Policies can be your best friend, or your worst enemy. When things go off track, it’s great to have guidance documents to put things right. However, there is nothing deadlier than not following established policy – whether institutional, federal, state, or sponsoring agency. Therefore, you want to ensure that what you do in practice is in keeping with policy, and if it doesn’t match up, then something must change.
Office for Human Research Protectionshttps://www.hhs.gov/ohrp/regulations-and-policy/index.html
The Belmont Reporthttps://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html
Food and Drug Administration (FDA) - FDA Rules and Regulationshttps://www.fda.gov/RegulatoryInformation/RulesRegulations/default.htm
Guidancehttps://www.fda.gov/RegulatoryInformation/Guidances/default.htm
CFR - Code of Federal Regulations Title 21https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
NIH Clinical Trials and Human Subjects Requirementshttps://grants.nih.gov/policy/clinical-trials.htm
Office of Laboratory Animal Welfare (OLAW) https://grants.nih.gov/grants/olaw/olaw.htm
United States Department of Agriculture Animal Welfare Acthttps://www.aphis.usda.gov/animal_welfare/downloads/AC_BlueBook_AWA_FINAL_2017_508comp.pdf
Office of Science Policy https://osp.od.nih.gov/biosafety-biosecurity-and-emerging-biotechnology/
NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules https://osp.od.nih.gov/biotechnology/nih-guidelines/
National Institutes of Health Guidelines for Human Stem Cell Research https://stemcells.nih.gov/policy/2009-guidelines.htm
NIH Human Embryonic Stem Cell Registry https://grants.nih.gov/stem_cells/registry/current.htm
US Munitions List - ITAR https://www.pmddtc.state.gov/regulations_laws/documents/official_itar/ITAR_Part _121.pdf
Commerce Control List - EAR http://www.bis.doc.gov/index.php/regulations/commerce-control-list-ccl
State, Commerce, or Treasury Department’s lists of entities of concern http://www.bis.doc.gov/index.php/policy-guidance/lists-of-parties-of-concern
Exporting http://export.gov/ecr/eg_main_023148.asp
National Institutes of Health (NIH) Grants Policy Statement (NIHGPS) https://grants.nih.gov/policy/nihgps/index.htm https://grants.nih.gov/grants/policy/nihgps/nihgps.pdf
National Science Foundation (NSF) https://www.nsf.gov/pubs/manuals/gpm05_131/index.jsp
Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards https://www.federalregister.gov/documents/2013/12/26/2013-30465/uniform-administrative-requirements-cost-principles-and-audit-requirements-for-federal-awards
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