The 2018 edition of the International Compilation of Human Research Standards has been released by the Office for Human Research Protections (OHRP) and can be found here. The Standards compile more than 1,000 laws, regulations, and guidelines from 130 countries, including new countries to the 2018 edition Algeria, Madagascar, Mali, and Saint Lucia. The Standards were created for Sponsors, Investigators, Ethics Committees, and other stakeholders in clinical research, globally. Social-Behavioral research is newly included in the 2018 edition of the Compilation.
The listing of the nine standards (from 2018 Standards):
1. “General, i.e., applicable to most or all types of human subject research
2. Drugs and Devices
3. Clinical Trial Registries
4. Research Injury
5. Social-Behavioral Research
6. Privacy / Data Protection
7. Human Biological Materials
9. Embryos, Stem Cells, and Cloning”
The 2018 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.
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-The Clinical Pathways Team