INSTITUTIONAL REVIEW BOARD
What is the IRB?
The IRB (Institutional Review Board) consists of four doctoral faculty members, at least one non-university member with a medical/scientific background, and at least one non-university member from the general public with no medical/scientific background (a layman). The current IRB for the Florida & Texas campuses consists of:
|Lisa Chase, PhD, PT, Chair
||Elwood Nelson, MS
|Elizabeth Ardolino, PT, PhD
||Gregory Oxford, DDS, MS, PhD
|Bonnie Decker, EdD, OTR/L
|Jodi Liphart, PT, DHSc, NCS
|The current IRB for the California campus consists of:
|Marilyn Miller, PhD, PT, GCS, Chair
||Edward Kane, PT, PhD, ECS, SCS, ATC
|Jennie DeGrado, OTD, OTR/L
||Erin Schwier, OTD, OTR/L
|Kristen Johnson, PT, MS, NCS
||Jeff Nessler, PhD
The IRB meets monthly to review research proposals involving the use of human subjects. The purpose of the IRB is to protect the human rights of those subjects and keep them from harmful procedures.
Who needs IRB review?
All projects involving human subjects must receive IRB approval before research can begin.
- If students/faculty are involved in collecting data for research that falls under the umbrella of the University of St. Augustine they MUST HAVE IRB approval.
- If the case report is being done for a class (not resulting in presentation or publication), it DOES NOT require IRB approval but as always patient confidentiality should be protected.
- If the research is being done for any type of presentation/publication it DOES require IRB approval.
- If USA IRB approval is necessary and if the case report/research involves another facility (clinic, hospital, etc.) it must have facility approval to use/collect the data as well.
- If the research involves another institution, it must have IRB approval from both, the USA IRB and the other institution(s).
- EXPEDITED REVIEW: If the research is being done for a class (and results in a presentation/publication) OR if the research involves(ed) collecting/analyzing pre-existing data (previous patients, chart reviews, etc.) and/or survey research.
- FULL REVIEW: Any other research involving human subjects.
- Utilization of the INFORMED CONSENT/INFORMATION RELEASE FORM: 7th term Case Report and Transitional DPT (t-DPT) and Transitional OTD (t-OTD) candidates incorporating current patients for case reports.
How do I get IRB review?
The IRB committee meets once each month. Please review IRB meeting dates (see page 3 below) as meeting schedule is subject to change. Any submissions for consideration must be received a minimum of two (2) weeks inadvance (FL & TX) or by the 1st of every month (CA) of the meeting to allow the committee members time to read the submitted materials.
Please direct all questions on submission deadlines or meeting times for the Florida/Texas committee to Cindy Kingry, Administrative Assistant at the University via e-mail (email@example.com) or phone: (904) 826-0084 x1234 or (800) 241-1027 x1234. Questions for the California committee should be directed to Corinne Tufo by email (firstname.lastname@example.org) or phone (760) 591-3012 x2454 or (866) 557-3731.
The proposal and accompanying consent forms to the Florida or Texas campuses should be submitted via e-mail to Cindy Kingry (email@example.com). Proposals to the California campus should be submitted to Corinne Tufo (firstname.lastname@example.org).
If emailed proposals are unsigned, you must fax the signed proposal page with the appropriate signatures, as well as the permission from the site where you will be conducting the research to: (904) 827-0069 (FL/TX), (760) 591-3053 (CA).
Please include a cover page that is directed to Ms. Kingry or Ms. Tufo.
Proposals can be mailed to: USAHS 1 University Blvd; St. Augustine, FL 32086 or 700 Windy Point Drive, San Marcos CA 92069.
Be sure to proofread all information prior to submission and use the checklists that are included in this information. Errors will delay the committee’s decision and/or require re-submission.
What is the IRB review process?
The IRB review process includes the following:
- Proposal documentation is received, including cover page which clearly indicates Expedited or Full review of IRB documents, two weeks prior to the next IRB meeting.
- Documents will be screened initially to assure adherence to basic submission guidelines.
- If paperwork is deemed complete/correct it will continue through the IRB process.
- If paperwork is deemed incomplete/erroneous it will be sent back to the Principal Investigator.
- Once past initial screening:
- Primary and secondary reviewers are assigned by the chairperson.
- The IRB meeting is confirmed.
- The primary and secondary reviewers lead the discussion at the meeting.
- The principal and/or secondary investigator should plan to be available either in person or by phone to address any questions/clarifications the IRB members might have.
- Following the discussion, the members vote on one of the following:
- APPROVED: Accept the proposal as is. Written approval is given for one year.
- APPROVED WITH REVISIONS: Accept the proposal with minor revisions. Revisions should be resubmitted for final approval. Written approval is given for one year.
- DENIED: Deny the proposal. The denial letter will outline the Board’s concerns. When the concerns are addressed, the proposal can be re-submitted to the IRB for review, and a vote.
2013 IRB Meeting Schedule and Submission Deadlines
FL & TX Campuses
Please remember to return to this page regularly when preparing a submission as meeting schedule is subject to change.