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MICA Institutional Review Board

The Institutional Review Board exists to evaluate research using human subjects conducted by members of the MICA community. The IRB operates under the guidelines enacted by the Office of Human Research Protection, a branch of the U.S. government's Food and Drug Administration.

Frequently Asked Questions

Does my project need to be reviewed?

Research involving human subjects needs to be approved by the IRB. "Research" is defined as "a systematic investigation designed to develop or contribute to generalizable knowledge." A "human subject" is defined as "a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or identifiable private information."

For additional information, see:
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.102

http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html

How do I get my project reviewed by the IRB?

In order to have a proposal reviewed by the IRB, the researchers must complete and submit an IRB form. The IRB form contains questions regarding the project procedures as well as ethical safeguards being used in the project. Detailed instructions for completing the form are available here. (link to form)

Is my project suitable for expedited review?

Projects that involve no more than minimal risk (the same risks incurred by normal conversation or day-to-day activity) may qualify for expedited review. An expedited review is carried out by the IRB chairperson and one other member of the IRB.

What are the criteria for the IRB to approve my research?

The IRB approves research if:

  • risks to subjects are minimized;
  • risks are reasonable in relation to anticipated benefits;
  • selection of subjects is equitable;
  • informed consent is sought from each subject;
  • informed consent is appropriately documented.

Additional criteria may apply where appropriate:

  • data collection is monitored to ensure subject safety;
  • privacy and confidentiality of subjects is protected;
  • additional safeguards are included for vulnerable populations

What is informed consent?

Informed consent refers to the voluntary choice of an individual to participate in research based on an accurate and complete understanding of its purposes, procedures, risks, benefits, alternatives, and any other factors that may affect a person's decision to participate. Complete information on informed consent and how to properly document it can be obtained by following these links:

http://www.hhs.gov/ohrp/policy/ictips.html

http://www.hhs.gov/ohrp/policy/consent/

http://www.hhs.gov/ohrp/policy/consentckls.html

How long does it take the IRB to review a proposal?

(TBD)