Academic medicine and health-related industries share the goal of improving the health of the public. This goal, by its nature, has given rise to many different interactions between industry and members of our community. These interactions must be transparent in all aspects. They should support unrestricted exchange of information, should be free of bias and should not in any way influence professional behavior. However, such relationships often give rise to Conflicts of Interest (COI) that must be disclosed and managed. 

Prior approval is required before engaging in these activities. Such prior approval must be made to Department Chairs/Section Chiefs/Center Directors (or to the Dean or the Dean’s designee if the Department Chair or Center Director is the individual seeking approval). 

Additionally, all LKSOM Faculty Members are required to complete an electronic COI Disclosure Form at the time of appointment and at least annually. 

LKSOM Conflict of Interest Policies and Disclosure Form 

• LKSOM Conflict of Commitment and Conflict of Interest Policy (PDF)  LINK IS BROKEN 

• Electronic disclosures (requires Accessnet ID and TUsecure password)  LINK IS BROKEN 

• Guidance for Relationships with Industry Representatives (PDF) 

• Conflict of Interest Frequently Asked Questions LINK IS BROKEN 

• Conflict of Interest - Sample Slides (PDF) 

Other COI Policies & Resources 

Temple University Policies 

• TU Conflict of Interest Policy – All Employees (PDF) 

• TU Conflict of Interest Policy – Faculty (PDF) 

• TU Financial Conflict of Interest in Research Policy (PDF) 

• TU Institutional Financial Conflict of Interest in Research Policy (PDF) 

Resources 

COI Disclosure and Training Instructions 

• Required for all researchers prior to engaging in any research on a project funded by any entity using the PHS COI regulations, if: 
  - The researcher is new to the institution. 
  - The researcher has not received training within the past 4 years 
  - The University or School of Medicine changes a COI policy as that policy pertains to the researcher 
  - The researcher is found to be not in compliance with University or School of Medicine COI policies or with an approved management plan 

• Office of the Vice President for Research COI 

• 2011 PHS Regulations – 42 CFR Part 50, Subpart F 
  2011 revised 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). An Institution applying for or receiving NIH funding from a grant or cooperative agreement must be in compliance with all of the revised regulatory requirements. 

• National Physician Payment Transparency Program (Open Payments) - Sunshine Act - 42 CFR Parts 402 and 403 
  - Physician financial relationships with certain companies are available for public viewing through CMS. 
  - Section 6002 of the Affordable Care Act established the National Physician Payment Transparency Program (Open Payments Program). It requires pharmaceutical and medical device/supply companies to report certain direct and indirect payments or transfers of value to physicians and teaching hospitals or certain physician ownership or investment interests. The overall goal of the program is to increase public awareness of financial relationships between drug and device manufacturers through transparency. Listing on the site does not mean that there is a conflict of interest.
  - The regulation covers all licensed physicians including doctors of medicine and osteopathy, dentists, podiatrists, optometrists, and chiropractors, who are legally authorized to practice by the State in which they practice. It excludes physicians in their capacity as an employee of an applicable manufacturer, physicians in their capacity as patients, as well as residents and medical students.
  - 42 CFR Parts 402 and 403 

Forms 

• IP Rider Form (DOC) 
  Faculty must include the IP Rider Form in all of their independent consulting agreements 

• Prior Approval Form 
  All faculty must receive prior approval for travel and any activity that may be a potential conflict of interest or commitment issue 

• Familial COI Disclosure (DOC) 
  If an employee supervises or participates in a decision affecting a relative of the employee, the employee must refrain from acting until receiving written approval from the cognizant University officer and the University Counsel that such action is appropriate. This includes but is not limited to involvement in the employee’s research. If the familial conflict arises in a research project, the employee must also receive approval from the Senior Vice Provost for Research. A relative includes a spouse, domestic partner, child, parent, sibling, grandparent, grandchild, aunt, uncle, first cousin, or corresponding in-law or “step” relation) 

LKSOM Conflict of Interest Contacts 

Email: [click-for-email] 
Phone: 215-707-1986 

Heather E. Clauss, MD, FACP, FIDSA 
Senior Associate Dean, Faculty Affairs 

Adam Nester, JD, MS 
Director, COI Office 

Sheila McMillan, MBA  
Lead Administrative Specialist, Office of Faculty Affairs