Tip of the Week
April 18, 2008
Authorship and Ghostwriting
The Industry Relationships Policy prohibits SOHS and UPMC personnel from lending their name to articles or presentations ghostwritten by industry. The Uniform Requirements for Manuscripts Submitted to Biomedical Journals provide detailed guidance about the accepted standards for being listed as an author on a submitted manuscript. Individuals shall have made specific and substantial contributions in the design, conduct, analysis and writing of a manuscript in order to be listed as an author. Acquisition of funding, collection of data, or general supervision of the research group, alone, does not justify authorship. Many journals now require the corresponding author to describe the roles of each author. In addition, each author is expected to take public responsibility for the integrity and accuracy of the publication.
In the past several months, access to litigation documents has revealed an unsavory apparent disregard for authorship requirements by members of the academy in collaboration with for-profit sponsors of clinical trials. Academics who have had little or no participation in the clinical trial have been asked to add their and their institution’s good names to a manuscript that is in essentially final form having been writing by the sponsor. In addition to being the ethical antithesis of the precepts of scientific reporting, such actions may also result in very public embarrassment.
A series of articles from the April 16, 2008 edition of the Journal of the American Medical Association provides both data and discussion on this topic:
Editorial: Impugning the Integrity of Medical Science: The Adverse Effects of Industry Influence
APRIL 14, 2008
Participation in Industry-Sponsored or Supported Off-Campus Meetings
Faculty and staff are often invited to attend educational meetings conducted outside of the Schools of the Health Sciences or UPMC. Section 6 of the industry relationships policy provides guidance regarding participation in these activities. In order to comply with the policy, such programs must:
- Be designed to promote evidence-based clinical care and/or scientific research
- Prominently disclose the financial support of Industry
- Provide only modest meals that are consistent with the IRS standard meal allowance and the intent of the activity
- Not compensate participants for time spent in the activity or for travel or lodging expenses
Individuals who function as faculty for the programs must be in full control of the content of their presentation, i.e., Industry cannot reserve the right to approve the content. Presentations must contain a balanced assessment of the current science and treatment options and the speaker must make it clear that the views expressed are those of the speaker and not the Schools of the Health Sciences or UPMC. Program faculty may receive reasonable compensation for travel and lodging as well as honoraria not to exceed $2,500 per event. Department chairs must verify that the off-campus activity meets these requirements before approving a consulting agreement.
February 4, 2008
UPMC has surveyed all of its outpatient facilities to determine which sites will continue to maintain and dispense medication samples provided by Industry. For those sites that have opted to provide samples to their patients, training has been undertaken to assist them in complying with regulatory requirements for inventory management and proper dispensing.
These sites will be permitted to invite Industry representatives who have completed required educational modules to deliver samples to their office. Representatives must comply with all aspects of the new Policy, including prohibitions on gifts and meals. A working group composed of physicians, pharmacists, and administrators from across the Health System are developing a plan to centralize the receipt of samples from manufacturers. Under this plan, offices will be able to select a supply of the medications they need from the inventory. Samples will be delivered to sites through couriers or overnight express service. A number of issues related to this plan are currently being addressed and it is hoped that the process will be operational within the next few months.
Information Center by phone at 412-647-2406 or by email at IndustryRelation@upmc.edu. The Policy and other supporting materials can be found at: http://www.coi.pitt.edu/IndustryRelationships.
You can click this link to view the details about this event.
January 14, 2008
This week’s tip of the week concerns procedures for review of proposed faculty or UPMC employee consulting agreements. The initial responsibility for the review of proposed consulting relationships is the responsibility of the department chair. Faculty should send agreements directly to the University or UPMC counsel’s office for review and approval only after the Department Chair has determined that the proposed engagement is acceptable and acknowledges that the agreement be forwarded. Additionally, the Conflict of Interest Office is prepared to provide advice to Deans on individual cases, upon request. Consulting is only permitted for University faculty (not for staff), and consulting arrangements should not use University or UPMC facilities, resources or data. Consulting may not exceed one day per week in the aggregate. In addition to these long standing policies regarding outside consulting, the new Industry Relations policy has added additional guidance and restrictions. In order to ensure that consulting agreements are not gifts in a different guise, all consulting agreements must be prospectively reviewed by the department to determine that University and UPMC policies are satisfied.
A set of Guidelines for Contracting with Outside Industry are available on the web at: http://www.coi.pitt.edu/IndustryRelationships/faq.htm#faq7 (for physicians) and http://www.coi.pitt.edu/IndustryRelationships/faq.htm#faq8 (for PhD faculty), which set forth the basic requirements for any proposed consulting arrangement. These Guidelines have been designed to be shared with the companies seeking the services of University and UPMC personnel, and can be provided to such companies to assist in crafting acceptable agreements. These Guidelines include proposed language to ensure that payment received is tied to clear deliverables, and to ensure that UPMC and/or University rights are protected. Merely because an agreement meets the requirements of the Guidelines, a department chair still has discretion to determine whether or not to permit the relationship. Where a University faculty member will receive in excess of $10,000 from a consulting relationship in one year, additional approval must be sought in writing from the faculty member’s Dean. For faculty who are also employed by UPP, after departmental approval, the documents should be submitted to PSD legal for final review.
January 7, 2008
This week’s tip of the week addresses industry support for continuing education and community education programs. Under the new industry relationships policy, industry can provide funds to the University or UPMC for accredited or non-accredited activities (including training programs on new devices) through guidelines established in the the Accreditation Council for Continuing Medical Education Standards for Commercial Support. According to these standards, the University and/or UPMC must retain control over the content and faculty selection, and presentations must allow for balanced discussion of alternative approaches, as appropriate. Industry can provide financial support through an educational grant but cannot directly pay for food, social events, faculty honoraria, or any other costs associated with the activity. Industry-sponsored exhibits are permitted in off-campus and certain on-campus locations for the purpose of disseminating information about products and services. However, the distribution of gifts is not permitted.
Further guidance on more specific types of activities can be found at the following FAQs on the Industry Relationships website: http://www.coi.pitt.edu/IndustryRelationships/faq.htm#faq14
Note that different limitations apply to UPMC and University personnel attending Industry supported educational programs at off-site locations: http://www.coi.pitt.edu/IndustryRelationships/faq.htm#faq13 http://www.coi.pitt.edu/IndustryRelationships/faq.htm#faq17
December 24, 2007
Weekly tips will be posted to assist with answering questions and conforming your departmental practices to the new Industry Relationship Policy. The tip for this week provides further guidance on acceptable procedures for inviting Industry Representatives to meetings at the Schools of the Health Sciences ("SOHS"), and/or UPMC premises.
First, all Industry Representatives seeking a vendor relationship with the SOHS or UPMC must first complete a mandatory training course, which is available on-line at:
https://cme.hs.pitt.edu/servlet/IteachControllerServlet?actiontotake=loadmodule& moduleid=3684.
Registered representatives may then be invited by SOHS or UPMC, via the appropriate Purchasing Department, to schedule a meeting to discuss a new drug, device or other hospital supply item.
The appropriate procedure is outlined in the following FAQs: http://www.coi.pitt.edu/IndustryRelationships/faq.htm#faq1 and http://www.coi.pitt.edu/IndustryRelationships/faq.htm#faq6.
This training and registration process is NOT required for 1) visits from Industry auditors reviewing Industry-sponsored clinical trials; or, 2) visits ntial or on-going research relationships. You can click this link to view the details about this event.