4/28/2020
The Office for Human Research Protections (OHRP), released the 2020 edition of the International Compilation of Human Research Standards, which is available here. The Standards compile more than 1,000 laws, regulations, and guidelines from 133 countries. The Standards are applicable to stakeholders in clinical research globally, including sponsors, investigators, and Ethics Committees.
The listing of the nine standards (from 2020 Standards):
“General, i.e., applicable to most or all types of human subject research
Drugs and Devices
Clinical Trial Registries
Research Injury
Social-Behavioral Research
Privacy/Data Protection
Human Biological Materials
Genetic
Embryos, Stem Cells, and Cloning”
The 2020 edition of the International Compilation of Human Research Standards is organized in table format and is searchable by topic and country, with hyperlinks to the legislation, regulation, guideline, or key organization. Although it is not an exhaustive list of all current standards, 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 Clinical Pathways Team
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