SOLICITATION NOTICE
R -- Central Institutional Review Board (CIRB) Initiative
- Notice Date
- 1/13/2005
- Notice Type
- Solicitation Notice
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
- ZIP Code
- 20852
- Solicitation Number
- N02-CM-57006-48
- Response Due
- 3/14/2005
- Point of Contact
- John Manouelian, Contract Specialist, Phone (301) 435-3813, Fax (301) 402-6699, - Richard Hartmann, Contracting Officer, Phone (301) 496-8620, Fax (301) 402-6699,
- E-Mail Address
-
jm486p@nih.gov, rh75f@nih.gov
- Description
- The Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institutes’ Division of Cancer Treatment and Diagnosis (DCTD) has a new innovative requirement to develop and implement a centralized model of Internal Review Board (IRB) review for multi-site NCI-sponsored clinical trials. The goal of the Initiative is two-fold: 1) To decrease the duplicative burden of protocol review that currently occurs at hundreds of local IRBs nationwide on NCI- sponsored multicenter trials by providing a single, centralized review that can be utilized by local IRBs participating in these trials, and 2) to maintain, and in some aspects enhance, high standards for the protection of research participants by providing consistent, expert IRB review at the national level. Currently, the Initiative involves one central IRB that reviews all adult Cooperative Group Phase 3 treatment trials and more than 170 participating local IRBs who use the CIRB review materials to conduct their own facilitated review. Under the facilitated review mechanism, the local IRB no longer needs to conduct a full Board review in order to approve a protocol; instead, the local IRB chair or subcommittee reviews all the CIRB documents for any local concerns and accepts or rejects the CIRB review. The local facilitated review process can take hours or days instead of weeks. The CIRB has been providing reviews for adult Cooperative Group trials since January 2001. In the summer of 2004, NCI established a pediatric CIRB to review all COG phase 2, 3 and pilot protocols. The pediatric CIRB will begin reviewing protocols by Fall 2004. It will utilize the same infrastructure that has been developed for the adult CIRB. The CIRB Initiative has the potential to serve the nearly 2,000 sites that conduct Cooperative Group trials. Major tasks required of the Contractor include the following: 1) Manage and provide administrative/regulatory support for two Central IRBs, one for adult trials and one for pediatric trials; 2) Manage and support current and newly enrolled participating local sites; 3) Conduct the recruitment and integration of new sites into the Initiative; 4) Provide informatics support and system integration; 5) Support NCI’s internal and external communications efforts regarding all aspects of the Initiative; 6) Implement and manage an Initiative-wide Quality Improvement Plan; 7) Provide support for the formal accreditation of both CIRBs in contract year 2 or 3, as determined by NCI; 8) Develop and implement a system for utilizing central review for sites that do not have a local IRB; 9) Establish and support a second Board for adult trials if it is needed to handle the growth in the menu of Phase 2 protocols. This is a new requirement and the Government anticipates 1 (one) contract will be awarded on an incrementally funded basis for a period of three years with incentive options for three additional years. RFP-N02-CB-57006-48 will issued on or about January 28, 2005. The RFP will be available at the website of the Research Contracts Branch, NCI (http://rcb.cancer.gov/rcb-internet/). The NAICS Code is 541690. Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. No Collect Calls accepted. NOTE: THIS NOTICE MAY HAVE POSTED ON WWW.FEDBIZOPPS.GOV ON THE DATE INDICATED IN THE NOTICE ITSELF (13-JAN-2005). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 19-JUL-2005, BUT REAPPEARED IN THE FTP FEED FOR THIS POSTING DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.eps.gov/spg/HHS/NIH/RCB/N02-CM-57006-48/listing.html)
- Place of Performance
- Address: To be negotiated.
- Record
- SN00850564-F 20050721/050719213038 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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