External Professional Activities Policy | Conflicts of Interest

Original Effective Date: April 27, 2022

Purpose
Applicability
Disclosure Requirements
Disclosure Method and Frequency
Review
Identifying Overlapping Activities and Potential Conflicts of Commitment
Mitigating EPAs and Potential Conflicts of Commitment
Appeal Process
Non-compliance with this Policy
Definitions
Policy Approval
Potentially Applicable Other University Policies

1. Purpose

Washington University recognizes that activities and relationships with external organizations may further the professional development of faculty, foster beneficial collaborations and provide professional satisfaction. These relationships may be domestic or international with academic institutions, industry partners, foundations and other entities and may benefit the educational, clinical, and research enterprises of the University. While the University recognizes the importance and value of these external activities, this does not diminish the expectation for individuals’ primary professional commitment of time and intellectual energies be directed to fulfilling their duties and obligations to the University and supporting the University’s mission.

This policy establishes institutional standards around external professional activities. It prescribes disclosure and review requirements, strategies for structuring external relationships and addresses potential conflicts of commitment. Accordingly, individuals must structure their external professional activities in accordance with this policy and other applicable institutional requirements.

This policy is designed to support the following principles:

Promote the value of transparency through reporting;
Encourage appropriate international and domestic collaborations and relationships;
Support faculty to proactively comply with the policy requirements and applicable federal guidance and expectations;
Leverage the existing conflict of interest reporting process and mitigate redundancies with the University’s conflict of interest (COI) policies;
Minimize administrative burden where possible;
Provide mechanisms for review and guidance to the schools and departments; recognizing accepted practices of schools/disciplines;
Educate about activities needing review and approval that may create potential conflicts of commitment; and
Identify strategies to structure external relationships that adhere to University policies and address potential conflicts of commitment when they arise

The intention of this policy is to complement and function in tandem with other University COI policies and does not supersede, eliminate or reduce the requirements under those policies. When there is overlap, the Research, Institutional, and Clinical Care COI Policies take precedence over school decisions on external professional activities.

2. Applicability

Covered Individuals include:

All full and part time faculty (having a >0.0 FTE appointment) with an academic appointment of instructor or higher regardless of track (e.g. Tenure, Teaching, Investigator/Research, Clinical, Practice)
Any other individual who, regardless of title or position, is independently responsible for the design, conduct, or reporting of research at WUSTL as defined by the Research Conflicts of Interest procedures.

3. Disclosure Requirements

Additional Guidance on Disclosure Requirements Including Examples

External Professional Activities are defined as: Professional activities not directly associated with the fulfillment of a Covered Individual’s teaching, research, clinical, or administrative commitments to the University. Such activities generally rely on the professional, academic, or scientific expertise of the Covered Individual and often bring professional benefits to the Covered Individual. These activities may or may not involve remuneration.

Disclosure is required for all External Professional Activities that appear to be related to a Covered Individual’s professional, academic, or scientific expertise or Institutional Responsibilities regardless of remuneration, unless otherwise exempted below. Covered entities include: all foreign and domestic governments, institutions and entities; public or non-publicly traded companies; non-profit organizations; university/academic organizations, and government and professional societies.

Individuals should resolve any doubt about whether an activity should be disclosed in favor of disclosure.

Includes, but may not be limited to (activities denoted with * require prior approval):
1. *All academic, professional, scientific, or institutional appointments outside of WashU; includes any form of employment or engagement, research oversight, teaching courses or student advisory activities;
2. *Service, position, or role involving a fiduciary responsibility to an entity including service as member of the Board of Directors, an officer, a trustee, or any other executive or management position;
3. Voluntary service for an entity, including service on scientific or medical advisory boards (unless excluded below);
4. Personal activities that include or provide for:
  - *Employing undergraduate or graduate students, or University staff in an EPA creating overlapping supervisory/authoritative relationships;
  - *Using University resources, equipment or space to fulfill obligations related to an EPA beyond basic office equipment and supplies;
  - *Accessing resources, space, or making services available to third parties related to an EPA; including creating obligations on WashU to host or provide access to information or equipment to students/visitors as well as enabling an entity’s personnel to use WashU equipment or space
  - Receiving resources, or other financial support, for equipment or supplies that support WashU activities (when received outside a WashU contract/agreement).
5. *Serving as Principal Investigator on research not sourced or routed through WashU;
6. *Conducting research at or on behalf of another entity (including academic or research institutions, government, or non-profit) not within the scope of WashU research activities;
7. Reviewing grant applications for funding agencies (unless excluded below, e.g. U.S. funding agencies);
8. Any other benefit, agreement, service, or function with an entity not otherwise described above.
Unrelated activities and those excluded from disclosure:
1. Activities unrelated to a Covered Individual’s professional, academic, or scientific expertise (e.g. owning a rental property, other unrelated volunteer work);
2. Activities deemed necessary or expected for academic appointment progression that do not include remuneration:
  - Professional Membership: Membership in or serving on board or as officer of a U.S. academic or professional society;
  - Speaking, Conferences, & Seminars: Participating in scientific or educational conferences or other events while representing the University (e.g., serving as educational speaker, conference organizer, etc.); providing presentations or trainings for U.S. professional societies or academic institutions; planning/coordinating symposiums or conferences;
  - Academic Peer Review Activities: Reviewing proposals for a U.S. federal or state government sponsor, or a domestic non-profit organization; providing journal/editorial reviews; serving as a journal editor;
  - Consulting or mentoring on a U.S. federal grant outside the University (with no effort); and
  - Thesis/Dissertation: Serving as an external member of a thesis or dissertation committee at a U.S. academic institution.
    
    It is expected these activities would be documented on the Covered Individual’s annual performance evaluation.

External activities related to academic appointment progression or otherwise excluded from disclosure may be required if the total time commitment associated with all external activities exceeds, or is likely to exceed, an average of one day per week (e.g. 20%) of a covered individual’s time. Covered individuals are responsible for monitoring all external professional time commitments whether or not they are required to be reported under this or other university policies.

4. Disclosure Method and Frequency

All disclosures are submitted using the External Professional Activities Disclosure form using the COI Module in the Research Management System (RMS). Disclosure forms are routed through the applicable review processes and Designated Reviewers.

Disclosures must be submitted at least once a year or within 30 days for newly acquired interests or activities.
Prior Approval Requests must be submitted prior to engaging in the activity, and at least 30 days prior to the anticipated start date of the activity when possible.

5. Review

Addressing external professional activities differ across schools and departments, and therefore the ability to accurately ascertain the impact of external professional activities best resides within the schools and departments.

AUTHORITY

Deans of each of the schools shall identify Designated Reviewers within their areas with the appropriate expertise and authority to assess and manage EPAs. These individuals typically have final decision-making authority over:

Faculty appointments, salaries, and promotions; AND
Resource allocations necessary to support principal operations of their area (e.g. academic, clinical, research).

The Office of Research Integrity and Ethics (ORIE) shall conduct assessments of EPAs for compliance with institutional policies and school/department review requirements. ORIE shall identify and communicate activities needing review and/or approval by the Designated Reviewers or other individuals, as prescribed by this policy and corresponding procedures.

PRIOR APPROVALS

EPAs that present a higher risk for potential overlap with a Covered Individual’s Institutional Responsibilities or have the potential to create higher compliance risks for the individual or institution require approval prior to initiating the activity (before contract/agreement is signed or specific arrangements are made). Activities requiring prior approval are noted within the policy. No Covered Individual shall engage in these activities without first having obtained approval. Designated Reviewers shall evaluate prior approval requests in a timely manner.

Deans may identify additional activities requiring prior approval beyond those required by this policy. To maintain transparency with Covered Individuals, a list of all activities requiring prior approval, including those unique to a school will be maintained and available to the WashU community through a centralized resource.

ANNUAL REVIEW ASSURANCES

Designated Reviewers shall report, at least annually, the status of EPA reviews to the applicable Deans, provost and executive vice chancellor for academic affairs, and the executive vice chancellor for medical affairs and dean of the School of Medicine.

CENTRALIZED SUPPORT

The ORIE provides centralized support for the schools and departments by:

providing guidance on the policy and its implementation by departments such as disclosure requirements, prior approvals, and the identification and addressing of potential conflicts of commitment;
completing preliminary reviews as prescribed above and in accordance with applicable procedures; see EPA Disclosure Review Process for additional details;
coordinating EPA reviews and determinations, as appropriate, with other COI Programs;
ensuring appropriate documentation of EPA reviews within the COI module; and
coordinating and providing system support for disclosures and reviews.

6. Identifying Overlapping Activities and Potential Conflicts of Commitment

Part of the intent in reviewing certain professional activities is to address those that could reasonably appear to:

influence the way the individual performs Institutional Responsibilities;
impair an individual’s availability or judgment in performing Institutional Responsibilities or making decisions that are in the best interest of WashU; or
induce an individual to disclose confidential or proprietary information acquired through the performance of Institutional Responsibilities.

A ‘Conflict of Commitment’ (COC) is defined as: A situation caused when an individual undertakes EPAs that may interfere with his or her primary obligations and commitments to the University in terms of time, responsibilities, resources, and dedication, even if the outside activity is valuable to the university or contributes to professional development and competence. This includes situations in which the external commitments create an overlap of resources between WashU and the external entity, or actions of the individual indicate a prioritization or dedication to external activities resulting in a potential detriment to the University, including students, research, patients, or colleagues.

Activities that represent conflicts of commitment include but are not limited to the following:

Exceeding the time allotments for external activities allowed under the Faculty Consulting Privileges Policies, including activities that are otherwise not required to be disclosed under this policy, as noted above;
Using University resources in activities that may lead to personal gain for the faculty member (or their immediate family) or to benefit the entity;
Unauthorized or inappropriately using University resources for personal external activities;
Activities interfering with or detracting from a Covered Individual’s Institutional Responsibilities;
Putting the interests of another entity on equal or greater footing than the University that negatively influences University decisions, such as contracts, hiring, research, or in advisory roles; and
Personally acquiring, from an entity associated with the individual’s EPA, information, materials or resources to use in fulfilling one’s Institutional Responsibilities.

7. Mitigating EPAs and potential conflicts of commitment

A. MITIGATING EXTERNAL PROFESSIONAL ACTIVITIES

Prior approval is required, under the processes described in this policy, for any academic, professional, or institutional appointments outside of WashU that include any form of employment, research, teaching or substantive student advisory activities with a U.S. academic institution, any foreign entity (government, non-profit, for-profit, university/academic organization), or any public or non-publicly traded company.
The Covered Individual must ensure the terms of personal agreements, such as confidentiality, intellectual property terms, or commitment of time are consistent with the individual’s obligations under applicable University policies. Personal agreements must not create contractual obligations that could put the individual at risk for abrogating their ability to comply with University policies. For additional guidance, refer to Guidance for Personal Agreements or the Clinical Care COI Policy Consulting “Do’s and Don’ts”. Additionally, the University must not be included as a party in any personal agreement entered into by the Covered Individual. Neither the individual nor the agreement should imply any connection between the University and the activity or an endorsement of the outcome. Furthermore, use of University resources is not permitted to satisfy personal obligations under such personal agreements.
Contracting for services, products, materials, or other resources on behalf of the University from an Entity in which a Covered Individual has an EPA requires justification to ensure the activity is appropriate and remains in the best interest of the University. External activities involving the use of University facilities, materials, services, personnel or students, or information requires prior approval and a written agreement negotiated by the appropriate University office.
Activities able to be conducted by/at the University shall be given priority as a University activity over pursing the activity as a personal activity.

B. MITIGATING CONFLICTS OF COMMITMENT

If it is determined that a Covered Individual has a Conflict of Commitment resulting from an EPA, the Designated Reviewer shall prescribe actions necessary to manage the conflict, which may include requiring the Covered Individual to:

reduce the amount of effort/time engaged in an EPA;
alter the scope of work affiliated with the EPA;
discontinue the EPA activity entirely;
obtain additional bids for services/products/materials or provide sole-source justifications;
recuse themselves from University roles for decisions involving the Entity (e.g. vendor selection); and/or
apply other conditions or actions as needed to appropriately address the conflict.

8. Appeal Process

Unresolved disagreements concerning the determinations of Designated Reviewers shall ultimately be referred for final resolution to the Dean of the applicable School or Provost, as appropriate.

9. Non-Compliance with this Policy

Failure to comply with the requirements of this policy may subject the Covered Individual to corrective actions or other sanctions as deemed appropriate by the Dean. For potential failures related to research activities, consult the vice chancellor for research to determine what reviews, reporting requirements, and corrective actions/sanctions are required.

10. Definitions

Conflict of Commitment (COC): refer to section VI.
Covered Individual: refer to Section II, Applicability.
Designated Reviewer: refer to Section V(A), EPA Review, Authority.
External Professional Activity (EPA): refer to section III.
Institutional Responsibilities: a Covered Individual’s professional duties and responsibilities on behalf of the University. These may include, but are not limited to activities such as research or other scholarly inquiry, education, professional practices, clinical activities, administration, institutional committee membership, and service on panels such as internal review boards and data and safety monitoring boards (as defined under the Research Conflicts of Interest Policy).

11. Policy Approval

Approved by University Council on October 20, 2021, with review by Faculty Senate Council and Medical School Executive Faculty.

12. Potentially Applicable Other University Policies

Download the External Professional Activities (EPA) Policy (PDF).

Contents