Objectivity in Research Policy
This policy addresses NCQA’s responsibility for ensuring objectivity in research in accordance with 42 CFR Part 50, Subpart F “Promoting Objectivity in Research,” and 45 CFR Part 94, “Responsible Prospective Contractors.”
Regulations promulgated by the U.S. Department of Health and Human Services require institutions that apply for or receive funding from the Public Health Service (PHS) and its components,¹ to adopt a financial conflict of interest policy and comply with certain reporting obligations as described below. Any terms used but not defined in this Policy shall have the meanings described in 42 C.F.R. Parts 50 and 94.
“Financial conflict of interest (FCOI)” means a significant financial interest determined in accordance with this Policy that could directly and significantly affect the design, conduct or reporting of sponsored research.
“Financial interest” means anything of monetary value, whether or not the value is readily ascertainable.
“Institution of higher education” has the meaning defined in 20 U.S.C. §1001(a) and includes a public or other nonprofit education institution that is legally authorized by a State to provide a program of education beyond secondary education and is accredited by a nationally recognized accrediting agency or association.
“Investigator” means the project director, principal investigator and any other person, regardless of title or position, who is planning to participate in, or is participating in, the sponsored research and is responsible for the design, conduct or reporting of the sponsored research. Investigators include NCQA’s employees and external subrecipients, collaborators and consultants that are relying on NCQA’s Objectivity in Research Policy for the sponsored research.
“Key personnel” means the project director or principal investigator and any other person identified as senior or key personnel in the proposal, application, progress report or other report submitted by NCQA for the sponsored research.
“Significant financial interest” means a financial interest that is reportable in accordance with this Policy and reasonably related to investigator’s professional responsibilities on behalf of NCQA, including an investigator’s research, teaching, education and consultative services.
“Sponsored research” means a research project funded under contract, grant or cooperative agreement by PHS and for which NCQA is the awardee institution or subrecipient.
“Sponsor” means the organizational unit of PHS that funds the sponsored research.
Policy Effective Date
This policy is effective for all sponsored research with an issue or effective date that is on or after August 24, 2012.
Reporting Significant Financial Interests
All NCQA investigators are required to disclose significant financial interests in accordance with this Policy. Disclosure must include the investigator’s personal financial interests and those of his/her immediate family members.
- Publicly Traded-Entities: A significant financial interest exists and must be disclosed if the value of any salary or other payments for services (e.g., consulting fees, honoraria or paid authorship) received from the publicly traded entity in the 12-months preceding the disclosure, or anticipated over the next consecutive 12-months, and the fair market value of any equity interest in the publicly traded entity (e.g., stock, stock option or other ownership interest), when aggregated exceeds $5,000.
- Non-Public and Private Entities: A significant financial interest exists and must be disclosed if the value of any salary or other payments for services (e.g., consulting fees, honoraria or paid authorship) received from the private entity in the 12-months preceding the disclosure, or anticipated over the next consecutive 12-months, when aggregated exceeds $5,000. In addition, any equity interest in the private entity (e.g., stock, stock option or other ownership interest) must be reported, regardless of the monetary value.
- Intellectual Property: A significant financial interest exists and must be disclosed upon receipt of any income, regardless of monetary value, related to intellectual property rights and interests (e.g.,patents, copyrights and royalties), unless the income is subject to an exclusion below (e.g., income received from NCQA). An investigator must report income received from a license of intellectual property rights during the 12-months preceding the disclosure, or anticipated over the next consecutive 12-months if it is not subject to exclusion below.
- Sponsored Travel Payments: A significant financial interest exists and must be reported for the occurrence of any sponsored travel in the 12-months preceding the disclosure, or anticipated over the next consecutive 12-months. Sponsored travel are travel expenses that are paid for on behalf of the investigator related to his/her professional responsibilities on behalf of NCQA, but are not reimbursed to the investigator or NCQA so that the exact monetary value may not be readily available. Travel expenses that are reimbursed or sponsored by a Federal, State or local government agency, an academic teaching hospital or medical center, an institution of higher education, or a research institute affiliated with an institution of higher education are excluded from reporting.
A “significant financial interest” does not include: salary or other payments from NCQA to the investigator; intellectual property rights assigned to NCQA; income from seminars or teaching engagements sponsored by a Federal, State or local government agency, an academic teaching hospital or medical center, or an institution of higher education; income from service on an advisory committee or review panel for a Federal, State or local government agency, an academic teaching hospital or medical center, an institution of higher education, or a research institute affiliated with an institution of higher education ; and income from investment vehicles that the investigator does not directly control the investment decisions (e.g., mutual funds and retirement accounts).
If an investigator is in doubt about the applicability of this Policy to a financial or other interest, the investigator should disclose the interest for review by the Office of General Counsel.
The Disclosure Process
Each investigator must file with the Office of General Counsel an Objectivity in the Research Questionnaire to identify any significant financial interest as defined in this Policy. The Office of General Counsel will distribute the Questionnaire on an annual basis to collect information on any significant financial interest related to sponsored research that is ongoing or anticipated at that time. In addition to this annual disclosure, investigators must disclose upon the following occurrences:
- New Sponsored Research: For new sponsored research not ongoing or anticipated at the time of the annual disclosure, all investigators must update the Questionnaire for any previously undisclosed significant financial interest prior to submission of the proposal or application to request funding.
- New Investigators: For investigators new to NCQA, or new to the sponsored research, as soon as the investigator is identified as a potential investigator for the sponsored research and prior to the investigator’s participation in the sponsored research.
- New Significant Financial Interest: For all investigators, within thirty (30) days of acquiring or discovering a new significant financial interest not previously reported. A new financial interest may be acquired by purchase, transfer, marriage or inheritance.
If the information provided on the Questionnaire indicates a potential financial conflict of interest related to a sponsored research activity, then the Office of General Counsel may require the investigator to provide additional information. This additional information may include a proposed plan for managing a financial conflict of interest, if appropriate.
The Review Process
The Office of General Counsel will collect and maintain the Objectivity in Research Questionnaires and any required follow-up information from each investigator. The Office of General Counsel will review each Questionnaire to assess its significance and potential effect on the objectivity of sponsored research and the design, conduct or reporting of the sponsored research activity.
- Determination of a FCOI: The General Counsel or her designee will be responsible for the determination of whether a disclosed significant financial interest constitutes a FCOI, and, if so, will oversee the development and implementation of a management plan as described in this Policy. The General Counsel or her designee will complete review and make a determination within sixty (60) days after receipt of the investigator’s disclosures and prior to any expenditure of funds for the sponsored research affected by the FCOI.
- Retrospective Review: If the Office of General Counsel becomes aware of a significant financial interest that was not timely disclosed by an investigator, for whatever reason, and was not previously reviewed after the expenditure of funds for a sponsored research project that is potentially affected by the newly discovered significant financial interest, the General Counsel, or her designee, shall complete a review as soon as possible but no later than sixty (60) days after discovery. If it is determined that the significant financial interest constitutes a FCOI then a retrospective review of the investigator’s activities and the affected sponsored research project will be completed no later than 120 days after discovery to determine if the sponsored research, or any portion of the project, was biased in the design, conduct or reporting due to the FCOI. The Office of General Counsel will prepare and submit a mitigation report and all required subsequent reports to the Sponsor.
Investigators will cooperate in good faith with the Office of General Counsel to provide the necessary information needed to ensure timely review and reporting, if required, to the Sponsor.
The Management Plan
A management plan, if required, will be developed by the Office of General Counsel in coordination with the Vice President of Research and, in appropriate situations, the principal investigator for the sponsored research. The investigator, at the discretion of the Office of General Counsel, may be required to submit a plan to manage the FCOI. The Office of General Counsel, in consultation with the Vice President of Research, will decide whether to accept the plan and/or allow the investigator to continue participating in the sponsored research project. If the Vice President of Research is the investigator with a FCOI, then the Office of General Counsel will coordinate with another qualified staff member with appropriate expertise, and determined by the Office of the General Counsel to be free of any real or apparent personal, professional or financial conflicts of interest to evaluate the FCOI.
A management plan will specify actions taken by NCQA to eliminate, reduce and/or manage the FCOI, and may include, by way of example only: disclosure of the FCOI as part of all public presentations and publications relating to the sponsored research and the research results; disclosure as part of the IRB submission and all communications to prospective research subjects; modification of the research plan; monitoring of the sponsored research by the Office of General Counsel or its designee to protect the objectivity of the design, conduct and reporting of the research; change of personnel or roles and responsibilities for the sponsored research; or sale or divesture by the investigator of the significant financial interest that gave rise to the FCOI. Additional investigator responsibilities and obligations, including periodic reporting, may be included as part of the management plan. Investigators must comply with all elements and conditions of their management plan and may be required to provide documentation of compliance to all or some elements, such as in the case of sale or divesture of an FCOI.
Failure to Comply
If an Investigator fails to comply with this Policy or any management plan implemented under this Policy, the Office of General Counsel shall perform a retrospective review of the research as promptly as possible but in no event more than 120 days after discovery of the non-compliance. If the review concludes that the sponsored research, or any portion of the project, was biased in the design, conduct or reporting of such research as a result of the non-compliance then the Office of General Counsel will develop and implement a corrective action plan that includes, without limitation, prompt notification to the Sponsor with a mitigation report that includes a description of the FCOI and impact on the research.
The mitigation report will also include the project number and title, the name of the principal investigator or project director and the investigator with the FCOI, the name of the entity that is the subject of the FCOI, a description of the methods used for the review including documents reviewed, the findings and conclusions of the review, and details of all corrective actions. NCQA will provide updated reports to the Sponsor during the duration of the research as appropriate, but not less than on an annual basis in accordance with applicable law and policy of the Sponsor. NCQA will adopt and implement any conditions or requirements of the Sponsor for continuation of the sponsored research to maintain the objectivity of the research.
Notice to Sponsor
NCQA will report to a Sponsor any identified FCOIs prior to expending any funds under the sponsored research project. If NCQA identifies a FCOI and eliminates it prior to the expenditure of any funds, NCQA is not required to submit a FCOI report to the Sponsor.
If NCQA identifies a FCOI subsequent to the expenditure of funds for the sponsored research, NCQA will file an FCOI report with Sponsor within sixty (60) days of the identification of the FCOI, along with a mitigation report prepared as described in this Policy, and will submit updated reports to the Sponsor during the duration of the research as appropriate, but not less than on an annual basis in accordance with applicable law and policy of the Sponsor.
NCQA shall ensure public accessibility to information regarding this Policy and all FCOIs held by key personnel for sponsored research by posting on its public Website, www.ncqa.org. NCQA will post the current version of the Policy and information regarding FCOIs, which will include, without limitation, the name of the investigator and title and role with respect to the research, the name of the entity, the nature and value of the FCOI, or, if value cannot be readily determined a statement to that effect.
The information will be updated within sixty (60) days of NCQA’s revision to the Policy and/or identification of a reportable FCOI. NCQA will also post if there are no FCOIs to report and will update this information as appropriate, but not less frequently than on an annual basis. Information of reportable FCOIs will remain posted for at least three (3) years from the date that the information was most recently posted on the web site.
The Office of General Counsel will provide a training program to inform investigators about NCQA’s Policy and the Federal regulations noted above and the investigator’s responsibilities regarding disclosure of significant financial interests. All investigators are required to complete initial training within 60 days of starting employment with, or being engaged under agreement by, NCQA or immediately upon announcement of a change in the Policy.
All investigators are also required to complete a refresher training program no less frequently then every four years. Investigators that fail to complete the required refresher training will not be permitted to participate in sponsored research. If an investigator is found not to be in compliance with this Policy, the investigator must immediately complete refresher training as part of a management plan prior to being permitted to engage in sponsored research.
Maintenance of Records
The Office of General Counsel will maintain and retain all information, records and reports collected and prepared under this Policy for at least three (3) years from the date of the final expenditure reports for the applicable sponsored research project, or longer as required by the applicable law or policy of the Sponsor.
¹Components of PHS include National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the Health Resources and Services Administration (HRSA), the Substance Abuse and Mental Health Services Administration (SAMHSA), the Food and Drug Administration (FDA), and the Agency for Healthcare Research and Quality (AHRQ).