Safety and Compliance Flashcards

Under the Common Rule IRB approval criteria, what must research plans include 'when appropriate'?

Answer: Adequate provision for monitoring the data collected to ensure the safety of subjects

45 CFR 46.111(a)(6) requires, when appropriate, adequate provisions for monitoring data to ensure subject safety.

NIH policy generally requires a Data and Safety Monitoring Board (DSMB) for which type of study?

Answer: Multisite clinical trials involving interventions that entail potential risk

NIH requires DSMBs for multisite clinical trials with interventions posing potential risk to participants.

Which characteristic is most important for DSMB members?

Answer: They are independent of the study and free of significant conflicts of interest

DSMB independence ensures objective review of accumulating safety and efficacy data.

In a blinded randomized trial, who typically reviews unblinded interim safety and efficacy data?

Answer: The DSMB

The DSMB reviews unblinded interim data while investigators remain blinded to protect trial integrity.

Prespecified stopping rules in a clinical trial protocol are used to:

Answer: Define criteria for terminating the trial early for harm, overwhelming benefit, or futility

Stopping rules give objective thresholds that trigger early termination to protect participants or avoid futile research.

Under the 21st Century Cures Act, Certificates of Confidentiality are:

Answer: Automatically issued for NIH-funded research collecting identifiable, sensitive information

Since 2017, NIH automatically issues Certificates of Confidentiality for funded research collecting identifiable sensitive information.

A Certificate of Confidentiality primarily protects researchers from:

Answer: Compelled disclosure of identifiable sensitive information in legal proceedings

Certificates protect against compelled disclosure, such as subpoenas, of identifiable sensitive research information.