Human Research Protection Program

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Regulations, Guidances, and FWA

 

Federalwide Assurances

The Federalwide Assurance number for MCW is FWA#00000820.

The Federalwide Assurance number for Froedtert Hospital is FWA#00002157.

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.  

 

Regulations and Guidances
Access OHRP federal regulations for Protection of Human Research Subjects or obtain a list of guidance topics from OHRP
  OHRP Regulations for Protection of Human Research Subjects 
  OHRP Federal Guidances
 
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 
  FDA Part 50 –   Protection of Human Subjects 
  FDA Part 56 – Institutional Review Boards  

 

 FDA Part 312 – Investigational New Drug Application (IND)

 

 FDA Part 314 – Applications for FDA Approval to Market a Drug (NDA)

 

 FDA Part 601 – Applications for FDA Approval of a Biologic License

 

 FDA Part 812 – Investigational Device Exemptions (IDE)

 

 FDA Part 814 – Premarket Approval of Medical Devices (PMA)

 

 The Belmont Report
    The fundamental ethical principles for all human subject research – respect for persons, beneficence, and justice. 
  FDA Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors
  Device Advice 

 

 Good Clinical Practice (GCP) and Good Laboratory Practice (GLP)
  Good Clinical Practice (GCP) Guidelines
    Link to U.S. Food and Drug Administration webpage on GCP in FDA-Regulated Clinical Trials
  Statement of Compliance with International Conference on Harmonization Guidelines for Good Clinical Practice  (.pdf) 
    View Statement of Compliance from the Institutional Review Boards for Froedtert Hospital
  Good Laboratory Practice (GLP) Guidelines 
    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
  MCW HIPAA Website 
    Access MCW HIPAA policies, procedures, and forms. Find information about who to contact with questions related to the HIPAA Privacy Rule 
  OCR      45 CFR   Parts 160 & 164 - HIPAA Final Rule  
     Access HIPAA regulations
  Clinical Research and the HIPAA Privacy Rule  
    Obtain information on HIPAA regulations and how they affect research.
  Authorization to Use or Disclose PHI in Research (MSWord)  
    Obtain direct authorization to use or disclose PHI for screening purposes. 
  Authorization to Use or Disclose PHI in Research - Large Print (MSWord)  
    Obtain direct authorization to use or disclose PHI for screening purposes. 
  Request for PHI in Research Without Patient Authorization (MSWord)  
    Obtain access to PHI for research on decedents. 
  Privacy of Information in Research 
   

Review the MCW policy surrounding health care information of Research Subjects 

 

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Page Updated 02/29/2008