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New rules spark key research questions

Universities prepare to meet stiffer disclosure requirements

Research institutions that take funding from the National Institutes of Health will soon have to comply with a new set of financial disclosure rules issued in August.

The rules revise previous conflict-of-interest regulations implemented in 1995, and in doing so highlight a range of complicated issues, such as the relationship between industry and the academy, the potential for bias in science, and the public’s trust in medical research.

In announcing the new rules, NIH Director Dr. Francis S. Collins said the rules ensure research is conducted with the highest scientific and ethical standards.

“Strengthening key provisions of the regulations with added transparency will send a clear message that NIH is committed to promoting objectivity in the research it funds,” Collins said.

The new rules lower the monetary threshold at which researchers must report a financial interest, from $10,000 to $5,000. They also require institutions to track such disclosures, and make them available to the public upon request. The rules also shift the onus to deal with potential conflicts to institutions, rather than the scientists themselves. All NIH-funded institutions must comply by August 2012.

Judith Neubauer, associate vice president of research and regulatory affairs at the University of Medicine and Dentistry of New Jersey, said her school already has a fairly robust disclosure requirement for faculty members.

“We do have an electronic system that captures that (data), but we have to upgrade that a bit,” she said. “That’s really one of the major expenses that these new rules are going to place on academic institutions.”

Under UMDNJ’s system, a committee reviews any potential conflicts. If a true conflict is found, the committee designs the study in such a way to avoid the conflict, which could include using controls like “blinding,” where certain information is omitted to prevent a researcher from unduly influencing the results.

Neubauer said institutions must create a culture of disclosure, because it’s very difficult to determine whether bias exists after research is already done.

Kate Greenwood, a researcher and lecturer in law at Seton Hall Law School, said the issue is one of trust and human nature.

“A conflict of interest just creates a risk that your judgment will be affected by a secondary financial interest,” Greenwood said. “Your primary interest is supposed to be research integrity, and protecting research participants’ safety and welfare.”

Kathleen Scotto, senior associate dean for research at UMDNJ’s Robert Wood Johnson Medical School, said researchers pride themselves on their science, so the disclosure requirements took some getting used to back in 1995.

“When the whole concept of conflict of interest started, the faculty were so offended that anyone would suggest that a pen, a coffee cup or even $500 would in any way inspire them to do anything but pure science,” Scotto said.

Now, most faculty members have come around to see the necessity of disclosure.

Scotto said it’s important for top researchers to collaborate with companies, because that ensures the best science will reach patients. She said the majority of relationships between industry and academic researchers don’t introduce bias, and Neubauer said conflict of interest findings are rare at UMDNJ. Still, Scotto worries that the growing public perception is the opposite.

Greenwood concedes there is a risk that such disclosures could potentially undermine public trust in research. But she thinks those concerns are outweighed by the benefit of giving the public, academics and journalists access to information they could use to provide context to medical studies.

“A huge advantage of government-funded research is we can trust the results,” she said. “To be spending our money and not be sure we can trust the results seems wasteful to me.”

The rules came about in part because of the advocacy of U.S. Sen. Charles Grassley, of Iowa, the GOP’s ranking member on the Senate Finance Committee. He uncovered several instances of researchers not disclosing financial relationships that could have affected their research.

Researchers sometimes get speaking or consulting fees from drug companies, and researchers also may have interest in companies or intellectual property that could be affected by the outcome of their research.

Grassley criticized the new rules because they dropped a provision requiring the disclosures to be posted online.

“It’s easier to look up information online than to find the right addressee, write the letter and wait for a response,” Grassley said in a press release. “This is a missed opportunity to inject transparency where it’s really needed.”

Greenwood also has qualms with the rules. For instance, they don’t address institutional conflicts of interest, nor do they address intellectual property equity.

Still, Neubauer said ultimately it’s in everyone’s interest that the science be correct.

“We want the science to be true,” she said. “I think that good science is unbiased science, and it’s reproducible, and it moves the field ahead, and it created commercializable products and it helps benefit everyone.”

E-mail to: jkaltwasser@njbiz.com
On Twitter: @JaredKaltwasser

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