LSUHSC-NO Principal Investigator:

Study Title:

LSUHSC-New Orleans Institutional Review Board

Central Institutional Review Board (CIRB)

Local Review Application for Continuing Review or Closure

This form should only be utilized if the LSUSHC-NO IRB will be the Relying IRB for a CIRB study. This application should only be used if the lead IRB is not the National Institute of Health (NIH) CIRB.

PLEASE NOTE THE FOLLOWING:

  • If the LSUHSC-NO IRB is going to be considered as the Lead IRB (primary IRB), the standard IRB forms are to be utilized as listed on the IRB homepage.
  • Please include a COI Team Member form, Redacted Consent documentation for a re-approval submission as discussed below, and ensure all study team member have current KDS and CITI training.

1.Study Information:

A.Please list the name of the CIRB or Network used for the study:

B.Has the study received any amendments or risk:benefit changes within the past year?

Yes* No

*Please provide a brief summary of changes:

C.Have there been any site changes in which the study will be conducted under the local PI?

If residential home visits are requested, please refer to Chancellor’s Memo 16.

Yes* No

*Please provide new sites:

D.What is the total number of local subjects enrolled within the past year:

What is the total number of local subjects enrolled overall:

What is the total number of local subjects voluntarily withdrawn in the past year:

What is the total number of local subjects withdrawn by the PI/SI in the past year:

E.Does the study still involve the enrollment of:

Minors? No Yes

Vulnerable Populations? No Yes

Pregnant Women? No Yes

LSUHSC-NO Employees/Staff? No Yes* Refer to IRB Guidebook section 5.6

LSUHSC-NO Students? No Yes*Refer to IRB Guidebook section 5.6

Prisoners? No Yes* Refer to Chancellor’s Memo 45

F.Is subject/data enrollment still open? Yes* No

F.1 Subjects are in treatment or survival follow-up that involve no more than minimal riskOR procedures that would have been performed as routine clinical practice for monitoring of disease regardless if described in the protocol

F.2 Subjects are in treatment or survival follow-up that require research interventions that would not have been performed as routine care or monitoring for clinical indications, even if interventions involve no more than minimal risk

F.3 Subject accrual is completed at this site but is in data analysis stage

F.4. Study is completed at this site and may be fully closed. Please include brief summary of study findings if not already included with LeadIRB documentation.

2.Informed Consent Language.

Please attach two (2) redacted local ICF/Assent Forms with this application

N/A- LeadIRB granted Documentation of ICF Waiver of Consent/Documentation of Consent

  1. Have any local consent processes changed within the past year?

Yes* No

*Please describe new consent process changes:

3.HIPAA/Waiver of Authorization.

Please attachtwo (2) redacted LSUSHC-NO HIPAA Authorizationswith this application

N/A- LeadIRB granted HIPAA/waiver of Authorization.

4.Funding.If any changes have been made to the funding source in the past year, please attach.

N/A

Please indicate the new source of funding:

Principal Investigator Attestation:

I, as a local Investigator, am aware that I will remain responsible for the following during the conduct of the study at our local site:

  • Adherence to the protocol and conduct of the study
  • Adherence to LSUHSC-NO Institutional Policy(s) regarding research
  • Ensuring local regulatory documentation is maintained, including the conduct and training of the local study team members and delegation of duties as such
  • Reporting of any local SAEs and/or protocol deviations/noncompliance to the LSUHSC-NO IRB within the timeframes as stated in the IRB Guidebook, Sections 4.7-4.8, utilizing pre-existing forms.

Principal Investigator Printed Name:

Principal Investigator Signature:

Date:

CIRB Application for Re-approval or Closure, LSUHSC-NO

Revised July 28, 20171 of 3