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Study Sample Application Instructions
NIDDK TrialNet Natural History Study Sample Request
Send the completed application to:
Lisa Spain, Ph.D.
NIDDK Program Director
National Institute of Diabetes and Digestive and Kidney Diseases/NIH
Two Democracy Plaza
6707 Democracy Blvd., MSC 5458
Bethesda, MD 20892-5458 (Courier use Zip 20817)
301-451-9871
FAX 301-480-3503
spainl@niddk.nih.gov
Applications are invited for access to samples from Type 1 Diabetes TrialNet’s Natural History Study. Because the study is ongoing, access to samples will be fully collaborative among applicants and the TrialNet Study Group. Samples are from subjects characterized for type 1 diabetes risk, including some samples from at-risk subjects who later went on to develop diabetes. Specific information about the samples and how risk is determined is located
Samples will be masked with respect to patient identification, and sample characteristics (i.e., the investigator will not know whether individual samples are from pre-diabetic or control subjects, or from which visit, etc. until after assays are completed). Exceptions to sample characteristic blinding will be considered upon request, but must be well justified in the application. Data from the Applicant’s assay will be transmitted to the TrialNet Coordinating Center in a mutually agreed-upon format and frequency. Once the Applicant’s study is completed, analysis of the data and unblinding will occur, and conclusions and interpretations will be collaborative involving the assay provider (Applicant), coordinating center biostatisticians and the members of the TrialNet Mechanistic Outcomes Committee as appropriate.
- Title, submission date, Executive Summary
The protocol should be accompanied by a one page Executive Summary that includes a highly condensed version of the study objectives, background, importance, and design.
- Background information
The background should succinctly highlight gaps in the current knowledge or practice in the field of study. The researcher must show that he or she understands the important studies that form the foundation for the protocol and indicate how the project will go beyond them. Please include a literature review. The literature review need not be lengthy, but it should be reasonably comprehensive and up to date.
This section should also describe the importance of the project. There are two main points that should be addressed here: the significance of the question or study issue proposed and the significance of the researcher's particular project. This is the place to make a strong case for the importance of the project being proposed. This section should also address the question why these particular samples are required for the study. A strong case needs to be made that the proposed study requires access to the non-renewable, finite samples, and will be a highly scientifically meritorious use, relative to other potential uses. Please be sure to address how the proposed use relates to the design and goal (diabetes prediction) of the original study in which the samples were collected. Include preliminary data where relevant to support the rationale for the study.
- Study design
Access to non-renewable resources will be subject to stringent scientific review. Applicants are encouraged to provide all the information required to make a strong case for the scientific merit and likely success of the proposed study. Details of prior assay performance, including variability, reproducibility, accuracy, robustness, and performance under blinded conditions are important. While there is no page limit, brevity is encouraged.
Objectives
The objectives should pinpoint what the researcher plans to do and expects to achieve. The number of objectives should be listed in approximate order of priority or importance. The objectives listed should underscore the major elements of work that are realistically achievable.
Hypothesis(es)
There should be at least one important hypothesis that can be tested using the proposed methods and non-renewable samples.
Method of Approach
The objective is to describe how the requested materials will be used. There should be discussion of the specific procedures by which the samples will be tested and analyzed.
Analysis and Interpretation
A discussion of how the data resulting from the new measurements will be analyzed and integrated with existing data from the original clinical study or trial, including any limitations, and statistical procedures. Applicants should also explain how the results will interpreted to provide important scientific insights.
- Management of samples
- Description of data security relevant to requested samples: responsible party, computer access, etc
The protocol should explicitly address how the data files will be held, managed, and processed. For example, who will have the main responsibility for organizing, storing, and archiving the data? Who will maintain computer data files and make needed work files available to those who will analyze the data? How will the privacy of information of beneficiaries in the files be guarded and guaranteed?
- Description of sample processing
The protocol should explicitly address how the samples will be held, managed, and processed. For example, who will have the main responsibility for storing and testing the samples?
- Timeframe for the project
The protocol should discuss the tasks to be completed and the expected time frame for completion of the project, including analyses and manuscript preparation and publications.
- Statement that results will be returned to the NIDDK and that the supplied samples will be returned to the NIDDK at the end of the project.
Access to TrialNet samples while the Natural History Study is in progress will be considered to be fully collaborative between Applicants and TrialNet. Samples will be provided after masking with respect to patient identification, and sample characteristics (i.e., the investigator will not know whether individual samples are from pre-diabetic or control subjects, or from which visit, etc.). Exceptions to sample characteristic blinding will be considered upon request, but must be well justified in the application. Data from the Applicant’s assay will be transmitted to the DCC in a mutually agreed-upon format and frequency. Once the Applicant’s study is completed, unblinding and analysis of the data will occur, and conclusions, interpretations, and publications will be collaborative involving the assay provider (Applicant), coordinating center statisticians and the members of the TrialNet Mechanistic Outcomes Committee as appropriate. The proposal should also state a specific date that any residual samples are expected to be returned.
- List of samples needed, including amounts
Describe the characteristics of the specimens needed, quantities of materials, and any requirements relevant to sample quality. Applicants are required to request only the minimum amount of non-renewable sample required for their study.
- Outline of estimated costs of project and source(s) of funding
It is expected that in some cases, requests for access to the samples in the repository will be precede application for funding. If this is the case, it should be clearly stated. If access to samples is granted, NIDDK staff may choose not to distribute the samples until proof that funding for the study is in place is provided by the applicant.
- IRB clearance (or waiver)
The requestor must submit an IRB clearance or waiver before samples will be released. A copy of the human subjects approval should be attached to this form. An annual human subjects review is required and must be forwarded to maintain your eligibility to use the samples.
- Signed agreement for release of data
The sample and data use agreement must be signed by all persons who will have direct access to the samples and data.
- Investigator information for principal investigator and co-authors, supply:
Name
Affiliation
Business address
Business phone number
Business fax number
Email address
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