United States

Human Research Protection

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BioChain has established an Institutional Review Board (IRB) compliant to 45 CFR part 46, 21 CFR part 56.

The IRB is registered with the Office for Human Research Protections(OHRP) with the registration number of IRB00008283.

BioChain has been issued with Federalwide Assurance (FWA), FWA00017355, for the Protection of Human Subjects for Institutions within the United States by OHRP of the Department of Health and Human Service (DHHS), USA.

The IRB is established to protect the rights and welfare of human research subjects recruited to participate in research activities.

The IRB approve, require modifications in, or disapprove all research activities according to compliance with both the federal regulations and local institutional policy.

BioChain assures that whenever it engages in human subjects research conducted or supported by any federal department or agency that has adopted the Federal Policy for the Protection of Human Subjects, known as the CommonRule, the Institution will comply with the Terms of the Federalwide Assurance for Institutions Within the United States (contained in a separate document on the OHRP website), unless the research is otherwise exempt from the requirements of the Common Rule or a department or agency conducting or supporting the research has determined that theresearch shall be covered by a separate assurance.