Statement of Compliance

Pearl IRB, LLC is an independent 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 registered with OHRP and FDA.  The Pearl IRB Organization number is 0006471.  The Pearl IRB registration number is 00007772 (effective through July 20, 2018).

Pearl IRB is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). This distinction offers assurance of our commitment to providing high standards of excellence for quality, ethics, and protection to all research participants, researchers, sponsors, government regulators, and the general public.

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 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 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 protecting the rights and welfare of subjects in Human Research. The purpose of this document is to describe our plan to comply with ethical and legal requirements for the conduct and oversight of Human Research. To view Pearl IRB’s Human Research Protection Program plan, click here.

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.