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May 12 — Business plans and other confidential information shouldn't be submitted to the NIH in a conflict-of-interest report because it could be made available to the public, the agency's grants compliance director advised May 12.
Any information provided to the National Institutes of Health is subject to the Freedom of Information Act, which is why Diane Dean of the agency's grants program recommended not submitting any confidential information to the agency. It's also why the NIH's financial conflicts of interest policy says research institutions should submit only key elements of a plan to manage conflicts of interest—such as the role and duties of the investigator and any safeguards to ensure objectivity in the research—but not the plan itself.
“Once we have it, it's subject to FOIA. We can try to protect it but we can't guarantee it,” she said during an NIH regional seminar in Baltimore. “If you've got sensitive information like that, don't send it to us.”
Dean is the director of the Division of Grants Compliance and Oversight in the Office of Policy for Extramural Research Administration (OPERA), which is part of the Office of Extramural Research at the NIH. She delivered a presentation on the Public Health Services' financial conflict-of-interest requirements, which the NIH led through sweeping reforms in 2011 (5 LSLR 875, 9/9/11). The new rule —the first update since 1995—lowered the minimum threshold for what investigators must disclose by half, to $5,000 from $10,000, and increased the types of interests that must be disclose.
“Our regulations are the floor. They're not the ceiling,” she said. “That's a great thing.” Institutions have the option of adding more rigorous requirements than what the NIH requires, which they often do to comply with state regulations. But if an institution incorporates stricter reporting requirements into its policy, such as a lower threshold for what must be disclosed, then that institution must stick to that lower threshold when submitting information to the NIH.
“Whatever your policy says, either $5,000 or lower, is what you have to comply with when you report to us,” she said.
At the same time, she cautioned that plans for managing investigator conflicts of interest are sometimes so restrictive that the investigator can't perform basic job duties. Dean said she has read conflict-of-interest management plans that are well-meaning but say that an instructor can't supervise employees or perform necessary laboratory work.
“And there could be a time when you can't manage it. It's just so much that you can't manage it adequately and still have this person participate,” she said.
These financial interests are actually a good thing, Dean said, because the NIH wants to encourage academic researchers to collaborate with the drug industry and other partners to solve important health questions.
“The only bad ones are unidentified ones,” she said.
Dean encouraged using the eRA Commons, an online interface where signing officials, principal investigators, trainees and post-doctorate researchers at institutions or organizations can access and share administrative information relating to research grants, submit financial conflict-of-interest reports for awardee and subrecipient institutions, or employ the eRA Commons' user guide and help desk when questions come up. She also recommended checking the NIH's frequently asked questions page, which is updated on a rolling basis.
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More information on the NIH regional seminar is at http://regionalseminars.od.nih.gov/baltimore2016/schedule.
More information on the NIH financial conflicts-of-interest policy is at http://grants.nih.gov/grants/policy/coi/.
The NIH FAQ page on financial conflicts of interest is at http://grants.nih.gov/grants/policy/coi/coi_faqs.htm.
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