Update on Annual Disclosure Process and HHS Conflict of Interest Regulations Conflict of Interest Contacts September 14, 2012 Melanie Loots, Executive Associate Vice Chancellor for Research

Thanks! Thank you for all you do to support disclosure and management of conflicts of interest at Illinois. We hope that this presentation is helpful. Please send suggestions or feedback to mloots@illinois.edu.

Presentation Overview Quick Overview of University of Illinois Policy on Conflicts of Commitment and Interest and RNUA Process Applies to all academic employees GRAs are NOT included Update on New HHS Regulation Applies to all PHS investigators, including GRAs Changes in Financial Disclosure and Grant Proposal Submission

Overview of Policy on Conflicts of Commitment and Interest The University of Illinois Policy on Conflicts of Commitment and Interest was revised effective August 21, 2012 2011http://research.uillinois.edu/policy/coci The Policy has been approved by the Board of Trustees. It mandates our annual RNUA disclosure process for all academic employees. It is compliant with new HHS regulations

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 our annual disclosure process in September, 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.

Examples of Apparent Conflicts of Interest A Professor’s start-up company employs the Professor’s thesis students Students are involved in faculty consulting A spouse’s company sponsors faculty research University resources are used to support research for a company in which the employee has a financial interest Immediate family members are 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.

UIUC Policy – Key Points 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.

RNUA Process - Dates September 17, 2011: Notification to employees of form availability October 1, 2011: Completed forms turned into departments October 22, 2011: Reviewed forms forward from departments to colleges November 12, 2011: Reviewed forms due from colleges to OVCR Please see http://research.uillinois.edu/rnua

Do PHS investigators need to complete the RNUA? Yes, all academic staff must complete the RNUA Yes, both the RNUA and the PHS Investigator Disclosure Form must be completed by PHS Investigators

Overview of New HHS Regulation Applies to grants and cooperative agreements from PHS (NIH, CDC, FDA, etc.) effective August 24, 2012 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

PHS Agencies That Fund Research 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)

Other Organizations that have Adopted this Rule Alliance for Lupus Research American Cancer Society American Heart Association American Lung Association Arthritis Foundation Susan G. Komen Foundation

Illinois Policy vs. HHS Regulation University of Illinois Policy on Conflicts of Commitment and Interest focuses on disclosure of income-producing outside activities to identify conflicts of interest for all academic employees. HHS Regulation focuses on disclosure of significant financial interests (SFI) and externally sponsored travel to identify conflicts of interest for PHS investigators.

What is a significant financial interest (SFI)? Must disclose within 30 days > $5000 for payments and equity interests in publicly traded companies, aggregated over preceding 12 months. > $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

Travel Disclosure PHS Investigators are required to disclose all externally reimbursed or sponsored travel Must disclose corporate, foreign university, non-profit sponsored travel. Travel paid by UIUC, other US academic institutions or federal government is exempt

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) FCOI must be reported to NIH Disclosure of external travel reimbursement must become routine

Who are PHS Investigators PHS Investigator defined as anyone involved in the design, conduct and reporting of PHS-funded research (PI, co-PI, postdoc, RA, fellows, emeritus faculty, research coordinators, others). This is a very broad definition. $86.3M (FY11 expenditures, a 30% increase over FY07).

PHS Training and Disclosures Have Begun Regulation was effective August 24, 2012 Approximately 1300 PIs, Co-PIs, Postdocs, GRAs, and APs are PHS Investigators Over 250 PHS investigator financial disclosures received and reviewed 750 PHS investigators trained

Action Needed Now http://www.research.illinois.edu/coi/PHS_Disclosure_Regulations.asp All PHS investigators should first complete ONE of the training options available at http://www.research.illinois.edu/coi/PHS_Training.asp  Simplest option is the Illinois Compass2g training.  Compass tracks your completion of this training and it takes about 15 minutes.   $86.3M (FY11 expenditures, a 30% increase over FY07).

Action Needed Now All PHS investigators complete the disclosure form at http://www.research.illinois.edu/coi/PIFID_2012.pdf and either return by email to phsdisclosure@illinois.edu or in hard copy to me. Then keep disclosures of SFI up to date. All PHS investigators should bring their travel disclosures up to date for the past year and then continue to keep them current, using the web page at http://phstraveldisclosure.research.illinois.edu/  You may have a proxy enter travel disclosures for you. If you have no travel to disclose, no need to use this web page.  $86.3M (FY11 expenditures, a 30% increase over FY07).

Action Needed Now Identify PHS Investigators with Known Financial Conflicts of Interest Review Conflict Management Plans Work with Unit Head to Update and Modify as Necessary

Action Needed Now Identify subrecipients Communicate with subrecipients who are not from “standard” academic research institutions Initiate training and disclosure

Implementation of HHS Rule at UIUC The HHS Regulation applies to research funded by PHS as well as other organizations who have adopted its requirements, e.g. American Heart Association, American Cancer Society. A disclosure form for financial interests is available at http://www.research.illinois.edu/coi/PHS_Financial_Disclosure.asp A travel disclosure web page is available at http://www.research.illinois.edu/coi/PHS_Travel_Disclosure.asp Additional information is available at http://www.research.illinois.edu/coi/PHS_Disclosure_Regulations.asp

Implementation of HHS Rule OSPRA Procedures Prior to proposal submission, investigators are asked to certify on the transmittal that financial disclosure is up to date for those named in the proposal – NB - signatures will be needed. Prior to award, investigators are asked to certify for all participating investigators that Financial disclosure up to date All financial conflicts of interest are managed Training completed

Certification Form

Training and Disclosure Records will be Published in Box Business managers may request access to read-only copies of excel lists These will be updated at least 2X weekly

Implementation of HHS Rule Subrecipients If the proposal contemplates a subrecipient relationship with a third party, the Authorized Administrative Approval provided at the proposal submission stage must include a statement indicating the subrecipient certifies that at the time of award, they will either (1) have a conflict of interest policy that is compliant with the PHS regulations, or (2) agree to adopt and abide by the UIUC conflict of interest policy

Subrecipient Disclosure Subrecipients without an HHS-Compliant policy will need to comply with UIUC requirements for training and disclosure. A subrecipient disclosure form is in preparation. This can be used for SFI and for travel For training, suggest NIH tutorial Email us NIH certificate and our form

Small Business Grants The HHS regulation does not apply to Small Business Innovative Research (SBIR) and small Business Technology Transfer (STTR) Programs Phase I applications and awards. However, investigators on these projects must still comply with the University’s Policy and annual disclosure process.

Public Access to FCOI Information Institution must 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 Illinois plans to respond to written requests

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)

Extra Slides

Disclosure of Significant Financial Interests (SFI) PHS Investigator defined as anyone involved in the design, conduct and reporting of research (PI, co-PI, postdoc, RA, others) Investigators must disclose all SFI relating to the investigator’s institutional responsibilities Includes interests of spouse or domestic partner, parents, siblings and children. SFI are then reviewed by the institution to determine whether they are financial conflicts of interest (FCOI)

Institutional Responsibilities Defined Institutional responsibilities means an Investigator's professional responsibilities on behalf of the institution, and as defined by the institution in its policy on financial conflicts of interest, which may include for example: activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

Review of SFI An SFI is related to NIH-funded research when the University, through its designated official(s), reasonably determines that the SFI could be affected by the NIH-funded research; or the SFI is an entity whose financial interest could be affected by the research. An FCOI exists when the University, through its designated official(s), reasonably determines that an SFI could directly and significantly affect the design, conduct or reporting of NIH-funded research.

Reporting of FCOI If an FCOI exists, a management plan must be implemented and an FCOI report submitted to NIH within 60 days. NIH must be notified when bias is found in the design, conduct or reporting of NIH-funded research. University must provide an annual FCOI report that addresses the status of the FCOI and any changes to the management plan

Subaward Requirements Institutions must take reasonable steps to ensure that investigators working for subawardee institutions comply with the regulation Subawardee institution may have its own policy or else comply with UIUC policy

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.