CIRO Laws, Directives & Regulations

U.S. Code

• 10 USC 980 (Limitation On Use Of Humans As Experimental Subjects)
• 10 USC 1107 (Notice of use of an IND or a drug unapproved for its applied use)

Code of Federal Regulations

• 21 CFR 50 (FDA ? Protection of Human Subjects)
• 21 CFR 50.24 (Exception from Informed Consent)
• 21 CFR 312 (FDA ? IND)
• 21 CFR 314 (FDA ? NDA)
• 21 CFR 56 (FDA ? IRBs)
• 21 CFR 812 (FDA ? IDE)
• 32 CFR 219 (OSD ? Protection of Human Subjects)
• 45 CFR 46 (DHHS ? Protection of Human Subjects)
• 45 CFR 160 (HIPAA)
• 45 CFR 164 (HIPAA)

DOD Directives and Instructions

• DODI 3216.01 (Use of Lab Animals)
• DODI 3216.02 (Protection of Human Subjects and Ethical Standards)
• DODD 6000.08 (Funding & Admin of CIP)
• DODD 6200.04 (Force Health Protection)
• DODI 6490.3 (Implementation of DODD 6490.2)
• DODD 6025.18 (DOD Heath Insurance Portability and Accountability Act Regulation)
• DODI 3210.7 (Research Integrity and Misconduct)

Army Regulations and Supplements

• AR 1-100 (Gifts and Donations)
• AR 40-38 (Clinical Investigation Program)
• AR 40-66 (Medical Record Admin)
• AR 40-7 (Investigational Drugs)
  
• AR 40-33 (Use of Animals)
• AR 70-25 (Use of Volunteers as Subjects of Research)
• AR 70-57 (Military-Civilian Technology Transfer)
  
• HSC Sup 1 to AR 40-38 (245 KB)
• MEDCOM Sup 1 to AR 1-100 (168 KB)
• MEDCOM Policy on Use of Animals for Medical Purposes (729 KB)

Policy and Procedure Documents

• Army Human Subjects Research Protection Management Plan (221 KB)
• CIRO Operational Policies and Procedures (440 KB)
• CIP Policy - INDs for Force Health Protection (55 KB)
• DOD Assurance Approval (317 KB)
• CIRO HIPAA Guidance (95 KB)
• Draft Authorization (59 KB)
• Authorization (BAMC) (124 KB)
• Waiver (BAMC) (92 KB)
• HIPAA Road Map (WRAMC) (92 KB)
• DA 5303-R Template - DOC format (Thank you MAMC for sharing) (51 KB)
• DA 5303-R (minor) Template - DOC format (Thank you MAMC for sharing) (51 KB)

Simple to use CRADA models

Just download (.doc) & fill in the red areas...

• Simple CRADA Model (140 KB)
• Master CRADA Model (127 KB)