IRB Submission Tips
Below are some tips that we believe will help make the application and approval process go more smoothly.
IRB Frequently Asked Questions
Click on a question to jump to its answer, or continue scrolling to read the answer to each question.
What is the Institutional Review Board (IRB)?
The Institutional Review Board, or IRB, is a standing university committee established under federal regulations to protect the rights and welfare of all human subjects who volunteer to participate in research studies conducted under the partnership of the University of Southern Indiana. It oversees institutional compliance with all federal, state, and University guidelines relating to research with human subjects.
The IRB is responsible for reviewing all research involving human subjects, insuring the equitable selection of research subjects, ensuring that potential research-related risks are minimized, and that there is full disclosure so that volunteers can make an informed decision to participate.
What is Human Subjects Research (HSR)?
Research is defined as a systematic investigation, inquiry, or analysis—such as scholarly or critical study or inquiry or scientific investigation, development, testing, or evaluation—designed to develop or contribute to generalizable knowledge. Research includes activities that aim to test a hypothesis, discover or collate facts, principles, or effects, reach new conclusions, or reexamine information by the critical study of a subject or by a course of scientific inquiry. Under the purview of the IRB, Human Subjects Research, sometimes abbreviated as HSR, is considered to be any activity that matches the above description and involves human participants as part of the data collection process. Examples may include surveys, interviews, medical tests, or physical fitness/exercise.
I don't think my project meets the definition of Human Subjects Research, but I'm not sure. What should I do?
Not all research-related projects will require IRB review. The most common type of project we see that does not require IRB review are quality improvement (QI) projects, but for a more exhaustive list of projects that may not require IRB review please visit our page on this topic, Research That May Not Require IRB Review.
If you are still unsure whether your project requires IRB review, we recommend that you submit a Human Subjects Research Determination Form. This form can be found in the IRBNet library and should be submitted through IRBNet. Upon receipt of your HSR Determination Form, it will be forwarded to one of our IRB members who will review it* and determine whether or not your project meets the definition of Human Subjects Research. If your project is determined to NOT meet the definition of HSR, you will receive a letter confirming this determination.
*NOTE: Reviewers have up to 7 business days to review HSR Determination Forms; Please keep this in mind in deciding when to submit your form.
How do I know which IRB Application Form to use?
All of the above forms are available in IRBNet under the "Forms and Templates" tab.
*IRB Research/Review Category definitions can be found on the OSPRA webpage, IRB Research Categories and Definitions.
I'm using existing data and won't be working with human subjects myself. Do I need to go through the IRB?
Yes. Even if you weren't the one to collect the data through intervention or interaction with human subjects and you have no intention for additional intervention or interaction with those individuals, you must still submit your project for IRB review. Depending on the nature of the data and the reason for initial collection, studies using secondary data* are either submitted for Exempt or Expedited IRB review.
*The definition of secondary data can be found on the OSPRA webpage, IRB Research Categories and Definitions.
How long will the review and approval process take?
It depends.
The IRB only reviews complete applications. To be considered complete, a submission should:
If your submission is not complete, you will receive a notification that there is "Information Required" along with an "Acknowledgment Not Complete" letter outlining what is needed. These items must be addressed before your application can be consider complete and move forward to review.
A complete application will be sent to an IRB member or members for review. The review periods vary based on the type of research category the application falls under:
Once the reviewers have completed their review, you will be notified that your application has been approved OR that your application requires modifications. Most applications will require at least some minor modifications, and some will require major modifications. Once you submit your modifications, our office will review your application to ensure that all required modifications have been completed, at which point your application will be approved.
*For the most current IRB Meeting schedule, please see our webpage, IRB Meeting Schedule.
How long is my project approved for?
The IRB can only approve in one-year increments. Projects that extend over more than one year must submit a Continuing Review form via IRBNet towards the end of the initial approval period to renew the project for additional time. The continuing review form must be submitted before the initial approval period is over. Any applications that need to be renewed but do not submit a continuing review form before the project expiration date must submit a new application and begin the review process.
Please note that the length of approval will not automatically be one full year. If you have requested an earlier end date in your application, the IRB will approve your project through that date. Additionally, if the CITI training of any project team member, including the faculty sponsor(s), expires prior to the one-year mark from approval or before the requested end date, the IRB will only be able to approve through the expiration date of that team member's CITI training.
What happens after the IRB reviews my application? How can I check on the status of my application?
Once your application has been reviewed, our office will contact you through IRBNet to notify you of any required revisions/modification or approval.
The principal investigator (PI), faculty sponsor(s), and any project team members with whom the project has been shared on IRBNet can check the status of the application any time by logging into IRBNet and selecting the "My Projects" tab. If you are still unsure about or have questions regarding the status of your application, you can contact our office by email at rcr@usi.edu or by phone at 812-465-7000.
What is the role of an investigator?
Investigators are responsible for obtaining IRB approval before beginning any human subjects research. Investigators must provide the IRB with sufficient information and related materials about the research (e.g., grant applications, research protocols, sample consent documents, ethics training certifications) so that the IRB may conduct an appropriate level review of the proposed research. Along with meeting the specific requirements of a particular research study, investigators are responsible for meeting ongoing requirements in the conduct of approved research that include: obtaining and documenting informed consent of subjects prior to participation in the research, obtaining prior approval from the IRB for any modifications of the previously approved research, providing the IRB prompt reports of any unanticipated problems involving risks to subjects or others and proper storage and disposal of all collected data.
What is the role of a faculty sponsor?
The University requires that the faculty sponsor assume meaningful supervision for each student researcher listed on the application form. The faculty sponsor must be reasonably available to assist in the resolution of and reporting of any problems that may arise during the course of the research. Faculty sponsors are responsible for imparting to students an understanding of the ethical principles of human research to which the University adheres. If a student is conducting research or a class activity that falls within the IRB’s purview, the faculty sponsor must ensure that the student completes appropriate training and secures IRB approval before beginning the study or activity. The faculty sponsor also has primary responsibility for overseeing the conduct of the research in its entirety and for ensuring that student adheres to the approved protocol. The duty of the faculty member is to assess, and, if prudent, veto, activities proposed by a student to fulfill a class assignment should more than minimal risk for harm to either the participants or the student exist.
What is informed consent?
Informed consent is the process by which a fully informed research subject can determine whether they wish to enroll in a research study. It is based on the legal and ethical rights of humans to make voluntary and autonomous decisions about whether they wish to be a research subject. Informed consent can only be obtained from individuals over the age of 18. Minors (age 7-17) must complete an assent document AND have a parent or guardian complete an informed consent document.
Informed consent is required for all research studies involving human subjects unless the investigator specifically requests a waiver or alteration of informed consent, which must be approved by the IRB. In order to participate in a research study, human subjects must understand that they are part of a research project, that participation is voluntary, and that they may withdraw at any time without penalty. They must also understand the procedures involved, time commitment, benefits and risks, and the extent to which confidentiality is maintained. This information is presented to prospective subjects in consent forms.
Investigators are required to keep all signed informed consent documents.
NOTE: The University of Southern Indiana IRB requests that all informed consent and assent documents follow the templates provided in the IRBNet Library.
I'm conducting my research online. How should I handle the consent process?
When conducting research online, we recommend using the Informed Consent Template for Online or Web-Based Surveys, available in the IRBNet library. When conducting electronic surveys, it is sometimes appropriate to use implied informed consent. In these situations, the participants are presented with the informed consent document at the beginning of the survey and informed that by proceeding and/or submitting the survey they are providing their implied consent. Some researchers choose to require participants select an "I consent" option before they can proceed to the survey questions.
What is CITI training and why do I need to have it?
The Collaborative Institutional Training Initiative (CITI) is a high-quality, peer-reviewed, web-based educational program which provides efficient and effective training for the protection of human subjects in research. The CITI Program was developed by experts and is used by many research, healthcare, technology, and educational institutions to train individuals in areas such as ethics, research, meeting regulatory requirements, responsible conduct of research, and research administration.
All USI-affiliated personnel (faculty, staff, and students) conducting human subject research projects are required to complete CITI training to ensure investigators are well educated on the ethical conduct of, and the regulations regarding, research with human subjects. Approval will not be granted for IRB applications until this training has been completed and training certifications are submitted on IRBNet.
Instructions on how to register for and use the CITI program can be found on our webpage, Collaborative Institution Training Initiative (CITI), or in this CITI Registration and Use PowerPoint.
I see that there are multiple CITI courses available. Which one(s) do I need to obtain IRB approval?
Completion of any one of the USI CITI courses below satisfy the CITI training requirement for Type 1 Research (Exempt) Applications:
Completion of any one of the USI CITI courses below satisfy the CITI training requirement for Type 2/Type 3 Research (Expedited/Full Board) Applications:
NOTE: Responsible Conduct of Research (RCR) training is not accepted for IRB applications.
I've completed CITI training at another institution. Will the USI IRB accept my CITI training?
The USI IRB carefully selected specific CITI training modules for our institution's CITI courses. If you have completed these modules for your CITI training at another institution, the USI IRB will accept that CITI training.* If you have not completed the necessary modules, you will be required to before your CITI training will be accepted. Please contact our office at rcr@usi.edu for a list of the required training modules for each of our CITI courses.
*Please note that USI's CITI courses are good for 3 years. If you are using CITI training completed under another institution, the USI IRB will consider your training expired 3 years after the completion date, even if the certification states otherwise.
My study has already been approved, but I need to make some changes. How do I go about doing this?
If you need to make any modifications to your ongoing study, no matter how small, you must submit an Amendment form (IRB Application Form C) via IRBNet. Your amendment will be reviewed, after which you will be notified that your amendment has been approved or requires modifications. (The modifications process for amendments is the same as with new submissions.) Once your amendment has been approved, you may implement the changes to your study.
If you have questions about how to submit an amendment in IRBNet, please consult the portion of the IRBNet User's Manual about this topic here.
My study's expiration date is approaching, but I need more time. How do I go about extending the expiration date?
If you want to renew your study for additional time, you will need to submit a Continuing Review form via IRBNet. The continuing review form must be submitted before the initial approval period is over/the current expiration date. (Continuing Review forms also subject to IRB review, so please allow time for the review process.) Any applications that need to be renewed but do not submit a continuing review form before the project expiration date must submit a new application and begin the review process over.
What happens if I don't have IRB approval for my project before conducting research?
Engaging in human subject research without IRB approval has serious ethical implications and violates university and federal policies. Students, faculty, and staff are required to submit IRB applications before embarking on any data collection. There is no provision in the federal regulations that allow for IRB approval of research that has already been conducted.
If it is discovered that research is being conducted without IRB approval, the investigator must immediately stop, appropriately discard/destroy all collected data and submit an application for IRB approval through IRBNet.
NOTE: Most academic journals now require proof of IRB approval before an article can be accepted for publication.