Regulatory Status

At New England IRB, we endeavor to attain the highest quality and efficiency standards in all our business operations. As a result, our organization 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 three times- in 2006, 2009, and again in 2015.
New England IRB has been audited by the United States Food and Drug Administration most recently in July 2016, and were found to be in good standing and compliant with federal regulations. This accomplishment underscores New England IRB’s commitment to championing scientifically and ethically sound research, safeguarding clinical trial participants, and demonstrating continuous improvement.


  • U.S. Food and Drug Administration Regulations 21 CFR Parts 50 and 56
  • U.S. Department of Human Health Services Regulations 45 CFR 46A
  • International Conference on Harmonisation (ICH) E6 Good Clinical Practices (GCP)
  • Environmental Protection Agency 40 CFR Part 26
  • Applicable Federal and State Laws
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