Overview
The Individual (Research) Conflicts of Interest Policy, Institutional Conflict of Interest Policy, External Professional Activities Policy and associated supportive processes effectively address and ensure the objectivity of research conducted at WashU and such activities are not impacted by bias due to personal or institutional financial interests related to the research.
The Joint Research Office of Contracts (JROC) and the Office of Research Integrity & Ethics (ORIE) have existing SOPs requiring JROC and ORIE employees to disclose personal interests and recuse themselves from official activities on behalf of WashU related to their institutional responsibilities that could result in a conflict of interest, potential or otherwise.
WashU supplements these existing COI Processes for research project proposals, contracts, or awards that include requirements pertaining to Organizational Conflicts of Interest (OCI) such as Federal Acquisition Regulations (FAR 9.5) and Uniform Guidance (UG 2 CFR 200.318 (c) 2). This supplemental process address WashU researchers having a potentially unfair competitive advantage over other applicants in pursuing research funding opportunities or impaired objectivity in the implementation or conduct of the research. Based on the requirements of the funding agency or specific funding opportunity/Request for Proposals (RFPs), this process may be implemented prior to the submission of a proposal, during the contracting process, or prior to acceptance of an issued award.
See the Organizational Conflicts of Interest (OCI) Information Sheet for additional information.
Supplemental Disclosure, Identification, and Mitigation Process
In order to supplement the existing COI processes, the following steps are taken for research that includes OCI provisions :
- The PI or Department Administrator will notify the Office of Research Integrity & Ethics (ORIE) along with their Grant Analyst in OSRS and/or the contracting office when preparing a proposal for a funding agency with OCI requirements.
- The PI and/or other applicable individuals will complete the Supplemental Disclosure for Organizational Conflicts of Interest Form and submit the forms to ORIE.
- Applicable individuals include:
- The PI/PD of the project
- All Covered Individuals on the proposal as defined by the Individual (Research) Conflicts of Interest Policy
- Any other individual contributing in a substantive, meaningful way to the scientific development or execution of the project
- These forms are specific to OCI requirements addressing activities that are not typically required to be disclosed as part of the External Professional Activities disclosure and include:
- Providing scientific, engineering and technical direction to the sponsor (see FAR 9.505-1 for examples)
- Serving as an advisor and providing analysis, assistance or evaluation services to the sponsor
- Preparing specifications and work statements for funding opportunities
- Having access to proprietary, confidential or sensitive data in the custody and possession of the federal government and not readily available to researchers
- The identification and selection of subcontractors or sub-awardees on a research proposal
- Applicable individuals include:
- ORIE will evaluate the OCI disclosures for circumstances that could give rise to an OCI. ORIE conducts an OCI activities assessment of WashU’s financial interests and applicable individuals for the specific project.
- If no OCI, has been identified, the assessment is concluded.
- In the event a potential OCI is identified related to proposed or ongoing research at WashU, ORIE will work with the PI, applicable department(s), the Conflicts of Interest Review Committee (CIRC) or Institutional Conflict of Interest Committee (ICOIC), and Vice Chancellor for Research as necessary to develop a mitigation plan to address the OCI.
- Mitigation may include disclosure, recusal of individuals from certain activities, maintaining confidentiality of data (restricting access or establishing non-disclosure agreements), review of work by an independent third party, transfer research components to subcontractor or the requiring of bids or sole-source justifications for subcontracts.
- Documentation of the outcome of the OCI assessment (certification of no OCI or information on the conflict and mitigation plan) is communicated to the sponsor as required by federal regulation or contractual obligation.
- This process does not address financial conflicts of interest (FCOI). FCOIs for individuals and WashU will be addressed in accordance with the Individual (Research) Conflicts of Interest Policy and Institutional Conflict of Interest Policy.
Organizational Conflicts of Interest (OCI) Information Sheet
Organizational Conflicts of Interest (OCI)
An OCI is unique type of conflict of interest which may arise when members of an organization assist in the development of new federal programs or federal contract specifications, and that organization later competes for federal support through those new programs or contracts. This can result in circumstances in which WashU (or a WashU researcher), may have unequal access to information or the existence of a conflicting role(s) that might bias judgement in the proposal for, or conduct of, research. The existence of an OCI may mean WashU is unable or potentially unable to render impartial assistance or advice to the sponsor, WashU’s objectivity in performing the research is or might be impaired, or that WashU may have an unfair competitive advantage.
An OCI can occur when a member of WashU’s community is providing a sponsor with engineering, scientific, and technical direction, or advisory, analysis, assistance, and evaluation services, or preparing specifications and work statements, or acting in a capacity that gives them access to proprietary data.
Types of OCI include:
Unequal Access to Information
- An unfair competitive advantage resulting from the university obtaining information not generally available to others seeking federal funding.
Impaired Objectivity
- Assessing performance or evaluating products of someone within your own organization or a direct competitor seeking federal funding.
- Recipient is unable or appears to be unable to be impartial in conducting a subaward action involving a related organization because of relationships with a parent company, affiliate, or subsidiary organization.
Biased Ground Rules
- Having provided engineering or technical assistance or written the work requirements for a funding opportunity where someone within your own organization is an applicant.
Examples
- A faculty member in the School of Biomedical Engineering provides DARPA with technical direction for the development of a Broad Agency Announcement (BAA). If anyone from WashU submits a proposal pursuant to that DARPA BAA an organizational conflict of interest may be created (due to biased ground rules). There may be exceptions.
- A WashU researcher in the Department of Computer Science & Engineering collaborates on a project for Homeland Security and has access to confidential government information. Another researcher at WashU submits a proposal for funding to Homeland Security related to the same scientific area and would have an unfair advantage if he/she had access to the confidential government information of the other researcher (regardless whether or not he/she actually has access to the confidential information). This may create an organizational conflict of interest (due to unequal access to information).
- A WashU researcher wants to subcontract a portion of the research aims from a DOD grant to a company she co-founded.
- WashU receives royalties for licensed intellectual property (IP) developed by a WashU researcher. Another researcher at WashU submits for a Department of Defense (DOD) grant that will be evaluating the licensed IP. This may create an organizational conflict of interest (due to impaired objectivity or inability to remain impartial).
Note: Serving as a grant reviewer would typically not create an OCI.
Other COI Processes at WashU
The External Professional Activities Policy and program seeks to address Conflicts of Commitment that may arise as a result of professional activities not directly associated with the fulfillment of an individual’s teaching, research, clinical, or administrative commitments to the University.
The Individual (Research) Conflicts of Interest Policy and program seeks to assure that the objectivity and integrity of the researcher, university, and academic research, training, or other activities are not compromised or perceived to be compromised by considerations of personal gain or financial benefit.
The Institutional Conflict of Interest Policy and program seeks to ensure that the financial interests of the University and covered Institutional Officials are managed so that they do not compromise, or reasonably appear to compromise, the integrity of the University’s research mission activities.
These programs develop strategies to effectively and successfully manage financial conflicts of interest to assure the objectivity and integrity of research. The essential components of the COI programs are disclosure, review, assessment and determination, and management of conflicts of interest.
Related Policies
This process is not intended to replace other University policies or applicable laws and regulations. University members must also comply with the following related Policies: