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Research Integrity & Education

Student Investigators

OVERVIEW OF PROCESS: WHAT CAN I EXPECT?             

Step 1: CITI: Complete required CITI training to help give an overview of research

Step 2: What Needs IRB Review: Determine if your research require IRB Review

  • If your project requires a review,determine if your project is exempt, expedited, or full board

Step 3: How to Submit: Submitting your application

  • Download student checklist
  • Fill out TWO applications: DU IRB Application (Wizard Form) located on IRBNet AND either the Exempt Application OR Part 1: Human Subjects Application (Expedited and Full Board Application)
  • Complete supplemental forms for specific research topics (i.e. prisoners, children, schools, ect)
  • Create consent forms, waivers, recruitment materials, and advertisement materials

Step 4: IRBNet: Fill out DU IRB Application (Wizard Form) on IRBNet

Step 5: Sign and lock IRBNet application (if student, have faculty sponsor sign and lock application)

Step 6: Study Closure: Once study is complete, close your study

  • Final Report/Closure Form |Word | PDF
  • Project Closure Guidance | PDF

Checklist 

Checklist for Student Researchers | Word

~Don't miss a step~

Guidance 

Student Researcher at DU Guidance | Word

step 1: do I have to go through the irb?

Human Subjects Research

All research projects that meet the definition of human subjects research must submit their proposal to the IRB office. 

You have two options for submitting your research proposal:

     Option 1: If human subjects research, fill out formal IRB application via IRBNet

     Option 2: If not human subjects research, fill out appendix E and email to [email protected]

Is my project human subjects research?
  • Research is defined in the Code of Federal Regulations, 45 CFR 46.102(d), as a systematic investigation designed to develop or contribute to generalizable knowledge.
  • Human subject is defined in the Code of Federal Regulations as "a living individual about whom an investigator conducting research 1) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; OR 2) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens"

*ALL HUMAN SUBJECTS RESEARCH MUST OBTAIN IRB APPROVAL PRIOR TO STUDY ACTIVITIES (that includes obtaining participants, emailing participants, or displaying recruitment materials)

I'm still not sure if my project needs IRB review...

If you are still not sure if your project qualifies as human subject research, please follow these steps:

Step 1: Fill out Assessing Your Project. (discuss with your faculty sponsor)

Step 2: If you assess your project as NOT human subjects research, you are strongly encouraged to complete Appendix E: IRB Determination Form for documentation purposes.

  • Please submit the form directly to: [email protected]. Within 10 business days, a review will be conducted and a formal letter will be issued from the DU IRB stating whether a project meets the definition of human subject research. 
  • For Program Evaluation Projects: Complete Appendix E for documentation purposes. 

Step 3: If you are still unable to make a determination, please contact the IRB office at [email protected] for a consultation. 

DU investigators are encouraged to submit their proposed research to the IRB for ethical and regulatory review. The IRB will provide the necessary documentation by issuing formal IRB determination letter for professional and academic endeavors.

 

Examples:

Examples of Activities Determining Whether IRB Review is Required

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STEP 2: 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 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, ect.)?
  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 

Step 3: 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 

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 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


Exemption Information Letter |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

Expedited Review
Checklists

Expedited Review Submission Checklist |Word 

Student Researcher Checklist |Word 

Application

Part 1: Human Subject Research Application (Expedited and Full Board 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

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

Using Students or Employees in Subject Pool | Word

Research and Risk of Suicide | Word

Full Board Review
Checklists

Full Board Review Submission Checklist |Word 

Student Researcher Checklist |Word 

Application

Part 1: Human Subject Research Application (Expedited and Full Board 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 

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 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

Using Students or Employees in Subject Pool | Word

Research and Risk of Suicide | Word

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 you will 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: application, recruitment materials, consent, ect (refer to checklist on How To Submit
  5. Sign the IRBNet Package (if you are a student investigator, your faculty sponsor must sign package as well. You CANNOT sign the package on behalf of your faculty sponsor.) 
  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 Userprofile 

 I forgot my login password...

If you forgot your password to login, contact [email protected]

Step 5: Completing 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

Reference Materials

Step 6: 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, your faculty adviser must also sign the application. You cannot sign the application on behalf of your adviser. Applications submitted without your faculty adviser's electronic signature will not be reviewed. 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!

Frequently asked questions

the process: Frequently asked questions
How long will it take for the IRB to review my application?

Depending on the nature of the study, IRB review may take two weeks or as long as one month. The IRB may request additional information from the investigator which could lengthen the process.

How long is my approval valid?

For federally-funded projects that are reviewed by expedited review or by full board review, your approval is valid for one year from the date of approval.

Projects that are classified as more than minimal risk, your approval is valid for one year or less, as determined by the full board.

For non-federally funded projects that are reviewed by expedited review or are classified as exempt, a two-year time period is applied to the study. These studies are not issued expiration dates, but rather the IRB will request a status report on the study at the end of the two-year period to confirm if the study is still active or has been completed.

Can I begin my research as soon as I file my application with the IRB?

No - research can only begin once you have written approval from the IRB.

Do I need to let the IRB know when I have completed the study?

Yes. An investigator needs to inform the IRB that the study is being terminated or closed. The IRB will continue oversight of the study for follow-up purposes.

Am I required to list all of the research faculty that might participate on my protocol - or only ones giving significant time?

Yes, the Principal Investigator (PI) must be listed along with all other research staff.

Does the IRB continue to review my projects once it has been approved?

Yes. Under 45 CFR 46.111, the IRB must determine risks, potential benefits, informed consent and safeguards for human subjects. According to the OHRP -IRB members should receive and review a protocol summary and a status report on the progress of the research including: 1. the number of subjects accrued 2. a summary of adverse events 3. unanticipated problems involving risks to subjects or others 4. any withdrawal of subjects from the research or complaints about the research since the last IRB review 5. amendments or modifications.

Does everyone listed on my protocol have to have training?

All personnel listed on the protocol that will have contact with participants involved in the study are required to complete the Human Subjects Protections Training. Human Subjects Training is available on the CITI Program Website.

Does the training requirement apply to students conducting interviews?

Yes, anyone contacting the human subjects in any way needs to complete training.