Podcast
Questions and Answers
A researcher's membership on an advisory board with an organization sponsoring research can create a COI because:
A researcher's membership on an advisory board with an organization sponsoring research can create a COI because:
During an Institutional Review Board (IRB) meeting, an IRB member who may have a potential COI with a study under review should:
During an Institutional Review Board (IRB) meeting, an 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.
What is the aim of the COI management plan?
What is the aim of the COI management plan?
Provide procedures or extra steps to minimize the risk of bias when a COI is disclosed.
What is the term for management controls that are built into a research study?
What is the term for management controls that are built into a research study?
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At what point must a researcher submit COI disclosures to comply with PHS regulation?
At what point must a researcher submit COI disclosures to comply with PHS regulation?
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Give an example of a COI.
Give an example of a COI.
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What do FDA regulations require regarding the disclosure of individual COIs?
What do FDA regulations require regarding the disclosure of individual COIs?
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Why can the peer review process create conflicts of interest?
Why can the peer review process create conflicts of interest?
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Which of these is generally not a good practice with respect to oral communications in organizations like healthcare facilities?
Which of these is generally not a good practice with respect to oral communications in organizations like healthcare facilities?
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Which of these is not a good practice for physical security?
Which of these is not a good practice for physical security?
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Which of these is not generally a good practice for fax machine use?
Which of these is not generally a good practice for fax machine use?
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Which of these would be considered a technical safeguard?
Which of these would be considered a technical safeguard?
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Which of these is not generally a good practice for telephone use?
Which of these is not generally a good practice for telephone use?
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Study Notes
Conflicts of Interest (COI)
- Membership on an advisory board can create a COI due to potential bias from a researcher's interest in the research's success.
- An IRB member with a potential COI must disclose it, answer questions, and recuse themselves from voting.
- A COI management plan outlines procedures to minimize bias when a COI is disclosed.
- A common example of a COI is when an industry sponsor finances the construction of a research lab at an organization.
Institutional Review Board (IRB) and COI
- COI disclosures to comply with PHS regulation must be submitted no later than when the proposal is submitted to NIH.
- FDA regulations require the disclosure of financial COIs from researchers in clinical studies during marketing applications.
Peer Review Process
- The choice of reviewers for a potentially publishable project can lead to biases based on the peer reviewer's research area.
Information Security
- Oral communications in healthcare settings should avoid using full names in public areas or on intercoms to maintain privacy.
- Visitors should not be granted unrestricted access to all areas of a facility as a standard practice for physical security.
- Sensitive faxes must not be left unattended near the machine to prevent unauthorized access.
Safeguards and Security Measures
- Security measures include physical, technical, and administrative safeguards, often referred to as PTA safeguards.
- Technical safeguards encompass device data encryption, anti-malware software, and communications encryption.
Telephone Use Practices
- Voicemail systems and answering machines should require passwords or PINs to protect access, which is a recommended practice for telephone use.
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Description
Test your knowledge on Conflicts of Interest and the basics of information security as related to Institutional Review Boards (IRBs). This quiz includes flashcards that address key concepts and definitions essential for understanding COI in research settings.
