MCW Human Research Protection Program - Regulations and Guidance

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.

Nuremburg Code A set of research ethical principles for human experimentation set as a result of the subsequent Nuremberg Trials which occurred at the end of the Second World War. 

FDA website - 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.

21 CFR 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

MedWatch Reporting System

OHRP Website - Access OHRP federal regulations for Protection of Human Research Subjects or obtain a list of guidance topics from OHRP

45 CFR 46 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 (HHS).

OHRP Decision Charts:  These decisions charts provide 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 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. 

OHRP Federal Guidances by Topic

OHRP 2015 Edition of the International Compilation of Human Research Standards

FWA Registration Process Guidance - An overview and step by step process on how to file a federal-wide assurance (FWA) with OHRP.  This may be useful for smaller community based organizations who are partnering with MCW in the conduct of a federally funded research project.

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 MCW IRB Committees

International Conference on Harmonization (ICH) - 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) Regulations Food and Drug Administration (FDA) regulations regarding Non-Clinical Good Laboratory Practices*

*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.

MCW HIPAA policies  Find information about who to contact with questions related to the HIPAA Privacy Rule

45 CFR 164 HIPAA Regulations This part applies to investigators using protected health information during the course of a clinical investigation

Office for Civil Rights 45 CFR Parts 160 & 164 - HIPAA Final Rule, Access HIPAA regulations

Clinical Research and the HIPAA Privacy Rule (NIH) NIH's information on HIPAA regulations and how they affect research.