Protocol Writing
How to describe your research design, risks, and participant protections in the protocol narrative.
Walkthroughs covering the core skills every IRB applicant needs, from first protocol draft through multi-site reliance and decentralized designs.
How to describe your research design, risks, and participant protections in the protocol narrative.
Section-by-section walkthrough of an informed consent form with annotated examples.
Extra protections for minors, prisoners, pregnant individuals, and cognitively impaired participants.
Security, anonymization, storage, and sharing expectations the IRB will ask about.
When you need to amend an approved protocol and how to do it without delaying your work.
What to expect from CITI modules and how to prepare efficiently.
NIH sIRB policy, SMART IRB reliance, and what stays with the local site in multi-site studies.
IRB considerations for remote consent, wearables, telehealth visits, and at-home biosampling.