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Tips for UM-Flint Student Researchers Conducting Human Subjects Research

   

Does my research require IRB review?

Projects that meet the regulatory definition of research with human subjects require review and approval by an Institutional Review Board (IRB) BEFORE research (including subject recruitment) can begin.

 Research is defined as “systematic investigation…designed to develop or contribute to generalizable knowledge.” The key here is “generalizable knowledge”- will you present findings at a conference, prepare a poster, publish or report on your findings and might others rely on this knowledge for further exploration.

   A human subject is a “living individual about whom and investigator conducting research obtains (1) data through and intervention or interaction with the individual or (2) identifiable private information.”  See the Human Research Protections Program Operations Manual, Part 4, for examples of projects that do not require IRB oversight. http://research-compliance.umich.edu/operations-manual-activities-subject-hrpp

Types of IRB Review

  • Full Board Review-Any research with humans that poses more than minimal risk to subjects, or minimal risk research with vulnerable populations or complex protocols. Average review time 4-8 weeks.
  • Expedited Review-Research posing no more than minimal risk to subjects that meets one of 9 categories of expedited research.  Reviewed by a single member of the IRB. Average review time 1-3 weeks.
  • Exempt Review- Projects meeting one of 7 categories of exempt research. Reviewed by a designated individual.  Average review time 1 week.

How do I apply for IRB review?

  1. Identify a faculty advisor- this is your dissertation chair, masters or undergraduate research advisor.  Your advisor will mentor you through the research process and must be included on your IRB application as a member of your study team.
  2. Formulate your research question/study design- development any survey instruments or interview protocols, identify subject populations, develop recruitment strategies.
  3. Determine how you will seek consent-see the IRB website for consent templates and sample documents. www.umflint.edu/humansubjects/
  4. Complete the PEERRS human subjects training module- all UM researchers (including faculty advisors) must complete this training. http://my.research.umich.edu/peerrs/
  5. Prepare your IRB application via eResearch- you will need the following materials
  • Research protocol
  • Performance site information, including site agreement letters or IRB approval
  • Informed consent documents
  • Recruitment materials-flyers, posters, letters, emails, oral scripts
  • Survey/interview/focus group questions
  1. Submit your application for IRB review via eResearch- your faculty advisor and any other members of the study team must accept their role on the project before you can submit
  2. Monitor your email- all eResearch notifications will be sent to you via email.  Respond promptly to any requested changes or requests for information.  Your IRB approval will be sent via an eResearch email notice
  3. Conduct your research as approved by the IRB-any changes to research projects requiring IRB oversight must be approved before implementation.  Submit an amendment via eResearch system
  4. Renew your IRB approval prior to the expiration date-submit a continuing review application via eResearch at least 30 days prior to expiration
  5. Report any adverse events or other problems or incidents to the IRB via eResearch

UM-Flint IRB     810-762-3384      irb-flint.edu