The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research is a statement of basic principles, developed by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The three basic principles are the principles of Respect for Persons, Beneficence and Justice. These principles should assist scientists, subjects, reviewers and interested citizens to understand the ethical issues inherent in research involving human subjects.
Federal Regulations and Granting Agency Requirements
The Common Rule is the Federal Policy for the Protection of Human Subjects published in 1991 and codified in separate regulations by 15 federal departments and agencies, as listed below. The U. S. Department of Health and Human Services (DHHS) regulations, 45 CFR part 46, include four subparts: subpart A, also known as the Federal Policy or the “Common Rule”; subpart B, additional protections for pregnant women, human fetuses, and neonates; subpart C, additional protections for prisoners; and subpart D, additional protections for children. Each agency includes in its chapter of the Code of Federal Regulations (CFR) section numbers and language that are identical to those of the DHHS codification at 45 CFR part 46, subpart A. For all participating departments and agencies the Common Rule outlines the basic provisions for IRBs, informed consent, and assurances of compliance.
- whether an activity is research that must be reviewed by an IRB
- whether the review may be performed by expedited procedures, and
- whether informed consent or its documentation may be waived.
OHRP Human Subjects Regulations Decision Charts
Chart 1: Is an Activity Research Involving Human Subjects?
Chart 2: Is the Human Subjects Research Eligible for Exemption?
Chart 3: Does Exemption 45 CFR 46.101(b)(1) (for Educational Settings) Apply?
Chart 4: Does exemption 45 CFR 46.101(b)(2) or (b)(3) (for Tests, Surveys, Interviews, Public Behavior Observation) Apply?
Chart 5: Does Exemption 45 CFR 46.101(b)(4) (for Existing Data, Documents, Records and Specimens) Apply?
Chart 6: Does Exemption 45 CFR 46.101(b)(5) (for Public Benefit or Service Programs) Apply?
Chart 7: Does Exemption 45 CFR 46.101(b)(6) (for Food Taste and Acceptance Studies) Apply?
Chart 8: May the IRB Review Be Done by Expedited Procedures?
Chart 9: May the IRB Continuing Review Be Done by Expedited Procedures?
Chart 10: May Informed Consent Be Waived or Consent Elements Be Altered under 45 CFR 46.116(d)?
Chart 11: May Documentation of Informed Consent Be Waived Under 45 CFR 46.117(c)?