Conflicts of Interest in Human Subjects Research Exam
2023 with complete solution
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.
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.
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.
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).
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
2023 with complete solution
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.
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.
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.
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).
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
