Regulations and Guidance

 Office for Human Research Protections (OHRP)

Office for Human Research Protections (OHRP)

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.

    • OHRP Decision Charts provides graphic aids as a guide for institutional review boards (IRBs), investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46 . The charts address decisions on whether an activity is research that must be reviewed by an IRB, among other topics (referenced in other sections of this guide). 


  • 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


 U.S. Food and Drug Administration (FDA)

U.S. Food and Drug Administration (FDA)

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:


 Ethics

AnchorEthics

  • 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.


 Good Clinical Practice (GRP) and Good Laboratory Practice (GLP)

Good Clinical Practice (GRP) and Good Laboratory Practice (GLP)

Good Clinical Practice (GCP) Guidelines

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 with International Conference
on Harmonization Guidelines for Good Clinical Practice
  (pdf)

Statement of Compliance from the Institutional Review Boards for Froedtert Hospital

International Conference on Harmonization (ICH) E6 - Good Clinical Practice:

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*

*The Medical College of Wisconsin does not meet the FDA requirements for a "GLP"  site
and sponsors should be notified of this prior to entering into any research agreement
.

 


 HIPAA for Research

HIPAA for Research

MCW HIPAA Website *

Access MCW HIPAA policies, procedures, and forms. Find information about who to contact with questions related to the HIPAA Privacy Rule

Office for Civil Rights

45 CFR Parts 160 & 164 - HIPAA Final Rule, Access HIPAA regulations

NIH's Clinical Research and the HIPAA Privacy Rule

Obtain information on HIPAA regulations and how they affect research.

 

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Page Updated 11/11/2014
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