IRB Submission Process

The Collaborative Institutional Training Initiative (CITI) is an online educational platform that provides researchers and research personnel with comprehensive education on research ethics, including understanding the ethical principles that guide research involving human participants, animals, and data, as well as the responsible conduct of research. The course must be completed every three years with a cumulative score of 80%. Upon successful completion of CITI courses, you will receive a certificate of completion. You will use the certificate of completion to demonstrate/document your training in research ethics and compliance. 

If your research involves conducting social and behavioral research with human subjects, including observational, interview, survey, and experimental research with people, complete the Social & Behavioral Science Investigator CITI course. Most researchers at UTPB complete this course. 

If your research primarily involves biomedical research with human subjects, complete the Biomedical Research Investigator CITI course. 

If your research primarily involves human specimens or data with no direct contact with human subjects, complete the Research with Data or Laboratory Specimens Only. 

CITI Training

Complete CITI human research training

• Required once every three years
• Faculty supervisors need to have current human subjects research training
• Contact irb_chair@utpb.edu to receive assistance with external study team members, as needed.

Submit your IRB application and all relevant documents to irb_chair@utpb.edu

New study checklist:

1.  Complete Institutional Review Board application
2.  Create/gather supporting documents, such as:
   • Informed Consent documents
   • Assent forms for minors
   • Recruitment materials
   • Interview/survey/focus group questions
   • Tests/assessments
   • Debriefing statement for deceptive or omission studies
   • External site approval letter (as needed)
   • Other relevant forms
3. Attach CITI training certificates for all project personnel.
4. Submit your IRB application and all relevant documents to irb_chair@utpb.edu

Upon receiving your IRB application, the IRB Chair conducts an administrative check to ensure that the application is complete and that it includes all necessary documentation, such as informed consent forms, recruitment materials, study protocols, and each researchers CITI course completion certificate(s). The IRB Chair also reviews the application to determine if your study meets the criteria for human subjects research, the level of risk and review category.    

If there are any issues or missing documents, the IRB Chair will contact the principal investigator to request corrections or provide additional information.    

Once all necessary documents are submitted, the IRB Chair assigns the submission to one or more IRB members who have expertise in relevant fields. These reviewers are responsible for conducting an in-depth evaluation of the research proposal.     

If your IRB submission is considered minimal risk, and is either exempt or expedited research, you will be notified of the review outcome in 7-10 business days.    

If your research is considered more than minimal risk and needs a full IRB review, your IRB submission will be reviewed at the next monthly IRB meeting. During the monthly IRB meeting, reviewers gather to discuss and assess research proposals collectively. Reviewers may present their findings and discuss any concerns or questions they have about your research.     

If your IRB submission goes to a full board review, the review process may take anywhere from 25-45 days.    

Following the review, the IRB will issue one of the following decisions:  

1. Approval - this means the research is approved as submitted.  
2. Approval with modifications - this decision means that the research is approved with specific conditions or changes that the researcher must address before beginning the study.  
3. Deferred - a deferred decision means that the IRB requires additional information or clarifications before making a decision.  
4. Not approved - this decision means that the research is not approved due to ethical or methodological concerns that cannot be adequately addressed.    

The IRB will communicate its decision to the researcher, providing feedback and instructions for any required revisions or modifications. Researchers are required to address any concerns or conditions set by the IRB.    

If your research is approved, the IRB specifies the duration of approval, typically one year. However, depending on the conditions (if any) of your approval, your study may require continuing review or renewal more frequently.    

For approved studies, the IRB continues to monitor the research to ensure ongoing compliance with ethical and regulatory standards. Researchers must report adverse events, protocol deviations, or other issues to the IRB.  

The modifications step in the IRB process is when researchers request changes or amendments to an already approved research protocol. This is a crucial step when researchers need to make adjustments to their study design, procedures, recruitment methods, informed consent documents, or other aspects of their research after it has received initial IRB approval.    

If you need to make a modification to your approved IRB protocol, use the Modification Request form. Make sure to include all the requested information about the proposed modifications and include any necessary supporting documentation. Once your Modification Request form is complete and you have gathered your supporting documentation, submit your modification to irb_chair@utpb.edu.   

The IRB will review the modification request, consider the proposed changes, rationale, and their potential impact on participant safety and welfare. After evaluating the modification request, the IRB will issue a decision, typically complete within 7-10 business days.    

If the research requires continuing review, the researcher must submit periodic reports to the IRB for re-evaluation. This will ensure that the research remains ethical and compliant over time.   

A study is considered "continuing review" when it involves ongoing research with human participants, and the initial IRB approval stipulates that it requires periodic reviews to ensure the ongoing protection of participants. There are several key factors that make a study eligible for continuing review, including:  

1. Ongoing involvement of human participants, meaning the study continues to involve human participants who are actively participating in research activities, including data collection, interviews, surveys, or interviews.  
2. The initial IRB approval granted for the study specifies that it requires continuing review. This stipulation is often based on the nature of the research, potential risks to participants, and ethical considerations.  
3. If the study is of a longer duration, the IRB may determine that is should be subject to a periodic review to ensure that the research remains ethical and compliant with regulations.  
4. A risk assessment, particularly in studies that involve certain levels of risk to participants, such as potential physical or psychological harm, confidentiality risks, or sensitive data collection. Studies with higher risks often require more frequent continuing reviews.  
5. If there have been significant changes to the research protocol or procedures since the initial approval, the IRB may require a continuing review to assess the impact of these changes on participant safety and ethical considerations.  
6. If the informed consent process or documents have been modified or need updating, the IRB may require a continuing review to evaluate these changes.  
7. Studies that involve safety monitoring procedures or adverse event reporting may require ongoing oversight by the IRB.  
8. If the study is subject to regulatory requirements, such as the U.S. Common Rule, which mandates continuing review for certain types of research.  
9. The nature of the research raises ethical concerns that warrant periodic reassessment of the study's conduct and its impact on participants.  

You will be notified in your IRB approval notice if your study requires continuing review, as well as how often it is required and what information or documentation is needed for each review. Researchers must adhere to the IRB's requirements to ensure the ongoing ethical conduct of their research involving human participants. Failure to conduct timely continuing reviews can result in a suspension or termination of the study. 

When closing a research study with an IRB, it is essential to provide the IRB with the necessary information and documentation to ensure a smooth and ethical conclusion to the research. To close a research study with UT Permian Basin, you will need to submit a Study Closure Request form to irb_chair@utpb.edu.