BIOMED IRB Compliance

Statement of Compliance

The BioMedical Research Institute of America (BIOMED) is a non-profit corporation located in San Diego, CA dedicated to promoting the sciences in research and education. Founded in 1955, the organization aims to bring together talents and professionals from a diverse array of ethical, medical, and scientific backgrounds. In this space, BioMed sponsors organizations and internships that promote science and research. BioMed IRB aims to maintain the highest ethical standards in human research subjection protection.

The BioMedical Research Institute of America conducts ethical review under the U.S. Food and Drug Administration’s code of federal regulations (Title 21, Parts 50, 54, 56, 312, and 812) and the International Conference on Harmonization’s (ICH) guidelines for good clinical practice, E6.

BioMed IRB is NOT accredited with the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP), but is audited by the FDA and have been under congressional subpoenas. The FDA’s last audit on Biomed IRB was November of 2015 and no written findings were given. More information regarding BioMed’s history with the FDA and congressional subpoenas is found here.

The institution is registered with the United States Department of Health and Human Services (DHSS) as parent organization number IORG0000453 and registration number IRB00000773.

Proof of this registration may be viewed by searching the aforementioned IORG number at the DHSS’s website here. Key in the digits “0000453” in the IORG search field and “Biomedical Research Institute of America” should be a search result. Following that link, “Biomedical Rsch Inst of America IRB #1 - BioMed IRB” should be listed clicking that link should display the IRB’s information as shown below:

compliance

For any questions or concerns, please do not hesitate to contact us. Our contact information is provided below.

P.O. Box 600870
San Diego, CA 92160
(619) 282-9997
Email

FDA Controversies

FDA Controversy Close Out Letter

IRB Apology to Investigators

IRB Response to the FDA Restriction

FDA Restricts the IRB

Congressional Subpoena

2007 Congressional Subpoena

March 2016 Congressional Subpoena from Energy & Commerce Committee | Read more from E & C Committee