What is the purpose of Army regulation AR 40-7?
Army regulation AR 40-7 provides guidance and procedures for the use of U.S. Food and Drug Administration (FDA)-regulated investigational products in humans, including Schedule I controlled substances, within the Army.

What does FDA-regulated investigational products include?
FDA-regulated investigational products include drugs, biologics, medical devices, and dietary supplements used in clinical investigations or studies.

Who does Army regulation AR 40-7 apply to?
Army regulation AR 40-7 applies to all Army personnel involved in the use of FDA-regulated investigational products, including healthcare providers and researchers.

What is the purpose of using Schedule I controlled substances in human studies?
Schedule I controlled substances may be used in human studies when they have been deemed necessary for scientific research and have a potential medical benefit.

What are the requirements for obtaining approval to use investigational products in human studies?
Prior to using any investigational product in human studies, appropriate approvals must be obtained from the FDA, the Army Research and Materiel Command (RMC), and the Institutional Review Board (IRB).

Can Army personnel obtain and administer investigational products without proper approvals?
No, Army personnel must not obtain or administer investigational products without obtaining all required approvals as per Army regulation AR 40-7.

Are there any restrictions on the use of Schedule I controlled substances in human studies?
Yes, the use of Schedule I controlled substances in human studies must comply with all applicable federal, state, and local laws and regulations, as well as the requirements outlined in Army regulation AR 40-7.

What happens if a healthcare provider or researcher fails to comply with Army regulation AR 40-7?
Non-compliance with Army regulation AR 40-7 may result in disciplinary action, loss of privileges to conduct research, and potential legal consequences.

What are the reporting requirements for adverse events related to the use of investigational products?
Any adverse events related to the use of investigational products must be promptly reported to the IRB, RMC, and FDA as per the specific reporting requirements outlined in Army regulation AR 40-7.