Independent Review Board (IRB)/Ethical Review

About RCRC IRB

RCRC IRB, established in 1985, oversees research conducted by individual investigators and serves as a central IRB for multi-site national studies. The committee is dedicated to the protection of research participants involved in clinical research trials. The board is established in accordance with the FDA regulations and has the authority to approve, require modifications or disapprove all research activities under its review. RCRC IRB is a member of the Consortium of Independent Review Boards (CIRB) and reviews biomedical research studies in a wide area of therapeutic specialties.

Board Composition

RCRC IRB is organized and operates in compliance with FDA procedures described in 21 CFR Parts 50 and 56 and the International Conference of Harmonization Good Clinical Practice (ICH GCP) Guidelines. Within these guidelines, our boards adhere to the following:

• Two separate review boards meet weekly
• The majority of the members of each board are scientific in a variety of therapeutic areas, including general practice, pharmacy, toxicology, psychology, psychiatry, nephrology, internal medicine and infectious disease
• Each board also includes professionals from the community who do not have scientific or medical backgrounds
• Additional alternate members ensure that each board is able to meet once a week, providing weekly meetings as well as additional meetings if needed

Board Experience

We offer ethical review and guidance in a variety of areas, including:

• Bioavailability
• Bioequivalence
• Consumer products
• Cosmetics
• Devices
• Dose proportionality
• First-in-man testing
• Foods - taste testing
• HIV-related illness
• Cancer therapies
• Metabolic profile
• Other medical/dental devices
• Radiolabeled
• Special pharmacology

The board members have expertise in a broad range of specialties, including:

• Allergy
• Cardiology
• Dentistry
• Dermatology
• Endocrinology
• Gastroenterology
• Geriatric
• Hormonal
• Infectious diseases
• Joint and bone
• Metabolic
• Nephrology
• Ob/gyn, fertility
• Oncology
• Ophthalmology devices and implants
• Optometry
• Psychology/psychiatry
• Renal

Each board will contract with outside consultants where a specialist is needed.