citi training-PHO 308 module 6

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.

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. 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 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.

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.

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.