IRB

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Institutional Review Board

If you are a part of the USAHS community, click here to access our internal IRB site

 

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:

Lori Kupczynski, EdD

[email protected]

IRB Administrator:

Kylee Barlowe

[email protected] 

 

What is the IRB Review Process?

  1. 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. 
  2. Expedited/Exempt reviews
    1. 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.
  3. Convened reviews
    1. 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.
    2. 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

2023

California/due the first of the month by 5pm PST

Florida #A/due the first of the month by 5pm EST

 Florida #B/due the first of the month by 5pm EST 

Texas/due the first of the month by 5pm CST

 

*CA meetings are held at 12pm PST*

*FL #A meetings are held at 12pm EST*

*FL #B meetings are held at 1pm EST*

*TX meetings are held at 12pm CST*

January

19

19

19

18

February

16

16

16

15

March

16

16

16

15

April

20

20

20

19

May

18

18

18

17

June

15

15

15

21

July

20

20

20

19

August

17

17

17

16

September

21

21

21

20

October

19

19

19

18

November

16

16

16

15

December

No meeting

No meeting

No meeting

No meeting

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.

 

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. 

 

Who do I reach out to for further information?

 Please direct all questions on submission deadlines or meeting times to the USAHS IRB Administrator:

  • Kylee Barlowe by e-mail ([email protected]) or phone: (737) 202-3270 x 3270.
  • Please direct all correspondence related to submission in the OneAegis database to: [email protected]