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Information on the IRB
What is the IRB?
IRB is an acronym for Institutional Review Board for Human Use. UAB has two IRBs. Together, they review all research conducted at UAB or by UAB faculty, staff and students research procedures that involves human subjects.
The IRB also has jurisdiction over research involving UAB data on human subjects. The IRB can approve, require modifications in, or disapprove all research activities that fall within its jurisdiction.
The aim of the IRB review is to ensure that research involving human participants is conducted in an ethical manner. This includes ensuring that risks to participants are minimized, the selection of participants is equitable, and participants are informed fully of what their participation will entail and of the potential risks and benefits.
For purposes of human subject protection, how is research defined?
Research is defined by the regulations as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” If you are conducting a study that you expect to publish or report in a public forum, you should consider it research and subject to IRB jurisdiction if it involves human subjects. If you are collecting data only for internal use, for example to improve customer service in your department, you are not doing research.
Who must obtain advance approval if humans are proposed as subjects of research?
Faculty, staff, postdoctoral fellows, and students (undergraduate or graduate) must obtain IRB approval before involving humans (or data collected about or from humans) as subjects of research. If you are unsure whether your research needs approval, contact the IRB for clarification. If you are a student, your advisor may have obtained IRB approval for the study that you are conducting. If you think that this is the case, it is important to verify it before you start.
Ultimately, who is responsible for all research activities that are part of a project?
As stated in federal regulations and UAB policy, the Principal Investigator of the study is responsible for all activities relating to the research study. Delegation of authority does not delegate responsibility.
How can the CCTS Regulatory Knowledge and Support component assist investigators who are new to human subject research?
The Research Subject Advocate (RSA) office can assist investigators with questions related to IRB submissions and the consent process, the development of appropriate data safety monitoring plans, and compliance with regulatory reporting requirements.
The RSA office is available to meet with research participants to review “participant’s rights,” observe the consent process, and assess participant’s understanding of the consent process.
To request assistance, please contact Kathleen Powell, PhD at 205-975-6023 or by email kpowell@uabmc.edu.
The Most Laurel
Do you remember a school experience where “superlatives” were given? Some people were The Coolest or The Best Dressed or The Most School Spirited (perhaps in some of these…can you say “peaked in high school”?) Well…have I got one for you: The Most Laurel.
After three illustrious years, Laurel Iverson Hitchcock is leaving UAB and the CCTS. She has finished her doctoral dissertation, will successfully defend it soon, and is moving on to a faculty position at another institution. Yeah for Laurel! Boo for us! You know Laurel …she coordinates the Scientific Writing Seminars, she manages the application and review process for the CCTS Pilot Projects, she has guided our foray into the cyberspace with this blog , she is the go-to-gal for many questions and projects in the CCTS Research Commons.
What else does she do? Laurel is a do-er. She is capable and dependable. She is a fabulous listener. She has been committed to serve the variety of programs she has worked on within our former Office of Program Planning and Educational Research and our place here in the Research Commons of the CCTS. She has been an extraordinary colleague and officemate. Plus she is just downright fun. So as we search to replace her, we also want to thank her for all she is and present her with her very own superlative The Most Laurel.
(psst, Laurel…the sash and pageant wave are optional!)
Melissa
