FAQ: About the HSIRB

Frequently Asked Questions About the HSIRB About IRB Applications Adverse Events/Deviations/and Unanticipated Problems Informed Consent HIPAA The VA Compensating Participants Other Health Sciences Institutional Review Board FH 125 Dockery-Folk Hall One Hospital Drive Columbia, MO 65212 (mail distribution code Dc074.00) 573 882-3181 phone 573 884-4401 fax irb@missouri.edu

1. What is an IRB?

The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects. An IRB is comprised of at least 5 members with a diverse background and enough expertise to review the research activities at the institution. An IRB has the authority to approve, require modifications of, or disapprove research.

2. What is research?

A systematic investigation designed to develop or contribute to generalizable knowledge. Only research involving human subjects or data on/about people needs to be submitted to the IRB. If you have any questions about whether you need to submit to the IRB please call 882-3181.

3. Do I need IRB approval?

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4. How do I create an account?

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5. I have an account and want to start a research project. What is the next step?

You will need to fill out an application and have it reviewed and approved before you can start. You will not be able to submit the application until you have completed the HSIRB compliance training and if the research involves medical information; you will probably need to complete the HIPAA training. Applications may require supporting documents such as a protocol, consent, a HIPAA form, and/or a safety plan depending on the type of study. There are 3 types of applications, exempt, behavioral and medical.

6. How long does it take for an exempt study to be reviewed?

The review process starts after the paper copy of the signature page and any supporting paperwork has been received by the HS IRB. The reviewer will start the review right away. The reviewer may need additional paperwork or clarification on issues. Once all information has been clarified it takes about one week for the study to be reviewed. Not all studies submitted as exempt actually qualify for exempt. You will be notified if this is the case.

7. How long does it take for an expedited study to be reviewed?

The review process starts after the paper copy of the signature page and any supporting paperwork has been received by the HS IRB. The compliance specialist will start the review right away and ask for any missing required documents or clarifications. The compliance specialist will then send the study to a primary reviewer. The reviewer may have additional questions and always has the right to bump the study to the Full-board for review. If this occurs the study will go to the next available meeting. Generally it takes about two weeks for a study to be reviewed. Not all studies submitted as expedited actually qualify and the compliance specialist will let the investigator know if this is the case.

8. How long does it take for a full-board study to be reviewed?

Studies that are electronically submitted between the 5th and the 19th of the month are scheduled for the mid-month meeting of the following month. Studies received between the 20th and the 4th are scheduled for the meeting at the end of the month. (Click here for submission dates.) The compliance specialist will start the review right away as all questions typically need to be answered at least 14 days prior to the meeting. Generally it takes one month for the study to be reviewed and any requested changes to be sent back to the investigator.