Common Rule

{
  "id": "MLC-T-ENV-005798",
  "term": "Common Rule",
  "field": "Environment",
  "definition": "1. The U.S. Department of Health and Human Services regulations (45 CFR 46) for protecting human subjects, which has been adopted by 17 federal agencies. The Common Rule includes subparts with additional protections for children, neonates, pregnant women and fetuses, and prisoners.\n\n2. Federal Policy for the Protection of Human Subjects that was established in 1991 by the Office of Science and Technology Policy and codified in 1991 by EPA and 14 other Federal departments and agencies (see the FEDERAL REGISTER issue of June 18, 1991 (56 FR 28003)) and subsequently codified by other Federal departments and agencies. The Common Rule contains a widely accepted set of standards for conducting ethical research with human subjects, together with a set of procedures designed to ensure that the standards are met. Once codified by a Federal department or agency, the requirements of the Common Rule apply to research conducted or sponsored by that Federal department or agency. EPA’s codification of the Common Rule appears in 40 CFR part 26, subpart A.\n\n3. Federal Policy for the Protection of Human Subjects as established in 1991 and codified by EPA and 14 other Federal departments and agencies (see the Federal Register issue of June 18, 1991 (56 FR 28003)) and its subsequent revisions as adopted by EPA and other federal departments and agencies (see the Federal Register issue of January 19, 2017 (82 FR 7149)). The Common Rule contains a widely accepted set of standards for conducting ethical research with human subjects, together with a set of procedures designed to ensure that the standards are met. Once codified or adopted by a Federal department or agency, the requirements of the Common Rule apply to research conducted or sponsored by that Federal department or agency. EPA's codification of the Common Rule appears in 40 CFR part 26, subpart A.[84 FR 35315; Protection of Human Research Subjects]",
  "references": [
    "NIH National Institute of Environmental Health Sciences Glossary of Commonly Used Terms in Research Ethics",
    "40 CFR 26.1102 (CFR 2018)",
    "40 CFR 120.2 (CFR 2020)"
  ],
  "url": "https://mlchart.com/terminology/environment/common-rule/"
}