Do I have to fill out the Conflicts Survey? I am certain I have no conflicts.
Yes. Cornell University Policy requires that all employees, including faculty, must complete a Conflicts Survey annually.
Do I have to indicate that I receive a salary/stipend from WCM?
No. Financial arrangements outside of WCM are what you must disclose.
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 research. A Study Specific Report must be filled out with each new grant proposal and/or research protocol (both human and animal subjects) application for which a discloser has related financial interests. Information provided in the Study Specific Report is used by the Conflicts Management Office (CMO) 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.
I have no change in my external activities since I reported last year. Must I still complete this Conflicts Survey?
The WCM policy requires recertifying external activities annually. When you initially engage the conflicts management system, you will create your initial Conflicts Survey. In subsequent years, your Conflicts Survey may be updated and recertified electronically.
Will I receive a response from the Conflicts Management Office (CMO) 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 Conflicts Management Office. If you fully complete the disclosure 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 Conflicts Management 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 Conflicts Management Office at (646) 962-8200 or email at conflicts@med.cornell.edu.
What happens if I disclose a potential conflict of interest or commitment?
The Conflicts Management Office may contact you with a determination of your disclosed relationship(s) or request for additional information.
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 Conflicts Management Office, 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.”
Am I required to disclose interests in mutual funds or retirement accounts?
No, you do not need to disclose interests held in mutual funds, pensions, institutional investments, or other investment vehicles where you have no ability to control what shares you buy and sell. But if you are in doubt about whether a particular fund meets this description, disclose.
What if my financial interests change since I last disclosed my interests? When do I report these new interests?
You should disclose new entities as follows:
-If the interest is significant, or involves intellectual property or licensing, contact the Conflicts Management Office directly before engaging the interest. In addition, please note that university policy requires that any compensated consulting must be reported to, and approved by, your department chairperson prior to being undertaken.
-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 thirty (30) days of discovering or acquiring a new significant financial interest and on an annual basis.
-If the entity is for profit and related to your ongoing research or research grant(s), you must disclose within 30 days of acquiring the conflict. Do this by updating your Conflicts Survey in the Weill Research Gateway (WRG). You should then submit an updated Study Specific Report.
-Whenever you complete a Study Specific Report. Before completing the Study Specific Report, you should update your Conflicts Survey in the Weill Research Gateway (WRG) with the new entity. Since the Study Specific Report process requires certification of your entire Conflicts Survey, this will reset your annual disclosure date to 12 months hence.
Must I disclose income I received from an outside non-profit organization?
Yes. Irrespective of dollar amount, conflicts of commitment should be reported.
What is a speaker’s bureau?
Speaker’s 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 speaker’s bureau, please contact the Conflicts Office.
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.
I already have an approved speaker’s bureau arrangement that is expected to continue through the 2016 academic year. Do I have to end this arrangement immediately?
Speaker’s bureau events contracted prior to the date of the policy announcement and occurring before December 31, 2016 will be permitted in a 6-month transition period.
May I have a consulting relationship with a pharmaceutical or medical device company?
You are permitted to accept honoraria or consulting fees and participate in scientific consulting with companies provided that: 1) you have received approval from your department or division head, 2) you are abiding by the Cornell University Faculty Handbook
and 3) you have included the “Addendum for Consulting Agreement.”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.
Can I give a talk at a symposium that is being sponsored by a pharmaceutical or device company? The symposium has received the funding and I was asked by the symposium steering committee to participate and they will pay my travel, accommodations and an honorarium for my participation. I am not receiving money from the company. Is this allowed?
Yes, as long as the symposium meets the standards for a CME activity (the company does not pick the speakers, control the content, etc.), participation in the symposium is permitted.
May I accept gifts from pharmaceutical or medical device companies when I am at a conference?
No, you may not.
Physicians should be aware that transfers of value at $10 or more (as well as multiple individual transfers of value under $10 from a single entity that add up to more than $100 over the course of a year) will be recorded by the entity 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.
Can vendors supply refreshments or food for educational activities sponsored by our department, such as grand rounds seminars and lecture series?
Food may only be purchased by unrestricted funds controlled by the department.
Can I accept textbooks from publishers asking me to look over the book for potential adoption, or as an instructor's copy after the book has been adopted?
Accepting free textbooks that contain promotional pages or logos is prohibited under the policy. Departments may accept gifts of textbooks, medical journals, or educational devices to be used in skills labs. Publishers may also donate an unrestricted grant submitted to the department or division.
Medical device company representatives need to demonstrate the appropriate use of a device or product. Are they permitted on WCM-Controlled Spaces?
Company representatives must have an appointment to visit WCM-Controlled Spaces. You may allow non-marketing product specialists to visit patient care areas to demonstrate the appropriate use of a device or product. Otherwise, company representatives must meet with you outside of patient care areas.
Am I allowed to hold an executive position with an external entity?
It depends. It is important that your relationship with a company does not interfere with your primary obligations as a WCM employee in such a way that it could create a conflict of commitment with your WCM responsibilities.
I perform research. Why are my equity and stock holdings important?
Equity can raise the issue of such incentives compromising objectivity and can raise questions about insider trading. In the case of researchers, the more significant the equity is financially, or the more likely the research may benefit the company (and thus your equity--particularly in the case of stock options), the greater the risk of biasing the research or research results.