IRB Services
“Learn more about how we provide clients with an Independent IRB solution that adapts to their needs, processes, and preferences.”
Raffaella Hart, MS, CIP Sr. Vice President, IRB and IBC Services SCHEDULE A CALL
Services & Resources
IRB Committee
IRB Administration
Workflow Review & Recommendations
Transfer of IRB Oversight
Conflict of Interest
Consent Requirements Review
Notifications, Alerts and Reporting
Compliance & Audit Services
IRBManager™ for Online Submissions
Training
Whitepaper
“Conflict of Interest: Implications for Clinical Research Sites.”
Establishing a new relationship with an Independent IRB may seem complicated. We help make it easy with an efficient, connected, and flexible approach.
AAHRPP Accreditation & Academic Medical Center Ownership
We have full AAHRPP accreditation, which was granted in 2006. In our 26 years since inception we have served as an independent IRB for multi-site research studies and a local institutional review board to academic medical centers, research organizations, and research sites. And because we were founded and currently owned by four nationally-recognized academic medical centers we have always held ourselves to the same high standards as these institutions.
Efficiency & Flexibility
Over the years, we’ve developed an efficient IRB review process that can be adapted to fit the needs of your institution.
Full Board Review (Greater than minimal risk)
| First Row | Second Row |
|---|---|
| Frequency of IRB Meetings | 2 meetings per week |
| Screening of New Submissions | Begins within 1 business day of receipt |
| When will IRB review occur | Complete submissions reviewed within 7 days or less |
| Notification of IRB decisions | Communicated within 1-2 days of the meeting |
Exempt/Expedited Review (Minimal risk)
| First Row | Second Row |
|---|---|
| Review frequency | Daily |
| Screening of New Submissions | Begins within 1 business day of receipt |
| When will IRB review occur | Complete submissions reviewed and decision communicated within 7 days or less |
| Additional sites for multisite studies | Reviewed in 1 business day |
Connected IRB Model
We understand that institutions need to stay connected to all their studies and oversee their entire research program. Our Connected IRB Model helps maintain this connection by promoting communication across the key institutional stakeholders and serving as an extension of your research team. This includes email alerts for investigators and research coordinators as well as specific alerts for critical study concerns such as unanticipated problems involving risks to subjects or others.
Compliance & Auditing
Our compliance department routinely screens active research and selects studies for in-person or remote compliance review. This helps organizations meet their post-approval monitoring goals.
Internal Compliance
BRANY IRB also looks critically at its own processes and procedures through regular internal compliance audits to ensure the highest levels of compliance with federal regulations and AAHRPP standards.
Thoughtful, Collaborative Approach
Our staff works closely with the institution’s leadership, IRB administration, and research compliance representatives to understand the specific requirements and preferences for working together. Our clients have expressed their appreciation for this level of involvement. It helps pave the way for strong and successful relationships.
Expert Committee & Staff
Many of our IRB committee members are physicians, pharmacists, and nurses from leading academic medical centers. Representation on our institutional review board committee includes thought leaders from a wide range of therapeutic areas with diverse backgrounds and decades of experience as IRB members. BRANY staff includes Certified IRB Professionals, legal experts, and research professionals many with more than 10 years of experience in IRB administration. Your team will also be given access to IRBManager™ for online study submission and management.
Privacy Board
BRANY IRB can serve as the Privacy Board if needed. We can help ensure applicable requirements of the HIPAA Privacy Rule for use or disclosure of protected health information for research purposes are met.
Frequently Asked Questions
Get answers to common questions related to IRB services.
What does IRB review entail?
For IRB review, you must submit a research protocol or study plan detailing your study's purpose, methods, participant protections, and informed consent process. Other documents may also be required, such as recruitment materials, drug/device brochures, etc. The IRB will review the submission to ensure the following key criteria:
- Research is based on sound research design
- Risks are minimized and are reasonable when compared to the potential benefits
- Selection of subjects is equitable
- Privacy and confidentiality of participants is maintained
- Adequate provisions are in place to monitor the data collected
- Informed consent is sought from prospective participants and will be appropriately documented or waived
Are there different types of IRB review?
Yes, there are different types of IRB review. For example, research that falls into certain categories under the federal regulations may qualify for an exemption from IRB review.
For non-exempt research, review types include:
- Expedited review: When research is no more than minimal risk to participants and fits into one of the 9 expedited review categories that may be reviewed by an expedited procedure.
- Review by the convened IRB:When research involves more than minimal risk to participants and research does not meet the criteria for expedited review.
BRANY IRB streamlines the approval process with an efficient review system.
What types of research require IRB review?
For FDA-regulated research, activities are considered human research subject to FDA regulations when they meet the FDA definition of “research,” which is an activity involving an FDA-regulated test article and a “subject,” which is an individual who is a research participant who either receives the test article or serves as a control.
Under DHHS regulations or the Common Rule, activities are human subject research when they are a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. (Note: If the activity is NOT a systematic investigation designed to develop or contribute to generalizable knowledge, the activity does not meet the definition of human subject research under the DHHS regulations. However, it may meet the definition of human subject research under the FDA definition.)
Do I need IRB approval if I want my research to be published in a journal?
Most peer-reviewed journals require evidence that an IRB review was sought before starting the research. IRBs cannot grant retrospective approval for research that has been completed. BRANY IRB provides IRB review services for researchers seeking IRB review of their independent research projects.
What are independent IRB services?
Independent IRB services (sometimes called commercial IRB services) are provided by private, non-institutional IRBs that review research studies for sponsors, CROs, and investigators. Establishing a relationship with an independent IRB may seem complicated, but BRANY IRB makes it easy with a connected approach to IRB review.
Does BRANY IRB have experience reviewing multi-site studies?
BRANY IRB has served as a central IRB reviewing multi-site studies for over 25 years.
How does BRANY IRB support compliance and auditing?
BRANY IRB’s quality assurance department routinely completes Good Clinical Practice (GCP) reviews for active research studies based on certain criteria. Study sites appreciate the educational approach the BRANY IRB auditors have when completing a GCP review. These reviews can help detect, correct and prevent research non-compliance.
BRANY IRB also conducts internal quality assurance audits to maintain the highest levels of adherence to federal regulations and AAHRPP standards.
How can I submit my research to BRANY IRB?
First, contact us to discuss your IRB needs. Then, our experienced team of IRB professionals will guide you through the review process to ensure a smooth submission. At that time, you can submit your study through IRBManager, our online platform for IRB submission and management.