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Organization and Administration Resources Requesting Repository Resources
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Application for Repository Resources: Process
The purpose of the Research Program is to provide biological specimens and data to support the highest quality research that contributes to our fundamental scientific knowledge, particularly as it addresses the health of women at the mid-life and helps address the concerns of the public health. In brief, the solicitation, review and award process for the SWAN Repository consists of several levels. First, Letters of Intent to the Repository Organization ensure that proposals are relevant to the program purpose and can actually be achieved given the resources of the Repository. If sufficient material is available, given the constraints of the Repository resources, applications are then reviewed by science advisors for scientific and technical quality. A portfolio about the application is submitted to the Repository Advisory Group for their recommendation. This application and the Advisory Group recommendation is then delivered to the SWAN Steering Committee for final approval. A SWAN investigator is assigned to any approved proposal in which the investigative team does not include a SWAN investigator. The purpose of this assignment is to facilitate that the investigative team appropriately and effectively utilizing the information resources provided to the grantee and to provide assistance to the investigators toward the successful completion of the project. This project investigator is expected to have full status accorded a co-investigator on any research endeavor. When a project is completed, the investigators submit a final report and are encouraged to publish the work in an independent, peer-reviewed journal for the benefit of the scientific community at large. Additionally, within an agreed upon time period (i.e. 3--years) of release of the resources, the investigator will also remit back to the Repository those newly-developed data generated from the specimen resources. This will include appropriate documentation of methodology and quality assurance, with the expectation that this data will become a part of the universe of resources available through the Repository. Steps in the application process include initial communication and familiarization
with the SWAN Repository and its resources, submitting a formal letter
of intent and follow-up with a written application.
A three to six page Letter of Intent is submitted, including a synopsis of the proposed research with reference to the project's specific goal(s), the general approach to be used, and identification of all participating investigators and their institutions. The Letter of Intent should be accompanied by an itemization of specimens requested, a justification of the selection of these particular specimens, and the characteristics of women that provided the specimens. Most particularly, the prospective resource recipient is asked to identify the following:
The Letter of Intent should identify the nature of the supporting data that might be required from the SWAN database with as much specificity as possible. It is highly desirable to identify the variables of interest. Additionally, the Letter of Intent should identify the resources available or that will have to be sought in order to undertake the research project. Thus, the prospective applicant is asked to identify the following:
Finally, the Letter of Intent should document the capacity of the applicant laboratory to actually undertake the proposed work. This documentation could include published work, validation studies, progress reports that document laboratory acumen, or novel assay approaches for specific questions of interest. Investigators are encouraged to include a comprehensive description of the existing physical resources and environment, including their laboratory, its equipment, laboratory space and computing resources related to the proposal. These Letters of Intent will serve at least two purposes. First, they allow the Repository Organization to ascertain whether specimen (and data) resources are available that are consistent with the investigators project goals. Second, the Letters of Intent can be used to evoke the scientific review process. In all correspondence, investigators should include appropriate communications information including fax number, telephone number and e-mail address.
The Letter of Intent should be received no later than 30 days prior
to the deadlines of November 1, April 1 or August 1 for submitting applications,
at the following address:
Applications should be submitted in a format similar to the NIH-398 format and need be no longer than 10-12 pages. The application should be submitted electronically by diskette or e-mail to the Repository Organization to: swan_repository@umich.edu. Applications are expected to use a 12 point font, maintain 1 inch margins, and be consistent with high standards of grammar usage, spelling and sentence structure. While this is not an application for funding, it is nevertheless an application for resources. Thus, a budget and budget justification are not necessary A concise, descriptive summary of the project must be submitted with the application. Abstracts are limited to 450 words and 12 point font. The Research Plan should include sufficient information needed for evaluation of the project, independent of any other document. Be specific and informative, and avoid redundancies. It is expected that the Research Plan will have the following major sections:
However, the Research Plan (Methods and Materials section) for the SWAN Repository must contain elements that are uniquely different from most research applications. These are as follows:
Each of the four major sections should address factors relevant to the use of the specimen and data resources from the Repository. For example, the Preliminary Studies Section could address the investigator's previous experience with the specimens that are requested, with the assays to which the specimens will be subjected, and with quality assurance systems that are appropriate to the data that will be generated. Organize the presentation to answer these questions:
All tables, graphs, figures, diagrams, and charts must be included within the 12-page limit. Full-sized glossy photographs of material such as electron micrographs or gels may be included in the Appendix; however, a photocopy of each must also be included within the page limitations of the Research Plan. Format and Page Distribution The NIH-398 application suggests the following format and page distribution:
Consortium and Contractual Arrangements Some applications for specimens may include consortium and contractual arrangements. The application should identify and explain arrangements that are proposed between the applicant organization and the consortium organization(s). For example, two or more laboratories may embark upon a combined effort to address a question. All consortium investigators must sign a letter indicating their knowledge
of the consortium and their agreement to adopt and implement the policies
of the Repository with respect to the utilization of the specimens, return
of the data, acknowledgement of the contribution of the Repository and
the SWAN-designated co-investigator.
Documentation of Human Subjects Training Specimens made available through the Repository were collected from individuals who provided documented informed consent that the specimens were being collected and would be made available to scientists to expand our knowledge of the public's health. Nonetheless, investigators are required to provide documentation of approval by an Institutional Review Board prior to the actual release of data or specimens. Additionally, investigators and their key staff must provide written documentation that they have successfully completed training about the ethical use of materials from human subjects, the role of informed consent and the protection of confidentiality.
Revised or Supplemental Applications Only to the Repository All revised or supplemental applications must include an Introduction that addresses issues or concerns of the initial application. Do not exceed three pages for comments directed toward the revision or provision of supplemental information. In a revised application, there must be substantial changes in the content
of the application. The application must include an Introduction of not
more than three pages that summarizes the substantial additions, deletions,
and changes. The Introduction must also include responses to the criticisms
and issues raised in the summary statement. The changes in the Research
Plan must be clearly marked by appropriate bracketing, indenting, or changing
of typography, unless the changes are so extensive as to include most of
the text. This exception should be explained in the Introduction. Please,
do not underline or shade changes or other markings that cannot be successfully
transmitted by e-mail.
Revised Applications for Funding Applicants may not be successful in initial applications for external
funding. Investigators must provide a status report as to funding resources,
annually. The Repository reserves the right to re-evaluate the application
in the face of other demands for materials and data.
Applications for Resources from the Repository to Expand Scope A supplemental application may be submitted to request support for a significant expansion of a project's scope or access to specimens. A supplemental application will not be accepted until after the original specimens and data have been awarded and there is evidence that expanded access will substantially enhance the impact of the research findings. The introduction to the supplemental application should provide an overall description of the nature of the supplement and how it will influence the specific aims, research design, and methods of the award. The body of the application should contain sufficient information from the original application to allow evaluation of the proposed supplement in relation to the goals of the original application. A progress report is required for supplemental applications. Provide the beginning and ending dates for the period covered since the project was reviewed. A single request for supplemental data focused on the approved aims
will be responded to in the 12 months following release of the data provided
it does not substantially expand the scope of the project beyond that identified
in the initial application. Data requests that broaden the scope of the
application will be re-reviewed.
Notice of Proprietary Information Applicants are discouraged from submitting information considered proprietary unless it is deemed essential for proper evaluation of the application. If the application contains information that the applicant organization considers trade secrets or information that is confidential or privileged, identify those pages in the application that contain this information with an asterisk (*) in the left-hand margin and provide the page numbers before the "Specific Aims" section. When information in the application constitutes trade secrets or information that is commercial or financial, confidential or privileged, it is furnished in confidence with the understanding that the information shall be used or disclosed only for evaluation of the application. If specimens and data are awarded as a result of or in connection with the submission of this application, the Repository retains the right to use information to appropriately document methodology or quality assurance.
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