How Single IRB Review Mandates Help Research Sponsors
The Food and Drug Administration’s (FDA’s) proposed single institutional review board (sIRB) mandates are in part designed to support greater
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How Single IRB Works in Practice: Challenges and Efficiencies
The single institutional review board (sIRB) model is gaining popularity due to NIH and OHRP mandates, but it’s creating new challenges for institutions and IRBs.
Beginner’s Guide to Single IRB Mandates
As clinical trial efficiencies grow, understanding single IRB mandates becomes crucial for sites and sponsors navigating ethical review processes.
Why Keep HIPAA Separate from the Informed Consent Form
The research informed consent form (ICF) is designed to provide prospective participants with the necessary information to make an informed
FDA’s September 2022 NPRMs: What They Mean for Academia and Industry
On September 28, 2022, the Food and Drug Administration (FDA) released two Notices of Proposed Rulemaking (NPRM). These notices proposed
Advarra Launches Dedicated Support Services for Research Grant Applicants
Services help ensure researchers submit a complete budget application that accounts for all necessary research support and avoids post-award financial
Local Versus Central IRBs: What’s the Difference?
Central and local IRBs share the same research oversight goals, but NIH’s single IRB mandate challenges local IRBs to adapt their broader responsibilities.
Why Institutions Should Consider an Externally Administered IBC
Clinical trials for gene therapy are booming, especially in the fields of oncology, infectious diseases, rare diseases, and regenerative medicine.
Community Consultation in the Time of COVID-19
How should sites conducting planned emergency research approach community consultation in the time of COVID-19?
Keep in Touch: Tips for Working with a Single IRB for the First Time
Recent regulations and policies have ushered in the era of mandated single IRB (sIRB) review. Many institutions must now establish policies and processes for working with an external sIRB.