Statement of Compliance

Pearl IRB, LLC is an independent institutional review board with written procedures for efficient review of clinical trials, proper documentation and record retention.  In accordance with federal regulations, our IRB is comprised of highly experienced and trained individuals with a diverse background in science, medicine and ethics.

Pearl IRB is guided by the ethical principles regarding all research involving human subjects as set forth in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. We are committed to providing high quality institutional review board (IRB) services as participants in an overall human subjects protection program

Pearl IRB operates in compliance with the United States Department of Health and Human Services regulations 45 CFR Part 46, entitled Protection of Human Subjects. United States Food and Drug Administration as described in 21 CFR Parts 50 and 56, the International Conference on Harmonization Good Clinical Practice Guidelines (ICH E6).

Pearl IRB is registered with OHRP and FDA.  The Pearl IRB Organization number is 0006471.  The Pearl IRB registration number is 00007772 (effective through June 9, 2013).

Pearl IRB is dedicated to leading Quality Improvement, and we review our processes along with their documentation and training on a regular and routine basis.  Accreditation of human subjects protection programs is a concept we promote and support.  We are committed to continuous improvement and therefore welcome client feedback about all aspects of our business.

Pearl IRB is in compliance with Good Clinical Practices as defined under the U.S. Food and Drug Administration (FDA) regulations and the International Conference on Harmonization (ICH) guidelines. This statement also appears on all Certificates of Approval issued by Pearl IRB.