Umbrella Grant Application

North Shore-Long Island Jewish Health System Institutional Review Board

Application for Initial Administrative Review of an Umbrella Grant

THIS FORM MUST BE TYPED. THE IRB WILL NOT ACCEPT HANDWRITTEN APPLICATIONS.

When to Use this Form

This form should be used to submit an Umbrella Grant for administrative review. Umbrella Review is recognized by the IRB only as a compilation of research being conducted under a specific grant. It does not constitute a review of the risk/benefit ratio of protocols to be conducted under it. Those protocols (including informed consent documents) must be submitted for IRB review and approval separate from this request. The grant will also be reviewed and approved with the separate protocol submissions.

Attachments Include:

Always submit these documents:

Application for Initial Administrative Review of an Umbrella Grant (This form)

Grant

External Interest (COI) Disclosure electronically at era.northshorelij.com/login.asp: for all staff listed on the grant

Submission Instructions – NSLIJ IRB and Staten Island University IRB

Our website provides full instructions on submitting applications through email to the IRB: . Please contact the IRB office at 516-321-2100 with any questions.

Submission Instructions – Huntington Hospital IRB

Applications may be submitted through email to the IRB: or in hard copy format to the Office of the IRB, Huntington Hospital, Dept. of Medical Affairs, 270 Park Avenue, Huntington, NY 11743. Please contact the IRB Office at 631-351-2750 with any questions.

Version Date: IRB NUMBER: ______

Title:

Principal Investigator
/ Study Coordinator
Name: / Phone #: / Name:
Dept/Div: /
Fax:
/ Phone #:
Affiliation: / Email: / Email:
(Hospital/Facility)
Person/Address to which correspondence should be mailed:

Section A Study Funding

Specify the funding sources for your study.

1.  Funding Sources:

Federal grant; Other:

Sponsor Name:

External Agency Grant Award #: N/A

NSLIJ HS Fund #:

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Umbrella Grant Application

North Shore-Long Island Jewish Health System Institutional Review Board

Section B Study Personnel Requirements

Required Education- These completion dates can be found online at www.feinsteininstitute.org/hrpp/training/dates.

The Human Subjects Training CITI Date is the date of most recent completion of the CITI tutorial program for the basic or refresher human subjects’ research course.

The Researcher Registration Date is the date the person signed the researcher registration form. If not complete, this form can be found online here.

The COI Training CITI Date is the date of most recent completion of the Conflict of Interest Training Course.

External Interest (COI) Disclosures for Research

By July 1, 2013, all NSLIJHS researchers must complete their annual External Interest (COI) Disclosure electronically at era.northshorelij.com/login.asp.

If COI disclosures are submitted with paper questionnaires, do not complete this section of the table below.

The Date of Disclosure is the date of the most recent external interest disclosure for each individual on the project.

Study Personnel / Role on Project / Department & Hospital or Facility Affiliation
(e.g. Pediatrics/ NSUH)
/
REQUIRED EDUCATION
/
External Interest (COI) Disclosures for Research
Human Subjects Training (CITI)
Date /
Researcher Registration
Date /
COI
Training
(CITI)
Date / Date of Disclosure / Management Plan Required? / Disclosure has been reviewed is accurate as of the date of this submission?
Yes No / Yes No*
Yes No / Yes No*
Yes No / Yes No*
Yes No / Yes No*
Yes No / Yes No*
Yes No / Yes No*
Yes No / Yes No*
Yes No / Yes No*
Yes No / Yes No*
Yes No / Yes No*
Yes No / Yes No*

If additional space is needed, you can find a study personnel addendum at www.feinsteininstitute.org/hrpp/forms.

*Please revise disclosure through the electronic external interest disclosure process at era.northshorelij.com/login.asp

1.  Are all investigators listed above employed by NS-LIJ Health System? Yes No.

If no, please indicate which investigators are employed elsewhere and where they are employed:

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Umbrella Grant Application

North Shore-Long Island Jewish Health System Institutional Review Board

Section C Review Request

Specify the purpose of this review request.

Individual Training Grant (salary support only – research activities occurring under separate approved protocol(s))

Program Project (all research activities occurring under separately submitted protocols)

Grant when the research has yet to be developed (no research activities contained within the initial grant submission)

If this is checked, skip Section D.

*Note: When the human subject research activities are developed, you must submit a human subject protocol for review and approval prior to the research activities beginning.

Section D IRB Protocols

List the IRB#, study PI, the study titles, and the corresponding grant page numbers associated with this Umbrella.

IRB# / PI / Study Title / Grant Page
Number*

* provide the page number in the grant where the study is mentioned

PRINCIPAL INVESTIGATOR STATEMENT

As Principal Investigator of this study, I assure that the following statements are true:

I understand that Administrative Review of an Umbrella Grant or Projects to be Developed is recognized by the IRB as,

1.  A compilation of research being conducted under a specific grant or,

2.  A grant which has no human subjects activities at the time of award.

It does not constitute a review of risk/benefit in human subject research.

I understand that protocols must be submitted for IRB review and approval separate from this request.

______

Printed name of PI Signature of PI Date

DEPARTMENT CHAIR STATEMENT

By signing below, I acknowledge that the execution of the project has my endorsement.

______

Printed name of Dept. Chair Signature of Dept. Chair Date

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