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ATTENTION: IMPORTANT NOTICE
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Newly Implemented Requirement: Documentation of Training for Investigators and Research Staff
RCRC IRB now require Principal Investigators and their Research Staff to provide documentation of Human Subject Protection Training. Please click on the Required Training link for more information about ways to meet this requirement.
Newly Implemented Requirement: Financial Disclosure and Conflict of Interest for Investigators and Research Staff
RCRC IRB now requires Principal Investigators and their Research Staff to complete and submit FORM 515 Financial Disclosure/Conflict of Interest document with all initial submissions, as an attachment to FORM 110. Your submission will not be reviewed by the Board without this attachment.
In the past, RCRC IRB only required the Principal Investigator to disclose this information. We are now requiring all research staff to complete and submit this form. RCRC IRB defines Research Staff as anyone designated by the Principal Investigator to perform research-related procedures per the protocol, such as sub-investigators, research coordinators, and anyone named on the Form 1572.
FORM 515 is available on our web site under the Submission Forms and Guidance Documents link.
Please note that some of our forms have been revised; use only the forms available on our web site to ensure that you are using the most current version.
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About RCRC IRB
RCRC IRB, an Independent Review Board (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.
Independent Review 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 Harmonisation
(ICH) and Good Clinical Practice (GCP) guidelines. Within these guidelines,
our boards adhere to the following:
- We operate two separate review boards that 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.
Independent Review 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.
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