Regulatory Status

Regulatory Status 2017-05-26T20:35:49+00:00

AAHRPP
In September of 2010, Midlands IRB was first awarded accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), which endeavors to improve safeguards for clinical research participants. Through this seal of approval, Midlands IRB clients and clinical trial participants can be assured that we continue to set the highest bar in regulatory compliance.

FDA
In keeping with our commitment to enhancing safeguards for clinical trial participants, we have maintained a clean audit history by the Food and Drug Administration (FDA) since our inception. It is of utmost importance to us that our panels meet the highest possible regulatory and ethical standards when reviewing clinical research.

Midlands IRB also complies with:

  • 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 (ICG) E6 Good Clinical Practices (GCP)
  • Environmental Protection Agency 40 CFR Part 26
  • Applicable Federal and State Laws