JCVI POLICY: Promoting Objectivity in Research under Public Health Service Regulations

Effective Date: August 24, 2012

1. Introduction.
   
   The National Institutes of Health (NIH) and other Public Health Service (PHS) agency funding represents the largest source of research funding at JCVI. The PHS has issued financial conflict of interest regulations that have unique financial conflict of interest reporting and conflict management provisions. This Policy is for the purpose of ensuring JCVI compliance with these important regulations. All investigators (as defined in Section III below) applying for funds from the NIH or other PHS agencies are required to comply with this Policy. The PHS agencies include: National Institutes of Health (NIH), 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).
2. Purpose and Scope.
   
   This Policy is implemented to comply with the 2011 PHS regulations on Promoting Objectivity in Research. It is applicable to all PHS Research Activities with an award issue date of August 24, 2012 or later, and to proposals for research activities submitted to PHS on or after August 24, 2012. PHS Research Activities that are ongoing as of August 24, 2012, will become subject to this policy as additional funds are requested through submission of a progress report, competing renewal application, proposal for supplemental funding, or through approval of a no cost time extension. This Policy applies to the Principal Investigator (PI) and all other Investigators (regardless of position or title) who are responsible for the design, conduct, or reporting of a PHS Research Activity.
   
   The Policy is applicable to all research activities supported by PHS and by other sponsors and programs that specifically request review consistent with the PHS regulations on objectivity in research. This Policy complements and augments the JCVI Policy on Conflicts of Interest — Employees.
3. Definitions
   
   For purposes of this Policy, the following terms shall apply:
   
   Conflict of Interest Review Committee (CIRC): A JCVI committee charged with determining if Significant Financial Interests (SFI) that are related to the proposed research constitute financial conflicts of interest. The CIRC is appointed by the President.
   
   Designated Official(s): JCVI official(s) designated to solicit and conduct review of disclosures of SFI from each Investigator who is planning to participate in, or is participating in a PHS Research Activity.
   
   Financial Conflict(s) of Interest (FCOI): A SFI that could directly and significantly affect the design, conduct, or reporting of a PHS Research Activity.
   
   Institutional Responsibilities: Teaching/education, research, outreach and public service on behalf of JCVI which are in the course and scope of the Investigator’s JCVI appointment/employment.
   
   Principal Investigator (PI): An Investigator (normally a faculty member) who has primary responsibility for the scientific and technical conduct, reporting, fiscal and programmatic administration of a sponsored project.
   
   Investigator: Any individual who shares responsibility for the design, conduct, or reporting of the results of a sponsored project with the PI. This includes, but is not limited to, Key Personnel named on a proposal budget.
   
   Key Personnel: A PHS research Project Director, PI, and any other personnel considered essential to work performance and identified as Key Personnel in the contract or grant proposal.
   
   PHS Research Activity(ies): Any award for which research funding is available from PHS including research contracts, research grants, career development awards, center grants, individual fellowship awards, infrastructure awards, institutional training grants, program projects or research resources awards, and conference grants. Only Phase I Small Business Innovative Research (SBIR) and Small Business Technology Transfer Research (STIR) awards programs are excluded.
   
   Significant Financial Interest (SFI): Anything of monetary value that meets the PHS thresholds for reporting received by the Investigator (including the Investigator’s spouse or registered domestic partner, and dependent children for the following categories except travel) that reasonably appears to be related to or is in the same field of expertise as the Investigator’s Institutional Responsibilities. Examples of SFI include:
   • Stock or stock options in a company that is developing, manufacturing, or selling products or providing services used in an Investigator’s research, teaching, administrative or committee responsibilities.
   • Receipt of Income from any organization other than JCVI for use or sale of patented or copyrighted intellectual property, such as software, textbooks, or other scholarly works for which royalties or licensing fees are received, including income from prior employers and other independent research institutes.
   • Travel reimbursements made to, or on behalf of, the Investigator, regardless of the amount, by a for-profit or nonprofit entity, excluding a state, federal, or local government, a U.S. institution of higher education or an affiliated medical center/hospital or research institute.
   • Income or honoraria received for activities such as:
     • Providing expert testimony or consulting services
     • Serving on a board of directors, scientific advisory board, committee, panel or commission sponsored by a for-profit or non-profit organization, including professional or scholarly societies;
     • Acting in an editorial capacity for a professional journal, reviewing journal manuscripts, book manuscripts, or grant or contract proposals for a non-profit or for-profit organization; or
     • Salary received outside of JCVI.
4. Statement on Mandatory Training and Disclosures
   
   The PHS regulations on Objectivity in Research (revised in August 2011) are designed to promote objectivity by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of PHS Research Activities will be free from bias resulting from any Investigator’s Financial Conflicts of Interest (FCOI). The NIH Office of Extramural Research Conflict of Interest Website contains helpful information and resources about the FCOI Regulations. See http://grants.nih.gov/grants/policy/coi/coi_faqs.htm . JCVI, through this policy and its enforcement, ensures that:
   1. Investigators complete a training/education program on FCOI, the responsibilities to disclose, and the PHS regulations:
      1. Before engaging in PHS Research Activities and at least every four (4) years thereafter while receiving PHS research funding, and
      2. Whenever an Investigator is not in compliance with this Policy or has failed to comply with a plan put in place to manage or mitigate a FCOI.
   2. Investigators disclose SFI at the following times:
      1. Initial disclosures must be made by all Investigators planning to participate on a proposed PHS Research Activity before the application for funding is submitted.
      2. JCVI Investigators who are engaged in PHS Research Activities have an ongoing responsibility to update their disclosures throughout the period of PHS support:
         • 1. Within thirty (30) days of acquiring or discovering any new SFI and
           2. At least annually
      3. New Investigators must complete a disclosure of SFI before joining an ongoing PHS Research Activity.
   3. Investigators disclose to JCVI all SFI that meet the following PHS thresholds:
      1. From a publicly traded entity: income or other payment for services including salary, and any payment for services not otherwise identified as salary, including but not limited to, consulting payments, honoraria, paid authorship, or any other payments or consideration of value, including payments made to a health sciences compensation plan, received during the prior twelve (12) months and the value of any equity interest (including stock, stock options, or other ownership interests, as determined by public prices or other reasonable measure of fair market value) in the entity as of the date of disclosure, which, when aggregated exceeds $5,000.
         
         Investigators are not required to disclose SFI in mutual funds or other investment vehicles such as retirement provided the Investigator does not directly control the investment decisions made for these investment vehicles.
      2. From a non-publicly traded entity: Income or other payment for services including salary, and any payment for services not otherwise identified as salary, including but not limited to, consulting payments, honoraria, paid authorship, any other payments or consideration of value, including payments to a health sciences compensation plan, received during the prior twelve (12) months that exceeds $5,000, or any equity interest, including but not limited to stock, stock options, or ownership interest in the entity.
         
         Investigators are not required to disclose (a) payments made by JCVI, including salary, stipends, royalty payments, honoraria, reimbursement of expenses, or any other remuneration from JCVI; or (b) income for seminars, lectures, teaching engagements, or service on advisory committees or review panels sponsored by federal, state, or local governments, a U.S. institution of higher education, or a research institution, academic medical center, or hospital that is affiliated with an institution of higher education.
      3. Intellectual property rights and interests: Income from each organization that exceeds $5,000 during the twelve (12) months preceding disclosure of such rights and interests. However, SFIs do not include any royalties received from JCVI related to patents or copyrights.
      4. Travel:Reimbursements of any amount received during the prior twelve (12) months made to, or the value of travel paid on behalf of, the Investigator by a for-profit or non-profit organization.
         
         Investigators are not required to disclose travel that is reimbursed or sponsored by federal, state, or local governments, a U.S. institution of higher education, or a research institution, academic medical center, or hospital that is affiliated with an institution of higher education.
5. Disclosures by Collaborators/Subrecipients
   1. Collaborators from other institutions who share responsibility for the design, conduct, or reporting of research results, and who will be conducting research under a subaward from JCVI are expected to comply with the policies and procedures of the organization at which they are employed. Subawards issued by JCVI will indicate that the subrecipient organization is responsible for reviewing SFI disclosures and, if FCOI are identified, for sending JCVI notification of their ability to manage, reduce, or eliminate the identified conflicts, in accordance with PHS reporting requirements.
   2. Collaborators who share responsibility for the design, conduct, or reporting of research results and who will participate in research under an independent consulting agreement issued by JCVI should be identified as Investigators by the JCVI PI and must complete the JCVI disclosure forms. If, upon review, JCVI determines that the disclosed SFIs could directly and significantly affect the design, conduct, or reporting of the research to be performed under the agreement, these collaborators will be expected to adhere to the mitigation plans put in place to eliminate, reduce, or manage the identified conflicts of interest.
6. Management of Financial Conflicts of Interest
   1. JCVI will identify a designated institutional official(s) to review all PHS Disclosure forms and determine whether an Investigator’s SFI is related to PHS-funded research and, if so related, whether the SFI is a FCOI. (The designated institutional official(s) may include a committee (the CIRC) to assist with these determinations). With each PHS proposal, progress report, incremental funding, or extension, all Investigators who have disclosed any SFI will be asked to provide additional information about the SFI they previously have disclosed. This information will be used by JCVI to conduct a preliminary review in order reasonably to determine whether any or any Investigator’s SFI:
      1. Could be affected by the PHS Research Activity; or
      2. Is in an entity whose financial interest could be affected by the research.
   2. The following are examples of when an Investigator would be deemed to have a financial conflict of interest (FCOI):
      1. If the Investigator (either alone or together with the Investigator’s spouse or domestic partner and dependent children) has a SFI in an entity that could be affected by the research results from a proposed PHS-funded contract based on any analysis of the scope and subject matter of the proposed project described in the application, or
      2. The Investigator (either alone or together with the Investigator’s spouse or domestic partner and dependent children) has a SFI in an entity that licenses technology from JCVI which has resulted in license income and that technology is the subject of a proposed PHS-funded award.
   3. If, after review, it is determined that an SFI is related to the proposed PHS Research Activity, there will be a second review conducted by the CIRC or a Designated Official to determine whether the SFI(s) reasonably appears directly and significantly to affect the design, conduct or reporting of the PHS Research Activity and, thereby, constitute a FCOI that may need to be eliminated, reduced, or managed. All cases involving the disclosure of SFI having a value greater than $10,000 shall be receive a second review.
      
      In making this determination, the designated institutional official(s) may consult with all appropriate institutional and governmental officials.
   4. In accordance with the PHS regulations, plans put into place to manage identified FCOI will be monitored for compliance until the completion of the PHS’s Research Activity. Each management plan will specify the way in which that will be accomplished.
   5. Examples of conditions or restrictions that might be imposed to manage FCOIs include, but are not limited to:
      1. Public disclosure of SFIs:
      2. Appointment of independent monitor(s) capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the FCOI;
      3. Modification of the research plan;
      4. Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;
      5. Severance of relationships that create financial conflicts.
7. Reporting Financial Conflicts of Interest to PHS
   1. Initial reports of FCOI must be made to PHS prior to JCVI’s expenditure of any funds provided under a PHS Research Activity. When identified conflicts of interest are eliminated before research funds are expended, JCVI is not required to submit a report to PHS.
   2. Additional FCOI reports, including any management plans implemented, must be submitted to PHS under the following circumstances:
      1. Throughout the lifetime of an award when progress reports are submitted, or at the time that an award is extended, either through extension notification or an NIH prior approval request. When during the course of an ongoing PHS Research Activity’s FCOI ceases to exist, updated information about the status of that FCOI should be provided with the subsequent progress report.
      2. Within sixty (60) days of determining that a FCOI exists based on disclosure of a newly acquired SFI by an Investigator during the course of an ongoing PHS Research Activity.
      3. Within sixty (60) days of determining that a FCOI exists for an Investigator who joins an ongoing PHS Research Activity.
   3. When during the course of an ongoing PHS Research Activity, JCVI identifies an SFI that was not disclosed in a timely manner for an Investigator, or which was not previously reviewed, the Designated Official will review the SFI within sixty (60) days to determine whether it is related to PHS Research Activities and whether a FCOI exists. If a FCOI is identified after such a review, a management plan must be implemented, at least on an interim basis.
   4. Whenever a FCOI is not identified or managed in a timely manner, regardless of whether the Investigator did not disclose a SFI that was later determined to be a FCOI, or JCVI’s failure to review or manage the FCOI, or because the Investigator failed to comply with a previously implemented management plan, JCVI must, within one hundred twenty (120) days of the determination of noncompliance, complete a retrospective review of the Investigator’s activities and the PHS Research Activities. The purpose of this retrospective review is to determine if the ongoing PHS Research Activity was biased in its design, conduct or reporting.
      1. Based on the results of the retrospective review, the previously submitted FCOI report must be updated to specify the actions that JCVI will take to manage the identified FCOI.
      2. If bias was found during the retrospective review, JCVI promptly will notify PHS and will draft a mitigation report that, at a minimum, documents the key elements of the retrospective review, describes the impact of the bias on the research, and outlines JCVI’s plans to eliminate or mitigate the effect of the bias.
8. Records Access and Retention.
   1. JCVI is required to respond within five (5) business days to any request for information about SFIs held by Key Personnel when JCVI has determined that the disclosed SFIs are related to PHS Research Activities and constitute FCOIs.
   2. Records of financial disclosures, Designated Official’s determination, CIRC recommendations, and JCVI action regarding management of a conflict of interest will be retained for at least three (3) years beyond the date of submission of the award’s final expenditure report, or until the resolution of any actions by PHS involving the records, whichever is longer. Records relating to unfunded projects need not be retained.
9. Enforcement and Sanctions
   
   All persons subject to this Policy are expected to comply with it fully and promptly. Failure by an individual to file a complete and truthful financial disclosure for pending proposals or when a new interest is obtained, or failure to comply with the conditions or restrictions directed or imposed, including failure to cooperate with appointed project monitoring bodies, will be grounds for disciplinary or other appropriate action. Agreements with consultants who either fail to file a complete disclosure or fail to comply with any conditions or restrictions imposed may be terminated for cause. Similarly, agreements with subrecipient organizations may be terminated for cause if that organization fails to comply with its obligations under the PHS regulations. In addition, federal regulations may require reports to the federal sponsor of any violations of federal regulations and JCVI policy.
10. References Public Health Service (PHS) “Objectivity in Research,” Code of Federal Regulations (42 CFR Part 50, Subpart F and 45 CFR Part 94), August 25, 2011. See: http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf.