The Common Rule

The Common Rule is an extensive set of guidance for the protection of human subjects involved in scientific experimentation.

Highlighted below the Common Rule’s provisions that are most relevant to the subject of this web site. You can access the entire Common Rule as adopted by the EPA by clicking here.

  • Institutional Review Board (IRB) Duties. All experiments involving humans must be reviewed and approved by a duly constituted IRB. [40 CFR 26.109]
  • Criteria for IRB Approval of Research. Risks to human subjects must be minimized and not unnecessary. Risks must be reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. Informed consent must be sought documented from each subject. [40 CFR 26.111]
  • Suspension or termination of IRB approval of research. An IRB shall have authority to suspend or terminate approval of research that is associated with unexpected serious harm to subjects. [40 CFR 26.113]
  • Informed Consent. Subjects must be informed of the reasonably foreseeable risks or discomforts of the experiment and any reasonably expected benefits. [40 CFR 26.116]

The EPA has enhanced the protection of human subjects through its own EPA Order 1000.17.

NEXT: EPA Order 1000.17

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