Regulations and Guidance

Information on regulations that may apply to your research from the Office for Human Research Protections, Food and Drug Administration, National Institutes of Health, Office of Research Integrity, Association for the Accreditation of Human Research Protection Programs and others.

Data Safety Monitoring (DSM)

The investigator is responsible for determining if a study needs formal ongoing monitoring of data to ensure that research subjects will be protected. The IRB is responsible for review and evaluation of the plan to ensure the adequacy of the Data Safety Monitoring Plan in relationship to the size, complexity, and level of risk of the proposed research. This responsibility stems from DHHS and FDA regulations stating a criterion for study approval be that when appropriate, the research plan makes adequate provisions for monitoring the data collected to ensure the safety of subjects (45 CFR 46.111[a][6])

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  Federalwide Assurances

Federalwide Assurances

The Federal Policy (Common Rule) for the protection of human subjects Section 103(a) requires that each institution engaged in federally supported human subject research file an Assurance of Protection for Human Subjects. The Assurance documents the commitment of the Medical College of Wisconsin and Froedtert to protect human subjects.

Under Federal Policy (Common Rule) Section 102(f), awardees and their collaborating institutions become engaged in human subject research whenever their employees or agents intervene or interact with living individuals for research purposes or obtain, release or access individually identifiable private information for research purposes. In addition, awardee institutions are automatically considered to be engaged in human subject research whenever they receive an HHS award to support such research.

The Food and Drug Administration (FDA) issued a final rule in the Federal Register (Vol. 74, No. 10, 1/15/09) that required institutional review boards (IRBs) to register through a system maintained by the Department of Health and Human Services (HHS). The MCW/FH IRBs are in compliance with this requirement. Evidence of an institution's FWA and IRB registration can be obtained by accessing the HHS database.

The Medical College of Wisconsin
  • FWA#00000820, expiration date: 02/24/2021
Froedtert Hospital
  • FWA#00002157, expiration date: 11/30/2021
Blood Center of Wisconsin
  • FWA#00005505, expiration date: 07/16/2020
  MCW/FH IRB Registration numbers

MCW/FH IRB #1 IRB00001395 
MCW/FH IRB #2 IRB00001396 
MCW/FH IRB #3 IRB00001564 
MCW/FH IRB #4 IRB00000078 
MCW/FH IRB #5 IRB00006380

  Professional Organizations

Professional Organizations

PRIM&R - Public Responsibility in Medicine and Research
ACRP - Association of Clinical Research Professionals
SoCRA - Society of Clinical Research Associates
RAPS - Regulatory Affairs Professionals Society

  Affiliated Institutions
  Resources for Sponsors


  MCW Local Context Response Information

As collaborative research continues grow, MCW IRB has received requests to describe our local context and state laws which need to be followed if MCW IRB is not serving as the IRB of record for a project.  The following document has been developed as a resource for investigators. MCW Office of General Counsel should be consulted for questions regarding Wisconsin State and local laws.

HRPP Contact Information

(414) 955-8422
(414) 955-6575 (fax) (for general IRB questions) (questions about reliance agreements/deferral requests)

Location:  MFRC 3040
MACC Fund Research Center

Office of Research
8701 Watertown Plank Road
Milwaukee, WI 53226-0509

HRPP Staff Contact Info

HRPP Organizational Chart

Accreditation of Human Research Protection Programs, Inc. (AAHRPP)