Part I: Introduction
This policy is in response to Financial Conflict of Interest (FCOI) Regulation 42 CFR Part 50 Subpart F (grants and cooperative agreements) and 45 CFR Part 94 (contracts). The regulation pertains specifically to responsibility of applicants for promoting objectivity in research for which Public Health Service (NIH, AHRQ, HRSA, CDC, IHS, SAMHSA, ATSDR) funding1 is sought. This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest.
Pro-Change Behavior Systems, Inc. (Pro-Change) has the responsibility to identify, manage, reduce, or eliminate any conflicts of interest (COI) that may exist between the financial interest(s) of an individual as related to research conducted at or by Pro-Change. Failure to adhere to this policy may jeopardize current and future funding, and impact personal and institutional reputations. Thus, Pro-Change requires that individuals disclose any relevant financial interests. While full and accurate disclosure is required, Pro-Change recognizes that many potential conflicts of interest are not actual conflicts of interest, or may be acceptable with proper oversight and monitoring. A FCOI exists when Pro-Change, through procedures outlined below, determines that an individual’s financial interests could affect the design, conduct, or reporting of research.
The purpose of this policy is to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest. To address FCOI, Pro-Change has established a process by which Investigators disclose potential conflicts and are evaluated on a case-by-case basis. This policy describes procedures for disclosure, review, and oversight when necessary.
Part II: Definitions
Investigator: The project director or Principle Investigator and any other person regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the NIH, or proposed for such funding, which may include collaborators or consultants.
Significant Financial Interest (SFI): A financial interest consisting of one the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities. As pertains to Pro-Change, a SFI exists:
- If the value of any remuneration received from an entity in the 12 months preceding the disclosure, when aggregated, exceeds $5,000
- When the Investigator (or Investigator’s spouse or dependent children) holds any equity interest (e.g. stock, stock option, or other ownership interests) in an entity
- When income is received as related to intellectual property rights and interests (e.g. patents, copyrights)
- Note: Investigators must also disclose any reimbursed or sponsored travel (paid on behalf of Investigator and not reimbursed to the Investigator, such that the monetary value may not be able to be determined). (This refers to things like “business vacations” – e.g. 5 day all expenses paid trips to Hawaii to discuss “research” with an outside entity, and paid for by the outside entity.)
- Salary or other remuneration paid by Pro-Change to the Investigator if the Investigator is employed or otherwise appointed by Pro-Change
- Intellectual Property Rights assigned to Pro-Change and agreements to share in royalties related to such rights
- Any ownership interest in Pro-Change held by the Investigator
- Mutual funds and retirement accounts
- Income from seminars, lectures, or teaching engagements sponsored by a federal, state, local government agency, an institution of higher learning, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher learning
- Income from service on advisory committees or review panels for a federal, state, local government agency, an institution of higher learning, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher learning
Example of SFI/FCOI: Pro-Change has an intervention that is currently in Phase II clinical trial. Over the course of the trial, Company X has become interested in the intervention and is pursuing a contract to license it. Investigator Z owns more than $5,000 of stock in Company X. Although Investigator Z’s ownership of Company X’s stock is entirely unrelated to the research and the contract, it could still be construed by outsiders as a FCOI and therefore must be disclosed.
Part III: Investigator Training
FCOI training is required per NIH. Each Investigator must complete training prior to engaging in research related to any NIH-funded grant and at least every four years after that.
In the circumstances below, training must be done within 7 business days:
- Institutional FCOI policies change in a manner that affects Investigator requirements
- An Investigator is new to the institution
- An institution finds an Investigator to be noncompliant with the institutions FCOI policy or management plan
FCOI training includes thorough review of Pro-Change’s policy, as well as the completion of NIH’s Financial Conflict of Interest tutorial (available online by clicking the link). Upon completion of training, Investigators must sign the FCOI Training Certificate.
Part IV: Disclosure, Review, and Monitoring Disclosure
- An annual disclosure form for each federally funded project is required from:
- Pro-Change employees responsible for the design, conduct, and reporting of PHS funded research
- Investigators and other individuals identified on PHS funded grants and responsible for the design, conduct, or reporting of research
- Investigators and other individuals identified on IRB applications and responsible for the design, conduct, or reporting of research
- Individuals required to provide an annual reporting form must disclose any SFI greater than $5,000 (for themselves, spouse, or dependent children). See Part II for definitions of SFI.
- Individuals will be informed by Pro-Change’s COI officer of the need to complete the annual disclosure form on August 1. Completed disclosure forms are due back September 1.
- Individuals are responsible for maintaining a current accurate disclosure form. If a new relationship or change in a current relationship could be perceived as a FCOI, individuals must update their disclosure form to reflect such conflicts within 30 days.
- Investigators are required to disclose all SFI/FCOI at time of application for PHS funds (i.e. complete a disclosure form for proposed research)
After disclosure forms are returned to Pro-Change’s COI officer, they will be reviewed to determine whether or not an overlap with research and external interests might exist. Individuals will be notified if a COI exists such that it could directly and significantly affect the design, conduct, and reporting of NIH funded research. Individuals will then work with the COI team to mitigate the conflict (by managing, reducing, or eliminating it). Pro-Change’s IRB will be called upon as needed.
Acceptable strategies for managing, reducing, or eliminating FCOIs include:
- Disclosure of FCOI when publishing or presenting research findings: Investigators will disclose relationships with [business entity] to all journals where this research will be published and in all public presentations of this research
- NOTE: If applicable, the Investigator will request an addendum to all previously published presentations of research
- Disclosure of FCOI to potential human subjects: Any FCOIs will be disclosed to all potential research participants in the consent process
- NOTE: The IRB will decide whether the possibility of bias is sufficient to justify disclosure of FCOI to potential human subjects
- Changes to informed consent documents: Any FCOIs will be clearly and simply stated in the consent documents
- NOTE: The IRB will decide whether the possibility of bias is sufficient to justify disclosure of FCOI in the informed consent process
- Oversight and monitoring of research and decisions by a DSMB or non-conflicted member of the research team: Name person(s), clearly state responsibilities and decision making powers, provide documentation of agreement
- Severance of relationships that create actual or potential FCOIs
Part V: Reporting to NIH
NIH will be notified within 30 days if bias is found with the design, conduct, or reporting of research and will include a Mitigation Report outlining the management plan. Initial, annual (ongoing), and revised FCOI reports will be submitted to NIH (via eRA Commons):
- Prior to expenditure of funds
- Within 60 days of identification for an Investigator who is new to the project
- Within 60 days for new, or newly identified, FCOIs for existing Investigators
- At least annually (in conjunction with annual progress reports or at the time of an extension)
- Following a retrospective review to update a previously submitted report
NIH will be notified within 30 days if an Investigator fails to comply with this policy or if the FCOI management plan appears to have biased the design, conduct, or reporting of research.
Compliance with Pro-Change’s FCOI policy for PHS research is a condition of employment with Pro- Change. See employee handbook for more information.
Per NIH, within 120 days of Pro-Change determining noncompliance, Pro-Change will complete a retrospective review of the Investigator’s activities and the NIH-funded research project to determine if there was bias in the design, conduct, or reporting of research. Pro-Change is required to document the retrospective review.
Part VI: Maintenance of Records
All FCOI records (disclosures, management plans, retrospective reviews) will be held for three years after the final report is submitted to NIH.
Part VII: External Agencies and Sub-Awards
Before grant application is made, all collaborators/subcontractors must:
- Provide Pro-Change with documentation of their institution’s COI policy and written intent to abide by that policy, and disclosure of any COIs, or
- Sign a disclosure of any FCOIs and a statement that they will abide by Pro-Change’s COI policy
Part VIII: Public Accessibility
Pro-Change’s FCOI policy will be publicly available on prochange.com by August 24, 2012.
In the event that FCOIs are identified, information regarding the COI and the Investigator will also be publicly available on prochange.com. Publicly available information will be:
- Updated annually
- Updated within 60 days of newly identified FCOIs
- Remain available for 3 years from the most recent update.
Information to be made publically available is to include, but is not limited to:
- Investigators name
- Investigators title and role with respect to the research project
- Name of the entity in which the SFI is held
- Nature of the SFI
- Approximate dollar value of SFI (or a statement that the interest of one whose values cannot be readily determined)
1 This policy does not pertain to SBIR/STTR Phase I funding.