Institutional Review Board

Compliance and cooperation with the applicable oversight body for your research is required by the University of Mount Union. This ensures the protection of our research subjects and personnel. Failure to comply with applicable federal laws, regulations, and the University of Mount Union policies can result in the permanent loss of research privileges at Mount Union. Serious offenses can also result in the loss of federal funding currently being received or future requests.

All research and training projects conducted by faculty, staff, students, or outside personnel require a review to determine if a full review is required. A request can be made to the IRB Chair to determine if a full review needs to be completed by the IRB committee(s). This determination can be completed via email communications. Below is a summary of what should be sent in for a complete review.

*Please also review the Campus Survey Policy, as some research or training projects may need more coordination with the Office of Institutional Effectiveness (OIE) first before completing the IRB submission form.

*Other University of Mount Union Policies that may need to be reviewed pending the research or training project include but are not limited to: Bloodborne Pathogen Policy, Minors on Campus Policy, Animals on Campus

IRB/HSC: Approval is required for all human subject research activities designed to develop or contribute to generalizable knowledge (e.g., publication, presentation, dissertation, or surveying). This includes student dissertation and thesis projects. This applies regardless of funding source.

IACUC: Because the University receives Public Health Service (PHS) funding, ALL vertebrate animal activities, except any College of Veterinarian Medicine studies using client-owned animals, are to be reviewed by the IACUC, regardless of funding source.

IBC: Approval is required for all work with infectious agents, human and/or non-human primate agents (even if purchased from a vendor), all modified organisms/plants, and/or the use of recombinant/synthetic nucleic acids. This applies regardless of funding source.

Investigator(s) may begin work on a study/project upon receipt of the Full Approval Letter and Study Number assigned. Please be advised there are different letters sent to applicants. Each letter informs the applicant of the review status assigned to the application. Any work begun beforehand violates federal law and puts all research and data obtained in jeopardy.

All applications are reviewed by IRB as they are received on a rolling basis. For full consideration, the committee requires 3-4 weeks to review materials prior to the monthly meeting. Additional time may be required if an OIE collaboration is needed.

Any study/project that received IRB full approval that extends beyond 1 year (12 months) from the date approved, requires a renewal to be completed.

* See Tab Below For Renewal/Continuation Process

Training Instructions:

New User Registration Information for CITI Training Link

Submission Forms:

Only online submissions will be considered. The online site used by the University of Mount Union IRB does not allow an applicant to save their progress and return to complete the application later. Please download the associated Working Document for Human Subjects or Working Document for Animal Subjects. Applicants are encouraged to complete all fields in that document thoroughly first, and then copy and paste the documentation into the appropriate online application format for submission.

Online Application Links:

IRB Application for Human Subjects

IRB Application for Animal Subjects

Step 1:

• For Human Subject studies:
  • Complete the required Assurance Training by reading each Module (1-3) and reading additional resources/links that are provided by the U.S. Department of Health and Human Services.
  • Sign the certificate of completion for this training.
  • Complete the Human Research Protection Foundational Training by completing the 5 lessons.
    
    
• · For Animal Subject studies:
  • Complete the required CITI training for animal subject research

Step 2:

• Complete the appropriate working document in preparation for the required online submission of the application.

Step 3:

• Complete the Informed Consent and/or Assent Documentation for Human Subject studies.
  • What documents do I need?
    • If participants are 18 years or older and capable of offering informed consent, complete the UMU IRB Informed Consent Form
    • If participants are less than 18 years old, complete the Parental Consent Form and when necessary the Minor Assent Form.

Step 4:

• Gather all supporting materials.
  • Recruitment or informational materials (e.g., recruitment scripts, email scripts, fliers, etc.)
  • Complete the required (Link updated debriefing form here).
  • Intervention instruments (e.g., any video clips, music clips, photos, etc., that participants will be exposed to as part of your investigation).
  • Grant description, if study/project is funded.
  • Copies of all investigator's subject protection certification(s) that are needed. This is dependent on the subject type being researched (human vs. animal) and any additional needs such as biomedical, public health, etc.

Step 5:

• Use the application link above that pertains to the proposed study for submission of all requirements.
• All applications are reviewed on a rolling basis as they are received. For full consideration, the committee requires three to four weeks to review materials prior to the monthly meeting. Additional time may be required if collaboration with Mount Union's Office of Institutional Effectiveness is needed.

Step 6:

• Wait for the IRB Committee's decision and feedback.
  • The three possible decisions the committee may make:
    • Granted Full Approval- This requires no additional action, and research may start on or after the submitted start date listed within the application.
    • Approval with Minor Revisions- This requires very minor revisions that are often requests for additional materials, clarifications, etc. and no research may begin until revisions are submitted, and Full Approval is Granted.
    • Revise and Resubmit- This requires a more in-depth review of the proposal(s) by the investigator(s) and major revisions. No research may begin until the resubmission has been reviewed and a determination by the committee is made.

Step 7:

• All applications (both Human and/or Animal investigations) that are not granted full approval, and are required to submit minor revisions or complete revisions are required to submit their revisions using the Online IRB Application for All Requested Revisions
• Submission of revisions is not a guarantee that full approval will be granted. The IRB Committee may still require further revisions after their additional review(s).
• All submitted revisions may take 3-4 weeks to be reviewed by the IRB Committee before a decision is provided to the applicant.

Fully approved investigations are approved for 12 months from the time approval was granted. If research requires investigation beyond the 12 months use the steps below. Applicants are only permitted to renew an original application 1-time. Applicants may submit a new application for the same investigation after the 1-time renewal period if continued investigation is required.

Step 1:

• Review the original application for any changes that may need to be made.
  
  • If amendments are needed, researchers are responsible for the submission of any additional documents that may be needed.

Step 2: · Use the working document IRB Continuation/Renewal Application as a guide to prepare for the online application submission.

Step 3: · Complete the IRB Continuation/Renewal Application no later than 4 weeks prior to the original approval date.

• Example: 12-month Approval granted for study #000 on December 30th, 2024, application for renewal would be due no later than December 2nd, 2024.

Step 4:

• Wait for renewal approval which may take 3-4 weeks.
• · Renewal approval will be emailed to the address provided within the renewal application.
  • Assigned investigation IRB numbers remain the same for the 12-month renewal period.