CITI IRB: Conflicts of Interest & Info Security

Questions and Answers

A researcher's membership on an advisory board with an organization sponsoring research can create a COI because:

There is no interest in the research's success.

It does not create a conflict.

It may influence the researcher's objectivity. (correct)

It may not affect the researcher's neutrality.

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?

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?

Inherent controls. Signup and view all the answers

At what point must a researcher submit COI disclosures to comply with PHS regulation?

No later than the time of proposal submission. Signup and view all the answers

Give an example of a 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 the disclosure of individual COIs?

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

Why can the peer review process create conflicts of interest?

There may be bias by the peer reviewer as to the area of research. Signup and view all the answers

Which of these is generally not a good practice with respect to oral communications in organizations like healthcare facilities?

Use of full names in public areas. Signup and view all the answers

Which of these is not a good practice for physical security?

Allowing access to all areas unless suspicious behavior is observed. Signup and view all the answers

Which of these is not generally a good practice for fax machine use?

Leaving sensitive faxes around the machine. Signup and view all the answers

Which of these would be considered a technical safeguard?

Device data encryption. Signup and view all the answers

Which of these is not generally a good practice for telephone use?

Using voicemail systems without password protection. Signup and view all the answers

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.

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.