IRB Forms (Cayuse Era)

The consent templates have been designed to include all required elements of consent. Please do not modify the forms to remove required elements. You may make whatever modifications are required to include the necessary information for your project. Before submitting your form(s), please remove all comments and extraneous information. (Note that the more modifications you make the longer it will take to verify that the required elements are present, delaying your review.)

For Research with Adults:

Written informed consent:

Informed Consent

Online 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:

Parental Consent

Child assent:

Child Assent

Language to Be Inserted into Informed Consent for Special Cases:

Confidentiality for Protected Health Information:

PHI Form

Conflict of Interest Disclosure:

Conflict Of Interest Language

Compensation for Injury for Funded Studies:

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.

Flyer:

IRB Recruitment Flyer

Email/Online Recruitment:

IRB Recruitment Email

Genetic Research Consent Rider:

Genetic Screening Consent Rider

Data Use Agreement Form:

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