IRB Regulations
The IRB operates under the following federal regulations. Additional information is available concerning protected groups, HIPPA and the FDA.
Federal Regulations and Guidance
- Common Rule 45 Code of Federal Regulations Par 46 Department of Health and Human Services regulations for the protection of human research subjects
- 21 Code of Federal Regulations 50 and 56 U.S. Food and Drug Administration, DSHS regulations
- U.S. Dept. of Education Subpart D (34 CFR 97)
- Family Educational Rights and Privacy Act (FERPA) Guidance
- OHRP Policy Guidance on Research Involving Coded Private Information or Biological Specimens
- Guidelines for Conduct of Research Involving Human Subjects at NIH
- OHRP Guidance on Reviewing and Reporting Unanticipated Problems
- United States Office of Management and Budget