New: Consultation and Pre-Review Services
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| INFORMED CONSENT | |||
| Q & A Consent Template for Clinical Trials (New) | 6-23-2008 |
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| This consent template, appropriate for FDA-regulated studies, is written in a Question and Answer format. | |||
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Consent Form Template 1 | 6-23-2008 |
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This template is appropriate for studies involving FDA-regulated products. It is also recommended for any other study in which external parties (such as sponsors or collaborators) will receive study data that has not been fully de-identified according to HIPAA standards. * |
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Consent Form Template 2 | 6-23-2008 |
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This template should be used for
internal studies and for other projects where all data released
to external parties has been de-identified according to HIPAA
standards. * |
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Consent Template for Surrogate Decision-Makers | 7-2-2009 |
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This template is appropriate for persons who are consenting to research on behalf of another adult who does not have decisional capacity. |
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Consent Template for Humanitarian Use Devices | 3-10-2008 |
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| Approval for a humanitarian use device (HUD) involves special considerations from FDA and the HSC. Please contact the HSC Office for more information when proposing the use of an HUD. |
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Consent Template for Optional Genetic Research | 7/242008 |
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Consent Template Parental Permission | 5/18/2009 | |
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Consent Template Child Assent Examples | 1/26/2009 |
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