Conflicts of Interest in Human Subjects Research
This deck covers key concepts related to conflicts of interest (COI) in human subjects research, including management plans, disclosure requirements, and examples of individual and institutional COIs.
What is the term for management controls that are built in to a research study (for example, independent data analysis)?
Key Terms
When developing conflict of interest management plans, COI committees typically examine the study design to determine whether it includes inherent controls that mitigate the researcher's opportunity to bias the research. Inherent controls may include independent data analysis, randomization, blinding, or low subject enrollment percentage at a local site for a large multi-center trial.
COI committees check for built-in study controls to reduce researcher bias.
The PHS regulations about financial conflict of interests require the researcher to disclose significant financial conflicts of interest to the organization. The FDA's regulation governing disclosure of individual COI requires applicants submitting marketing applications for drugs, biologics, or devices to certify the absence of certain financial interests or disclose financial interests of researchers who conducted clinical studies covered by the regulation.
PHS requires disclosure of financial COIs; FDA requires COI disclosure or certification in marketing applications.
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| Term | Definition |
|---|---|
What is the term for management controls that are built in to a research study (for example, independent data analysis)? | Inherent controls |
When developing conflict of interest management plans, COI committees typically examine the study design to determine whether it includes inherent controls that mitigate the researcher's opportunity to bias the research. Inherent controls may include independent data analysis, randomization, blinding, or low subject enrollment percentage at a local site for a large multi-center trial. | COI committees check for built-in study controls to reduce researcher bias. |
A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation. | No later than the time of proposal submission |
The NIH is a PHS agency. Therefore, this proposed research is subject to the PHS regulation regarding objectivity in research, which requires researchers to submit COI disclosures no later than the time a proposal is submitted to a PHS funding agency. | Researchers must submit COI disclosures before or at the time of submitting a proposal to a PHS agency like NIH. |
The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest? | Researcher |
The PHS regulations about financial conflict of interests require the researcher to disclose significant financial conflicts of interest to the organization. The FDA's regulation governing disclosure of individual COI requires applicants submitting marketing applications for drugs, biologics, or devices to certify the absence of certain financial interests or disclose financial interests of researchers who conducted clinical studies covered by the regulation. | PHS requires disclosure of financial COIs; FDA requires COI disclosure or certification in marketing applications. |
An example of an individual financial COI is: | A researcher's spouse holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study. |
Conflicts of interest may arise in the peer review process (for example, bias causes a reviewer to respond positively to a manuscript because it involves research or methodology in which the reviewer has a personal interest). | COIs in peer review can occur when a reviewer’s personal interests bias their evaluation. |
The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show: | There may be bias by the peer reviewer as to the area of research |
The COI management plan aims to: | Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed |
A COI management plan is a document that explains the procedures or extra steps to be taken to minimize the risk of bias. The procedures or protections put into place to minimize the risk of bias are often called controls. Management plans are typically tailored to the study and the researcher's financial interests. Management plans are not designed to eliminate COIs, nor reduce IRB regulatory review burden. Although management plans may be used for single site or multi-center research, their aim is to provide controls not just address disclosure of COIs. | A COI management plan outlines tailored controls to minimize bias risk, not to eliminate COIs or reduce IRB review. |
An example of an institutional COI is: | An industry sponsor pays for the construction of a new research laboratory at the organization |
An institutional COI can arise when the financial interests of an organization or institutional official (acting within his or her authority on behalf of the organization) may affect or appear to affect the research conducted under the organization's auspices. This could include significant gifts received by the organization from the sponsor of human subjects research. | Institutional COIs arise when an organization’s or official’s financial interests may influence its research. |
The FDA regulations governing disclosure of individual COIs require: | Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies |
An individual COI may arise when an individual has a personal or financial interest, which may affect or appear to affect the design, conduct, or reporting of the research. | An individual COI occurs when personal or financial interests may influence research design, conduct, or reporting. |
A researcher's membership on an advisory board with an organization sponsoring research can create a COI because: | It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success |
The FDA's regulation governing disclosure of individual COIs requires applicants submitting marketing applications for drugs, biologics, or devices to certify the absence of certain financial interests or to disclose financial interests of researchers who conducted clinical studies covered by the regulation. The regulation specifies that the FDA may refuse to file any marketing application that does not contain a disclosure of researchers' financial interests or a certification that the applicant acted with due diligence to obtain researchers' disclosures, but was unable to do so. | FDA requires COI disclosure or certification in marketing applications and may refuse applications lacking this information. |
A researcher's membership on an advisory board of an entity sponsoring research can create a conflict of interest because there may be a perception that the researcher has a motive to bias the research to create an outcome that is favorable for the sponsor. | Advisory board membership can create a COI due to perceived bias favoring the research sponsor. |
During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should: | Disclose their potential COI and may answer questions, but recuse themselves from voting |
IRB policies and procedures generally specify that members with conflicts of interest related to an agenda item must disclose their conflicts of interest, and may answer questions from the IRB about the item with which they have a conflict, but are prohibited from voting on that item. | IRB members with COIs must disclose them, may answer questions, but cannot vote on the conflicted item. |
A researcher's membership on an advisory board with an organization sponsoring research can create a COI because: | It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success |
A researcher's membership on an advisory board of an entity sponsoring research can create a conflict of interest because there may be a perception that the researcher has a motive to bias the research to create an outcome that is favorable for the sponsor. | Advisory board roles can create COIs due to perceived bias toward favorable outcomes for the sponsor. |
A researcher's membership on an advisory board with an organization sponsoring research can create a COI because: | It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success |
A researcher's membership on an advisory board of an entity sponsoring research can create a conflict of interest because there may be a perception that the researcher has a motive to bias the research to create an outcome that is favorable for the sponsor. | Advisory board roles can create COIs due to perceived bias toward favorable outcomes for the sponsor. |