UMB HRPP SOP I.3.G: Investigator, Study Staff, and Family Member Conflicts of Interest (COI) Policy: The University of Maryland, Baltimore (UMB) Human Research Protections Program (HRPP) and the Institutional Review Board (IRB) requires that all conflicts of interest (COI) be disclosed to the IRB for review to assure elimination or appropriate management and disclosure of the conflict.
Definitions: •
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Conflict of Interest: Situations in which compensation or other personal consideration given or promised to an investigator, study staff, or family member of the aforementioned individuals compromises or may compromise or bias, the professional judgment of the individual in regards to planning, evaluating, and carrying out research activities involving human participants. The bias resulting from these situations can affect evaluation of research and protocols, enrollment of research participants, assessment of risks and benefits, collection, analysis, interpretation and publication of data, hiring of staff, procurement of materials, sharing of results, protocol design, and use of statistical methods. Such situations include active participation in external activities to enhance professional skills or constitute public service if such participation could lead to a conflict of commitment, even though no economic interest or benefit results from the participation (examples of situations in which no direct economic interest exists include direction of a program of research or scholarship at another institution that could be conducted at UMB; board or director seat; or study section and review panel memberships; involvement in the design, conduct, or reporting of the research). Immediate Family Member: Spouse, parent, child, sibling, or domestic partner of a Principal Investigator, member of study staff or of an IRB member or consultant.
Process and Rationale: I.
It is the responsibility of the Principal Investigator (PI) to assure all conflicts of interest are disclosed and reviewed as required by UMB policy and that the outcome of such review is submitted to the UMB IRB prior to its final action on the research proposed.
II.
Changes in COI status must be reported to the IRB in writing within 10 days of the investigator becoming aware of the conflict by submitting a modification. The PI is responsible for promptly updating this information if any relevant changes occur during the course of the study and for one
year following the completion of the study [this includes any COI involving the PI or the research team].
III.
The information disclosed in a conflict on interest must be accurate and not known by the PI or research staff member to be false, erroneous, misleading, or incomplete.
IV.
Each individual has an obligation to cooperate fully with the IRB and the COI Officer in the review of the pertinent facts and circumstances regarding any conflict of interest disclosed.
V.
The UMB IRB adopts the presumption that, in the absence of a compelling rebuttal, an investigator with a conflict of interest may not conduct human participants research. However, an investigator will have the opportunity to present compelling reasons and circumstances to justify exceptions to this general rule. Compelling circumstances may include, but are not limited to: A. The nature of the research; B. The magnitude of the interest or the degree to which it is related to the research; C. The extent to which the interest could affect the research; D. The fact that the specific individual is unique in her/his clinical or scientific qualifications to conduct the research; and/or E. The degree of risk to the human participants involved that is inherent in the research protocol.
VI.
This Policy is not meant to prohibit relationships with companies that have no influence on the design, conduct, or publication of a study and that occur prior to the initiation of a sponsored study or after its publication. Compensation in the form of an economic interest which may be impacted by the outcome of the study is to be avoided. Examples of conflicts of interest due to compensation which require disclosure include, but are not limited to, consulting agreements, speaking or other fees, honoraria, gifts, licensing revenues, equity interests, loans or notes, including stock options, regardless of value, expectations of receiving equity interests, and/or other fees or compensation received from companies. A. The IRB may require that any compensation or economic interest be disclosed in the consent form.
B.
C. D.
E.
F.
VII.
The IRB must review the investigator's conflict of interest status with all new study submissions and at the time of each continuing review until study closure in accordance with applicable IRB review policies and procedures. The IRB will forward disclosures of conflicts of interest to the COI Officer. The IRB may delay action on a protocol pending the outcome of any conflict of interest review actions taken by the COI Officer or the University. The IRB may grant final approval of projects with a disclosed conflict of interest, provided appropriate language regarding conflict of interest has been incorporated into the informed consent documents or, if available, any recommendations made by the COI Officer and/or the UMB Conflict of Interest Advisory Committee have been incorporated into the informed consent documents; and provided the IRB finds that protocol has been reviewed to incorporate any changes required to disclose and/or manage the conflict of interest. The IRB has the final authority to determine whether a conflict of interest has been eliminated or managed appropriately. The IRB is not obligated to approve any research, or participate in research or research evaluation-oversight, if the IRB finds that a conflict of interest cannot be eliminated or managed.
UMB IRB Reports to the COI Officer. A. A. The COI Officer will assure that all conflict of interest disclosures are reviewed in accordance with University policies and Federal regulations including, where appropriate, referral to the UMB COI Advisory Committee and committees established in UMB schools to advise their academic administrators. If the conflict of interest involves a VA study, then a VA representative will be a member of the COI Advisory committee. B. B. The UMB IRB and the investigator will be notified in writing by the COI Officer and/or the UMB Conflict of Interest Committee of the outcomes of any review involving human participants research where a conflict of interest exists. Any differences between the conclusions of the IRB review and the COI Officer and/or the UMB Conflict of Interest Committee or other committees must be reconciled in a manner acceptable to the IRB before research may begin. If the COI involves a VA study, then the VA Research & Development Committee will be notified of any conflict of interest review involving human participant research.
Information for Disclosure
VIII.
Investigators and research team members, including those operating or employed outside of the UMB, must disclose in advance the following regardless of the study's funding or regulatory oversight: A. Financial interests of individuals or of their immediate family members involved in the design, conduct, or reporting of the research; B. Financial interests related to the research; C. Financial interest in the sponsor; D. Financial interest in the product or service being tested which may be sponsored by a government agency or be investigator initiated; E. Ownership interest (equity or stock options) of $10,000 or greater value when referenced to publicly traded prices or other measure of fair market value and when aggregated for the disclosing individual and immediate family members; F. Ownership interest (equity or stock options) of any amount whose value could not be referenced to publicly traded prices or other measure of fair market value (e.g., the stock is not publicly traded); G. Ownership interest (equity or stock options) of any amount when the value of the interest would be affected by the outcome of the research (e.g., an arrangement has been made where the value of the interest will change depending on the outcome of the research); H. Ownership interest (equity or stock options) whose value when aggregated for the disclosing individual and immediate family members represented 5% or more interest in any one single entity; I. Compensation of $10,000 or more in the past year when aggregated for the disclosing individual and immediate family members; J. Compensation of any amount when the value of the interest would be affected by the outcome of the research (e.g., an arrangement has been made where the value of the interest will change depending on the outcome of the research); K. Proprietary interest related to the research of any value including, but not limited to, a patent, trademark, copyright or licensing agreement. L. Board or executive relationship related to the research, regardless of compensation.
The IRB, Conflict of Interest Officer, and Conflict of Interest Advisory Committee IX.
The Director of IRB Operations/designee will notify the UMB Conflict of Interest Officer of any protocol submissions involving disclosure of a conflict of interest.
X.
Where applicable, the UMB COI Officer will inform the individual of the procedures for disclosing a conflict of interest and requesting an exemption from the Maryland State Public Ethics Law, which would otherwise prohibit the economic interest.
XI.
The COI Officer will assure that all conflict of interest disclosures are reviewed in accordance with University policies and Federal regulations including, where appropriate, referral to the UMB COI Advisory Committee and committees established in UMB schools to advise their academic administrators. If the conflict of interest involves a VA study, then a VA representative will be a member of the COI Advisory committee.
XII.
Where applicable, the COI Officer will provide a copy of the COI Disclosure and Exemption Request as well as the letter granting an exemption to the HPA. The HPA will provide the documents to the convened IRB to assist it with its deliberations concerning the protocol.
XIII.
If the COI Officer finds that the conflict of interest appears to be difficult to manage, or not manageable, the COI Officer will make recommendations to the UMB Conflict of Interest Advisory Committee and/or the VA Maryland Health Care System (VAMHCS) according to University policies. (link to other policies-Joe Giffels should provide info)
XIV.
The IRB, the PI, and the VAMHCS, if applicable, will be informed in writing of the outcome of the review by the COI Officer and/or the COI Advisory Committee.
XV.
Findings, including management plans where applicable, of the UMB COI Officer and COI Committee are provided to the IRB.
XVI.
The IRB will determine whether the disclosed economic interest is likely to compromise or appears to compromise the design, conduct or reporting of the study. Specifically, the IRB will consider the impact of the economic interest on:
A. B. C. D. E. F. G. H. I. J.
Study design; Protocol; Informed consent document (particularly representations of risks and benefits); Data collection and reporting; Eligibility determinations and application of inclusion and exclusion criteria; Continuing consent; Clinical determinations (e.g. dose modifications, removing patients from study, related care); Determination and reporting of adverse events and their relationship with study mechanism for data and safety monitoring; Data made available on continuing review (integrity and sufficiency); and Consequences affecting the clinician researcher's clinical duties to the patient as a participant.
XVII.
The IRB has the final authority to determine whether the interest and its management, if any, are sufficient for IRB approval. The IRB may disapprove research that involves a conflict of interest or it may require changes at the investigator's or sponsor's expense to eliminate or manage the conflict. Required may actions include, but are not limited to: A. Requiring divestiture or termination of relevant economic interest; B. Requiring investigator recusal from a study; C. Altering participation by the investigator in all, or a portion, of the research funded D. In case of equity, imposing a bar on insider trading, or requiring the transfer of securities to an independent financial manager or blind trust, or limiting the timing of sales or distributions; E. Monitoring of research, i.e., independent review of data and other retrospective or prospective reviews for bias, objectivity, comprehensiveness of reporting (versus withholding data); F. Requiring independent clinical review of appropriateness of clinical care given to research participants; G. Monitoring the consent process; and/or H. Requiring disclosure to institutional committees, research participants, journals, and data safety monitoring boards.
XVIII.
IRB and Institutional Official (IO) approval of a protocol will not be granted where an investigator or study staff's COI is neither eliminated nor managed.
XIX.
IRB and IO approval of a means to manage a conflict of interest is not final University approval for the research to be conducted notwithstanding the conflict. Under the UMB Policy on Human Subjects of Research, the President of UMB or his designee has final authority to allow or disallow research; however, no research may be conducted if the IRB has not approved it because of a conflict of interest.