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MICA Institutional Review Board

The Institutional Review Board exists to evaluate research involving 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

You must also submit an informed consent form and complete the online training in research ethics, attaching your certificate of completion of this training to your submission.

The research ethics training is here:
https://phrp.nihtraining.com/users/login.php

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?

Within one week of submission of your application for review, the IRB will contact you to let you know if your submission was complete and to inform you of your application's status (whether your research proposal is considered to be exempt from IRB review, suitable for expedited review, or requiring full review). If your proposed research qualifies for expedited review, you will hear from us within two weeks of submission. If your proposed project requires full review, it will be considered at the next full meeting of the IRB. The IRB meets as necessary during the semester in the first week of the month.

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) and do not involve engaging with a high risk population may qualify for expedited review. An expedited review is carried out by the IRB chairperson and one other member of the IRB.

The decision whether or not a project is suitable for expedited review rests with the chair of the IRB.

This page was last updated on 08/23/2017.