Forms and Templates
All completed forms should be submitted through the myIRB system unless otherwise noted.
Please refer to the Initial Study Submission page for details on which forms may be required for a new study submission.
Forms and templates overview:
- Consent Templates
- Continuing review (renewal) and Closures
- Flexibility
- HIPAA/Waivers/Recruitment
- Modifications
- Project Descriptions
- Protocols
- Reliance
- Supplemental forms
- Wichita Campus Documents
Consent Templates - Greater than Minimal Risk
Form Name | Notes | Date Modified |
---|---|---|
Child Assent Examples | ||
Emergency Use | 12/2021 | |
Full Board Consent Template | This template incorporates all full board templates: FDA regulated, non-FDA regulated, parental permission, surrogates, and optional future use. | 09/2024 |
Key Information Section Tips |
These examples are provided to help write the key information sections of the Q&A FDA regulated and Q&A non-FDA regulated consent templates. |
|
1: Key Information Randomized Trial Header Template with example | 11/2022 | |
2: Key Information QA format template with Example | 11/2022 | |
Pregnant Participant/Partner Follow Up | 09/2024 | |
Single Patient IND template | 05/2021 | |
Withdrawal or Partial Withdrawal of Consent for Research | Only use this form if the sponsor requests that withdrawing participants return for study visits other than the standard EOT visit and/or that they allow the ongoing collection of outcome data. | 05/2021 |
Spanish surrogate decision maker addendum | 11/2021 |
Consent Templates - Minimal Risk/Flex Review
Form Name | Notes | Date Modified |
---|---|---|
These templates can be used for any minimal risk research whether flex review, exempt, or expedited. | ||
QA Minimal Risk research consent template | 12/2021 | |
Biorepository | 05/2021 | |
Focus Groups with HIPAA | 05/2021 | |
Focus Group - without HIPAA | 05/2021 | |
Minimal risk procedures (for Flex Studies only) | 12/2021 | |
Registry | 05/2021 | |
Combined survey templates | This document includes all survey templates for anonymous surveys w & w/o HIPAA and identifiable surveys | 03/2021 |
Consent Forms and Process for Non-English Speaking Subjects
Continuing Review (Renewal) and Closures - How to submit Continuing reviews
Form Name | Notes | Date Modified |
---|---|---|
Continuing Review Supplement | 01/2024 |
Flexibility Documents
Form Name | Notes | Date Modified |
---|---|---|
Documents for a Flex Review can be found in their respective sections such as the consent form templates for minimial risk section, the project description section, and the protocol section for secondary use of data. |
HIPAA/Waivers/Recruitment
Form Name | Notes | Date Modified |
---|---|---|
Application for Partial Waiver of HIPAA Privacy Authorization for Recruitment Purposes | ||
PHI Checklist | ||
Research Waiver Application | 01/2024 |
Modifications - How to submit modifications
Form Name | Notes | Date Modified |
---|---|---|
Informing Subjects of New Information - Guidance | 12/2020 | |
Informing Subjects of New Information - Form | 01/2024 | |
Notification letter template | 08/2016 |
Project Descriptions
Form Name | Notes | Date Modified |
---|---|---|
Exempt Project Description | Use for research that is federally funded or supported. Otherwise, use the Flexibility Project Description. | 05/2024 |
Expedited Project Description | Use for research that is federally funded or supported. Otherwise, use the Flexibility Project Description. | 05/2024 |
Flex Review Project Description | Please use this document for minimal risk research that is not federally funded or supported. The Flexibility Project Description applies to minimal risk behavioral or biomedical study activities. If the project involves only secondary analysis of data or specimens, use the combination protocol/application forms for secondary research posted under Protocols below. | 05/2024 |
Full Committee Project Description - Industry Trials | Use for Full Board/Greater Than Minimal Risk industry studies | 09/2024 |
Full Committee Project Description - Investigator Initiated Trials | Use for Full Board/Greater Than Minimal Risk researcher initiated studies | 09/2024 |
Principal Investigator Supplement | This has been revised so that both Industry Trials and IIT trials should use this one form. | 11/2023 |
Not Human Subjects Research | Download, complete, and email to IRBhelp@kumc.edu | 12/2015 |
Quality Improvement Determination |
Complete the REDCap request form. REDCap will notify the appropriate reviewers depending on the type of project and the source of data and participants. As you complete the form in REDCap, please upload any related project plans, data instruments, surveys or dissertation materials. After review, you will receive confirmation of the final determination or additional information on how to proceed. |
03/2021 |
Secondary analysis | secondary analysis forms can be found in the protocol sub-section below |
Protocols
Form Name | Notes | Date Modified |
---|---|---|
Protocol and Application for Secondary Research | The secondary research forms serve as both the project description and the study protocol. They apply to research that involves only re-use data and specimens. | 08/2020 |
503- Biomedical Protocol Template | 02/2023 | |
503a- Social and Behavioral Protocol Template | 02/2023 |
Reliance - IRB Reliance Resources
Please find all the Reliance forms on the KUMC Reliance Forms and Templates webpage
Supplemental Forms
Form Name | Notes | Date Modified |
---|---|---|
Administrative Certification for IRB Submission | 01/2024 | |
Community-Based Participatory Research Supplemental Form | 01/2024 | |
Genome Wide Association Studies (GWAS) forms | ||
IRB checklist | 01/2024 | |
Mobile App Guidance | 06/2016 | |
Mobile App Supplemental Form | 02/2017 | |
Nursing Impact Form | 03/2016 | |
Application for Use of Radiation in Research Involving Human Subjects | 05/2024 | |
Research Request for Human Specimens | ||
Scientific Review and Administrative Certification (combined form) | Only a requirement in Wichita | 03/2015 |
Scientific Merit Form | 01/2024 |
Wichita Campus Documents - Additional Information
Form Name | Notes | Date Modified |
---|---|---|
Common Application Form | 06/2020 | |
Scientific Merit Form | 03/2018 | |
Wesley Reliance Studies Form | 02/2020 |