State Laws, Federal Regulations & Policy Guidance
The following federal regulations apply to all research proposals submitted to the Washington State Institutional Review Board:
- Protection of Human Subjects 45 CFR Part 46
The following may apply to research proposals submitted to the Washington State Institutional Review Board:
- Promoting Objectivity in Research 42 CFR 50 Part F
- Protection of Human Subjects in Clinical Trials 21 CFR parts 50, 56, 312, and 812
- Confidentiality of Alcohol and Drug Abuse Patient Records 42 CFR Part 2
- Protection of Identity - Research Subjects 42 CFR Part 2a
- General Administrative Requirements - ("HIPAA Privacy Rule") 45 CFR Part 160
- Security and Privacy ("HIPAA Privacy Rule") 45 CFR Part 164
- Responsible Prospective Contractors 45 CFR Part 94
Note: while we strive to keep this site up to date with the latest regulations, we recommend that you check the Government Printing Office Code of Federal Regulations (Annual Edition) and FDA Clinical Trials and Human Subject Protection for the most current versions of regulations.
US Dept. of Health & Human Services, Office for Human Research Protections (OHRP) Policy Guidance
The following state policy applies to all research proposals submitted to the Washington State Institutional Review Board:
The following DSHS policy applies to all PHS-funded research:
The following state laws & regulations apply to many research proposals submitted to the Washington State Institutional Review Board:
- Abuse of Vulnerable Adults RCW 74.34
- Abuse of Children RCW 26.44
- Abuse of Patients RCW 70.124
- Confidentiality of Prescription Information RCW 70.225.040 (section 4)
- Release of Records for Research RCW 42.48
- Medical Records Health Care Information Access and Disclosure RCW 70.02
- Newborn Screening - Privacy and Security WAC 246-650-050
- Notifiable Conditions WAC 246-101
- Protection of Human Research Subjects WAC 388-04
- Research with Vital Records:
- Release of Records RCW 70.58.082
- Disclosure for Research Purposes RCW 70.58.104
- Requesting a listing or file with Personal Identifiers WAC 246-490-030
- Requesting Records without Personal Identifiers WAC 246-490-020