IRB Frequently Asked Questions
Do I Need to Get IRB Approval?
|Q. When am I required to submit a human participants proposal?|
|All proposed research projects involving the use of human participants conducted under the auspices of the University of Nebraska-Lincoln are to be submitted for IRB review.|
|Q. I am just doing a simple survey; do I need to submit to the IRB?|
|Yes. UNL’s Assurance with the Department of Health and Human Services says all research conducted under the auspices of this institution will undergo the IRB review and approval process.|
|Q. I believe my protocol is exempt. Do I have to have it reviewed?|
|Yes. It is the policy of the UNL IRB that all proposed exempt research is reviewed by the IRB staff for final determination of status.|
|Q. I am not collecting any identifying information; do I need to file for approval?|
|Yes. Federal regulations and UNL regulations require that ALL research (a systematic investigation) soliciting information from human subjects be submitted for review.|
|Q. I am only working with previously collected data; do I need to file for approval?|
|Yes. Federal regulations require that if the study will use existing data, documents, records, pathological specimens or diagnostic specimens from human subjects, it is to be submitted for review.|
|Q. My research is based on de-identified tissue samples; is it exempt?|
|Research involving the study of existing pathological specimens from participants who cannot be identified, directly or through identifiers linked to the participants, may qualify for exemption. However, all of the de-identified specimens must exist prior to the start of the research project for this to apply.|
|Q. I will be collaborating with a researcher at another institution; do I need to file for IRB approval at both UNL and the other institution?|
|Investigators should contact an IRB staff person whenever collaborative research is planned. Separate applications may be necessary, or an IRB collaboration agreement may be reached with the other institution.|
|Q. Should I wait until my research proposal has been funded to submit a protocol for IRB approval?|
|No. It's best to submit your IRB protocol at the time your research proposal is submitted to the sponsor so the protocol can be reviewed and approved. Then, when your proposal is funded, you will be ready to conduct the work, and the sponsored funding can be released.|
Before/During the Review Process...
|Q. How do I submit my application for IRB approval?|
|All IRB protocols should be submitted through NUgrant. The NUgrant system is easy to use and leads you through the application process step by step. You may be asked to upload certain files to accompany your application, such as measures used in the study (surveys, questionnaires, interview questions, etc), recruitment materials (flyers, e-mails, letters, scripts, etc), informed consent/assent forms, grant proposals, approval letters, follow-up materials, etc.|
|Q. How long does it take to review an application for IRB approval?|
It varies. The length of time depends both on the IRB and on the investigator. In 2007, the IRB reviewed 539 protocols. At certain times of the years, a large volume of protocols appear in the reviewing queue. More complex protocols often take more time. So far in 2008, the mean length of time from submission to approval for simpler protocols was 18-24 days, and for more complex protocols, 63 days. Sometimes, the investigator needs to make modifications to the research and to the protocol as a result of review. The faster you make these changes, the less time it will take for approval.
Please note: Full board protocols must be submitted to the IRB office by the 1st of the month in order to be reviewed at that month's meeting.
|Q. Who is required to complete the human participants (CITI) training?|
|All faculty, students, and staff proposing to use human participants in research under the auspices of UNL are required to complete the human participants training offered through CITI. Approvals for use of human participants in proposed research projects will be not be granted until this training has been completed and verified.|
|Q. What if I am only entering data? Do I have to take the whole CITI training?|
|A provision in the CITI curriculum allows limited research workers to take an abbreviated version to fulfill the training requirement. Limited research workers must meet ALL of the following conditions to be eligible for abbreviated training: 1) no responsibilities in project design; 2) not enrolled as a graduate student at UNL; 3) not UNL faculty; AND must meet at least ONE of the following conditions: 1) very limited independent decision-making in study implementation and data collection; and 2) no role in data collection, but may have access to participant identity and confidential data.|
After Approval is Granted...
|Q. When should I submit a request to modify an approved protocol?|
|All changes to an approved protocol are to be submitted for review and approval before you incorporate the changes into the research project, including but not limited to, changing surveys/questionnaires, adding participants, sampling a different participant population, a title change, change in principal investigator, change of funding source, increased time for participant participation, etc.|
|Q. What do I have to do if I need to amend my approved protocol?|
|All requests for changes should be made through NUgrant.|
|Q. Does approval of a modification for an approved protocol extend the original approval date?|
|No. The expiration date of the original approval is not changed by the review and approval of a modification.|
|Q. How do I renew my project for continued approval?|
The principal investigator is responsible for ensuring the continued approval of research projects involving human participants.
To remind you of this obligation, approximately two months before the approval expires, you'll receive notice via e-mail that you need to file for continuing review if you plan to continue this research beyond the one-year approval period.
|Q. In the case of an adverse event, when am I expected to report this occurrence to the IRB?|
|You should report a significant adverse event within five working business days. Mild/moderate events are reported at the time of continuing review.|
|Q. Can the IRB temporarily or permanently discontinue a research project as result of an adverse event?|
|Yes. If an adverse event poses an unexpected risk to the participants, the IRB may temporarily discontinue a research project until a thorough investigation has been conducted. Depending on the results of the investigation, the IRB may request changes to a research project or permanently discontinue the research project.|