Conflicts of Interest

Introduction

Welcome to the Weill Cornell Medicine (WCM) Conflict of Interest Office ("COI"). On this page, you will find information to assist you in understanding the meaning of the terms "Conflict of Interest" and "Conflict of Commitment." We also provide information concerning University and federal policies regarding conflicts of interest.

WCM Conflicts Survey

All WCM faculty members and staff are required to complete the Conflicts Survey. The Conflicts Survey is required at a minimum once annually; however, should any financial interests change over the course of the year, an update to the Conflicts Survey is required within 30 days of the change.

For those who have no interests to disclose, the submission of the Conflicts Survey is required as a certification of such. If you have financial interests to disclose you will be required to answer the initial questions plus an additional set of questions for each entity with which you have a financial interest. For example, if you have financial interests in three different entities, you will be required to answer the additional set of questions for each of those entities.

FDA Research

If you are an investigator on research that is overseen by the Food & Drug administration (FDA), you will also need to report financial conflicts to the research sponsor for their reporting, as required, to the FDA. Further information on conflicts reporting in FDA-Sponsored Research.

Please refer to the Policies and Forms section below for specific definitions on what constitutes a financial interest and/or commitment that may be a conflict to the institution.

External Consulting Agreements

External Consulting Agreements are considered to be personal arrangements between the WCM faculty member and the Company. Therefore, WCM does not provide legal review or negotiation assistance for such agreements or, otherwise, represent faculty members in this individual capacity. However, for WCM’s protection, University Counsel requires that a non-negotiable Addendum be signed by the Company and incorporated into all employee Consulting Agreements. The faculty member will also need his/her department chairperson’s approval in order to pursue the outside consulting, and must update their Conflicts Survey accordingly.

To download the Model Addendum for Consulting Agreements, click here.

Travel

Travel disclosures can be made through your conflicts survey in Weill Research Gateway.

Travel for a U.S. Non-Profit Entity

Reimbursed travel expenses and other compensation greater than $5,000 per year in aggregate from a single U.S. non-profit entity need to be reported.

You only must report travel sponsored or reimbursed by a single U.S. non-profit entity if:

The trip was more than $5,000,
Multiple trips for that entity in aggregate exceed $5,000,
You receive more than $5,000 for services from that entity, or
A combination of trips and services in aggregate from a single entity exceeds $5,000.

You do not have to report travel reimbursed or paid for by Cornell University, nor travel paid by:

a federal, state, or local government agency,
a U.S. non-profit institution of higher education as defined at 20 U.S.C. 1001(a),
a U.S. academic teaching hospital, U.S. medical center, or
a research institute that is affiliated with an institution of higher education.

There are additional rules for individuals applying for or funded by Public Health Services (PHS), which includes the National Institutes of Health (NIH) and other non-profit agencies that chose to invoke PHS COI policy.

Sponsored travel means (a) travel expenses paid to an investigator or travel paid on an Investigator's behalf, by a single entity in any 12 month period and/or (b) travel reimbursed to or paid on behalf of an Investigator's spouse and dependent children by a single entity in any 12 month period.

Travel for a For-Profit Entity

All paid or reimbursed travel paid or reimbursed by "for-profit" entities must be disclosed within 30 days of completing travel.

If you need further explanation about the Conflicts Survey, please contact the Conflict of Interest Office at (646) 962-8200 or conflicts@med.cornell.edu.

Conflicts of Interest Training

Research personnel on any grants or contracts funded by an agency or organization that follows the Public Health Service (PHS) FCOI regulations (NIH, AHRQ, ACS, AHA, CDC, etc.) are required to complete conflicts training. This training must be renewed every four years.

Training is available via the Weill Research Gateway (WRG) by using your WCM CWID and password.

Please visit: CITI Training Instructions for instructions, additional information, and FAQs.

External Investigators and Research Personnel

All external (non-WCM) investigators and research personnel must complete an External Study Specific Report (SSR) regardless of whether or not they have any relationships to disclose.

To download the WCM External SSR, click here.

Public Requests for Information

WCM is committed to overseeing the conduct of research in a manner that ensures the integrity of the research process and maintains the public trust and that of sponsors in the integrity and credibility of its faculty, its staff, and its research programs. Cornell's policy 1.7, Financial Conflict of Interest describes WCM's commitment and procedures related to the identification and management of real or apparent conflicts of interest that arise from the intersection of personal financial interests and research activities.

To comply with the Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought [(42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94)], Weill Cornell Medicine will make available within 5 business days upon receipt of a request as described below, of information concerning Significant Financial Interest (SFI) disclosed to WCM that meets the following criteria:

NIH (National Institutes of Health) Conflicts of Interest (COI) Training Requirements FAQs

The individual for whom information is sought, is identified by WCM in the grant application, progress report, or any other required report submitted to the NIH as a senior/key personnel on an NIH grant or cooperative agreement for which a notice of award was issued on or after August 24, 2012;
The SFI is still held by the senior/key personnel for the NIH-funded research project;
WCM has determined that the SFI is related to the NIH-funded research; and
WCM has determined that the SFI is a Financial Conflict of Interest.

If your request meets the conditions outlined above, please follow these instructions:

Complete this form for each SFI for which you are seeking information. Incomplete forms will not be considered and will not be responded to.
Please print the completed form, sign and send it by regular mail to:
Conflict of Interest Office – Office of Research Integrity
Weill Cornell Medicine
575 Lexington Avenue, 9th Floor
New York, NY 10022
WCM will respond via email to the email address provided in the form. If a paper copy is required, please enclose a self- addressed, postage paid envelope. Mailed responses will be postmarked no later than five (5) days after receiving a valid request (as described above) at the email address or the mailing address provided above.

Open Payments

The Open Payments Program facilitates greater transparency with regard to financial relationships between manufacturers, physicians and teaching hospitals. This legislation requires that manufacturers of drugs, devices, biologicals and medical supplies report to the Centers for Medicare & Medicaid Services (CMS) any payments or other transfers of value made to physicians and teaching hospitals. "Physicians" include those who are legally authorized to practice medicine, osteopathy, dentistry, dental surgery, podiatry, optometry and chiropractic medicine (note that medical residents are specifically excluded from this definition). Additional information for physicians about the Open Payment Program is available from the Centers for Medicare & Medicaid Services.

Important Information for WCM Physicians

"Payments" are defined very liberally. E.g., meals or other items of value greater than $10 will be reported.
Reporting of payments is done by industry, not by WCM.
WCM staff members do not have access to reported information and therefore cannot review this information for you.
Open Payments information will be published on a public website and will likely be of interest to the press and others.
WCM policy requires all faculty members to review Open Payments industry postings to ensure that the information is accurate and, when necessary, work with posting entities to correct inaccuracies.

WCM Physician Requirements

If you have not already registered with the CMS, register through the CMS Enterprise Portal. Note that you may already have an Enterprise IDentity Management (EIDM) account if you use the Health Insurance Oversight System (HIOS), the Medicaid And CHIP Program (MACPro) System or other CMS systems.
If you have not already registered for Open Payments, register through the CMS Open Payments System to review what has been reported about you and dispute it (if necessary).
Ensure that your WCM Annual Survey Statement of External Financial Interests and External Time Commitments are complete, accurate and up-to-date.

WCM-Qatar

WCM-Q is part of Cornell University and functions as an entity of the WCM-NY Conflict of Interest Office.

Study-Specific Conflict of Interest

All research team members, external and internal, who will be conducting human subject research in collaboration with WCM-Q must complete the manual WCM-Q COI Study Specific Form (provided in the link below) regardless of whether or not they have any relationships to disclose.

For Animal Research, all External animal researchers (other than WCM-NY, the Hospital for Special Surgery (HSS), and the Memorial Sloan Kettering Cancer Center (MSK)) who are listed on grants as sub awardees must complete the WCM-Q COI Study Specific Form (provided in the link below) regardless of whether or not they have any relationships to disclose.

To download the WCM-Q COI Study Specific Form, click here.

Policies and Forms

Forms

WCM-Q COI Study Specific Form
Speakers' Bureau Identification Checklist

This checklist is to assist in determining whether WCM considers a speaking activity a “Speakers’ Bureau,” which is prohibited per Cornell policy.

Guidelines

Policies

FAQs

If my position at WCM does not involve any research activity, must I still complete the Conflicts Survey?

Yes. The disclosure requirement applies to all persons who hold appointments at WCM or are employees of WCM. There are types of conflicts that do not involve research. Here are some examples:
- A WCM employee is involved in purchasing and/or procurement decisions made on behalf of WCM but has a financial interest in a company doing business with WCM.
- A WCM employee holds an executive position in an entity and therefore has a fiduciary duty to that entity.

What is the Study Specific Report? Do I need to fill that out?

A Study Specific Report (SSR) is a form that is applicable to individuals involved in the design, conduct and reporting of animal research. A Study Specific Report must be filled out with each new grant proposal and/or animal research protocol application for which a discloser has related financial interests. Information provided in the Study Specific Report is used by the Conflict of Interest Office ("COI") to determine whether there is a financial interest that needs to be managed. If disclosers do not have a study specific interest to report, they do not need to submit a Study Specific Report.

Will I receive a response from the Conflict of Interest Office (COI) regarding my disclosure?

If you have disclosed a possible conflict of interest or commitment and a determination is made that further information is required or that there are special procedures you must follow in view of the possible conflict, you will receive an email from the Conflict of Interest Office. If you fully complete the Conflicts Survey and indicate no possible conflicts, you will receive an email stating that your submission was received and that no further action will be required.

What should I do if I am unsure about how to answer a question on the Survey?

If in doubt, please disclose and the Conflict of Interest Office staff will determine if you have a conflict. Please use the comments sections where you can provide a clear and accurate description of your relationship with a disclosed entity. The comments sections do not have word count limitations. If you have any questions, you may always call the Conflict of Interest Office at (646) 962-8200 or email at conflicts@med.cornell.edu.

When the Conflicts Survey asks about the financial interests of my family, what is meant?

The term “family” is meant to include spouses, domestic partners, siblings, parents, children, and any other blood relatives, (if that other blood relative resides in the same household). In some circumstances, you may feel that it is appropriate for you to include other persons as “family.” Within the Conflicts Survey, there will be comment boxes available to provide more detailed information. When disclosures are reviewed by the Conflict of Interest Office ("COI"), the term “family” will be used in the review determination as prescribed by the specific federal regulation(s) to which a research is required to adhere.

Is it necessary for me to disclose all of my external financial activities, even those unrelated to my work for the WCM?

The policy requires disclosure of all activities/relationships that could be or give the appearance of a conflict of interest or commitment to your Cornell responsibilities. If a problem should arise in the future, you having reported the activity/relationship offers some protection to you and to the institution in terms of how people may interpret the problem. A failure to report an activity/relationship may be interpreted as a desire to hide the activity because you feel there is something undesirable about it. No one is criticized for “over-reporting.”

What if my financial interests change since I last disclosed my interests? When do I report these new interests?

Should any financial interests change over the course of the year, an update to the Conflicts Survey is required within 30 days of the change.

If you are an investigator on a grant that follows the Public Health Service Financial Conflict of Interest regulation, you must disclose new significant financial interests by the time an application is submitted to the agency for funding, within 30 days of discovering or acquiring a new significant financial interest and on an annual basis.

What is a speakers' bureau?

Speakers' bureaus are typically funded by the marketing division of pharmaceutical companies with the focus of having physicians give talks that promote a company’s product and information to other health care providers. These relationships tend to be primarily for commercial marketing where the company: 1) has the contractual right to dictate what the speaker says; 2) has full autonomy to create presentation materials with final approval of content and edits; 3) provides the speaker with remuneration for the purposes of disseminating company-generated presentation materials.

If you are not sure if a given activity constitutes a speakers' bureau, please contact the Conflict of Interest Office ("COI").

Why is participation on a company’s speaker’s bureau prohibited?

The principles of professionalism may be compromised through participation in speakers’ bureaus. WCM representatives must retain full control and authority over professional material s/he presents and must not allow such communications or presentations to be subject to prior approval by any commercial interest other than approval for the use of WCM proprietary information. WCM representatives should not participate in speaking engagements (whether under written agreements or otherwise) that would violate these principles.

The pharmaceutical or medical device company sponsor for my research would like to use a medical writer that is not a co-author to compose the manuscript. Does this fall under the ghostwriting policy?

Yes. All individuals who were retained by the company that contribute or assist in the composition of such work must be listed as contributors or authors on any research manuscript or article on which you appear as an author. In addition, their company affiliation must be disclosed in the published article. You must maintain editorial independence regarding the content of the manuscript and must provide final approval of the version to be published. Please be aware that payments to a medical writer by a company may be attributed to you as a “transfer of value” on the CMS Open Payments website.

I have a consulting relationship that is permissible under the policy. Does the restriction on gifts exclude a company from paying for my travel or meals connected with that relationship?

If you have a consulting relationship, pharmaceutical or medical device companies may pay for reasonable travel, accommodations and meals. Please note that the travel must be reported on your Conflicts Survey. Also note that if you are a physician, the sponsor is likely to report these transfers of value under your NPI on the CMS Open Payments website.

May I attend a dinner event sponsored by a pharmaceutical or medical device company?

WCM discourages attendance at such events. However, if you do attend such events, you must pay for your own meal. WCM employees may not accept meals from pharmaceutical or device companies, unless it is related to consulting or training activities.

This restriction does not include off-campus continuing medical education (CME) events in which it would not be reasonable to attribute individual consumption, e.g. large conferences featuring buffet-style meals.

Announcements

January 19, 2021: Be advised that the federal government has imposed reporting requirements on all persons travelling to China, Russia, or Venezuela. Under the Export Administration Regulations (EAR), every person that travels to China, Russia, and Venezuela, must report all items carried into the above countries. Click here for full memo.

July 7, 2020: The Centers for Medicare & Medicaid Services’ Open Payments System (Open Payments) published Open Payments Program Year 2019 data, along with newly submitted and updated payment records for previous program years. The data is accessible at https://openpaymentsdata.cms.gov/. Physicians have until the end of the calendar year, in which the data is first published, to log in to review and, if necessary, to dispute the data that have been reported to the government by industry about payments made to them during the 2019 calendar year. Click here for full announcement.

July 1, 2020: Acting Manhattan U.S. Attorney announces $678 million settlement of fraud lawsuit against Novartis Pharmaceuticals Corporation for operating sham speaker programs through which it paid over $100 million to doctors to unlawfully induce them to prescribe Novartis cardiovascular and diabetes drugs reimbursed by federal healthcare programs. Click here for full story.

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