1. New HHS Conflict of Interest Regulations
PHS Investigator Training
February 16, 2012
Melanie Loots, Associate Vice Chancellor for Research

2. Introduction
Illinois PHS funded research makes unique contributions to the health and well-being of the US
Illinois PHS funding increased 30% from FY07 to FY11($86.3M)
How can we best help this growing research community comply with the new HHS regulations?
$86.3M (FY11 expenditures, a 30% increase over FY07).

3. PHS Agencies Administration for Children and Families (ACF)
Administration on Aging (AoA)
Agency for Healthcare Research and Quality (AHRQ)
Agency for Toxic Substances and Disease Registry (ATSDR)
Centers for Disease Control and Prevention (CDC)
Centers for Medicare & Medicaid Services (CMS)
Federal Occupational Health (FOH)
Food and Drug Administration (FDA)
Health Resources and Services Administration (HRSA)
Indian Health Service (IHS)
National Institutes of Health (NIH)
Substance Abuse and Mental Health Services Administration (SAMHSA)

4. Presentation Overview
University of Illinois Policy on Conflicts of Commitment and Interest
Applies to all academic employees
RAs have not been included
New HHS Regulation
Applies to all PHS investigators
Planning Changes in Financial Disclosure and Grant Proposal Submission

5. Policy on Conflicts of Commitment and Interest
The University of Illinois Policy on Conflicts of Commitment and Interest was revised effective July 1, 2011.
Revisions were developed by a three-campus committee involving faculty and staff, reviewed by the University Senates Conference, and approved by the University of Illinois Board of Trustees.

6. Definitions
A conflict of interest exists when an academic staff member is in a position to advance his/her own interest or that of others to the University’s detriment
A conflict of commitment arises when the external activities of an academic staff member are so demanding of time or attention that they interfere with the individual’s responsibilities to the University

7. Financial Disclosure and Conflict of Interest Management
Identification of conflicts is facilitated by the annual disclosure process, currently using the Report of Non-University Activities
The Unit Executive Officer works with the academic staff member to identify and evaluate potential conflicts and to manage or eliminate them.
Electronic process RFP in progress…

8. Some Apparent Conflicts of Interest
A Professor’s start-up company employing the Professor’s thesis students
Student involvement in faculty consulting
A spouse’s company sponsors faculty research
Using University resources to support research for a company in which the employee has a financial interest
Immediate family paid by a faculty grant

9. Conflict Management Strategies
Disclosure
Monitoring
Oversight committees or review panels
Disclosure in publications and presentations
Recusal from decisions
Divesting financial interests
Leave of absence or reduction in appointment
Severing relationships
modifying a research plan, implementing an impartial research review mechanism, appointing an ombudsperson or panel to monitor the involvement of students, disclosing significant conflicts in presentations or publications, recusal from promotional or purchasing decisions, divesting financial interests, implementing non-conflicted oversight of university projects and expenditures (including travel), severing relationships that constitute actual or potential conflicts, and applying for a leave of absence or reduction in appointment.

10. Points to Emphasize
The employee’s primary responsibility is to the Institution.
Essential – FULL DISCLOSURE
Essential – PRIOR APPROVAL
Unit heads should not approve an activity unless satisfied that it benefits the institution and the employee and conflicts can be managed.
Increased federal and internal scrutiny.

11. Updating University of Illinois Policy
Vice President for Research is planning small changes to the Policy on Conflicts of Commitment and Interest for consistency with HHS regulations
At Urbana, these are currently under review by the Senate Committee on General University Policy.

12. HHS Final Rule for PHS Funding 42 CFR Part 50 Subpart F
Applies to grants and cooperative agreements from PHS (NIH, CDC, etc.) effective August 24
Applies to broad group of PHS investigators
Lower financial disclosure thresholds
Requirements for disclosure of external travel reimbursement or payment
New COI Training Requirement
New public accessibility requirements

13. Disclosure of Significant Financial Interests (SFI)
Disclose all SFI relating to the investigator’s institutional responsibilities
Includes interests of spouse and dependent children
PHS Investigator = involved in the design, conduct and reporting of research (PI, co-PI, postdoc, RA, others)
SFI are then reviewed by the institution to determine whether they are financial conflicts of interest (FCOI)

14. What is a significant financial interest (SFI)?
Must disclose within 30 days
> $5000 for payments and equity interests in publicly traded companies
> $0 for payments and equity interest in non-publicly traded companies (e.g. start-up companies)
> $0 for reimbursed or sponsored travel (see below)

15. More on Disclosure
Excludes income from investment vehicles that the investigator does not control (e.g. mutual funds)
Excludes income from seminars, lectures, teaching, advisory board or review panel for government, institutions of higher education, academic teaching hospitals, research institutes affiliated with institution of higher education

16. Financial Disclosure Examples
Faculty member with NIH grant consults for a start-up company and is paid with stock options
Company is not publicly traded
ANY financial interest must be disclosed
Faculty member must disclose this financial interest within 30 days

17. Financial Disclosure Examples
Research coordinator paid on NIH grant invests $6000 in a mutual fund
Mutual funds are exempt from disclosure if independently managed
Coordinator is not required to disclose
Research Professor with NIH grant to study a chemotherapy drug buys $6000 of stock in Bristol-Myers-Squibb
RP must disclose as this is a significant interest in a publicly traded company

18. Financial Disclosure Examples
Research associate establishes a start-up company and rents a small office in EnterpriseWorks
The research associate has invested >$0 in a non-publicly traded company
This is a significant financial interest and must be disclosed by the PHS investigator

19. Reimbursed Travel Disclosure
Investigator must disclose any externally reimbursed travel or sponsored travel related to institutional responsibilities (purpose of trip, sponsor/organizer, destination, duration)
Exempted: travel reimbursed or sponsored by government agency, institutions of higher ed, research institute that is affiliated with institutions of higher ed.
Institution determines if further investigation is needed

20. Travel Disclosure Examples
Ohio State Chemistry Department invites a faculty member with NIH grant to give a seminar in Columbus
Academic institution
Payment is exempt
Pharmaceutical company invites an RA on CDC funds to give a seminar at the company.
Company pays for travel
RA must disclose

21. Travel Disclosure Example
Postdoctoral Research Associate travels to Connecticut to give a talk to Pfizer as part of a job interview
Postdoc is paid on NIH funds
Travel is paid by a company related to institutional responsibilities
Travel reimbursement must be disclosed

22. Travel Disclosure Example
Emeritus Professor with a grant from the NIGMS travels to Atlanta, Georgia to give a talk at the American Cancer Society.
ACS pays for the travel
ACS is a non-profit organization and not exempt from disclosure
Professor must disclose the travel as a significant financial interest.

23. Reporting Financial Conflicts
New requirements for reporting FCOI and value of FCOI relating to grants will be implemented in the NIH commons.
Report the value as a range, e.g. $20K-$100K.
Describe how the SFI relates to the PHS funded research and basis for determination of FCOI
Describe key elements of management plan

24. Annual reporting to PHS
Status of FCOI
Changes to the management plan

25. Subaward Requirements
Institutions must take reasonable steps to ensure that investigators working for subawardee institutions comply with the regulation

26. Public Access to FCOI Information
Either post information concerning identified FCOIs held by senior or key personnel on a public web site OR
Provide a written response to any requestor within five business days of a request
Update as required by the rule

27. Training
Each investigator must complete training prior to engaging in research related to any PHS-funded grant or contract and at least every four years, and immediately under certain circumstances
Please make sure that you fill out a form to document your attendance at this presentation.

28. Mitigation Reports
Institution is required to conduct a retrospective review in cases of non-compliance, but is not required to report unless research bias is found.

29. Key Points Once-a-year disclosure is no longer sufficient
Investigators must disclose new SFI within 30 days to meet time requirements
Unit heads must manage FCOI promptly to meet time requirements (within 60 days)
Disclosure of external travel reimbursement must become a reflex

30. Your Help is Needed
Your comments and feedback are needed on how to inform investigators and meet the requirements while adding as little burden as possible.

31. Implementation of HHS Rule Ideas for Urbana
Apply the rule only to PHS-funded investigators
Illinois Policy applies to all academic staff
It would be burdensome to apply the HHS regulation if not required (think of Extension, F&S, many non-PHS investigators)
Communicate with investigators paid on PHS funds

32. Implementation of HHS Rule Ideas for Urbana
Use an online training system and track completion
Training for each investigator must cover institutional policy and HHS policy
Compass?
A CITI training package?
Modify ethics training software?

33. Implementation of HHS Rule Ideas for Urbana
Update disclosures when grant proposal submitted
Update disclosure form for HHS investigators at submission
Alert researchers to HHS requirements
Consider using a SEAM form as UIC does now to document financial interest and conflict management, with administrative review

34. Implementation of HHS Rule Ideas for Urbana
Document training, disclosure, FCOI management
before award is made
Consider having an assurance form for PHS investigators and their teams at award
Financial disclosure up to date
Training completed

35. Implementation of HHS Rule Ideas for Urbana
Require subaward institutions to certify that they are in compliance with the HHS regulations
Consider what steps we need to take with organizations that are not research universities

36. Implementation of HHS Rule Ideas for Urbana
Consider administrative review of disclosures, rather than departmental review
Disclosure could be submitted directly to OVCR
Only involve department if conflict of interest is apparent
Would aid in maintenance of central records and potentially speed review

37. Implementation of HHS Rule Ideas for Urbana
At least initially, maintain files of FCOI disclosure related to PHS projects
Don’t create a public web page right away
Electronic system RFP has been issued

38. References
(the NIH FCOI page)
(the FAQ)
(federal register)
(FCOI presentation for NIH grantees)