Beneficence - Protecting Human Subject Research Participants

Protecting Human Research ParticipantsCodes and RegulationsMain Menu | Glossary | HelpEquivalent Protections for International ResearchPrevious Page 16 of 19NextWhen research covered by the HHS regulations takes place in countries other than the United States, theHHS regulations (45 CFR 46.101(h)) allow a Department or Agency head to approve the substitution ofalternative polices, codes, or regulations to protect human subjects in lieu of the requirements of 45 CFR46 as long as the alternatives afford protections that are at least equivalent to those provided in 45 CFR46.In a Federal Register Notice on July 7, 2006, HHS clarified thatthe requirements of the HHS regulations (45 CFR 46) must besatisfied for all HHS-conducted or -supported research covered bythe Federalwide Assurance, regardless of whether the research isconducted domestically or internationally. As of the publication ofthat Notice, HHS had not deemed any other procedural standardsequivalent to 45 CFR 46.Previous Page 16 of 19Nexthttp://phrp.nihtraining.com/codes/16_codes.php6/20/2008 9:45:14 AM