CITI IRB (CONFLICTS OF INTEREST & BASICS OF INFO SECURITY)

CITI IRB (CONFLICTS OF INTEREST & BASICS OF INFO SECURITY) 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. - ANSWER-No later than the time of proposal submission A researcher's membership on an advisory board with an organization sponsoring research can create a COI because: - ANSWER-It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success An example of a COI is: - ANSWER-An industry sponsor pays for the construction of a new research laboratory at the organization During an Institutional Review Board (IRB) meeting, an IRB member who may have a potential COI with a study under review should: - ANSWER-Disclose their potential COI and may answer questions, but recuse themselves from voting Security measures are sometimes described as a combination of physical, technical, and administrative (PTA) safeguards. Which of these would be considered a technical safeguard? - ANSWER-Measures including device data encryption, anti-malware software, and communications encryption. The COI management plan aims to: - ANSWER-Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed The FDA regulations governing disclosure of individual COIs require: - ANSWER-Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies. The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show: - ANSWER-There may be bias by the peer reviewer as to the area of research What is the term for management controls that are build in to a research study (for example, independent data analysis)? - ANSWER-Inherent controls Which of these is generally not a good practice with respect to oral communications (that is, talking) in organizations like healthcare facilities? - ANSWER-Use of full names in public areas or on intercom/paging systems, because there is no security issue with identifying persons in public areas and using full names helps avoid mis identification. Which of these is not a good practice for physical security? - ANSWER-To preserve good customer relations, visitors are generally allowed access to all areas of a facility unless it appears they are doing something suspicious. Which of these is not generally a good practice for fax machine use? - ANSWER-Sensitive faxes -- inbound or outbound -- are left sitting in or around the machine. Which of these is not generally a good practice for telephone use? - ANSWER-Using voicemail systems and answering machines that do not require a password or PIN for access.