IRB Policies and Forms

IRB Manuals

 

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.

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.

 

Study Specific Disclosure Form

Download Study Specific Disclosure Form (SSDF)