Human Subject Research Protection Training

Prior to starting the design, conduct, data analysis or reporting of research that involves human subjects, the Institutional Review Board (IRB) at University Hospitals Portage Medical Center requires a researcher to complete Human Subject Research Protection Training. A refresher course must be completed every two years. Either of the following options are acceptable for course completion:

National Institutes of Health Protecting Human Research Participants

This activity is free. This is the course that UH Portage Medical Center employees who are new to research should complete.

Collaborative Institutional Training Initiative (CITI)

This activity is a subscription based service and will depend on your organization affiliation.

  • UH Portage Medical Center Institutional Review Board Application for Approval to Use Human Research Subjects.
  • The IRB makes the final determination of the need for IRB approval and the level of review needed. There are three types of review: exempt, expedited and full board. Exempt studies are reviewed by the Chair of IRB. Expedited and Full Board categories of studies are reviewed by the IRB at UH Portage Medical Center.

To help you understand the process we offer the following information based on the more materials from DHHS found at the U.S. Department of Health & Human Services Office for Human Research Protections website.

Notes: The IRB makes the final determination of the need for IRB approval and the level of review needed and the guide is to help you in choosing the form to fill out.

  1. All human subjects research is considered at least minimal risk.
  2. At UH Portage Medical Center, expedited studies are heard before the IRB as a matter of routine.
  3. “Exempt” does not mean review by the IRB does not apply. Exempt refers to exempt from the 45CFR46 requirements. Only the IRB can exempt your protocol from these requirements. Exempt studies are de-identified and not greater than minimal risk.

Levels of IRB Review

Full Board:

  • More than a minimal risk
  • Not covered under other review categories
  • Examples:
    • Intervention involving physical or emotional discomfort or sensitive data
    • Involve a survey of a protected group like pregnant women

Expedited:

  • No more than a minimal risk
  • Fits 1 of 9 expedited review categories
  • Examples:
    • Collections of non-invasive specimens
    • Research on existing documents like charts which were not originally part of research

Exempt:

  • No more than a minimal risk
  • Fits 1 of 6 exempt categories
  • Examples:
    • Research with de-identified records
    • Anonymous surveys that do not have a known risk

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