W.M. 
              Keck Center for Cancer Gene Therapy
            Developmental 
              Grants Program Bylaws for Grant Review and Award Process
            Purpose 
              and Function 
            Process 
              of Grant Award Selection 
            Procedure 
              for Preparing the Application 
            Notice 
              of Awards, Committee Decisions, Evaluations 
            Conditions 
              Associated with Use of Funds 
            Eligibility 
            Administrative 
              Support 
             
            Purpose and 
              Function  
            The W.M. Keck 
              Center for Cancer Gene Therapy Developmental Grants Program provides 
              a funding mechanism to support new investigators in the field of 
              gene therapy, innovative research where preliminary data is necessary 
              to support an extramural funding application, and clinical research 
              where other funding is not available. Guidelines have been established 
              for the application and are distributed to all faculty. Grants of 
              $50,000 for laboratory research and $150,000 for clinical research 
              may be used over one or two years. At present this program is funded 
              only by a grant from the Keck Foundation which will expire in 2003. 
              The total amount available and size of awards are dictated by the 
              financial state of the Keck Center and is subject to change.  
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            Process of 
              Grant Award Selection 
             All grants 
              will be initially reviewed by an External Scientific Advisory Board 
              (ESAB). The members of the ESAB will be selected by the Steering 
              Committee and will be representative of the many disciplines encompassed 
              by the field of gene therapy. Grants will be assigned to reviewers 
              based on their expertise. A minimum of two reviews will be obtained 
              for each grant. Reviewers will be asked to rank the grants and the 
              priority scores will be directly based on the rankings. A current 
              membership list of the ESAB is available from the administrative 
              office of the Keck Center and will be posted on the Keck Center 
              web site. The grants will be distributed to member of the ESAB for 
              review shortly after the annual application deadline of October 
              1. The Steering Committee will function as a secondary review group. 
              The Steering Committee will review the priority scores from the 
              ESAB and determine the percentage of grants to be funded based on 
              available funds and overall scientific merit. No Steering Committee 
              member with a potential conflict of interest with a specific grant 
              will participate in the review of that grant. The Steering Committee 
              will meet shortly after completion of the reviews by the ESAB. The 
              specific date, time, and location are included on an agenda sent 
              to each member at least five working days in advance of the meeting. 
               
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            Procedure 
              for Preparing the Application  
             In order to 
              insure a consistent and systematic approach to the application process, 
              application guidelines have been developed. The procedures described 
              are to be followed regardless of the amount of financial support 
              being requested. These guidelines are available in the Keck Center 
              administrative office, along with assistance in understanding the 
              policy and procedures of these Committees. An electronic version 
              of the guidelines may be downloaded from Keck Center site on the 
              MDACC Internet.  
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            Notice of 
              Awards, Committee Decisions, Evaluations
             During the 
              Steering Committee deliberations on grant applications, members 
              from the same department as the applicant will be absent during 
              discussions and scoring. All reviews are confidential and anonymous 
              outside of the committee. Communications concerning reviews are 
              done through the committee chair. Steering Committee actions which 
              may be reported include: approved-funded or not funded. ESAB ratings 
              are available in the Keck Center administrative office. Applicants 
              not funded are formally advised. Following the Steering Committee’s 
              decision, successful applicants will be advised by the Keck Center 
              administrative office of the amount of the award. Fiscal Services 
              will also be notified of the award and a company/center will be 
              established. Fiscal Services will advise the researcher of the company/center, 
              specified restrictions on use of the funds, and source of funds. 
             
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            Conditions 
              Associated with Use of Funds 
            1. 
              Restriction 
              on use of funds: 
             
              
                Funds may be 
                requested by the investigator for the purchase of supplies, experimental 
                animals, equipment, computer time, and salary support for research 
                personnel. All unencumbered funds remaining in a project account 
                after the award period will be returned to the allotment account 
                for award to other investigators. If an investigator desires additional 
                time to use these funds, the investigator must submit a justification 
                for this extension to the Steering committee which will determine 
                whether such an extension will be granted. 
               
             
            
            2. Reporting 
              Requirements: 
             
              
                Progress 
                reports describing the research accomplishments, publications, 
                and presentations, and extramural funding received as a result 
                of the grant must be submitted to the Keck Center administrative 
                office annually. Progress reports must be supplied as needed for 
                other required reports. The Keck Center must be acknowledged in 
                all publications resulting from research supported by these grants. 
                
            
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            Eligibility 
             
            
            Keck grants 
              are not renewable. Full-time faculty members at the level of Research 
              Associate, Instructor, Assistant Professor, Associate Professor, 
              and Professor are eligible. Previous recipients of a Keck Center 
              grant are eligible to apply provided the grant is for a novel project 
              that has not been previously funded by the Keck Foundation. Eligible 
              faculty may submit only one application per review cycle. Members 
              of the committee are eligible to apply but may not participate in 
              the review of their application.  Applications from Research 
              Associates must be accompanied by a letter of support and commitment 
              from his or her immediate faculty supervisor.  
              If human subjects or specimens from humans are involved in a clinical 
              protocol and are not exempt from the regulations, a current (within 
              12 months) approval from the Surveillance Committee (IRB) will be 
              required prior to initiation of the protocol and award of funding 
              specifically for the protocol. Likewise, research involving experimental 
              animals should have clearance from the Institutional Animal Care 
              and Use Committee (IACUC) prior to funding. The Institutional Biosafety 
              Committee (IBC) must approve research involving biohazardous material 
              or recombinant DNA. All regulatory approvals must be obtained from 
              the Office of Research Administration prior to funding. 
             
            Administrative 
              Support 
            The Keck Center 
              administrative office acts as the administrative support arm to 
              the ESAB and the Steering Committee. In this role, it is responsible 
              for preparing agendas, attending all meetings, recording recommended 
              changes to the budget and tabulating voting results by the members. 
               All of the above, as well as records of applications, notices 
              to investigators, and reviewers' evaluations are retained on file 
              in the office.   
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