Templates and Forms
Quick Links
- Biomedical
- Social Behavioral
- Support Documents
- Short Form Consent
- Investigator Checklists
- Recruitment Materials and Guidelines
Biomedical
See also: Suggested consent form language
Consent Forms
| File | Version Date |
|---|---|
|
Consent and HIPAA Authorization Form Replaces Version Dated: 9/13/12 |
2/4/13 |
|
Consent Form (No HIPAA) Replaces Version Dated: 7/17/12 |
9/13/12 |
|
Emergency Use Consent Form Replaces Version Dated: 7/13/03 |
4/5/12 |
|
Humanitarian Use Device Clinical Consent Replaces Version Dated: 4/5/12 |
9/13/12 |
|
Online Consent Replaces Version Dated: 9/13/12 |
4/13/13 |
|
Verbal Consent Replaces Version Dated: 9/13/12 |
4/13/13 |
Parental Consent and Assent Forms
| File | Version Date |
|---|---|
|
Parental Consent and HIPAA Authorization Form Replaces Version Dated: 9/13/12 |
2/4/13 |
|
Parental Consent Form (No HIPAA) Replaces Version Dated: 4/5/12 |
9/13/12 |
|
Assent Form Replaces Version Dated: 9/13/12 |
4/13/13 |
|
Assent Script Replaces Version Dated: 9/13/12 |
4/13/13 |
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: 9/13/12 |
4/13/13 |
| Consent Form and HIPAA Authorization Form | 4/13/13 |
|
Online Consent Replaces Version Dated: 9/13/12 |
4/13/13 |
|
Verbal Consent Replaces Version Dated: 9/13/12 |
4/13/13 |
Parental Consent and Assent Forms
| File | Version Date |
|---|---|
|
Parental Consent Form (No HIPAA) Replaces Version Dated: 4/13/13 |
5/10/13 |
|
Assent Form Replaces Version Dated: 9/13/12 |
4/13/13 |
|
Assent Script Replaces Version Dated: 9/13/12 |
4/13/13 |
Protocol Templates
| File | Version Date |
|---|---|
|
Social Behavioral Protocol Template Replaces Version Dated: 4/5/12 |
4/13/13 |
| 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 |
| Compassionate Use Request Form for Investigational Devices | 2/27/13 |
|
Emergency Use Form Replaces Version Dated: 3/12/09 |
4/5/12 |
| Good Clinical Practice Guidance for Industry | 4/1/96 |
|
Human Subject Research Determination Form Replaces Version Dated: 12/10/12 |
5/10/13 |
| IRB Authorization Agreement | 3/26/12 |
| Letter for Subjects to Revoke HIPAA Authorization | 4/5/12 |
|
Letter to Notify Subjects of Change in Contact Information Replaces Version Dated: 4/5/12 |
10/22/12 |
|
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
