SOP: Institutional Conflicts of Interests
1
NUMBER
DATE
AUTHOR
APPROVED BY
PAGE
HRP-014
2/6/2016
C. Bienstock
J. Silverstein
1 of 2
PURPOSE
1.1
2
This procedure establishes the process to identify institutional financial interests that may cause an
institutional conflict of interests.
1.2 The process begins when the Office of Technology and Business Development, the Development
Office, or the Finance Department acquire or relinquish a financial holding of the institution.
1.3 The process ends when the financial databases are updated.
REVISIONS FROM PREVIOUS VERSION
2.1
3
None
POLICY
3.1
4
An institutional financial conflict of interests exists when any of the following might affect the
design, conduct, or reporting of research:
3.1.1 Licensing
3.1.2 Investments
3.1.3 Gifts
3.1.4 Financial interests of senior administrative officials
3.1.5 Other financial interests
3.2 The Office of Technology and Business Development, the Development Office, or the Finance
Department update their databases when they are involved in a change in the institution’s financial
holdings related to:
3.2.1 Licensing (e.g., licensing or technology transfer agreements)
3.2.2 Investments
3.2.3 Gifts
3.2.4 Financial interests of senior administrative officials
3.2.5 Other financial interests
3.3 The fiduciary responsibility of the institution’s investment managers is to maintain a diversified
portfolio of holdings that that meets the institution’s goals in terms of capital appreciation, income,
and risk. Institutional officials may not influence the decisions of the institution’s investment
managers. This institution considers such investments to be similar to diversified mutual funds and
not subject to disclosure under this policy.
3.4 The convened IRB has the final authority to decide whether the interest and management, if any,
allows the research to be approved.
RESPONSIBILITIES
4.1
5
The Office of Technology and Business Development, the Development Office, or the Finance
Department is responsible to identify financial interest that represent a potential institutional conflict
of interest and maintain a database of these.
4.2 The Grants and Contracts Office is responsible to review all new research proposals (funded or
unfunded) against the database of institutional financial interests and identify those that may
represent an institutional conflict of interest, and if so, to notify the IRB staff.
PROCEDURE
5.1
5.2
Upon a change in financial interest, update the list of investments in the database. Include
information about the name of the company, the names of related companies, and affected
products or services.
Upon receipt of a new research proposal (funded or unfunded) the Grants and Contracts Office
evaluates the proposal against the database of institutional financial interests to identify any that
may represent an institutional conflict of interest.
5.2.1 If such interests are identified, notify the IRB staff
SOP: Institutional Conflicts of Interests
5.3
6
DATE
AUTHOR
APPROVED BY
PAGE
HRP-014
2/6/2016
C. Bienstock
J. Silverstein
2 of 2
The Mount Sinai School of Medicine Conflict of Interests Committee determines whether
institutional financial interests represent an institutional conflict of interest. If so, the Committee:
5.3.1 Institutes a management plan that prevents the institutional financial interest from
affecting the design, conduct, or reporting of research. The management plan may
include:
5.3.1.1
Review by an external IRB
5.3.1.2
Oversight by an external auditor
5.3.1.3
Involvement of external individuals in key portions of the protocol
5.3.1.4
Public disclosure and comment
5.3.2 If the Committee cannot institute a management plan that prevents the institutional
financial interest from affecting the design, conduct, or reporting of research, the
Committee does not allow the research to be conducted.
MATERIALS
6.1
7
NUMBER
None
REFERENCES
7.1
None