Understanding the regulatory foundation behind translated informed consent documents and why many institutional review boards (IRBs) require certificates or attestations of translation.
Gene therapies and gene-based therapeutics are giving way to a new era of interventional genetics. Integrated ethics review and biosafety review have developed into an operational advantage to facilitate this
IRB approval is a critical milestone in clinical research, but it isn’t the end of the oversight process. For sponsors, approval marks
Institutional review board (IRB) approval is a critical milestone in clinical research, but it can also become a source of
Multisite research and clinical trials increasingly rely on a single IRB (sIRB) for review. This increase reflects federal mandates, sponsor expectations, and the operational realities of modern multisite or cooperative research. For institutions with a local
A strong protocol and well-drafted consent form are essential, but they are not enough on their own to support a
Federal Public Policy Briefing: Understanding 21 CFR 50.54: When FDA-Regulated Pediatric Research Requires Federal Review Research involving children that poses
Let me start with a question I get more and more frequently from research sites as mRNA continues to expand
For sponsors, informed consent is one of the most visible signals of study quality during IRB review. It’s also a
A strong clinical trial protocol does more than describe how a study will run. It also helps reviewers understand why
Introducing the “‘Sponsor’s Guide to IRB Approval’“ Institutional review board (IRB) approval protects the rights, safety, and welfare of research participants, and
AI is becoming a routine part of how research proposals are prepared and reviewed, from drafting applications to supporting administrative
