Proposals Requiring NMDP Repository Samples
Guidelines for Submission of Proposals
Requiring NMDP Repository Samples
The rules of the CIBMTR state that anyone may propose a study. The person proposing the study must complete a Study Proposal Outline (see below). Individuals proposing studies which involve the use of repository specimens must also include a Biosketch or brief Curriculum Vita documenting experience in the laboratory methods proposed. Proposal materials are reviewed by the relevant Working Committee (typically the Immunobiology Working Committee) statisticians and staff to determine that the necessary data and samples and are available and that patient numbers are adequate. When these reviews are complete, the proposal is presented to the CIBMTR Statistical Center scientific staff.
Studies deemed feasible and consistent with the CIBMTR's scientific goals are forwarded to the Working Committee Chairs for further input and assignment of a priority score at the annual Working Committee meeting held at the BMT Tandem meetings. Some proposals may be forwarded for review to the NMDP Histocompatibility Committee (see below) without discussion at the annual Working Committee meeting if judged to be of exceptional merit by the Working Committee Chairs and/or they use existing data and samples and will be analyzed by non-Statistical Center personnel, but most proposals will be deferred to this meeting for discussion by the larger group.
The NMDP Histocompatibility Committee (Repository Steering Committee) provides oversight for the use of the repository inventory. This committee reviews proposals approved by the Working Committee or Working Committee Chairs for appropriate specimen use and confirmation that required samples are available. Proposals are formally accepted as CIBMTR studies and assigned a protocol number at the discretion of the Working Committee Chairs and Scientific Director based on priority scores assigned at the annual meeting, input from the Histocompatibility Committee, competing projects and available resources. Due to the use of human samples, proposed studies also require review by the NMDP Institutional Review Board before samples can be distributed. Upon final approval, a formal protocol document is completed by the Principal Investigator to guide conduct of the study, using the original proposal as a model and incorporating recommendations of the committees and statisticians.
The lead author for these studies is typically limited to the Principal Investigator who holds primary responsibility for the study and performs the laboratory tests on the samples. It is his/her choice to determine co-authors who will actively participate in the study. The Working Committee Chairs may also require inclusion of CIBMTR and/or NMDP personnel who contribute to the specimen procurement and data analysis. To assure co-authorship of the manuscripts, these individuals, with the oversight of the Working Committee, must make timely and substantive contributions to study design, data analysis, interpretation of results or preparation of the typescript for publication. Members of this Writing Committee who do not fulfill expected requirements should withdraw as a co-author or, alternatively, their names may be deleted by the Principal Investigator. The person awarded primary responsibility is required to prepare a first draft of the typescript within 60 days of the first receipt of data from the CIBMTR. Failure to do so may result in forfeiture of lead authorship.
The Principal Investigator is responsible for abiding by the NMDP Research Sample Reporting Requirements for submission of laboratory data. In return for access to the samples the Principal Investigator will be required to submit the interpreted results of all assays performed on the samples. Data should be submitted to the NMDP as directed prior to submission of the study for publication. The data submission requirement ensures that all sample testing yields information that is readily available to the research community for subsequent analysis and eliminates or reduces duplicative testing to preserve resources and sample inventory. Data will only be made available for subsequent study following publication of the original analysis.
Suggested Proposal Outline for
Studies Requiring NMDP Repository Samples
Prepare a brief description of the proposed study as you envision it. This should be no more than three pages, excluding biosketch, using standard 8½" X 11" paper with 1" margins. Use the outline below and send your description to the cibmtr@mcw.edu.
- Study Title
Include the name(s) and institution(s) proposing the study.
- Specific Aims
State the primary purpose(s) of the study as concisely and clearly as possible. A reader should have a clear idea of the purpose for which the data will be analyzed.
- Scientific Justification
Summarize the rationale of the study, citing relevant previous work. This should convey the importance of the intended study.
- Patient Eligibility Population
Include the study requirements for age, disease, disease stage, years of transplant, graft and donor type, prior treatment, specific transplant regimens or any other restrictions relevant to the study. If the study involves combining CIBMTR data with data from another group, the selection criteria for patients from the other database should also be specified including how the additional data will be obtained and when.
Include a list of variables you believe will be informative and the outcome variables you wish to analyze. Specify whether additional data would have to be collected and how this would be accomplished.
- Data Collection
Please visit cibmtr.org to assess existing data collection forms or contact the Statistical Center (cibmtr@mcw.edu) to inquire. If your study will require supplemental data collection, the specific variables and data collection plan should be specified.
- Sample Requirements
The utilization of samples from the NMDP Research Repository requires definition of sample type (DNA, serum, cell lines or viable peripheral blood mononuclear cells) and quantity (amount of DNA, serum volume or cell count). This should be clearly specified. The number of specimens requested should be justified based on sample size consideration.
- Study Design (Scientific Plan)
Describe, in non technical terms, how the specific aims would be addressed using information from the CIBMTR database. It should include the specific statistical methodology planned, with discussion of limitations, if relevant. Statistical Center staff members are available to provide assistance, including relevant power calculations, if necessary. Studies that will utilize NMDP Research Repository samples should include a detailed description of the testing methodology proposed and a summary of the investigator's previous experience with the proposed assay systems.
E-Mail your proposal to: cibmtr@mcw.edu
Letters of invitation for retrospective proposals to the CIBMTR are distributed by broadcast email twice annually, once in late spring and once again in late summer. There is a mid-December deadline for proposals to be included in the agenda of the Working Committee meetings at the annual BMT Tandem meetings. Proposals, however, are welcome throughout the year.
NMDP Histocompatibility Committee - www.marrow.org
NMDP Institutional Review Board - www.nmdpresearch.org
NMDP Research Sample Repository - www.nmdpresearch.org