2010-05-20
On May 20, the National Institutes of Health
(NIH) unveiled a proposal
to make several revisions to rules concerning disclosure of financial interests
and conflicts. A Notice of Proposed Rulemaking (NPRM) seeking to amend current
regulations governing "Responsibility of Applicants for Promoting
Objectivity in Research for Which Public Health Service Funding Is Sought"
will be published on May 21, and NIH will be soliciting public comments and
input for 60 days.
Noting that "managing financial conflicts of interest can be a major challenge because of the complex relationships
among government, academia, and industry," the NIH proposes to make several
revisions to the rules governing financial disclosure that have been in place
since 1995, including:
- Lowering
the threshold for determining if a "significant financial interest" exists to
$5,000 (from the current $10,000) for the value of any remuneration received
from a particular entity in the 12 months preceding the disclosure.
- Requiring
investigators to disclose to their institutions all “significant
financial interests” related to his/her institutional responsibilities and
research (current rules require an investigator to only disclose
interests they believe may either impact or be impacted by their NIH-funded
research).
- Requiring
institutions to review the "significant financial interests" disclosed by
investigators to determine those that may or may not impact NIH-funded
research. Institutions would then be required to disclose to NIH (or any
other Federal Public Health Service agency funding the research) the value of
the financial interest and the nature of that interest (whether it is equity, a
consulting fee, honoraria, etc.). Institutions would also be required to
post these financial interests on a publicly accessible website.
ASH will be reviewing this issue in detail and
submitting comments in response to the NPRM.
All ASH members are encouraged to submit any particular concerns or comments on
this issue to ASH Research Advocacy Manager Tracy Roades at troades@hematology.org.
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