You are responsible for using the most current version of our IRB forms posted on this website.   If you do not, and outdated forms are submitted to OHRS, it is possible that the submission will not be processed or reviewed by the SRC and/or IRB.  Please make sure to to ALWAYS download forms directly from this website.  Forms downloaded to your computer will not be the most recent version and will delay review.  Opening forms directly from the OHRS website before filling them out and submitting them to us will assure you have the most up-to-date form and will save both you and the OHRS time. 

HIPAA Information for Researchers

The Health Insurance Portability and Accountability Act (HIPAA) Privacy Regulations establish rigorous guidelines which cover all "use and disclosure" of "protected health information."

HIPAA can be found at this link:
http://www.hhs.gov/ocr/hipaa

HIPAA Forms

Please contact OHRS at 617-632-3029 to determine if you should submit any of the following HIPAA forms.

• HIPAA Research Guidance Document
  
  
• Request for Waiver or Alteration to Use or Disclose of Protected Health Information in Research
• Investigator Representation for Review of Protected Health Information Preparatory to Research
• Investigator Representation for Research on Protected Health Information of Decedents
• Investigator Representation for Research on De-Identified Protected Health Information
• Investigator Representation for Research on Limited Data Sets of Protected Health Information
• Data Use Agreement for a Limited Data Set 

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  • Office for Human Research Studies (OHRS)
    • Contacts
    • Information for Sponsors
    • Submitting A New Protocol
    • Single Patient IND/Emergency Use of a Test Article
    • Consent Documents
    • After Activation Forms
    • HIPAA
    • OHRS Information Sheets
    • External Regulatory Guidance
    • OHRS News Updates
    • Oncology Protocol System and OHRS Submit
    • Presentation and Training Materials
    • Partners Policy and Guidance Links
  • Quality Assurance Office for Clinical Trials (QACT)
  • Clinical Investigations Leadership Committee (CLC)
  • Clinical Trials Education Office (CTEO)
  • Clinical Research Unit (CRU)
  • Protocol Review and Monitoring System (PRMS)
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