Recent news about approved immunotherapy and gene therapies has generated excitement around the possibilities of treating difficult diseases. Organizations have increased funding in this area, including a recently announced $1.3 million grant in funding by the Alliance for Cancer Gene Therapy for research in gliobastoma, sarcoma and ovarian cancer. The increased attention and funding means […]
Last year we asked research staff and managers to tell us about their staff training needs. We want to thank those who took the time to complete the questionnaire. The results are in and here is what we learned. The majority of those who responded to the survey either have limited or no funding for […]
It’s once again time to get ready for the National Football League (NFL) Super Bowl, and the odds-makers are making their forecasts. Many an office worker is looking to join the fun by participating in office pools to see if, this year, they get lucky. One person, however, is raising his eyebrows as people make […]
Representatives from BRANY, CITI, Protocol Builder, and HPR Consulting are all still abuzz about the great conference hosted by PRIM&R this year. We have returned to our work newly energized and inspired and have spent the past couple weeks back in our offices talking about what we learned and would like to share these reflections […]
BRANY announced today the release of a new research protocol template specifically designed to address the unique needs of social-behavioral-education researchers, as part of Protocol Builder®, a secure, cloud-based protocol writing application. “Social and behavioral research is distinct from biomedical research,” says Jeffrey Cohen, PhD, a principal with HRP Consulting Group, also a division of […]
The National Institutes of Health (NIH) Policy on the use of a Single Institutional Review Board of Record (sIRB) for Multi-Site Research establishes the expectation that all sites participating in multi-site studies involving non-exempt human subjects research funded by the NIH will use a sIRB to conduct the required ethical review for the Protection of […]
The process of launching a clinical trial can be daunting for an inexperienced researcher and his or her team. From carefully reviewing a research protocol to navigating the IRB process, the researcher and team must ensure certain steps are followed to comply with federal and state regulations, as well as their own institutions’ policies and […]
Final revisions to the Common Rule were published January 19, 2017. Our colleagues at HRP Consulting Group have assembled a summary of the changes. Please click here to read them => summary of the changes
As 2016 winds down we start to look ahead and prepare for the new year. With the elections over, much has been said about what a new administration may mean to pending research legislation, the regulatory landscape, or research funding. Even without a crystal ball, there are several things that a research professional can do […]
Focused IRB offers specific expertise in social and behavioral sciences, including: Qualitative Research Nursing Research (Magnet Designated) Quality of Life Research Evidence based research (Lake Success, NY) — BRANY announced today the launch of a new IRB focusing on social, behavioral and educational research (SBER). “The aim of BRANY’s SBER IRB is to offer social, […]
Feds Announce Requirements Aimed at Providing more information about clinical trials to the public The US Department of Health and Human Services (HHS) recently announced a final rule, which outlines new requirements for registering and recording certain clinical trials on its ClinicalTrials.gov website. At the same time, the National Institutes of Health (NIH) issued a […]
Pediatric hematologist-oncologist Kris Michael Mahadeo, MD., has been with Children’s Hospital at Montefiore (CHAM) in New York for two years. He was previously at University of Southern California, Keck School of Medicine and Children’s Hospital in Los Angeles. Like many other specialists in pediatric cancer, he credits the low mortality rate among children with cancer […]
BRANY recently completed an analysis to assess how principal investigators are enrolling in active clinical trials. The ten investigators listed below, along with their research teams, consistently enrolled subjects in their ongoing clinical trials, hitting their recruitment goal at an average of 70 percent or higher. We were impressed with these statistics and wanted to […]
In May 2016, BRANY (Biomedical Research Alliance of NY), a national organization providing support services to research institutions and investigators in a wide variety of therapeutic areas, medical devices, biologic and diagnostic trials, announced its acquisition of the Collaborative Institutional Training Initiative Program (CITI). The link below will bring you to frequently asked questions about the acquisition. https://support.citiprogram.org/customer/portal/articles/2477581-citi-program-a-division-of-brany—faq If you have any […]
The NIH has released its final policy on the use of central IRBs for multi-site research. Starting May 2017, in multi-site studies in the United States involving non-exempt human subjects research funded by the National Institutes of Health (NIH), research institutions will be expected to use a single Institutional Review Board (sIRB) to conduct the […]
The FDA recently released a draft guidance policy categorizing investigational device exemption (IDE) devices. The guidance was developed to assist the Centers for Medicare & Medicaid Services (CMS) in determining whether or not an IDE device should be covered (reimbursed) by CMS. The guidance has significant implications for research sites and investigators who are responsible […]
(Lake Success, NY) — BRANY (Biomedical Research Alliance of NY), a national organization providing support services to research institutions and investigators in a wide variety of therapeutic areas, medical devices, biologic and diagnostic trials, announced today its acquisition of the Collaborative Institutional Training Initiative Program (CITI), a leading provider of online research ethics education to the research community. “With […]
HRPs Conulting Group joining BRANY HRP Consulting Group, Inc. (“HRP”) will be joining BRANY (Biomedical Research Alliance of New York, LLC (“BRANY”) as a separate division of the company, both companies announced today. The partnership will provide a platform to support the growth of HRP as it continues to respond to the needs of its public […]
We are pleased to announce that Laura Donohue has joined the team as IRB Supervisor, where she will work with BRANY’s central, AAHRPP-accredited IRB. “Laura’s extensive experience as a research coordinator at one of our founding institutions provides her with insights that will be invaluable to our other clients,” says Raffaella Hart, vice president, […]
September 30 marked the first day of implementation of the Physician Payment Sunshine Act, with the launch of the Open Payments Program and the release of an online database of the financial relationships between drug and device companies’ and physicians. The Web site will eventually report all payments or transfers of value—including payments for […]
BRANY is pleased to announce its participation in AWARE for All-New York City, a free educational event featuring a health fair and informative presentation about clinical research participation. AWARE for All is a free program that aims to educate and empower patients and the public to make informed decisions about clinical research participation. Learn how […]
News release March 2015 BRANY Earns Five-Year AAHRPP Accreditation BRANY has successfully continued its Full Accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). The five-year accreditation reflects BRANY’s continuing commitment to protecting the rights and welfare of research participants. AAHRPP’s accreditation process help organizations consistently meet ethical principles and standards […]
BRANY (Biomedical Research Alliance of New York) has licensed its proprietary SMART (Study Management and Revenue Tracking) system to Tech Software, an information technology company that currently offers IRBManager, a fully Web-based software product that supports the administration of institutional review boards at leading hospitals throughout the country. The BRANY SMART system is a clinical study […]