Regulatory Status

FDA Audit Results

New England Institutional Review Board was audited by the United States Food and Drug Administration most recently in August 2011, and was found to be in good standing and compliant with federal regulations. In addition, New England IRB has been audited by numerous sponsor and contract research organizations. Again, the results have been favorable.

AAHRPP Accreditation

New England IRB achieved Full Accreditation status from the Association for Accreditation of Human Research Protection Programs (AAHRPP) in May 2003. Since that time, AAHRPP has awarded re-accreditation to New England IRB twice, once in 2006, and again in 2009. AAHRPP accreditation was recently extended from three to five years.

Click here to read New England IRB's most recent Accreditation Press Release.

IRB Registration Information

New England IRB is registered with both the FDA and the Office for Human Research Protections (OHRP) under IORG Number IORG0000444. New England IRB's registration can be verified via the OHRP website, using the search terms "New England Institutional Review Board", "NEIRB" or the IORG number.

Under the IORG number, New England IRB has 2 IRB Registration Numbers:

Tuesday Board: IRB00005806
Thursday Board: IRB00000755

To request that New England IRB be the IRB of record on your FWA, complete an IRB Authorization Agreement and list both of New England IRB's registration numbers on the form. The form should then be sent to New England IRB for signature.

Please note that while New England IRB is fully registered with FDA and OHRP, it does not hold an FWA number. It is the entity conducting research that is responsible for obtaining an FWA number from OHRP.

More Information

Please click on a link below for further information:

FDA Status
AAHRPP Accreditation
New England IRB Statement of Compliance
OHRP and FDA Registration 

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