Outside Activity Reporting Quality Assurance Program Overview Harvard Medical School Outside Activity Reporting Quality Assurance Program Overview February 13, 2014

Agenda Background Sample Size and Selection Process Method Results and Next Steps Future Improvements

What is this all about? HMS seeks to promote transparency of outside activities and financial interests as well as discussion about industry interactions. We have developed a monitoring program to be conducted following each annual outside activities reporting cycle to ensure that: faculty understand the regulatory and policy reporting requirements faculty reporting is complete and accurate Our goal is to support faculty compliance and is focused on providing additional outreach and education

Sample Specifications 50 faculty who reported outside activities 10 post-doctoral fellows with outside activities 10 faculty/investigators who have yet to report 10 faculty/investigators who reported no interests All faculty/investigators currently subject to management plans

Selection Process All investigators under management Custom Search developed in the Click Outside Activities Reporting System Specified sample conditions Counted down every 10 individuals and generated a list Custom Search needs improvement Did not allow for dividing of the population size by the sample size Working to improve selection process

Monitoring Process HMS examines each selected outside activities report and compares this form to available financial payment information disclosed by: (i) biomedical companies (ii) by the faculty member in publications or presentations (iii) other publicly or internally available sources including general internet searches.

Monitoring Process All discrepancies are highlighted and addressed. HMS works with the reporter to understand discrepancies and resolve them. A general report is issued following completion of the monitoring process. Describes common themes among reporting population

Method Internet searches conducted in the following manner: The Outside Activity Report is reviewed for disclosed relationships with outside entities The faculty member’s name is searched on the internet and results are recorded  All publications within the past calendar year are checked to verify disclosed entities When available, research laboratory pages are checked for consistent disclosure This is done through the initial internet search as many labs detail the individuals working within the lab on the lab website Webpages of disclosed outside business entities are checked for consistent disclosure  

Results There were not many discrepancies found. However we found the following: Over - reporting e.g.,  Faculty Member - Reports 2 US non-profit universities Postdoc -Disclosed City College of New Under - reporting

Example of Under-reporting Business Entity Reported in OAR Activities Reported in OAR Activities Found Elsewhere Notes -- Founder, Phase 2 Microtechnologies, 2010 – present (LinkedIn). Not clear he plays active role in company – not listed on Leadership Team page at company site. Medrobotics Equity Founder and service on SAB (LinkedIn). Company site: Founder; not on Advisors page. Heartlander Surgical, Inc. Serves on SAB (LinkedIn). Company does not list SAB. Telecardia Consulting, Equity Chairs medical advisory board (Telecardia site). Should report advisory board service.

Follow-up OPSI contacts faculty member: Explains process References policy Emphasizes purpose of program Asks about discrepancies Works with faculty to update Outside Activity Report Points out relationships that one is not required to report non-profit U.S. universities, U.S. teaching hospitals

For the future Report of trends identified Outreach/education with respect to trends identified Larger sample size Need to improve the custom search for better filtration