Access OHRP federal regulations for Protection of Human Research Subjects or obtain a list of guidance topics from OHRP:
45 CFR 46 DHHS Regulations: This part applies to institutions and investigators that are engaged in human subjects research that is supported or conducted by the Department of Health and Human Services.
45 CFR 164 HIPAA Regulations: This part applies to investigators using protected health information during the course of a clinical investigation.
OHRP Federal Guidance by Topic
Access FDA federal regulations for Protection of Human Research Subjects, Information Sheets, information on early/expanded access to unapproved devices, applications and information on IND, NDA, biologic license and premarket approval:
21 CFR 50 - Protection of Human Subjects This part applies to clinical investigations regulated by the Food and Drug Administration as well as clinical investigations that support applications for research or marketing permits for products regulated by the FDA, such as drugs, medical devices and biological products for human use.
21 CFR 56 Institutional Review Boards: This part contains the general standards for the composition, operation and responsibilities of Institutional Review Boards.
21 CFR 312 Investigational New Drug Application: This part describes the procedures and requirements governing the use of investigational new drugs. Sponsor and investigator responsibilities are also described in this part.
21 CFR 314 Applications for FDA Approval to Market a New Drug: This part describes the procedures and requirements for submitting marketing applications to the FDA. FDA review of the applications is also included in this part.
FDA Part 601 - Applications for FDA Approval of a Biologic License
21 CFR 812 Investigational Device Exemptions: This part provides procedures for the conduct of clinical investigations of devices. Sponsor and investigator responsibilities are also described in this part.
21 CFR 814 Premarket Approval for Medical Devices: This part provides procedures for premarket approval of medical devices intended for human use. Humanitarian Use Devices (HUDs) are described in Subpart H.
FDA Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors
Device Advice
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Belmont Report: The fundamental ethical principles for all human subject research – respect for persons, beneficence, and justice.
Declaration of Helsinki: The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.
These guidances and information sheets represent the FDA's current guidance on GCP and the conduct of clinical trials. Content includes information for IRBs, investigators and sponsors regarding the conduct of research, the use of drugs, biologics and devices, and FDA operations
Statement of Compliance from the Institutional Review Boards for Froedtert Hospital
Consolidated Guidance: ICH GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve human subjects. This guidance document provides a unified standard in order to facilitate the mutual acceptance of clinical data by regulatory authorities in the US, Europe and Japan.
Non-Clinical Good Laboratory Practice (GLP) Guidelines
U.S. Food and Drug Administration webpage on NON-CLINICAL GLP*
MCW HIPAA Website *
Access MCW HIPAA policies, procedures, and forms. Find information about who to contact with questions related to the HIPAA Privacy Rule
45 CFR Parts 160 & 164 - HIPAA Final Rule, Access HIPAA regulations
Obtain information on HIPAA regulations and how they affect research.