News Archives

Preparing for COVID-19 Impacts on Research Institutions

The rapidly evolving federal, state and local policies regarding COVID-19 are impacting every walk of life in the United States and around the world. Companies, as well as academic and government researchers, have pivoted their focus on vaccines and possible treatments for the novel coronavirus. Health and research institutions are trying to keep up with […]

Reporting Changes to Research and Reportable Events due to COVID-19

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 […]

Taking Advantage of NIH Funding Increases for Investigator-Initiated Clinical Research Requires Thoughtful Protocol Writing

Earlier this year, the National Institutes of Health (NIH) announced the approval of a budget appropriation bill for funding through September 2020. In it, the NIH receives $41.68 billion in funding, an increase of $2.6 billion from FY 2019. For NIH, the new budget appropriation includes $500 million for the All of Us precision medicine study and a […]

Challenges and questions remain as the one year anniversary of the implementation of the Revised Common Rule approaches

One year has passed since the implementation of the Revised Common Rule, and many challenges and questions remain. While IRBs wait for promised guidance to materialize, we are left to interpret various aspects of the rule ourselves. This has resulted in variability across IRBs in how the new requirements are interpreted and operationalized. Variability in […]

Asentral IRB Joins BRANY IRB (Biomedical Research Alliance of New York)

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 […]

The Critical Issues Sites Need to Track During a Clinical Trial – Part Three – Enrollment

Congratulations! You have gone through all the necessary steps to launch a clinical trial. Now it’s time to move on to the next one, right? Wrong! A successfully managed clinical trial requires ongoing tracking throughout its duration. Careful tracking ensures your research organization remains compliant and that your site is compensated properly for the study. […]

The Critical Issues You Need to Track During a Clinical Trial

Congratulations! You have gone through all the necessary steps to launch a clinical trial. Now it’s time to move on to the next one, right? Wrong! A successfully managed clinical trial requires ongoing tracking throughout its duration. Careful monitoring ensures your research institution remains compliant and that your site is compensated properly for the study. […]

The Critical Issues Sites Need to Track During a Clinical Trial

News Release – BRANY Names Michael Belotto as Chairperson for Social-Behavioral IRB

NEWS RELEASE BRANY (brany.com) has announced that Michael Belotto, PhD, MPH, CCRC, CCRA, will serve as chairperson for their social-behavioral IRB. The SBER IRB is comprised of a multidisciplinary group of experts in social and behavioral research, as well as human subject protection. “Dr. Belotto has been a great contributor to BRANY IRB’s success over the past […]

The Revised Common Rule and New “Concise Summary” Requirements

Our own Linda Reuter offers thoughts on how to meet new ‘concise summary’ requirements on informed consent for clinical trials. https://bit.ly/2JUQ8o3