Skip navigation

Office of Research & Sponsored Programs

mary reed scene

Human Subjects Research (HRPP/IRB)

How To Submit

STEP 1: DETERMINING YOUR TYPE OF IRB REVIEW

Is My Project Exempt, Expedited, or Full Board?

If you answer YES to any of the following questions, your proposal may NOT qualify as exempt and you must fill out an expedited or full board review application.

  1. Will you be working with prisoners, pregnant women, fetuses, or institutionalized mentally disabled individuals? 
  2. Will you be surveying, interviewing, or observing minors?
  3. Will you be collecting identifiable data (i.e. names, id numbers, etc.)?
  4. Will your research involve obtaining sensitive information (i.e. drug use, sexual activity, or other illegal activities)? 
  5. Could your research create an increased risk for your subjects participation (physical, emotional, social, or financial risk)? 

Examples of common exempt projects:

  1. Anonymous educational tests, surveys, interviews, or observations
  2. Online anonymous surveys, such as Qualtrics or Survey monkey
  3. Analyzing or receiving pre-existing, de-identified, secondary data 
FAQs: Frequently Asked Question
What is the difference between "exempt" and "expedited" review?

Research studies can be categorized by the amount of risk involved. If a research study involves little or no risk to the subject, the research is exempt from further IRB review. Exemption waives the need for further IRB review; however, it does not negate the need for the consent of subjects where applicable.

If the research study presents no more than minimal risk, it may qualify for an expedited review if the involvement of human subjects falls into one or more categories approved by DHHS. An expedited review is conducted by a qualified member of the IRB. The member reviews the appropriate materials and determines to either approve the research or return it for modification. A research study may only be disapproved by a full IRB meeting.

Does exempt mean I don't have to apply to the IRB?

No. Only the IRB may make the determination that research is exempt from IRB review. Therefore, the investigator must submit the Request for Exemption application to the IRB, which details the research.

What is "minimal risk"?

"Minimal risk" means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Step 2: Choose Your review type

Exempt from IRB Review
Checklists

Exemption Submission Checklist |Word

Student Researcher Checklist |Word 

Application

Exemption Application |Word 

* In addition to the Exempt Application, you must also fill out the DU IRB Application (Wizard Form) located only on IRBNet. 

Supplemental Forms
Students and Schools

Appendix M: Research in Schools |Word

Appendix F: Research Involving Children |Word

Guidance Documents

FERPA and Research | PDF

FERPA, PPRA, and Research | PDF

HIPAA 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

International Research

Appendix G: International Research |Word | PDF

Appendix J: Community Based Research |Word | PDF

Appendix K: Certificate of Translation |Word | PDF

Guidance Documents

International Compilation of Research - 2018 | PDF

International Research |Word 

International Travel by Students, Faculty, and Staff | Word

policies

HRPP 1201 - International Research | PDF

Non-English Speaking Participants

Appendix K: Certificate of Translation |Word | PDF

Appendix C: Populations with Additional Considerations |Word | PDF

Guidance Documents

Consenting Non-English Speaking Research Subjects |Word 

Children

Appendix F: Research Involving Children |Word

Guidance Documents

Child Assent and Parental Permission |Word 

Special Subject Populations - Children and Minors |Word 

Pregnant Women

Appendix H: Research Involving Pregnant Women |Word | PDF

Research "In The Field"
  • Phenomenological & Ethnographic Research Proposals

Appendix B: Field Work |Word | PDF

Populations with Additional Considerations

Researchers who are working with the following populations must fill out Appendix C:

  • Subjects who are mentally, emotionally, or developmentally disabled
  • Adults lacking capacity to consent
  • Non-English Speakers 
  • Economically or educationally disadvantaged populations
  • Minority groups

Appendix C: Populations with Additional Considerations |Word

Community Based Participants

Appendix J: Community Based Research |Word | PDF

Policies

HRPP 1101- Community Based Research | PDF

Research Involving Deception

Appendix L: Research Involving Deception |Word | PDF

policies

HRPP 1301 - Research Using Deception or Incomplete Disclosure | PDF

Research Involving the Internet

Appendix N: Research Involving the Internet |Word | PDF

Guidance Documents

Verbal, Electronic or Implied Consent |Word 

Policies

HRPP 1401 - Utilizing Surveys and Internet Research | PDF 

Storing Data for Future Use or Secondary Use

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

Appendix O: Secondary Data Use |Word | PDF

Guidance Documents

Data Safety Monitoring Plan (DSM) |Word 

Data Transfer and Use Agreement (DTUA) |Word

Consent Forms and Waivers
Templates

Exempt 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

Informed Consent Guidelines for Classroom- Based Research|Word

Appendix Forms

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

Appendix K: Certificate of Translation |Word | PDF

Guidance Documents

Child Assent and Parental Permission |Word 

Collaborative Research Consent Checklist|Word

Consent Guidance for Exempt Research|Word 

Consenting Non-English Speaking Research Subjects |Word 

Verbal, Electronic or Implied Consent |Word

Waivers and Exceptions |Word 

Policies

HRPP 601 - Informed Consent | PDF

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

HRPP 401 - Subject Recruitment & Participation | PDF

Guidance Documents

Information Sheet for Exempt Research | Word

Exempt Research Consent |Word 

Using Students or Employees in Subject Pool | Word

Secure Locations to Store Sensitive/Confidential Research Information | PDF

Expedited Review
Checklists

Expedited Review Submission Checklist |Word 

Student Researcher Checklist |Word 

Application

Part 1: Human Subject Research Application |Word

* In addition to the Human Subject Research Application (Part 1), you must also fill out the DU IRB Application (Wizard Form) located only on IRBNet.

 

Supplemental Forms
Students and Schools 

Appendix M: Research in Schools |Word

Appendix F: Research Involving Children |Word

Guidance Documents

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

International Research

Appendix G: International Research |Word | PDF

Appendix J: Community Based Research |Word | PDF

Appendix K: Certificate of Translation |Word | PDF

Guidance Documents

International Compilation of Research - 2018 | PDF

International Research |Word

International Travel by Students, Faculty, and Staff | Word

policies

HRPP 1201 - International Research | PDF

Non-English Speaking Participants

Appendix K: Certificate of Translation |Word | PDF

Appendix C: Populations with Additional Considerations |Word | PDF

Guidance Documents

Consenting Non-English Speaking Research Subjects |Word 

Children

Appendix F: Research Involving Children |Word

Guidance Documents

Child Assent and Parental Permission |Word 

Summary Table on Subpart D |Word 

Special Subject Populations - Children and Minors |Word 

Prisoners

Appendix D: Research Involving Prisoners |Word

Guidance Documents

Research Involving Prisoners |Word

Policies

HRPP 1001 - Vulnerable Populations |PDF

Pregnant Women

Appendix H: Research Involving Pregnant Women |Word | PDF

Research "In The Field"
  • Phenomenological & Ethnographic Research Proposals

Appendix B: Field Work |Word | PDF

Populations with Additional Considerations

Researchers who are working with the following populations must fill out Appendix C:

  • Subjects who are mentally, emotionally, or developmentally disabled
  • Adults lacking capacity to consent
  • Non-English Speakers 
  • Economically or educationally disadvantaged populations
  • Minority groups

Appendix C: Populations with Additional Considerations |Word

Community Based Participants

Appendix J: Community Based Research |Word | PDF

Policies

HRPP 1101 - Community Based Research | PDF

Research Involving Deception

Appendix L: Research Involving Deception |Word | PDF

policies

HRPP 1301 - Research Using Deception or Incomplete Disclosure | PDF

Research Involving the Internet

Appendix N: Research Involving the Internet |Word | PDF

Guidance Documents

Verbal, Electronic or Implied Consent |Word 

policies

HRPP 1401 - Utilizing Survey and Internet Research | PDF

Storing Data for Future Use or Secondary Use

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

Appendix O: Secondary Data Use |Word | PDF

Guidance Documents

Data Safety Monitoring Plan (DSM) |Word

Data Transfer and Use Agreement (DTUA) |Word

Collaborative Research with Ceding

Forms

Appendix Q: Unaffiliated Investigator Agreement Approval Request Form | Word

  • To be filled out by DU Principal Investigator
  • This form petitions the DU IRB to serve as IRB of Record for Unaffiliated Investigators who are engaged in human subjects research with DU who do not work at an institution covered by a Federal Wide Assurance (FWA). 
  • Must be filled out with Individual Investigator Agreement (IIA) form and posted in IRBNet package. 

Appendix P: Collaborative Research with Ceding Form | Word  

  • To be filled out by DU Principal Investigator
  • To be used if ceding to DU IRB will occur for a single IRB review

Individual Investigator Agreement (IIA) Form | Word

To be filled out by non-DU researcher who do NOT work at an institution, organization, or entity that has a Federal Wide Assurance (FWA).

IRB Authorization Agreement Form | Word 

  • To be filled out by DU principal investigator. 

Guidance

Data Safety Monitoring Plan (DSM) |Word

Data Transfer and Use Agreement (DTUA) |Word

Collaborative Research Guidance | Word

Checklists

Consent Form Checklist for Collaborative Research | Word

Consent Forms and Waivers
Templates

Expedited Informed Consent Template | Word

Implied Consent Template for Online Surveys | Word

Informed Consent Guidelines for Classroom-Based Research|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

Appendix Forms

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

Appendix K: Certificate of Translation |Word | PDF

Guidance Documents

Child Assent and Parental Permission |Word 

Collaborative Research Consent Checklist|Word 

Consenting Non-English Speaking Research Subjects |Word 

Verbal, Electronic or Implied Consent |Word 

Waivers and Exceptions |Word 

Policies

HRPP 601 - Informed Consent | PDF

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

HRPP 401 - Subject Recruitment & Participation | PDF

Guidance Documents

Expedited Review Research |Word

How To: Respond to a Preliminary Review | Word

Using Students or Employees in Subject Pool | Word

Research and Risk of Suicide | Word

Secure Locations to Store Sensitive/Confidential Research Information | PDF

Full Board Review
Checklists

Full Board Review Submission Checklist |Word 

Student Researcher Checklist |Word 

Application

Part 1: Human Subject Research Application |Word 

* In addition to the Human Subject Research Application (Part 1), you must also fill out the DU IRB Application (Wizard Form) located only on IRBNet.

Supplemental Forms
Students and Schools

Appendix M: Research in Schools |Word

Appendix F: Research Involving Children |Word

Guidance Documents

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 Research |Word 

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

International Research

Appendix G: International Research |Word | PDF

Appendix J: Community Based Research |Word | PDF

Appendix K: Certificate of Translation |Word | PDF

Guidance Documents

International Compilation of Research - 2018 | PDF

International Research |Word 

International Travel by Students, Faculty, and Staff | Word

policies

HRPP 1201 - International Research | PDF

Non-English Speaking Participants

Appendix K: Certificate of Translation |Word | PDF

Appendix C: Populations with Additional Considerations |Word | PDF

Guidance Documents

Consenting Non-English Speaking Research Subjects |Word 

Children

Appendix F: Research Involving Children |Word

Guidance Documents

Child Assent and Parental Permission |Word 

Summary Table on Subpart D |Word 

Research Involving Children and Minors |Word 

Prisoners

Appendix D: Research Involving Prisoners |Word

Guidance Documents

Research Involving Prisoners |Word 

Policies

HRPP 1001 - Vulnerable Populations | PDF

Pregnant Women

Appendix H: Research Involving Pregnant Women |Word | PDF

Research "In The Field"
  • Phenomenological & Ethnographic Research Proposals

Appendix B: Field Work |Word | PDF

Populations with Additional Considerations

Researchers who are working with the following populations must fill out Appendix C:

  • Subjects who are mentally, emotionally, or developmentally disabled
  • Adults lacking capacity to consent
  • Non-English Speakers 
  • Economically or educationally disadvantaged populations
  • Minority groups

Appendix C: Populations with Additional Considerations |Word

Community Based Participants

Appendix J: Community Based Research |Word | PDF

Policies:

HRPP 1101 - Community Based Research | PDF

Research Involving Deception

Appendix L: Research Involving Deception |Word | PDF

policies

HRPP 1301 - Research Using Deception or Incomplete Disclosure | PDF

Research Involving the Internet

Appendix N: Research Involving the Internet |Word | PDF

Guidance Documents

Verbal, Electronic or Implied Consent |Word 

policies

HRPP 1401 - Utilizing Surveys and Internet Research | PDF

Storing Data for Future Use or Secondary Use

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

Appendix O: Secondary Data Use |Word | PDF

Guidance Documents

Data Safety Monitoring Plan (DSM) |Word 

Data Transfer and Use Agreement (DTUA) |Word 

Collaborative Research with Ceding

Forms

Appendix Q: Unaffiliated Investigator Agreement Approval Request Form | Word

  • To be filled out by DU Principal Investigator
  • This form petitions the DU IRB to serve as IRB of Record for Unaffiliated Investigators who are engaged in human subjects research with DU who do not work at an institution covered by a Federal Wide Assurance (FWA). 
  • Must be filled out with Individual Investigator Agreement (IIA) form and posted in IRBNet package. 

Appendix P: Collaborative Research with Ceding Form | Word  

  • To be filled out by DU Principal Investigator.
  • To be used if ceding to DU IRB will occur for a single IRB review.

Individual Investigator Agreement (IIA) Form | Word

To be filled out by non-DU researchers who do NOT work at an institution, organization, or entity that has a Federal Wide Assurance (FWA). 

IRB Authorization Agreement Form | Word 

  • To be filled out by DU principal investigator.

Checklists

Consent Form Checklist for Collaborative Research | Word

GUIDANCE DOCUMENTS

Collaborative Research Guidance | Word

Data Safety Monitoring Plan (DSM) |Word

Data Transfer and Use Agreement (DTUA) |Word

Consent Forms and Waivers
Templates

Full Board Informed Consent Template | Word

Implied Consent Template for Online Surveys | Word

Informed Consent Guidelines for Classroom-Based Research|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

Appendix Forms

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

Appendix K: Certificate of Translation |Word | PDF

Guidance Documents

Child Assent and Parental Permission |Word 

Collaborative Research Consent Checklist|Word 

Consenting Non-English Speaking Research Subjects |Word

Verbal, Electronic or Implied Consent |Word 

Waivers and Exceptions |Word 

Policies

HRPP 601 - Informed Consent | PDF

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

HRPP 401 - Subject Recruitment & Participation | PDF

Guidance Documents

Full Committee |Word 

IRB Committee Action Options |Word

How To: Respond to a Full Board Review | Word

How To: Respond to a Preliminary Review | Word

Using Students or Employees in Subject Pool | Word

Research and Risk of Suicide | Word

Secure Locations to Store Sensitive/Confidential Research Information | PDF

Modifying or Closing a Project

Amendments to Previously Approved Research

Amendment Application |Word | PDF

Checklist

Amendment Checklist |Word 

Guidance Documents

Amendments to Previously Approved Research |Word | PDF

How To: Submit an Amendment/Modification | Word

Policies

HRPP 801 - Amendments | PDF

Continuing Review

Continuing Review Application |Word | PDF

Checklist

Continuing Review/Progress Report Checklist | Word

How To: Submit a Continuing Review | Word

Policies

HRPP 701 - Continuing Review | PDF

Reportable New Information

Reportable New Information Form |Word | PDF

Policies

HRPP 901 - Reporting Unanticipated Problems | PDF

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

Guidance Documents

Project Closure | PDF

How To: Close a Study | Word

Troubleshooting for mac users

If you are having trouble filling out a form using a Mac, try using the Pages app. It can be downloaded from the App Store here.
After downloading Pages, Pages will appear in the iCloud Drive section of your directory system. Drag the form into the Pages folder and edit the form there. Then, save the form as a PDF or Word document.