How to Use IRB Forms

Listed below are the IRB forms presently available online. The forms are in MS Word format.

1. Click on the form you wish to download. The time it takes to download depends on your connection to the Internet and the file's size.
   
2. Save the file to your (C) hard drive by going to the very top of screen and choose File, Save As. Do this for any and all forms you wish to have available. Now you are able to work as usual in Word on your own computer without the website.
   
3. In order to complete the forms, simply type your text into the gray fields that appearin each of the forms.
   
4. Each form must not exceed its one-page format. If there is not enough space to accommodate your information (i.e., the protocol title or number of investigators) please continue on a separate page.

Please note: If a part of your text is rather LENGTHY, it is advised that you create the text in a SEPARATE MS Word document and then CUT AND PASTE that text into the appropriate form field. (You may also cut and paste text from other documents as well.) All editing (i.e., spell/grammar check, subscripts, superscripts, symbol insertions, etc.) must be done BEFORE cutting and pasting the text in to the form fields. You will NOT be able to edit your text after it has been typed or pasted into the form fields.

List of Forms

Q & A Check List

IRB Form 1. Proposal Cover Sheet

IRB Form 1a. Study Personnel/Required Education Sheet

IRB Form 2. Protocol Summary

IRB Form 2a. Chart Review Research Plan

IRB Form 3. Conflict of Interest Questionnaire

IRB Form 4. Application for Approval for Research Involving Human Subjects (ARIHS)

IRB Form 4a. Application for Determination of Exempt Status

IRB Form 4b. Informed Consent: Request for Waiver, Documentation or Elements

IRB Form 4c. HIPAA Compliance

Data Use Agreement for Research

IRB Form 5. Projected Utilization of Resources for Clinical Research Protocols

IRB Form 6. Fee Form

IRB Form 7a. Report of Serious Internal Adverse Event

IRB Form 7b. Report of Serious External Adverse Event

IRB Form 7c. Report of Unanticipated Problems

IRB Form 8a. Modifications Request

IRB Form 8b. Report of Protocol Exception

IRB Form 8c. Report of Protocol Violation

IRB Form 8d. Change of Principal Investigator

FDA Form 1572. Statement of Investigator
Note: FDA Form 1572 should only be completed when:

1. An investigator-initiated study involves an investigational drug, or
2. The study sponsor requests it.

Termination Report

Miscellaneous Forms

Optional Authorization for Research Contact

Application for Approval of International Research

Comprehension Assessment Form

Reviewer's Evaluation Sheet - Full Board

Reviewer's Evaluation Sheet - Expedited Review

Reviewer's Evaluation Sheet for Continuing Review

Prisoner Addendum to Reviewer's Evaluation Sheet

If you have any questions regarding these forms please contact the IRB via telephone at 516-562-3101.

Please refer to the IRB Meeting and Deadline Schedule for the list of submission and meeting dates for both IRB committees.

Incomplete proposals will NOT be accepted.

Copyright ©1997-2002 North Shore - LIJ Health System
Office of the Institutional Review Board (IRB)