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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

Application

Part 1: Human Subject Research Application |Word

Exemption Application |Word 

Amendment Application |Word | PDF

Continuing Review Application |Word | PDF

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 E: Determination of Human Subjects Research | 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

Collaborative Research Guidance | Word

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