IRB Regulations and Guidelines

The TDMHSAS IRB will apply regulations 45 Code of Federal Regulations (CFR) Part 46, Subpart A through E. The subparts deal with the following:

Subpart A – Basic DHHS Policy for Protection of Human Research Subjects (also known as the “Common Rule”) 

Subpart B – Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research

Subpart C – Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects

Subpart D– Additional Protections for Children Involved as Subjects in Research

Subpart E – Registration of Institutional Review Boards

The IRB will follow additional regulations such as the Health Insurance Portability and Accountability Act of 1996 (HIPAA), when appropriate, in reviewing research involving human participants. Specifically, the IRB will adhere to 45 CFR Parts 160 and 164.   The IRB will also follow additional regulations where relevant, including Tennessee Code Annotated (Tenn. Code. Ann.) Title 33 and 42 CFR Part 2 of the Confidentiality of Alcohol and Drug Abuse Patient Records.