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Access to the SWAN Repository Resources: Overview

The SWAN Repository is designed to provide access to well-characterized biological specimens to scientists. There is a multi-stage process designed to facilitate access to these already-collected samples to the general scientific community as well as SWAN investigators.

There is a submission process encompasses two levels. These are:

• A Letter of Intent that formalizes a discussion about availability of samples and whether other data used to characterize the population is appropriate for the question being posed.
• A written prospectus similar to an NIH application is developed that is adapted to specifically address access to biological specimens and accompanying data as the resource rather than funding.

The application processes are detailed in the section entitled Application Processes.
 
 

Evaluation of Applications: The Letter of Intent

The three to six page Letter of Intent that will include 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 will be evaluated by members of the Repository Organization. The prospective resource recipient will have identified:

• type of specimen (s) that are required (serum, plasma, urine, DNA)
• volume of specimen (s) required
• ability to use previously thawed specimens
• the number of specimens that are required (power estimates are important)
• nature of the specimens required with respect to the SWAN design (i.e.: all cross-sectional samples of women who have transitioned; Asian women only; those with hyperinsulinemia plus age, weight, ethnic matched controls)
• quality of the laboratory procedures being proposed.
• Pilot data to support proposed hypothesis being tested.

SWAN Repository Organization Review

The members of the Repository Organization will determine if the resources requested by the prospective applicant are actually available in the Repository inventory.

The Repository Organization will provide a written evaluation of whether the application is consistent with the research goals of the Repository. Further members of the Repository Organization will determine from information about the anticipated project whether access to Repository resources will have to be encumbered and the duration of that encumbrance. The following will be evaluated by the members of the Repository Organization based on the content of the Letter of Intent:

Materials Reviewed: Letter of Intent.

Review Criteria:

• Hypotheses proposed are consistent with the type of specimens collected, type of data available and includes an appropriate sample size estimate.

• Hypotheses or questions posed are consistent in time frame with the availability of data and specimens in the Repository

• Hypotheses are not readily conducted in other samples

• The amount of Repository resources that would be required and if thawed and refrozen material could be used

• Whether the project has merit given the utilization or encumbrance rate of the Repository samples

• Demonstrated high quality laboratory to use the samples

• The primary hypothesis is supported by pilot data.

• Higher value:

  • hypothesis testing rather than validation or assay development studies

  • uniquely relevant to women's health and the menopausal transition

  • requires information that is not applicable to questions across clinical sites

Decision Authority: A negative response by the RO can be directly submitted to the SWAN Repository Advisory Group and with its concurrence, the application will not be submitted for further review, and the investigator and the SWAN SC will be notified of the disapproval.

The Repository Organization can request that investigators provide additional information to appropriately inform further review. The Repository Organization can provide information to the applicant about needs for application modification if the request is inconsistent with the resources in the Repository.

Scientific Review: External Reviewers

The Letter of Intent combined with a written application is the mechanism through which scientists will gain access to the Repository resources. The requirements of the application can be identified in the section entitled Application Processes. The first stage of review occurs in the Repository Organization and their findings are transmitted to the SWAN Repository Advisory Group for the second level of review. This review can be supplemented by comments from external reviewers if the expertise within the membership of the Repository Organization or the Advisory Group is inadequate to provide an appropriate evaluation. Most external reviews are requested for studies involving genetics. If an external review is necessary, applicants will be notified by the Repository Organization that additional time may be required for external review. Applications sent for external review will be reviewed for their scientific and technical quality by at least two reviewers. These reviews will include a written summary that addresses the strengths and weakness of the proposed research as well as the impact of the scientific question being proposed. The Repository Organization will seek opinions as to the scientific integrity of the application, with quantitative ratings of the science and technical implementation.

The recommendations of external reviewers will be combined with the recommendation of the Repository Organization to form an overall recommendation about specimen release or encumbrance that will be reviewed by the SWAN Repository Advisory Group and Steering Committee.

SWAN Repository Advisory Group Review

• Relevance to spirit of the SWAN goal of examining the health of women at the mid-life and undertaking this in a manner representing the contemporary state of the science.
• Provision of a plan (and its timeline for implementation) to make the findings available to the larger scientific community and the public.
• Whether the question is addressing issues in very selected samples which are likely to have a high volume of interest (i.e., women who transitioned, women of selected ethnic subgroups, women who manifest with selected conditions).
• Considers the probability and timeliness of a funded investigation.
• Evidence of a clear positive benefit for using the samples relative to the cost of releasing samples considering the reports from RO and Scientific Review.
• Considers priorities for special types of samples to develop (smaller aliquots, types of QA measures).
• Assures that the proposed research question is not a question that is CURRENTLY or proposed (must be written as in SWAN III application) in SWAN Core.

Decision authority:
A negative response by the RO can be directly submitted to the SWAN Repository Advisory Group and with its concurrence, the application will not be submitted for further review, and the investigator and the SWAN SC will be notified of the disapproval

A positive decision by the RO and the SWAN Repository Advisory group leads to the transfer of the application to the SWAN Steering Committee for its endorsement.
 

SWAN Steering Committee Endorsement

The Repository Organization will provide the SWAN Steering Committee with its review of the Letter of Intent, along with the Scientific and Advisory Group reviews. Final disposition of the application includes the response of the Steering Committee.

Materials Reviewed: Repository Organization Review, Scientific Review, Advisory Group Review.

Endorsement:

• Confirm that the proposed research question is not a question that is CURRENTLY or proposed (must be written as in SWAN III application) in SWAN Core.

• Identify if the Committee endorses the response of the Advisory Group.

Decision authority:

Letter to applicant will identify if there is concordance or discordance in the recommendations of the Advisory Group and SWAN SC and an explanation of the rationale for discordance, if it exists.

Communication with Applicants

Written responses will be provided to all applicants by the Repository Organization identifying the status of their application for use of the Repository resources.

Review Timeline

 Responses will be sensitive to the demands of funding cycles.

1st Stage : SWAN Repository Organization (RO) Review

 
The SRO meets on the second Tuesday of every month. Therefore, an application must be submitted to the repository at least one week prior to the RO meeting. The RO meeting schedule is as follows:                                                               

Periodically, the RO will suggest that revisions be made to an application. Therefore, it is in the best interests of applicants to submit applications in January, May and September so that any revisions can be made prior to submission to the Advisory Group. 

2nd Stage: SWAN Repository Advisory Group (SRAG) Review

Once the RO has reviewed an application, the application is submitted to the SWAN Repository Advisory Group. The SRAG meets five times a year. This year's SRAG meeting schedule is as follows:                                                               

3rd Stage: SWAN Steering Committee Review

After an application has been reviewed by the SRAG, it is submitted to the SWAN SC for endorsement. The SWAN SC meets twice each month on the second and fourth Friday of the month.                                                                                    

 Letter of Agreement that Encumbers the Use of Samples and Data

Any application for external funding to use the Repository resources must be accompanied by letter from the Repository Organization indicating that resources have been approved for encumbrance. This encumbrance is valid for a 1-year period from the date specified on the letter. Encumbrance is contingent upon documentation of a funding plan.
 
 

Conditions for Release of Resources

Timing

Samples will be released approximately one time per year.
 
Documentation required for specimen release

Documentation of IRB Approval

Actual release is contingent upon provision of appropriate IRB approval to the Repository Organization. This documentation must include documentation of training of personnel in the ethical conduct of research.

Documentation of resources to conduct analysis

Actual release is contingent upon documentation of appropriate funding to support the laboratory analyses and appropriate data management and data analysis.
   

Documentation that an Investigator from the SWAN Core Study has been assigned to the protocol

Investigators will be designated to act as a co-investigator for those applications that have propose to access to Repository resources but whose investigator(s). SWAN Core Study investigators will be advised of developing proposals (as indicated by letters of intent) and can communicate their interest in affiliating with a project.

Documentation of Institutional Responsibility for Accepting Resources