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)
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Recent Developments

Policy on Financial Conflicts of Interest and
Research (2009)


Built on 1986, 1993 policies
2011 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
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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.
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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)
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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: “StudentInvestigator”
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New PHS Regulation:
Investigator Obligations

Broader disclosure


All “significant financial interests” (SFI) that relate to
investigators’ “institutional responsibilities,” not only to
their research.
 Form already captures research, clinical care,
education
Our current Rascal disclosure has been updated to
encompass broader requirement.
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New PHS Regulation:
Investigator Obligations

SFI that must be disclosed include:

Payments from most non-profits

“reimbursed or sponsored travel”
• Regardless of value
• We include some travel questions but PHS researchers will have
to provide more and update within 30 days

TravelUpdate@columbia.edu

Purpose, sponsor, destination, approximate value
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New PHS Regulation:
Investigator Obligations

No travel disclosure required for:


Travel funded through Columbia and charged to a
sponsored project or departmental account
Travel sponsored/reimbursed by:



Government agency
U.S. institution of higher education
Affiliated teaching hospital, medical center, or
research institute
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New PHS Regulation:
Investigator Obligations

Mandatory training every 4 years

Stand-alone Rascal training available





TC1450 - Financial Conflicts of Interest for PHS
Researchers
Human subjects protection training will fulfill the
requirement after August 2012, including refresher
training
Monitored through proposal/protocol submission
“Student-investigators” must complete training
New hires who are PHS Investigators must
complete training within 30 days of hire
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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.
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New PHS Regulation:
University obligations





Determinations project-by-project
Management
Reporting
Review/Mitigation
Public disclosure
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New PHS Regulation:
University obligations
Project-by-Project Determinations
1.
Do the disclosed SFIs “relate” to the research
project?


2.
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
If yes, is there a “financial conflict of interest”?

Assessed by FCOI Committee
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New PHS Regulation:
University obligations
Management

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.”
• FCOI Committee responsibility

University must monitor on an ongoing basis
• RCT/FCOI Committee responsibility
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New PHS Regulation:
University obligations
Reporting to PHS



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
Annual updates and updates for new issues
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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)?
University has 120 days to conduct a retrospective
review of the investigator’s activities and related NIHfunded 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
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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
• We plan to respond to written requests

FCOI Policy must be publicly available
• We have a Research COI website now
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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 emails
19
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Questions?
 Naomi


Schrag
ns2333@columbia.edu
212-854-8123
 Michael


mak67@columbia.edu
212-851-2896
 Joel


Klein
Roselin
jr2644@columbia.edu
212-851-2897
 www.researchcompliance.columbia.edu
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SPA Implementation
 At

Proposal Submission
SPA can not submit any PHS proposal
without :
• 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.
• Completed Sub-Awardee COI Policy Confirmation
Form for each sub named in the application. Form
is available at
http://spa.columbia.edu/forms/internal-forms
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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 2011.
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 grants-office@columbia.edu
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.
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SPA Implementation
 At


time of award, SPA will:
Confirm that there are no changes in
personnel from those listed in Rascal
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.
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SPA Implementation
 For

any projects with subawards
SPA will verify that all subawardees
• have filed the COI Policy Confirmation Form and if
needed, confirmed implementation of a new FCOI
policy
OR
• are 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.
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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 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.
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