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The Johns Hopkins Health System Corporation Policy on Institutional Conflict of Interest Principle and Purpose The Johns Hopkins University and The Johns Hopkins Health System Corporation (together, "Johns Hopkins," the "Institution," or the "Institutions") are committed to the highest standards of conduct in research, teaching, clinical care, professional practice, business transactions, and other activities that support their core missions. Relationships with the commercial sector play an important role in supporting the Institutions' missions, and institutional financial interests arise in the normal course of Institutional operations. However, these financial interests should not compromise the Institutions' standards or integrity or unduly influence decisions in any activity at Johns Hopkins. Potential conflicts of interest between the Institutions' primary objectives and its financial interests must be identified and properly managed with policies and procedures that support integrity and advance the Institution's missions. The purpose of this policy is to set forth the standards and procedures for reporting and review of potential Institutional conflicts of interest ("ICOIs")1. Scope of the Policy This ICOI policy outlines standards of conduct and general procedures for all Johns Hopkins divisions. It applies to The Johns Hopkins University, including all its divisions, institutes, centers, and units, and to The Johns Hopkins Health System Corporation and all its constituent entities. Institutional financial interests may be created by gifts, payments, royalty income, equity, and other benefits from or interests in for-profit organizations. Institutional financial interests also are created by financial and fiduciary interests of Institutional Officials. Institutional Officials should recognize that any investment in an entity with which the Institution does business may and will give rise to review for ICOI. Institutional Officials are strongly advised to avoid investing in or otherwise engaging in personal financial or fiduciary relationships with for-profit entities that sponsor research at or have significant business relationships with the University where the official is likely to have involvement in or direct supervisory authority over decisions relating to such entities. All financial interests of Institutional Officials must be reported and will be reviewed in accordance with this policy. Institutional Officials may not participate in decisions relating to entities in which they have an interest as defined in this Policy, except as provided for pursuant to review under the Policy This policy applies to all institutional activities, including research activities; educational activities; clinical care; professional practice; business activities; purchasing; and technology transfer. General Standards and Requirements Each division of the University and the Health System should develop, publish, and implement procedures for dealing with ICOIs. In the alternative, a division may adopt this Institution-wide policy or the policy of another division as its own procedures. A divisional policy may not conflict with this policy. Divisional ICOI procedures must be based on the principle that no area of Institutional activity should be subject to undue influence from the Institution's outside financial interests. The procedures must incorporate the highest ethical standards for the conduct of the activities covered by this policy. They must satisfy key requirements of this policy. They also must set forth the process for reviewing and making determinations in cases involving ICOIs. They should identify review criteria, including those outlined in this policy (See Review Criteria, below). Divisions that conduct or oversee human subject research must adopt especially rigorous standards that support protection of subjects' safety and welfare, including close scrutiny of ICOIs and stringent review and management. Reporting Requirements Outlined below are reporting requirements for specific categories of financial and fiduciary interests. These are not prohibited arrangements. Rather, they trigger reporting requirements to allow for the review and management of potential institutional conflicts. For purposes of this policy, there are two kinds of Institutional financial interests.
This policy mandates that both of these types of financial interests, above certain thresholds that are defined below, be reported, in order to ensure that ICOIs are identified and addressed. Reporting of the Institutions' Financial Interests The following financial interests of the Institutions must be reported to a single, secure database:
The senior staff member responsible for the arrangement (e.g., technology license, gift, Institutional consulting agreement) must make the report to the database at the time the arrangement is proposed. The database will require sufficient detail (e.g., number of shares or percentage of ownership; amount of gift; magnitude and timing of payments, royalty, and consulting fees) for a thorough initial review of potential ICOIs; however, additional information may be requested for ICOI review of a given case. Reporting of Institutional Officials' Financial Interests For purposes of this policy, Institutional Officials4 include:
Divisional procedures may define additional categories, within their divisions, of Institutional Officials whose personal interests have the potential to generate ICOIs. For example, divisional procedures may include Department Directors/Chairs as Institutional Officials. The following financial interests of Institutional Officials must be reported to a single, secure database:
Divisional procedures may establish a more stringent
reporting standard for their Institutional Officials.
Institutional Officials must submit a report annually and
must update their reports within a reasonable time after
they learn that their financial interests have changed. In
the annual report, Institutional Officials will be required
to certify that they are in compliance with all applicable
conflict of interest policies. This requirement does
not affect reporting and other obligations as applicable
under each division's policy on individual conflict
of interest or reporting in connection with separate
policies, such as those addressing intermediate
sanctions.
Review Procedures
Each division or entity shall appoint an ICOI committee to
consider ICOIs that arise within the division. This may be
the same committee that reviews individual conflicts of
interest, the same committee with additional members, or a
separate committee.5 The University
President also shall appoint a central committee to
consider ICOIs involving institutional officials who are
not within a division and institutional financial interests
that do not arise within a division.
The division will develop a procedure to check the database
for ICOIs when an Institution is considering entering into
any of the following transactions.6
Detailed disclosure and review procedures are outlined
on the attached chart.
Review Criteria
Reviews must consider whether the financial or fiduciary
interests disclosed in accordance with this policy have the
potential to appear to affect any of the following:
Making Recommendations
The ICOI review of a specific case may result in one of
three types of recommendations: 1) the arrangement does not
represent a significant actual, potential, or perceived
ICOI that needs to be managed; 2) the arrangement can be
managed including required changes; or 3) the arrangement
is not manageable and either the activity may not proceed
or the financial interest must be eliminated (or reduced).
In type 3 recommendations, it is expected that the ICOI
committee will usually recommend that the elimination (or
reduction) of the financial interest would be preferable to
prohibiting the proposed research, clinical, or educational
activity. In all cases reviewed, the ICOI committee must
retain documentation of its review and determination.
On receiving a recommendation regarding an ICOI case, the
individual identified in the accompanying chart as
receiving the recommendation will make a decision to
accept, reject, or revise the recommendation. An aggrieved
party may appeal the decision to the JHU President or the
JHHS President, as appropriate. All final decisions made
by recipients of ICOI committee recommendations must be
reported to the ICOI committee that submitted the
recommendation.
Philanthropy and Endowments
Philanthropy
Gifts, pledges, and solicitation of gifts to the
Institutions (or any of their constituent entities or
units) are important to their missions. However, no
charitable donation is allowed to be contingent upon the
outcome of any research or business transaction conducted
at or by the Institutions. The Institutions hereby affirm
that they will not solicit or accept gifts that in any way
limit the ability of their investigators to conduct and/or
report the results of research in accordance with the
highest scientific, medical, professional, and ethical
standards. Nor will the Institutions solicit or accept
gifts (including gifts to support research) that are
contingent upon any particular business or purchasing
decision(s).
In some cases, the Institutions may enter into arrangements
involving the donation of all or a portion of capital
equipment, with the expectation the equipment will be used
for research or patient care. Such arrangements are
appropriate, provided they do not limit the professional
independence of faculty and staff.
Institutional Investment Assets, Including
Endowment
The Institutions' endowment includes assets received from
philanthropy, investment, and other sources. University
endowment assets are managed by the University's Chief
Investment Officer. The Johns Hopkins Hospital Endowment
Fund assets are managed by the Endowment which contracts
with outside investment managers to make investment
decisions on behalf of the Endowment.
The Institutions hereby affirm that the Office of the Chief
Investment Officer, and its outside investment contractors
and the Hospital Endowment managers and its outside
investment contractors are forbidden from communicating
with Institutional Officials or Institutional researchers
concerning the conduct and interpretation of ongoing or
planned research performed at the Institutions for the
purpose of influencing investment decisions. Maintaining
this robust "firewall" is essential for ensuring that the
core activities of the Institutions are not affected, or
perceived to be affected, by the Institutions' interest in
maximizing the value of the endowments.
If an individual becomes aware of a situation in which
there appears to be a conflict of interest involving
philanthropic gifts, solicitation of gifts, or management
of the endowments, the individual must notify the ICOI
committee of the division in which the related research or
other activity is proposed or underway. The divisional
ICOI Committee will review the arrangements and make a
recommendation to the appropriate official.
Regulations and Guidance
There is currently no general federal or state regulation
of ICOIs (although a subset of ICOIs also may constitute
arrangements requiring review for compliance with federal
anti-kickback laws, intermediate sanction rules, or other
federal regulations). The Department of Health and Human
Services (DHHS) has issued guidance on ICOI in human
subject research.8 The Association of
American Universities (AAU) offers guidance9
on ICOIs, and the Association of American Medical Colleges
(AAMC) issued recommendations for addressing ICOIs in human
subject research.10 Many of the principles
and procedures contained in this policy are based on these
documents.
___________________________
Fiduciary Role
Human Subject Research
Institution
Institutional Conflict of Interest
Institutional Official
Research/Conducting Research
___________________________
1 Terms whose first use in this
policy is italicized are defined at the end of the
policy.
2 The value of $100,000 in
publicly traded stock is set as a reporting threshold, as
recommended by the AAMC Recommendations; see page 6 of
Protecting Subjects, Preserving Trust, Promoting
Progress II: Principles and Recommendations for Oversight
of an Institution's Financial Interests in Human Subjects
Research, available at
www.aamc.org/research/coi/start.htm.
3 For equity acquired by the
Institution as the result of a technology license, the
equity is placed in escrow until the stock is publicly
traded. When public trading is initiated, as a matter of
standard procedure, the Treasurer s Office will arrange for
release of the stock from the escrow account. The
Treasurer s Office will manage the stock into liquidation.
This standard practice is intended to reduce or eliminate
the Institution s financial interest in licensees of
University technology and potential ICOIs with activity
involving licensees of University technology.
4 Trustees of the Institutions
are covered under separate conflict of interest policies
and are not subject to this policy.
5 It is anticipated that the
School of Medicine and the Health System will establish a
joint ICOI committee. That committee must include at least
one senior official of the Health System.
6 It is recommended that the
ICOI committees outlined in this policy include faculty
members and others with sufficient expertise to evaluate
the risks of potential ICOIs. The committees may include
as a member an individual from outside Johns Hopkins.
7 Purchases or procurements
involving the following will be reviewed: new vendor; sole
source vendor request; purchases of capital equipment or
supplies of over $XXXX (TBD). Routine purchases and those
under $XXXX (TBD) involving competitive bidding will not be
reviewed.
8 Department of Health and
Human Services Final Guidance Document — Financial
Relationships and Interests in Research Involving Human
Subjects: Guidance for Human Subject Protection,
available at
www.hhs.gov/ohrp/humansubjects/finreltn/fguid.pdf..
9 AAU Report on Individual
and Institutional Conflict of Interest, available at
www.aau.edu/research/conflict.cfm.
10 Protecting Subjects,
Preserving Trust, Promoting Progress II: Principles and
Recommendations for Oversight of an Institution's Financial
Interests in Human Subjects Research, available at
www.aamc.org/research/coi/start.htm.
11 Trustees of the
Institutions are covered under separate conflict of
interest policies and are not subject to this policy.
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