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Financial Conflicts of Interest in Research Policy

Introduction

This policy governing financial conflicts of interest in research applies to all Public Health Service ("PHS") organizational unit funded research applied for and/or staffed by the American Medical Association ("AMA").

This policy applies to all individuals who are responsible for the design, conduct, or reporting of PHS funded research, including, but not limited to principal investigators, co-investigators, and project directors.

This policy promotes objectivity in funded research by establishing standards to identify and address financial conflicts of interest. When an investigator has an outside economic interest that could affect the conduct of their AMA responsibilities, a financial conflict of interest may exist which could threaten the objectivity and integrity of their research. While this is not always problematic, consideration must be given to determine when these outside economic interests may bias the design, conduct, or reporting of funded research. Objectivity of researchers is essential in scientific research for the maintenance of public trust.

Definitions

Designated Official means the individual designated to solicit and review disclosures of significant financial interests of the Investigator, or the Investigator's family, related to the Investigator's AMA responsibilities.

Family means the spouse, domestic partner, and any dependent children of the Investigator.

Financial Conflict of Interest means a Significant Financial Interest that could directly and significantly affect the design, conduct or reporting of PHS-funded research.

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); an equity interest (e.g., stocks, stock options, or other ownership interests); and intellectual property rights and interests, upon receipt of royalties or other income related to such intellectual property rights or interests.

Investigator means any individual who is responsible for the design, conduct, or reporting of sponsored research, or proposals for such funding, and includes but is not limited to, project directors, principal investigators, co-investigators, collaborators and consultants.

Significant Financial Interest means a Financial Interest that reasonably appears to be related to the Investigator's AMA responsibilities, and:

  1. if with a publicly traded entity, the aggregate value of any salary or other payments for services received during the 12 month period preceding disclosure, or the value of any equity interest held during the 12 month period preceding disclosure, exceeds $5,000; or
  2. 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 disclosure,  exceeds $5,000; or
  3. if with a non-publicly traded entity, is an equity interest of any value during the 12 month period preceding disclosure; or
  4. is income related to intellectual property rights and interests (e.g. patents, copyrights) paid by an entity other than the AMA during the 12 month period preceding disclosure, the aggregate value of which exceeds $5,000.

Significant Financial Interest also includes any reimbursed or sponsored travel (e.g., air, taxi fare, auto rental, etc.), paid by an entity, including a nonprofit organization, undertaken by the Investigator and related to his/her  AMA responsibilities during the 12 month period preceding the disclosure; provided however 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 does NOT include:

  1. salary, royalties, or other remuneration from  AMA;
  2. income from seminars, lectures, or teaching engagements sponsored by or from  U.S. Federal, state or local governmental agencies; U.S. institutions of higher education; U.S. research institutes affiliated with institutions of higher education, academic teaching hospitals, and medical centers; or
  3. 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.

Public Health Service or PHS means the Public Health Service of the U.S. Department of Health and Human Services, and any organizational units of the PHS to which the authority of the PHS may be delegated. The PHS organizational units 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 develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and applied research (e.g., published article, book or book chapter) and product development (e.g., diagnostic test or drug). The term includes any such activity for which research funding is available from a PHS organizational unit.

Disclosure of Financial Interests

All Investigators are required to disclose their outside financial interests to AMA as described below. The Designated Official is responsible for the distribution, receipt, review and retention of disclosure forms.

Time of Grant Application

Prior to submitting a grant application for sponsored research, each Investigator must submit to the Designated Official a disclosure form listing his or her Significant Financial Interests.

Annual Disclosures of New Significant Financial Interests

All Investigators must disclose their Significant Financial Interests to the Designated Official, on an annual basis, and within 30 days of acquiring or discovering a new significant financial interest.

Ad hoc Disclosures

All Investigators commencing work on the PHS-funded research after the awarding of the grant, must disclose their Significant Financial Interests to the Designated Official within 30 days of commencing work on the sponsored research.

All Investigators working on PHS-funded research must disclose their Significant Financial Interest to the Designated Official within 30 days of acquiring or discovering a new Significant Financial Interest.

Travel

Investigators must also disclose reimbursed or sponsored travel related to their AMA responsibilities. 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 Designated 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.

Review and Decision of the Designated Official

Each disclosure form revealing a Significant Financial Interest will be reviewed within 60 days by the Designated Official or designee for a determination of whether the Significant Financial Interest constitutes a Financial Conflict of Interest. A Financial Conflict of Interest will exist when the Designated Official or designee determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of PHS-funded research.  

If the Designated Official determines that there is a Financial Conflict of Interest, he or she must develop and implement a written management plan that specifies the actions that will be taken to manage the Financial Conflict of Interest. The management plan must include:

  1. the role and principle duties of the conflicted Investigator in the research project;
  2. conditions of the management plan;
  3. how the management plan is designed to safeguard objectivity in the research project;
  4. written confirmation of the Investigator's agreement to the management plan strategies before the sponsored research goes forward;
  5. how the management plan will be monitored to ensure Investigator compliance; and
  6. other information as needed.

A management plan may impose any condition and prescribe any action necessary to manage a Financial Conflict of Interest, including an action reducing or eliminating the Financial Conflict of Interest, to ensure that the design, conduct, or reporting of the research is free from bias or the appearance of bias. Examples of conditions or actions that may be prescribed include, but are not limited to:

  1. public disclosure of the conflict of interest in presentations and publications;
  2. appointment of an independent monitor with authority to take measures to protect the design, conduct, and reporting of research against bias, or the appearance of bias, resulting from the conflict of interest;
  3. modification of the research plan;
  4. change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or any portion of the research;
  5. divesture or reduction of the financial interest; or
  6. severance of relationships that create an actual or potential Financial Conflict of Interest; and
  7. for research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants.

The Investigator must acknowledge receipt of the approved plan and indicate he/she understands the requirements of this policy and the required actions and other terms of the plan. The investigator must also agree to comply with the management plan.

Reporting of Financial Conflicts of Interest

Should any Financial Conflict of Interest be discovered by AMA, its Designated Official or designee will report it to the PHS organizational unit awarding the grant, as follows:

1)   Prior to AMA's expenditure of any funds under a PHS-funded research project, AMA shall provide to the PHS organizational unit awarding the grant a report regarding the Investigator's Significant Financial Interest found to be conflicting and ensure that AMA has implemented a management plan. In cases in which AMA eliminates the Financial Conflict of Interest prior to the expenditure of PHS-awarded funds, AMA shall not submit a report to the PHS organizational unit awarding the grant.

2)   For any Significant Financial Interest that AMA identifies as conflicting subsequent to an initial report during an ongoing PHS-funded research project (e.g., upon the participation of an investigator who is new to the research project), AMA shall provide to the PHS organizational unit awarding the grant, within 60 days, a report regarding the financial conflict of interest and ensure that a management plan has been implemented.

3)   For any Financial Conflict of Interest previously reported by AMA with regard to an ongoing PHS-funded research project, AMA shall provide the PHS organizational unit awarding the grant an annual report that addresses the status of the financial conflict of interest and any changes to the management plan for the duration of the PHS-funded research project.

Investigator Non-Compliance

Disciplinary Action

In the event of an Investigator's failure to comply with this policy, the Designated Official or AMA may suspend the Investigator's participation in all relevant activities.

A Designated 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 Designated Official, will be described in a written explanation of the decision to the Investigator.

Retrospective Review

If the Designated Official determines that a Significant Financial Interest that was determined to be a Financial Conflict of Interest was not disclosed in a timely manner by an Investigator or, the Investigator failed to materially comply with a management plan for a Financial Conflict of Interest, the Designated Official will, within 120 days of the determination of noncompliance, complete a retrospective review of the Investigator's activities and the 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. If bias is found, AMA is required to promptly notify and submit a mitigation report to the PHS organizational unit awarding the grant, including 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.

Documentation of the retrospective review shall include the project number, project title, principal investigator, 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.

Training

Each Investigator must complete training on this policy 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 Designated Official in the event that this policy is substantively amended in a manner that affects the requirements of Investigators, or if it is determined that the Investigator has not complied with this policy or with a management plan related to their activities. Upon successful completion of the training, the Investigator will provide a certificate of completion to the Designated Official, or designee.

Record Retention

The Designated Official, or designee, 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 PHS or other funder of the sponsored research.

Confidentiality

To the extent permitted by law, all disclosure forms, conflict management plans, and related information will be confidential. However, AMA may make such information available to the PHS organizational unit awarding the grant, to another funding source, to a requestor of information concerning financial conflicts of interest related to PHS funding, if requested or required. If AMA is requested to provide disclosure forms, conflict management plans, and related information to an outside entity, the Investigator will be informed of this disclosure.

Public Accessibility

 This policy is available on AMA internet website. Prior to the expenditure of funds, AMA will publish on its website or respond to any requestor within five business days of the request, information concerning any Significant Financial Interest that meets the following criteria:

  1. The Significant Financial Interest was disclosed and is still held by the project director, principal investigator, or other persons identified as key personnel in the grant application or progress report; and
  2. AMA determines that the Significant Financial Interest is related to the PHS-funded research; and
  3. AMA determines that the Significant Financial Interest is a Financial Conflict of Interest.

The information that  AMA makes available via a publicly accessible website or written response to any requestor, shall include, at a minimum, the following: the Investigator's name, the Investigator's title and role with respect to the research project; the name of the entity in which the Significant Financial Interest is held; the nature of the Significant Financial Interest; the approximate dollar value of the Significant Financial Interest, or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.

The information that AMA posts on the publicly accessible website will be updated at least annually. In addition, AMA will update the website within 60 days of AMA's receipt or identification of information concerning any additional Significant Financial Interest of the key personnel for the research project that was not previously disclosed, or upon the disclosure of a Significant Financial Interest of key personnel new to the research project, if AMA determines that the Significant Financial Interest is related to PHS-funded research and is a financial conflict of interest. The website shall note that the information is current as of the date listed and is subject to updates, on at least an annual basis and within 60 days of AMA's identification of a new Financial Conflict of Interest.

Information concerning the Significant Financial Interests of persons identified as key personnel in the grant application or progress report shall remain available, for response to written requests or posting via AMA's publicly accessible website for at least 3 years from the date that the information was most recently updated.

Sub-Recipients

If PHS-funded research involves a sub-recipient (i.e., sub-grantee or subcontractor), AMA will take reasonable steps to ensure that any sub-recipient investigator complies with this policy, or the sub-recipient's conflict of interest policy by:

      1)   establishing in writing with the sub-recipient whether this policy or the sub-recipient's  conflict of interest policy will apply to the sub-recipient's investigators.

If the sub-recipient's investigators must comply with the sub-recipient's conflict of interest policy, the sub-recipient shall certify that its policy is in compliance with PHS requirements. In the absence of this certification, the agreement shall state that sub-recipient investigators are subject to this policy for disclosing Significant Financial Interests that are directly related to the sub-recipient's participation in such PHS funded research.

If the sub-recipient's investigators must comply with the sub-recipient's conflict of interest policy, the written agreement will specify a deadline for the sub-recipient to report all indentified Financial Conflicts of Interest to AMA so AMA can provide timely reports to PHS.

If the sub-recipient's investigators must comply with this policy, the written agreement will specify a deadline for the sub-recipient to submit all investigators' disclosures of Significant Financial Interests to AMA so that AMA can review, manage, and report identified Financial Conflict of Interests to PHS in a timely manner.

2)   providing Financial Conflicts of Interest reports to PHS regarding all identified Financial Conflicts of Interest of all sub-recipient investigators consistent with this policy.

If other agencies funded research requires the disclosure of Financial Conflicts of Interest of a sub-recipient, AMA shall ensure sub-recipient's compliance in accordance with such agencies' requirements.

Regulatory Authority

This policy implements the requirements of 42 CFR 50 and 45 CFR 94; where there are substantive differences between this policy and the requirements, the requirements shall take precedence.