Statement of PI for New Projects

Request for DFCI IRB-Approval of External

Research Recruitment of DFCI Patients or Employees

Instructions: 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.
Please note:
·  No patient contact information can be released to the outside Institution’s Investigator or Study Team.
·  If approved, designated DFCI staff may provide a description of the outside study to patients or other potential participants as well as the contact information for the Principal Investigator.
·  DFCI investigators who wish to collaborate on studies where no DFCI patients will be approached or enrolled should submit the appropriate New Project Application to OHRS for review.

Part A – STUDY INFORMATION

Full Project Title:

Sponsor:

Name of DFCI Requester:

Institution: Disease/Discipline Program:

Phone: E-mail:

Mailing Address:

Name of Non-DF/HCC Principal Investigator (including degrees):

Institution: Disease/Discipline Program:

Phone: E-mail:

Mailing Address:

DFCI Contact for questions about this submission:

Institution:

Phone: E-mail:

Part B–REVIEWING INSTITUTIONAL REVIEW BOARD (IRB)

IRB of Record Name:

IRB of Record Study Number:

IRB of Record Current Approval Date:

IRB of Record Expiration Date:

Notes:

Part C – REQUEST INFORMATION

Please explain the DFCI requester’s role in the study:

Please explain how DFCI participants will be identified:

Please explain why the study will not be opened at DFCI and what benefit participating in this study would provide DFCI participants:

Part D – REQUIRED DOCUMENTATION

The following documents must accompany this request:

1.  Protocol;

2.  Consent;

3.  Research-Related Documents including recruitment materials, surveys, or focus group scripts;

4.  Statement of DFCI Principal Investigator;

5.  IRB approval from the Non-DF/HCC institution.

Part E– SIGNATURES

By checking this box:

·  I certify that I have completed this form and the information provided is accurate.

·  I agree to accept responsibility for the rights and welfare of the research participants involved with this study.

Name of DFCI Requester: Date:

Email Address: Phone Number:

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