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Regulatory References for Research A Quick Guide to Key Regulations
Public Health Services – Title 42 Public Health
Regulation
Description
42 CFR 50, Subpart F
Promoting Objectivity in Research
Federal Policy that outlines institutional responsibility and Investigator requirements to avoid or manage perceived or actual conflict of interests in research funded or supported by Public Health Service (PHS).
42 CFR 11
ClinicalTrials.gov Registration
Federal Policy that details the requirements for registering and reporting results of applicable clinical trials and certain other clinical trials on ClinicalTrials.gov. It identifies the parties responsible, outlines procedures for the submission of information, provides an explanation of the types of studies that must be submitted, and explains the consequences for non-compliance with the policy.
42 CFR 93
Research Misconduct
Federal Policy that addresses research misconduct involving PHS support. It outlines the responsibilities of institutions that receive PHS support, explains the processes of inquiry and investigation, specifies the requirements for notifying the Office of Research Integrity (ORI), describes the types of action that can be taken by HHS such as suspension or debarment, and outlines the process for contesting ORI findings of research misconduct and HHS administrative actions.
Department of Health and Human Services – Title 45 Public Welfare
Regulation
Description
45 CFR 46
Protection of Human Subjects
Federal Policy that dictates the basic protections for human subjects of research. This includes the Common Rule (Subpart A) that outlines the requirements for the structure, function, and responsibilities of Institutional Review Boards (IRBs) and Informed Consent requirements. Additional protections for certain vulnerable populations are included in associated Subparts (e.g., Subpart B – pregnant women, fetuses, and neonates; Subpart C – Prisoners; Subpart D – Children).
Food and Drug Administration – Title 21 Food and Drugs
Regulation
Description
21 CFR 11
Electronic Records; Electronic Signatures
Establishes the circumstances and requirements for which electronic signatures and records can be considered equivalent to hand-written signatures and paper records.
21 CFR 50
Protection of Human Subjects
Similar to 45 CFR 46, this regulation covers protections for human subjects of research. It applies to clinical investigations under the jurisdiction of the Food and Drug Administration (FDA) and addresses Informed Consent requirements and additional protections for children.
21 CFR 56
Institutional Review Boards
Similar to 45 CFR 46, this regulation outlines the requirements for the structure, function, and responsibilities of Institutional Review Boards reviewing clinical investigations under the purview of the FDA.
21 CFR 54
Financial Disclosure by Clinical Investigators
Describes the requisite disclosure process of financial arrangements between sponsors and clinical investigators involved in FDA-regulated research.
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