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Human Subjects Research (HRPP/IRB)

Forms

Checklists

Exemption Review Submission Checklist |Word

Expedited Review Submission Checklist | Word

Full Board Review Submission Checklist |Word

Student Researcher Checklist |Word

Collaborative Research Consent Checklist|Word

Amendment Checklist |Word 

Continuing Review/Progress Report Checklist | Word

Applications

Part 1: Human Subject Research Application (Expedited or Full Board Application) |Word

Exemption Application |Word 

* If you are completing an Exempt, Expedited, or Full Board Application, you must also complete the DU IRB Application (Wizard Form) located only on IRBNet. Each Exempt, Expedited, or Full Board Application must have TWO applications total. 

Amendment Application |Word | PDF

Continuing Review Application |Word | PDF

Determination Forms

Human Subjects Research (HSR) Determination Form (formerly Appendix E) |Word

Appendix Forms

Appendix A: Waiver of Informed Consent/Waiver of Written Documentation of Consent |Word | PDF

Appendix B: Field Work |Word | PDF

Appendix C: Populations with Additional Considerations |Word

Appendix D: Research Involving Prisoners |Word

Appendix F: Research Involving Children |Word

Appendix G: International Research |Word | PDF

Appendix H: Research Involving Pregnant Women |Word | PDF

Appendix I: Stored Data for Future Use |Word | PDF

Appendix J: Community Based Research |Word | PDF

Appendix K: Certificate of Translation |Word | PDF

Appendix L: Research Involving Deception |Word | PDF

Appendix M: Research in Schools |Word

Appendix N: Research Involving the Internet |Word | PDF

Appendix O: Secondary Data Use |Word | PDF

Appendix P: Collaborative Research with Ceding Form | Word  

Appendix Q: Unaffiliated Investigator Agreement Approval Request Form | Word

Consent Forms and Waivers

Exempt Informed Consent Template | Word

Expedited Informed Consent Template | Word

Full Board Informed Consent Template | Word

Implied Consent Template for Online Surveys | Word

Verbal Assent Script for Children 5 -12 | Word

 

Assent ages 7-13 | Word

Assent over the age of 13 | Word

Parental Permission Form | Word

Verbal, Electronic or Implied Consent |Word 

Consenting Non-English Speaking Research Subjects | Word

Sample Recruitment and Advertisement Materials

Research Recruitment Flyer |Word 

Sample Letter for an Anonymous Mail Survey | PDF

Sample Recruitment Letter or Email |PDF

Sample Response to Modifications IRB Letter |Word 

Sample Verbal Recruitment Script | PDF

Telephone Screening for Potential Subjects | Word

Closing A Project

Investigators are asked to close their project when data collection is completed and  when working with de-identified data. However, if investigators are working with identifiable data you must keep the project open until the study is completed. 

Final Report/Closure Form |Word | PDF

Project Closure Guidance | PDF

Reportable New Information

Reportable New Information Form |Word | PDF

Collaborative Research Forms

Appendix P: Collaborative Research with Ceding Form | Word  

IRB Authorization Agreement Form | Word

Appendix Q: Unaffiliated Investigator Agreement Approval Request Form | Word

Individual Investigator Agreement (IIA) Form | Word

Collaborative Research Consent Checklist|Word

Guidance Documents

Information Sheet for Exempt Research |Word

Expedited Review Research |Word

Full Committee Review Research |Word 

IRB Committee Action Options |Word

Using Students or Employees in Subject Pool | Word

Research Protocols and Risk of Suicide | Word

Research Involving Prisoners |Word

Consenting Non-English Speaking Participants |Word 

Verbal, Electronic or Implied Consent |Word 

Child Assent and Parental Permission |Word 

Summary Table on Subpart D| Word

Research Involving Children and Minors |Word 

HIPAA and Research | PDF

FERPA and Research | PDF

FERPA, PPRA, and Research | PDF

Research Involving Minors | PDF

Conducting Research in K-12 Schools |PDF

Classroom-based Educational Research Activities | Word

Research Involving Students and/or Conducted in Educational Settings |Word

Amendments to Previously Approved Research |Word | PDF

Data Safety Monitoring Plan (DSM) |Word

Data Transfer and Use Agreement (DTUA) |Word

Exempt Consent Template | Word

Informed Consent Waivers and Exceptions |Word 

International Compilation of Research - 2018 | PDF

International Research |Word

International Travel by Students, Faculty, and Staff | Word

Secure Locations to Store Sensitive/Confidential Research Information | PDF

CITI Guidance Documents

Student Step-by-Step Instructions for Human Subjects CITI Training | PDF

How to Register & Affiliate your training from previous institution| PDF

Refresher Course | PDF

How do you know when you've successfully finished the CITI training requirement? | PDF

Troubleshoot Help and Checking Your CITI Status | PDF

How To: IRBNet

For detailed instructions on how to register and navigate through IRBNet, please refer to one of the following guidances: 

How To: Register as a New User | Word
How To: Submit a New Project | Word
How To: Submit a Continuing Review | Word
How To: Respond to a Full Board Review | Word
How To: Submit an Amendment/Modification | Word
How To: Respond to a Preliminary Review | Word
How To: Uploading CITI Training to IRBNet Userprofile | PDF
How To: Close a Study | Word 
DU IRBNet User's Manual for IRB Submissions | Word
IRBNet - FAQs: Researcher Functions | PDF
Policies and Procedures
  • HRPP 101 - Introduction | PDF
  • HRPP 201 - Definitions | PDF
  • HRPP 301 - General Policies and Procedures | PDF
  • HRPP 401 - Subject Recruitment and Participation | PDF
  • HRPP 501 - Initial IRB Review of Research Activities | PDF
  • HRPP 601 - Informed Consent | PDF
  • HRPP 701 - Continuing Review | PDF
  • HRPP 801 - Amendments | PDF
  • HRPP 901 - Reporting Unanticipated Problems | PDF
  • HRPP 1001 - Vulnerable Populations | PDF
  • HRPP 1101 - Community-Based Research | PDF
  • HRPP 1201 - International Research | PDF
  • HRPP 1301 - Research Using Deception or Incomplete Disclosure | PDF
  • HRPP 1401 - Utilizing Surveys and Internet Research | PDF
  • HRPP 1501 - Protocol Deviations and Noncompliance | PDF
  • HRPP 1601 - Suspensions and Terminations | PDF