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About Biological Safety at the NIH All work with hazardous biological materials is conducted in compliance with the Centers for Disease Control and Prevention / National Institutes of Health publication, Biosafety in Microbiological and Biomedical Laboratories, 6th Edition. Biological Safety - NIH nih.gov safety Pages biochemsafety nih.gov safety Pages biochemsafety
The NIH Ethics Manual is comprised of numerous chapters in the NIH Manual Chapter 2400 series. Additional chapters may be added as needed. The chapter links go to the NIH Manual Chapter web site maintained by the NIH Office of Management Assessment (OMA).
NIH is the steward of medical and behavioral research for the Nation. Its mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. About the NIH - National Institutes of Health (NIH) nih.gov what-we-do nih-almanac abou nih.gov what-we-do nih-almanac abou
All institutions that receive NIH funding for research involving recombinant or synthetic nucleic acid molecules must comply with the NIH Guidelines. Researchers at institutions that are subject to the NIH Guidelines must comply with the requirements even if their own projects are not funded by NIH. Investigator Responsibilities - NIH Office of Science Policy nih.gov wp-content uploads Investig nih.gov wp-content uploads Investig
OHRP oversees and enforces the Common Rule and other HHS regulations for protecting participants in research that is funded with HHS money. HHS agencies include, for example, the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC).

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An experiment may be considered a Major Action if: 1) it involves the use of recombinant or synthetic nucleic acids to introduce drug resistance into a microorganism, and 2) the drug in question is used to treat disease caused by the organism in humans, veterinary medicine, or agriculture. Major Actions under Section III-A of the NIH Guidelines for Research nih.gov biosafety-and-biosecurity-policy nih.gov biosafety-and-biosecurity-policy
For all participating departments and agencies the Common Rule outlines the basic provisions for IRBs, informed consent, and Assurances of Compliance. Human subject research conducted or supported by each federal department/agency is governed by the regulations of that department/agency.
The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) detail safety practices and containment procedures for basic and clinical research involving recombinant or synthetic nucleic acid molecules, including the creation and use of organisms and viruses containing

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