Forms and Templates

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 Protocol Templates

FormDescription

Protocol Template (Cancer Related) 

Use this template if your research is cancer-related. This protocol template is required by PRMC at Simmons Cancer Center.

Refer to Protocol Guidelines for more information.

Protocol Template (Non-Cancer Related) 

Use this template if your research is not cancer-related AND if you do not have a separate protocol. This template is not required for chart review studies.

Refer to Protocol Guidelines for more information.

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 Consent Templates

Please note: The footers in these documents are designed to allow for electronic "stamping" of the IRB Tracking Number (STU#) and Approval Dates.
FormDescription

Consent Form (Template) - English

Consent Form (Template) - Spanish

Download the template and edit accordingly.

Template(s) may be used for minimal or more than minimal risk studies.

If study involves MRI, include the Additional Language for Studies Involving MRI Procedures

Consent Form Minimal Risk (Template) - English

Consent Form Minimal Risk (Template) - Spanish

Download the template and edit accordingly.

Template(s) may be used for minimal risk studies only.

If study involves MRI, include the Additional Language for Studies Involving MRI Procedures

DNA Consent Form (Template) - English

DNA Consent Form (Template) - Spanish

Download the template and edit accordingly.

Template(s) may be used for studies involving the collection/analysis of specimens for DNA/genetic analysis.

If study involves MRI, include the Additional Language for Studies Involving MRI Procedures

DNA/Main Consent Form Combined (Template)

Download the template and edit accordingly.

Template for studies in which the primary aim is not the collection/analysis of specimens for DNA/genetic analysis, yet the study includes this activity.

If study involves MRI, include the Additional Language for Studies Involving MRI Procedures

Database/Repository Consent Form (Template)

Download the template and edit accordingly.

Template for research where the primary aim is to Collect/Store/Distribute specimens and/or data as part of a Repository or Database for future research. 

If study involves MRI, include the Additional Language for Studies Involving MRI Procedures

Emergency Use Consent Form (Template)

Download the template and edit accordingly.

This consent template is for Emergency Treatment use of an investigational drug or device to treat patients with a life threatening condition and where there is not enough time to obtain IRB approval.

This template should be submitted to the HRPP office as soon as possible to ensure timely review by the IRB Chairperson.

Humanitarian Use Device Consent Form (Template)

Download the template and edit accordingly.

Template for cosent to Treatment (not research) involving a Humanitarian Use Device. Use this template when an adequate patient brochure is not avaialble or as required by the IRB.

See the Humanitarian Use Device Guidelines for more information

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 HIPAA Authorization Templates

FormDescription

HIPAA Authorization for Research Purposes - English

HIPAA Authorization for Research Purposes - Spanish

Download the template and edit accordingly for studies which utilize identifiable health information and where consent will be obtained.

Template for Authorization to use and/or disclose protected health information in research.

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 Short Form Consent Templates (Non-English Speaking Subjects)

FormDescription

Consent Short Form - English

Consent Short Form - Spanish

Consent Short Form - Vietnamese

Consent Short Form - Korean 

Consent Short Form - Russian

Consent Short Form - Chinese

Consent Short Form - Arabic

Consent Short Form - Burmese

Consent Short Form - Urdu

Download the appropriate template and edit accordingly for studies which need to enroll a non-English speaking subject and a long translated consent form is not available.

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Emergency Use Forms

FormDescription

Emergency Use Request/Notification Form

 

Download the template and edit accordingly.

Template for Emergency Treatment use of an investigational drug to treat patients with a life threatening condition and where there is not enough time to obtain IRB approval.

This template should be submitted to the HRPP office as soon as possible to ensure timely review by the IRB Chairperson.

See Emergency Use Guidelines for more information.

Emergency Use Consent Form (Template)

If consent can be obtained safely, download the template and edit accordingly.

This template should be submitted to the HRPP office as soon as possible to ensure timely review by the IRB Chairperson. 

Template for Emergency Treatment use of an investigational drug or device to treat patients with a life threatening condition and where there is not enough time to obtain IRB approval.

See Emergency Use Guidelines for more information.

Report to IRB of Emergency Use (No Template)

Per FDA guidelines, a physician must submit a report to the IRB within 5 days of administering an investigational drug or device in an Emergency Use situation.

Contact the HRPPO HRPP@utsouthwestern.edu or refer to the Emergency Use Guidelines for more information.

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 Non-Human/Non-Regulated Research Forms

FormDescription

Non-Human Research Request Form

Download the template when conducting research involving purely deidentified (anonymous) data/specimens.

The completed form may be submitted to the HRPPO by email for courtesy review and determination that IRB approval is not required.

When collecting deidentified data from another indiviudal or laboratory without a formal written agreement, you may utilize the De-Identification Agreement Form to document the agreement and submit with your Non-Human Research Request Form.

Non-Regulated Research Request Form

Download the template when conducting activities not considered research according to the federal definition of research (45 CFR 46.102(d)). Examples include: Quality Improvement, Program Evaluation, Case Reports, etc.

The completed form may be submitted to the HRPPO by email for courtesy review and determination that IRB approval is not required.

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 Miscellaneous Forms

FormDescription

Decedent Research Attestation Form 

(Collection of data/specimens from deceased individuals)

Download and complete this form anytime the research involves collection of data/specimens from deceased individuals whereas consent for the collection was not obtained prior to death.

Payment Request for Study Participants - English

Payment Request for Study Participants – Spanish

This form is used to request payment directly to a research participant. It must include information about the participant including his/her social security number and must also be signed by the participant.

Sponsor Request Form

This form is used to request the addition of a sponsor to appear in electronic systems for a research award, DSB, eGrants or eIRB.

Documented Training Request Form

Use this form to request documentation of completed Research Ethics training. 

Certificates of completion are available for download on the CITI training website.

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