The Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) recently published a follow up report from January 2008 on “How Grantees Manage Financial Conflicts of Interest in Research Funded by NIH.”
The report focused on the fact that 90% of the institutions that get NIH money–$29.5 billion in FY 2008—“rely solely on researchers’ discretion to determine which of their significant financial interests are related to their research and are therefore required to be reported.” As a result of this practice, OIG listed its findings and policy recommendations, which are very similar to the 2008 report.
OIG first noted that institutions receiving grants must already have a written policy for identifying financial conflicts of interest, and ensuring that such conflicts are managed, reduced, or eliminated by enforcing administrative processes. Grantees must also certify:
– That existing conflicts (but not the nature of the interest or other details) will be reported to NIH prior to the expenditure of any funds under that award;
– That these conflicts have been managed, reduced, or eliminated; and
– That any subsequently identified conflicts will be reported and will be managed, reduced, or eliminated, at least on an interim basis, within 60 days of identification.
The November 2009 report collected information from each of the 41 grantee institutions that reported conflicts to NIH in FY 2006. The report found that “the most common type of financial conflict of interest among NIH-funded researchers is equity ownership, (including stock and stock options) in companies in which the researchers’ financial interests could significantly affect the grant research.”
The average equity value for researchers was $232,464 and the median was $22,500. The average dollar amount of the compensation for all researchers was $79,248 and the median was $23,000. To date, only nine cases that involved NIH-funded researchers have been made public by the Senate Finance Committee staff.
In managing these conflicts, “Grantee institutions frequently disclosed the conflict in publications and/or presentations in which research results are presented.” As a result of this practice, “NIH found no instances of intentional noncompliance by grantee institutions” in disclosure.
Still, the report indicated that “vulnerabilities exist in grantee institutions’ identification, management, and oversight of financial conflicts of interest.” OIG stated that “specific financial interests of NIH-funded researchers are often unknown; grantee institutions do not routinely verify information submitted by researchers; conflicts were not uniformly reported by grantee institutions; the majority of grantee institutions do not have policies and procedures to address subgrantee compliance with Federal regulations regarding conflicts; grantee institutions lack documentation to support their oversight of conflicts; and grantee institutions are not required to report to NIH any financial interests that they have with outside companies.
Recommendations
To address these vulnerabilities, OIG recommended to NIH that increased oversight is needed to ensure that (1) these conflicts are managed appropriately, (2) the research conducted using Federal funds is not biased by any conflicting financial interests of researchers, and (3) human subjects are not subjected to unnecessary risks. Other recommendations that NIH will consider are:
– Require grantee institutions to collect information on all significant financial interests held by researchers and not just those deemed by researchers to be reasonably affected by the research.
– Require grantee institutions to collect information on specific amounts of equity and compensation from researchers.
– Overall, the NIH did not state whether it concurs or does not concur with OIG’other recommendations. “NIH also stated that many of the report findings were not made within the context of the current financial conflict-of-interest regulation and therefore, many of the recommendations are difficult to assess and/or cannot be implemented.”
OIG also made the same recommendation from its January 2008 report that NIH “request grantee institutions to provide details to NIH regarding the nature of all reported financial conflicts of interest and how they are managed, reduced, or eliminated.” NIH, as in January 2008, did not concur with this recommendation.
“NIH stated that the responsibility for identifying and managing conflicts must remain with grantee institutions and that collecting such information would effectively transfer the responsibility to the Federal Government.”