MEMORANDUM

Dear Chairs,

Under the current policy (in place since before 1995), Chairs and then the Dean’s office review and sign off on ALL agreements for faculty to engage in personal external compensated activities (consulting, speaking, scientific advisory boards, paid attendance at company meetings, etc.). It is very important for you to remind your faculty regularly to do this. We have put new training in place in the Dean's Office to turn these around faster, especially if they are routinely approved activities and/or the company quickly agrees to reasonable modifications in the contract. You can tell faculty that more information about the policy and resources (information , contract language, and routing sheet) are on the web under SOM Administration and Faculty Affairs (Consulting Resources). http://www.med.emory.edu/dean/facultyaffairs_policies.cfm#coi

Please emphasize that "consulting" is specifically defined broadly in the University and School policies to include all of these external activities except a few things like compensation for serving on a NIH study section or giving an invited lecture at another ac academic institution (unless a company pays the check). Recently a number of independent CME companies have been set up, often as extensions of drug companies. I suggest that faculty should also route contracts for speaking in continuing medical education, if done through one of these companies. Certainly any non-accredited CME activities should be submitted.

Here are the standards used in those departmental and Dean’s Office reviews:

• Commitment. The SOM policy that allows faculty to participate in certain external personal compensated arrangements is not an entitlement, but such activities may be approved when appropriate. The policy currently allows up to 20% of the faculty member’s total professional effort (regardless of time of day, day of week) in such external activities if approved by the chair and dean’s office. The Chair may decide whether department needs allow the faculty member, who is also being paid simultaneously by Emory, to be away to engage in the activity.

• Appropriateness. The Chair and Dean’s Office are charged with looking at whether the activity benefits the academic career of the faculty member, the department, and the School, and should use the principles of professionalism as a guide. For example, a promotional dinner put on by a drug company for its "customers" is not a venue that is respected by the public and thoughtful peers at which faculty should be the dinner speakers. While some educational material is presented, the speaker does not have freedom over content; he or she may not speak about experimental uses that are off-label (FDA regulations on the company) and may not speak about competing products. In fact, most often the contracts require the speaker to use the company's slides or at least to submit the slides for prior approval by the company. This kind of activity is classified as an FDA promotional activity, not as continuing medical education.

• Compensation. The Chair and Dean’s Office review the level of compensation to determine whether the amount proposed as compensation is fair market value. For this, we use the faculty member’s compensation at Emory as a guide, with reasonable flexibility. The CME policy at Emory is $2,500 per event, maximum plus reasonable travel expenses.

• Compliance. The Chair and Dean’s office review the agreement for.compliance with University and School policies, especially those on conflict of interest, intellectual property, use of Emory resources, etc. For example, contracts most often state that Company will own all intellectual property that is developed during the term of the contract. We would require modification, since the faculty member may well be developing IP at Emory during the term of the contract to which the company has no ownership rights. The language for this and other usual contract terms are on our web under Consulting Resources, and faculty may provide the "boilerplate terms" to companies in advance to shorten the process.

Thanks for your attention to these reviews at the department level.

Claudia R. Adkison, J.D., Ph.D.
Executive Associate Dean
Administration & Faculty Affairs
Emory University School of Medicine
413 School of Medicine Building
1648 Pierce Drive, N.E.
Atlanta, GA 30322
cadkison@emory.edu
(404) 727-5673 office; (404) 727-0473 fax