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Research Integrity & Education

Faculty & Staff Investigators

STEP 1: DETERMINe 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 complete an expedited or full board review application.

  1. Will you be working with prisoners, pregnant women, fetuses, or individuals with mental disabilities? 
  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

Whether your proposal qualifies for exempt, expedited, or full board review, you must complete the Part 1: Human Research Application.

Step 2: Choose Your review type

Exempt from IRB Review
Checklists

Exemption Submission Checklist | Word

Application

Part 1: Human Research Application | Word

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

Appendix J: Community Based Research | Word

Appendix K: Certificate of Translation | Word

Guidance Documents

International Compilation of Research - 2019 | PDF

International Research | Word

policies

HRPP 1201 - International Research | PDF

Non-English Speaking Participants

Appendix K: Certificate of Translation | Word

Appendix C: Populations with Additional Considerations | Word

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

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

Appendix B: Field Work | Word

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

Policies

HRPP 1101- Community Based Research | PDF

Research Involving Deception

Appendix L: Research Involving Deception | Word

policies

HRPP 1301 - Research Using Deception or Incomplete Disclosure | PDF

Research Involving the Internet

Appendix N: Research Involving the Internet | Word

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

Appendix O: Secondary Data Use | Word

Guidance Documents

Data Safety Monitoring Plan (DSM) | Word

Data Transfer and Use Agreement (DTUA) | Word

Consent Forms and Waivers
Templates

Exempt Information Letter 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


Exemption Information Letter | Word

Appendix Forms

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

Appendix K: Certificate of Translation | Word

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

Recruitment Flyer Guide | PDF
Sample Research Recruitment Flyer | PDF
Sample Letter for an Anonymous Mail Survey | PDF
Sample Recruitment Letter or Email | PDF
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

Using Students or Employees in Subject Pool | Word

Expedited Review
Checklists

Expedited Review Submission Checklist | Word

Application

Part 1: Human Research Application (Exempt, Expedited, and Full Board Application) | Word

 

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

Appendix J: Community Based Research | Word

Appendix K: Certificate of Translation | Word

Guidance Documents

International Compilation of Research - 2019 | PDF

International Research | Word

policies

HRPP 1201 - International Research | PDF

Non-English Speaking Participants

Appendix K: Certificate of Translation | Word

Appendix C: Populations with Additional Considerations | Word

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

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

Appendix B: Field Work | Word

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

Policies

HRPP 1101 - Community Based Research | PDF

Research Involving Deception

Appendix L: Research Involving Deception | Word

policies

HRPP 1301 - Research Using Deception or Incomplete Disclosure | PDF

Research Involving the Internet

Appendix N: Research Involving the Internet | Word

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

Appendix O: Secondary Data Use | Word

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

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

Appendix K: Certificate of Translation | Word

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

Recruitment Flyer Guide | PDF
Sample Research Recruitment Flyer | PDF
Sample Letter for an Anonymous Mail Survey | PDF
Sample Recruitment Letter or Email | PDF
Sample Verbal Recruitment Script | PDF
Telephone Screening for Potential Subjects | Word

HRPP 401 - Subject Recruitment & Participation | PDF

Guidance Documents

Expedited Review Research | Word

Using Students or Employees in Subject Pool | Word

Research and Risk of Suicide | Word

Full Board Review
Checklists

Full Board Review Submission Checklist | Word

Application

Part 1: Human Research Application (Exempt, Expedited, and Full Board Application) | Word

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

Appendix J: Community Based Research | Word

Appendix K: Certificate of Translation | Word

Guidance Documents

International Compilation of Research - 2019 | PDF

International Research | Word

policies

HRPP 1201 - International Research | PDF

Non-English Speaking Participants

Appendix K: Certificate of Translation | Word

Appendix C: Populations with Additional Considerations | Word

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

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

Appendix B: Field Work | Word

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

Policies:

HRPP 1101 - Community Based Research | PDF

Research Involving Deception

Appendix L: Research Involving Deception | Word

policies

HRPP 1301 - Research Using Deception or Incomplete Disclosure | PDF

Research Involving the Internet

Appendix N: Research Involving the Internet | Word

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

Appendix O: Secondary Data Use | Word

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

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

Appendix K: Certificate of Translation | Word

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

Recruitment Flyer Guide | PDF
Sample Research Recruitment Flyer | PDF
Sample Letter for an Anonymous Mail Survey | PDF
Sample Recruitment Letter or Email | PDF
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

Using Students or Employees in Subject Pool | Word

Research and Risk of Suicide | Word

Step 3: Complete Citi training

What is CITI?

The University of Denver uses the Collaborative Institutional Training Initiative (CITI) Program to provide the required training for all faculty, staff and student investigators. CITI offers a streamlined process that provides certification that is recognized not only at DU but at a variety of institutions nationwide.

Who has to complete the training?

All investigators and faculty sponsors conducting human subjects research at the University of Denver are required to complete an education program and become "certified" in human subjects protections.

• All members of the research team, including the principal investigator and all other individuals (faculty, staff, or student) who have contact or interactions with research subjects or with their private identifiable information
• Faculty supervisors of student research projects
• Investigators who are not affiliated with DU, who are engaged in a DU research study and whose IRB of record will be the DU IRB as designated by a formal, written agreement
• Members of the DU IRB

These training modules must be completed before IRB approval will be issued.

DU recognizes valid CITI training for four (4) years from the completion date. After four years, a refresher course is offered to maintain credentials.

In order to successfully pass the training curriculum, you will need to answer 80% of the questions correctly.

Please note: As of September 2018, the Office of Research Integrity & Education updated the HSP curriculums to provide a more efficient and streamline approach to fulfilling the training requirement. The modules you have previously completed will remain in your completion record. However, the module name may have changed, or it may appear differently or may no longer be required. Please select a new course or refresher course from the menu below to ensure you are taking the current curriculum of the required courses.

Which trainings are required?

Based on the type of research you will be conducting choose the most appropriate curriculum.

Step 1: Select one
a. I am a Student Investigator
b. I am a Faculty/Staff Investigator
c. I am an Unaffiliated Investigator
d. I am a Full Board Member

Step 2: Select one
a. Social Behavioral Education Research Investigator (Initial or Refresher Course)
b. Biomedical Research Investigator (Initial or Refresher Course)

Step 3: Select all that apply 
a. Study Design: schools, internet, biobanks, survey, international, and/or community-engagement
b. Subject Populations: children, prisoners, older adults, etc.

Reference Guide: Step-by-Step Instructions for Human Subjects CITI Training

Required Specific Courses

If your project uses any of these specific populations or topics, you must complete the module:

Study Design: 

  • Schools
  • Internet-Based Research
  • Biobanks or Databases
  • Survey Research
  • International Research
  • Community-Engagement
  • Genetic Research

Subject Populations:

  • Children
  • Prisoners
  • Older Adults
  • Pregnant Women, Fetuses, and Neonates
  • Subjects who are Decisionally Impaired
  • Subjects with Physical Disabilities
  • Subjects that are Critically Ill or at the End-of-Life
  • Subjects who Do Not Speak English
  • Subjects who are Socially or Economically Disadvantaged
  • Workers/Employees
  • Illegal Activities or Undocumented Status
  • Gender and Sexual Diversity 
Federally Funded  Projects

If you are receiving federal funding (National Science Foundation or National Institute of Health), you must complete 1 Responsible Conduct of Research (RCR) module and the Conflict of Interest (COI) module in addition to one of the required modules above.

• Social, Behavioral, Educational, and Responsible Conduct of Research (RCR) Course
• Biomedical Responsible Conduct of Research (RCR) Course
• Physical Science Responsible Conduct of Research (RCR) Course
• Engineering Responsible Conduct of Research (RCR) Course
• Conflict of Interest (COI) Course

Transferring Training from Another Institution

Please note: If you have completed CITI training affiliated with another institution, DU will not have access to those records. Investigators must affiliate their training records with the University of Denver in order for the IRB staff to validate the appropriate training has been completed.

Reference Guide: Transfer Certification from Another Institution

step 4: submitting through irbnet

Steps for submitting on IRBNet
  1. This Process Takes Time!  You must allow sufficient time to complete and post all necessary documents for IRB review. Once you have submitted your application through IRBNet and completed CITI training, it will enter the IRBNet queue in the order received.  During times when we receive high volumes of submissions, the review may take longer than anticipated; however, you can usually expect to hear back:

    Exempt: within two weeks
    Expedited: within two weeks
    Full Board Review: within 10 business days following the IRB Full Board meeting

  2. Register at www.irbnet.org. Protocols submitted in hard copy or to an IRB staff member's email will NOT be reviewed.
  3. Create a New Project. Refer to How To: Register as a New User & How To: Submit a New Project for step-by-step instructions.
  4. Upload All Required Documents. Part 1 Application, recruitment materials, study materials, consent, relevant appendices, etc. The Wizard Form, otherwise known as IRB Application, is no longer required
  5. Sign the IRBNet Package.
  6. Submit the Signed Package to DU IRB.

instructional guides for submitting 

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
HOW TO: Submit a New Project
HOW TO: Submit a Continuing Review
HOW TO: Submit an Amendment/Modification
HOW TO: Respond to a Preliminary Review
HOW TO: Close a Study
DU IRBNet User's Manual for IRB Submissions
Downloading CITI Training to IRBNet User Profile

 I forgot my login password...

If you forgot your password to login, contact support@irbnet.org

Step 5: Sign and lock your application

Finishing Your Application

Once you have completed your application on IRBNet, uploaded all the reference material, and completed your CITI training, you must also sign the application. Remember to lock your package by submitting it!

Sometimes, after submission are reviewed, the IRB will reply to you with requests for clarification and/or additional information about your study; this is called a Preliminary Review. Please see this document for guidance: Responding to a Preliminary Review.
When you have completed your revisions, remember to re-lock your package by submitting it!

Modifying or Closing a Project

Amendments to Previously Approved Research

Amendment Application | Word

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

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

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

Guidance Documents

Project Closure | PDF

How To: Close a Study | Word