Who makes up the IRB?
Who must obtain advance approval if humans are proposed as subjects of research?
Who is ultimately responsible for all research activities that are part of a project?
Who will review my research?

What is the IRB?
What is a human subject?
What is the "Common Rule"?
What does minimal risk mean?
What will happen if someone working in my study doesn't follow the rules?

When does the IRB meet?
When does the "renewal clock" start ticking on my approval?

Why is my research subject to review by the IRB?
Why does an expedited review take as long as a full review?

How is research defined, for purposes of human subjects protection?
How do I determine which review process is right for a project?
How many copies must I submit to the IRB office of a protocol which requires full IRB review?
How will the IRB review my research?

1. What kinds of studies are common at UAB?
2. What is a "phase" in a clinical trial, and which one am I in?
3. What are the risks of participating in a study?
4. What are the benefits of participating in a study?
5. Whom can I ask a question about the study?
6. What if I don't want to enroll in the study?
7. What if I want or need to stop participating?
8. Will I be paid to participate?
9. Will it cost me any money to participate in a trial?

How do I complete (or update) IRB training?
When do I have to update my IRB training?

Which IRB training course should I take?
What are my username and password for the online course?

Do I have to be a UAB employee to do IRB training?
Do I have to have a BlazerID to take IRB training?

How can I check my training if my name isn't in e-reports?
Does training for OH&S, Effort Reporting, or HIPAA count as IRB training?
What other training is required?

What if I haven't received my certificate from the IRB?
What if I lost my UAB IRB training certificate? Can I get another copy?
What if I completed initial IRB training, but it lapsed?

Why is IRB training required?
Who needs IRB training?
Do I get CME or Nursing Contact Hours for IRB training?

How do we assure someone is the participant’s “legally authorized representative”?
Why does the title of my protocol have to match the title of the funding application?

Do I need IRB approval to interview people or observe their behavior?
Do I need IRB approval of audio, video, print advertisements?
Do I need to report to the IRB when a study has been completed?

Exemption
If my project appears to meet the requirements for an "exemption," does that mean I don't have to do anything else?
How can I obtain an approved exemption?
How long does approval of an exemption take?
Can a PI, department head, or faculty mentor approve an exemption?

Expedited
Besides the application form, what do I need to include with my application for Expedited Review?

If a sponsor is making no provision for injury compensation how should this be stated in the consent form?
What is an IND?
What is an FDA form 1572?
What is an IDE?
Must I submit an investigator’s brochure to the IRB when the IRB is reviewing an investigational drug study?

Can faculty in a Division review their patient records to identify possible enrollees in clinical trials conducted through the Division and to speak with the patients about the clinical trials? 

Can a researcher in a specialty division look at Hospital and Clinic patient records of individuals who are not  patients in that division and flag the records of patients eligible for a study conducted in that researcher's division?

May a specialty division researcher obtain a list of patients from the Division of Internal Medicine who may qualify for the researcher's clinical trial?

With concurrence of the treating physician and IRB approval of recruitment plans in place, can the specialty division researcher ask the treating physician in Internal Medicine to discuss enrollment in the trial with the physician’s patients?

Can the specialty division researcher and the treating Internal Medicine physician send a co-signed letter to identified patients that describes the research study and requests that the patients directly contact the specialty division researcher?

Can a specialty division researcher contact the Internal Medicine patients unilaterally from the list given to them by the treating physician?

A physician provides care to a patient who would be a good candidate for a study his colleague in another Department is conducting.  The physician wants to tell the faculty member in this other Department about the patient.  Is this permissible?

May a researcher review the results of clinical tests performed in the Hospital on individuals who are not this researcher’s patients, with the purpose of contacting those patients with a positive result to discuss enrollment in a clinical trial conducted through that researcher’s division/department?