IRB Forms and Templates

Instructions

Template Documents

As of September 10, 2015, all IRB submissions will need to
be done through our electronic portal. To access the electronic
portal, please click here.

Commonly Used Forms for New Submissions

Forms for Study Personnel

Forms for Previously Approved Research

Miscellaneous Forms

 

Commonly Used Forms for New Submissions

As of September 10, 2015, all IRB submissions
will need to be done through the eRA Portal.

Form Name

Description

Pre-Submission Checklist This checklist has been developed to assist investigators and coordinators in preparing their IRB submissions. This form should not be submitted to the IRB.
Human Subjects Research Determination Request form Use if you would like the IRB to determine whether or not your project is research or not and whether it may require IRB review.
Exempt Application Use this form if you believe your study qualifies for exempt review
Application for Chart Review Use to submit a new retrospective or prospective chart review study
Application for Humanitarian
Use Device
Use if you need approval for use of Humanitarian Device, according to labeling.
Application for Emergency
Use of a Test Article
Use if you need to notify the IRB of the emergency use of an unapproved device, drug, biologic, etc.
Application – Request for
Use of External IRB Review
Use this form is you would like to request to use an external IRB
Application for a New Study Use to submit a new study to the IRB for expedited or full board review

Appendices and Other Supplemental Forms

Appendix – Children Submit when you plan to enroll children in your study
Appendix – Pregnant Women, Fetuses, and Neonates Submit when you plan to enroll pregnant women and fetuses, AND/OR neonates (of uncertain or non-viability) in your study.
Appendix – Prisoners Submit when you plan to enroll prisoners in your study
Appendix- Cognitively Impaired Submit when you plan to enroll cognitively impaired persons in your study
Appendix – Devices Submit when your study involves the use of a device
Appendix – Drugs/Biologics Submit when your study involves the use of a drug or biologic
Appendix – Department of Defense Supplement Submit if you will be using funding from the Department of Defense to conduct this study
Application for Waiver of Informed Consent and/or HIPAA authorization Submit to request any type of waiver or alteration of consent or HIPAA authorization
Controlled Substance Form Submit when your study involves the use of a controlled substance

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Forms for Study Personnel

Researcher Registration Form Completion is required for anyone conducting or participating in research. This form only needs to be submitted once. UPDATE 12/2013: The form is now incorporated into the CITI training. Anyone who completed CITI training after 12/1/13, does not need to complete a separate researcher registration form. The date of completion of the researcher registration form will be the same date of completion of the Human Subjects Research CITI course. For those that need to complete the form: Please type your answers into the form, sign it, scan it, and then email it to irb@nshs.edu. Updated 1/27/14
Study Personnel Addendum Use this form to report on study personnel in conjunction with the eRA progress report form. Updated 2/5/16

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Forms for Previously Approved Research

As of September 10, 2015, all IRB submissions
will need to be done through the eRA Portal.

Application for Requested Modifications Use to request any change to a previously approved research study including: modifications to study documents, personnel changes, protocol exceptions, & a change in principal investigator
Application for Continuing Approval Use to request the continuation of your study
Application for Continuing Approval – Humanitarian Use Device Use to request the continuation of an HUD
Final Report Use to close a study

Forms for Reporting to the IRB

Protocol Deviation Log Use to capture minor protocol deviations during an approval year. It should be submitted with the Application for Continuing Approval, each year.
Reportable Event Form Use to report any events that may be an unanticipated problem involving risk to subject and/or other, serious non-compliance, or continuing non-compliance.

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Miscellaneous Forms

Enrollment Report Use this form for initial submissions and progress reports to indicate the target/actual enrollment of each ethnic category for your site
Data Use Agreement for Research For use with a limited data set Updated 5/28/14
Optional Authorization for Research Contact Use this form to obtain optional authorization to contact patients about future research studies
External Site Questionnaire Submit this form if an external site wants to rely on Northwell Health for IRB review  Updated 1/23/15
Application for Approval of International Research Submit this form if you plan to conduct research internationally
Application for an Umbrella Grant Submit this form for administrative review of an Umbrella Grant

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