Initial Submissions

How To Submit a New Study

All new human research studies must be submitted electronically using the OneAegis (formerly IRBManager) system. When you log into OneAegis, you will start a New Protocol Submission xForm, answer all of the form questions, and attach the requested documentation for review.

→ Be sure you have reviewed the Getting Started webpage.

What type of submission is this?

The New Protocol Submission xForm will ask if you believe your study is eligible for Exempt Review. Studies eligible for exempt status are exempt from some regulatory and institutional requirements, so the review form asks different questions for that type of review. Here you can learn more about the Levels of IRB Review. 

If you are submitting a study request to rely on an external IRB, you can learn more about that process here.

What Needs to be Included in the Submission?

You will complete the New Protocol Submission xForm in OneAegis (formerly IRBManager), and you will need to answer each question thoroughly so that the IRB reviewer(s) understand your proposed study and procedures. The IRB has to ensure that regulatory and institutional criteria for approval are met and that there are appropriate protections in place for the research participants. The application asks for all of the information the IRB needs to complete the review, and there are questions that ask you attach your study materials.

Required study materials include recruitment documentation, informed consent document(s), data collection materials (i.e., surveys, interview guides, observation checklists, etc.), intervention materials (i.e., investigational drug packet insert, educational handouts/presentations, etc.), scientific references, regulatory documentation (i.e., FDA letters, IND or IDE documents), study site approvals, and applicable grant proposals/contracts. The IRB reserves the right to request additional information if needed to conduct a complete review.

  • Information Needed to Complete the xForm
    • List of study staff names, contact information, roles, responsibilities, and CITI/HIPAA training completion records
    • List of external study sites/locations where research will occur and contact information for their IRB offices, as applicable
    • Conflict of Interest disclosure forms from all study staff
    • Study Details & Objectives
    • Procedures for recruitment & enrollment of participants
    • Informed Consent process and documentation
    • Plan to balance potential risks and benefits
    • Procedures for payments and costs to participants
    • Plan for Privacy  & Confidentiality 
    • Data storage and backup plan
  • Common Attachments You May Need
    • Informed Consent Document (note that we have templates on our website)
    • Survey, Interview Guide, observation checklist
    • Letters of support from sites/facilities where research will occur
    • Emails, Verbal/Phone Script, Ads, Flyers, etc. used to recruit participants
    • CV/Resume for Principal Investigator
    • References/Bibliography demonstrating scientific validity
    • Investigator Brochure, study drug packet insert, study device information
    • Grant proposal, research contract/agreement
  • Other ETSU Approvals May be Needed

    Researchers are responsible for ensuring compliance with all applicable university policies and obtaining approvals as applicable before beginning the research.

    • Environmental Health & Safety (EH&S) oversees compliance with safety issues in research such as use of radiation, biohazards (i.e., blood, stool, infectious agents), and chemicals
    • Office of Research and Sponsored Programs Administration (ORSPA) oversees administration and compliance of all externally funded research
    • Office of HIPAA Compliance oversees compliance for research that uses PHI or HIPAA data (i.e., medical record data)
    • Office of Grant Accounting oversees compliance with use of ETSU funds to pay for research including payments to research participants
    • Office of Legal Counsel provides legal opinions related to applicable laws that may impact research including FERPA, GDPR, PIPL, and other privacy laws

FAQs

  • How do I submit to the IRB?
    The IRB uses the online system called OneAegis (formerly IRBManager) for submission and review. You will need to request access to IRBManager and submit the completed New Protocol Submission xform in OneAegis. Here are instruction for OneAegis.
  • When is the deadline for IRB submission?
    For most research, there is no deadline for submission. Research that is minimal risk and does not required full board review are reviewed on a continuing basis in the order received. Research that is greater than minimal risk must be reviewed by the full board at a convened meeting. Each IRB meets monthly, and the schedule is available here.
  • What happens after I submit my study?
    Following your submission in IRBManager, your xform is routed for applicable institutional signatures. For example, department chairs electronically sign for faculty submissions, and Faculty Advisors electronically sign for student/resident submissions. Then, the IRB staff receive the submission and complete the administrative Pre-Review to check for consistency and completeness. Once the IRB staff determine the submission is complete, it is forwarded to the IRB Chair of the appropriate committee for review. The IRB Chair may assign designated reviewers depending on the Level of IRB Review and expertise needed to complete the review. The IRB staff, Chairs, or reviewers can all send the xform back to you for questions at any time. You will receive an email notification if the xform is sent back to you with questions to address.
  • When will I hear about the IRB's decision?

    For most initial submissions, the Principal Investigator will hear from the IRB staff within 24 hours regarding the clarification or information needed during IRB Pre-Review. This is when the IRB Staff check the application for consistency and completeness before sending it to the IRB for review. 

    You receive an email each time the IRB requests for information during the review process. In most cases, you will hear about the IRB review decision via email within 2 weeks of submission. This can vary depending on complexity of the ethical or technical questions that arise during the review.

  • Does my data-only study need to have IRB review?

    If you are using data for research and you can reasonably identify the human participants, you need IRB approval before obtaining the data for research. Humans can be reasonably identifiable when you have direct identifiers (i.e., name, SSN, Enumber, contact information, images/recordings) or enough indirect identifiers that you could probably match the data to individual people.

    You will complete the New Protocol Submission xForm to describe your secondary research/data-only study. Some questions may not appear to be applicable like how will you recruit participants, but we still expect you to explain how you will obtain the data about humans. Answer each question to the best of your ability as applicable to your study design.

  • What do I do to request that ETSU IRB accept another IRB's approval of my study?

    If another IRB has already approved the study that you want to collaborate on, you may be able to request that ETSU IRB rely on the approval of the external IRB. Guidance on that process is available here.

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