slide1 l.
Download
Skip this Video
Loading SlideShow in 5 Seconds..
The NCI’s Central IRB Initiative PowerPoint Presentation
Download Presentation
The NCI’s Central IRB Initiative

Loading in 2 Seconds...

play fullscreen
1 / 12

The NCI’s Central IRB Initiative - PowerPoint PPT Presentation


  • 338 Views
  • Uploaded on

Jacquelyn Goldberg, JD CIRB Review Board Administrator Clinical Investigations Branch, CTEP Division of Cancer Treatment & Diagnosis. The NCI’s Central IRB Initiative. June 26, 2007 Clinical Trials Break Out Session. Overview.

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'The NCI’s Central IRB Initiative' - salena


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
slide1
Jacquelyn Goldberg, JD

CIRB Review Board Administrator

Clinical Investigations Branch, CTEP

Division of Cancer Treatment & Diagnosis

The NCI’s Central IRB Initiative

June 26, 2007

Clinical Trials Break Out Session

overview
Overview

CIRB Initiative is a program which enables IRB review to take place quickly at the local site while maintaining a high degree of human subject protection

2 Central Boards exist (adult and peds)

All phase adult 3 Cooperative Group trials and all COG trials receive review and approval prior to being made available to investigators for patient enrollment

how does the nci cirb model work
How does the NCI CIRB model work?

NCI/CTEP approves pending CIRB approval

CIRB approves protocol

NCI sends Group final approval

Local investigator is notified of protocol via

Routine Group activation

announcement

CIRB e-mail bi-monthly

slide4
If the local investigator decides to open protocol,

OPTION 1: Investigator or CRA downloads the completed application, protocol and consent from the CIRB website and submits documents to local IRB; (LIRB then downloads confidential documents)

OPTION 2: PI/CRA downloads all the documents and submits them to the LIRB

How does the NCI CIRB model work?

slide5
Local chair/subcommittee reviews for local concerns and decides whether to approve (“facilitated review”)

If LIRB accepts, they notify CIRB.

The CIRB becomes the IRB of record. It handles amendments, continuing reviews, adverse events etc.

If LIRB does not accept, LIRB can decide to review the protocol themselves as per their own local procedures.

How does the NCI CIRB model work?

slide6
CIRB and LIRB share regulatory responsibilities

The CIRB’s primary function is initial and continuing review of protocols

The local institution’s primary function is consideration of local context and oversight of local performance

slide7
CIRB review occurs BEFORE the protocol is distributed nationally;  Board has authority to make changes in the protocol (unlike local Boards which can only accept or reject these trials)

Extricates Board review process from local institutional politics

Protocols are reviewed by sophisticated patient advocates and cancer experts

Benefits to Research Participants

benefits to local investigators cras
Benefits to Local Investigators/CRAs

No advance preparation for IRB review at the local site—no IRB application to complete, just download the IRB packet from the CIRB website

No waiting for the next meeting of the full board, therefore investigators can enroll patients sooner

CIRB becomes IRB of record, no need to submit continuing reviews, amendments or AE reports (except for AEs at local site) to the LIRB or the CIRB

slide9
Total studies presently on menu

Adult – 98

Pediatric – 46

Total 144

Studies open to accrual

Adult – 64

Pediatric – 42

Total 106

Studies available for facilitated review currently on CIRB menu

Current as of 05/10/2007

slide10

NCI Designated Cancer Centers

Current as of 05/10/2007

nci cirb initiative 6 easy steps to join
NCI CIRB Initiative: 6 Easy Steps to Join

Modify institution’s FWA to include the CIRB and sign authorization agreement

Create a local IRB SOP for utilizing the CIRB

Determine the composition of the LIRB subcommittee

Notify local investigators of the new process

Copy the CIRB on the notification (which will show that the process is complete)

Provide CIRB with contact information for LIRB and PI to establish website access and facilitate communication

contact the nci cirb
Contact the NCI CIRB

http://www.ncicirb.org

Email: ncicirbcontact@emmes.com

CIRB Toll-free Number: 888-657-3711

Fax Number: 301-560-6538

Mailing address:

NCI CIRB

C/O The EMMES Corporation

401 N. Washington Street, Suite 700

Rockville, MD 20850