For organizations that need a Single Institutional Review Board (sIRB) of Record to meet federal guidelines for NIH-funded multi-site research, BRANY’s experts in research and human subject protection offer AAHRPP-accredited IRB services. Our expertise allows us to carry out the regulatory requirements as specified under the HHS regulations at 45 CFR Part 46, as well as 21 CFR 56 for FDA regulated research.
With staff from leading academic medical centers serving as IRB members, we combine the expertise of academics with the efficiency of a central board.
We work closely with investigators to ensure smooth communication between our IRB and the participating sites. To do this, we have developed:
- Workflows and alerts to investigators and research coordinators at all sites
- Specific notifications alerting of unanticipated events occurring at the organization
- Customized reports listing deviations, SAEs and other critical information
- Organizational access to BRANY IRB’s electronic protocol management system, IRB-ManagerTM
Efficient review processes
- IRB meetings twice weekly
- Expedited IRB reviews on a daily basis (when submissions qualify)
- Notification of IRB decisions within 2 days of the meeting; and 5 days for formal communication
Compliance and audit services
- BRANY’s Compliance department routinely screens active research and selects studies for either in person, or remote compliance review which helps the organization meet it post-approval monitoring goals.
- Access to IRB-ManagerTM collaborative software
- Emergency contact 24/7
BRANY IRB can also serve as the Privacy Board to ensure applicable requirements of the HIPAA Privacy Rule for use or disclosure of protected health information for research purposes are met.
For more information on BRANY’s Central IRB Services contact Carmela Houston-Henry at 516.470.6979 or email@example.com