Investigations of Unapproved Foreign and other External Research Relationships
As has been publicized, the National Institutes of Health is actively investigating cases where faculty failed to disclose outside research relationships. Francis Collins reported to Congress that “[t]here are multiple instances of faculty members who will not be faculty members anymore.” https://www.sciencemag.org/news/2019/04/universities-will-soon-announce-action-against-scientists-who-broke-nih-rules-agency. Congress and agency leads are focused on ethical violations related to a small minority of faculty who have entered into undisclosed or unpermitted research relationships overseas, which may have resulted in theft of intellectual property or theft of compensated effort, in violation of federal rules as well as university policies.
USC takes the matter of undisclosed and unmanaged relationships seriously. Failing to appropriately disclose these relationships is considered serious misconduct under the Faculty Handbook and will be referred for consideration of disciplinary action, up through and including termination.
Please be reminded of your obligations as USC faculty:
1) Investigators, other employees and paid students supported by federal R&D grants/contracts must complete the assignment of intellectual property (IP) to the university. The federal government and USC are concerned with the potential for IP theft. You are also required to promptly disclose your inventions to the university through the Sophia system: https://stevens.usc.edu/researchers/what-is-sophia/. Please see https://research.usc.edu/files/2018/09/Bayh-Dole-Obligations-2018.pdf for more information on your obligations under federal contracts and grants.
2) Faculty are not permitted to conduct research at other institutions without exceptional approval. USC policy provides as follows:
“6.2.3 Participation as a principal investigator, co-principal investigator, co-investigator, paid consultant or paid staff member on sponsored projects at another entity (as distinct from research collaborations with other entities via a subcontract or subaward to USC) must be disclosed to the appropriate dean and the Vice President for Research and are prohibited unless specially approved by the dean and the Vice President for Research.”
Please be particularly mindful that this policy applies to relationships at both domestic institutions as well as foreign institutions (e.g., China).
3) Disclosure to USC of Outside Professional Activity: Examples of relationships that require disclosure and approval include: consulting payments or ownership interests that benefit from your research and any consulting by clinicians to the pharmaceutical industry (whether or not research is involved). Please remember that a relationship cannot begin until approved. diSClose is the single portal for disclosing all outside interests at USC.
4) Annual Reporting for HHS Funded Faculty: Faculty and other investigators supported by Health and Human Services funding (including NIH) are obliged to “disclose to their institutions all of their significant financial interests related to their institutional responsibilities.” The required annual HHS disclosure must include all activities that relate to responsibilities at USC, including anything that relates to research, education or clinical activities.
5) Disclosure to Sponsors and Current/Pending Support: Principal Investigators and key personnel must disclose all current and pending support in connection with their proposals, which includes all financial resources, whether Federal, non-Federal, commercial or institutional, available in direct support of an individual’s research endeavors, including but not limited to research grants, cooperative agreements, contracts, and/or institutional awards. This includes all support for USC faculty research received from foreign sponsors, government or private, even if the funding does not go directly to USC.
What to Do? It is critical that external relationships for which you are personally paid (outside of USC compensation) and entail research of any kind are promptly disclosed, if they haven’t already. Such relationships may be approved as an exception, depending on the circumstances, if they do not conflict with your obligations to USC or obligations to your research sponsors, are permitted under the law, and do not compromise the objectivity and integrity of the research you conduct, or compromise USC’s reputation.
Monitoring: USC monitors policy compliance by cross-checking disclosures against Open Payments data and other public sources. Failure to file a required disclosure, initiating an activity without approval, and failure to comply with an approved management plan, are subject to USC’s disciplinary processes. Failure to comply with federal regulations can lead to additional consequences imposed by sponsors or other authorities.
Randolph W. Hall, Ph.D.
Vice President, Research
Professor, Epstein Department of Industrial and Systems Engineering
University of Southern California