Financial Conflict of Interest Policy

Policy Number: 01/2021
Effective date: May 26th 2021

PURPOSE

The purpose of this Policy is to ensure compliance of the Max Planck Institute for Heart
and Lung Research (Institute) with US Federal Regulations (42 CFR Part 50, Subpart F
for PHS grants and cooperative agreements) which outlines the responsibilities of
applicants for promoting objectivity in Public Health Service (PHS) funded research. The
Policy aims to establish standards so that there is no reasonable expectation that the
design, conduct, or reporting of research funded under NIH grants or cooperative
agreements will be biased by any conflicting financial interest of an Investigator. This
regulation is commonly referred to as the Financial Conflict of Interest (FCOI) regulation.

APPLICABILITY

The policy applies to Investigators participating in PHS research, as defined by PHS
regulations including sub-grantee/contractor/collaborating Investigators, but excluding
applications for Phase I support under the SBIR and Small Business Technology
Transfer (STTR) programs.
DEFINITIONS

1. DIO (Designated Institute Official) The Designated Institute Official is
responsible to enforce the FCOI policy in the respective Institute and will deal with
complaints or inquiries. This function shall be performed by the Managing Director
of the Institute.

2. HHS. The United States Department of Health and Human Services, and any
components of the Department to which the authority involved may be delegated.

3. Institution (Institute). Any domestic or foreign, public or private, entity or
organization (excluding a Federal agency).

4. Investigator. The principal investigator and any other person, who is responsible
for the design, conduct, or reporting of research funded by PHS, or proposed for
such funding. For purposes of the requirements of this subpart relating to financial
interests, “Investigator” includes the Investigator's spouse and dependent
children.

5. NIH means National Institutes of Health, one of the world’s foremost medical
research centers.

6. PHS means 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.

7. PHS Awarding Component. The organizational unit of the PHS that funds the
research.

8. Research. A systematic investigation designed to develop or contribute to overall
knowledge relating broadly to public health, including behavioural and social
sciences research. The term encompasses basic and applied research and
product development. The term includes any such activity for which research
funding is available from a PHS Awarding Component through a grant or
cooperative agreement, whether authorized under the PHS Act or other statutory
authority.

9. Significant Financial Interest. Anything of monetary value, including but not
limited to, salary or other payments for services (e.g., consulting fees or
honoraria); equity interests (e.g., stocks, stock options or other ownership
interests); intellectual property rights (e.g., patents, copyrights and royalties from
such rights); and travel paid on behalf of the investigator and not reimbursed to
the investigator related to institutional responsibilities unless reimbursed or
sponsored by excluded sources (by a federal, state or local government agency
or an institution of higher education). The term does not include:
a. Salary, royalties, or other remuneration from the Institute.
b. Any ownership interests in the Institute, if the Institute is an applicant under
the SBIR Program.
c. Income from seminars, lectures, or teaching engagements sponsored by public
or nonprofit entities.
d. Income from service on advisory committees or review panels for public or
nonprofit entities.
e. An equity interest that when aggregated for the Investigator and the
Investigator's spouse and dependent children, meets both of the following tests:
Does not exceed $5,000 in value as determined through reference to public
prices or other reasonable measures of fair market value, and does not represent
more than a five percent ownership interest in any single entity; or salary,
royalties or other payments that when aggregated for the Investigator and the
Investigator's spouse and dependent children over the next twelve months, are
not expected to exceed $5,000.

10. Small Business Innovation Research (SBIR) Program. The extramural
research program for small business that is established by the Awarding
Components of the Public Health Service and certain other Federal agencies
under Pub. L. 97-219, the Small Business Innovation Development Act, as
amended. For purposes of this subpart, the term SBIR Program includes the
Small Business Technology Transfer (STTR) Program, which was established by
Pub. L. 102.564.

POLICY STATEMENT

No employee of the Institute should have any interest, financial or otherwise, direct or
indirect, or engage in any business or transaction or professional activity or incur any
obligation of any nature that is in substantial conflict with the proper discharge of their
duties in the best interests of the Institute.

No investigator of the Institute should have any financial interest that will, or may be
reasonably expected to, bias the design, conduct, or reporting of sponsored programs.
All investigators must have a current Disclosure Statement on file with the Institute.
DISCLOSURE STATEMENT
Disclosure statements must be filed by Investigators at the time of application and
updated either annually or within 60 days of new reportable significant financial interests.
This 60 day policy also applies to Investigators who are newly participating in the PI’s
project. Identified FCOI’s held by senior/key personnel are required to be made publicly
accessible prior to the expenditure of federal funding and will remain available for three
years.

REAL, APPARENT, OR POTENTIAL CONFLICTS
All real, apparent, or potential conflicts of interest as defined under the Policy
Statement must be disclosed for review and determination as to whether a violation of
this policy exists.

COMPLAINTS AND INQUIRIES

Anyone may bring a complaint or make inquiries concerning possible violation of this
conflict of interest policy. All these complaints or inquiries should be immediately
reported to the DIO. Upon receipt or notification of such complaint or inquiry, the DIO
shall immediately advise the responsible Vice President and the Director of the
department as well as the person against whom the complaint is made.

INVESTIGATOR TRAINING

Each investigator must complete FCOI training:
1. Prior to engaging in research related to PHS funded research.
2. At least every four years;
3. If the Institute revises FCOI policy;
4. When an investigator is new to the Institute;
5. When an investigator is found to be noncompliant with the Institute’s FCOI policy
To complete training:
1. Go to http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm to reach
the NIH FCOI tutorial
2. View tutorial and answer the review questions
3. At the end of the tutorial, click the “Certificate” button
4. When the certificate appears, type your name in the Participant’s Name text box
5. Print, and send to DIO

PROCEDURES FOR INVESTIGATING FCOI

The DIO will review all financial disclosures. Affected individual(s) will be afforded
confidential treatment to the maximum extent possible, and are entitled to a prompt and
thorough investigation and an opportunity to comment on any allegations or findings
resulting from the investigation. The DIO shall advise the Director of the department and
the responsible Vice President of the substance of the disclosure. The Vice President
shall appoint an independent panel to determine whether a conflict of interest exists and,
if so, determine what actions should be taken by the Institute to manage, reduce or
eliminate such conflict of interest. This process may include the creation of a Mitigation
Report containing specific recommendations. A conflict of interest exists when the
designated panel reasonably determines that a Significant Financial Interest could
directly and significantly affect the design, conduct, or reporting of the PHS-funded
research or the Investigator’s institutional responsibilities. Examples of conditions or
restrictions that might be imposed to manage conflicts of interest include, but are not
limited to:
1. Public disclosure of significant financial interests.
2. Monitoring of research by independent reviewers.
3. Modification of the research plan.
4. Disqualification from participation in all or a portion of the research funded by the
PHS.
5. Divestiture of significant financial interests.
6. Severance of relationships that create actual or potential conflicts.
Retroactive reviews, where the Institute’s determination of non-compliance for significant
financial interest not disclosed timely or previously reviewed or whenever a FCOI is not
identified or managed in a timely manner, will be completed and documented within 120
days.

The FCOI Policy for PHS Projects also applies to subrecipients. If an Investigator carries
out PHS-funded research through a subrecipient, the Institute will take reasonable
steps to ensure that any subrecipient Investigator complies with this policy. This will
require a financial disclosure form to be filled out at the proposal stage, which includes
certification that the subrecipient has a policy in place that meets the PHS requirements.
Alternatively, terms that verify the subrecipient has a financial conflicts of interest policy
that meets the PHS requirements will be included as part of a written agreement with the
subrecipient.

PHS NOTIFICATION

If the failure of an Investigator to comply with the conflict of interest policy of the
Institute has prejudiced the design, conduct, or reporting of the PHS-funded research,
the Institute will promptly notify the PHS Awarding Component of the action it has taken
or intends to take. The PHS Awarding Component will consider the situation and, as
necessary, take appropriate action, or refer the matter to the Institute for further action.
These may include directing the Institute on how to maintain appropriate objectivity in
the funded project.

The HHS may at any time inquire into the Institute procedures and actions regarding
conflicting financial interests in PHS-funded research, including a requirement for
submission of, or review on site, all records pertinent to compliance. To the extent
permitted by law, HHS will maintain the confidentiality of all records of financial interests.
On the basis of its review of records and/or other information that may be available, the
PHS Awarding Component may decide that a particular conflict of interest will bias the
objectivity of the PHS-funded research to such an extent that further corrective action is
needed or that the Institute has not managed, reduced, or eliminated the conflict of
interest. The PHS Awarding Component may determine that suspension of funding
under 45 CFR 74.62 is necessary until the matter is resolved.

RETENTION OF DOCUMENTATION

Detailed documentation of each review will be maintained for at least three (3) years,
and will, upon request, be provided to the official (s) of the Institute.
Documentation to substantiate an investigation's findings will be retained for at least
three (3) years after completion of a final report.

APPEAL

An investigator or employee who disagrees with the determination of the review panel
may appeal to the responsible Vice President for reconsideration of such determination.
The determination of the responsible Vice President shall be final and binding.