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Johns Hopkins University
Policy on Individual Financial Interests and Financial Conflict of Interests^1 ,^2 in Research
This policy applies to the Bloomberg School of Public Health, Krieger School of Arts and Sciences, School of Medicine, School of Nursing, and Whiting School of Engineering.^3
A. Introduction
The mission of the Johns Hopkins University is to generate knowledge for the world through research, teaching, clinical practice and service. To advance the research mission, the University needs to ensure that research is conducted with integrity and openness and that the rights and interests of human subjects are protected.^4 The University also seeks to foster creativity and facilitate the translation of discoveries into products, techniques, and processes that improve human welfare. Increasingly, the private, for-profit sector plays an important role in this process. Industry involvement can benefit research and its translation into useful products. However, the financial incentives that accompany such involvement may have the potential to create or increase bias in research, thus affecting research integrity and placing human research subjects at additional risk. Such conflicts may also reduce public confidence in the research enterprise.
To ensure the integrity of research in the setting of related financial and fiduciary interests, the University has adopted a revised Policy on Individual Financial Interests and Conflict of Interest in Research. This policy is designed to identify arrangements involving investigators and others who have a financial or fiduciary interest in an outside entity where such arrangements may create risks or the appearance of risks in the conduct and reporting of all research. The financial interests and arrangements reported in accordance with divisional policies on disclosure and professional commitment must be reviewed by the appropriate University division for financial conflict of interest with research. This policy is designed to maintain the trust of the public, research volunteers, and the research community in the University’s research
(^1) Terms used in this policy are defined in Section B. (^2) Different University policies govern other financial interest and conflict of interest issues (e.g.,
institutional financial conflicts of interest, financial conflicts of interest with purchasing). Policies on disclosure and professional commitment may require disclosure of additional information. 3 Faculty members at other University divisions must comply with the JHU Policy on Conflict of Interest and Conflict of Commitment. 4 The welfare of animal subjects is also a mission of the academic research center; animal welfare is the subject of separate, related policies that are implemented by the Animal Care and Use Committee. (See Handbook on Use of Experimental Animals at Johns Hopkins University.)
enterprise and to support institutional compliance with PHS 42 CFR Part 50, Subpart F^5 and other applicable government regulations.
Separate University and divisional policies govern disclosure and professional commitment for faculty and staff. This policy is effective August 24, 2012. The JHU Schools of Arts and Sciences, Engineering, Medicine, Public Health, and Nursing must follow this policy or adopt policies that are consistent with this policy. This policy applies to all Covered Parties. Faculty members at other University divisions must comply with the JHU Policy on Conflict of Interest and Conflict of Commitment.
B. Definitions
Covered Party(ies) o Covered parties are investigators on all research conducted under the auspices of JHU, including research that is funded by or through the University, its divisions, centers or institutes, or conducted under the aegis of any JHU IRBs (including JHM IRBs). Entity o Any for-profit or not-for-profit organization, whether private or governmental. This does not include: the Johns Hopkins University and local, state, and federal government entities; institutions of higher education as defined at 20 U.S.C. 1001(a), academic teaching hospitals, medical centers, or research institutes affiliated with an institution of higher education. Institution o Institution means the Johns Hopkins University, its divisions, centers, and institutes and any other constituent parts. Institutional responsibilities o The responsibilities and roles investigators are assigned in the course of their faculty appointment or employment by the Johns Hopkins University. This includes, for example, clinical practice, teaching, research, administrative roles, and committee service.
Investigator
(^5) "Promoting Objectivity in Research"
conflict of interest management requirements and administrative conditions associated with financial interests related to research.
D. Review of Disclosures
Review Process and Standards
Responsibility for review of disclosures o Disclosures will be reviewed by designated divisional staff and/or a Committee appointed or designated by the divisional dean or vice dean for research. For purposes of this policy, “Committee” will mean the committee or individuals (e.g., staff assigned to review financial disclosures) appointed by the dean to review financial disclosures for FCOI (defined below). o Review generally will occur in the division of an individual’s primary appointment or employment. However, in some cases, review will occur in the division with the primary responsibility for research or other activity potentially affected by the financial interest. Standards for review of disclosures o Disclosures are reviewed in light of related research activity for the following: potential of disclosed interests to directly and significantly affect the design, conduct, or reporting of research funded by a PHS Awarding Component or other sponsor (“financial conflict of interest”, or “FCOI”); and risks to the rights and safety of human research subjects; and impact on the integrity of research data; and risks to the rights and obligations of students and trainees participating in research; and impact on the availability of research results to the scientific community for use in the public interest; and appearance of a conflict of interest.
Determination/Management/Administrative Conditions
The Committee will determine whether or not the disclosed interests constitute a financial conflict of interest (FCOI). If the Committee identifies an FCOI, the Committee will recommend to the Dean that the proposed arrangements be either (a) prohibited, or (b) permitted, subject to specific management measures. In cases where the Committee does not judge the arrangement to be an FCOI, the arrangements nevertheless may be subject to administrative conditions. All
arrangements may be reviewed again if circumstances change or there is new information. After reviewing the recommendation of the Committee, the divisional Dean will render a final decision and will communicate that decision, with a description of management measures or administrative conditions, to the involved covered party in writing. The Committee will be notified of the Dean’s decision if it differs from the recommendation of the Committee. For proposed arrangements involving human subject research, the Committee will make recommendations to the Dean and to the IRB. This procedure is described more fully below. If the Committee determines that a particular financial interest is not prohibited in the presence of related human subject research, it will recommend that the conflict of interest be made subject to a management plan or administrative conditions. This may consist of one or more of the following: o Disclosure - Disclosure is required in most cases and generally includes: i) public disclosure of the financial interests of the investigator and of the University, if applicable, in all relevant publications, presentations (whether or not academic presentations), including presentations at the level of the covered party's primary department or higher, ii) disclosure to the appropriate co-investigators, members of the laboratory or research group, and students or trainees, and iii) disclosure on human subject consent forms; o Restriction on Equity - i) placement of stock in escrow until a trigger date specified by the Committee, as outlined in The Johns Hopkins University Intellectual Property Guidelines and associated policies, or ii) requirement that options, warrants, and similar instruments not be exercised without the prior permission of the Committee;^7 o Limiting the Role of the Investigator with a Financial Interest - requiring that the role of the investigator with the financial interest be limited in some way (e.g., the investigator may not be allowed to i) serve as principal investigator, ii) analyze data, iii) determine whether potential subjects are eligible for enrollment, iv) solicit consent, or v) determine whether an adverse event report is required); o Oversight - appointment of a disinterested individual or group to monitor the relevant research activity. Oversight might include review of abstracts and manuscripts before submission for presentation or publication to ensure that the research is conducted and reported according to scientific and ethical standards and that there is compliance with conflict of interest management plans. Oversight of human subject research might involve review of protocols, subject accrual, adverse events, and other issues as appropriate;
(^7) Covered parties should be aware that separate Securities and Exchange Committee and other state and
federal regulations may apply to their ownership of such equity. Obtaining the necessary information and complying with such regulations is the responsibility of the covered party.
Presumptively Prohibited Financial Interests in Human Subjects Research
The financial interests that must be reported are outlined in divisional policies on disclosure and professional commitment. Presumptively prohibited financial interests include:
Fees, honoraria, gifts or other emoluments, or "in kind" compensation from a financially interested entity (or entitlement to the same), whether for consulting, lecturing, or any other purpose, that in the aggregate exceed $25,000 in a given twelve month period;
An equity interest of any amount, including stock options or warrants, in a non- publicly-traded financially interested entity (or entitlement to the same);
An equity interest, including stock options or warrants, (or entitlement to the same) in a publicly-traded financially interested entity that exceeds $25,000 in value as determined through reference to current prices. (Should the value of the equity interest increase to more than $25,000 during the conduct of the research project, the covered party must notify the IRB.) This does not apply to diversified mutual funds or similar instruments in which the shareholder has no control over the equities held by the fund. Equity holdings worth less than $25,000 and rights to acquire additional equity will nevertheless be subject to restrictions;
Royalty income or the right to receive future royalties from commercialization of research results, including entitlement to any "milestone" payments conditioned upon specified research-related dates or events, whether such payments are received from a financially interested entity or via the Institution;^9
Any non-royalty payments or entitlements to payments in connection with the research that are not directly related to the reasonable costs of the research (as specified in the applicable research agreement). This includes any bonus or milestone payments (other than those addressed above) to the investigator in
(^9) Royalty interests arising from post-marketing sales of approved products are an example of a financial
interest that promote translational research and may be amenable to successful management. To encourage the development of new products, the Bayh-Dole Act obligates institutions to attempt to commercialize inventions resulting from federally funded research and to distribute a portion of the royalty income from marketed products to inventors. This public policy objective of the Act and the eventual recognition of value of the innovation to the public may, in the judgment of the Committee, constitute compelling justification to permit a potential future financial interest concurrent with human subjects research, subject to appropriate and extensive management or administrative conditions. The foregoing may not be interpreted so as to eliminate reporting obligations, limit the Committee's ability to restrict or prohibit these arrangements, or determine what constitutes a compelling justification.
excess of reasonable costs incurred, whether such payments are received from a financially interested entity or from the Institution;
Service as an officer, director, or in any other fiduciary role for a financially interested entity, whether or not remuneration is received for such service.^10
Royalty income and the right to receive future royalties as a result of traditional academic publishing activity, such as the publication of textbooks, are excluded from the presumptive prohibition.
Review and Determination/Management and Administrative Conditions in Cases Involving Human Subject Research
The Committee will review reports of proposed financial interests for potential to create FCOIs in human subject research projects. Recommendations concerning the covered party's relationship to the outside entity will be communicated in writing to the Dean and to the appropriate IRB. The Dean will communicate his decision concerning the covered party's relationship with the outside entity to the covered party in writing. Nevertheless, to ensure the primacy of the welfare and rights of human subjects, the IRB will have the full and final authority for implementing the decision concerning the role of the involved covered party in the human subjects research protocol. Accordingly, the IRB will communicate its decision concerning participation in the human subjects research protocol to the covered party and will provide a copy of that communication to the Committee.
If the IRB deems a specific research project involving human subjects to be exempt from IRB review, the financial interest issues associated with that project will remain subject to review by the Committee, and the Committee may review the project as if it were "human subjects research" for the purposes of this Section.
The Committee's recommendation may involve prohibition, management, or administrative conditions to achieve transparency and promote research integrity. These options are described below.
(^10) A researcher's time-limited service as an officer or director of a company formed to obtain a grant
under the federal Small Business Innovation Development Act or the Small Business Technology Transfer Program may be treated analogously to royalty interests arising from post-marketing sales of approved products, as described in Footnote 9.
information, the covered party may request additional Committee review by submitting a written request to the Vice Dean for Research. If, after a second review by the Committee and second determination by the Dean, the covered party still wishes to appeal, the covered party may appeal to the University Provost. The decision of the Provost shall be final.
In the event the Dean decides not to adopt a Committee recommendation and the Committee wishes to appeal that decision, it may appeal to the University Provost. The decision of the Provost shall be final.
Covered parties who believe that the measures adopted by an IRB are not appropriate or are based on erroneous information must follow applicable IRB procedures for requesting additional review.
G. External Reporting
To comply with federal regulations, the Institution will make available to the public within 5 days of a request the following information with respect to financial conflicts of interest with PHS-funded research: o Investigator’s name o Investigator’s title and role with respect to the research project o Name of entity in which a significant financial interest is held o Nature of the significant financial interest o Approximate dollar value of the significant financial interest within ranges (e.g., $0-$4,999; $5,000-9,999; $10,000-19,999; $20,000-$100, by increments of $20,000; amounts above $100,000 in increments of $50,000), or a statement that the value of the interest cannot be readily determined through reference to public prices or other reasonable measures of fair market value To comply with federal regulations, the Institution will report to the PHS Awarding Component the following information with respect to financial conflicts of interest with PHS-funded research: o Project number o Program director/principal investigator o Name of investigator with financial conflict of interest o Name of entity in which a significant financial interest is held o Nature of the significant financial interest o Approximate dollar value of the significant financial interest within ranges (e.g., $0-$4,999; $5,000-9,999; $10,000-19,999; $20,000-$100,000 by increments of $20,000; amounts above $100,000 in increments of $50,000), or a statement that the value of the interest cannot be readily determined through reference to public prices or other reasonable measures of fair market value
o Description of how the financial interest relates to the PHS-funded research and basis for the Institution’s determination of a financial conflict of interest o 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
Covered parties must abide by other disclosure requirements and standards, such as for journals and professional societies; in publications, presentations, and to colleagues, students and trainees -- even if an interest is not identified as a FCOI with research.
H. Compliance
Failure to comply with this policy and with Committee recommendations adopted by the Dean and IRBs is subject to review under the applicable division’s policies and procedures on professional or research misconduct. Potential sanctions under these policies range from a warning from the Dean and placement of a letter in the covered party's file, to suspension for a specified period of time, to termination.
In the event of any of the following, an interim management plan will be implemented and a retrospective review of ongoing research will be undertaken to determine whether bias is present in the design, conduct or reporting of the research: failure to disclose in a timely manner financial interests that are determined to constitute an FCOI with PHS-funded research; failure by the institution to review or manage an FCOI; or failure by a covered party to comply with a management plan. If bias is identified, the institution will develop and implement a mitigation plan.
If the failure of an investigator to comply with this conflict of interest policy has, or appears to have, biased the design, conduct, or reporting of PHS-funded research, in accordance with PHS regulations, the institution must promptly notify the PHS Awarding Component of the findings and corrective action(s) taken or to be taken. The PHS Awarding Component will consider the situation and make take appropriate action or refer the matter to the Institution for further action, potentially including directions on how to maintain appropriate objectivity in the funded project.
