Regulatory Compliance
Cell & Gene Therapy
The Basics of the Individual Expanded Access Request Process: A Resource for Physicians
Whitepapers
Diversity & Inclusion
The Role of IRBs in Research Oversight: Information for Research Teams to Support Diverse Research Participation
Whitepapers
Ethics in Clinical Research
The Role of IRBs in Research Oversight: Information for Potential Participants in Clinical Research
Whitepapers
Participant Recruitment
Does the IRB need to approve doctor-to-doctor letters?
Blog Posts
Regulatory Compliance
What are the IRB review requirements for human factors/usability testing?
Blog Posts
Clinical Trial Safety
Changes in Research: What are They and When do They Need to be Submitted to the IRB?
Whitepapers
FDA & ICH
Can a physician submit a single humanitarian use device (HUD) submission to the IRB?
Blog Posts
Ethics in Clinical Research
Compensating Research Participants FAQ
Blog Posts
Ethics in Clinical Research
Ask the Experts: When Do I Report a Protocol Deviation to the IRB? Do I Need To Report a Summary of Deviations at the Time of Continuing Review?
Blog Posts
FDA & ICH