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Clinical Research Support

Office for Human Research Studies (OHRS)

Submitting A New Protocol


For information relating to protocol development or submission, please:

  1. Review the guidance on the OHRS website; or,

  2. Contact one of the offices below:

    a. Questions from DFCI & BWH staff contact the DFCI CTO,  617.582.9040 or email dfci_clinicaltrials@dfci.harvard.edu

    b. Questions from MGH staff contact the MGH CCPO, 617.724.0695 or email your CCPO contact.

    c. Questions from BIDMC staff contact the BIDMC CCTO, Jonathan Dinsmore at 617.632.9473 or email bidmccctoregulatoryaffairs@bidmc.harvard.edu

    d. Questions from BCH staff(Children’s users) contact Jane O’Brien at 617.632.3549  or email jane_obrien@dfci.harvard.edu

 Quick Help Guides for New Protocol Submissions:

Specific requirements for:

  • PI-Initiated Multi-Center Trials [Guidance]
  • Single Patient INDs & Emergency Use of a Test Article [Guidance]

New Project Application Forms & Guidance

  • Clinical Trials  [Form
    • Research Nursing and Pharmacy Protocol Screening  [Form]
    • Radiation Safety Protocol Screening  [Form] | [Guidance]
  • Social/Behavioral Research  [Form] | [Guidelines For Writing This Protocol Type]
  • Research Use of Retrospective Medical Records and/or Previously Collected Specimens  [Form]
  • Prospective Collection of Human Material and/or Clinical Data for Research Purposes [Form]  | [Guidelines for Writing This Protocol Type]
  • Request for Exemption or Determination that Activity is Not Human Subject Research [Form] | [Guidance]
  • Request for DFCI IRB to Cede IRB Review [Form]
  • Quality Improvement Determination [Form]
  • Statistical Guidelines for Non-Clinical Research Protocols [Guidance]

Statement of Investigators

Other Submission Forms