This policy governing financial conflict of interest applies to all Federally-sponsored (including PHS) Investigators of the Castner Incorporated Institution. The Institutional Official is responsible for ensuring implementation of this policy and may suspend all relevant activities until the financial conflict of interest is resolved or other action deemed appropriate by the Institutional official is implemented. Violation of any part of these policies may also constitute cause for disciplinary or other administrative
action pursuant to Institutional Disciplinary (2019_070) policy.
Castner Incorporated will comply with the policy and procedures of the institution to which the primary award is made, if other than Castner Incorporated by offering to voluntarily report all investigator financial conflicts of interest through the primary award institution’s usual mechanisms and will comply with determinations, oversight and management plan, as indicated. The primary award institution’s policy will supercede this policy if 1) the investigator is given access to the conflict of interest reporting
system, 2) the administration and oversight of Castner Incorporated’s investigator(s) conflict of interest procedures are identical to those applied to the institution’s faculty, and 3) this administration arrangement was made prior to bid/proposal as part of the subrecipient letter of intent.
Clinical Trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
Conflict of Interest Committee (COI Committee) means the Institution’s committee or individual that advises the Institutional Official on conflict of interest matters. The committee consists of either 1) an external consultant, or 2) the COI Committee at a collaborating/prime awardee institution with voluntary COI reporting under the collaborating/prime awardee institution policy. For option 2), deadlines and
policies at the collaborating/prime awardee institution supersede this policy.
Family means any member of the Investigator’s immediate family, specifically, any dependent children and spouse.
Financial Interest means anything of monetary value received or held by an Investigator or an Investigator’s Family, whether or not the value is readily ascertainable, including, but not limited to: salary or other payments for services (e.g., consulting fees, honoraria, or paid authorships for other than scholarly works); any equity interests (e.g., stocks, stock options, or other ownership interests); and intellectual property rights and interests (e.g., patents, trademarks, service marks, and copyrights), upon receipt of royalties or other income related to such intellectual property rights and interests.
Financial Interest does NOT include:
a) salary, royalties, or other remuneration from the Institution;
b) income from the authorship of academic or scholarly works;
c) income from seminars, lectures, or teaching engagements sponsored by or from advisory committees or review panels for U.S. Federal, state or local governmental agencies; U.S. institutions of higher education; research institutes affiliated with institutions of higher education, academic teaching hospitals, and medical centers; or
d) equity interests or income from investment vehicles, such as mutual funds and retirement accounts, so long as the Investigator does not directly control the investment decisions made in these vehicles.
For Investigators, Financial Interest also includes any reimbursed or sponsored travel undertaken by the Investigator and related to his/her institutional responsibilities. This includes travel that is paid on behalf of the Investigator as well as travel that is reimbursed, even if the exact monetary value is not readily available. It excludes travel reimbursed or sponsored by U.S. Federal, state or local governmental agencies, U.S. institutions of higher education, research institutes affiliated with institutions of higher education, academic teaching hospitals, and medical centers.
Significant Financial Interest means a Financial Interest that reasonably appears to be related to the Investigator’s Institutional Responsibilities, and:
a) if with a publicly traded entity, the aggregate value of any salary or other payments for services received during the 12 month period preceding the disclosure, and the value of any equity interest during the 12 month period preceding or as of the date of disclosure, exceeds $5,000; or
b) if with a non-publicly traded entity, the aggregate value of any salary or other payments for services received during the 12 month period preceding the disclosure exceeds $5,000; or
c) if with a non-publicly-traded company, is an equity interest of any value during the 12 month period preceding or as of the date of disclosure; or
d) is income exceeding $5,000 related to intellectual property rights and interests not reimbursed through the Institution, or
e) is reimbursed or sponsored travel related to their institutional responsibilities.
Financial Conflict of Interest means a Significant Financial Interest (or, where the Institutional official requires disclosure of other Financial Interests, a Financial Interest) that the Institution reasonably determines could directly and significantly affect the design, conduct or reporting of Federally (including PHS) sponsored research.
Institutional official means the individual within the Institution that is responsible for the solicitation and review of disclosures of significant financial interests including those of the Investigator’s Family related to the Investigator’s institutional responsibilities. For the purposes of this policy, the Institutional Official is designated as either 1) an external consultant if the President is investigator, or 2) the President.
Institutional responsibilities means the Investigator’s professional responsibilities associated with his or her Institutional appointment or position, such as research, teaching, clinical activities, administration, and institutional, internal and external professional committee service.
Investigator means any individual who is responsible for the design, conduct, or reporting of Federally (including PHS) sponsored research, or proposals for such funding. This definition is not limited to those titled or budgeted as principal investigator or co-investigator on a particular proposal, and may include postdoctoral associates, senior scientists, or graduate students. The definition may also include collaborators or consultants as appropriate.
Public Health Service or PHS means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority of the PHS may be delegated. The components of the PHS include, but are not limited to, the Administration for Children and Families, Administration on Aging, Agency for Healthcare Research and Quality, Agency for Toxic Substances and Disease Registry, Centers for Disease Control and Prevention, Federal Occupational Health, Food and Drug Administration, Health Resources and Services Administration, Indian Health
Service, National Institutes of Health, and Substance Abuse and Mental Health Services Administration.
Research means a systematic investigation, study, or experiment designed to 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).
CONFLICT OF INTEREST:
This policy is predicated on the expectation that Investigators should conduct their affairs so as to avoid or minimize conflicts of interest, and must respond appropriately when conflicts of interest arise. To that end, this policy informs Investigators about situations that generate conflicts of interest related to research, provides mechanisms for Investigators and the Institution to manage those conflicts of interest
that arise, and describes situations that are prohibited. Every Investigator has an obligation to become familiar with, and abide by, the provisions of this policy. If a situation raising questions of conflict of interest arises, an Investigator should discuss the situation with the Institutional official.
1) DISCLOSURE OF FINANCIAL INTERESTS
All Investigators are required to disclose their outside financial interests as defined above to the Institution on an annual and on an ad hoc basis, as described below. The Institutional official is responsible for the distribution, receipt, processing, review and retention of disclosure forms, facilitated by the President. The COI Committee will assist with the review of those forms and processes. The disclosure form is attached to this policy.
a) Annual Disclosures
All Investigators must disclose their Significant Financial Interests that are related to the
investigator’s institutional responsibilities to the Institution, through the Institutional
Official, on an annual basis. All forms should be submitted to the Institutional official or
designee by May 16 for the previous calendar year.
b) Ad hoc Disclosures
In addition to annual disclosure, certain situations require ad hoc disclosure. All
Investigators must disclose their Significant Financial Interests to the Institution, through the Institutional Official, within 30 days of their initial appointment or employment.
Prior to entering into Federally (including PHS) sponsored projects or applications for
Federally (including PHS) sponsored projects, where the Investigator has a Significant
Financial Interest, the Investigator must affirm the currency of the annual disclosure or
submit to the Institutional Official an ad hoc updated disclosure of his or her Significant
Financial Interests with the outside entity. The Institution will not submit a research
proposal/accept the award unless the Investigator(s) have submitted such ad hoc disclosures.
In addition, all Investigators must submit to the Institutional official an ad hoc disclosure of any Significant Financial Interest they acquire or discover during the course of the year
within thirty (30) days of discovering or acquiring the Significant Financial Interest.
Investigators must also disclose reimbursed or sponsored travel related to their institutional responsibilities, as defined above in the definition of Financial Interest and Significant Financial Interest. Such disclosures must include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, the duration, and, if known, the monetary value. The Institutional Official will determine if additional information is needed (e.g., the monetary value if not already disclosed) to determine whether the travel constitutes a Financial Conflict of Interest with the Investigator’s research.
2) REVIEW AND DECISION OF THE INSTITUTIONAL OFFICIAL
If the disclosure form reveals a Significant Financial Interest, it will be reviewed promptly by the Institutional Official or designee for a determination of whether it constitutes a Financial Conflict of Interest. If a Financial Conflict of Interest exists, the Institutional Official will take action to manage the financial conflict of interest including the reduction or elimination of the conflict, as appropriate. The Institutional Official may establish and/or consult the COI Committee for guidance in specific cases, or in the application of the policy to particular situations.
A Financial Conflict of Interest will exist when the Institutional Official or designee determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of Federally (including PHS) sponsored research. If the Institutional Official determines that there is a Financial Conflict of Interest that can be managed, he or she must develop and implement a written management plan. The affected Investigator must formally agree to the proposed management strategies and sign the written management plan before any related Federally (including PHS) sponsored research goes forward.
The Institutional Official will periodically review the ongoing activity, monitor the conduct of the activity (including use of students and postdoctoral appointees), to ensure open and timely dissemination of the research results, and to otherwise oversee compliance with the management plan.
3) CLINICAL TRIALS
Review of Significant Financial Interests Related to Clinical Trials
Clinical trials involve particularly sensitive issues if the Investigator has a Financial Interest related to the clinical trial.
a) Castner Incorporated is committed to ensure scientifically rigorous and valid results that are not unduly influenced by a financial conflict of interest. If it is deemed that the investigator has a significant financial conflict of interest, the research may be conducted with a management plan that addresses removing the risk of bias from the significant financial conflict of interest. If elements of the research design are sufficient to limit or prevent the influence of financial conflicts of interest, the research may still take place. Examples of these elements of the research design to be addressed in determining sufficiency to limit or prevent the influence of conflict of interest include disclosures to potential participants, IRB review of the proposal, additional consultant review of the proposal, public registration of the trial, adequate blinding and allocation techniques, appropriate comparisons, and proper data analytic techniques. If design elements are insufficient to adequately manage the financial conflict of interest, an abstention or limited role in the research will be negotiated with the investigator. If the study design or investigator role do not adequately remove bias from the study, the funding may be returned to the sponsor.
b) In the event of non-compliance with reporting and/or management of a financial conflict of interest involving a PHS-sponsored clinical research project whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment as required by this Policy, the investigator must disclose the financial conflicts of interest in each public presentation of the results of the affected PHS-sponsored research and request an addendum to previously published presentations.
4) REPORTING TO PHS
The institutional official will report financial conflicts of interest or non-compliance to PHS in accordance with PHS regulations. If the funding for the Research is made available from a prime PHS-awardee, such reports shall be made to the prime awardee prior to the expenditure of any funds and within 60 days of any subsequently identified financial conflict of interest such that the prime awardee may fulfill their reporting obligations to the PHS.
5) INVESTIGATOR NON-COMPLIANCE
a) Disciplinary Action
In the event of an Investigator’s failure to comply with this Policy, the Institutional official
may suspend all relevant activities or take other disciplinary action until the matter is
resolved or other action deemed appropriate by the Institutional official is implemented.
This action will comply with Castner Incorporated’s Conflict Resolution Policy (2019_080)
and Disciplinary (2019_070) policy.
An Institutional Official’s decision to impose sanctions on an Investigator because of failure to comply with this Policy, or failure to comply with the decision of the Institutional official, will be described in a written explanation of the decision to the investigator, COI
Committee, and, where applicable, the IRB, and will notify the individual of the right to
appeal the decision. The institution will promptly notify the PHS Awarding Component of
the action taken or to be taken. If the funding for the research is made available from a
prime PHS awardee, such notification shall be made promptly to the prime awardee for
reporting to PHS.
b) Retrospective Review
In addition, if the Institutional Official determines that a Financial Conflict of Interest was
not identified or managed in a timely manner, including but not limited to an Investigator’s
failure to disclose a Significant Financial Interest that is determined to be a Financial
Conflict of Interest, or failure by an Investigator to materially comply with a management
plan for a Financial Conflict of Interest, a committee appointed by the Institutional Official
will complete a retrospective review of the Investigator’s activities and the Federally
(including PHS) sponsored research project to determine whether the research conducted
during the period of non-compliance was biased in the design, conduct or reporting of the
Documentation of the retrospective review shall include the project number, project title, PI, name of Investigator with the Financial Conflict of Interest, name of the entity with which the Investigator has the Financial Conflict of Interest, reason(s) for the retrospective review, detailed methodology used for the retrospective review, and findings and conclusions of the review.
The Institutional official will update any previously submitted report to the PHS or the
prime PHS-awardee relating to the research, specifying the actions that will be taken to
manage the Financial Conflict of Interest going forward. This retrospective review will be
completed in the manner and within the time frame established in PHS regulations. If bias is found, the institution will promptly notify the PHS Awarding Component and submit a
mitigation report in accordance with the PHS regulations. The mitigation report will
identify elements documented in the retrospective review, a description of the impact of the bias on the research project and the plan of action to eliminate or mitigate the effect of the bias.
Each Investigator must complete training on this Policy, the investigator’s responsibilities
regarding disclosure and the PHS regulations prior to engaging in research funded by PHS, and at least every four years thereafter. They must also complete training within a reasonable period of time as determined by the Institutional Official in the event that this Policy is substantively amended in a manner that affects the requirements of Investigators, if the investigator is new to the institution, or if it is determined that the Investigator has not complied with this policy or with a management plan related to their activities. Training will include review of the US DHHS Office of Research Integrity Conflicts of Interest Chapter, Conflicts of Interest CITI program modules as assigned by the supervisor. Additional modules may be assigned by the supervisor on a project-by-project basis for Federally sponsored research that is not PHS-sponsored.
7) RECORD RETENTION
The Institutional Official will retain all disclosure forms, conflict management plans, and
related documents for a period of three years from the date the final expenditure report is
submitted to the Federal sponsor (including PHS) or to the prime awardee, unless any litigation, claim, financial management review, or audit is started before the expiration of the three year period, the records shall be retained until all litigation, claims or audit findings involving the records have been resolved and final action taken.
To the extent permitted by law, all disclosure forms, conflict management plans, and related information will be confidential. However, the Institution may be required to make such information available to the Federal Sponsor (including PHS) Awarding Component and/or HHS, to a requestor of information concerning financial conflict of interest related to Federal (including PHS) funding or to the primary entity who made the funding available to the Institution, if requested or required. If the Institution is requested to provide disclosure forms, conflict management plans, and related information to an outside entity, the Investigator will be informed of this disclosure.
9) PUBLIC ACCESSIBILITY
Prior to the expenditure of funds, the Institution will respond to any requestor within five
business days of the request, information concerning any Significant Financial Interest that meets the following criteria:
a) The Significant Financial Interest was disclosed and is still held by the senior and key
b) A determination has been made that the Significant Financial Interest is related to the
Federally (including PHS) funded research; and
c) A determination has been made that the Significant Financial Interest is a Financial
Conflict of Interest.
The information to be made available shall be consistent with the requirements of the PHS regulation.
10) REGULATORY AUTHORITY
This policy implements the requirements of 42 CFR 50 Subpart F and 45 CFR 94; where there are substantive differences between this policy and the requirements, the requirements shall take precedence.
FINANCIAL INTEREST FORM
Available pursuant to the requirements of the Castner Incorporated Conflict of Interest policy)
Conflict of Interest Policy 2018_010
Page 2 of 9 Initial Approval 8/7/2018; Last revised 03/19/2019