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

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).

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)

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

Policy on Conflicts of Commitment and Interest The University of Illinois Policy on Conflicts of Commitment and Interest was revised effective July 1, 2011. http://www.vpaa.uillinois.edu/policies/COCI.cfm 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.

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

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…

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

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.

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.

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.

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

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)

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)

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

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

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

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

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

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

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

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.

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

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

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

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

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.

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.

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

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.

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

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?

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

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

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

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

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

References http://grants.nih.gov/grants/policy/coi/index.htm (the NIH FCOI page) http://grants.nih.gov/grants/policy/coi/coi_faqs.htm (the FAQ) http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf (federal register) http://grants.nih.gov/grants/policy/coi/fcoi_webinar_20111130.htm (FCOI presentation for NIH grantees)