There are several steps researchers need to take before submitting a new study request to the institutional review board (IRB). This webpage will help walk you through the process and provide resources to help you get started.
Step 1: Determine if your study requires IRB review
All faculty, students and administrators conducting research with human participants must submit their research proposals to the ETSU Institutional Review Board (IRB) for review.
Not sure if your study involves Human Subjects Research? Click here to find out how to obtain that determination.
If you already received a determination or you are sure your study requires IRB review, proceed with the steps below.
Step 2: All Study Staff Must Complete Research Ethics and Compliance Training Courses
The ETSU IRB requires all study team members to successfully complete human subjects training through an online program called the CITI Program prior to conducting any human subject research. This includes persons who will have access to identifiable research data and students serving as research assistants.
We recommend that you complete your CITI training prior to starting your OneAegis (formerly IRBManager) submission as it covers information that must be considered when designing your protocol and answering the protocol application questions. Other training may be required depending on your proposed study such as HIPAA training, Good clinical practices training, or Blood borne pathogens training. More information and instructions are available here.
Note: While CITI training is not required prior to submitting a study in OneAegis (formerly IRBManager), a study cannot be approved until CITI training is completed by all study staff.
Step 3: Understand Your Responsibilities / Investigator Responsibilities
Taking on the role of Principal Investigator for research studies can be challenging. Not only are you responsible for the overall conduct of the study, but you are also responsible for all of those individuals working on the study. Please review the ETSU IRB policy related to the Roles and Responsibilities of Investigators before you begin your project.
If you are a student, resident, or fellow, the ETSU IRB accepts and supports you taking on the role of Principal Investigator. However, you must identify a Faculty Advisor for your project. Your Faculty Advisor should be someone who has conducted human subjects research and is familiar with the IRB submission process and IRB policies. He/she will be a resource and a mentor to guide you through submitting your research application to the IRB and conducting your study after you receive IRB approval. Please note that the IRB electronic application will prompt you to name a Faculty Advisor.
Step 4: Collect Conflict of Interest Disclosures from study staff
A conflict of interest arises when a researcher is or may be in a position to put his or her own interest before the best interests of research subjects. There can be situations in which financial or other personal interests/considerations may compromise — or have the appearance of compromising — a researcher's professional judgment in conducting or reporting research. Researchers should review the ETSU IRB policy related to Conflict of Interest for Researchers.
Principal Investigators are responsible for obtaining a disclosure statement from all study staff members who are involved in designing, conducting, or reporting the research presented in the protocol. The PI and study staff should complete the "Potential Conflict of Interest for Study Staff Form." Principal Investigators must retain these forms in the study records and will answer a question to that affect on the IRB application form.
Step 5: Allow Sufficient Time
The length of time for review and approval depends on the type of human research, the level of risk, and the complexity of ethical or technical questions that arise during review. The IRB review process for submissions has several steps and investigators should plan ahead to allow sufficient time for the process before beginning the research.
- When you submit your new protocol, your study goes to IRB Pre-review where the IRB staff will work with you to make sure your submission is consistent and complete. The IRB staff may request revisions or missing/additional information as needed.
- Next, the IRB Coordinator will forward the submission to the Department Chair or Faculty Advisor for scientific review. If the application is not complete enough to move forward, it will be returned to you for corrections and/or additions.
- Once the submission is deemed complete, it will begin the review/signature process. At this point it will take approximately 1 week (exempt reviews) to 6 weeks (expedited and full reviews) for the review to be complete.
- The IRB Chair, or assigned reviewers, may return the application to you asking for additional information. Please respond promptly to the IRB's request for information to ensure timely review.
- Final approval will come in the form of an electronic letter sent via email from the IRB Coordinator in IRBManager. IRB-approved consent documents and paper flyers (as applicable to your study) will also be stamped with the IRB approval date.
Note: Do not begin your research study until you have a final, formal approval letter from the ETSU IRB as well as other required institutional approvals (i.e., VA R&D approval if a VA study, Ballad Health IRB approval if using Ballad data, etc.)
Step 6: Request Access to OneAegis & Complete the New Protocol Submission xForm
The ETSU IRB use an electronic system called OneAegis (formerly IRBManager) to facilitate review. All new users must request access and complete a brief training. More information and instructions are available here.
Each submission within OneAegis consists of an "xForm," which is all the questions used to capture the information necessary to carry out IRB review. It uses branching logic to populate questions and pages based on the responses to earlier questions, and it provides the user with an experience similar to filling out an online form. We have included help text, links, and other resources throughout the xForm to assist you in completing your submission. For information on what to include in your New Protocol Submission xForm, click here.