1. Who must apply for human subjects review through the IRB?
Anyone who intends to conduct research that involves people must apply for and receive IRB approval before beginning any research.
2. What is Human Subjects Research?
"Research" refers to a systematic investigation designed to develop or contribute to generalizable knowledge. This usually implies collection and analysis of data the researcher hopes to report in a scientific publication or at a professional meeting, but that isn’t always the case. "Human subject research" is research where the investigator obtains from a living human individual (1) data through intervention or interaction with the individual; OR (2) identifiable private information.
3. What is “generalizable knowledge”?
"Generalizable knowledge” means that the intent of the research is to add information to your field of study; the results can be applied beyond the subject population to other settings. It doesn’t matter if the results will be published or not, if your research activity is designed with the aim of discovering information that can be applied in other settings, it can be considered research.
4. What does “intervention or interaction with the individual” mean?
If you perform physical procedures on a person, manipulate the person, manipulate the person’s environment, communicate with a person, or have interpersonal contact with a person, you are engaged in an intervention or interaction with that person. Interaction includes but is not limited to surveys, interviews, and questionnaires.
5. Where do I send my continuing review/final report, amendment/modification forms and what happens after I turn in my forms?
The forms are found on IRBNet, under the Forms and Templates link on the homepage. Continuing Reviews, Amendments and Final reports must be submitted via IRBnet.
Once the forms are submitted, it is routed for review. Investigators are notified as soon as possible, via email, of the IRB's decision.
6. What are the different levels of IRB review?
There are three types of IRB review:
7. What is a vulnerable subject?
Subjects that are minors, prisoners, fetuses, pregnant women or individuals that have a diminished mental capacity are considered vulnerable subjects.
8. I need to plan data collection around IRB approval. How long does review take?
Please note: You may not begin your research until the IRB has given your research protocol full unconditional approval.
Review of Exempt or Expedited protocols takes about two to three weeks. The review process for protocols submitted for Full Review can take up to a month or longer to complete. You should include sufficient time in your research plan as allowance for any IRB-required changes to the research protocol.
9. How often does the IRB meet?
The UI-IRBs meet once every week to conduct full-board reviews. Expedited and exempt reviews occur on a rolling basis.
10. Do I have to attend the IRB meeting when my protocol is reviewed?
No. If the IRB has questions, or believes the investigator(s) could lend valuable insight for review, the IRB may contact the researcher during the meeting. Please be sure that contact numbers on the application are correct.
11. How do I know when my protocol has been approved?
You can check the progress of your submission on your IRBNet homepage. Once an approval letter has been issued, an email will be sent to you notifying you of this.
12. I want to administer my study in a language other than English. What do I do?
All consent documents and instruments must be translated. The IRB must certify that the translated documents translate equivalently in English.
13. Do I need any special training to use human participants in research?
Yes. We have an assurance with the Office of Human Research Protection (OHRP), U.S. Department of Health and Human Services. This assurance includes a requirement that all key personnel working with human subjects receive training in ethical guidelines and regulations. "Key personnel" is defined as any individual responsible for the design and conduct of the study. This would include persons who have direct and substantive involvement in proposing, performing, reviewing, analyzing, or reporting research and includes students fulfilling these roles as well as their faculty advisors.
The CITI training will satisfy this training requirement. Certificates are issued at the completion of the training.
14. I'm working with other researchers on this project. What should I do?
The IRB will want to know the name of each person on the project. The protocol package on IRBNet should be shared with these researchers and their CITI certificates must be linked to the package being submitted for review.
15. What happens if my protocol is not approved?
The Committee will send its comments to you asking for revisions to your protocol. Changes must be submitted to the Committee for its review.
16. How long is the approval for?
A standard approval is for a period of one year. However, the Board may grant approval for less than one year.
17. My protocol was approved, but now I want to modify it. How do I do that?
Changes to a research protocol must be reviewed and approved by the IRB prior to their implementation. To submit proposed changes for IRB review, complete an IRB Request for Amendment/Modification for Approved Protocol and submit via IRBNet. Attach new or revised instruments, measures, consent documents, etc., as appropriate. Requests for modifications are reviewed at the same level as the original protocol - i.e., Full Review modifications are reviewed by the Full IRB.
18. What is an adverse event and how do I report it?
Breaches in protocol, adverse events and unanticipated problems, include, but are not limited to breakdowns in the consent process, violations of confidentiality of the data, complaints by participants, and adverse physical events. Serious problems and adverse events must be reported to the IRB within 48 hours.
The IRB will hold office hours in February on Mondays, 2-4 p.m. or by appointment for one-on-one assistance with IDEATE in Room A-504