Artificial intelligence (AI), connected wearables, and Software-as-a-Medical-Device (SaMD) are expanding the very definition of a “device.” New technological innovations continue to obscure traditional applications of research tools and interventions, challenging sponsors, CROs, and study monitors to rethink how risk is defined, how submissions are prepared, and how Institutional Review Boards (IRBs) assess safety and ethics. […]
Informed consent is a cornerstone of ethical clinical research. As stated in the Belmont Report, a foundational research ethics document, true informed consent must have three components: information, comprehension and voluntariness. Delivering information is the most straightforward part of informed consent. In addition to the informed consent document, research teams, sponsors, CROs and/or study monitors […]
The FDA recently released draft guidance to help sponsors, clinical investigators and Institutional Review Boards (IRBs) better define, identify and report protocol deviations in clinical trials. By establishing a standardized approach, the FDA aims to minimize risks associated with deviations and ensure trials remain trustworthy. In cell therapy clinical trials, protocol deviations pose a significant […]
On June 1, 2025, an implementation update from the NIH Office of Science Policy (OSP) took effect. These requirements apply to institutions conducting NIH-funded research involving recombinant or synthetic nucleic acid (r/sNA) molecules that fall under Section III of the NIH Guidelines. Under the new rules, Institutional Biosafety Committees (IBCs) must take two key steps: […]
When an IRB determination letter indicates that reconsent is required, it can feel like a rigid mandate that adds to the workload of teams already operating with limited time and resources. Reconsent can feel like a disruption if you see it as a complete, formal consent process all over again: revising documents, reviewing changes in […]
IRB review and approval are required before a clinical trial can begin. The faster your protocol is approved, the faster you can get to your trial’s starting line. How can you work to get the initial IRB submission right the first time? Depending on your study, the initial IRB submission process can involve common challenges […]
Think the IRB review process can’t be easier? Think again. Submitting your protocol to an IRB is the first of many steps in a successful clinical trial. Get it right the first time, and you keep your pace in the drug development race. But any problem at this stage — whether it’s slow responses, […]
By Linda Reuter Informed consent is a cornerstone of ethical clinical research. As stated in the Belmont Report, a foundational research ethics document, true informed consent must have three components: information, comprehension and voluntariness. Delivering information is the most straightforward part of informed consent. In addition to the informed consent document, research teams, sponsors, CROs […]
Salt Lake City, UT – November 14-18, 2022
Milwaukee, WI and Virtual – October 14-19, 2022
Chicago, IL and Virtual – June 19-23, 2022
Office for Human Research Protections (OHRP) and Northwell Health Forum – May 11-12, 2022
Virtual Summit – May 9-10, 2022
Virtual Summit – March 8-10, 2022
End-to-end solution is designed to help hospitals and institutions attract and administer sponsored clinical research studies (Lake Success, NY) — BRANY today announced the launch of CTrials, an innovative end-to-end solution that offers a clinical trials administrative support service focused on helping hospitals and institutions accelerate their research goals. CTrials by BRANY is built around […]
BRANY IRB is monitoring the COVID-19 epidemic and has been notified that organizations conducting research have implemented guidelines to ensure the health and safety of employees, visitors, patients and research participants. In some cases, such guidelines may impact a research team’s ability to carry out study procedures and visits as required. We recognize that this […]
For Immediate Release 17 December 2019 Asentral, Inc. Institutional Review Board (IRB), based near the biotech hubs of Boston and Cambridge, Massachusetts, is joining BRANY, company officials announced today. BRANY will provide its full suite of IRB services to Asentral’s current clients. “Asentral was founded by research professionals with deep research experience, and has been […]