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Must I obtain IRB approval for my research?

Federal regulations require IRB approval for research that involves human subjects. If you plan on conducting research at Baptist Health Lexington, you are required to submit your research to the Baptist Health Lexington IRB for review.   Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Do all research personnel on my study have to complete human subject protection training?   

Yes.  Visit Required Training for more information.

Do I have to attend the IRB meeting when my application is being reviewed?

If you have submitted a new protocol to the IRB and the IRB office has determined it meets the qualifications for full Board review, then you are required to attend the meeting in which your application is reviewed. The IRB will ask that you do a five to ten minute presentation on your research and be available for questions. If you are not able to attend the IRB meeting, a sub-investigator can attend on your behalf. If you do not have a sub-investigator or a sub-investigator cannot attend, your study will be deferred to a future meeting in which you can attend.

 Can I appeal an IRB decision?

 The Baptist Health Lexington IRB holds ultimate authority over research conducted at Baptist Health Lexington.  All IRB determinations are final, however, should the IRB deny approval for a protocol, the investigator can choose to revise items of concern and resubmit for review. 

 How do I access the currently approved informed consent document for my study?

 To find the current IRB stamped informed consent document, log into Imedris, click on “Research Assistant” on the left hand column, then click on “My Projects”, click open the study you desire, and select “Informed Consent” listed under the heading “Protocol Items”.   All current and previous consent documents will be located here.  Select the PDF formatted consent document with the most recent approval date to open and print.