Original Effective Date 09/30/2003
Last Revised Date 08/16/2018
All faculty with an academic appointment of instructor or higher and all individuals, who by definition have independent responsibility for the design, conduct, or reporting of research at WU are required to proactively submit a disclosure:
- at least annually;
- within 30 days of acquiring a new financial interest; or
- when they initiate new research projects.
Upon request by the Office of Research Integrity & Ethics (ORIE) or the Office of Sponsored Research Services (OSRS), other individuals covered under this policy that my be required to submit a disclosure:
- Individuals entitled to receive remuneration from licensing agreement or hold equity ownership in a non-publicly traded entity as described under COI Procedures: Who is required to submit a financial disclosure ( C ).
- Individuals designated by the PI as being independently responsible for the design, conduct, or reporting of research.
- Study team members listed on HRPO application with a financial relationship related to the research project.
- Subrecipients that defer to WU’s policies and process.
a. Sponsored Research Projects (e.g. grants or contacts)
For Proposals: Annual Financial Disclosure Statements (FDS) or COI Certification (see How to Disclose) for all covered individuals must be received by the Conflict of Interest Review Committee (CIRC) prior to the submission of an application to the Public Health Services, the National Science Foundation, the American Heart Association, or any other agency requiring disclosure at the time of proposal submission.
For Award Acceptance/Set-up: For all other research funding sources, the FDS or COI Certification (see How to Disclose) for covered individuals must be received by the CIRC prior to acceptance/set-up of an award. Regardless of research funding source, the FDS must be reviewed by the CIRC and any necessary management plans implemented prior to any expenditures under the award (e.g. acceptance/award set-up).
Typically, subrecipients will provide, when required, appropriate assurances and certifications to WU regarding COI at the time of submission of the grant/contract. For example, for PHS grant applications, the subrecipient will provide, at the time of submission, a signed face page, letter of intent, or consortium letter providing the appropriate assurances and certifications regarding federal regulations, which includes conflicts of interest. However, if the subrecipient cannot provide the appropriate assurances that it has COI policies and process that comply with 42 CFR Part 50 or 45 CFR part 94, then the covered individuals under the sub-agreement will be required to comply with WU’s COI policies and process.
c. Human Subjects Research
Any individual engaged in the design, conduct, or reporting of human subjects research (anything needing the Institutional Review Board (IRB) approval) must report in each protocol application, any personal financial interests related to the research. For example, an individual should disclose any financial interests with the sponsor of the study, the supporting organization, or the company that owns or licenses the technology/drug being studied. It is the PI/PD’s responsibility to ensure that the protocol application reflects the appropriate disclosures for all study team members.