System and Technical Questions
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External Professional Activities (EPA) Overview
Washington University is implementing a new External Professional Activities (EPA) Policy to align with updated requirements from federal funding agencies and enable Schools/Departments to assess for conflicts of commitment. This policy supplements existing financial disclosure requirements established under WashU’s current conflicts of interest policies.
- All faculty must disclose external professional activities (EPAs) conducted with entities other than Washington University, even if individuals are not compensated for these activities.
- Some activities may require Department/School approval prior to engaging in the activity.
The policy went into effect on April 27, 2022.
- All full and part-time faculty with a >0.0 FTE appointment with an academic appointment of Instructor or above
- Certain individuals who are independently responsible for the design, conduct, or reporting of research.
All professional activities with entities other than Washington University must be disclosed, even if the individual is not compensated. EPAs generally rely on the individual’s professional, academic, research, or clinical expertise. Examples include:
- Teaching a summer course at another institution*
- Serving on a Board of Directors*
- Voluntary service on a scientific advisory board
- Reviewing grant applications for a non-US funding agency
- Serving as Principal Investigator on a project on behalf of another organization outside of WashU*
* Prior Approval is required before engaging in or agreeing to this type of activity.
- Professional development activities necessary for academic advancement (e.g. being a member of a professional society, presenting or speaking at a conference on behalf of WashU, reviewing grant proposals for a US federal agency).
- Non-professional activities not related to your university appointment (e.g. unrelated volunteer work, owning/operating rental property)
- Prior approval is required for activities more likely to overlap with a covered individual’s institutional responsibilities. Deans may identify additional activities requiring prior approval.
- Examples of activities requiring prior approval include academic, professional, scientific, or institutional appointments outside of WashU including any form of employment; conducting research on behalf of other entities, taking on fiduciary or managerial roles or positions, or activities that involve using WashU resources to fulfill obligations related to the external activity.
- Approval must be granted by the university before agreements are made with the external entity.
- For physicians and health professionals:
- Expert Witness Services including any expert witness consultation or testimony (per Expert Witness Policy)
- Entity-supported educational lectures as defined by the Clinical COI Policy, including CME and non-CME entity-sponsored events.
- Health Professionals Only: Consulting or other professional services provided to an Entity (as defined by the Clinical COI Policy)
- Activities will be entered into the current disclosure system used for financial and travel disclosures: the Research Management System (RMS).
- The Prior Approval form should be used to request authorization from your school/department to initiate any new activity if prior approval is required. Approved activities will automatically be pulled into the comprehensive disclosure required to be completed at least annually.
- If prior approval is required, the request must be submitted before engaging in the activity, preferably at least 30 days prior to the anticipated start date.
- Ongoing activities must be disclosed at least once a year. New activities not requiring prior approval must be disclosed within 30 days of their start.
Deans of each school have identified Designated Reviewers, individuals with the appropriate expertise and authority to evaluate external activities and prior approval requests to determine if those activities create a potential conflict of commitment. Additionally the Office of Research Integrity and Ethics is providing administrative support to the Schools for this policy.
Applies to all part-time/full-time faculty (Instructor or higher with >0 FTE appointment). This includes Instructor; Senior Instructor; Assistant, Associate, or Teaching Professor; Professor; and Professor of Practice (Lecturers, Senior Lecturers and volunteer/adjunct faculty are typically not considered covered individuals.
Adjunct faculty with >0 FTE appointments are considered part-time faculty and are Covered Individuals under the EPA policy. However, adjunct faculty with 0 FTE appointments are not considered a Covered Individual.
Faculty appointments that have 0 FTE appointments are not automatically covered under this policy. However, any individual, regardless of position or title and including those described above, is covered under the policy and required to disclose if identified as having an independent responsibility for the design, conduct, or reporting of research.
Non-tenured faculty (with the exceptions of Lecturers and Senior Lecturers as noted above), with a >0 FTE appointment, are considered Covered Individuals.
For non-faculty appointments the policy applies only to individuals identified (by the PI or by definition of role) as having independent responsibility for the design, conduct, or reporting of research (e.g. listed as Key Personnel, mentors on fellowships)
For example, this could include staff, students, trainees, visiting researchers, and ACGME and Non-ACGME fellows.
EPA Disclosure Requirements
No, if the contract underlying your services is an agreement between the entity and the University, these activities are considered part of you Institutional Responsibilities (as defined in the policy) and you do not need to disclose them.
In general, you do not have to disclose activities that are not related to your professional, academic, or scientific expertise or Institutional Responsibilities unless the time devoted to them interferes with your obligations to the University.
Yes, if those activities are included in the disclosure requirements defined by the EPA policy.
Any Activities specifically included as part of the McDonnell Academy Ambassador role, such as recruiting students to WashU or facilitating collaborations between WashU investigators and the outside entity do not need to be reported. All additional activities with the outside entity, including any appointments, teaching or lecturing activities, research support received, talent programs or research projects not contracted through WashU must be disclosed.
Yes, this should be disclosed if the fellow is a Covered Individual.
Disclosure of professional society membership is not required unless you have effort in your role. For example, if you are serving on the board and have an official role or set of responsibilities such as coordinating society events; time would be required for this role and thus would fall under reporting requirements for External Professional Activities.
EPA Prior Approval Process
Yes, a prior approval request does need to be submitted before engaging in a new, or significantly modified, activity with an entity, even if other activities for that entity have been previously reviewed and approved.
For example, someone who had previously received approval to serve as a member of the Board of Directors for a startup would need prior approval before taking on the role as National PI for a research project for that same entity.
Activities that were already ongoing at the time the policy went into effect will need to be disclosed on the External Professional Activities Disclosure form (EPAD) and discussed with your supervisor, however it is not necessary to submit an EPA Prior Approval Request. New activities that require prior approval, even for the same entity, will need to receive prior approval before engaging in the activity.
Entering Time Commitments
For all External Professional Activity (EPA) disclosures, whether through the annual disclosure process or prior approval requests, time commitments associated with each activity must be reported. The Consulting Privileges Policy allows for an ‘average of one day per week’ for external activities.
Based on feedback from schools, there is general consensus to define the ‘one day per week’ for external professional activities as 10 hours across the university. This definition of time does not supersede the Consulting Privileges Policy, but rather provides additional granularity by quantifying the ‘one day per week’ allowance as 10 hours. Additionally, given the variable ways time has been reported for external professional activities, it has presented a challenge for data collection and reporting.
To meet reporting requirements, it is necessary to provide a uniform measurement for faculty to report time commitments, specifically in hours per year. Defining ‘one day’ as 10 hours allows for the following conversions:
- 1 day = 10 hours
- 1 week = 50 hours (assumes someone would typically not spend more than 5 days per week on an y singular external activity)
- 1 month = 217 hours (52 weeks / 12months * 50 hours per week)
Start-ups, Investors, and Investments
Equity, officer role and/or external research should be listed as unique activities with this entity. Prior Approval Requests are required for an officer role, external research, use of WashU resources and any involvement of WashU staff, students, or trainees
Disclose the investors as the financial interest itself. Due to recent changes to agency funding guidelines, it is necessary to report investments in individuals as well as organizations.
Yes, disclosure is required if the company is related to your area of expertise or institutional responsibilities. In the case that you are not receiving shares of the company for your investment, then in Section B of the disclosure form you should select “Other Compensated Activity or Interest” as the Type of Activity/Interest and then describe your expected return on investment in B5 (Other benefit description).
Yes. Recent changes to agency funding guidelines require reporting of investors for investigators themselves as well as investigators’ companies.
The type of documentation can be determined by your department/school. One example, would be documenting those activities on your CV.
WashU should not be a party to your personal contracts. Negotiation of the terms of the contract or agreement is the responsibility of the individual. The faculty member should ensure the terms of any such agreement, including confidentiality and intellectual property terms, are consistent with his/her obligations under applicable WashU policies.
For Institutional Officials
Institutional officials are determined by title and include Deans, Department Chairs, and Department Heads and Division Chiefs at the School of Medicine.
According to Washington University’s ICOI Policy, an ICOI exists whenever the financial interests of the University or the personal financial interests of an Institutional Official (IO) either affect, or reasonably appear to affect, the design, conduct, reporting, review, or oversight of research. Examples of ICOIs include research studies which:
- Evaluate a technology licensed by the University in exchange for equity and / or a promise of future royalties.
- Are led by faculty direct reports of a financially-conflicted IO, regardless of whether the IO serves as an investigator on the research.
Other COI and Programs Questions
There are four COI programs at Washington University:
|Research COI Program|
|The Research COI (RCOI) program seeks to assure that the objectivity and integrity of the university research, training, or other activities are not compromised or perceived to be compromised by considerations of personal gain or financial benefit.|
RCOI employs strategies to manage financial conflicts of interest to assure the objectivity and integrity of research. The essential components of the RCOI program are disclosure, review, assessment and determination, and management of conflicts of interest.
To learn more about research conflicts of interest, visit the OVCR website.
|Clinical COI Program|
|The Clinical COI (CCOI) program seeks to ensure that Washington University and its physicians and health professionals avoid conflicts of interest or the appearance of conflicts of interest between their individual financial interests and the best interests of their patients.|
To learn more about clinical conflicts of interest, review the CCOI Policy.
|Institutional COI Program|
|The Institutional COI (ICOI) program seeks to ensure that institutional conflicts of interest are managed so that they do not compromise, or reasonably appear to compromise, the integrity of the University’s research mission.|
To learn more about institutional conflicts of interest, review the ICOI policy.
|Continuing Medical Education COI Program|
|The Continuing Medical Education COI (CME COI) program seeks to ensure balance, independence, objectivity, and scientific rigor in all Continuing Medical Education (CME) activities that it provides and credits.|
To learn more about CME conflicts of interest, review the CME COI policy.
With RMS, there is no need to complete separate forms for each program. All programs are able to review your External Professional Activities Disclosure, Research Disclosures, and Travel Disclosures.
A research conflict is a situation in which it is reasonably determined that a material financial interest could directly and significantly affect the design, conduct, or reporting of research.
An institutional conflict is generally created when an institutional official’s financial interests can be affected by the outcome of research led by their faculty direct reports. An ICOI is also created when the University’s financial interests can be affected by the outcome of the research.
A clinical conflict of interest exists what a physician or health professional (or his/her immediate family member) has a financial relationship with an entity, and the physician or health professional is in a position to affect a patient’s decision and/or consent to the use of that entity’s products or services.
In accordance with ACCME criteria, circumstances create a CME conflict when an individual has an opportunity to affect CME content about products or services of a commercial interest with which he/she or his/her spouse/partner has a financial relationship.
With RMS, all COI programs are able to review your External Professional Activities Disclosure, Research Disclosures, and Travel Disclosures.
Each COI office will be able to see the outcome of issue review and resolution posed by another COI office, and will coordinate when an issue is identified with the most appropriate office taking the lead.