What is the IRB?
An IRB is an appropriately constituted group that has been formally designated to review and monitor research involving human subjects. An IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group serves an important role in the protection of the rights and welfare of human research subjects.
To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.
The IRB (Institutional Review Board) consists of at least four doctoral faculty members, at least one member who does not have a medical/scientific background, and at least one non-university member from the general public with no medical/scientific background (community member).
The IRB meets monthly to review research proposals involving the use of human subjects that require a convened review. Research proposals that may be reviewed at the expedited or exempt level are reviewed on an as received basis.
IRB reviews for expedited and exempt review may take, on average, two weeks to complete provided they do not need to be returned to the researcher for modifications. In the case of return, the time for review is extended.
What Constitutes the IRB at USAHS?
There are four IRBs within the University of St. Augustine for Health Sciences. There is one IRB administrator who oversees the daily functioning and compliance of all four IRBs and one Institution-wide IRB Chair who oversees them all.
Institutional-wide IRB Chair:
Mohan Ganesan, PT, PhD
mganesan@usa.edu
IRB Administrator:
Kylee Barlowe, MHA
kbarlowe@usa.edu
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California IRB
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Chair: Pedro Gonzalez-Cabrera, MS, PhD
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Faculty Members:
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Community Members:
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Eilish Byrne, PT, DSc
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Osman Alikhan (non-scientist)
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Karen Park, OTD, OTR/L, BCP, SWC, CLE
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Aaron Bonsall PhD, MSOT, OTR/L
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Faris Alshammari, PT, PhD, MPT
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Jessica De Brun, OTD, OTR/L
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Jerome Higgs, PT, DPT, PhD
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Bindu Balakrishnan, MSc, PhD
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Florida IRB #A
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Chair: Kristin Domville, DrOT, OTR/L
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Faculty Members:
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Community Members:
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Evan Pucillo, PT, DPT, EdD
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Debra Pueschel (non-scientist)
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Catherine Andrea, PT, MPT, EdD
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Marcio Dos Santos, PT, MSc, PhD
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Miguel Garcia, PT, DPT, EdD
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Pamela Kasyan-Howe, OTD, OTR/L
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Marti Kessack, PhD, RN, HCM, PPA
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Florida IRB #B
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Chair: Zeida Gutierrez, Ph.D., MHS, OTR/L
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Faculty Members:
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Community Members:
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Sabina Khan, Ph.D., OTD, OTR/L, CBIS
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Debra Pueschel (non-scientist)
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Blanche Leeman, EdD, OTR, CHT
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Janice Dunlap, DNP, ARNP, AGPCNP-BC, ACNS-BC
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Nancy Hellman, PT, DPT, EdD
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Bob Salvatori, PT, DPT, MBA, DSc
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Dana Kolbfleisch, OTD, OTR/L
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Texas IRB
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Chair: Halah Alateeq, PhD, CCC-SLP
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Faculty Members:
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Community Members:
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Lesley Khan-Farooqi, PhD, OTD, OTR/L
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Osman Alikhan (non-scientist)
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Edla da Silva, PT, BS, PhD
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Steven Gerardi, PhD, OTD, MSS, OTR
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Allan Besselink, PT, DPT, PhD, Dip.MDT
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Neeraj Kumar, PT, DPT, PhD
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What are the Standard Operating Procedures that the IRB follows?
For a list of our Standard Operating Procedures (SOPs) click the link: USAHS IRB Standard Operating Procedures (SOPs).
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 for Health Sciences, 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 USAHS 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 USAHS IRB and the other institution(s).
- In most situations, researchers should FIRST gain USAHS approval and then gain approval from other institution(s). That approval should be submitted to USAHS before research begins.
- Investigators who are conducting research for the purpose of masters or doctoral studies outside of USAHS must FIRST gain approval from that institution’s IRB and then gain approval from the institution where the research will take place.
- If you are conducting research involving another institution, you may obtain a reliance agreement (IAA). If USAHS is the IRB of record, you may use the USAHS IAA form located in OneAegis. If the other institution is the IRB of record, you should request a reliance form from their IRB.
What Type of Review Do I Need?
Use the flowchart below to determine the level of review that you may need. In addition, when you complete the IRB application, you will be able to review the categories for both exempt and expedited review to determine where your research may fall. The final decision regarding the level of review does rest with the IRB.
USAHS IRB Flowchart
For additional information on the review categories, a brief submission guideline document is also available to you:
USAHS IRB Submission Guide
Here is a sample of what the initial application looks like in OneAegis:
Sample Initial Application
Where Should I Submit My IRB Application?
USAHS now utilizes the OneAegis database for all IRB related submissions and materials. You may access OneAegis through the link located at the bottom of this page.
USAHS faculty and staff who submit a proposal will have their research reviewed by the IRB that is closest to the geographical location of the principal investigator.
USAHS students will have their research reviewed by the IRB that is closest to the geographical location of the supervising principal investigator.
IRB Applications that do not have all signatures will not be forwarded for review.
Please direct all questions on submission deadlines or meeting times to the IRB Administrator:
Please direct all correspondence related to submission in the OneAegis database to: oneaegisalerts@usa.edu.
What Should I Submit with My IRB Application?
All researchers should submit a completed IRB application and all attachments required for the study. This may include email script, surveys, informed consent/assent documents, questionnaires, etc. Any documents that are pertinent to the study must be submitted with the IRB application and noted in the IRB application in the appropriate locations. Within the IRB application, researchers must provide requested information to link their CITI training to their application.
**If you plan to survey USAHS faculty/students, it will need to be approved by Dr. Maria Puzziferro before your study can be approved by the IRB. Please see the following Survey Policy and application form. The completed form will need to be submitted to oair@usa.edu for Dr. Puzziferro's approval. Then, that final approval will be the first item required before beginning an IRB application. Please make sure this approval is completed before completing an IRB application.
USAHS Survey Policy Draft v.8
USAHS Survey application form v.9
**If you plan to use USAHS institutional data for your study, it will need to be approved by Dr. Puzziferro before your study can be approved by the IRB. Please see the following Institutional Data Usage Policy and application form. The completed form will need to be submitted to oair@usa.edu for Dr. Puzziferro's approval. Then, that final approval will be the first item required before beginning an IRB application. Please make sure this approval is completed before completing an IRB application.
Institutional Data Usage Policy Draft v.9
Institutional Data Usage application form v.9
What Is Informed Consent?
Informed consent may be needed for a research study. The purpose of informed consent is to provide the prospective subject or legally authorized representative with the information that a reasonable person would want to have in order to make an informed decision about whether to participate in a study and an opportunity to discuss that information.
There are five key elements that should be provided at the beginning of the form.
- A statement that the project is research and participation is voluntary,
- A summary of the purposes of the research, the expected duration of the prospective subject’s participation and the procedures to be followed,
- The reasonably, foreseeable risks or discomforts to the prospective subject,
- The reasonably, expected benefits, and
- The appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the prospective subject.
Information should be sufficiently detailed relating to the research and must be organized and presented in a way that does not merely provide lists of isolated facts but rather facilitates the prospective subject’s or legally authorized representative’s understanding of the reasons why one might or might not want to participate.
USAHS requires that all research originating with us utilizes the informed consent templated provide in OneAegis.
You may review the full regulation regarding Informed Consent at §46.116. You may also use the checklist below to ensure you meet all criteria.
USAHS IRB Informed Consent Checklist
Important information regarding the Informed Consent - At this time, we are unable to accept digital signatures as we do not have the certified electronic signature program required by OHRP guidelines. Therefore, any projects requiring IRB approval for “Expedited” or Convened Board review will need to have the participant sign the consent form in person while witnessed by someone listed on the IRB application or additional personnel form OR sign the consent from virtually with a witness present during the entire consent process**
**This does NOT impact applications for “Exempt” review.**
Signed consent forms or documentation of consent is not required for research at the exempt level; however, a consent process (which often includes a consent form without signature lines) is still needed. However, if this is a retrospective data collection study the consent process is not required.
**Informed Consent Process for Virtual consent**
This consent will be used for studies that normally required a face-to-face process because a signature is required. This policy allows for investigators to do a virtual informed consent with potential participants with a witness present. The witness needs to be present during the entire virtual consent discussion.
Here are the step-by-step instructions that need to be followed when conducting the virtual informed consent teleconference:
- Use the USAHS approved virtual consent form.
- The investigator will mail or email the virtual consent to the potential participant prior to the informed consent meeting. This allows the potential participant with adequate time to review before the meeting.
- Investigator will email the witness a copy of both the informed consent and the IRB form: Verification from witness during the virtual informed consent process.
- During the teleconference:
- The witness must be present for the entire virtual informed consent discussion (either in the same room as the investigator or signed onto the same virtual chat room).
- The potential participant/participant Legally Authorized Representative (LAR) must show proof of identification to both the investigator and witness prior to the consent process.
- The investigator goes through the consent process as they would normally in a face-to-face consent, answering any questions that the potential participant may have.
- The investigator and witness both watch the potential participant sign the consent form.
- The participant then sends the signed consent form to the investigator. Email is allowed.
- The witness fills out and signs the IRB Form: Verification from Witness during the Virtual Informed Consent Process (IRB-FRM-002) located in OneAegis and emails it back to the PI.
- Data collection with the participant cannot occur until the investigator physically receives the signed consent form.
- Once the investigator receives the signed copy of the informed consent, they will sign and date their name to the informed consent and fill out the information of the witness who was present.
- The investigator will either mail or email a copy of the signed form back to the participant.
What boilerplate statement do I need on my documents?
The University of St. Augustine Boilerplate Statement should be included on the bottom of all documents that human subjects will read, including informed consent, surveys, questionnaires, etc.
For convened and expedited protocols, the University of St. Augustine Boilerplate Statement is:
THIS PROJECT HAS BEEN REVIEWED AND APPROVED BY THE UNIVERSITY OF ST. AUGUSTINE FOR HEALTH SCIENCES INSTITUTIONAL REVIEW BOARD FOR THE PROTECTION OF HUMAN SUBJECTS.
IF YOU HAVE QUESTIONS OR CONCERNS, PLEASE CONTACT THE INSTITUTION-WIDE IRB CHAIR, DR. MOHAN GANESAN, EMAIL: MGANESAN@USA.EDU, PHONE: 760-410-5279.
For exempt protocols, the University of St. Augustine Boilerplate Statement is:
THIS PROJECT HAS BEEN REVIEWED BY THE UNIVERSITY OF ST. AUGUSTINE FOR HEALTH SCIENCES INSTITUTIONAL REVIEW BOARD FOR THE PROTECTION OF HUMAN SUBJECTS.
IF YOU HAVE QUESTIONS OR CONCERNS, PLEASE CONTACT THE INSTITUTION-WIDE IRB CHAIR, DR. MOHAN GANESAN, EMAIL: MGANESAN@USA.EDU, PHONE: 760-410-5279.
How Do I Complete the Required CITI Program Training?
USAHS subscribes to the CITI program for Research Ethics and Compliance Training. This training is required with all IRB submissions and is valid for three years from the date of completion. We have provided instructions on how to register for CITI and information on what courses are required through CITI depending upon what type of research you will be doing.
CITI instructions here
**As of January 2025, we will only accept the following CITI certificates**
For Social Science Research only: CITI Responsible Conduct of Research (RCR) and CITI Conflict of Interest (COI)
- Social Science research is focused on finding reasons for human behavior. Social Science research is conducted using the scientific method: ask a question, form a hypothesis, conduct empirical research, draw a conclusion, and evaluate the conclusion.
For Clinical Research only: CITI Responsible Conduct of Research (RCR), CITI Good Clinical Practice (GCP), and CITI Conflict of Interest (COI)
- Clinical research is a branch of healthcare science that determines the safety and effectiveness of medications, devices, diagnostic products, and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis, and for relieving symptoms of a disease.
What is the IRB Review Process?
- Once received, applications will be screened initially to assure adherence to basic submission guidelines and completeness of application. They will be returned to the researcher if there are any concerns, or if all is deemed complete and correct, the application will continue through the process.
- Expedited/Exempt reviews
- These reviews are completed on a continual basis and expected completion time is two weeks from date of initial submission unless the IRB determines that there are concerns that should be addressed by the researcher, or the IRB determines the study will require a Convened review. In such cases, the timeframe may be extended or returned to the researcher to resubmit based on the Convened review schedule.
- Convened reviews
- These reviews are completed at the monthly IRB meeting that is held on each campus. 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.
- IRB applications for convened review must be submitted by the 1st of the month by 5 pm for consideration for that month’s meeting. If the 1st falls on a weekend or holiday, IRB applications are due on the last business day before the 1st.
Convened Board Meeting Schedule
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2026
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California/due the first of the month by 5pm PST
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Florida #A/due the first of the month by 5pm EST
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Florida #B/due the first of the month by 5pm EST
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Texas/due the first of the month by 5pm CST
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*CA meetings are held at 12pm PST*
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*FL #A meetings are held at 12pm EST*
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*FL #B meetings are held at 1pm EST*
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*TX meetings are held at 12pm CST*
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January
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22
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22
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22
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21
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February
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19
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19
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19
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18
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March
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12
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12
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12
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11
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April
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16
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16
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16
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15
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May
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21
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21
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21
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20
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June
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18
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18
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18
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17
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July
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16
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16
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16
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15
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August
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13
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13
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13
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12
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September
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17
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17
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17
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16
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October
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15
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15
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15
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21
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November
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12
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12
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12
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11
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December
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No meeting
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No meeting
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No meeting
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No meeting
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Please note: There are no Convened meetings in December. Applications submitted between November 2nd and January 1st will be reviewed at the January Convened meetings.
** USAHS researchers requiring Institutional Review Board (IRB) approval to conduct studies: Any applications received after December 1 will be processed once the 2025 Spring Term begins. This deadline has been put in place to accommodate the schedules and end-of-term assignments of IRB staff and faculty members of the IRB committees. **
IRB Decisions?
Exempt Protocols—The IRB will make the determination that the research qualifies as exempt.
Expedited and Convened Approval Levels—
- APPROVED: Accept the proposal as is. Written approval is given for one year.
- APPROVED WITH REVISIONS: Accept the proposal with minor revisions. Revisions are 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.
** Please Note - During the trimester breaks, NO studies will be reviewed. Once the next trimester begins, the reviews will continue and will be completed in the order they were received. **
Where do I submit my IRB application?
The IRB utilizes OneAegis for submission of all IRB applications and other IRB documents.
All forms, including consent forms, assent forms, initial application, amendment forms, study closure form, etc. are located in OneAegis on the dashboard when you log into the system.
**OneAegis help guide for Researchers.
CLICK OneAegis to enter the database.
What if I have questions?
Members of the USAHS IRB's are available for office hours six times a month. Please visit the iLife page for information. iLife