike the proposed guidance published several years ago by the Office for Human Research Protection (OHRP), the draft guidance published March 31, 2003, in the Federal Register offers more questions to be considered than specifics to be followed.
The toned-down approach appeals to some people who had comments and criticism of the earlier guidance.
"They had softened it to a great extent from the language of that earlier guidance, which didn’t seem like guidance at all because it had a tone of how IRBs should do this and they shouldn’t do that," says Ann J. Gellis, JD, associate dean for research compliance in the Office of Research and University Graduate School at Indiana University in Bloomington.
The current guidance proposal is more flexible and will allow different organizations to fashion their own policies to fit their institutional and organizational needs, she adds.
Others find fault with the guidance’s flexibility.
"I felt it was overall too vague," says Steven C. Schurr, an attorney in Chicago. He represents site management organizations and has worked as a clinical monitor for research.
Although the guidance offers some examples of conflicts of interest, it is vague on the details of resolving conflicts of interest, he says.
"The part that concerns me the most is the last section about receiving payment per participant," Schurr says.
The guidance asks IRBs and institutions consider ways to examine the issues, including whether individuals or institutions receive payment per participant or incentive payments and whether those payments are within the norm.
Schurr says he wants to know what the norm is and how an IRB or institution may determine when a payment falls outside this norm. The federal guidance offers no more information on the matter.
This point is particularly important to site management organizations, which are small businesses affiliated with a clinic for the purpose of research, he says.
"These companies subsist on landing pharmaceutical contracts," Schurr explains. "The way the contracts are written they get paid per patient they enroll, so their whole revenue comes from this, and everyone’s job depends on their getting contracts and enrollment."
One could argue that such arrangements are inherent conflicts of interest and there is an incentive to enroll patients who don’t fit the criteria, he notes. "But pharmaceutical companies want good data — not bad data, and they monitor and reward sites for doing a good job."
So Schurr’s question is whether these arrangements are something that should be noted by the IRB as a conflict of interest and whether a conflict of interest committee needs to make a determination about such an arrangement and require corrective action.
One early comment submitted to HHS about the guidance suggested that the addition of a waiver would make the guidance stronger and provide better human subjects protection.
In the first comment submitted to the Food and Drug Administration, posted April 4, 2003, the Alliance for Human Research Protection of New York City, suggested that HHS include with its guidance a model affidavit that investigators, IRB members, and others would sign to attest to their having no significant conflicts of interest.
However, some university research officials say they already have checks and balances in place, and the proposed guidance is fine as it is.
"Basically, I’m pleased with it," Gellis says. "We have set up a conflicts of interest committee, and we have specific questions on our form related to conflicts of interest."
If the government were to mandate specific procedures it would create more problems, Gellis adds.
First, it’s difficult to convince faculty to buy-in and comply with procedures that may not be a good fit for a particular institution, and secondly, it makes the process a rigid, one size fits all.
"That’s always the problem with human subject regulations, because they’re designed for clinical research, and so those doing behavioral and social science research say this doesn’t fit what they do," Gellis explains.
The guidance as it now is written allows institutions to develop procedures that are best for their particular institution, while simultaneously giving IRBs and institutions a consensus of best practices, she says.
Although the guidance creates no new regulations or requirements it will and already is having an impact on how academic institutions handle financial conflicts of interest and research, says Kathy McClelland, research compliance director of Stanford (CA) University.
"Academic institutions will change policies with regard to the guidance," McClelland says.
Stanford already has a strong program for protecting against financial conflicts of interest, and it continues to be improved, McClelland says.
In the early 1980s, the university implemented conflict of financial interest policy into the IRB system, and within the past five years, the policy has been revamped according to federal guidance, McClelland adds. "We’ll do so with this guidance, as well."
Also, Stanford has a strong conflict of interest committee that keeps in close communication with the IRB. The IRB’s protocol form includes questions about conflicts of interest, and this form is sent to the conflict of interest committee when an investigator indicates any sort of conflict of interest, McClelland says.
While the committee assesses the conflict of interest, the IRB goes forward with assessing the protocol’s risks and benefits and informed consent form. However, there have been instances when the conflicts of interest committee has informed the IRB that a particular protocol has potential conflicts of interest that make it unsuitable for Stanford, McClelland says.
[Editor’s note: The proposed guidance, called "Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subjects Protection," may be viewed on the Internet at http://www.fda.gov/OHRMS/DOCKETS/98fr/03-7691.html.]
The draft guidance on financial conflicts of interest and research published March 31, 2003, in the Federal Register offers more questions to be considered than specifics to be followed.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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