Conflicts of Interest in Research
HACKENSACK UNIVERSITY MEDICAL CENTER
Administrative Policy Manual
Conflicts of Interest in Research
Procedure Number: 541
Original Issue: September, 1997
Revised:
November, 2012
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General Policy Statement
It is the policy of HackensackUMC to manage, eliminate, or reduce any actual or perceived
Conflicts of Interest in Research to minimize the risk to Research subjects and to make
unbiased results of Research available to the public.
All Investigators and Research Staff actively engaged in Research at Hackensack
University Medical Center must conduct their Research in accordance with the Institutional
Policies governing Conflict of Interest in Research, including without limitation this Policy
and the Related Policies.
Purpose
Consistent with its CORE values--patient care, community outreach, research and
education, Hackensack University Medical Center seeks to advance and expand medical
knowledge through Research and, where appropriate, to transfer the outcomes of Research
to clinical practice for the benefit of the patients it serves and the public. In its endeavors to
advance medical knowledge through Research, HackensackUMC recognizes its obligation
to protect the rights and the safety of both human and vertebrate animal subjects
participating in Research. Actual, perceived or potential Conflicts of Interest can arise when
an Investigator and /or other Research Staff Member involved in Research activities
sponsored by an industry or other organization has Financial or Associational Interests
directly or indirectly linked to the Sponsor of the Research in which s/he is engaged.
Regardless of the circumstances under which a Financial or Associational Interest is
obtained or exists, the perception may exist that it introduces a bias into the Research
process. It is the position of HackensackUMC that, although Investigators may be
compensated for their participation in Research, there is a rebuttable presumption of a
Conflict of Interest in Research when an Investigator or other Research Staff Member has
an Associational or Financial Interest in a Sponsor of Research activities at
HackensackUMC or derives other significant benefit from an Investigator’s participation in
the sponsored Research. As such, Investigators and other HackensackUMC Members
must comply with the requirements set forth in this Policy regarding any interest in or
responsibilities for a Research Sponsor or Supporter.
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Revised: July 2004, Revised: September 2006
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Conflicts of Interest in Research
Policy Requirements
Industry / Grant Sponsored and Hackensack Sponsored Studies
Investigator(s) and other Research Team Members are required to cooperate with the
HackensackUMC Committee on Conflicts of Interest in Research in its efforts to identify and
assess, and to determine appropriate action required to manage, eliminate, or reduce, any
actual, perceived or potential Conflicts of Interest in Research.
Each year, Investigators and Members of the Research Team shall make full and detailed
electronic disclosure(s) to the HackensackUMC Committee on Conflicts of Interest in
Research of any Financial or Associational Interest in. any pharmaceutical, biotech and/or
public health agency. Disclosure shall be made annually and at any time between annual
disclosure that the details of their disclosure change.
The disclosure of Interests to the Committee on Conflicts of Interest in Research shall not
be a substitute for other Conflicts of Interest disclosure required of the Investigators and
other Members of the Research Team (e.g., disclosures to the Food and Drug
Administration) and each member of the Research Team shall be responsible for assuring
the consistency of such disclosures with those made to the Committee.
Each Investigator or Research Team Member who is involved in Research involving human
subjects who has a Financial or Associational relationship with a Sponsor or Supporter shall
state in the patient consent form used in the study that he/she has such Financial or
Associational relationship using language approved by the Committee on Conflicts of
Interest in Research and the IRB of Record.
The results of Research reported in publications and presentations shall expressly
acknowledge the source of Research support. Disclosure of Financial or Associational
Interests relationships with Sponsor(s) or Supporter(s) shall be made by Investigator(s) in
articles submitted for publication in accordance with policies of publishers (journals) to
which articles are submitted. The HackensackUMC Committee on Conflicts of Interest in
Research may require further documentation of such disclosure under certain
circumstances.
If an individual engaged in Research provides a compensated service (other than the
contracted research activities) to the Sponsor, such compensation shall not exceed fair
market value for the service. These services shall be provided in compliance with other
applicable HackensackUMC policies and shall be disclosed pursuant to this policy.
Federal Regulations Relating to Financial Conflicts of Interest Related to Public
Health Service (PHS) and National Science Foundation (NSF)- Funded Research
This Policy is intended to implement the U.S. Department of Health and Human Services
(HHS) final rule published September 26, 2011 in the Federal Register that amends the
Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting
Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F)
and Responsible Prospective Contractors (45 C.F.R. Part 94) and to provide the
reasonable expectation that the design, conduct, and reporting of the Research will be free
from bias resulting from Investigator Financial Conflicts of Interest.
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Conflicts of Interest in Research
Investigators conducting Research funded by the PHS (including National Institutes of
Health (NIH)) and the NSF, as well as those conducting studies regulated by the Food and
Drug Administration, are subject to agency-specific regulations and Federal regulations.
This Policy is applicable to Investigators conducting basic and applied Research funded by
the PHS, as well as clinical research studies funded by PHS agencies regulated by the
Food and Drug Administration. These regulations set forth the obligations of Investigators,
Sponsors and Institutions for Research involving significant financial or other Conflicts of
Interest, and affected parties are advised to review the relevant regulations prior to
submission of a Research proposal or application, or contact the Sponsored Programs
Office for assistance in determining what regulations may be applicable
Every Investigator and Research Staff Member participating in PHS- or NSF-funded
Research must comply with Federal Regulations (as defined below). When
HackensackUMC carries out PHS-funded Research through sub-grantees, contractors, or
collaborators, the Medical Center shall take reasonable steps to ensure that Investigators
working for such entities comply with Federal Regulations, either by requiring those
Investigators or Research Staff Members to comply with the HackensackUMC’s Policy or
by requiring the entities to provide assurances to the Institution that will enable the
Institution to comply with such regulations. The terms of which will be outlined in the Clinical
Trial Agreement.
As a recipient of PHS funding, the Signatory Official for the grant application at
HackensackUMC is certifying to the governmental agency that HackensackUMC has a
written and enforced Policy regarding Conflict of Interests, and that all conflicts are
disclosed:
(1) At the time of submission;
(2) Annually; and
(3) Within thirty (30) days of acquiring a new interest.
The Signatory Official certifies that any actual, perceived and potential conflicts are
managed, reduced, or eliminated according to PHS regulations, prior to the expenditure of
any funds granted under an award.
Prior to HackensackUMC’s expenditure of any funds under a PHS or other government
award, HackensackUMC shall report to the PHS-Awarding Component the existence of a
Conflicting Interest found by the Institution, and assure that the Interest has been managed,
reduced or eliminated in accordance with Federal Regulations. For any Interest that
HackensackUMC identifies as conflicting subsequent to HackensackUMC’s initial report
under the award, the report shall be made and the Conflicted Interest managed, reduced, or
eliminated, at least on an interim basis, within sixty (60) days of that identification.
I. DEFINITIONS

Associational Interest: An “Associational Interest” occurs when an Investigator or
HackensackUMC Member has a non-financial relationship, formal or informal, or other nonfinancial involvement, with a Sponsor or Supporter of Research activities at
HackensackUMC, or with an entity that has a direct or indirect financial interest in the
Sponsor or otherwise stands to benefit from the results of the Research study
(e.g., uncompensated position on Sponsor’s scientific advisory board, board of directors or
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Conflicts of Interest in Research
authorized committee of the board of directors, service on a board of a venture capital fund
that invests in the Sponsor). See Exhibit C for examples of Associational Interests.

Chair: “Chair” refers to the Investigator’s department chairperson, Medical Center director
or other unit head within the HackensackUMC entity in which the Investigator’s Research is
performed.

Clinical Trial Agreement: A “Clinical Trial Agreement” is a contract between the Sponsor of
Research activities at HackensackUMC and/or an Investigator that sets forth each party’s
obligations with respect to such Research activities.

Compelling Circumstances: “Compelling Circumstances” refer to those facts that the
Committee on Conflicts of Interest in Research considers sufficient to permit an Investigator
to conduct Research involving human or vertebrate animal subjects pursuant to an
appropriate Conflict Management Plan, despite the existence of an interest that could give
rise to an actual, perceived or potential Conflict of Interest in Research.

Conflict of Interest in Research: A “Conflict of Interest in Research” refers to
circumstances in which financial or other personal interests may compromise or bias, or have
the appearance of compromising or biasing, an Investigator’s professional judgment in
conducting, interpreting, or reporting Research.

Conflict Management Plan: A “Conflict Management Plan” or “CMP” refers to the collection
of management strategies developed by the Committee on Conflicts of Interest in Research
and documented in writing for the purpose of appropriately managing actual, perceived or
potential Conflicts of Interest in Research, so as to prevent the introduction of bias that can
adversely affect the integrity of the study and create a risk to the safety of study subjects.

Disclosure Statements: “Disclosure Statements” refers, collectively, to the Protocol
Disclosure Statement and any interim disclosure.
Financial Interest: A “Financial Interest” in the Sponsor or Supporter of Research is anything
of potential monetary value provided to the Investigator or other Research Staff Member, or a
Member of his/her Immediate Family by the Sponsor, or by an entity that has a direct or indirect
financial interest in the Sponsor or otherwise stands to benefit from the results of the Research
study, with the exception of payment of reasonable compensation for the services provided under a
Clinical Trial Agreement or reimbursement of reasonable expenses incurred in connection with the
provision of such services. Examples of Financial Interests are consulting fees, honoraria or
expense reimbursement for speaking engagements, intellectual property royalty or license fee
payments, stock, stock options, partnership interests, warrants, loans of equipment. As required by
the federal regulations and only for Research Personnel on PHS-funded awards or cooperative
agreements issued on or after August 24, 2012, any travel over the previous twelve (12) months that
is reimbursed or paid on the individual’s behalf that is related to the individual’s responsibilities must
reported as a Significant Financial Interest. Investigators must submit an updated disclosure of
reimbursed or sponsored travel within thirty (30) days of the occurrence. See Exhibit C for a nonexhaustive list of examples of Significant Financial Interests.

HHS: “HHS” refers to the United States Department of Health and Human Services.

HackensackUMC: All entities that comprise the Hackensack University Medical Center are
referred to in this Policy collectively as “HackensackUMC.”
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Conflicts of Interest in Research

HackensackUMC Member: A “HackensackUMC Member” includes (a) any member of the
HackensackUMC Medical Staff; (b) any full-time, part-time, adjunct, voluntary, administrative
HackensackUMC employee, and any other individual who received at least a portion of
his/her salary from HackensackUMC either directly or indirectly (e.g., via Industry-Sponsored
Research at HackensackUMC); (c) any individual performing HackensackUMC Business; (d)
visitors; (e) students; (f) unaffiliated staff; and (g) independent contractors.

HackensackUMC Committee on Conflicts of Interest in Research: The Committee of the
HackensackUMC Medical Board that is charged with overseeing, implementing, and
monitoring Conflict of Interest compliance at HackensackUMC. The Committee membership
shall be determined by the Chairman of the Committee in accordance with any applicable
policies, procedures or guidelines.

IACUC: “IACUC” refers to the Institutional Animal Care and Use Committee.
Scientist/ Physicians who wish to do research using live animals must fill out an application
(protocol) to do so The application has a main body and appendices one of which is a
conflict of interest questionnaire..The application and appendices are submitted to the
IACUC for review. Protocols submitted without the conflict of interest questionnaire will not
be considered until the questionnaire is submitted. Any “irresolvable” conflict will be sent to
the conflict of interest committee.

Immediate Family: “Immediate Family” refers to a Research Team Member’s spouse,
domestic partner, sibling, grandparent, child, grandchild, or great grandchild; provided,
however, that “Immediate Family” shall refer to such person only if the individual lives in the
Research Team Member’s household, the Research Team Member manages the financial
affairs of the individual, or the Research Team Member is aware without special inquiry that
the family member holds a particular interest inquired by this Policy or any disclosure form
pursuant to this Policy.

Institutional Official. “Institutional Official” refers to a person who holds a position with
authority to make decisions on behalf of HackensackUMC that can directly or indirectly affect
Research activities at HackensackUMC, including, without limitation a member of the Board
of Directors or a committee of the Board of Directors, a member of senior management, any
other officer of HackensackUMC, a department or division chair, and a member of the IRB.
Institutional Responsibilities: “Institutional responsibilities” are defined as an
Investigator’s professional responsibilities on behalf of the Institution, which may include, for
example, activities such as Research, Research consultation, teaching, professional practice,
Institutional committee memberships, and service on panels such as Institutional Review
Boards or Data and Safety Monitoring Boards.

Manage: “Manage” refers to taking action to address an actual, perceived or potential
Associational or Financial Conflict of Interest, which can include reducing or eliminating the
Associational or Financial Conflict of Interest, to ensure, to the extent possible, that the
design, conduct, and reporting of research will be free from bias.

Interest. “Interest” refers collectively to Associational Interests and Financial Interests.
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
Interim Disclosure Statement: “Interim Disclosure Statement” refers to the
HackensackUMC Interim Disclosure Statement set forth in Exhibit B.

Investigator: “Investigator” includes any individual who is responsible or partially
responsible for the design, conduct or reporting of the Research activity funded or to be
funded by the Sponsor, whether as the Principal Investigator, Co-Principal Investigator, CoInvestigator, Consultant or Collaborator on any Research project or clinical evaluation
performed at HackensackUMC.

Institution Review Board (IRB):”Institutional Review Board (IRB)” refers to the IRB of
Record at HackensackUMC. This many include Hackensack University Medical Center IRB,
the National Cancer Institute’s Central IRB or any IRB authorized as the IRB of record for
research in which HackensackUMC is engaged.

Sponsored Programs Office (SPO): “Sponsored Programs Office (SPO)” refers to the
Medical Center’s grants office, which oversees all federal and non-federal research grant
submissions.

NIH: “NIH” refers to the National Institutes of Health.

NSF: “NSF” refers to the National Science Foundation.

PHS: “PHS” refers to the Public Health Service, an operating division of the U.S. Department
of Health and Human Services, and any components of the PHS to which the authority
involved may be delegated. The operating divisions of the DHHS are as follows:
Administration for Children and Families (ACF)
Administration for Children Youth and Families (ACYF)
Administration on Aging (AOA)
Agency for Healthcare Research and Quality (AHRQ)
Agency for Toxic Substances and Disease Registry (ATSDR)
Centers for Disease Control and Prevention (CDC)
Centers for Medicare and Medicaid services (CMS)
Food and Drug Administration (FDA)
Health Resources and Services Administration (HRSA)
Indian Health Service (HIS)
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Office of the Inspector General (OIG)
Substance Abuse and Mental Health Services Administration (SAMHSA)

PHS-Awarding Component: “PHS-Awarding Component” refers to the organizational unit
of the PHS that funds the research that is subject to 42 CFR Part 50 Subpart F.

Protocol Disclosure Statement: “Protocol Disclosure Statement” refers to the
HackensackUMC Protocol Disclosure Statement, attached hereto as Exhibit A.

Research: For PHS- or NSF-funded research, Research is defined as a systematic
investigation, study or experiment designed to develop or contribute to generalizable
knowledge relating broadly to public health, including behavioral and social-sciences
research. The term encompasses basic and applied Research (e.g., a published article, book
or book chapter) and product development (e.g., a diagnostic test or drug).
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
Research Team: The “Research Team” refers to the Principal Investigator, SubInvestigators and Member who will assist the Investigator and make a direct and significant
contribution to the data. The decision to list an individual depends on his/her level of
responsibility (i.e., whether s/he is performing significant clinical investigation-related
duties). In general, if an individual is directly involved in the performance of procedures
required by the protocol, and the collection of data, that person should be listed on the
1572.

Significant Associational Interest: A “Significant Associational Interest” refers to any
position held by a Research Team Member in a Sponsor of a Research study that
imposes upon that Member a fiduciary responsibility to the Sponsor under applicable
state law. See Exhibit C for a non-exhaustive list of examples of Significant Associational
Interests.

Significant Financial Interest (SFI): “Significant Financial Interest” refers to (1) any
Financial Interest or combination of Financial Interests of a Research Team Member, or a
Member of his/her Immediate Family, that is derived from a relationship with a Sponsor of a
Research study and that is valued at greater than $10,000 (e.g., an agreement providing for
payment by the Sponsor of more than $10,000 in compensation, license fees or royalties,
other intellectual property rights (e.g., patents)); (2) any ownership interest or combination of
ownership interests in a Sponsor that is a public company if it is equal to more than one
percent (1%) of the total ownership interests of the company (other than an interest held
through a mutual fund); (3) any ownership interest or combination of ownership interests in a
Sponsor that is a privately owned company (e.g., a limited partnership); (4) any warrants or
options to purchase stock in a Sponsor (regardless of the value or expected value); and
(5) any of the Financial Interest described in 1 through 4 that is derived from a relationship
with or interest in an entity that has a direct or indirect interest in or relationship with the
Sponsor.
*Significant Financial Interest for PHS or NSF funded research:
1. All financial interests that have monetary value, whether or not the value is readily
ascertainable. (1) A financial interest consisting of one or more of the following interests of
the Investigator (and those of the Investigator’s spouse and dependent children) that
reasonably appears to be related to the Investigator’s institutional responsibilities:
(i) With regard to any publicly traded entity, a Significant Financial Interest exists if
the value of any remuneration received from the entity in the twelve (12) months
preceding the disclosure and the value of any equity interest in the entity as of the
date of disclosure, when aggregated, exceeds $5,000. For purposes of this
definition, remuneration includes salary and any payment for services not otherwise
identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest
includes any stock, stock option, or other ownership interest, as determined through
reference to public prices or other reasonable measures of fair market value;
(ii) With regard to any non-publicly traded entity, a Significant Financial Interest exists
if the value of any remuneration received from the entity in the twelve (12) months
preceding the disclosure, when aggregated, exceeds $5,000, or when the
Investigator (or the Investigator’s spouse or dependent children) holds any equity
interest (e.g., stock, stock option, or other ownership interest); or
(iii) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of
income related to such rights and interests.
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(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel
(i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so
that the exact monetary value may not be readily available), related to his/her Institutional
responsibilities; provided, however, that this disclosure requirement does not apply to travel
that is reimbursed or sponsored by a federal, state, or local government agency, an
Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching
hospital, a medical center, or a Research institute that is affiliated with an Institution of higher
education.
(3) The term Significant Financial Interest does not include the following types of Financial
interests: salary, royalties, or other remuneration paid by the Institution to the Investigator if
the Investigator is currently employed or otherwise appointed by the Institution, including
intellectual property rights assigned to the Institution and agreements to share in royalties
related to such rights; any ownership interest in the Institution held by the Investigator, if the
Institution is a commercial or for-profit organization; income from investment vehicles, such
as mutual funds and retirement accounts, as long as the Investigator does not directly
control the investment decisions made in these vehicles; income from seminars, lectures, or
teaching engagements sponsored by a federal, state, or local government agency, an
Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching
hospital, a medical center, or a Research institute that is affiliated with an Institution of higher
education; or income from service on advisory committees or review panels for a federal,
state, or local government agency, an Institution of higher education as defined at 20 U.S.C.
1001(a), an academic teaching hospital, a medical center, or a Research institute that is
affiliated with an Institution of higher education.”
(4) Financial interests received from a foreign Institution of higher education or the
government of another country
(5) Paid authorship
“New” Significant Financial Interest: A New SFI is a different type or nature of SFI (e.g.,
royalty payment versus consulting fees) than what had previously been disclosed from the
same source that meets or exceeds the threshold. In addition, a “New” SFI is also
considered to be the same type or nature of SFI (e.g., royalty payment) from a different
source (e.g., company A versus company B).
NOTE: For PHS- or NSF-funded research, the disclosure threshold for the reporting
year is $5000 and applies to all interests related to the Investigator’s Institutional
responsibilities. For Research Personnel on PHS funded awards or cooperative
agreements issued on or after August 24, 2012, this threshold includes any travel that
was reimbursed within the previous twelve (12) months or paid on the individual’s
behalf that is related to the individual’s Institutional responsibilities.
See Exhibit C for a non-exhaustive list of examples of Significant Financial Interests.

Significant Interests: “Significant Interests” refers to any Interest that is either a Significant
Associational Interest or a Significant Financial Interest.

Sponsor(s): “Sponsor(s)” of Research include entities that are providing financial support to
Investigator(s), Research Staff and/ or HackensackUMC in Research studies or to which
applications for such support are made by Investigators, Research Staff and/or
HackensackUMC regardless of whether such Sponsors are also serving as the “Sponsor”
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under 21 C.F.R. § 50.3(e) (for FDA regulation). Sponsor includes the National Institutes of
Health and any companies providing financial support and/or drug for such studies.
II.
DISCLOSURE PROCESS
All information provided by an Investigator or other Research Staff Member during the
disclosure or review process under this Policy shall be confidential, except as necessary to
implement this Policy or as otherwise required by law.
A. Annual Financial Disclosure Statement: During the first quarter of each calendar year,
the Principal Investigator and each other Investigator and other Member of the Research
Team shall complete a Protocol Disclosure Statement via the designated electronic system
(See Exhibit A for a sample form HackensackUMC MediRegs Conflict of Interest Form).
The Principal Investigator shall be responsible for verifying all such electronic disclosure
statements have been completed and submitted.
B. Disclosures at the Time of Continuing Review: At the time of the IRB/ IACUC continuing
review of a Research study, the Research Integrity Office shall verify that the Principal
Investigator of a Research study and each Member of the Research Team has submitted a
current Annual Protocol Disclosure Statement for himself/herself. The Principal Investigator
shall be responsible for verifying all such disclosure statement have been completed and
submitted to the Research Integrity Office (RIO)).The Principal Investigator and Members of
the Research Team may view a copy of the most recent Protocol Disclosure by reviewing
their profile in the designated system (HackensackUMC MediRegs COIR Electronic Portal).
C. Interim Disclosure Statement: The Principal Investigator and each other Member of the
Research Team shall submit a new revised electronic financial Disclosure Statement
(HackensackUMC MediRegs Conflict of Interest Form) if any change(s) occur before the
next Annual Protocol Disclosure submission deadline or if there is a previously undisclosed
SFI affecting a new application for extramural funding for a Research study. This interim
disclosure must be made prior to initial IRB/ IACUC review and approval of the Protocol for
the study. The Principal Investigator and each Member of the Research Team shall
complete a Protocol Disclosure Statement.
Interim Disclosure Statements shall be submitted to the Research Integrity Office via the
designated system.
Disclosures for PHS and NSF funded research:
For disclosures of SFI related to PHS- or NSF-funded research, additional information shall
be required as follows:
1. Investigators who are planning to participate in PHS-funded research must disclose
their SFIs over the previous twelve (12)-month period to their Institution no later than at the
time of application for PHS-funded research.
2. Each Investigator who is participating in PHS-funded research must submit an updated
disclosure of SFIs at least annually, in accordance with the specific time period prescribed
by the Institution, during the period of award.
3. Each Investigator who is participating in the PHS-funded research must submit an
updated disclosure of SFIs within thirty (30) days of discovering or acquiring a new SFI.
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4. Prior to the submission of grant applications to the NIH/PHSP or NFS, all Investigators
must also complete and submit to the Chair of Research SPO Form 1 (Exhibit E). In
submitting this form, investigators will be certifying that they have read and understand this
Policy; they have made required yearly disclosures; and they will comply with any
conditions imposed by HackensackUMC to manage, reduce or eliminate actual, perceived
or potential Conflicts of Interest; if a Conflict of Interest is reported.
III. REVIEW PROCESS
A.
Significant Interests
1. The Research Integrity Office shall forward all Significant Interests disclosed on Disclosure
Statements to the Chair of the Committee on Conflicts of Interest in Research. For PHS- or
NSF-funded research, the Chair of the Research Department must review SFIs disclosed by
Investigators on Disclosure Statements and SPO Form 1 to determine whether a Financial
Conflict of Interest exists; and, if so, determine necessary actions that should be taken by the
Institution to manage, reduce, or eliminate such Conflict of Interest in accordance with the
regulation. A Conflict of Interest exists when the Chair of the Research Department and the
Chair of the Committee on Conflicts of Interest in Research reasonably determine that a
Significant Financial Interest could directly and significantly affect the design, conduct, or
reporting of the Research funded by the NIH.
2. The Director of Regulatory Affairs shall prescreen any disclosed SFI and evaluate
against prescreening criteria (see Exhibit D for Prescreening Criteria and Management
Requirements). Disclosed SFI meeting criteria shall be noted as having met policy
requirements for compelling need and include any elements for management.
Disclosed SFI that are approved in this manner shall be noted in a log and reviewed by
the full committee at the next convened meeting. Disclosed SFI not meeting criteria
shall be referred to the Committee for review.
3. The Committee shall then review and assess the disclosed SFI and potential Conflict of
Interest in Research arising from each such disclosure at its next scheduled meeting.
The Committee shall refer to the Guidelines for Evaluation of Potential Conflicts of
Interest in Research, attached hereto as Exhibit B. The Committee may also request
additional information from the Principal Investigator or the disclosing party in the
course of its review.
4. The Committee shall determine whether Compelling Circumstances exist to warrant
further consideration of the disclosing party’s involvement in the study, despite the
existence of an actual, perceived or potential Conflict of Interest.
5. If the Committee determines that Compelling Circumstances exist to support the
disclosing party’s involvement in the study, the Committee shall develop a Conflict
Management Plan. The Committee shall refer to the “Guidelines on Development of a
Conflict Management Plan,” attached hereto as Exhibit C. All Conflict Management
Plans shall
o
include methods by which the Committee will oversee compliance with the Plan
throughout the course of the study using means such as requiring written reports
pertaining to compliance with the Conflict Management Plan and having the right
to audit the study for such compliance. If the Committee determines that audits
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o
o
are required, the Committee shall identify the party responsible to conduct the
audit and the timeframe for reporting;
state that the Plan must be shared with the disclosing party whose Interests it
was developed to manage; and
state whether the Plan should be shared with, and periodic reports on
compliance with the Plan should be provided to, the HackensackUMC Board,
HackensackUMC senior management, the relevant department chair, the
Sponsor, other members of the applicable Research Team, and/or government
agencies (e.g., FDA, PHS).
6. If the Committee determines that no compelling circumstances exist, the Committee
shall:
o
o
o
require that the disclosing party divest the disclosed Interest in order to
participate in the study; or
if the disclosing party will not divest the disclosed Interest, recommend that the
IRB/ IACUC not approve the study (if the disclosure occurred on a Protocol
Disclosure Statement filed prior to IRB/IACUC approval of the study), or
require that the IRB/IACUC terminate, suspend or reduce the disclosing party’s
participation in the study or terminate the study in its entirety (if the disclosure
occurred at the time of Continuing Review or on an Interim Disclosure
Statement).
7. As reflected in the Guidelines set forth in Exhibit B and Exhibit C, the Committee has
the discretion to take into account in its assessment of a Conflict, its determination of
whether Compelling Circumstances exist, and its development of a CMP, the
differences in circumstances that may arise when an Interest giving rise to an actual,
perceived or potential Conflict of Interest is disclosed during the course of a Research
study (i.e., the Interest is disclosed at the time of Continuing Review or on an Interim
Disclosure Statement).
8. The Chair of the Committee, in his or her discretion, may delegate to the Director of
Regulatory Affairs the responsibility for undertaking, and with such others as s/he
considers appropriate, the initial review and assessment of the potential Conflict of
Interest and, where applicable, for the development of a Conflict Management Plan.
This delegation shall be in a manner consistent with the Guidelines set forth in Exhibit B
and Exhibit C and with the provisions of Section III.A.3 through 6 above; provided, however,
that the Chairman of the Research Department shall provide the Committee with a detailed
written and oral report of its findings conclusions, recommendations, and proposed Conflict
Management Plans to the Committee for its thorough review and approval before the same
shall be implemented.
B.
Interests other than Significant Financial Interests
1. The Director of Regulatory Affairs shall review all Interests other than Significant
Financial Interests (including, without limitation, Associational Interests) that are
disclosed on Disclosure Statements. In the course of the review, s/he shall refer to the
Guidelines for Evaluation of Potential Conflicts of Interest in Research, attached hereto
as Exhibit C and confer with the Corporate Compliance Officer. The Director of
Regulatory Affairs also may request additional information from the Principal
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Investigator or the disclosing party in the course of its review and confer with others as
s/he considers necessary and appropriate.
2. If the Director of Regulatory Affairs concludes that the Interest gives rise to an
actual, perceived or potential Conflict of Interest, s/he will determine whether
Compelling Circumstances exist to warrant further consideration of the disclosing
party’s involvement in the study despite the existence of an actual, perceived or
potential Conflict of Interest.
a. If the Director of Regulatory Affairs determines that Compelling Circumstances exist,
s/he shall develop a Conflict Management Plan. S/he shall refer to the
“Guidelines on Development of a Conflict Management Plan,” attached hereto
as Exhibit C. All Conflict Management Plans shall (a) include methods by which
the Committee on Conflicts of Interest in Research will oversee compliance with
the Plan throughout the course of the study using means such as requiring
written reports pertaining to compliance with the Conflict Management Plan and
conducting audits of the study for such compliance; (b) state that the Plan must
be shared with the disclosing party whose Interests it was developed to manage;
and (c) state whether the Plan should be shared with, and periodic reports on
compliance with the Plan should be provided to, the HackensackUMC Board,
HackensackUMC senior management, the relevant department chair, the
Sponsor, other members of the applicable Research Team, and/or government
agencies (e.g., FDA, PHS).
b. If the Committee determines that no Compelling Circumstances exist, s/he shall
(a) require that the disclosing party divest the disclosed Interest in order to
participate in the study; and (b) if the disclosing party will not divest the
disclosed Interest, recommend that the IRB not approve the study (if the
disclosure occurred on a Protocol Disclosure Statement filed prior to IRB
approval of the study), or that the IRB terminate the disclosing party’s
participation in the study or terminate the study in its entirety (if the disclosure
occurred at the time of Continuing Review or on an Interim Disclosure
Statement).
3. The Director of Regulatory Affairs shall provide the Committee on Conflicts of Interest in
Research with periodic written reports (no less frequently than quarterly) on actions that
s/he has taken on Conflicts matters under this Section.
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Conflicts of Interest in Research
4. If the Director of Regulatory Affairs concludes that Committee involvement is
needed to assess the extent to which the Interest creates a Conflict of Interest, s/he
shall refer the matter to the Committee. The Committee shall then review and assess
the Interest to determine or verify whether it gives rise to an actual, perceived or
potential Conflict of Interest at its next scheduled meeting, using the same procedures
as are set forth above with regard to Significant Interests.
5. If either the Director of Regulatory Affairs or the Committee on Conflicts of Interest
in Research concludes that the Interest does not give rise to an actual, perceived or
potential Conflict of Interest, the Director of Regulatory Affairs or the Committee, as
applicable, shall report the finding to the IRB/ IACUC of record in accordance with the
communication provisions of this Policy.
6. As reflected in the Guidelines set forth in Exhibit B and Exhibit C, the Director of
Regulatory Affairs and the Committee have the discretion to take into account in the
assessment of a Conflict, the determination of whether Compelling Circumstances exist,
and the development of a CMP, the differences in circumstances that may arise when
an Interest giving rise to an actual, perceived or potential Conflict of Interest is disclosed
while a study is ongoing (i.e., the Interest is disclosed at the time of Continuing Review
or on an Interim Disclosure Statement).
C.
General Communication Procedures
1. The Committee or the Director of Regulatory Affairs (as applicable) shall
communicate the findings and recommendations to the IRB/IACUC of Record, along
with any required and approved Conflict Management Plan. The IRB/IACUC of Record
may request additional information concerning the findings and recommendations, and
may require additional protections to safeguard against potential bias and protect
human subjects, including, without limitations, modifications to any informed consent
form to inform subjects of such potential Conflicts.
2. The Committee Chair or the Director of Regulatory Affairs (as applicable) shall
communicate the findings to the Investigator. The Investigator shall be notified in writing
of the outcome and any accompanying recommendations, including, without limitation,
any Conflict Management Plan recommended by the Committee or the Chair of
Research (as applicable). The Investigator may appeal the findings of the Committee
or the Chairman of the Research Department (as applicable), as indicated below. This
appeal process, however, can only consider the findings of the Committee on Conflicts
of Interest in Research or the Chair of Research (as applicable). The decisions of the
IRB/IACUC of Record are final.
3. If the IRB/IACUC of Record approves the Research study, it will so notify the
Committee or the Director of Regulatory Affairs (as applicable), and inform the
Committee or the Director of Regulatory Affairs (as applicable), whether the IRB/IACUC
of Record has made any changes or additions to the CMP.
4. The Committee or the Director of Regulatory Affairs (as applicable) shall take the
steps necessary to share the Conflict Management Plan with others pursuant to the
terms of the Plan.
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Conflicts of Interest in Research
D.
Election to Appeal
Investigators who disagree with the recommendations of the Committee or the Director
of Regulatory Affairs (as applicable) may appeal decisions to the Chief Executive
Officer of HackensackUMC (CEO) or his/her designee. In evaluating the potential
Conflicts of Interest in Research and the decision(s) of the Committee on Conflicts of
Interest in Research or the Director of Regulatory Affairs (as applicable), the CEO or
his/her designee shall confer with the Corporate Compliance Officer and shall use the
Guidelines for Evaluation of Potential Conflicts of Interest in Research (Exhibit B) or
seek additional guidance before rendering a determination. The CEO’s decision shall
be communicated in writing to the Investigator and the IRB/IACUC of Record.
IV. MONITORING/OVERSIGHT
The Committee on Conflict of Interest in Research shall monitor compliance with each Conflict
Management Plan developed and approved by the Committee for use in a study throughout the
course of the study.
V. REPORTING FINANCIAL CONFLICTS OF INTEREST TO PHS AGENCIES
For Research Personnel funded under a PHS award or cooperative agreement awarded on or
after August 24, 2012, the Chairman of the Research Department or designee shall provide to
the appropriate PHS agency a Disclosed Conflict report regarding any Investigator’s SFI found
to be a Conflict as follows:
a.
b.
c.
d.
prior to the expenditure of funds
during the period of award
within sixty (60) days of identifying a new disclosed Conflict
at the same time as when the grantee submits an annual progress report, including
multiyear progress: report annually for the duration of the project period (including
extensions with or without funds), addressing the status of the Financial Interest and
any changes to the Management Plan and whether the disclosed Conflict is still being
managed, or explain why the disclosed Conflict no longer exists
e. upon determinations of Investigator non-compliance with disclosures of SFI
f. upon the failure of the institution to review an existing SFI
A new report shall be submitted if any of the following elements of a previously submitted FCOI
report changes:
a.
b.
c.
d.
project Number
name of Investigator with the FCOI
name of the entity
nature of the Significant Financial Interest
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Conflicts of Interest in Research
All reports will include the following information:
a.
b.
c.
d.
e.
the project number;
the PD/PI or contact PD/PI if a multiple PD/PI model is used;
the name of the Investigator with the disclosed Conflict;
the name of the external entity with which the Investigator has an SFI;
the nature of the Financial Interest (e.g., equity, consulting fee, travel reimbursement,
honorarium);
f. the value of the financial interest (dollar ranges are permissible: $0-$4,999; $5,000$9,999; $10,000-$19,999; amounts between $20,000-$100,000 by increments of
$20,000; amounts above $100,000 by increments of $50,000), or a statement that the
Interest is one whose value cannot be readily determined through reference to public
prices or other reasonable measures of fair market value;
g. a description of how the Financial Interest relates to the PHS-funded research and why
it was determined that the Financial Interest creates a Conflict with such Research; and
h. a description of the key elements of the Institution’s Management Plan, including the
following:
 the role and principal duties of the conflicted Investigator in the Research project
 the conditions of the Management Plan
 how the Management Plan is designed to safeguard objectivity in the Research
project
 a confirmation of the Investigator’s agreement to the Management Plan
 how the Management Plan will be monitored to ensure Investigator compliance
 Other information as needed.
Disclosures of reimbursed or sponsored travel related to Institutional responsibilities:
PHS regulations require Investigators to disclose the occurrence of any reimbursed or sponsored
travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so
that the exact monetary value may not be readily available), no matter the dollar level, within the
previous twelve (12) months, that was related to the Investigator’s Institutional responsibilities.
The disclosures will include the following:




purpose of the trip;
the identity of the Sponsor/organizer;
the destination; and
the duration of the travel.
The disclosure requirement does not apply to travel that is reimbursed or sponsored by the
following:




a federal, state, or local government agency;
an Institution of higher education, as defined at 20 U.S.C. 1001(a);
an academic teaching hospital; or
a medical center, or a Research institute that is affiliated with an Institution of higher education.
VI. NON-COMPLIANCE
Whenever a Conflict is not identified or managed in a timely manner, including failure by the
Investigator to disclose an SFI, failure by the Institution to review or manage a disclosed
Conflict, or noncompliance with the Management Plan, the Director of Regulatory Affairs shall
within one hundred twenty (120) days of the determination of noncompliance, coordinate and
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Conflicts of Interest in Research
complete a retrospective review of the Investigator’s activities and the project to determine bias
in the design, conduct or reporting of such Research.
The retrospective review shall include the following:
a. the project number;
b. the project title;
c. the PD/PI or contact PD/PI if a multiple PD/PI model is used;
d. the name of the Investigator with the disclosed Conflict;
e. the name of the entity with which the Investigator has a disclosed Conflict;
f. the reason(s) for the retrospective review;
g. the detailed methodology used for the retrospective review (e.g., methodology of the
review process, composition of the review panel, documents reviewed); and
h. the findings and conclusions of the review.
When bias is found, for Research under PHS grants or cooperative agreements issued on or
after August 24, 2012, the Chair of the Research Department shall notify the appropriate PHS
agency promptly and submit a mitigation report with the following pieces of information required
under the regulations:
a. the key elements documented in retrospective review;
b. a description of the impact of the bias on the Research project; and
c. a plan of action to eliminate or mitigate the effect of the bias.
Non-Compliance with financial disclosures in PHS-funded Clinical Research:
In any case in which the HHS determines that an NIH-funded project of clinical Research,
whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or
treatment has been designed, conducted, or reported by an Investigator with a Conflicting
Interest that was not managed or reported by the Institution as required by the regulation, the
Institution must require the Investigator(s) involved to disclose the Financial Conflict of Interest
in each public presentation of the results of the Research and request an addendum to
previously published presentations.
VII. SANCTIONS
Sanctions for violations of this Policy, including failure to disclose Financial or Associational
Interests and failure to abide by decisions and recommendations made pursuant to this Policy,
including, without limitation, recommendations made following the review process set forth in
Section III of this Policy, shall include disciplinary action up to and including termination of
employment or denial of further opportunities to conduct Research within the HackensackUMC
System.
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Conflicts of Interest in Research
VIII.
TRAINING
All Research Personnel must attest as part of the annual disclosure statement and any interim
report, that they have reviewed this Policy, and understand and agree to comply with the
requirements outlined in this Policy.
In addition to the above, all research Personnel funded under PHS awards/cooperative
agreements issued on or after August 24, 2012 must complete training on their responsibilities
for disclosure of external Interests and other aspects of the National Institutes of Health (NIH)
regulations under 42 CFR 50 (Subpart F) prior to engaging in NIH-funded Research and at
least every four (4) years, and immediately under the designated circumstances whenever:
a. Institutional policies change in a manner that affects the requirements for research
personnel; and/or
b. it is identified that an individual is not in compliance with the this Policy or a
Management Plan
IX. DOCUMENT RETENTION
Documents related to Conflicts of Interest disclosure and management will be retained for ten
(10) years after the conclusion of the study.
X. PUBLIC ACCESSIBILITY
Information related to Financial Conflicts of Interest related to PHS-funded Research shall be
made available to the public as specified. Requests can be submitted to :Research Integrity
Office at Hackensack University , 40 Prospect Avenue, Hackensack, NJ 07601 (1-551-9962255). The information shall include the following:
 the Investigators name;
 the Investigator’s title and role in the Research project;
 the entity in which the SFI is held; and
 the nature and approximate value of the SFI
XI. PERIODIC REVIEW
The Committee on Conflicts of Interest in Research shall review this Policy periodically, but no
less frequently than every three (3) years, recommending changes as it considers necessary
and appropriate to the HackensackUMC Board for its approval.
Attachments incorporated by reference:
A- Annual and Continuing Electronic Disclosure Statement (Financial Conflict of Interest
Disclosure Form)
B – Guidelines for Evaluation of Potential Conflicts of Interest in Research
C – Guidelines on Development of a Conflict Management Plan
D – Pre-Screening Criteria
E – Sponsored Programs Office (SPO Form 1)
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Conflicts of Interest in Research
Exhibit A
Hackensack University Medical Center
Annual and Continuing Electronic Financial Disclosure Statement
MediRegs Financial Conflcit of Interest Electronic Portal
Dear Researcher
The 2012 Conflicts of Interest in Research
Disclosure Statement is required to be completed yearly and amended when an interest changes.
This year's disclosure will now be captured online. Kindly begin, complete and return within the
next two (2) weeks. Please note that this questionnaire must be completed by all Research Staff as
defined by Hackensack University Medical Center Conflicts of Interest in Research Policy # 541 (
to view click this link: irb.humed.com . Thank you for your anticipated cooperation.
1. What position(s) do you hold relative to research?
IRB member
staff
Research administration
Data coordinator
Investigator
Research coordinator
Other study
2. Do you or any of your immediate family members currently hold, or expect to hold, orally
or in writing, within the next 12 months, a financial or associational interest with a Sponsor
or potential Sponsor or an entity that in turn has a financial interest in the sponsor above the
threshold limit of $5,000? -
Yes
No
3. Do you or and/or your spouse, domestic partner, children, parent or sibling residing in the
same household have a financial or associational or other personal interest with a Sponsor
or potential Sponsor? -
Yes
No
4. Do you participate in any public health sponsored research? if yes, please provide detail. Yes
No
5. You have indicated that you have a relationship with a Sponsor. Please press submit to
continue and you will be asked to provide more detail. -
Yes
No
6. ACKNOWLEDGMENT I hereby state each of the following:
I have received a copy of the Conflicts of Interest Policy; I have read and understand the Policy; I agree to
comply with the Policy; I understand that the Medical Center is a charitable organization and that to maintain
its federal tax-exempt status it must engage primarily in activities which accomplish its tax-exempt purposes; I
understand that the questions noted as a 990 disclosure may be included on the HackensackUMC tax filing and
could be available to the public. I agree to report promptly to the Chairperson of the Governance Committee
any change in the responses to each of the foregoing questions which may result from changes in
circumstances or any further financial interest, situation, activity, interest or conduct that may develop before
completion of my next annual questionnaire;
By typing my name below, I acknowledge that the information I have disclosed is true and
accurate to the best of my knowledge:
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Conflicts of Interest in Research
_________________________________________________________________________
Sponsor Answers
1
Add Comment
Please identify each Sponsor with whom you have a relationship or potential conflict. You we be prompted to repeat the
following questions for each sponsor you chose. If you select "other", please indicate the name of the Sponsor..
2
Add Comment
What type of interest are you disclosing? Please check below all that apply. Click in the add comment section and supply
the dollar amount associated with each interest. If you select "other", indicate the name of the sponsor in the add
comment section.
1.
Consulting fees
2.
Honoraria
3.
Lecture fees
4.
Employment services
5.
Gifts
6.
Loans
7.
Grants
8.
Stock public
9.
Stock Private
10.
Options
Other (please adds comment and disclose dollar amount)
3.
Do you or a member of your family have any intellectual property with the Sponsor selected above? If so, please explain.
If not, please indicate "none" in the space below.
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Conflicts of Interest in Research
Add Comment
4.
Do you or a member of your family have any relationships (compensated or not) with the Sponsor selected above? If yes
indicate in what capacity.
1.
Serve as a Corporate Officer
2.
Serve as an Elected Official
3.
Serve on an Advisory Board
4.
Serve on a Board of Directors or Trustees
5.
None
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Conflicts of Interest in Research
EXHIBIT B
HACKENSACK UNIVERSITY MEDICAL CENTER
Guidelines for Evaluation of Potential
Conflicts of Interest in Research
EXAMPLES OF CONFLICTS OF INTEREST
The following examples are provided to assist in the evaluation of potential Conflicts of Interest in
Research or situations in which Conflicts may arise. It must be recognized that it is not possible to
identify every possible situation that might present a Conflict of Interest in Research, and therefore,
the following listing is not all inclusive.
Examples of Significant Financial Interests
1) An Investigator, or a Member of his/her Immediate Family, holds stock in the Sponsor of the
Research study valued, or expected to be valued, at $10,000 or more, excluding investments
held through mutual funds.
2) An Investigator, or a Member of his/her Immediate Family, holds stock in the Sponsor of the
Research study that represents, or is expected to represent, 5% or more of the total
outstanding ownership interests in the Sponsor, excluding investments held through mutual
funds.
3) An Investigator, or a member of his/her Immediate Family, has received within the previous
twelve (12) months license fees, royalties, or contractual rights to receive future royalties of
more than $10,000 per year from the Sponsor (regardless of whether the technology to for
which the royalties are to be paid is related to the Research study for which the disclosure has
been made).
4) An Investigator is currently in negotiations relating to an interest in or a relationship with the
Sponsor that could result in a Significant Financial Interest within the next twelve (12) months.
An Investigator receives an unrestricted research grant from the Sponsor within the previous 12
months.
5) An Investigator receives a Research grant from the Sponsor within the previous twelve (12)
months that provides funds in excess of those required for reasonable expenses incurred in the
performance of the Research activity.
6) A Sponsor loans anything (e.g., money, equipment) to the Investigator or his/her Immediate
Family.
7) An Investigator, or a member of his or her Immediate Family has received from the Sponsor a
gift with an aggregate value of one hundred dollars ($100) or more within a twelve (12) month
period.
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Conflicts of Interest in Research
8) The Research agreement with the Sponsor provides financial incentives to the Investigators
and other Research Team Members to recruit and enroll subjects in the study, and based on
the targeted number of subjects in the study, such incentives could exceed $10,000 or more for
one or more of the members of the Team.
Examples of Financial Interests other than Significant Financial Interests that may give rise
to an actual, perceived or potential Conflict of Interest
1) An Investigator or a Member of his/her Immediate Family, holds stock in the Sponsor of the
Research study valued, or expected to be valued, at less than $10,000, excluding investments
held through mutual funds.
2) An Investigator or a Member of his/her Immediate Family has received within the previous
twelve (12) months license fees, royalties, or contractual rights to receive future royalties of any
amount less than $10,000 per year from the Sponsor when the technology for which the
royalties are to be paid is related to the Research study for which the disclosure has been
made.
3) An Investigator or a Member of his/her immediate family holds stock in the Sponsor of the
Research study that represents, or is expected to represent, less than 5% of the total
outstanding ownership interests in the Sponsor, excluding investments held through mutual
funds.
4) The Sponsor provides ghost writing services free of charge to an Investigator.
5) An Investigator is a participant in speaker’s bureaus of the Sponsor.
6) The Sponsor periodically pays for an Investigator to attend CME programs.
7) An Investigator who is also an Institutional Official has any type or amount of Financial Interest
in the Sponsor.
8) The Research agreement with the Sponsor provides financial incentives to the Investigators
and other Research Team Members to recruit and enroll subjects in the study, based on the
targeted number of subjects in the study, regardless of the potential amount any one or more of
the Members of the Team can derive from such incentives.
Examples of Significant Associational Interests
1) An Investigator is a voting member of the Board of Directors of a Sponsor of a Research study,
or of a key Committee of the Board of Directors of a Sponsor of a Research study.
2) The Investigator serves in an advisory capacity to the Sponsor either as an individual or a
member of a committee.
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Conflicts of Interest in Research
REVIEW QUESTIONS
The following list of review questions1 shall be utilized by the Committee on Conflicts of Interest in
Research in evaluating whether an actual, perceived or potential Conflict of Interest in Research
exists. These questions are intended to guide the Committee in its review and assessment and, as
such are not intended to be an exclusive list. Other questions appropriate to specific situations
under review may also be posed.
1.
Has all relevant information concerning the activities, interests and relationships of the
Investigator and members of his or her Immediate Family been acquired (i.e., has there
been full disclosure)?
2.
Do the disclosed financial interests constitute Significant Financial Interests, either alone or
in the aggregate (taking into account all the interests in the Sponsor held by the Investigator
or other Research Team member and of members of each of their Immediate Families)?
3.
Do the Investigator’s reported Associational Interests constitute Significant Associational
Interests?
4.
If the interest disclosed is other than a Significant Financial or Significant Associational
Interest, to what extent does the nature and extent of the interest otherwise create the risk
that research activities and results could be influenced by the interest? (e.g., What is the
relative value of the Interest to the holder of the Interest and the corresponding potential
that it will influence or bias decisions about the design, conduct and reporting of the
Research?)
5.
If the interest is other than a Significant Financial Interest, is the amount sufficiently de
minimis to be unlikely to influence decisions about the design, conduct and reporting of the
Research?
6.
Is there any indication that Research results have not been faithfully and accurately
reported in the course of the study?
7.
Does the Investigator or any other Member of the Research Team receive financial
incentives to recruit and enroll subjects in the Research study?
8.
Is there any indication that the Investigator in his or her professional role has improperly
favored any outside entity or appears to have incentive to do so?
9.
Is the Investigator involved in a situation similar to any of those described previously that
might raise questions of bias, self-dealing, inappropriate use of HackensackUMC assets,
poor data management, or other impropriety?
10.
Could the Investigator’s circumstances represent any possible violations of federal, state, or
local laws and requirements?
11.
Has the HackensackUMC Investigator agreed as part of a consulting relationship to limit
his/her rights to disseminate the results of Research in published or other form, except for
reasonable delays not to exceed ninety (90) days for patient filing, or other logistics?
1
Included in this list are questions that have been formulated by the Association of American
Medical Colleges.
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Conflicts of Interest in Research
12.
13.
Is the study a multi-site study or cooperative study and, if so:
(a)
How many of the total anticipated study subjects will be under the supervision of the
HackensackUMC Research Team?
(b)
To what extent is the holder of the Interest involved in the study design, evaluation
and recruitment of subjects, obtaining informed consent, review, analysis and
reporting of study data and adverse events?
Compelling Circumstances
(a)
Is the Investigator who holds the Interest an Inventor of the drug or device being
studied? Are there other circumstances that uniquely qualify the Investigator to
conduct the Research? Would those qualifications provide equivalent value to the
study if the Investigator were other than the Principal Investigator?
(b)
Other factors to consider in determining whether there are compelling
circumstances for the holder of the Interest to be involved in the Research include:
(1) the nature of the science involved, (2) the nature of the Interest and how closely
it is related to the Research, and (3) the degree to which the Interest might be
affected by the Research.
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Conflicts of Interest in Research
EXHIBIT C
HACKENSACK UNIVERSITY MEDICAL CENTER
Guidelines for Development of Conflict Management Plans
The following questions should be asked to evaluate whether appropriate controls are in place or
can be put in place to manage possible Conflicts. The goal in applying these questions should be
to determine whether Conflict management strategies can be implemented to achieve an
acceptable balance between the benefits of allowing the holder of an Interest to be involved in the
Research and the risk of bias or the appearance of bias that can arise from the Interest.
14.
Is the holder of the Interest also a member of the IRB or other Institutional Official? If so, is
elimination of the Interest through divestiture likely to be the only appropriate means of
allowing the holder to participate in the Research?
15.
Is divestiture of the Interest for other holders of an Interest the only way to allow the holder
of the Interest to participate in the Research?
16.
Will the negotiation of relevant Research affiliations or other contracts be handled by truly
disinterested representatives of HackensackUMC entities?
17.
Will the Research work plan receive independent peer review prior to its initiation?
18.
Is the structure and amount of any recruitment or enrollment incentives in the Clinical Trial
Agreement appropriate for the time and effort required for those activities? Do adequate
subject eligibility criteria exist?
19.
Will disinterested Members of the Research Team or of an independent oversight
committee be involved in subject evaluation, recruitment and enrollment and in obtaining
informed consent from subjects?
20.
Will independent oversight of data collection, analysis and reporting be provided (e.g., by a
Data and Safety Monitoring Board, internal monitoring committee)?
21.
Will there be independent review and oversight of adverse events, including review of
subject records on a comprehensive, periodic or sampled basis to assure that reports have
been timely and properly made?
22.
Do all independent oversight bodies formed to manage the Conflict of Interest report to the
Committee on Conflicts of Interest in Research ?
23.
Are there other aspects of the study design that, by their nature, will prevent the
introduction of bias into Research projects (i.e., Is the protocol double-blinded or tripleblinded? Is it a cooperative study or multi-site study in which an HackensackUMC
Investigator does not play a leadership role or a small percentage of total subjects will be
overseen by HackensackUMC Investigators? Are Research subjects randomly selected?)
24.
Will the study be supervised by someone with authority and no Conflicting Interest? (e.g.,
another IRB besides the HackensackUMC IRB?)
25.
Are there means to verify Research results (e.g., independent corroboration in another lab,
FDA review)?
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Conflicts of Interest in Research
26.
Will data and materials be shared openly with independent researchers? If not, who
determines accessibility to such resources?
27.
Will the product of the collaborative effort with an outside party be published in the peerreviewed scientific literature or presented at scientific or medical meetings? Alternatively,
will the results of the Research collaboration with an outside party be submitted to a federal
regulatory agency (e.g., FDA, PHS)? Does the collaboration with the outside party
represent one component of a multi-center investigation, in which case delays in publication
may be appropriate?
28.
Will the Sponsor receive acknowledgment in public presentations of the Research results?
29.
Can the Interest be restructured to reduce the risk of bias or influence (e.g., reducing the
amount of the compensation, stock ownership, stock options; requiring CME funding to be
channeled through a general fund that is overseen by an independent body or other means
that avoids an Institutional Conflict of iIterest?
30.
Will the existence of an actual, perceived or potential Conflict of Interest and the fact that
steps have been taken to manage the Conflict be disclosed in the informed consent
document signed by study subjects? Is the nature and extent of the disclosure (i.e., the
degree of detail and level of specificity regarding the nature of the Interest giving rise to the
Conflict, who holds the Interest, the particular management strategies that have been
implemented, and an offer to provide more information on those factors) commensurate
with the degree of risk and the extent to which the risk can be managed?
31.
Will the existence of the actual, perceived or potential Conflict of Interest and Conflict
Management Plan be disclosed to other Members of the Research Team, the Sponsor,
HackensackUMC senior management, or the Board of Directors?
32.
Special Circumstances Created by Disclosure of an Interest by an Investigator in the
Course of a Research Study
(a)
Does the Investigator bring unique expertise to the Research study (e.g., one of the
inventors of the drug, device or procedure that is the subject of the Research
study)?
(b)
Can the Investigator’s role be assumed by another Investigator on the Research
Team or another HackensackUMC Member not previously involved in the
Research?
(c)
Will immediate removal of the Investigator from the study significantly delay or
disrupt the study? Will such delay or disruption or any other consequences of
removal create meaningful risk of harm to subjects?
(d)
If the Investigator is the Principal Investigator, is immediate removal not feasible in
light of the need to report a change in the PI to, and obtain approval for a change in
the PI from, the Sponsor or a government agency (e.g., FDA, PHS)?
(i)
If immediate removal of the Principal Investigator is not feasible, can
appropriate interim steps be taken to allow the PI to continue in that role
while the Committee undertakes its evaluation of the Interest and the
development of a Conflict Management Plan required by this Policy (e.g., reconsenting all enrolled subjects, disclosing the Interest in informed consent
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Conflicts of Interest in Research
documents for future subjects, appointing a Co-Investigator to oversee all
aspects of the study, appointing an independent oversight body (internal or
external) to monitor all aspects of the study, requiring ongoing reporting to
the Committee on Conflicts of Interest in Research by such Co-Investigator
and/or independent body, and/or other types of Conflict management
measures addressed in the foregoing list)?
(ii)
(e)
If not, then immediate divestiture of the interest by the PI must be required.
If the informed consent document does not disclose the existence of actual,
perceived or potential Conflicts in general terms, or it includes a disclosure only of
other Conflicts in specific terms, is it possible to re-consent the enrolled subjects
before continuing with the study without significantly delaying or disrupting the
study?
(i)
Will such delay or disruption create meaningful risk of harm to subjects?
(ii)
If so, will a lesser means of informing the subjects be sufficient (e.g., a letter
notifying the subjects) until written consents can be obtained?
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Conflicts of Interest in Research
EXHIBIT D
PRE-SCREENING CRITERIA
The following list of review protocol design types shall be utilized by the Director of Regulatory
Affairs in evaluating whether a potential Conflict of Interest in Research exists and the necessary
management plan development. These examples are intended to guide the Director in his/her
review and assessment and, as such, are not intended to be an exclusive list. Other research
protocols appropriate may utilize pre-screening/ administrative review as warranted.

Retrospective Chart Review

Registry Studies

Double Blinded

Randomized

Phase 3

Phase 4

Case Review Presentations
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Conflicts of Interest in Research
EXHIBIT E
HACKENSACK UNIVERSITY MEDICAL CENTER
Sponsored Programs Office (SPO Form1)
Financial Interest Disclosure Form For Investigators with NIH/PHS and NSF Proposals
PROJECT TITLE:
PRINCIPAL INVESTIGATOR:
FUNDING AGENCY OR SPONSOR:
DEPT:
PROJECT START DATE:
Study Personnel Information
Role
Name (Last, First, MI), Title
Degree
Department/Division
Principal
Investigator/Program
Director:
Co-Investigator (Co-I)/Key
Personnel:
Co-I/Key Personnel:
Co-I/Key Personnel:
Co-I/Key Personnel:
A. Financial Conflict of Interest
The Department of Health and Human Services (HHS) final rule on Financial Conflicts of Interest
(FCOI) Policy (effective August 24, 2012) requires transparency and accountability for those seeking
Public Health Service (PHS) funding. The goal is to promote objectivity in Research by establishing
standards that provide a reasonable expectation that the design, conduct, and reporting by
establishing standards under NIH grants or cooperative agreements will be free from bias resulting
from study team member’s fFnancial Conflicts of Interest.
1. For this proposal, is there any potential for actual, perceived or potential Financial Conflicts of
Interest (FCOI) that needs to be disclosed? Please refer to Institution’s FCOI policy regarding PHS
Financial Conflict of Interest regulation (42 CFR 50 subpart F) and definition of Significant Financial
Interest (SFI).
A SFI exists if the value received from the entity in the twelve (12) months preceding the disclosure
and the value of any equity interest in the entity as of the date of disclosure, when aggregated,
exceeds $5,000.
yes
no
2. If yes, please describe the name of the entity with which you have an FCOI and the nature of the
FCOI (e.g. consulting fees, travel, spouse is employee, etc.).
You do not have to disclose payments from HackensackUMC for yourself or your immediate family.
You also do not have to disclose payments from public or non-profit organizations if they are for
lectures, seminars, or service on advisory committee. Financial interest in a company that are the
result of your holding shares in a mutual fund or being a member of the HackensackUMC’s
retirement plan or similar pooled funds do not need to be reported, as long as you do not control the
selection of investments.
3. Does your grant involve a contract, subcontract or collaboration with an outside institution or group?
yes
no
If yes, please provide collaborator’s list of key personnel.
In accordance with PHS financial conflict of interest regulations (42 CFR 50 subpart F), the Investigator
attests that neither they, nor their immediate family member have significant financial conflict of interest
(FCOI) with respect to the above grant application. If the status of FCOI changes with respect to this grant;
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Conflicts of Interest in Research
the individual would notify the Chairman of the Department of Research and follow HackensackUMC’s
Conflict of Interest in Research policy in terms of the reporting and resolution of FCOI in research.
B. Certification of Suspension and Debarment (Required for all PI and Co-Investigators listed on
PHS sponsored studies)
As a potential participant on a federal grant, PI and Co-Investigators, attest to the best of their knowledge
that they have not been suspended or debarred from engaging in research sponsored by DHHS as noted in
45 CFR 76, “Government-wide Debarment and Suspension (Nonprocurement).”
C. Certification of Institutional Compliance (Required for all PI’s on PHS sponsored studies)
PI certifies that the information submitted on within the application is true, complete and accurate to the best
of my knowledge. Any false, fictitious or fraudulent statements or claims may subject the PI to criminal, civil,
or administrative penalties. If funded, the PI agrees to accept responsibility for the scientific conduct of the
project and to provide the required progress reports if a grant is awarded as a result of the application.
Signature: _________________________
Print Name: ________________________
Title: ______________________________
Date: ______________________________
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