Templates and Forms
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Biomedical
See also: Suggested consent form language
Consent Forms
| File | Version Date |
|---|---|
|
Consent and HIPAA Authorization Form Replaces Version Dated: 8/11/11 |
4/5/12 |
|
Consent Form (No HIPAA) Replaces Version Dated: 8/11/11 |
4/5/12 |
|
Emergency Use Consent Form Replaces Version Dated: 7/13/03 |
4/5/12 |
|
Humanitarian Use Device Clinical Consent Replaces Version Dated: 4/8/11 |
4/5/12 |
|
Online Consent Replaces "Waiver of Documentation" dated 2/8/10 |
4/5/12 |
|
Verbal Consent Replaces "Waiver of Documentation" dated 2/8/10 |
4/5/12 |
Parental Consent and Assent Forms
| File | Version Date |
|---|---|
|
Assent Form Replaces Assent from ages 7-12 and ages 13-17 |
4/5/12 |
|
Assent Script Replaces Assent Script for under 7 |
4/5/12 |
| Parental Consent and HIPAA Authorization Form | 4/5/12 |
| Parental Consent Form (No HIPAA) | 4/5/12 |
Protocol Templates
| File | Version Date |
|---|---|
|
Biomedical Protocol Template - Interventional Replaces "Key Elements of a Biomedical Protocol" |
4/5/12 |
|
Biomedical Protocol Template - Non-Interventional Replaces "Key Elements of a Biomedical Protocol" |
4/5/12 |
|
Chart Review Protocol Replaces Version Dated: 2/3/11 |
4/5/12 |
| Data Coordinating Center Protocol | 4/5/12 |
| Lead Coordinating Center Protocol | 4/5/12 |
Social-Behavioral
See also: Suggested consent form language
Consent Forms
| File | Version Date |
|---|---|
|
Consent Form Replaces Version Dated: 8/11/11 |
4/5/12 |
|
Online Consent Replaces "Waiver of Documentation" dated 2/8/10 |
4/5/12 |
|
Verbal Consent Replaces "Waiver of Documentation" dated 2/8/10 |
4/5/12 |
Parental Consent and Assent Forms
| File | Version Date |
|---|---|
|
Assent Form Replaces Assent from ages 7-12 and ages 13-17 |
4/5/12 |
|
Assent Script Replaces Assent Script for under 7 |
4/5/12 |
| Parental Consent Form (No HIPPA) | 4/5/12 |
Protocol Templates
| File | Version Date |
|---|---|
|
Social Behavioral Protocol Template Replaces Version Dated: 7/28/03 |
4/5/12 |
| Data Coordinating Center Protocol | 4/5/12 |
| Lead Coordinating Center Protocol | 4/5/12 |
Support Documentation
| File | Version Date |
|---|---|
| Certificate of Translation Template For Non-English Documents | 4/5/12 |
| Checklist for Documenting Informed Consent | 4/5/12 |
|
Emergency Use Form Replaces Version Dated: 3/12/09 |
4/5/12 |
| Human Subjects Research Determination Form | 4/5/12 |
| IRB Authorization Agreement | 3/26/12 |
| Letter for Subjects to Revoke HIPAA Authorization | 4/5/12 |
| Letter to Notify Subjects of Change in PI | 4/5/12 |
|
Media Relations Form Replaces Version Dated: 5/24/11 |
4/5/12 |
|
Radiation Dosimetry Form Replaces Version Dated: 3/23/10 |
4/5/12 |
Short-Form Consent
The following are posted with permission from the University of Minnesota. See OHRP's Guidance on obtaining and documenting informed consent of subjects who do not speak English.
See also: Consent Translation and Short Form Guidance
