Changes to the SOM COI policy - 2012
The table below summarizes disclosure requirements for faculty and other investigators that will be in place in April 2012, in response to revisions in the new Public Health Service COI policy (referenced below). Refer to the School of Medicine Policy on Conflict of Interest and Conflict of Commitment for detailed definitions of financial interests and disclosure requirements.
Note: previously, disclosure was required for all external financial interests; effective April 2012, disclosure will be required only for financial interests related to the individual's institutional responsibilities (IRs).
| Activity/source of income | Old requirement | New requirement |
Source |
| Thresholds for disclosure of financial interests: | |||
| Publicly traded company: ownership, income | >3%, >$10K | n/a | Virginia |
| Publicly traded company: total
(ownership+income) |
n/a | >$5K | PHS |
| Non-publicly traded company: ownership |
>3% | >0% | PHS |
| Non-publicly traded company: income |
>$10K | >$5K | PHS |
| Sponsored and reimbursed travel | >$10K (sponsored travel only) |
Related to IRs |
PHS |
| Exemptions from
disclosure (for ownership, income, travel): |
|||
| Option 1 consulting (faculty-company contract) |
Disclose | Disclose | SOM/PHS |
| Option 2 consulting, grants & contracts |
Exempt | Exempt | SOM/PHS |
| Grant panels, seminars (gov. agency, acad. inst.) |
Exempt | Exempt | SOM/PHS |
| Grant panels, seminars (non-profit) |
Exempt | Disclose | SOM/PHS |
Investment vehicles such as retirement or mutual funds* |
Exempt |
Exempt |
SOM/PHS |
* where the faculty member does not control the investment decisions of those vehicles (e.g., purchase/sale of component stocks)
Sources of disclosure requirements:
PHS: Public
Health Service policy, "Promoting Objectivity in Research,"
8/25/11.
SOM:
SOM Policy on Conflict of Interest and Conflict of
Commitment. Includes the "SOM rebuttable presumption"
that institutional approval is required in order for financially
conflicted investigators to participate in human subjects
research.
Virginia:
Virginia State COI statute.
Travel disclosures:
Faculty must disclose the destination, sponsor, number of days,
and reason for travel (but not the cost of the travel) for all
externally sponsored/reimbursed travel outside of University
agreements.
Contact for additional information:
Steven
Wasserman (Assistant Dean for Research).
