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

Current Regulation  Public Health Service regulation: “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought” (1995) 2

Recent Developments  Policy on Financial Conflicts of Interest and Research (2009) Built on 1986, 1993 policies Built on 1986, 1993 policies 2011 U. Senate review: the Policy working as expected U. Senate review: the Policy working as expected.  CUMC Policy on COI in Clinical Care and Education for all schools. For P&S, public website access to financial interests.  Revised Public Health Service (PHS) regulation Takes effect Aug. 24, 2012 Takes effect Aug. 24,

Revised PHS Regulation  Broadens scope of financial interests that investigators need to disclose to the University  Broadens scope of University review of disclosed financial interests  Broadens requirements for the University to report to NIH  New requirements for disclosure to the public 4

Overall CU Policy Approach  2009 Policy anticipated some changes in the new regulation.  Some technical amendments have been made.  We will continue to have a single overall Policy governing Columbia research.  Some implementation will be specific to PHS-funded research and researchers. 5

New PHS Regulation: Who is covered?  National Institutes of Health (NIH)  Centers for Disease Control and Prevention (CDC)  Food and Drug Administration (FDA)  Agency for Healthcare Research and Quality (AHRQ)  Substance Abuse and Mental Health Services Administration (SAMHSA)  Agency for Toxic Substances and Disease Registry (ATSDR)  Health Resources and Services Administration (HRSA)  Indian Health Service (IHS) 6

New PHS Regulation: Who is covered?  All PHS Investigators: the Project Director or Principal Investigator and any other individual who is responsible for the design, conduct, or reporting of research funded by the Public Health Service.  Individuals who are purely advisory or are not sufficiently independent to be in a position to influence design, conduct or results of the research are not included.  Postdocs and grad students are covered if they meet the definition of an “Investigator” New designation in Rascal Proposal Tracking: “Student- Investigator” New designation in Rascal Proposal Tracking: “Student- Investigator” 7

8 New PHS Regulation: Investigator Obligations  Broader disclosure All “significant financial interests” (SFI) that relate to investigators’ “institutional responsibilities,” not only to their research. All “significant financial interests” (SFI) that relate to investigators’ “institutional responsibilities,” not only to their research. Form already captures research, clinical care, education Form already captures research, clinical care, education Our current Rascal disclosure has been updated to encompass broader requirement. Our current Rascal disclosure has been updated to encompass broader requirement. 8

9 New PHS Regulation: Investigator Obligations  SFI that must be disclosed include: Payments from most non-profits Payments from most non-profits “reimbursed or sponsored travel” “reimbursed or sponsored travel” Regardless of valueRegardless of value We include some travel questions but PHS researchers will have to provide more and update within 30 daysWe include some travel questions but PHS researchers will have to provide more and update within 30 days Purpose, sponsor, destination, approximate value Purpose, sponsor, destination, approximate value 9

10 New PHS Regulation: Investigator Obligations  No travel disclosure required for: Travel funded through Columbia and charged to a sponsored project or departmental account Travel funded through Columbia and charged to a sponsored project or departmental account Travel sponsored/reimbursed by: Travel sponsored/reimbursed by: Government agency Government agency U.S. institution of higher education U.S. institution of higher education Affiliated teaching hospital, medical center, or research institute Affiliated teaching hospital, medical center, or research institute 10

New PHS Regulation: Investigator Obligations  Mandatory training every 4 years Stand-alone Rascal training available Stand-alone Rascal training available TC Financial Conflicts of Interest for PHS Researchers TC Financial Conflicts of Interest for PHS Researchers Human subjects protection training will fulfill the requirement after August 2012, including refresher training Human subjects protection training will fulfill the requirement after August 2012, including refresher training Monitored through proposal/protocol submission Monitored through proposal/protocol submission “Student-investigators” must complete training “Student-investigators” must complete training  New hires who are PHS Investigators must complete training within 30 days of hire 11

New PHS Regulation: Subrecipient Requirements  Proposal Submission: confirmation that subrecipient has its own conflict-of-interest policy that complies with the PHS regulation.  New Policy Confirmation Form will be required.  Award: agreement specifies that subrecipient will apply its own policy. 12

New PHS Regulation: University obligations  Determinations project-by-project  Management  Reporting  Review/Mitigation  Public disclosure 13

New PHS Regulation: University obligations Project-by-Project Determinations 1. Do the disclosed SFIs “relate” to the research project?  Lower threshold for SFI - $10k is now $5k  Assessed by Research Compliance & Training, with input from experts as needed, at just-in-time where possible 2. If yes, is there a “financial conflict of interest”?  Assessed by FCOI Committee 14

New PHS Regulation: University obligations Management Implement a management plan to address FCOI Implement a management plan to address FCOI “To ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.”“To ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.” FCOI Committee responsibilityFCOI Committee responsibility University must monitor on an ongoing basis University must monitor on an ongoing basis RCT/FCOI Committee responsibilityRCT/FCOI Committee responsibility 15

New PHS Regulation: University obligations Reporting to PHS Initial FCOI Report prior to expenditure of funds Initial FCOI Report prior to expenditure of funds Including: Project #, PI, conflicted investigator, SFI entity, nature and value of SFI (range), relation to research, key elements of management plan Including: Project #, PI, conflicted investigator, SFI entity, nature and value of SFI (range), relation to research, key elements of management plan Annual updates and updates for new issues Annual updates and updates for new issues 16

New PHS Regulation: University obligations Review/Mitigation FCOI not identified or managed in a timely manner (due to failure by an investigator to disclose or the institution to review or manage an FCOI)? FCOI not identified or managed in a timely manner (due to failure by an investigator to disclose or the institution to review or manage an FCOI)? University has 120 days to conduct a retrospective review of the investigator’s activities and related NIH- funded research University has 120 days to conduct a retrospective review of the investigator’s activities and related NIH- funded research Was there bias in the design, conduct, or reporting of the research? Was there bias in the design, conduct, or reporting of the research? If bias is found, a mitigation report must be submitted to NIH documenting key elements of retrospective review; impact of bias on research; institutional plan to eliminate or mitigate bias If bias is found, a mitigation report must be submitted to NIH documenting key elements of retrospective review; impact of bias on research; institutional plan to eliminate or mitigate bias 17

New PHS Regulation: University obligations Public Disclosure Make available to the public – either on a website or promptly in response to requests from the public – information concerning FCOI’s of key personnel identified in connection with PHS research Make available to the public – either on a website or promptly in response to requests from the public – information concerning FCOI’s of key personnel identified in connection with PHS research We plan to respond to written requestsWe plan to respond to written requests FCOI Policy must be publicly available FCOI Policy must be publicly available We have a Research COI website nowWe have a Research COI website now 18

Implementation Strategy  Project plan; weekly meetings; regular discussions with key partners (SPA, Rascal)  U. Senate approved necessary “technical amendments” to Policy  Rascal changes implemented  Website updates, including new FAQs  At least monthly meetings with peer institutions  Outreach to and input from senior leadership, FCOI Committees, members of the research community  Briefings and targeted s 19

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Questions?  Naomi Schrag  Michael Klein  Joel Roselin  21

SPA Implementation  At 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 on the Rascal PT record.All personnel listed on proposal budget being listed on the Rascal PT record. All investigators having current COI disclosures on record in Rascal. Disclosure must be filed on or after July 23, 2012.All investigators having current COI disclosures on record in Rascal. Disclosure must be filed on or after July 23, Completed Sub-Awardee COI Policy Confirmation Form for each sub named in the application. Form is available at Sub-Awardee COI Policy Confirmation Form for each sub named in the application. Form is available at

SPA Implementation  Subrecipient Policy Confirmation Form Your institutional official’s signature below serves as confirmation that your institution A._________ has a conflict of interest policy and process which 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 Promoting Objectivity in Research for which PHS Funding is Sought” as amended in OR OR B._________ will have implemented a conflict of interest policy and 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 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 the above application is funded. Please check Option A or Option B, above. If neither option is applicable, you must immediately submit an explanation to but your institution may not qualify to be a subrecipient for this project.

SPA Implementation  At Just-in-Time (JIT) SPA will notify ORCT of the receipt of the JIT notice so they can begin work on their relatedness reviews. SPA will notify ORCT of the receipt of the JIT notice so they can begin work on their relatedness reviews. 24

SPA Implementation  At time of award, SPA will: Confirm that there are no changes in personnel from those listed in Rascal Confirm that there are no changes in personnel from those listed in Rascal Reconfirm that all investigators have COI clearance for this specific project Reconfirm that all investigators have COI clearance for this specific project  SPA cannot set up any award for any funding until all COI issues have been resolved. 25

SPA Implementation  For 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 needed, confirmed implementation of a new FCOI policyhave filed the COI Policy Confirmation Form and if needed, confirmed implementation of a new FCOI policyOR are included on the FDP COI Registryare included on the FDP COI Registry SPA cannot issue any subawards from PHS funding to any entity which has not completed COI Policy Confirmation Form and resolved any issues. SPA cannot issue any subawards from PHS funding to any entity which has not completed COI Policy Confirmation Form and resolved any issues. 26

SPA Implementation  At Non-competing Continuation (NCC) submission, SPA will: Confirm that the personnel included in the NCC match those listed in the NEW Rascal record Confirm that the personnel included in the NCC match those listed in the NEW Rascal record Confirm that all subs have filed their required certifications (form or FDP registry) Confirm that all subs have filed their required certifications (form or FDP registry)  SPA cannot submit any PHS NCC applications until all COI issues have been resolved. 27