Question

What law established to need for institutional review boards for clinical trials in the US?

Answer 1

Due to the various notorious experimenta which were done on humans in 20th century such as Nazi's experiment , Tuskegee syphilis study etc the establishment of National Research Act was done in 1974 . The National Research Act of 1974 established the modern IRB ( institutional review board ) system for regulating research involving human subjects .The primary purpose of the IRB is to protect the rights and welfare of human subjects involved in research activities being conducted under its authority.

In the United States, IRBs are governed by Title 45 Code of Federal Regulations Part 46. These regulations define the rules and responsibilities for institutional review, which is required for all research that receives support, directly or indirectly, from the United States federal government. IRBs are themselves regulated by the Office for Human Research Protections (OHRP) within the Department of Health and Human Services (HHS). Additional requirements apply to IRBs that oversee clinical trials of drugs involved in new drug applications, or to studies that are supported by the United States Department of Defense.

In addition to registering its IRB with the OHRP, an institution is also required to obtain and maintain a Federalwide Assurance or FWA, before undertaking federally funded human research. This is an agreement in which the institution commits to abiding by the regulations governing human research. A secondary supplement to the FWA is required when institutions are undertaking research supported by the U.S. Department of Defense