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Updated Training for 2021 COI Disclosure Process in OPACS

Why Do I Have to Complete the OPACS Annual Disclosure?

OPACS (Outside Professional Activities Certification System) certifies compliance with the Faculty Policy on Conflict of Commitment and Interest. This secure site allows Stanford personnel to certify and submit electronically their annual report on outside professional interests.

Annual certification on outside professional activities serves two major purposes. First, it provides each faculty member and those named as senior/key personnel on NIH and NSF proposals and awards with a reminder about the University's policies in this important area. Second, it provides Stanford with an opportunity to review and document the compliance with Stanford’s policies on Conflict of Interest and Conflict of Commitment.

A Conflict of Interest occurs when there is a divergence between an individual's private interests and their professional obligations to the University such that an independent observer might reasonably question whether the individual's professional actions or decisions are determined by considerations of personal financial gain.

A Conflict of Commitment usually involves an issue of time allocation that creates a risk of divided loyalty between Stanford and an outside entity. At Stanford, when an individual’s outside professional activities exceed the permitted limits (normally thirteen days per quarter), or when the researcher’s outside professional activities interfere with their professional obligation and commitment to Stanford, a Conflict of Commitment exists.

2021 Annual Disclosure Timeframe

The 2021 Annual Disclosure for Outside Professional Activities will commence on Monday April 11th for all Stanford faculty and Senior/Key Personnel named on NIH or NSF pending proposals or funded awards. The Annual Disclosure should be completed by Monday, May 2nd. All Stanford faculty and Senior/Key Personnel will disclose their outside professional interests for the calendar year 2021 (Jan 1, 2021-Dec 31, 2021). If you have any questions regarding this process, please contact your School COI manager.

Who is required to Disclose?

This year all faculty and anyone listed as Senior/Key Personnel on an NIH or NSF pending proposal or funded award (as recorded in the SeRA system, based on information provided in those proposals) will be required to complete an annual disclosure. RPH 4.2 - PHS and NSF Requirements Regarding Financial Disclosures and Agency Notifications.

How do I disclose?

As of Monday, April 11th, 2022 you will be able to log in to OPACS (OPACS.Stanford.edu) and complete your annual disclosure. A quick reference guide with step-by-step instructions to complete the Annual Disclosure, as well as a PowerPoint presentation regarding this process can be found below.

Helpful Resources

Required COI Training

Faculty who receive PHS funded grants and contracts MUST complete on-line training about Conflicts of Interest before any funds for new grants or competing/non-competing renewals that are received by Stanford.

In addition, Stanford requires all newly-hired faculty to complete training on identifying and reporting conflicts of interest. 

COI training provides an overview of high-risk situations which can lead to conflicts of interest for faculty.

Go To Training
 

Best Practices for Faculty Start-Ups

Stanford is committed to avoiding either perceived or actual conflict of interest issues with respect to faculty start-ups. Both Stanford and faculty have responsibilities to optimize technology transfer and mitigate COI whenever licensing Stanford intellectual property to a faculty start-up is considered.

University/Office of Technology Licensing (OTL) Responsibilities

Make licensing decisions based on OTL’s professional judgment about technology transfer to achieve the best possible benefit to the public, without undue influence from internal or external parties. View the OTL Inventors Guide. 

To determine the most effective way to transfer the technology:

  • OTL “markets” all Stanford technology to ensure fair and open access to potential licensees:

    • Faculty start-ups should not receive or be perceived as receiving preferential treatment.

  • Stanford faculty/employees are not allowed to represent the potential licensee and must not negotiate directly with OTL.

  • The faculty’s School Dean and the Dean of Research must review any actions that present a potential conflict of interest:

    • If OTL, after thorough marketing, determines that a faculty-affiliated company is the appropriate licensee, OTL documents its marketing and rationale for its licensing decision.

    • The faculty must disclose to the Deans any interest (consulting fees and/or options) in the start-up.

    • The faculty must agree to separate University responsibilities from company responsibilities according to the criteria listed under Faculty Responsibilities, below.

    • If the conflict is deemed manageable by the Deans based on this agreement with the involved faculty, OTL may proceed with the licensing.

  • OTL licensing agreements may be exclusive or non-exclusive depending on what is most suitable for achieving technology transfer.

Faculty Responsibilities

Separate University duties for research and education from personal financial interests in the company.

Faculty must:

  • Separate and clearly distinguish on-going University research from work being conducted at the company.

  • Limit consulting for the company to a maximum of 13 days a quarter, per University policy.

  • Serve only in advisory or consultative roles at the company:

    • Do not take managerial roles or titles (i.e CTO) suggesting management responsibility.

    • Take a leave of absence from Stanford if engaging in a management role.

Faculty must not:

  • Negotiate with the University on behalf of the company.

  • Receive gifts or sponsored research from the company.

  • Involve research staff or other University staff in activities at the company;

    • Company personnel cannot be affiliated with the University.

  • Involve company personnel in Stanford research.

  • Involve current students in company activities:

    • If a student asks to take a leave of absence to participate in the company, refer the student to the School Dean for review of the request and independent advice.

  • Involve junior faculty in company activities for whom you have supervisory responsibility:

    • Even if no supervisory role, avoid situations in which junior faculty might feel expected to be involved.

  • Use University facilities for company purposes.

  • Undertake human subjects research at the University as PI/protocol director.

  • Supervise faculty who are PI/protocol directors for human subjects research related to the company.

Request for Information on Identified Financial Conflicts of Interest (FCOIs) in PHS-funded Research

In order to request information on a Financial Conflict of Interest (FCOI) identified on or after 8/24/12 related to Public Health Service (PHS) sponsored research, please click this link to make such a request. This form must be completed and returned via email to facilitate a timely response.

Responsible Conduct of Research Casebook

The HHS Office of Research Integrity has posted a new responsible conduct of research casebook. The teaching resource features cases organized on the following topics: authorship and publication, research misconduct, collaboration, data acquisition and management,conflicts of interest, peer review, mentor and trainee relationships, and social responsibility.

CMS's Open Payments Physician's Database (Sunshine Act)

Physicians who received payments or gifts from pharmaceutical or medical-device companies in the previous fiscal year should allocate several days before the May 15th deadline to register, affirm or dispute any errors in reporting on the government’s Open Payments database. This data will be made public in an online database on June 30th of each year.

Please use the help section on the CMS.gov Enterprise Portal for guidance on how to use the system.

 (If a Physician disputes data reported by Industry in the Open Payments database and it has not been resolved by the deadline, the public database will still publish the amounts but with a “disputed” notation.)
 

CMS's Open Payments Training Slides

Correspondence from Association of American Medical College (AAMC)

 

Dear Colleagues,

We are pleased to share that the CMS Open Payments team, in consultation with the AAMC’s FOCI Steering Committee and AAMC Staff, have developed two educational resources for your use: one contains information to educate physicians about the Open Payments program and another for authorized representatives of teaching hospitals.

The Open Payments review and dispute period for physicians and teaching hospitals begins on April 1 and ends May 15 each year.

The resources are available in PowerPoint format on the AAMC’s Open Payments website and are specifically designed to be distributed as a complete slide deck. Please click here to access the Open Payments resources or use the links below.

If you have any questions or need assistance with the Open Payments program, please contact the CMS Open Payments Help Desk at openpayments@cms.hhs.gov or by calling 855-326-8366.

Links:

https://www.aamc.org/openpayments

https://www.cms.gov/openpayments/

Sincerely,

Association of American Medical College

Created: 12.21.20
Updated: 04.08.22