Program for the Protection of Human Subjects

Institutional Review Board (IRB)

InfoEd Electronic Submission

For IRB Members

HIPAA for Research

Grants and Contracts Office

  1. How the Process Works
    1. Is it Human Subject Research?
    2. Types of Review
    3. Periods of Approval
  2. Download Forms
    1. MSSM Grants and Contracts Office forms
    2. MSSM IRB forms New!
    3. HIPAA for Research
  3. Preparing Your Application
    1. Checklists for Standard Submissions
    2. Exempt Projects
    3. Expedited Projects
    4. Device Studies
      1. Device Form Word Document
      2. Humanitarian Use Device Only Form Word Document
    5. Disclosing a Potential Conflict of Interest in the Research
    6. Emergency Use
      1. Emergency Use Guidance Word Document New!
      2. Emergency Use Form (Unapproved Drug/Biologic) Word Document New!
      3. Emergency Use Form (Unapproved Device) Word Document New!
      4. Emergency Use Consent Form Template Word Document New!
      5. Previous One-Time Emergency Uses Excel Spreadsheet New!
    7. "Just In Time" Applications pdf
    8. Literature Search Techniques for Determining Drug and Device Safety pdf
    9. Research on Human Data (including existing medical records)
      1. Guidance pdf
      2. Flow Chart pdf
      3. Forms for Doing Research on Existing Data
        1. Existing Data Collected during Previous Research Word Document
        2. Existing Data Collected during Clinical Care Word Document
      4. Review of HIV Information
        1. Guidance pdf
        2. Application Form Word Document
    10. Pharmacy
      1. Drug/Biologic Information Sheet Word Document New!
      2. Emergency Use Guidance (Unapproved Drugs/Biologics/Devices) Word Document New!
    11. Personnel Changes pdf
    12. Repository Establishment (Data or Biological Material)
    13. Risk/Benefit Analysis
      1. Points to Consider
      2. Compensation/Treatment Resulting from Injury
    14. Research on Human Specimens
      1. Forms for Doing Research on Existing Specimens
        1. Collected during Previous Research Word Document
        2. Collected during Clinical Care Word Document
  4. Meeting Dates, Deadlines, and Results
    1. Meeting dates and deadlines
      1. 2009 pdf New!
      2. 2008 pdf
      3. 2007 pdf
      4. 2006 pdf
      5. 2005 pdf
      6. 2004
    2. Availability of Meeting Results
    3. FAQs about Continuation Application Submissions
  5. Research at Our Affiliates
    1. Research Affiliate Locations
      1. James J. Peters VA Medical Center
      2. Elmhurst Hospital Center
      3. Queens Hospital Center
      4. Jewish Home and Hospital
  6. Doing Research at External Sites
    1. Working with other Domestic Sites under active FWAs
    2. Working with International Sites
      1. Those with an active FWA
      2. Those without an active FWA
  7. IRB Fees
    1. Review Fees
  8. Changing Approved Applications
    1. Amending a Submission
    2. Protocol Deviations, Exceptions, Violations pdf

Please note that information above is forthcoming.

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