Standard Operation Procedures
GA 105: Prohibition of Financial Conflicts
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SOP No.: 105     PROHIBITION OF FINANCIAL CONFLICTS
Author:    Office of Human Research
Effective Date:  October 1, 2007 Supercedes document dated:   N/A
Last Reviewed on:   N/A                                  Results of Review:   N/A
This SOP pertains to:  :  Any financial conflicts of interest of Clinical Investigators (Principal Investigators, Co-investigators, Sub-investigators, key personnel and including their spouses and children) who are participating in a clinical study within Thomas Jefferson University.
Responsibility for executing this SOP:  Investigator and Designated Research Personnel
Approved By:
J. Bruce Smith, MD
Associate Vice President for Research
(signature on file at OHR)
Approved By:
Steven E. McKenzie, MD, Ph.D.
Vice President for Research
(signature on file at OHR)

 

1. PURPOSE

This procedure defines financial conflicts of interest (hereinafter referred to as “financial COI”) for Clinical Investigators engaged in the conduct of FDA-regulated human subject research and the steps that must be taken to report such conflicts to the IRB, Thomas Jefferson University, and if appropriate, governmental regulatory authorities.

2. GENERAL INSTRUCTIONS

All Clinical Investigators (hereinafter referred to as Investigators) are responsible for complying with all federal regulations and institutional requirements governing conflicts of interest in a clinical study that may an impact upon its conduct, evaluation or outcome. Investigators should participate in education and training programs concerned with financial COI issues that are required by their institutions.

3. SPECIFIC PROCEDURES

3.1 General and Institutional Considerations
  1. Thomas Jefferson University's Conflicts of Interest Policy (COI Policy) for Employees (Policy No. 107.03) must be reviewed and understood by Investigators prior to commencing a clinical investigation. The COI policy may be accessed via the OHR website or the Office of University Counsel website.
  2. As part of the submission for the IRB approval of a clinical study or continuing review of such studies, Investigators and other individuals who are “conducting research” must complete and submit a COI Disclosure to the COI Officer of Thomas Jefferson University, and complete and submit the appropriate IRB forms to the IRB, disclosing any significant financial interest in the sponsor or any other entity whose financial interests might reasonably be affected by the outcome of the research. Investigators who are not employees of Thomas Jefferson University or Thomas Jefferson University Hospitals, Inc. must complete and forward to the COI Officer a "Disclosure Statement for Non TJU/TJUH Employees Conducting Research" (see Attachment D to the COI Policy). 
  3. If, at any time between disclosure periods, an Investigator becomes aware of a change in his/her financial circumstances which may constitute an actual, perceived, or potential conflict, the situation must be reported to the COI Officer and the person’s supervisor as soon as possible. In addition, the Investigator must submit a new COI Disclosure listing all entities with which the Investigator has a significant financial interest. When an Investigator is uncertain whether a particular situation might present a conflict, the circumstances should be discussed with the COI Officer.
  4. As defined by Attachment B (Operating Definitions) to the COI Policy “conducting research” means, with respect to a research protocol, designing research, directing research or serving as the principal, co-investigator or key personnel, enrolling research subjects (including obtaining subjects' informed consent) or making decisions related to eligibility to participate in research, analyzing or reporting research data, or submitting manuscripts concerning the research for publication.
  5. “Significant financial interests” include, but are not limited to, the following: Consulting fees; honoraria; gifts or other financial compensation; or "in kind" compensation from a financially interested company for any purpose not directly related to the reasonable cost of conducting the research (as specified in the research agreement) or engaging in the activity; that when aggregated for the covered individual and his/her family in the prior calendar year exceeded, or in the next calendar year are expected to exceed, $10,000. 
    • Equity interests, including stock options, of any amount in a non-publicly-traded financially interested company (or entitlement to the same).
    • Equity interests, including stock options, (or entitlement to the same) in a publicly-traded financially interested company (excluding any interest arising solely by reason of investment in a business by a mutual, pension, or other institutional investment fund over which the covered individual or his/her family does not exercise control) that (when valued in reference to current public prices) when aggregated for the covered individual and his/her family exceeds $10,000 in value and/or represents more than a 5% ownership interest in any single entity.
    • Intellectual property rights (e.g., patents and/or copyrights).
    • Royalty income or the right to receive future royalties under a patent license or copyright agreement or any other type of agreement, where the research or activity is directly related to the licensed technology or work.
    • Any non-royalty payments (or entitlements to payments) in connection with the research or activity that are not directly related to the reasonable costs of the research (as specified in the research agreement between the sponsor or company providing research funding and the University) or activity. This includes any bonus or milestone payments to investigators in excess of reasonable costs incurred, whether such payments are received from a financially interested company or from the University.
    • Service as an officer, director, or in any other fiduciary role for a financially interested company, whether or not remuneration is received for such service.
    • Exceptions. Significant financial interests do not include the following:
      • Interests of any amount in publicly-traded, diversified mutual funds.
      • Stock in a publicly-traded company that (when valued in reference to current public prices) when aggregated for the covered individual and his/her family does not exceed $10,000 in value and does not represent more than a 5% ownership interest in any single entity. 
      • Stock options in a publicly-traded company that (when valued using accepted valuation methods) when aggregated for the covered individual and his/her family do not exceed $10,000 in value and do not represent more than a 5% ownership interest in any single entity. 
      • Payments to the University, or via the University to the individual, that are directly related to reasonable costs incurred in the conduct of research as specified in the research agreement(s) between the sponsor and the University. 
      • Salary, royalties, and other payments for services from the University.
      • Any ownership interest in an organization that is funded through the federal Office of Technology’s Phase I Small Business Innovation Research or Small Business Technology Transfer Programs (“"Phase I SBIR/STTR”).
      • Income from seminars, lectures, or teaching engagements sponsored by governmental or nonprofit entities. 
      • Income from service on advisory committees or review panels for governmental or nonprofit entities. 
  6. The COI Officer will review all OSA-1 and OSA-9 proposals submitted to the IRB and will refer any significant financial interests between Investigators and Sponsor(s) to the COIC and the IRB for a determination as to whether there is a conflict of interest and, if so, how the conflict should be managed.
  7. The Director or Associate Director of DHSP will forward to the COI Officer any information received concerning an individual's conflict related to human subjects research. The COI Officer will refer potential or actual conflicts to the Committee for review.  The Committee’s determinations will be submitted to the Director of DHSP for review by the IRB, including any determination that the circumstances do not compel allowing a conflicted individual to conduct research. The IRB must consider the report of the Committee prior to its final review of the research, whether for initial or continuing review. In its discretion, the IRB may require additional safeguards or demand reduction or elimination of the financial interest before approving the research. Moreover, despite the Committee's finding that compelling circumstances warrant allowing a conflicted individual to conduct research, the IRB has the authority to disapprove the research. The IRB may not, however, remove or weaken the conditions and/or restrictions imposed by the Committee.

    The Director or Associate Director of DHSP will ensure that disclosed conflicts are made known to research subjects via a statement in the informed consent document, and upon request, to the study sponsor and the IRBs of other institutions participating in the relevant trial. If the failure of a covered individual to comply with the COI Policy has biased the design, conduct, or reporting of PHS-funded research, the Director or Associate Director of DHSP will promptly notify the PHS Awarding Component of the corrective action taken or to be taken .  In addition, the Director of DHSP shall make information available regarding identified conflicts as required by law.
  8. The Standing Committee on Conflicts of Interest & Commitment (COIC Committee) will review all referred potential conflicts brought to its attention by the COI Officer and make determinations as to whether an actual conflict exists and if so, whether and how it may be eliminated, reduced or managed. In conducting its review, the COIC Committee will presume that, in the absence of compelling circumstances, an individual having a significant financial interest (“conflicted individual”) may not engage in the research or activity in question ("the rebuttable presumption against financial interest"). This presumption does not suggest that every financial interest jeopardizes the integrity of research or the welfare of human subjects or an individual's fidelity in the performance of his/her job responsibilities, but rather ensures the systematic treatment of any financial interest that might give rise to the perception of a conflict of interest.

    If the COIC Committee determines that a conflicted individual is prohibited from conducting the research or engaging in the activity in question, the conflicted individual will be afforded the opportunity to rebut the presumption, either in writing or in-person, by demonstrating compelling circumstances for conducting the research or engaging in the activity despite the conflict.  The COIC Committee will review any request by a conflicted individual to rebut the presumption that s/he may not participate in a particular activity.

    After reviewing the relevant facts and documenting the compelling circumstances, the COI Committee may recommend that the research or activity may be conducted subject to conditions and/or restrictions that ensure effective management of the conflict and credible oversight of the research or activity. The President must review and approve any recommendations made by the COI Committee, including the compelling circumstances, and any conditions or restrictions imposed to manage the conflict.

    If the conflict involves a clinical trial or basic science research, enforcement shall also reside with the DHSP and /or ORA which shall receive copies of the Committee’s written determination. In each instance, the individual responsible for enforcing the recommendations of the Committee, (including the Directors of DHSP or ORA, as applicable), must certify in writing that the recommendations of the Committee have been imposed. Copies of the Committee's summary report described below and the individual's agreement to comply, as well as the enforcing individual's certification will be kept on file in the Office of University Counsel with the COI Officer.
  9. The COI Officer and/or the COIC Committee will provide written notice of the COIC Committee’s determination to the conflicted individual with a copy sent to the individual’s chairperson or supervisor. The individual must indicate, in writing, his or her willingness to comply with the Committee’s determination and any conditions or restrictions. If the individual is a department chairperson, the appropriate dean shall be responsible for enforcing the recommended conditions or restrictions. For all other conflicted individuals, the appropriate senior officer and/or department chairperson shall be responsible for enforcing the recommendations. If the conflict involves a clinical trial or basic science research, enforcement shall also reside with the DHSP and /or ORA which shall receive copies of the Committee’s written determination. In each instance, the individual responsible for enforcing the recommendations of the Committee, (including the Directors of DHSP or ORA, as applicable), must certify in writing that the recommendations of the Committee have been imposed. Copies of the Committee's summary report described below and the individual's agreement to comply, as well as the enforcing individual's certification will be kept on file in the Office of University Counsel with the COI Officer.

FDA Reporting Requirements

The FDA requires anyone who submits a marketing application of any drug, biological product or device to submit certain information concerning the compensation to, and financial interests of, any investigator conducting clinical studies covered by the rule.  For Investigator initiated studies, the Investigator and/or Thomas Jefferson University would be considered the “sponsor” of the clinical study.  The sponsor is required to comply with these FDA reporting requirements for a “covered clinical study”.  If the FDA requires an IND or IDE, this is one type of “covered clinical study”, and the regulations, 21 CFR 312.53 and 21 CFR 812.43, provide that before permitting an investigator to begin participation in an investigation, the IND/IDE sponsor shall obtain sufficient accurate financial information that will allow an applicant to submit complete and accurate certification or disclosure statements required by the FDA. The sponsor is also required to obtain the investigator's commitment to promptly update this information if any relevant changes occur during the course of the investigation and for one year following completion of the study.

A “Covered clinical study” is generally defined asany study of a drug, biological product or device in humans submitted in a marketing application or reclassification petition that the applicant or FDA relies on to establish that the product is effective (including studies that show equivalence to an effective product) or any study in which a single investigator makes a significant contribution to the demonstration of safety. This would, in general, not include phase 1 tolerance studies or pharmacokinetic studies, most clinical pharmacology studies (unless they are critical to an efficacy determination), large open safety studies conducted at multiple sites, treatment protocols and parallel track protocols. An applicant may consult with FDA as to which clinical studies constitute "covered clinical studies" for purposes of complying with financial disclosure requirements.

For any covered clinical study:

  1. The Investigator will request a complete and accurate disclosing of financial interests and arrangements for all Co- Investigators (his/her own, and other participating Investigators), their spouses and dependent children for a covered study as follows:
    • Any compensation to the Investigator where the value if the compensation could be affected by the study outcome
    • Any proprietary interest in the investigational product including, but not limited to a patent, trademark, copyright or licensing agreement
    • Any equity or ownership interest in the Sponsor/CRO/Funding Agency of a covered study that is not publicly traded or whose value cannot be readily determined including, but not limited to stock options or royalty payments
    • An equity or ownership interest in excess of $50,000 in value in the Sponsor/CRO/Funding Agency of a covered study that is publicly traded. The requirement applies to interests held during the time the Investigator is carrying out the study and for 1 year following completion of the study
    • Any significant payments of a cumulative value of $25,000 from the Sponsor to the Investigator or institution for a covered study, when these payments are in excess of the actual costs of conducting the clinical study, and including but not limited to grants, equipment, consultation fees and honoraria during the time the clinical investigator is carrying out the study and for 1 year following completion of the study
  2. If the Investigator has any questions as to what constitutes a covered study, he/she or his designee should consult with FDA for clarification.
  3. This information for each covered study will be collected during the time the study is being conducted and for one (1) year following completion of the study.
  4. If any affected Investigator lacks FDA-reportable financial interests, the Investigator will asked him/her to provide written attestation of the absence of FDA-reportable financial interests.
  5. The Investigator will have Forms FDA 3454 or FDA 3455 completed and updated as appropriate for each Investigator collecting data under the Investigator's covered study. Forms are available at www.fda.gov/opacom/morechoices/fdaforms/cder.html.
  6. The Investigator will ensure the IRB(s) of record is/are aware of any financial interest the Sponsor and other participating Investigators have in the investigational product.
  7. The IRB will determine whether or how to appropriately disclose the Investigators' interest in the study to prospective study participants.
  8. If the Investigator is an applicant for an FDA marketing approval, he/she will submit Forms FDA 3454 and/or FDA 3455 with the appropriate FDA marketing application (e.g., PMA, NDA), accompanying a list of all Investigators who participated in the covered clinical studies, which also indicates whether those Investigators are full-time or part-time employees of the Investigator.
  9. The Investigator will retain copies of these forms in the appropriate section of the regulatory Master File for two (2) years after the FDA marketing application is approved or as otherwise required by the Institution.
  10. The Investigator will ensure that these records are made available to FDA Investigators upon request.

4. ATTACHMENTS

  1. Form FDA 3454 (PDF)
  2. Form FDA 3455 (PDF)

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