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NICHQ Conflict of Financial Interest Policy

INTRODUCTION

As an organization, NICHQ is committed to exhibiting the following core, behavioral values:

  • We are agile
  • We are bold
  • We innovate
  • Our integrity is unquestionable
  • We are a learning organization
  • We show genuine appreciation
  • We work hard and have fun
  • We believe in teamwork
  • We use quality improvement in all we do
  • We are attentive to value—ours and the health system’s
  • We build strong relationships

Consistent with our value of integrity, NICHQ is committed to the highest standards of integrity in its research activities and as a recipient of research funding. There will be zero tolerance for failure to disclose potential conflicts of interest.

This policy governing financial conflict of interest applies to all NICHQ contractors, faculty and staff. NICHQ’s CEO 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 NICHQ Compliance Officer is implemented. Violation of any part of these policies may also constitute cause for disciplinary or other administrative action pursuant to this NICHQ policy.

DEFINITIONS

Clinical Trial means any NICHQ sub-recipient, faculty, contractor or staff involved in a study or project that involves interaction with human subjects and the concurrent investigative use of drugs, biologics, devices or medical or other clinical procedures, such as surgery.

Compliance Officer (COICO) means the NICHQ designated COI Compliance Officer who oversees COI policy. The Compliance Officer reports to and advises the CEO on all COI matters.

Family means any member of a NICHQ contractor’s or NICHQ project manager’s immediate family, specifically, any dependent children and spouse.

Financial Interest means anything of monetary value received or held by a Contractor or a
Contractor’s Family Member or a Research Project Contributor or a Research Project Contributor’s Family or a Faculty Member or a Faculty Member’s Family, whether or not the value is readily ascertainable, including, but not limited to: salary or other payments for services (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 Funders;
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; institutions of higher education; research institutes affiliated with NICHQs 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 Research Project Contributor does not directly control the investment decisions made in these vehicles.

For Research Project Contributors, Financial Interest also includes any reimbursed or sponsored travel undertaken by the Research Project Contributor and related to his/her NICHQ responsibilities. This includes travel that is paid on behalf of the Research Project Contributor 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 NICHQ’s Research Project Contributor’s 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 NICHQ, or
e) is reimbursed or sponsored travel related to their NICHQ responsibilities

Financial Conflict of Interest means a Significant Financial fund that NICHQ reasonably determines could directly and significantly affect the design, conduct or reporting of any applicable research.

NICHQ Compliance Officer means the individual within NICHQ who is responsible for the solicitation and review of disclosures of significant financial interests including those of the Contractor, Faculty Member or Research Project Contributor or their Family members as related to their NICHQ Funded-Project responsibilities.

NICHQ responsibilities means the Contractor, Faculty or Research Project Contributor’s professional responsibilities associated with his or her NICHQ appointment or position, such as research, teaching, clinical activities, administration, and NICHQ, internal and external professional committee service.

Research Project Contributor means any individual who is responsible for the design, conduct, or reporting of all applicable research, or proposals for such funding and includes contractors, faculty and staff. This definition is not limited to those titled or budgeted as principal Research Project Contributor or co-Research Project Contributor 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 Research Project Contributors 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 Research Project Contributors about situations that generate conflicts of interest related to research, provides mechanisms for Research Project Contributors and the NICHQ to manage those conflicts of interest that arise, and describes situations that are prohibited. Every Research Project Contributor 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, a Research Project Contributor should discuss the situation with the NICHQ Compliance Officer.

1) Disclosure of Financial Interests

All Research Project Contributors are required to disclose their outside financial interests as defined above to the NICHQ Compliance Officer on an annual and on an ad hoc basis, as described below. The NICHQ Compliance Officer is responsible for the distribution, receipt, processing, review and retention of disclosure forms.

a) Annual Disclosures
All Contractors, Faculty and Research Project Contributors must disclose their Significant Financial Interests that are related to the NICHQ Research Project responsibilities to NICHQ, through the NICHQ Compliance Officer, on an annual basis. All forms should be submitted to the NICHQ Compliance Officer or designee by March 1 for the previous calendar year or as determined by the CEO.

b) Ad hoc Disclosures
In addition to annual disclosure, certain situations require ad hoc disclosure. All Research Project Contributors must disclose their Significant Financial Interests to NICHQ, through the NICHQ Compliance Officer, within 30 days of their initial appointment or employment.

Prior to entering into any PHS projects or applications for PHS-sponsored projects, where the Research Project Contributor has a Significant Financial Interest, the Research Project Contributor must affirm the currency of the annual disclosure or submit to the NICHQ Compliance Officer an ad hoc updated disclosure of his or her Significant Financial Interests with the outside entity. NICHQ will not submit a research proposal unless the Research Project Contributor(s) have submitted such ad hoc disclosures.

In addition, all Research Project Contributors must submit to the NICHQ Compliance Officer 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.

c) Travel
Research Project Contributors must also disclose reimbursed or sponsored travel related to their NICHQ 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 NICHQ Compliance Officer 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 Research Project Contributor’s research.

2) Review and Decision of the NICHQ Compliance Officer

If the disclosure form reveals a Significant Financial Interest, it will be reviewed promptly by the NICHQ Compliance Officer or designee for a determination of whether it constitutes a Financial Conflict of Interest. If a Financial Conflict of Interest exists, the NICHQ Compliance Officer will take action to manage the financial conflict of interest including the reduction or elimination of the conflict, as appropriate. The NICHQ Compliance Officer may consult other NICHQ Executives in special cases.

A Financial Conflict of Interest will exist when the NICHQ Compliance Officer, or Compliance Officer designee determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of PHS-sponsored research. If the NICHQ Compliance Officer 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 Research Project Contributor must formally agree to the proposed management strategies and sign the written management plan before any related research goes forward.

The NICHQ Compliance Officer 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 [option for those organizations conducting clinical trials as a sub-awardee]


Review of Significant Financial Interests Related to Clinical Trials
Clinical trials involve particularly sensitive issues if the Research Project Contributor has a Financial Interest related to the clinical trial.

a) 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 Research Project Contributor 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 Funders

The NICHQ Compliance Officer will report financial conflicts of interest or non-compliance to Funders in accordance with Funder regulations. If the funding for the Research is made available from a prime Funder-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 Funder.

5) Research Project Contributor Non-Compliance

 

a) Disciplinary Action
In the event of a Research Project Contributor’s failure to comply with this Policy, the NICHQ Compliance Officer in agreement with the CEO, may suspend all relevant activities or take other disciplinary action until the matter is resolved or other action deemed appropriate by the NICHQ Compliance Officer is implemented.

A NICHQ Compliance Officer’s decision to impose sanctions on a Research Project Contributor because of failure to comply with this Policy, or failure to comply with the decision of the NICHQ Compliance Officer, will be described in a written explanation of the decision to the Research Project Contributor, and, where applicable, the IRB, and will notify the individual of the right to appeal the decision. The NICHQ will promptly notify the Funder-Awarding Contact of the action taken or to be taken. If the funding for the research is made available from a prime Funder-awardee, such notification shall be made promptly to the prime-Funder-awardee contact for reporting to PHS.

b) Retrospective Review
In addition, if the NICHQ Compliance Officer determines that a Financial Conflict of Interest was not identified or managed in a timely manner, including but not limited to an Research Project Contributor’s failure to disclose a Significant Financial Interest that is determined to be a Financial Conflict of Interest, or failure by an Research Project Contributor to materially comply with a management plan for a Financial Conflict of Interest, the NICHQ Compliance Officer for COI will complete a retrospective review of the Research Project Contributor’s activities and the Funder research project to determine whether the research conducted during the period of non-compliance was biased in the design, conduct or reporting of the research.

Documentation of the retrospective review shall include the project number, project title, PI, name of Research Project Contributor with the Financial Conflict of Interest, name of the entity with which the Research Project Contributor 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 NICHQ Compliance Officer will update any previously submitted report to the Funder or the prime Funder-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 Funder regulations. If bias is found, NICHQ will promptly notify the Funder Awarding Contact and submit a mitigation report in accordance with the Funder 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.

6) Notifications/Training

Each Research Project Contributor will receive notification and may be required to complete training on this Policy, the Research Project Contributor’s responsibilities regarding disclosure and the Funder’s regulations prior to engaging in Funder’s research and at least every four years thereafter. They must also complete required training within a reasonable period of time as determined by the NICHQ Compliance Officer in the event that this Policy is substantively amended in a manner that affects the requirements of Research Project Contributors, if the Research Project Contributor is new to NICHQ, or if it is determined that the Research Project Contributor has not complied with this policy or with a management plan related to their activities. All NICHQ contractors, faculty and staff may be required to attend training on this policy prior to assignment to a research project. All NICHQ staff, faculty and contractors will be given a copy of this policy, to read and then to sign the policy statement indicating that the policy was read, that the policy is understood and will comply with the policy.

7) Record Retention

The NICHQ Compliance Officer 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 Funder or to the prime Funder 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.

8) Confidentiality

To the extent permitted by law, all disclosure forms, conflict management plans, and related information will be confidential. However, NICHQ may be required to make such information available to the Funder Awarding Contact and/or PHS/HHS, to a requestor of information concerning financial conflict of interest related to funding or to the primary entity who made the funding available to NICHQ, if requested or required. If NICHQ is requested to provide disclosure forms, conflict management plans, and related information to an outside entity, including peer reviewed publications, the Research Project Contributor will be informed of this disclosure.

9) Public Accessibility

Prior to the expenditure of funds, NICHQ will publish on a publicly-accessible website or respond to any requestor within 10 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 personnel;
b) A determination has been made that the Significant Financial Interest is related to the 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.



Questions or Concerns
For questions or concerns about this Conflict of Financial Interest Policy, please send an email to webmaster@nichq.org.

Revision Date
March 14, 2013

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