What is the IRB?
It’s the office at UAB that ensures the safety and protection of human subjects in research studies of any kind.
Why were IRBs established?
IRBs were established ensure that research involving human participants is conducted in an ethical manner.
What do IRBs actually do?
The IRB review research protocols to ensure that
- risks to participants are minimized,
- selection of participants is equitable, and
- participants are informed fully of what their participation will entail and of the potential risks and benefits.
What is a research protocol?
A research protocol is the description of your proposed research project completed in the format required by the IRB for review.
What are the categories for research with human subjects?
There are four IRB categories for research protocols:
- No Humans designation
- Exempt from Further Review
- Expedited Review
- Full Review
Who decides which category my research belongs in?
The IRB makes all decisions about which category to place a research protocol in.
How is “human subjects” or ‘human use” defined at UAB?
According to Federal Policy 45 CFR 46 §102(f):
Living individual(s) about whom an investigator conducting research obtains
- data through intervention or interaction with the individual; or
- identifiable private information
In addition, UAB (and most other institutions with Federal wide Assurance) define human subject as not only a living human being but also
- human tissue
- blood samples
- pathology or diagnostic specimens
- study of medical records
- observation of public behavior
- all questionnaires
Is there anything else I need to do if my research project involves human subjects?
Yes, if your work involves human subjects, you need IRB training.
See www.uab.edu/irb/training for details.
How/when should I contact the IRB?
- Call or send an email before you begin work.
The IRB cannot approve research that’s already started or been done.
- Identify yourself, by name, as a graduate student.
“Hello. My name is Qin Xaio and I’m a graduate student in Joe Smith’s lab.”
- Explain, briefly, why you may need IRB approval.
“I’m planning a project that will involve using a human cell line. Is there someone I can talk to about getting approval for that?” or
“I’m planning to conduct a survey. Whom should I talk to about that?”
- Write down any information you’re given.
Names, telephone or fax numbers, email addresses, etc.
If your thesis or dissertation project involves human subjects, contact the IRB Office early in the project to ensure compliance (training, approval, etc.)
- You, not your mentor, are responsible for your compliance – contact the IRB.
For more information about the IRB, visit the web site: http://www.uab.edu/research/administration/offices/irb/Pages/Home.aspx