IRB Application Requirements and Resources
The IRB requires several mandatory trainings for ALL individuals lised on any human subjects research protocol:
TRAINING REQUIRED FOR HUMAN SUBJECTS RESEARCH
| All three CITI Trainings listed below: Create an account at the , selecting ¸ÌéÙÖ±²¥ University from the pull-down. To choose correct CITI courses, you will be prompted to fill out a questionnaire when you log in. |
| 1. CITI Conflicts of Interest (COI) (Do not confuse the COI COURSE with the COI MODULE in the other CITI courses.) Choose YES in the questionnaire when asked if you would like to take the COI course. Refresher required every 4 yrs. |
| 2. CITI Responsible Conduct of Research (RCR) according to department. When you first log in to CITI, use the questionnaire to guide your choice. Refresher required every 3 yrs. |
| 3. CITI Human Subjects Research according to department. There are two choices: Biomedical Research - Basic/Refresher or Social & Behavioral Research - Basic/Refresher. Refresher required every 3 yrs. |
FCOI DISCLOSURE REQUIREMENT FOR HUMAN SUBJECTS RESEARCH
FCOI Disclosure: Read Financial Conflict of Interest policy, then complete an electronic disclosure via Cayuse Outside Interests. Research faculty should have received an email with an access URL. Student researchers must email their VU User Name to the
CAYUSE HUMAN ETHICS ACCESS REQUIREMENT
The ¸ÌéÙÖ±²¥ IRB uses Cayuse Human Ethics for protocol applications. Researchers can apply for access by emailing Holli Moore at resadmin@villanova.edu
Help Me Determine applications are available for researchers that are looking for "Not Human Subjects Research," and "VU Not Engaged," determinations, as well as researchers who are struggling to determine which application is most appropriate for their research.
These applications can be evaluated by ORP and do not require the CITI/FCOI requirements, so they will take less time to process than human subjects research applications.
If a researcher is looking for a specific determination, the researcher can expect the determination in approximately 7 days.*
If the researcher is looking for the appropriate application to submit, the researcher can expect a comment with the appropriate application in approximately 5 days.*
*This timeline assumes the application provides the information required to make the determination.
Exempt determinations are appropriate applications for researchers conducting minimal risk research that fits into one of the eight regulatory categories for exemptions. Exempt determinations require all research personnel complete the CITI and FCOI requirements before the protocol is assigned to an IRB reviewer.
Exempt determinations that involve more sensitive data can receive an exempt limited review, which evaluates the data protection measures with higher scrutiny to determine if the protocol can remain in the exempt category. Exempt limited determinations require the completion of CITI and FCOI requirements before the protocol is assigned to an IRB reviewer.
Exempt determinations and exempt limited determinations will be assigned to an IRB reviewer within three days of submission.* IRB reviewers have an initial two weeks to review the submission and provide feedback. Once the application is returned to the reviewer, they have an additional week to evaluate the revisions.
The estimated time to receive an exempt determination is 3-5 weeks.**
*IRB applications are assigned within three days if the submission is complete and all personnel complete the application requirements.
**This timeline depends on the responsiveness of the IRB reviewer and the responsiveness of the researcher when submitting revisions.
Expedited applications are appropriate for researchers conducting minimal risk research that fits into one of the seven regulatory categories for expedited research. Expedited applications require all research personnel complete the CITI and FCOI requirements before the protocol is assigned to an IRB reviewer.
Expedited applications will be assigned to an IRB reviewer within three days of submission.* IRB reviewers have an initial two weeks to review the submission and provide feedback. Once the application is returned to the reviewer, they have an additional week to evaluate the revisions.
The estimated time to receive approval of an expedited application is 4-6 weeks.**
*IRB applications are assigned within three days if the submission is complete and all personnel complete the application requirements.
**This timeline depends on the responsiveness of the IRB reviewer and the responsiveness of the researcher when submitting revisions.
Full board applications are appropriate for researchers that are conducting more than minimal risk research, research with vulnerable populations, and/or research that does not fit into a lower regulatory category. Full board protocols are assigned to the entirety of the IRB and are reviewed at a monthly meeting. Full board applications require all research personnel complete the CITI and FCOI requirements before the protocol is assigned to a meeting.
Full board applications will be assigned to a meeting if the application is submitted by the monthly deadline, the application is complete, and all research personnel completed the application requirements.
The estimated time to receive approval of an expedited application is 2-4 months.**
**This timeline depends on the responsiveness of the IRB and the responsiveness of the researcher when submitting revisions.
In all cases the IRB will make every effort to review research in as timely a fashion as possible, and researchers should communicate extenuating circumstances such as ‘Just in Time’ requests from funding agencies.
Spring Semester (delay periods)
Spring break – March (5 business days)
Easter recess – April (3 business days)
Fall Semester (delay periods)
Fall break – October (5 business days)
Thanksgiving – November (3 business days)
Winter break (closure and delay periods)
While University is formally closed (typically around December 23/24 – January 3/4) review will not proceed. When University reopens, prior to start of Spring semester, review will be on extended timeline as described above.
Researchers planning to begin or modify research at the beginning of the Spring semester are encouraged to submit their protocols prior to winter break towards the end of the Fall semester to avoid delay.
Summer (generally normal cadence)
Review generally proceeds on normal schedule except for ‘Summer Fridays’, if in effect, in which case pre- and post-review activities may not occur. Some limited periods of reduced availability may apply to accommodate reviewer time off.
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