The consent templates have been designed to include all required elements of consent. Please do not modify the forms to remove any required elements. You may, however, make any necessary changes to include information specific to your project. Before submitting your form(s), ensure all comments and extraneous information are removed. (Please note that extensive modifications will lengthen the time required to verify the presence of all required elements, potentially delaying your review.)

For Research with Adults:

• Written Informed Consent
• Online Informed Consent

For Research with Minors:

Please note that parents must provide consent for allowing their children to participate in research. An “opt-out” consent procedure will not be approved.

• Parental Consent
• Child Assent

Language to Be Inserted into Informed Consent for Special Cases:

Confidentiality for Protected Health Information:

• Confidentiality for Protected Health Information (PHI Form)
• Conflict Of Interest Language / Disclosure
• Injury Compensation Language

Recruitment is part of the consent process, and recruitment forms must comply with OHRP requirements. Modify the existing templates to fit your study context, but do not remove required elements.

• IRB Recruitment Flyer
• IRB Recruitment Email

• Genetic Screening Consent Rider
• Data Use Agreement Form
• Application for Specimen Repository (PHI Form)

Making Amendments to an Active Protocol:

Minor Amendments Form:

Use this form to add/remove co-investigators, fix errors or omissions in the protocol documents and templates, extend participant sample size, and other non-procedural changes.  

• IRB Addendum Minor Revisions

Major Amendments:

Major changes to the protocol will have to be approved by the IRB and investigators should anticipate submitting a new protocol in Cayuse to address these changes.

IRB Progress Report / Final Report:

• IRB Progress Final Report