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
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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.
Beginner’s Guide to Institutional Review Boards (IRBs)
In clinical research, institutional review boards (IRBs) a vital role in ensuring participant rights and ethical standards are upheld throughout the trial.
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.
Revised Common Rule Compliance Now in Full Effect—and What That Means
After multiple delays, exceptions, and oh-so-many training sessions, on January 20, 2020, we reached the last remaining compliance milestone for the final revisions to the Federal Policy for the Protection of Human Subjects (“revised Common Rule”).
Revised Common Rule Single IRB Mandate Now Effective
Compliance with the single IRB mandate for cooperative research, as outlined in the revised Common Rule, is required as of January 20, 2020.