Statement of PI for New Projects



Institutional Certification Request Form

|Investigator Instructions: |

|Complete this form if you require Institutional Certification to allow for data submission to the NIH’s database for Genotypes and Phenotypes (dbGaP). |

|Template ICs can be found on the NIH Website. Example Institutional Certificate(s) with accompanying instructions on how to fill them out are available on the |

|OHRS Website. |

|Submit this form as well as the grant (if necessary) and appropriate Institutional Certificate(s) as a Special Submission |

|If requesting a provisional Institutional Certificate (to be used when the IRB has not completed its review of a new protocol application), please submit this |

|form along with the grant (if necessary) and the Provisional Institutional Certificate. For questions regarding this form, please refer to the Institutional |

|Certification Process for Genomic Data Sharing found on the OHRS Website. |

|Please contact OHRS at OHRS_OPS@dfci.harvard.edu with any questions. |

Please check the box for the type of certificate requested, and navigate to the appropriate section:

Provisional Institutional Certificate:

Institutional Certificate:

Provisional Institutional Certificate:

If a Just in Time is requested by the NIH, and the protocol and consent are not fully developed a Provisional Certification form may be issued for a prospective study where the certification is a condition of the award or the IRB has not completed its review of the protocol and therefore cannot attest to all the elements of the formal Institutional Certification.

Provide an explanation of the grant’s research strategy plan, resources sharing plan, and human subjects protection section (this can be submitted as an attachment as well):      

Date that the final Institutional Certificate will be provided to NIH:      

Previously DFCI IRB Approved Research

Protocol Review:

Please indicate the primary research protocols under which the data were collected and how this use of the data is allowed under each protocol.

|Protocol #: |PI Name: |Relevant Protocol Section(s) that described the collection and sharing plans: |

|(YY-###) |(Smith, John) |(e.g. 5.4 and Appendix A) |

|      * |      * |      * |

|      |      |      |

|      |      |      |

Consent Form Review:

Only list Consent Forms for studies listed above. If consent was waived by the IRB, do not list the protocol # below.

|Protocol #: |Date Range: |

|(YY-###) |Provide the range of dates to be|

| |covered by the IC |

|      |      |

|      |      |

|      |      |

Grant Congruency Review:

Provide an explanation of the grant’s research strategy plan, resources sharing plan, and human subjects protection section (this can be submitted as an attachment as well):      

Institutional Certification Review:

List which ICs will be submitted with this request form (further information regarding the appropriate ICs can be found on the NIH Website):      

SIGNATURE OF REQUESTOR

By submitting this form, I certify that the information provided is accurate.

Name of Requestor:       Date:      

Email Address:       Phone Number:      

Disease/Discipline Program:      

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