Conflicts of Interest in Human Research

Questions and Answers

What is the term for management controls that are built into a research study?

Inherent controls (correct)

Regulatory controls

External controls

Advisory controls

When must researchers submit COI disclosures to comply with the PHS regulation?

No later than the time of proposal submission

Who is required to disclose significant financial conflicts of interest according to the PHS regulations?

Researcher

What is an example of an individual financial COI?

A researcher's spouse holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study. Signup and view all the answers

What issue may arise in the peer review process?

Bias from reviewers due to personal interests Signup and view all the answers

What is the aim of a COI management plan?

Provide procedures or extra steps to minimize the risk of bias when a COI is disclosed. Signup and view all the answers

What is an example of an institutional COI?

An industry sponsor pays for the construction of a new research laboratory at the organization. Signup and view all the answers

What do FDA regulations require regarding individual COIs?

Applicants submitting marketing applications must disclose financial COIs of researchers who conducted clinical studies. Signup and view all the answers

During an IRB meeting, what must any IRB member with a potential COI do?

Disclose their potential COI and recuse themselves from voting. Signup and view all the answers

Study Notes

Inherent Controls and Conflict of Interest Management

Inherent controls are management methods integrated into a research study to reduce bias, such as independent data analysis.
COI committees assess study designs to verify the presence of inherent controls, which can include randomization, blinding, and minimal local site enrollment in multi-center trials.

COI Disclosures and Regulations

Researchers must submit COI disclosures at least by the proposal submission date when applying for NIH funding.
The PHS regulation mandates COI disclosures for researchers seeking NIH funding, emphasizing objectivity in research.

Disclosure Responsibilities

Significant financial conflicts of interest must be disclosed by the researcher to their organization.
FDA regulations require applicants to disclose financial interests of researchers involved in clinical studies for drugs, biologics, or devices.

Examples of Conflicts of Interest

Individual financial COI example: A researcher’s spouse owns shares in a pharmaceutical company sponsoring the research.
Institutional COI example: An organization receives funding for a new research lab from an industry sponsor.

Peer Review Process and COI

Conflicts of interest in peer review may arise when reviewers have personal interests in the studies they evaluate, potentially leading to bias.
The choice of peer reviewers can influence outcomes based on their interests in specific research areas.

Purpose of COI Management Plans

COI management plans outline procedures to minimize bias risk when a conflict is disclosed, tailored to each study and the researcher's interests.
Management plans are designed to provide controls rather than eliminate conflicts or reduce IRB regulatory burdens.

Advisory Board Membership and COI

Membership on an advisory board of a sponsoring organization may create a COI, as it challenges the researcher's neutrality and can raise perceptions of bias.
Researchers involved in advisory boards may appear incentivized to produce favorable outcomes for their sponsors.

Institutional Review Board (IRB) Policies

During IRB meetings, members with potential conflicts must disclose their COIs and can answer questions but must recuse themselves from voting on related items.
IRB procedures highlight that members with conflicts of interest are prohibited from voting, ensuring unbiased review of research proposals.

Description

This quiz focuses on the concepts of conflicts of interest in human subjects research, particularly the management controls inherent in study designs. It covers key terms and definitions related to ensuring ethical research practices. Test your understanding of these essential concepts in the realm of human subject research.