Financial Conflicts of Interest and Research: 2012 Developments Mike Klein Associate Director, Office of Research Compliance and Training August 2012

Financial Conflicts of Financial Conflicts of Interest and Research:Interest and Research:

2012 Developments2012 DevelopmentsMike KleinMike Klein

Associate Director, Office of Associate Director, Office of Research Compliance and TrainingResearch Compliance and Training

August 2012August 2012

Current RegulationCurrent Regulation Public Health Service regulation: Public Health Service regulation:

“Responsibility of Applicants for Promoting “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Objectivity in Research for which PHS Funding is Sought” (1995)Funding is Sought” (1995)

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Recent DevelopmentsRecent Developments Policy on Financial Conflicts of Interest and Policy on Financial Conflicts of Interest and

Research (2009)Research (2009) Built on 1986, 1993 policiesBuilt on 1986, 1993 policies 2011 U. Senate review: the Policy working as 2011 U. Senate review: the Policy working as

expected.expected. CUMC Policy on COI in Clinical Care and CUMC Policy on COI in Clinical Care and

Education for all schools. For P&S, public Education for all schools. For P&S, public website access to financial interests.website access to financial interests.

Revised Public Health Service (PHS) regulation Revised Public Health Service (PHS) regulation Takes effect Aug. 24, 2012Takes effect Aug. 24, 2012

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Revised PHS RegulationRevised PHS Regulation Broadens scope of financial interests that Broadens scope of financial interests that

investigators need to disclose to the investigators need to disclose to the UniversityUniversity

Broadens scope of University review of Broadens scope of University review of disclosed financial interestsdisclosed financial interests

Broadens requirements for the University Broadens requirements for the University to report to NIHto report to NIH

New requirements for disclosure to the New requirements for disclosure to the public public

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Overall CU Policy ApproachOverall CU Policy Approach 2009 Policy anticipated some changes in 2009 Policy anticipated some changes in

the new regulation.the new regulation. Some technical amendments have been Some technical amendments have been

made.made. We will continue to have a single overall We will continue to have a single overall

Policy governing Columbia research.Policy governing Columbia research. Some implementation will be specific to Some implementation will be specific to

PHS-funded research and researchers.PHS-funded research and researchers.

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New PHS Regulation:New PHS Regulation:Who is covered?Who is covered?

National Institutes of Health (NIH)National Institutes of Health (NIH) Centers for Disease Control and Prevention (CDC)Centers for Disease Control and Prevention (CDC) Food and Drug Administration (FDA)Food and Drug Administration (FDA) Agency for Healthcare Research and Quality (AHRQ)Agency for Healthcare Research and Quality (AHRQ) Substance Abuse and Mental Health Services Substance Abuse and Mental Health Services

Administration (SAMHSA)Administration (SAMHSA) Agency for Toxic Substances and Disease Registry Agency for Toxic Substances and Disease Registry

(ATSDR)(ATSDR) Health Resources and Services Administration (HRSA)Health Resources and Services Administration (HRSA) Indian Health Service (IHS)Indian Health Service (IHS)

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New PHS Regulation:New PHS Regulation:Who is covered?Who is covered?

All PHS Investigators: the Project Director or Principal All PHS Investigators: the Project Director or Principal Investigator and Investigator and any other individualany other individual who is responsible who is responsible for the design, conduct, or reporting of research funded for the design, conduct, or reporting of research funded by the Public Health Service. by the Public Health Service.

Individuals who are purely advisory or are not sufficiently Individuals who are purely advisory or are not sufficiently independent to be in a position to influence design, independent to be in a position to influence design, conduct or results of the research are not included.conduct or results of the research are not included.

Postdocs and grad students are covered if they meet the Postdocs and grad students are covered if they meet the definition of an “Investigator”definition of an “Investigator”

New designation in Rascal Proposal Tracking: “Student-New designation in Rascal Proposal Tracking: “Student-Investigator”Investigator”

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New PHS Regulation:New PHS Regulation:Investigator ObligationsInvestigator Obligations

Broader disclosureBroader disclosure

All “significant financial interests” (SFI) that All “significant financial interests” (SFI) that relate to relate to investigators’ “institutional responsibilitiesinvestigators’ “institutional responsibilities,” not only to ,” not only to their research.their research.

Form already captures research, clinical care, Form already captures research, clinical care, educationeducation

Our current Rascal disclosure has been updated to Our current Rascal disclosure has been updated to encompass broader requirement.encompass broader requirement.

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SFI that must be disclosed include:SFI that must be disclosed include:

Payments from most Payments from most non-profitsnon-profits

““reimbursed or sponsored travelreimbursed or sponsored travel””• Regardless of valueRegardless of value• We include some travel questions but PHS researchers will have We include some travel questions but PHS researchers will have

to provide more and update to provide more and update within 30 dayswithin 30 days [email protected] [email protected] Purpose, sponsor, destination, approximate valuePurpose, sponsor, destination, approximate value

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1010


No travel disclosure required for:No travel disclosure required for:

Travel funded through Columbia and charged to a Travel funded through Columbia and charged to a sponsored project or departmental accountsponsored project or departmental account

Travel sponsored/reimbursed by:Travel sponsored/reimbursed by: Government agencyGovernment agency U.S. institution of higher educationU.S. institution of higher education Affiliated teaching hospital, medical center, or Affiliated teaching hospital, medical center, or

research instituteresearch institute1010


Mandatory training every 4 yearsMandatory training every 4 years Stand-alone Rascal training availableStand-alone Rascal training available

TC1450 - Financial Conflicts of Interest for PHS TC1450 - Financial Conflicts of Interest for PHS ResearchersResearchers

Human subjects protection training will fulfill the Human subjects protection training will fulfill the requirement after August 2012, including refresher requirement after August 2012, including refresher trainingtraining

Monitored through proposal/protocol submissionMonitored through proposal/protocol submission ““Student-investigators” must complete trainingStudent-investigators” must complete training

New hires who are PHS Investigators must New hires who are PHS Investigators must complete training within 30 days of hirecomplete training within 30 days of hire

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New PHS Regulation:New PHS Regulation:Subrecipient RequirementsSubrecipient Requirements

Proposal Submission: confirmation that Proposal Submission: confirmation that subrecipient has its own conflict-of-interest subrecipient has its own conflict-of-interest policy that complies with the PHS policy that complies with the PHS regulation.regulation. New Policy Confirmation Form will be required.New Policy Confirmation Form will be required.

Award: agreement specifies that Award: agreement specifies that subrecipient will apply its own policy.subrecipient will apply its own policy.

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New PHS Regulation:New PHS Regulation:University obligationsUniversity obligations

Determinations project-by-projectDeterminations project-by-project ManagementManagement ReportingReporting Review/MitigationReview/Mitigation Public disclosurePublic disclosure

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Project-by-Project DeterminationsProject-by-Project Determinations1.1. Do the disclosed SFIs “relate” to the research Do the disclosed SFIs “relate” to the research

project?project? Lower threshold for SFI - $10k is now $5kLower threshold for SFI - $10k is now $5k Assessed by Research Compliance & Training, with input Assessed by Research Compliance & Training, with input

from experts as needed, at just-in-time where possiblefrom experts as needed, at just-in-time where possible

2.2. If yes, is there a “financial conflict of interest”?If yes, is there a “financial conflict of interest”? Assessed by FCOI CommitteeAssessed by FCOI Committee

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ManagementManagement Implement a Implement a management planmanagement plan to address FCOI to address FCOI

• ““To ensure, to the extent possible, that the design, conduct, To ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.”and reporting of research will be free from bias.”

• FCOI Committee responsibilityFCOI Committee responsibility University must University must monitor monitor on an ongoing basison an ongoing basis

• RCT/FCOI Committee responsibilityRCT/FCOI Committee responsibility

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Reporting to PHSReporting to PHS

Initial FCOI Report Initial FCOI Report prior to expenditure of prior to expenditure of fundsfunds

Including: Including: Project #, PI, conflicted Project #, PI, conflicted investigator, SFI entity, nature investigator, SFI entity, nature and and value of value of SFI (range), relation to research, key SFI (range), relation to research, key elements of management planelements of management plan

Annual updates Annual updates and updates for new issuesand updates for new issues

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Review/MitigationReview/Mitigation

FCOI not identified or managedFCOI not identified or managed in a timely manner (due to in a timely manner (due to failure by an investigator to disclose or the institution to failure by an investigator to disclose or the institution to review or manage an FCOI)?review or manage an FCOI)?

University has University has 120 days120 days to conduct a to conduct a retrospective reviewretrospective review of of the investigator’s activities and related NIH-funded researchthe investigator’s activities and related NIH-funded research

Was there biasWas there bias in the design, conduct, or reporting of the in the design, conduct, or reporting of the research?research?

If bias is found, a If bias is found, a mitigation reportmitigation report must be submitted to NIH must be submitted to NIH documenting key elements of retrospective review; impact of documenting key elements of retrospective review; impact of bias on research; institutional plan to eliminate or mitigate bias on research; institutional plan to eliminate or mitigate biasbias

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Public DisclosurePublic Disclosure

Make available to the public – either on a website or Make available to the public – either on a website or promptly in response to requests from the public – promptly in response to requests from the public – information concerning FCOI’s of key personnel information concerning FCOI’s of key personnel identified in connection with PHS researchidentified in connection with PHS research

• We plan to respond to written requestsWe plan to respond to written requests

FCOI Policy must be publicly availableFCOI Policy must be publicly available• We have a Research COI website nowWe have a Research COI website now

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Implementation StrategyImplementation Strategy Project plan; weekly meetings; regular Project plan; weekly meetings; regular

discussions with key partners (SPA, Rascal)discussions with key partners (SPA, Rascal) U. Senate approved necessary “technical U. Senate approved necessary “technical

amendments” to Policyamendments” to Policy Rascal changes implementedRascal changes implemented Website updates, including new FAQsWebsite updates, including new FAQs At least monthly meetings with peer institutionsAt least monthly meetings with peer institutions Outreach to and input from senior leadership, Outreach to and input from senior leadership,

FCOI Committees, members of the research FCOI Committees, members of the research communitycommunity

Briefings and targeted emailsBriefings and targeted emails

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2020

Questions?Questions? Naomi SchragNaomi Schrag

[email protected]@columbia.edu 212-854-8123212-854-8123

Michael KleinMichael Klein [email protected]@columbia.edu 212-851-2896212-851-2896

Joel RoselinJoel Roselin [email protected]@columbia.edu 212-851-2897212-851-2897

www.researchcompliance.columbia.eduwww.researchcompliance.columbia.edu

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SPA ImplementationSPA Implementation At Proposal SubmissionAt Proposal Submission

SPA can not submit any PHS proposal without :SPA can not submit any PHS proposal without :• All personnel listed on proposal budget being listed All personnel listed on proposal budget being listed

on the Rascal PT record.on the Rascal PT record.• All investigators having current COI disclosures on All investigators having current COI disclosures on

record in Rascal. Disclosure must be filed on or record in Rascal. Disclosure must be filed on or after July 23, 2012.after July 23, 2012.

• Completed Sub-Awardee COI Policy Confirmation Completed Sub-Awardee COI Policy Confirmation Form for each sub named in the application. Form is Form for each sub named in the application. Form is available at http://spa.columbia.edu/forms/internal-available at http://spa.columbia.edu/forms/internal-formsforms

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SPA ImplementationSPA Implementation Subrecipient Policy Confirmation FormSubrecipient Policy Confirmation Form

Your institutional official’s signature below serves as confirmation that your Your institutional official’s signature below serves as confirmation that your institutioninstitutionA.A. _________ has a conflict of interest policy and process which _________ has a conflict of interest policy and process which conforms to the requirements of PHS regulations set forth in 45 CFR Part conforms to the requirements of PHS regulations set forth in 45 CFR Part 94 and 42 CFR Part 50, Subpart F, “Responsibility of Applicants for 94 and 42 CFR Part 50, Subpart F, “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought” as Promoting Objectivity in Research for which PHS Funding is Sought” as amended in 2011.amended in 2011.

ORORB.B. _________ will have implemented a conflict of interest policy and _________ will have implemented a conflict of interest policy and process which conforms to the requirements of the PHS regulations set process which conforms to the requirements of the PHS regulations set forth in 45 CFR Part 94 and 42 CFR Part 50, Subpart F, “Responsibility of forth in 45 CFR Part 94 and 42 CFR Part 50, Subpart F, “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Applicants for Promoting Objectivity in Research for which PHS Funding is Sought” as amended in 2011, prior to receipt of any funds in the event that Sought” as amended in 2011, prior to receipt of any funds in the event that the above application is funded. the above application is funded. Please check Option A or Option B, above. If neither option is applicable, Please check Option A or Option B, above. If neither option is applicable, you must immediately submit an explanation to [email protected] you must immediately submit an explanation to [email protected] but your institution may not qualify to be a subrecipient for this project. but your institution may not qualify to be a subrecipient for this project.

SPA ImplementationSPA Implementation At Just-in-Time (JIT)At Just-in-Time (JIT)

SPA will notify ORCT of the receipt of the JIT SPA will notify ORCT of the receipt of the JIT notice so they can begin work on their notice so they can begin work on their relatedness reviews. relatedness reviews.

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SPA ImplementationSPA Implementation At time of award, SPA will: At time of award, SPA will:

Confirm that there are no changes in Confirm that there are no changes in personnel from those listed in Rascalpersonnel from those listed in Rascal

Reconfirm that all investigators have COI Reconfirm that all investigators have COI clearance for this specific projectclearance for this specific project

SPA cannot set up any award for any SPA cannot set up any award for any funding until all COI issues have been funding until all COI issues have been resolved.resolved.

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SPA ImplementationSPA Implementation For any projects with subawardsFor any projects with subawards

SPA will verify that all subawardees SPA will verify that all subawardees • have filed the COI Policy Confirmation Form and if have filed the COI Policy Confirmation Form and if

needed, confirmed implementation of a new FCOI policyneeded, confirmed implementation of a new FCOI policyOR OR

• are included on the FDP COI Registryare included on the FDP COI Registry SPA cannot issue any subawards from PHS SPA cannot issue any subawards from PHS

funding to any entity which has not completed COI funding to any entity which has not completed COI Policy Confirmation Form and resolved any issuesPolicy Confirmation Form and resolved any issues. .

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SPA ImplementationSPA Implementation At Non-competing Continuation (NCC) At Non-competing Continuation (NCC)

submission, SPA will:submission, SPA will: Confirm that the personnel included in the NCC Confirm that the personnel included in the NCC

match those listed in the NEW Rascal recordmatch those listed in the NEW Rascal record Confirm that all subs have filed their required Confirm that all subs have filed their required

certifications (form or FDP registry)certifications (form or FDP registry) SPA cannot submit any PHS NCC SPA cannot submit any PHS NCC

applications until all COI issues have been applications until all COI issues have been resolvedresolved. .

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Documents

Financial Conflicts of Interest and Research: 2012 Developments Mike Klein Associate Director, Office of Research Compliance and Training August 2012