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

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

3. 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

4. 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

5. 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

6. 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.

7. 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

8. 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  

9. 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

10. 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.

11. 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

12. 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