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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Regulatory Trends in Cell and Gene Therapies
As cell and gene therapy advances, the FDA is shaping regulatory trends to streamline approvals, support innovative therapies, and enhance global harmonization.
Evaluating Payment to Participate in Research: Ethical and Regulatory Issues
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
Understanding FDA’s Draft Guidance on Ethical Considerations for Involving Children in Clinical Trials
In 2016, the Food and Drug Administration (FDA) approved Spinraza (nusinersen). It was the first drug to treat children with
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
Unpacking IRB Innovations for Decentralized Clinical Trials
In the blink of an eye, the world has gone digital. So many tasks which used to require going to
Informed Consent Writing Tip Sheet
Crafting informed consent forms requires balancing regulatory compliance with participant understanding, ensuring consent is both meaningful and legally sound.
How the IND 30-day Hold Impacts Clinical Trial Activities
The Food and Drug Administration (FDA) is the federal entity in the U.S. charged with (among other things) “ensur[ing] that
Safe Sharps Handling When Dispensing Investigational Products
Institutional biosafety committees (IBCs) frequently receive questions about the proper methodology for preparing a syringe for transport from a drug
What Does an Endpoint Adjudication Committee (EAC) Do?
Learn how Endpoint Adjudication Committees ensure safe study conduct, mitigate participant risks, and provide unbiased medical event reviews.
Advarra Trend Report: Current State of Trial Opportunity and Selection
Discover survey findings on trial selection, from cumbersome feasibility questionnaires to improving transparency and site opportunities.
Clean Bench vs Biosafety Cabinet: What’s the Difference?
Institutional biosafety committees (IBCs) frequently receive questions about the proper type of hood for use with biological materials and the