Clinical Research

Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition

CDC and NIH advisory guidance on biosafety practices and containment levels for laboratories working with infectious agents and toxins.

Clinical Laboratory Improvement Amendments (CLIA)

Federal quality standards for US laboratories testing human specimens, administered by CMS with CDC and FDA under 42 CFR Part 493.

Common Rule (45 CFR Part 46) and IRB Oversight

HHS regulations at 45 CFR Part 46 protecting human research subjects and governing IRB review, overseen by the Office for Human Research Protections.

Good Clinical Practice (ICH E6(R3))

International standard for the design, conduct and reporting of clinical trials (ICH E6(R3)), issued by FDA as final guidance in the US.

ICH E6(R3) Good Clinical Practice

ICH's international guideline for the ethical and scientific conduct of clinical trials, revised as E6(R3), with Annex 2 adopted in June 2026.

NCI Best Practices for Biospecimen Resources

National Cancer Institute best practices for biospecimen resources: governance, collection, processing, storage, retrieval and dissemination of …

NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules

NIH biosafety requirements for research with recombinant or synthetic nucleic acid molecules at institutions that receive NIH support for such …

Research Data Management and FAIR Principles

Research data management and sharing practices, including the FAIR principles and the NIH Data Management and Sharing Policy for NIH-funded work.