Independent IRB Services

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

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.

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.)

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.

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.

• AAHRPP-Accredited since 2006
• Founded and owned by four nationally-recognized academic medical centers
• 26+ years serving as independent IRB for clinical trials and research studies
• Daily IRB meetings
• IRB review decisions within 7 days or less
• Expert committee members with thought leaders from a wide range of therapeutic areas
• Certified IRB Professionals (CIPs) and legal experts on staff
• Cost-effective pricing
• Connected IRB Model — stay linked to your research program

An Independent IRB (also known as a Commercial IRB) is a private, for-profit entity that provides external ethical review services, whereas a Central IRB (CIRB) is a designated board that oversees multiple sites for a specific study or network, acting as the IRB of record. While all Central IRBs are generally external, not all independent IRBs act as a study’s centralized board.

Often, a Central IRB is an independent board that has been designated as the Single IRB (sIRB) for a multi-center study.

BRANY IRB has served as a central IRB reviewing multi-site studies for over 25 years.

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.

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.