Forms and Templates

The HSC Consent Template has been revised to comply with the 2018 Common Rule. Ongoing research studies that are approved on the pre-2018 consent template (701-A, effective 6/26/2018) should contact the HRPP Office if you need access to that template. 

3/10/2022: The VA Consent Template has been revised and linked below. New compensation language was added to the Key Information Section, "Why Might I Not Want to Participate?" (pg 4), as well as the Detailed Section, "Will I be Paid for Participating in this Research Study?" (pgs 14-15). 

1/18/2022: The main OUHSC consent template has been revised. New language has been added to "How Will Participating in the Study Affect Me Financially?" if there are institutional requirements for payment to participants. 

NEW! 9/28/2021: The HSC Consent Template was updated effective 9/28/2021. Introductory language for legally authorized representatives (LAR) was added to the template. Other minor changes were made, including revisions to sub-headers for research involving biospecimens and future use/sharing of participant information or biospecimens. "Can I Withdraw...?" was relocated and placed after the confidentiality section. 

• 701-A HSC Consent Template, effective 1/18/2022
• Child Assent Template
• Consent/Assent Template - Tissue Banking
• Patient Information Sheet - Tissue Banking
• Addendum Consent Template
• Sample Consent for Emergency Use
• VA Form 10-1086 Consent Form Template - Effective 2.15.2022 - Supersedes VA 10-1086, dated 8.5.2020
• Surveys: EXAMPLE of a Consent Statement (Cover Sheet)

 HIPAA Webpage
 

• Form 1 - Authorization To Use or Disclose PHI
                     Used for most clinical research projects not involving psychotherapy or repository research.

• Form 2 - Authorization To Use or Disclose Psychotherapy Notes for Research 
                      Instructions (click here) -for preparing the authorization for disclosure of psychotherapy notes.

• Form 3 - Authorization To Use or Disclose PHI for Repository Research
                       For repository research only.

• Form 4 - Authorization To Use or Disclose PHI for Research That Also Includes Repository Research
                       Combination of Forms 1 & 3. Used for combined research that includes a repository. 

• Form 5 - Request for Waiver or Alteration to Use or Disclosure of PHI in Research   

•  Form 8 - Investigator Representation for Research on De-identified PHI

•  Form 9 - Investigator Representation for Research on Limited Data Sets of PHI

•  Form 10 - Data Use Agreement For a Limited Data Set
                        For use with Form 9, as appropriate. 

•  VA Form 10-0493: Authorization for Use & Release of Individually Identifiable Health Information for VHA Research - Sept. 2015

• Protocol Outline - Effective 3/12/2019 

• Modification Summary Report
        For use in tracking Modifications that are submitted to the IRB (and approved); to be reported at the time of Continuing Review.

• Protocol Deviation Summary Report
        For use in tracking all deviations - major and minor - to be reported at the time of Continuing Review. (See HRPP SOP 407 for more information and guidance regarding deviations) 

• Summary of Participant Harms Report
        For use in tracking all harms - anticipated and unanticipated; outside and local - to be reported to the IRB at the time of Continuing Review.

• Research Privacy Form 1 - UPDATED 9/28/2018

• Research Privacy Form 2 - UPDATED 9/28/2018

• Research Privacy Form 3 - UPDATED 9/28/2018

• Research Privacy Form 4 - UPDATED 9/28/2018

• Consent - Short Form - English

• Consent - Short Form - Spanish 

• Translator Attestation Statement (sample)

OHRP Guidance (Nov. 9, 1995)

 All study-related submission forms are available in iRIS, the IRB's electronic submission system.

This includes: 

• HSC IRB Application

• Modification / Notification Form

• Continuing Review / Final Closure Report

• HSC Incident Report Form* (used for reporting deviations and unanticipated problems to the IRB)

• Exempt Study Progress Report

• Inactivation Form - PI Left OU

**IMPORTANT: Effective August 2018, investigators must use the new HSC Incident Report Form to submit protocol deviations and unanticipated problems to the IRB. The Protocol Deviation and Unanticipated Problem Report Forms are now labeled with 'NC' to indicate that they are for the Norman Campus IRB only. 

Login to iRIS at https://iris.ouhsc.edu/ to create a new study or to add a new submission to your currently-approved study.

All submission forms not related to a study are available in iRIS, the IRB's electronic submission system.

 This includes: 

• Determination of Human Research Worksheet

• Review of PHI Preparatory to Rearch (aka, Research Privacy Form 6)

• Representation for Research on Decedents' PHI (aka, Research Privacy Form 7)

• One-time Emergency Use of a Test Article (5-Day Notice of Use)

Login to iRIS at https://iris.ouhsc.edu/ to access these forms, which are sub-forms of the Initial Submission Packet:

1. Click 'Add a New Study' under the Study Assistant Tab to create a new HSC Application.

2. Answer the questions in each section and click 'Save and Continue' until you reach Section 4.0.

3. The submission forms listed above are located in Section 4.0 of the application.

4. Complete the submission form and then proceed to complete the shortened application until you are able to signoff and submit the packet to the IRB.