Frequently Asked Questions

 

Accepting Gifts or Support from Industry


We are holding our annual departmental retreat; can we solicit funds from drug or device manufacturers to defray our costs?

No. Departmental meetings are an administrative expense and should be paid for with departmental funds. Contributions from Industry to pay for internal meetings present the same issues as direct provision of meals and are not permitted. Solicitation of philanthropic gifts from Industry for support of research or for support of educational programs may be coordinated through the Medical and Health Sciences Foundation.

 

We are having a fundraising event at which corporate sponsors will be invited to buy tables. Is this permitted under the policy?

Fundraising social events that are open to the general public, with ticket payments going to a general philanthropic goal (e.g., a scholarship fund, a general purposes fund for a particular school, etc.) are not prohibited by the policy. Departments should coordinate closely with the Medical and Health Sciences Foundation in the planning and marketing of such events.

 

Our professional organization’s annual meeting is supported by Industry sponsors; may I attend this meeting?

Provided that the meeting is designed to promote evidence-based clinical care, and/or to advance scientific research, and industry support is prominently disclosed, attendance would not be prohibited by the policy. Attendees must pay their own expenses and may not receive gifts or compensation for attendance. Any meals provided must be incidental to the event and modest in cost. Logo incidentals of nominal value (such as meeting folders, binders, or canvas bags) that are provided as a matter of course to all attendees may be accepted for use at the conference, but should not be utilized in SOHS or UPMC clinical areas.

A company wants to make an unrestricted gift for my use. Is that a potential conflict of interest?

While true philanthropic gifts, even when designated for the support of a specific investigator, are permitted under the Industry Relationships Policy, such gifts may still result in a conflict of interest for the investigator who is the beneficiary of the gift. As a threshold matter, unrestricted gifts in support of research of a named investigator will receive close scrutiny to ensure that there are no material transfer agreements, data transfer agreements, license agreements, pending IRB or IACUC protocols involving technology of interest to the company, or other relationships that suggest that the gift should more properly be categorized as a research grant. In cases where the Health Sciences Foundation and/or the Office of Research determine that the gift should more properly be considered a grant, the investigator’s department will be directed to develop an appropriate contract and budget through the Office of Research.
Where the gift is determined to be truly philanthropic, under FDA conflict of interest rules, you may have a reportable financial interest if you are serving as an investigator of a clinical investigation subject to FDA regulations. Under FDA regulations, if you are the beneficiary of any unrestricted grant or other payment from the sponsor of that FDA regulated study, you will have a reportable conflict of interest if the cumulative amounts of all payments and unrestricted grants designated for your benefit and received during the study and for one year following total $25,000 or more. The FDA regulations take into consideration all payments, including consulting payments, unrestricted gifts for your benefit, and provision of equipment, unless the equipment is necessary for the conduct of the study. In addition, if you are a physician or dentist, and therefore covered by the reporting obligations of the Physician Sunshine Payment Act, gifts received for your benefit may be reportable by the industry donor to Centers for Medicare and Medicaid Services (“CMS”). CMS will report all such payments as part of an online, searchable database.

 

Will the prohibition on gifts in the policy prohibit my laboratory from receiving donated drugs for use in basic research?

No. Materials donated for research use may be received by the University under an appropriate Material Transfer Agreement.

 

Our office has multiple anatomical models which have been provided to us for purposes of patient education, and these models also bear corporate logos. Does this policy require us to remove these items from our offices?

No; these items are acceptable because they primarily entail a benefit to patients; they are intended for patient education and may be retained. In accepting any new models from Industry, care should be taken to indicate to the offering company that such items need to be directly shipped, unless a manufacturer’s representative is invited to the office in accordance with the policy’s requirements. Logos or company advertising on the models should be removed or otherwise covered.

 

A vendor has offered to underwrite the cost of travel, lodging, and other expenses in connection with my attendance at an off-site meeting. May I accept the offer?

Subsidies from vendors should not be accepted directly or indirectly to pay for the costs of travel, lodging, or other personal expenses. There also should be no payment directly to a physician for attending the meeting if the physician’s participation is passive. It is appropriate for a speaker or other active conference participant to accept a reasonable honorarium and to accept reimbursement for reasonable travel, lodging, and meal expenses.

 

A company has offered me a Publication Support Agreement that does not pay me or the University any money, but gives me the services of a professional writer/editor in preparing a manuscript. The company will also help me with the figures and graphs, and clearing any copyright issues. This would be really helpful to me, and I would still get the final editorial review of the manuscript. Is this permitted under the Industry Relationship Policy?

No. Publication Support Agreements are considered impermissible ghostwriting arrangements under the Industry Relationship Policy.

 

Under what circumstances can I accept payment directly from Industry for speaking engagements conducted outside of the University of Pittsburgh and UPMC?

These types of activities fall under the guidelines and approval processes for consulting at the University of Pittsburgh and UPMC, including the consummation of a written agreement that is compliant with provisions in Section 6 of the Industry Relationships Policy and which is executed prior to the engagement. In addition to the limit of the honorarium to $2500, compensation for travel expenses must be reasonable (consistent with the duration and nature of the speaking engagement and in compliance with UPMC and/or University of Pittsburgh travel policies). For example, Industry cannot compensate for extra nights’ lodging beyond what would be required to conduct the speaking engagement, and payment for international travel for brief speaking engagements would not be considered reasonable.

In addition, the event itself must be an acceptable event under the Industry Relations Policy. In general, professional society sponsored scientific or clinical programs where CME is awarded and the content is not controlled by industry sponsors are acceptable. However, “satellite symposia” where a specific company sponsor is paying for the event and has oversight of the faculty member’s content and/or introduces a promotional component to the program through the content of the other speakers is not an acceptable speaking venue for our faculty.

 

A device, biologic, and/or drug manufacturer would like to conduct a training session using the company’s product(s) in our animal facilities. Is this permissible, and what approvals are needed?

In general, company-sponsored, product-specific training in University or UPMC facilities is not permitted under the Industry Relationship Policy. In particular, use of animals for product demonstration or product training would not be acceptable under University IACUC policies. Where UPMC has already approved a particular device through its Value Analysis Program, and that device is in use in clinical settings, training of residents and staff on its use should be conducted by UPMC physicians in that setting. If UPMC or University personnel wish to design and control their own training course, and if an animal model is absolutely the only way to accomplish this training, and the training is capable of and necessary to correct identified and quantified serious safety issues with the particular procedures or products in question, such a course may be approvable. In this latter case, Industry support may be allowable, subject to an appropriate agreement being negotiated through the University with the funding source. Agreements that seek to lease or rent the University facilities, or which permit instruction by Industry representatives, or which include third parties invited by Industry representatives, will not be approved.