Before you Submit
In this section, we will guide you through the four essential steps of preparing your research application.
Step 1: Define your study team.
The study team is made up of all the internal and external individuals who play a significant role in the research design, conduct or reporting of the research. Determine which team members will serve in what roles, such as principal investigator (PI), co-PI, faculty advisor, administrative staff, etc. Every research study requires a Principal Investigator (PI) who takes full responsibility for the study's conduct, including the eligibility and training of the research staff.
Step 2: Complete Human Subjects Protection Training in CITI.
All study team members working on active IRB studies must have completed Human Subjects Protection training within the past 5 years.
Step 3: Develop the Study Protocol and Informed Consent.
The study protocol is a working document that describes the study's objectives, procedures, risks, benefits, recruitment, consent processes, and procedures to maintain confidentiality.
Informed consent is the process by which a volunteer confirms their willingness to participate in the research after being informed of all aspects of the research that are relevant to their decision to participate. Importantly, informed consent is more than a signature on a document. It requires an ongoing process of information exchange between the investigator and the research participant or their legally authorized representative (LAR) with adequate information pertaining to the research study, sufficient opportunity to consider aspects of the research, including the risks and benefits, and whether to participate, and the opportunity for the subject to ask questions and receive answers to those questions, thus minimizing the possibility of coercion or undue influence.
Step 4: Gather Supporting Documents.
During the application submission process to iRIS (TAMU system-wide online protocol review system), you will be asked to attach all supporting documents. These documents may include, but are not limited to:
- Consent documents (consent form(s), child assent form(s), verbal script of the information provided orally to participants, debriefing scripts, sponsor or lead site-approval, etc.)
- Protocol (Protocol, thesis/dissertation proposal)
- Funding information (Grant applications, contracts, etc.)
- Recruitment materials (advertisements, recruitment materials and scripts, etc.)
- Data collection instruments (Survey questions, interview questions, focus group questions, scales and measures, participant observation checklist, case report forms, audio/video/image prompts, etc.)
- All other relevant documents
How to Submit
Online Application
Once the study protocol and all supporting documents have been developed, you will need to log into iRIS. (Note: The system is currently unavailable. Please contact irb@tamut.edu for submission) All supporting documents must be provided at the time of initial review.
Please note that You cannot begin recruitment or request the written informed consent of any subject to participate before obtaining IRB approval. 21 CFR 812.110; ICH 3.3.6.
How do I start a new submission in iRIS?
- Login into tamu.edu. You will need TAMU SSO to login. (Note: The system is currently unavailable. Please contact irb@tamut.edu for submission)
- In Study Assistant dashboard, select Create a new Study, then select IRB Application (Human Research).
- The online application uses smart form logic to branch out sections of the IRB Application that meet the needs of the investigator and the research protocol. Questions marked with an asterisk (*) must be answered, or an error message will be generated. Any sections not applicable to your study, please input n/a.
- Upon completing the IRB Application, select Save and Continue to Next Section until prompted to:
- Add a New Consent in the informed consent section
- Add a New Documentor Add Multiple Documentsin the Study Documents section
- Select Sign Off and Submit. You will then need to select all study personnel that are required to sign off (e.g., Department Chair, Investigators).
- The submission will not be visible to HRPP/IRB until all sign-offs have been completed.
After all sign offs have been completed, the application will move from draft to pending and be assigned an IRB number (IRB20XX-XXXX).
After you Submit
After submission of your application and receipt of the unique IRB number, the IRB Review Process commences.
Pre-Review
After you submit your study, TAMUT IRB will perform a pre-review to ensure that all the necessary information and supporting documents have been provided correctly. If everything is in order, the submission will be assigned to an IRB reviewer who will then evaluate it.
You can track the progress of your submission in iRIS by opening your study and selecting "Submission History". From there, click on the "Track Location" icon (the icon that looks like a document with a magnifying glass). Your study can be in one of the following stages during the review process:
- Pre-Submission: This is the stage where you are still preparing your application. The study will remain in this stage until you click "Submit".
- Pre-Review: Your submission is currently in the queue and is being reviewed by the assigned IRB Coordinator.
- Changes Requested: The IRB Coordinator has requested changes or additional information. You and your Primary Contact will receive an email notification with further details.
- Post Review: The IRB letter advising you of the IRB member or committee's decision is being prepared.
- Modification Required: The IRB has requested additional changes to secure final approval. You and your Primary Contact will receive an email notification with further details.
Three Types of Review
Exempt Determination
If the study poses little to no risks and fits one of the exempt categories (Section 15 of TAMUT IRB SOP), the submission is reviewed for an exemption determination. For more details, refer to
No expiration date for study protocol
Expedited Determination
If the study does not meet the criteria for an exempt determination and poses minimal risks, the submission is reviewed via expedited procedure.- The research presents no more than minimal risk to subjects.
- Document review, surveys or interviews, collection of specimens, routine noninvasive procedures, etc.
- The research is not classified.
- The category or categories of research allowing review using the expedited procedure.
The study is approved for one year. If the research needs an extension, the PI must submit an extension form.
Full Board Review (highest level of scrutiny)
If the study presents more than minimal risks to participants, or if the HRPP staff and/or the IRB reviewer determine that the study does not qualify for Exempt or Expedited Review, the study will be referred to the convened board for Full Board Review.
Examples of studies that may involve greater than minimal risk:
- Studies involving vulnerable populations. Clinical intervention studies that randomly assign human subjects to alternative experimental or placebo groups.
- Studies involving sensitive information connected to personal identifiers .
PI is invited to the meeting to clarify IRB concerns.
The study is approved for one year. If the research needs an extension, the PI must submit an extension form.
For more details, refer to Section 12 of TAMUT IRB SOP
After Approval
When your approved study protocol needs any modifications
As the PI, it is your responsibility to obtain approval for any proposed modifications through the online IRB system. It is crucial to keep in mind that along with submitting an Amendment/Modification form, the study application, protocol, or any relevant study documents may also need to be updated to reflect the changes.
When your approved study protocol needs more time on approved study protocol?
For Expedited and Full Board protocols continuing review is required at least annually. For studies determined to be exempt, the exempt determination is valid for 5 years at which point a new determination must be requested.
The Principal Investigator is responsible for submitting the Continuing Review no later than 30 days before the study’s current expiration date to ensure adequate time for the IRB to review and approve it. This review allows the IRB to monitor the progress of the study and ensures that the study continues to meet the requirements for approval.
Automatically generates continuing review reminder notices will be sent for each active study. The Principal Investigator and individuals listed as Study Contact will receive these notices. Notices are sent 60 days and 30 days before the due date and on the due date (which is 30 days before the study is set to expire). An expiration notice is also sent on the expiration date.
The investigator may resume the research activity only once continuing review and approval by the IRB has occurred.
When the research is complete
If all research-related activities with human subjects have been completed, and data collection and analysis of identifiable private information described in the IRB-approved research plan are finished, then the study should be closed via the online IRB system.