Financial Conflict of Interest: We Met the Deadline for the PHS Regulations...Now What? Brenda Seiton, Assistant Vice President for Research Administration, Emory University Tanta Myles, Director & Research Compliance Officer Office for Research Compliance, University of Alabama

Learning Objectives  Participants will review the core changes of the PHS FCOI requirements and the continuing obligations associated with these changes;  Participants will examine solutions and strategies used by other institutions to manage changes in their conflict of interest policies and procedures associated with the new PHS requirements;  Participants will begin developing best practices for their institutions FCOI program.

Presentation Overview Review of the Objectivity in Research Regulations Key Decisions in process change Policies, Procedures, and Education On-going obligations and what’s on the horizon

New PHS Regulations  Applies to all PHS award applications - new and continuing  Compliance Dates – for new applications and training; time of progress report for continuing awards  Who discloses What : All PHS Investigators must report all SFI related to Institutional Responsibilities  Threshold dropped  Remuneration and equity in a public company dropped to $5000 (remuneration from a non-profit is now included);  any equity in a private company;  travel reimbursement more than $5000 from an entity  Institutional Officials must determine whether SFI are related to PHS activity and whether it constitutes a Financial Conflict of Interest  Financial Conflict of Interest definition – an SFI that significantly and directly affects design, conduct, or reporting of PHS funded research

New PHS Regulations  FCOI Training  More Information Reported to PHS Agency  FCOI Information Reported Publicly  Subrecipient compliance  Retrospective Review - detailed review when there is non- compliance with the policy or management plan

Training Requirements  Investigators must be trained on PHS regulations, Institutional Policy & Disclosure Requirements  Prior to submitting an award under new policy  Prior to receiving award under new policy  Every 4 years thereafter  Immediately ▪ Upon change of policy ▪ Investigators new to Institution ▪ Upon finding of non-compliance

Subrecipient Requirements  Written clause in the agreement that establishes whether the FCOI policy of the awardee Institution or that of the subrecipient will apply to subrecipient Investigators and include time periods to meet disclosure and/or FCOI reporting requirements  Subrecipient Institutions who rely on their FCOI policy must report identified FCOIs to the awardee Institution in sufficient time to allow the awardee Institution to report the FCOI to the PHS Awarding Component (e.g., NIH through Commons)  If awardee Institution's policy are followed, terms of agreement must included specific time period for subrecipient investigators to report to awardee Institution

Agency Reporting Requirements Role and principal duties of the conflicted Investigator in the research project Conditions of the management plan How the management plan is designed to safeguard objectivity in the research project; Confirmation of the Investigator’s agreement to the management plan; How the management plan will be monitored to ensure Investigator compliance; and Other information as needed.

Public Reporting  Provide the following information on a website or in writing to recipients  Grant number  Conflicted Investigator’s name  Conflicted Investigator’s role  Name of the entity  Nature of the SFI  Value of SFI

2011 Non-Compliance Procedures Retrospective Review PHS requires specific documentation of the Retrospective Review that includes: (1) Project number; (2) Project title; (3) PD/PI or contact PD/PI if a multiple PD/PI model is used; (4) Name of the Investigator with the FCOI; (5) Name of the entity with which the Investigator has a financial conflict of interest; (6) Reason(s) for the retrospective review; (7) Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed); (8) Findings of the review; and (9) Conclusions of the review. Mitigation Review If bias is found, Institution is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. The mitigation report must include, at a minimum: the key elements documented in the retrospective review; a description of the impact of the bias on the research project; Institution’s plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable).

All in the timing….Life of the Award  Investigator who is new to an on-going project or who acquires a new SFI must disclose new SFI within 30 days  Institution has 60 days to determine if SFI related to a project and if FCOI exists  Annual reporting of FCOI status through the entire competitive period

Key Questions Apply PHS regulations to all research or only PHS awards? Disclosure Collection and Review Public Reporting – Website or letter? Who determines Relatedness and FCOI and how? What is required for subcontracts? What level of details for agency reporting?

Overview of Emory COI Review Transactional Reporting Physician Clinical staff activities Annual Certification Faculty External Activities Healthcare Compliance Review Research Administration – COI Review Office, IRB & OSP Dean’s Office review Reporting to Funding Agencies & Public

Relationships with Other Offices  Dean’s Offices review external consulting agreements, gifts, educational/training activities with industry, use of Institutional resources  Emory Healthcare Compliance involved  IRB must review and approve any management plan involving human subject research  IRB staff member ex officio member of COI Review Committee  OTT formal quarterly meetings with COI Office to review licensing opportunities  IACUC Director ex officio member of COI Review Committee & COI Review Staff guest member of IACUC  OSP staff member ex officio member of COI Review Committee  Quarterly meetings with liaisons

Education Roll Out Began in Spring staff members provided 50+ presentations across campus Standard Presentation that can be sent to any department FAQs on-line Guidelines on-line Lunch and learn with other units in central research administration

Implementation of Regulations at Emory One Policy – Different Forms: same thresholds but disclosure of sponsored travel required only for PHS investigators Training: included in eCOI system – minimum requirements of NIH Narrowed definition of Investigator All Significant Financial Interests undergo institutional review and management plans issued as needed Three review levels: Administrative, Expedited, Full Committee Quality Assurance review for awarded grants Determination of “Financial Conflict of Interest” made only for PHS & NSF Public Reporting only for PHS awards via written request Subrecipient oversight only for PHS awards SBIR/STTR Phase I and GRA awards exempt from disclosure requirements, unless human subject research is involved

Disclosure & Review Process Annual & Transactional Disclosures Required Faculty complete Annual Update for PHS information plus questions about other non-research related but potential conflict of interest questions PHS investigators can update disclosures electronically Transactional Disclosures provide information already collected and pose questions specific to the project Non-Faculty use transactional form as annual disclosure form Must complete new form for each year of project Algorithm in electronic system to direct disclosures to COI Review Process Determining Relatedness Investigator makes initial disclosure COI Review Staff, Committee Members, & OTT assist in making final determination Determining Financial Conflict of Interest Developed and posted guidelines FCOI must be determined by COI Committee Members

Subcontracting Developed consortium letter for pre-award External Investigator Form must be completed by sub- investigators whose institution does not have a compliant policy Utilize FDP website for checking compliance Developed standard terms for subcontracts Specify information required for FCOI reporting Specify deadline for reporting

Agency Reporting Re-review current cases to ensure that FCOI standard was met Developed some standard language for standard tools, e.g. disclosure, oversight, etc. Provide a copy of the report to the Investigator Ensure that any subawardees are responsible for developing the rationale for their plans

Overview of UA COI Review Transactional Reporting Clinical Annual Certification External Activities CCHS & Healthcare Compliance Review Research Administration – Office of Research Compliance Review, IRB & OSP

Coordination among Multiple Offices Disclosures under the policy must be made prior to proposal submission At Emory and UA, this is monitored by the Sponsored Programs Office Agency notification is required prior to expenditure of any award funds Jointly monitored by OSP and COI/ORC Office Requires communication between offices to ensure appropriate and timely notification

UA Response  New policy based on the principle that UA manages Significant Financial Interests that are related to research as determined by its institutional officials; FCOI determined only for PHS & NSF funded activities  Significant Financial Interest Thresholds lowered for all research  SBIR/STTR Phase I awards excluded unless involves Human Subject Research  Unified processes for collecting information for all research activities  FCOI determined only for PHS & NSF funded activities  Audit PHS funded awards disclosure statements  Provide FCOI information on PHS research as required by regulations  Investigator’s name  Investigator’s title and role with respect to the research project  Name of the entity in which the Significant Financial Interest is held  Nature of the Significant Financial Interest; and  Approximate dollar value of the Significant Financial Interest (dollar ranges are permissible  Mandatory training for all investigators – every 4 years, new to UA, non-compliance found

UA’s Implementation of Changes  Changes in the timing of reviews started in July 2012  Review SFI when proposal is in fundable range for PHS awards  Immediately review SFI for on-going awards, proposals to foundations or industry  Revised definition of Investigator  Revised Disclosure Form – adding new questions to form & submission method. Disclosure Form Disclosure Form  Revised training program via NIH Presentation and UA policy review – must be trained by the first NOA after implementation of policy FCOI Training  Reviewed currently managed cases to determine whether an FCOI exists under current regulations at the time of next NOA or monitoring plan review after 8/2012  New transactional disclosures and annual disclosures for continuing and new awards

Resources Emory COI Review Office University of Alabama Office for Research Compliance NIH FAQs