- Required Compliance/Implementation Date
An Institution applying for or receiving PHS funding from a grant or cooperative agreement must be in compliance with all of the revised regulatory requirements no later than 365 days after publication of the regulation in the Federal Register, i.e., August 24, 2012, and immediately upon making the Institution’s Financial Conflict of Interest policy publicly accessible as described in 42 CFR part 50.604(a).When the Institution posts its Financial Conflict of Interest policy (or, if the institution does not have a current presence on a publicly accessible Web site, makes the policy publicly accessible by written request), it signifies that the Institution applying for or receiving PHS funding from a grant or cooperative agreement that is covered by the 2011 revised regulation is in full compliance with all the regulatory requirements. The Institution must be in compliance with the 2011 revised regulation no later than August 24, 2012.
- Applicability of Revised FCOI Regulations (Institutions)
The regulation is applicable to each Institution that is applying for, or that receives, PHS research funding by means of a grant or cooperative agreement.The revised regulation will apply to each grant or cooperative agreement with an issue date of the Notice of Award that is subsequent to the compliance dates of the final rule (including noncompeting continuations) no later than August 24, 2012 and immediately upon making its Financial Conflict of Interest policy publicly accessible. Through their policies, however, Institutions may choose to apply the revised regulations to all active PHS awards. The regulation does not apply to Phase I Small Business Innovative Research (SBIR) Small Business Technology Transfer Research (STTR) applications.
- Applicability of Revised FCOI Regulations (Investigators)
The regulation is applicable to each investigator, through implementation of the regulation by the Institution, who is planning to participate in, or is participating in PHS research funded by means of a grant or cooperative agreement. The term investigator applies to the individual identified as the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such fundingand may apply to faculty, post-doctoral fellows and graduate students. For purposes of financial disclosure only, the regulation covers the Investigator’s spouse and dependent children. The regulation also applies to those few cases where an individual, rather than an Institution, is applying for or receives PHS research funding. However, in those cases, the PHS will make case-by-case determinations on the steps an Institution or an Investigator must take, consistent with the regulation, to provide a reasonable expectation that the design, conduct, and reporting of the research will be free from bias resulting from a Financial Conflict of Interest of the individual.
- Applicability of Revised FCOI Regulation (Subreceipients)
The revised regulation is applicable to each Institution that applies for or receives PHS funding for research through grants or cooperative agreements and, through the implementation of the regulation by each Institution, to each Investigator planning to participate in, or participating in, such research. A subrecipient relationship is established when federal funds flow down from or through an awardee Institution to another individual or entity and the subrecipient will be conducting a substantive portion of the PHS-funded research project and is accountable to the awardee institution for programmatic outcomes and compliance matters. Accordingly, as a recipient of federal funds from an awardee Institution, the Financial Conflict of Interest regulation applies to subrecipients (e.g., subcontractors or consortium members). See 42 CFR 50.604 (c).The awardee Institution must determine if the Conflict of Interest policy of the awardee Institution or the Subrecipient will apply to the Subrecipient’s investigator(s) and incorporate language into the written agreement that designates the applicable Conflict of Interest policy.
- Organizational Structure/Designated Official
An Institution may administer its policy through whichever office or structure it chooses as long as the policy is applicable to all Investigators and the policy meets all requirements of the regulation. Each institution must designate official(s) to review all financial disclosures by Investigators and determine whether any Significant Financial Interest is related to a PHS-funded research and a Financial Conflict of Interests exists by making a reasonable determination that the Significant Financial Interest could be affected by the PHS-funded research or is in an entity whose financial interest could be affected by the research.
- Required Training
Institutions are expected to develop and implement their Financial Conflict of Interest policies during the 365-day implementation period provided in the 2011 revised regulation. Once the Institution implements and posts their Financial Conflict of Interest policy as required under the final rule, Investigators are expected to then complete required training prior to engaging in PHS-supported research or by the issue date of the Notice of Award issued subsequent to the Institution’s implementation date. NIH has issued a Conflict of Interest tutorial that can be incorporated into campus training programs, which can be accessed from the URL cited at the beginning of section I of the Guidelines.Each Investigator (as defined by the regulation), including subrecipient Investigator(s), must complete training prior to engaging in PHS-funded research and at least every four years, and immediately under specifically designated circumstances:
- Institutional Financial Conflict of Interest policies change in a manner that affects Investigator requirements
- An Investigator is new to an Institution
- An Institution finds that an Investigator is not in compliance with the Institution’s Financial Conflict of Interest policy or management plan.
- Institutional responsibilities:
- Under the revised FCOI regulation, Significant Financial Interests that are subject to disclosure by an Investigator to an Institution are those that reasonably appear to be related to the Investigator’s ‘‘Institutional responsibilities,” as defined by the Institution. As a result, when read in conjunction with the revised Investigator disclosure requirements under 42 CFR 50.604, the revised Significant Financial Interest definition results in the disclosure by Investigators to Institutions of a wider array of interests on a more frequent basis. In addition to their own, Investigators are required to disclose the Significant Financial Interests of his/her spouse and dependent children.
- Monetary threshold:
- The Significant Financial Interest de minimis threshold is $5,000 and, in some circumstances monetary thresholds for disclosure may be $0.
- The definition also differentiates between remuneration to the Investigator (and the Investigator’s spouse and dependent children) from a publicly traded entity and remuneration from a non-publicly traded entity. With regard to a publicly traded entity, a monetary threshold of $5,000 applies to the aggregated amount of any remuneration received from the entity in the twelve months preceding disclosure and the value of any equity interest as of the date of disclosure. With regard to a non-publicly traded entity, a Significant Financial Interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest).
- The revised Significant Financial Interest definition applies to any remuneration received from an entity in the twelve months preceding the disclosure. Any Investigator who is planning to participate in PHS-funded research must disclose the Investigator’s Significant Financial Interests no later than the time of application for PHS-funded research.In addition, each such investigator must submit an updated disclosure or Significant Financial Interests within thirty days of discovering or acquiring (such as through purchase, marriage, or inheritance) a new Significant Financial Interest.
- Reimbursed or Sponsored Travel:
- Investigators must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to the Investigator’s institutional responsibilities. However, the disclosure requirement does not apply to travel that is reimbursed or sponsored by the following:
- a federal, state, or local government agency,
- an Institution of higher education as defined at 20 U.S.C. 1001(a),
- an academic teaching hospital,
- a medical center, or
- a research institute that is affiliated with an Institution of higher education.
- The revised regulation modifies the types of interests that are specifically excluded from the Significant Financial Interest definition.
The exclusions are:
- salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution;
- intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights
- any ownership interests in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization
- income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles;
- income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an Institution of higher education as defined in 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education;
- income from service on advisory committees or review panels for a federal, state, or local government agency, or an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.
- Paid Authorships:
- Paid authorships are considered payment for services under the revised regulations and must be disclosed.
- Consequences of Investigator Non-Compliance
- When an Investigator fails to comply with the Institution’s Financial Conflict of Interest policy or the management plan, the Institution shall within 120 days:
- complete a retrospective review of the Investigator’s activities and the PHS-funded research project to determine any bias in the design, conduct or reporting of research;
- document the retrospective review consistent with the regulation; and
- document the Institution’s determination as to whether any PHS-funded research, or portion thereof, conducted during the period of time of the Investigator’s non-compliance with the Institution’s Financial Conflict of Interest policy or a Financial Conflict of Interest management plan, was biased in the design, conduct, or reporting of such research.
- If bias is found, the Institution shall notify the PHS promptly and submit a mitigation report to the PHS that shall address the following:
- impact of the bias on the research project and
- the Institution’s plan of action or actions taken to eliminate or mitigate the effect of the bias.
- Thereafter, the Institution shall submit FCOI reports annually, in accordance with the regulation. Depending on the nature of the Financial Conflict of Interest, an Institution may determine that additional interim measures are necessary with regard to the Investigator’s participation in the PHS-funded research project between the date that the Financial Conflict of Interest is identified and the completion of the Institution’s independent retrospective review, in accordance with 42 CFR 50.605(a)(3) and 42 CFR 50.605(b)(3).
- Clinical Research to Evaluate the Safety or Effectiveness of Drug, Medical Device or Treatment
The revised regulations contain special provisions for Clinical Research.If the HHS determines that an PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a conflicting interest that was not managed or reported by the Institution as required by the regulation, the Institution must require the Investigator(s) involved to disclose the Financial Conflict of Interest in each public presentation of the results of the research and to request an addendum to previously published presentations. Institution’s Financial Conflict of Interest policy may have additional requirements.
- Institutional Reporting of Identified Financial Conflicts of Interest to PHS
Prior to the institution’s expenditure of any funds under a PHS-funded research project, the institution shall provide to the PHS awarding component any Investigator’s significant financial interest found by the Institution to be conflicting and ensure that the institution has implemented a management plan in accordance with the revised regulations. Further, the Institution will provide annual FCOI reports for the duration of the project period.Any FCOI report required under the revised regulations shall include, at a minimum, the following information:
- PHS-Funded Research Project Number
- Name of the Principal Investigator
- Name of the Investigator with the financial conflict of interest
- Name of the entity with which the Investigator has a financial conflict of interest
- Nature of the financial interest
- Value of the financial interest, or a statement if the interest is one whose value cannot be readily determined through to public prices or other reasonable measures of fair market value
- Description of how the financial interest relates to the PHS-funded research and the basis for the Institution’s determination that the financial interest conflicts with the research
- Description of key elements of the Institution’s management plan, including:
- Role and principal duties of the conflicted Investigator in the research project
- Conditions of the management plan
- How the management plan is designed to safeguard objectivity in the research project
- Confirmation of the Investigator’s agreement to the management plan
- How the management plan will be monitored
- Other information as needed
- Public Accessibility of Identified Financial Conflicts of Interest
Prior to the expenditure of PHS funds on or after August 24, 2012, the institution must ensure public accessibility (via publically-available website or response to written request within five (5) business days of the request) of information concerning significant financial interests disclosed to the institution that are:
- Previously disclosed and currently held by Investigators or Senior/Key Personnel;
- The significant financial interest is related to PHS-funded research; and
- The institution has determined the significant financial interest is a financial conflict of interest
The information the Institution must make publically-available must be updated at least annually, must be maintained for a period of three years from the last update, and must include the following data elements at a minimum:
- Investigator Name
- Investigator Title
- Investigator role with respect to the research project
- Name of the entity in which the significant financial interest is held
- Nature of the significant financial interest
- Approximate dollar value of the significant financial interest, or a statement if the interest is one whose value cannot be readily determined through to public prices or other reasonable measures of fair market value.