Laws and Regulations That Affect NIH's Programs
Here is a list of laws and regulations that are relevant to NIAID and a brief description of how each one affects our programs.
Table of Contents
Background
Laws and regulations get recorded in different places with different codes. To help you sift through those codes, we created a list of each.
Use both lists to get the whole picture. For example, if you want to see what spurred NIH to develop the Interagency Edison invention reporting system, you could look up the relevant patent law, Bayh-Dole Act of 1980, and the technology transfer rules established in regulation 37 CFR 401.14.
You can find the Bayh-Dole Act under Federal Laws Relevant to NIH, and find the federal regulation under Executive Branch Regulations Relevant to NIH.
If you want to do more research on your own, take a moment to read How to Use Online Resources to Read Public Laws, our brief summary of how to look up laws and regulations in public databases. For NIAID resources and advice about how to conduct your research, see our All About
Grants Tutorials.
Federal Laws Relevant to NIH
Laws affecting public health and the work of NIH include:
- American Recovery and Reinvestment Act of 2009 (ARRA) -- Stimulus package designed to create and save jobs, jump-start the economy, and build the foundation for long-term economic growth.
- Bayh-Dole Act of 1980 (P.L. 96-517) -- Through technology transfer, stimulates commercialization of inventions resulting from federally funded research.
- Drug-Free Workplace Act of 1988 (P.L. 100-690) -- Requires federal grantees and contractors to certify that they maintain a drug-free workplace.
- Federal Advisory Committee Act (FACA) of 1992 (P.L. 92-463) -- Provides guidance on managing public committees that advise federal agencies.
- Federal Financial Assistance Management Improvement Act of 1999 (P.L. 106-107) -- Mandates streamlined federal grants processing and provides the impetus for electronic grants. For information on electronic grants at NIH, go to Electronic Submission.
- Federal Grant and Cooperative Agreement Act of 1977 (31 USC 6304 and 6305) -- Distinguishes federal grants and cooperative agreements from contracts.
- Federal Information Security Management Act (FISMA; P.L. 107-347, Title III) -- Requires federal grantees and contractors to protect sensitive data. See the Data Security SOP.
- Freedom of Information Act (P.L. 90-23) -- Ensures public access to government records. For more information see the USDOJ Web site.
- Government Performance and Results Act (P.L. 103-62) -- Directs federal agencies to set goals, measure performance, and report on their accomplishments.
- Hatch Act for Federal Employees -- Describes allowable political activities for federal employees.
- Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L. 104-191) -- Improves access to health care, protects workers' health insurance coverage during job transition or loss, and ensures privacy and security of personal health information. Also see the full HIPAA text and NIH's HIPAA Web site.
- Health Research Extension Act of 1985 (P.L. 99-158) -- Ensures legal protection for animals in research. Also see Public Health Service Policy on Humane Care and Use of Laboratory Animals.
- National Research Act (P.L. 93-348, Title II) -- Establishes ethical principles and guidelines for the protection of human subjects in research. Also see the Belmont Report.
- NIH Almanac, Historical Data -- Lists a chronology of enactments leading up to the establishment of NIH and specific NIH legislation.
- NIH Reform Act of 2006 -- Amends title IV of the Public Health Service Act to revise and extend the authorities of the NIH.
- Privacy Act of 1974 (P.L. 93-579) -- Regulates federal agencies' collection, use, and disclosure of individually identifiable information, including medical records. To learn more visit the USDOJ Web site.
- Small Business Technology Transfer Program Reauthorization Act of 2001 (P.L. 107-50) -- Authorizes the Small Business Technology Transfer program through September 2009. For NIH-specific information, see Impact of Public Law 107-50.
- USA Patriot Act P.L. 109-177 and P.L. 109-178 -- Defines persons who are restricted from working with select agents and provides law enforcement tools for combating terrorism. Also see Patriot Act.
- Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (P.L. 107-188) -- Provides measures to prepare and coordinate public health response to bioterrorist attacks.
- U.S. Homeland Security Act of 2002 (P.L. 107-296) -- Establishes the U.S. Department of Homeland Security.
Executive Branch Regulations Relevant to NIH
Executive branch regulations pertinent to NIH programs and operations include:
- 37 CFR 401.14 -- Streamlines the reporting of inventions, patents, and licenses resulting from federally funded research. Also see A '20-20' View of Invention Reporting to the National Institutes of Health in the NIH Guide.
- 38 CFR 16 -- Regulates institutional review boards and establishes protection for human subjects in federally sponsored research.
- 41 CFR 102-106, 102-103 -- Regulates federal advisory councils. Also see NIH's Office of Federal Advisory Committee Policy Web site.
- 42 CFR -- Describes the roles and responsibilities of the Public Health Service.
- 42 CFR 2a, Protection of research subjects' identity.
- 42 CFR 50, Scientific misconduct. Also see the HHS Office of Research Integrity Web site.
- 42 CFR 50f, Financial conflict of interest; also see NIH's conflict of interest Web page.
- 42 CFR 52, Grants for research projects, including eligibility, application, grant award, and use of funds.
- 42 CFR 52a, NIH research center grants.
- 42 CFR 52b, NIH construction grants.
- 42 CFR 52h, Scientific peer review, including review criteria for grants and contracts.
- 42 CFR 63a, NIH training grants. Also see NIAID's training grants Web page.
- 42 CFR 66, National Research Service Awards (NRSA). Also see NIH's NRSA Web site.
- 42 CFR 73, Select agent program. Also see Select Agent Rule on NIAID's biodefense research Web site.
- 45 CFR -- Contains Department of Health and Human Services (HHS) regulations.
- 45 CFR 5, Freedom of Information Act (FOIA) implementation. Also see NIH's FOIA Web site.
- 45 CFR 16, Grant appeals process.
- 45 CFR 46, Protection of human subjects.
- 45 CFR 46 Subpart A, Common Rule, HHS protection of human subjects.
- 45 CFR 46 Subpart B, Protection of pregnant women in research.
- 45 CFR 46.208(a)(2), Ban on human embryo research and cloning.
- 45 CFR 46 Subpart C, Protection of prisoners in research.
- 45 CFR 46 Subpart D, Protection of children in research.
- 45 CFR 73, Standards of conduct for HHS employees. Also see HHS Residual Standards of Conduct.
- 45 CFR 74 or 92, Grant terms and conditions, including allowable costs, grantee reporting requirements, significant project changes, and award termination or suspension.
- 45 CFR 76, Drug-free workplace.
- 45 CFR 80, Nondiscrimination on the grounds of race, color, or national origin.
- 45 CFR 84, Nondiscrimination on the basis of disability.
- 45 CFR 86, Nondiscrimination on the basis of sex.
- 45 CFR 90, Nondiscrimination on the basis of age.
- 45 CFR 93, Restrictions on lobbying.
- 45 CFR 95, Administration of grant programs.
- 45 CFR 160 and 164, Privacy of individually identifiable health information. Also see the HHS Office for Civil Rights -- HIPAA Web site.
- 48 CFR, Federal Acquisition Regulation (FAR) -- Governs federal agency procurement of goods and services.
How to Use Online Resources to Read Public Laws
Laws get recorded in the United States Code (USC), which gets published every six years. You can search it electronically using the THOMAS or GPO Access databases.
To help you find a law, use one of the following identifiers:
- USC title and section number, e.g., 5 USC Sec. 552A
- Public law number, e.g., P.L. 93-579
- Popular name, e.g., Privacy Act of 1974
USC doesn't have executive agency regulations, court decisions, or state or local government laws that may also affect how you do your work.
Regulations get recorded in the daily Federal Register for inclusion in the Code of Federal Regulations (CFR). You can search electronically at the Code of Federal Regulations (CFR): Main Page.
You can also find regulations in the following places:
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