Human Research Protection Program

Resources

Federalwide Assurances

FWA information, registration numbers, and expiration dates for MCW, FH, etc.

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)

An IRB is responsible for determining if a study needs formal ongoing monitoring of data to ensure that research subjects will be protected. 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] 

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

• Blood Center of Wisconsin
• Clement J. Zablocki Veteran's Administration Medical Center
• VAMC Medical Research Services*
• Children's Hospital of Wisconsin
• Columbia St. Mary's Hospital
• Community Memorial Hospital
• Froedtert Hospital
• Milwaukee County Behavioral Health Division

Other

• MedWatch (FDA)
• Data Safety Monitoring
• Open Letter for Sponsors
  The MCW HRPP has drafted an open letter to Sponsors to address many of the common concerns and questions the HRPP office handles from MCW Investigators regarding the IRB practices and procedures. Please feel free to download a copy of this letter to your Sponsors. If you have any questions, please feel free to contact the HRPP office.
• Certificate for 21 CFR 11 for Electronic Health Records