Policies and Procedures; Corporate
This policy is in effect for Children’s Hospital of The King’s Daughters Health System (CHKDHS) to include the following subsidiaries: Children’s Hospital of The King’s Daughters, Incorporated (CHKD), Children’s Medical Group, Inc. and CMG of North Carolina, Inc. (together, CMG), Children’s Surgical Specialty Group, Inc. (CSSG), Children’s Health Foundation, Inc., CHS Insurance Limited, and Children’s Medical Tower, LLC.
Human Subject Research Conflict of Interest; Policy #C1108
Effective Date: August 24, 2012
Page 1 of 16
Individuals Reviewing
Arno Zaritsky, M.D.Joann RogersTina Allen
SVP Clinical ServicesSVP Physician Practice,Dir. Compliance Internal Audit
Executive Medical DirectorDiagnostic & Therapy Services
Amy QuinnCyndi FisherKaren Mitchell
Clinical ResearchDir. Hospital ResearchDir. Hematology Oncology
Program managerCoordination Program
Jane HollingsworthSusan B. Steelman, Esq.Sherri M. Matson, Esq.
Dir. Child Advocacy ProgramDir. Loss Prevention/VP/General Counsel
Associate Counsel
Policy No.: C1108 Effective Date: August 24, 2012 Previous Revision: New
DatesReviewed:
8/12SUBJECT: PUBLIC HEALTH SERVICES (PHS) FUNDED HUMAN SUBJECT RESEARCH – FINANCIAL CONFLICTS OF INTEREST
POLICY: It is the policy of Children’s Health System,Inc. and its subsidiaries(CHKDHS) to comply with 42 CFR part 50 and 42 CFR Part 94 (the “Regulations”). that promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under Public Health Service (PHS) grants,PHS cooperative agreements and PHS contracts (collectively, “PHS Funded Research”) will be free from bias resulting from investigator financial conflicts of interest.
I.Applicability; Individuals Permitted to Conduct Research Within CHKDHS.
(a)Applicability. As an institution that applies for and receives PHS research funding from time to time through grants, cooperative agreements and contracts, the Regulations apply to CHKDHS. The Regulations and this policy apply to each Investigator who is planning to participate in, or is participating in, PHS Funded Research where research funding is received by CHKD from a PHS grant, cooperative agreement or contract.
(b)Individuals Permitted to Conduct Research Within CHKDHS. Because the Eastern Virginia Medical School Office of Research may perform certain of the functions required under the Regulations for and on behalf of CHKDHS, in order to ensure compliance with the Regulations, individuals conducting research within CHKDHS shall either be (1)an EVMS faculty member subject to the EVMS requirements for researcher education and conflict of interest management; or (2)if the individual is not an EVMS faculty member, then the individual’s research study must be reviewed and approved by the EVMS IRB making such individual subject to the EVMS requirements for researcher education and conflict of interest management.
II.Responsibility; CHKD Designated Official. The CHKDHS Hospital Research Coordination Department (HRC) shall be responsible for the administration of this Policy. The Senior Vice President of Clinical Services shall be the CHKD Designated Official as required under the Regulations.
III.Publication on Website. As required under the Regulations, this policy shall be published and available to the public on the CHKDHS public website,
IV.Definitions.
(a)Financial conflict of interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
(b)FCOI Report means CHKDHS’ report of a financial conflict of interest to a PHS Awarding Component.
(c)Financial Interest means anything of monetary value, whether or not the value is readily ascertainable.
(d)HHS means the United States Department of Health and Human Services.
(e)Investigator means the project director (PD) or principal investigator (PI) 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 funding, which may include, for example, collaborators or consultants.
(f)Key Personnel includes the PD/PI and any other personnel considered to be essential to work performance or identified as key personnel in a contract proposal and contract.
(g)Manage means taking action to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.
(h)PD/PI means a project director or principal Investigator of a PHS-funded research project; the PDs and PIs are also considered senior key personnel.
(i)PHS means the Public Health Service of the U.S. Department of Health.
(j)PHS Awarding Component means the organizational unit of the PHS that funds the research.
(k)Public Health Service Act or PHS Act means the statute codified at 42 U.S.C. 201 et seq.
(l)Researchmeans 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 and product development (e.g., a diagnostic test or drug). The term includes any such activity for which research funding is available from a PHS Awarding Component through a grant, cooperative agreement or contract, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award.
(m)Senior/Key Personnel means the PD/PI and any other person identified as senior/key personnel by CHKDHS in the grant application, progress report, or any other report submitted to the PHS by CHKDHS.
(n)Significant Financial Interest (SFI) is defined on Exhibit A.
III.Certifications. As required under the Regulations, CHKD willcertify, in each application for PHS funding, that CHKD:
- Has in effect an up-to-date, written and enforced administrative process to identify and manage FCOI.
- Shall promote and enforce Investigator compliance with the regulation.
- Shall manage FCOI and provide initial and ongoing FCOI reports.
- Agrees to make FCOI and SFI information (including related Institutional reviews and determinations) available to HHS, promptly, upon request.
- Shall fully comply with the regulation’s requirements.
V.Education Requirements
CHKD shall comply with the requirements of the Regulations as described below:
Regulatory Citation / Responsibility(a) Educateeach Investigator applying for or receiving PHS funding from CHKD aboutthe Regulations, CHKD’s policy,and the Investigator’s responsibilities under the policy. / 42 CFR 50.604(b) / HRC
[through the EVMS Researcher Education Process]
(b) Require each PHS-supported Investigator to complete the FCOI training: / 42 CFR 50.604(b) / HRC
[through the EVMS Researcher Education Process]
(i) Prior to engaging in research related PHS-funded grant;
(ii) At least every 4 years;
(iii) Immediately, if:
(A) CHKD revises its FCOI policy that affects
requirements of Investigators;
(B) An Investigator is new to CHKD;
(C) An Investigator is not in compliance with the policy
or a management plan.
VI.Disclosure, Review and Monitoring Requirements
Regulatory Citation / Responsibility(a) Require each Investigator to discloseSFI’s by completing the Disclosure Form in Exhibit B: / 42 CFR 50.603
42 CFR 50.604(e)(1)-(3) / HRC
(i) No later than at the time of application for PHS-funded
Research;
(ii) At least annually during the period of the award;
(iii) Within 30 days of discovering or acquiring a new SFI.
(b) The CHKD Designated Official shall solicit and review the Disclosure Forms and determine whether anInvestigator’s SFI is related to PHS-funded research and, ifso related, prior to the expenditure of funds, determine whether the SFI is an FCOI (i.e., an FCOI exists when the Designated Official reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of thePHS-funded research / 42 CFR 50.604(d)
42 CFR 50.604(f)
42 CFR 50.605(a)(1) / HRC/Designated Official
(c) If the Designated Official determines an FCOI exists, the Designated Official will refer the investigator to the EVMS Conflict of Interest Committee to develop and implement a management plan, as needed to manage the FCOI. Management Plans will meet the requirements in Exhibit C and adhere to the EVMS Conflicts of Interest and Commitment Policy.
(d) In addition, the Designated Official shall review disclosures of SFIs, to identify anyFCOIs, and refer the investigator to the EVMS Conflict of Interest Committee to implement a management plan:
(i) when required for a new Investigator participating in the research project or for an existing Investigator whodiscloses a new SFI; and
(ii) whenever CHKD identifies a SFI that was not disclosed in a timely manner by an Investigator or not previously reviewed by CHKD. If CHKD identifies a SFI that was not disclosed in a timely manner by an Investigator or for whatever reason was not previously reviewed by CHKDHS, the actions specified on Exhibit D will be taken by the Designated Official. / 42 CFR 50.605(a)(2)
42 CFR 50.605(a)(3) and (i) – (iii) / HRC/Designated Official
EVMS
(e) The Designated Official will take such actions as necessary to coordinate with EVMS to manage FCOIs, including any financial conflicts of asubrecipient Investigator, if applicable, and monitorInvestigator compliance with management plans until
completion of the project. / 42 CFR 50.604(g)
42 CFR 50.605(a)(4) / HRC/Designated Official
EVMS
VII. Reporting Requirements to PHS :
Regulatory Citation / Responsibility(a) If the Designated Official has identified an FCOI, including subrecipient FCOIs, in addition to facilitating the Management Plan with EVMS, the Designated Official will send to the PHS Awarding Component initial, annual (i.e., ongoing) and revised FCOI reports, including the reporting elements in Exhibit E: / 42 CFR 50.604(h)
42 CFR 50.605(b) / HRC/Designated Official
(i) Prior to the expenditure of funds;
(ii) Within 60 days of identification for an Investigator who
is newly participating on the project;
(iii) Within 60 days for new, or newly identified, FCOIs for
existing Investigators;
(iv) At least annually (at the same time as when CHKD is required to submit the annual progress report,
multi-year progress report, if applicable, or at time of
extension) to provide the status of the FCOI, any changes to the management plan, until the completionof the project.
(v) Following a retrospective review to update a previouslysubmitted report, if appropriate, as described in Exhibit D and Exhibit E. / 42 CFR 50.605(a)(3)(iii) / HRC/Designated Official
(b) Notifythe PHS awarding component promptly if bias is found with the design, conduct or reporting of PHS-funded research and submit a Mitigation Report, as described in Exhibit D and Exhibit E. / 42 CFR 50.605(a)(3)(iii) / HRC/Designated Official
(c) Notify the PHS agency promptly if anInvestigator fails to comply with CHKD’s FCOI policy or a FCOI management plan appears to have biased the designconduct, or reporting of the PHS-funded research. / 42 CFR 50.606(a) / HRC/Designated Official
(d) Take corrective action for noncompliancewith CHKD’s policy or the management plan. / HRC/Designated Official
VIII. Maintenance of Records
Regulatory Citation / Responsibility(a) Maintain FCOI-related recordsfor at least 3 years from the date the final expenditure report is submitted to the PHS agency. / 42 CFR 50.604(i) / HRC
IX. Enforcement Mechanisms and Remedies for Noncompliance
Regulatory Citation / Responsibility(a) Establish adequate enforcement mechanisms and provide for sanctions or other administrative actions to
ensure Investigator compliance. / 42 CFR 50.604(j) / HRC/Designated Official
(b) Complete and document retrospective reviews within 120 days of CHKD’s determination of noncompliance for SFIs not disclosed timely or previously reviewed or whenever an FCOI is notidentified or managed in a timely manner and to document the reviews as described in Exhibit D. / 42 CFR 50.605(a)(3) / HRC/Designated Official
(c) In any case in which the Dept of Health and Human Services
determines that a PHS-funded clinical research project 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 an FCOI that was not managed or reported by CHKD
as required by the Regulations, CHKD shall require the
Investigator to: / 42 CFR 50.606(c) / HRC/Designated Official
HRC/Designated Official
(i) Disclose the FCOI in each public presentation of the
results of the research; and
(ii) To request an addendum to previously published
work product(s) of the research.
X. Subrecipient Requirements
Regulatory Citation / Responsibility(a) Address subrecipientrequirements as required under the regulations and described in Exhibit F. / 42 CFR 50.604(c) (also see NIH Grants Policy Statement 15.2.1) / HRC
(b) Where applicable, establish, via a written agreement,
whether the subrecipient will follow the FCOI policy of
CHKD or the FCOI policy of the subrecipient. / 42 CFR 50.604(c)(1)(1)-(iii)
(i) If applicable, obtain a certification from the subrecipient
that its FCOI policy complies with the regulation.
(ii) If applicable, include the written subrecipient agreement
a requirement for the subrecipient to report identified
FCOIs for its Investigators in a time frame that allows
CHKD to report identified FCOIs to the NIH as required
by the regulation.
(iii) Alternatively, if applicable, include in the written
agreement a requirement to solicit and review
subrecipient Investigator disclosures that enable CHKD
to identify, manage and report identified FCOIs to PHS.
XI. Public Accessibility Requirements
Regulatory Citation / Responsibility(a) Make CHKD’s FCOI policy publicly accessible: / 42 CFR 50.604(a) / HRC/Designated Official
(i) Post the FCOI policy on CHKD’s public web site, or
(b) Prior to the expenditure of funds, make information concerning all identified SFIsavailable and publicly accessible as required under Exhibit G. The information will:
(i) Include the minimum elements as provided in Exhibit G;
(ii) Be posted on the CHKD Website or made available within 5 calendar days of a written request;
(iii) Be updated, at least annually (web site only but any response to a written request should include the updated information);
(iv) Be updated, within 60 days of a newly identified FCOI (web site only but any response to a written request should include the updated information);
(v) Remain available for three years from the date the information was most recently updated.
XII.Access to Records; Confidentiality; Special Conditions; Suspension of Funding.
The PHS Awarding Component and/or HHS may inquire at any time before, during, or after award into any Investigator disclosure of financial interests and CHKDHS’ review (including any retrospective review) of, and response to, such disclosure, regardless of whether the disclosure resulted in CHKDHS’ determination of a financial conflict of interest. CHKDHS is required to submit, or permit on site review of, all records pertinent to compliance with this Policy and the Regulations. To the extent permitted by law, HHS will maintain the confidentiality of all records of financial interests. On the basis of its review of records or other information that may be available, the PHS Awarding Component may decide that a particular financial conflict of interest will bias the objectivity of the PHS-funded research to such an extent that further corrective action is needed or that CHKDHS has not managed the financial conflict of interest in accordance with this subpart. The PHS Awarding Component may determine that imposition of special award conditions or suspension of funding or other enforcement action is necessary until the matter is resolved.
XIII. Non-Compliance with Policy or the Regulations.
In the event CHKD determines that an investigator has not complied with the requirements of this Policy or the Regulations, the Designated Official will provide notice to the investigator of the non-compliance and take such actions as deemed reasonably necessary, including without limitation, notifying the applicable IRB with oversight for the research project (which may result in the IRB’s issuing an order to stop the project).
In addition, failure to comply with this Policy and the regulations, including failure to file a complete or timely Disclosure Form or update or to comply with any conditions or restrictions imposed on the conduct of the project under this Policy, including a management plan, will be grounds for discipline up to and including termination for Investigators employed by the CHKDHS.
If the failure of an Investigator to comply with this Policy or an FCOI management plan appears to have biased the design, conduct, or reporting of the PHS funded Research, CHKDHS is required to promptly notify the PHS Awarding Component of the corrective action taken or to be taken. The PHS Awarding Component will consider the situation and, as necessary, take appropriate action, or refer the matter toCHKDHS for further action, which may include directions to CHKDHS on how to maintain appropriate objectivity in the PHS-funded Research project. In addition, federal regulations may require reports to the federal sponsor of any information which may show a violation of CHKDHS policy. Sponsors may impose special award conditions or may suspend or terminate the award and/or debar an Investigator from receiving future awards in the event of failure to comply with applicable federal regulations on disclosure, review, and management of Significant Financial Interests related to federally sponsored projects. ”
EXHIBIT A
SIGNIFICANT FINANCIAL CONFLICT OF INTEREST
Significant Financial Interest (SFI) means:
(1)A financial interest consisting of one or more of 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 Responsibilities:
(i)With regard to any 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 and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as a salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.
(ii)With regard to any non-publicly traded entity, a significant financialinterest 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); or
(iii)Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
(2)Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., 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 their Institutional Responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by 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 travel disclosures referenced under this Section will include the purpose of the trip, the identity of the sponsor/ organizer, the destination, and the duration. The institutional official(s), as defined below, will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.