Is IRB review required? Informational Worksheet This is an informative worksheet to help you determine whether your project requires IRB review. Do not submit this form to the IRB.

IRB-C Application Forms C1 form Initial Protocol Application for Social & Behavioral (IRB-C) Review Note: The C-1 is required for all submissions, including expedited review and exemption requests. Updated 12.7.2011 w/ removal of Fees section 3.4 C2 form Continuing (Annual) Review Application Updated 11.28.2011 w/ new recruitment materials requirement to include flyers, posters, brochures, audio/video ads, social media ads, web-based ads, etc. C3 Form Request for Expedited Review C4 form Request for Exemption Amendment Cover Letter Request to modify or revise study Study-Specific Disclosure Form (SSDF)Conflict of interest disclosureNote: An SSDF must be submitted for each investigator at initial and continuing reviews Human Subjects Protection Training Note: Proof of training must be submitted for everyone working on the study who will have access to participants or to study data (including student research assistants) at initial and continuing reviews.

IRB-C Informed Consent Form Templates

You should use an informed consent form (ICF) when you plan to document informed consent, that is, to collect signed ICFs from all participants. If you plan to collect participant names or identifying information at any point during the research, you should use one of the below ICF templates.

You should also use a (parental) ICF if you plan to conduct research with minors. When you use a parental ICF, you should also use a minor assent form (AF). Templates for parental ICFs and minor AFs are also below.

If you are conducting research that involves both interview and survey research (or neither), you should still use the below ICF templates as a guide but modify them as necessary to be relevant to your research.

ICF – Interview (Not Anonymous) ICF – Survey (Not Anonymous) ICF – Greater than minimal risk Parent for Minor ICF – Interview (Anonymous) Minor AF – Interview (Anonymous) Parent for Minor ICF – Interview (Not Anonymous) Minor AF – Interview (Not Anonymous) Parent for Minor ICF – Survey (Anonymous) Minor AF – Survey (Anonymous) Parent for Minor ICF – Survey (Not Anonymous) Minor AF – Survey (Not Anonymous) Parent for Minor ICF – Greater than minimal risk Minor AF – Greater than minimal risk

IRB-C Informed Consent Script Templates

You should use an informed consent (IC) script when you do not plan to document informed consent. If you use an IC script, you need to request a waiver of IC documentation, that is, a waiver of the requirement to collect signed ICFs from all participants. If you do not plan to collect participant names or identifying information at any point during the research, you should (1) request a waiver of IC documentation in your C-1 form and (2) use one of the below IC script templates.

The IRB may waive the requirement for documentation of informed consent (i.e. for the investigator to obtain a consent form) if either: (1) The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality; or (2) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

More information about waivers of IC documentation can be found at 45 CFR 46.117(c).

If you are conducting research that involves both interview and survey research (or neither), you should still use the below IC script templates as a guide but modify them as necessary to be relevant to your research.

IC script – Interview (Anonymous) IC scrip – Survey (Anonymous)

IRB of Record Forms

If another institution is going to the primary reviewing IRB (i.e. the IRB of Record) for your study, you should fully fill out and submit 2 copies of the below IRB of Record form. Further instructions are found on the form itself.

If you are working with another institution but the GU IRB will be the IRB of Record, contact the other institution’s IRB to find out what their requirements are for such a procedure.

Though it depends on the exact institution with which you will be working, it is possible that you will also need to submit 2 copies of the FWA Authorization Agreement below.

IRB of Record Form Updated June 7 2011 FWA Authorization Agreement