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 – 8.24.2012 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 ReviewPHS 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 ReviewIf 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

PhysicianClinical 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 2012• 3 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 Revised training program via NIH Presentation and UA policy review – must be

trained by the first NOA after implementation of policyFCOI 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• COI-OFFICE@LISTSERV.CC.EMORY.EDU

• University of Alabama Office for Research Compliance • Rscompliance@fa.ua.edu

• NIH FAQs• http://grants.nih.gov/grants/policy/coi/