Human Research Requirements

The Office for Human Research Protections (OHRP), has released their 2020 edition of the International Compilation of Human Research Standards.  This document is available on their webpage at: https://www.hhs.gov/ohrp/sites/default/files/2020-international-compilation-of-human-research-standards.pdf

The List compiles more than 1,000 laws, regulations, and guidelines from 133 countries. These Standards are applicable to stakeholders in clinical research globally, including sponsors, investigators, and Ethics Committees.  The International Compilation of Human Research Standards, as in the past, is organized in a table format and is searchable by topic and country, with hyperlinks to the legislation, regulation, guideline, or key organization.   It is not an exhaustive list of all current standards or countries where research may take place, but the Compilation is a valuable resource for stakeholders in clinical research to locate relevant laws, regulations, and guidelines and to compare standards across the world within one cohesive document.  The list is updated every year by OHRP with new details and additional countries as more information is collected.

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