Overview

Once a new DF/HCC protocol has been created, it must be submitted to the Office for Human Research Studies (OHRS) before research can begin. OHRS has developed application forms that request study information. This information is used to determine what type of review the new submission will require.

The application and other relevant study documents (e.g., protocol, consent) must be submitted to OHRS through a system called OHRS Submit.

This page is divided into two sections: the New Project Application types and "Other New Project Submission Forms". Please determine which New Project Application best describes your submission type. At the end of each New Project Application is a Document Checklist. This checklist lists the relevant documents that should be submitted with that New Project Application. Most of these documents can be found in the "Other New Project Submission Forms" section.

New Project Application Types

New Project Application: Clinical

  • The new project involves the use of a test article (drug, device, biologic) or other FDA-regulated research.
  • It is NOT a Single Patient IND.
  • The DFCI IRB will be the IRB of record. Please note, a Request to Rely may need to be submitted prior to the New Project Application in some cases. Please see the OHRS Single IRB page for details.

New Project Application: Non-Clinical Research

  • The new project involves non-clinical research such as Social/behavioral research, retrospective chart reviews, etc.)
  • The DFCI IRB will be the IRB of record. Please note, a Request to Rely may need to be submitted prior to the New Project Application in some cases. Please see the OHRS Single IRB page for details.

New Project Application: Secondary Use

  • Involves the secondary use of collected data or specimens.
  • involves Human subjects research as defined by 45 CFR 46. If only de-identified data/specimens will be used, please use the NHSR application.

New Project Application : Non-Human Subjects Research (NHSR)

  • The project does not meet the definition of human subject research as defined in 45 CFR 46 or a form a Non-Human Research Subjects determination from the IRB is required.
  • A Quality Improvement (QI) project can be submitted on this form or the specific QI project form.

New Project Application: Single Patient IND or Emergency Use

  • Single Patient IND/IDE or Emergency use trials

Single IRB

  • The IRB of Record will be an external Single IRB (e.g., NCI CIRB)
  • A Request to Rely may need to be submitted prior to submitting the New Project Application. See the Single IRB webpage for details.

New Project Application: Quality Improvement

  • The project is Clinical Quality Improvement that does not need IRB review.
  • Please note, the New Project Application: NHSR should be used for an NHSR IRB determination.

New Project Application: Off Site Research

  • For new projects that are supported by a grant where a DF/HCC institution is the primary awardee, but all of the research is being conducted at non-DF/HCC sites.

New Project Application: Request for DFC IRB Approval of Recruitment of DFCI Patients and Clinicians for Research at Non DFHCC Institution

  • Use this form to request that the DFCI IRB approve recruitment of DFCI patients and/or DFCI employees (e.g., clinicians) to participate in research approved by an external IRB and conducted by a non-DF/HCC institution.