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Science Policy Resources and Tools
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Click on the links below to access resources from across the globe!

ISBER Best Practices P3G Biobank Toolkit
OHRP Compilation of Human Research Standards Global Alliance for Genomics and Health
P3G International Policy Interoperability and Data Access Clearinghouse OECD Guidelines - OECD Guidelines for Human Biobanks and Genetic Research Databases
 Council of International Organization of Medical Sciences (CIOMS) International Guidelines for Health-related Research Involving Humans World Medical Association (WMA) Declaration of Tapei on Ethical Considerations Regarding Health Databases and Biobanks


NCI Best Practices for Bioresources
45 CFR Part 46*
Final Common Rule*
HIPAA Privacy Rule*
FDA Rules & Regulations*
 NIH Genomic Data Sharing Policy
* denotes United States Regulations


 EU General Data Protection Regulation
 EU General Data Protection Regulation - FAQs
 EU-US Privacy Shield
 Council of Europe Working Document on Research on Biological Materials of Human Origin
 US Office for Human Research Protections' Compilation of European GDPR Guidances


 The Nagoya Protocol on Access and Benefit-Sharing - Convention on Biological Diversity 


 1. Rothstein MA, Knoppers BM (guest eds). Harmonizing privacy laws to enable international biobank research, part I. Special symposium. J Law Med Ethics 2015;43: 673-674
 2. Rothstein MA, Knoppers BM (guest eds). Part II: Harmonizing privacy laws to enable international biobank research. Special symposium. J Law Med Ethics 2016;44:1-172
 3. Tasse A-M, Bledsoe MJ (guest eds). Towards harmonization of the ethical, legal and social issues mosaic-An International Consortium Experience. Special issue. Biopreserv Biobank 2016;14: 193-194.


Legislation and regulatory compliance change from time to time and therefore we advise additional consultation with your local or national regulatory bodies, as this is not a definitive list of resources and tools.















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