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.

Building and Fire Codes for Laboratory Facilities

Model building and fire codes used for laboratory and research facilities, published by the ICC and NFPA and adopted by state and local governments.

California Consumer Privacy Act (CCPA), as amended by the CPRA

California consumer privacy law, amended by the CPRA, enforced by the Attorney General and the California Privacy Protection Agency (CalPrivacy).

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.

Data Retention and Secure Destruction

Index of US federal sources on records retention and media sanitization, including HIPAA documentation rules, 21 CFR Part 11 and NIST SP 800-88.

EU In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR)

EU regulation for in vitro diagnostic medical devices, applicable since 26 May 2022, with legacy-device transitions running to 2027-2029.

Federal Risk and Authorization Management Program (FedRAMP)

GSA's government-wide program that assesses and certifies the security of cloud services used by US federal agencies.

Financial Conflict of Interest in PHS-Funded Research (42 CFR Part 50 Subpart F)

HHS rules at 42 CFR Part 50 Subpart F on managing investigator financial conflicts of interest in PHS-funded research, including NIH awards.

General Data Protection Regulation (EU) 2016/679

EU regulation on the processing of personal data, adopted by the European Parliament and Council and enforced by national supervisory authorities.

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.

Health Industry Cybersecurity Practices (HICP), HHS 405(d) Program

Voluntary cybersecurity practices for health care organizations from the HHS 405(d) program, published on the HHS Cyber Gateway.

Health Information Technology for Economic and Clinical Health (HITECH) Act

2009 US law that strengthened HIPAA privacy, security, breach notification and enforcement; HHS OCR enforces the HIPAA rules that implement it.

Healthcare Accessibility under the ADA and Section 504

Federal disability rights rules for health care under the ADA and Section 504, enforced by the HHS Office for Civil Rights and the Department of …

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.

ISO 14001 Environmental Management Systems

ISO 14001:2026 is the ISO standard specifying requirements for an environmental management system, with guidance for use.

ISO/IEC 27001 Information Security Management Systems

ISO/IEC 27001:2022 is the ISO and IEC standard specifying requirements for an information security management system (ISMS).

Medicare Clinical Trial Policy (NCD 310.1)

CMS national coverage determination 310.1 on Medicare payment for routine costs in qualifying clinical trials.

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 …

NIST SP 800-53 Rev. 5 Security and Privacy Controls

NIST catalog of security and privacy controls for information systems and organizations, developed under FISMA. Current: Rev. 5, Release 5.2.0.

OSHA General Industry Standards (29 CFR 1910)

US Department of Labor OSHA safety and health standards for general industry workplaces, codified at 29 CFR Part 1910.

OSHA Laboratory Standard (29 CFR 1910.1450)

OSHA standard on occupational exposure to hazardous chemicals in laboratories, requiring a Chemical Hygiene Plan, training and exposure controls.

Outbreak Investigation and Infection Control

Topic entry for outbreak investigation and infection control, pointing to CDC outbreak resources and related OSHA, CMS and state requirements.

Pharmacy Licensing and DEA Registration

State pharmacy board licensure and DEA controlled substance registration under 21 CFR Part 1301 for pharmacies, practitioners and researchers.

PHS Policy and Animal Welfare Act Requirements for Animal Research (IACUC)

Federal oversight of research animal care and use: NIH OLAW administers the PHS Policy and USDA APHIS enforces the Animal Welfare Act.

Public Health Reporting and Surveillance

State-mandated reporting of notifiable diseases by providers and labs to health departments, which share case data with CDC through NNDSS.

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.

Resource Conservation and Recovery Act (RCRA) Hazardous Waste Regulations

EPA's hazardous waste program under RCRA, which regulates hazardous waste from generation through transport, treatment, storage and disposal.

Resource Conservation and Recovery Act (RCRA) Hazardous Waste Regulations

US EPA rules under the Resource Conservation and Recovery Act for hazardous waste generation, transportation, treatment, storage and disposal.

SOC 2 (System and Organization Controls 2)

AICPA examination of service organization controls under the Trust Services Criteria: security, availability, processing integrity, confidentiality, …

U.S. Export Controls: EAR and ITAR

U.S. export controls: the EAR, administered by Commerce's Bureau of Industry and Security, and the ITAR, administered by the State Department's DDTC.

U.S. National Pandemic Influenza Strategy and HHS Pandemic Influenza Plan

Federal pandemic influenza planning documents, including the National Strategy for Pandemic Influenza and the HHS Pandemic Influenza Plan, indexed by …