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September 12, 2023

Date/Time
Tuesday, 09/12/2023
Location
Science and Technology Building room 275
Submitted By:
R Lee

ÃÛÌÒÊÓƵ University IRB Minutes 

September 12, 2023   12:30pm  |  Science and Technology Building Room# 275 

 I. Call to Order: Dr. Jerry Lin at 12:44pm

 II. Approval of March 2023 Minutes

a. Motion to approve by Chairman Dr. Alan Moore at 12:45pm

b. Seconded by Dr. Kaye Shelton at 12:45pm

III. Updates from the Office of Research and Sponsored Programs Administration (ORSPA):

a. Jerry Lin - Associate Provost for Research

i. Welcome of new membership

1. Dr. Ashly Greene, new member.
2.Dr. Kaye Shelton, re-appointed member.

ii. Research Integrity is becoming a stronger trend in research.

iii. Ryan Lee to attend Association of Research Integrity Officers conference in Boston this fall and report back.

b. Ryan Lee – Research Compliance Specialist

i. Revisions of existing policies, including IRB manual, Conflict of Interest, Conflict of Commitment, Export Control, and Comprehensive Research Procedures.

ii. Agreement signed with University of Texas to designate them as the single IRB for DOE-IFL study.
1. No human subjects research will be carried out by LU personnel.

 IV. List of Approved Exempt and Expedited Studies

a. Exempt

i. 177 Approved in FY23

ii. 91 Approved since last meeting

b. Expedited

i. 11 Approved in FY23

ii. 4 Approved since last meeting

c. Full

i. 1 Approved in FY23

ii. 1 Approved since last meeting

 V. CITI Certification reminder, specifically for faculty members sponsoring students’ research.

 VI. CITI Certification for Board Members

a. Reminder: Board Members need to complete the CITI IRB Members Course to satisfy the requirements for the Social/Behavioral and BioMed courses.

VII. Full Board Review of IRB Application:

a. IRB-FY23-242 – The Development of a Baseline Voice Evaluation program and Its Impact on Undergraduate voice Students – Abigail Dueppen and Nyah Sciarilla

i. Board could not determine if this proposal qualified as research based on the information submitted.

1. Ryan Lee will follow up with investigators to clarify:

                              a. If this project clones existing programs or is new or novel in any way. 
                              b. Additionally, he will ask for clarification on long-term goals to determine the validity of the   research.

2. If study does appear to be research the Board requests:

a. That the investigators describe the laryngoscopy procedure in the study procedures, not in the risks section.

b. To clarify if there is a physician, nurse practitioner, or other licensed and capable medical practitioner on site at the health clinic.

i. Include this in the Informed Consent

ii. State that these tests will only be carried out while the Clinic is open or when such medical personnel are available.

c. That the risk of bleeding be addressed in risks, as well as contingencies to resolve it.


 VIII. Updates from the Chair

a. No updates

IX. Other Business Items

a. Proposed dates for 2024 IRB Meetings:

February 6, 2024
April 2, 2024
July 2, 2024
September 3, 2024
November 5, 2024 

  1.  

 X. Adjournment

a. Motion to adjourn by Dr. Jeremy Shelton at 1:29pm

b. Seconded by Dr. Clayton Jeffryes at 1:29pm.

 

Next meeting November 7th, 2023 at 2pm (if necessary).