The process to request specimens from the SGTB is outlined below. Please contact us if you have any questions or need additional information.
Step |
Approximate Time |
| Letter of Intent Submitted to SGTB | |
| Initial Review of LOI by TUC (Feasibility Determination) | 10 business days after receipt by the SGTB |
| Full Application due | |
| ESR Review of Full Application and TUC Decision | Within 60 days after receipt of application |
| Steering Committee Decision | 2-4 weeks after TUC Decision |
| Notification of Decision | Within 90 days upon receipt of Full Application |
The investigator first submits a Letter of Intent (LOI) form via email to the SGTB Coordinator at SGTB@mdanderson.org. Submitting a LOI first prevents investigators from preparing a complete application if the proposed research could not proceed forward due to either the lack of sound hypothesis, specimens or data availability. The contents required in the LOI are given below.
Click here for a copy of the LOI.
The LOI form includes the following sections:
• Applicant information
• Name(s) of investigator(s)/collaborator(s)
• Location(s) and Institution(s) where research will take place
• Specific aim(s) and/or primary hypothesis to be tested
• Type(s) and number of biological specimens required
• Requirements for clinical data (optional)
1. The LOI will be reviewed to assess feasibility by Tissue Utilization Committee (TUC), which consists of Dr. Diana Bell (SGTB representative), Dr. Lilian Shum (NIDCR representative) and an ad hoc reviewer from a current satellite center. Within 10 business days, investigators will be notified of the outcome of the initial feasibility review. LOIs that are not approved will receive a letter specifying the reason(s) for the decision and any options for recourse.
2. Criteria in determining feasibility
To maximize the utilization of biospecimens for current and future investigators’ demands, the following factors will be considered in granting requests:
a. Amount of tissue per sample (>25mg)
b. Number of specimens per tumor category (<15 unless deemed justified by the scientific reviewers)
c. Amount of normal samples (>3mg)
d. Lymphocytes (on case-by-case basis)
e. Serum (>100µl)
Note: Maximum number of applications per site
The SGTB will only review a maximum number of two (2) applications per year per site.
Once feasibility is established, investigators can submit a full application (not more than 10 pages total) to the SGTB. The full application must include the following sections:
• Project Title
• Name(s) of investigator(s) including all contact information
• Location(s) and institution(s) where research will take place
• Funding Status: Funded or Not Funded.
Also include funding sources, including type of funding application and schedule for grant submission and/or earliest possible funding and source of funds.
• Research proposal. This section must be no longer than 5 pages, including tables and figures. Appendices may include only key publications and relevant material(s). The following should be addressed in this section:
Specific Aims
Background and Significance
Study Design and Procedures, including data on characteristics of laboratory assays
Analysis Plan
Statistical Power
• Detailed description of and justification for requested biologic samples, including specimen types and amounts needed
• Description of additional clinical information needed
• Proposed timeline for study
The completed application should be sent via email to the SGTB Coordinator at SGTB@mdanderson.org.
1. Applications will be forwarded to the External Scientific Review (ESR) group and TUC members for review (see Review, Priority and Decision Procedures) on the last business day of the month.
2. Comments by the ESR members will be collated, and based on the final review by each member, the following steps will be taken:
a. All members in agreement (approved or disapproved only): comments will be forwarded to the Steering Committee (SC) for approval.
b. All members in agreement (approved with modifications only): reviewers comments will be sent to the applicant and the TUC.
i. Applicant revisions are due to the SGTB administrator within 5 business days.
ii. SGTB administrator will forward to the TUC for voting.
iii. SGTB administrator forwards the TUC decision to the SC for final approval.
c. Disagreement: comments will be forwarded to the remaining TUC members for voting.
3. Final decision by SC at the next scheduled SC meeting.
4. Notification of Decision will be sent to applicant within 90 days of receipt by the SGTB.
In the case an application is not approved, investigators will receive a letter specifying the reason(s) for the decision along with unedited comments of the reviewers.
Once the application is approved, the requested biological specimens will be sent to the investigator after submitting the required Materials Transfer Agreement (MTA) (see Material Transfer Agreements below).
The specimens must be used only for the RESEARCH PROJECT approved and in compliance with all applicable Federal, State and local statutes and regulations, which include the Common Rule (45 CFR Part 46, Subpart A) and HIPAA. The applicant is responsible for obtaining any necessary human subjects research approvals or exemptions required to use the biological specimens. In addition, the applicant is not permitted to further distribute the biological specimens to others who are not under his/her direct supervision without written permission from MDACC. He/she shall refer any request for the biological specimens to MDACC.
The primary objective of the SGTB is to facilitate the conduct of high-quality basic and translational research in an efficient, coordinated, and equitable manner. Priorities will be given to research proposals that increase the knowledge base in the basic science area as well as those with high translational impact. These include, but are not limited to, the development of cell lines, xenografts, reagents and resources that help understand the molecular pathogenesis of salivary gland tumors. Applicants are encouraged to propose a plan for potential interactions and/or collaborations with other scientists in salivary gland tumor research.
Applications will be reviewed by the ESR and TUC members. The ESR group is comprised of at least 3 independent scientists with expertise in biologically and epidemiologically-based cancer studies. Additional scientists may be invited to participate if specialized areas of expertise are needed. Each application will be scored based on the Core Review Criteria and Additional Review Criteria (below).
Core Review Criteria
• Overall Impact After considering all of the review criteria, do the significant strengths and weaknesses of the application exert a sustained powerful influence on the field?
• Significance Does the project address an important problem or a critical barrier to progress in the field? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
• Investigator(s) Does the PI, collaborators, and other researchers have the appropriate expertise suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established PIs, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?
• Innovation Are the concepts, approaches or methodologies, instrumentation, or interventions novel to the field of research or novel in a broad sense?
• Approach Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the Specific Aims of the project? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
• Environment Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Additional Review Criteria
• Amount of Materials Requested
• Number of Materials Requested
• Funding Status: Is this project funded by any funding agencies? Does the PI plan to collect preliminary data for future funding support?
Priority access to tissues/biospecimens/cell lines will be given to scientifically meritorious applications from the following:
1. Fully funded and/or highly scored applications submitted to funding agencies.
2. Members of the satellite centers.
3. Others who wish to obtain preliminary/feasibility data for application submission to a funding agency i.e., in response to an RFA.
The recommendations from the ESR group, in an unedited format, will be sent to the TUC which will make recommendations to the SC. The SC will make the final decision for tissue disbursement. The following decisions are possible:
• Approve without modification for use of specimens signifies that that the applicant had a well-written, significantly sound, and technically feasible proposal which did not require any additional clarifications.
• Approve with modifications signifies that the review panel thought the application needed clarification on specific points before any specimens would be released for the study. Depending on the responses by the applicant, the study would be approved for specimen release or denied.
• Disapprove signifies that the applicant did not present a significantly sound research plan that would move the field forward.
Within 90 days of submitting the full application, the applicant will be informed of the final decision.
A form with the required information to submit the MTA can be found on the “Researchers” page of the SGTB website. The MTA will include a statement about data sharing.