CONSENT DOCUMENT TEMPLATES
Informed Consent is a process by which a subject voluntarily confirms his or her willingness to participate in a particular study, after having been informed of all aspects of the study that are relevant to the subject’s decision to participate. The method of obtaining and documenting informed consent must be outlined in the study protocol and approved by the LSUHSC-NO IRB. Please refer to the Guidance on Informed Consent for additional information.
| Template ID | Template Title | About the Template | Version # |
| Standard Consent Form Templates | |||
| HRP-2250 | LSUHSC Joint Consent/HIPAA Template | Complete Instructions | 3.2 |
| HRP-2251 | LSUHSC Joint Consent/HIPAA Template | Minimal Instructions | 3.2 |
| HRP-2251 | LSUHSC-UMC Joint Consent/HIPAA Template | Use when UMC is a performance site | 3.2 |
| HRP-2251 | LSUHSC-OLOL Joint Consent/HIPAA Template | Use when OLOL is a performance site | 3.2 |
| LSUHSC-CHNOLA Joint Consent Form | Use when Children's Hospital is a performance site | ||
| Short Consent Form Templates | |||
| HRP-2252 | Short Consent Form - English | Example Form Only | 1.0 |
| HRP-2253 | Short Consent Form - French | Use when unexpectedly enrolling a French-speaking subject (max of 2 uses) | 1.0 |
| HRP-2254 | Short Consent Form - Spanish | Use when unexpectedly enrolling a Spanish-speaking subject (max of 2 uses) | 1.0 |
| HRP-2254C | CHNOLA-LSUHSC Short Consent Form - Spanish | Use when unexpectedly enrolling a Spanish-speaking subject at Children's Hospital | 1.0 |
| HRP-2255 | Short Consent Form - Vietnamese | Use when unexpectedly enrolling a Vietnamese-speaking subject (max of 2 uses) | 1.0 |
| Expanded Access and Humanitarian Use Device Consent Templates | |||
| HRP-2257 | Emergency Use of a Test Article Consent Template | Use when emergently treating a patient with an unapproved drug or device | 1.2 |
| HRP-2257C | CHNOLA-LSUHSC EUTA Consent Template | Use when emergently treating a patient at Children's Hospital with an unapproved drug or device | 1.0 |
| HRP-2257 | Non-Emergency Use of a Test Article Consent Template | Use when non-emergently treating a patient with an unapproved drug or device | 1.1 |
| HRP-2258 | HUD Treatment Consent Template | Use when treating a patient with a Humanitarian Use Device | 1.5 |
| Other Consent Templates | |||
| HRP-2259 | Exempt Research Information Sheet | Use when Waiver of Documentation of Informed Consent is granted for Exempt research | 1.2 |
| HRP-2260 | Case Report Consent Template | Use when accessing a patient chart to write a case report (optional) | 1.1 |
| HRP-2261 | Biorepository Consent Template | Use when enrolling a subject in an optional biorepository arm of a study | 1.1 |
| HRP-2262 | Pregnant Partner Consent Template | Use when the study requires monitoring of a subject's pregnant partner | 1.2 |
| HRP-2267 | Healthy Volunteer Consent Template | Use when enrolling healthy volunteers | 3.2 |
| Verbal Consent Templates | |||
| HRP-2263 | Verbal Informed Consent Template | Use when Permission for Verbal Consent is granted by the IRB | 1.2 |
| HRP-2264 | Verbal Consenting Script Template | Use when Permission for Verbal Consent is granted by the IRB (optional) | 1.1 |
| Assent Templates | |||
| For research being conducted at Children's Hospital, please contact the CHNOLA Research Office for their Assent Templates | |||
| HRP-2265 | Assent Template - Ages 7-12 | Use when enrolling children ages 7-12 in a study not occurring at Children's Hospital | 1.1 |
| HRP-2266 | Assent Template - Ages 13-17 | Use when enrolling children ages 13-17 in a study not occurring at Children's Hospital | 1.1 |
| Informed Consent Cover Letters | |||
| LSUHSC ICF Cover Letter Template | Attach to the front of a consent packet when using a non-HSC consent template | ||
| CHNOLA-LSUHSC ICF Cover Letter Template | Attach to the front of a consent packet when using a non-HSC consent template to enroll subjects at Children's Hospital | ||
Translation of Study Documents
Certified translations are required for studies that intend to enroll non-English-speaking individuals. The investigator is responsible for the cost of translating study materials. Please include the associated certificate(s) of translation upon submission of the translated document(s) to the IRB. To learn more about what qualifies as a certified translation please review the ATA website (Certification – American Translators Association (ATA) (atanet.org).
Translation Companies (Note: The IRB does not endorse any translation service)
The “short form” method for obtaining informed consent should only be used for the occasional and unexpected enrollment of a non-English-speaking participant. If the study design includes intent to enroll non-English-speaking individuals, or once the study team encounters one unexpected participant speaking a non-English language, the Informed Consent Form must be fully translated to that language.
Use of Sponsor Consent Forms Templates
LSUHSC prefers use of our local-approved template; however, if the study team wishes to use the Sponsor template, the LSUHSC ICF Cover Letter must be provided along with the Sponsor consent, or the required language must be embedded into the form. If the designated reviewer does not feel that the Sponsor template contains all the appropriate information or that the quality is poor, the reviewer reserves the right to request the team switch to use of the local-approved template.