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1. 1 NCRR-CTSA-NICHD Workshop on
Comparing IRB Models for Multisite Pediatric Studies
Jacquelyn Goldberg, JD
Head, NCI CIRB Initiative
goldberj@mail.nih.gov Central Institutional Review Board (CIRB) Initiative
2. Topics Background of the CIRB Initiative
How the CIRB model works
Profile
3. The NCI CIRB Initiative - Background Established in 1999 as recommended in the Armitage Report from the NCI's Clinical Trials Program Review Group:
Help NCI create a more efficient and effective clinical research effort
Streamline or eliminate redundant processes and procedures
4. The NCI CIRB Initiative Goals:
To reduce the significant local administrative burdens for multi-site trials while maintaining a high level of human subjects protection
To enhance the protection of research participants by providing consistent expert IRB review at the national level
5. Adult and Pediatric Boards Adult CIRB
Started reviewing protocols November 2001
Menu is all adult Cooperative Group Phase 3 treatment trials
16-18 members with adult oncology expertise
25% patient advocates
Pediatric CIRB
Started reviewing protocols January 2004
Menu is all COG phase 2, 3 and pilot protocols
16-18 members with pediatric oncology expertise
25% patient advocates
6. Selecting a CIRB Model OHRP allows for different centralized IRB models
See Guidance of August 27,1998 (updated July 21, 2000) entitled “Knowledge of Local Research Context” http://ohrp.osophs.dhhs.gov/humansubjects/guidance/local.htm
Model B– Central IRB review with some local IRB review
More appropriate where local IRB exists
Value of this model: LIRB provides understanding of local context
CIRB provides full Board review at no charge
7. Division of Responsibilities CIRB and LIRB share regulatory responsibilities
The CIRB’s primary function is initial and continuing review of studies
The local institution’s primary function is consideration of local context, oversight of local performance, review of locally occurring adverse events
8. Institution must formally enroll
Modify FWA
Sign Authorization Agreement
Local investigator is notified of new study via
Routine Group activation announcement
CIRB semi-monthly Study Activity Update email
If the local investigator decides to open study
All the CIRB initial review documents are downloaded from the website: the completed CIRB application, the protocol, the CIRB approved consent, CIRB meeting minutes, approval letters, etc.; PI/CRA and/or the LIRB can do this
9. Contact the NCI CIRB
10. Local chair/subcommittee assesses CIRB review and decides whether to accept it or not
If accepts CIRB review - assure their local concerns are addressed (“facilitated review”)
If does not accept CIRB review – decide to review study per local procedures
Full Board does not meet; approval can occur in days
If LIRB accepts, they notify CIRB via CIRB website.
The CIRB becomes the IRB of record for that study at that site and is responsible for reviewing amendments, continuing reviews, adverse events distributed by the Group, recruitment materials, etc.
11. Examples
No prisoners
Assent requirement CIRB; whether and how to document LIRB
Translated consents are local
Consent template approved by CIRB; Ok for LIRB to add local boilerplate involving institutional policy and state law; Ok to tweak consent as per OHRP-Cooperative Group agreement
HIPPA
Local PI and IRB notified of all CIRB actions
12. Operations A single contractor Operations Office supports both Boards and participating institutions and recruitment of new institutions; 2 NCI FTEs and contractor has 14 staff
Volume of protocols on Pediatric side est. 25 new protocols a year max; COG phase 2,3 and pilot
Contract close to $3 million annually; have not separated out peds costs; NCI covers cost; no fee for institutions
Pursuing AAHRPP accreditation 2009-2010
13.
Total Number of Institutions Enrolled: 341
Number of Institutions using Adult CIRB only: 223
Number of Institutions using Pediatric CIRB only: 52
Number of Institutions using both Adult/Peds: 66
Estimate of Potential Pool of Institutions Enrolled
Adult CIRB: 55+% of 2,000 research sites
Pediatric CIRB: 63% of 189 COG institutions
Number of Total Studies Available for
Facilitated Review 216
Adult 136
Pediatric 80
CIRB Initiative Profile
16. Challenges When began in 2001 was radical; less so 2004; less so now
Managing expectations: the stakeholders who clamor for a new model may not be prepared for what that actually means
Adult has 9 Groups/Peds has 1 Group
Don’t underestimate complexity and therefore cost As previously discussed and present in the handout…As previously discussed and present in the handout…
17. Website: 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
As previously discussed and present in the handout…As previously discussed and present in the handout…