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