13. RESOURCE SHARINGPLAN
Although this study does not meet the requirements for a resource sharing plan (e.g. we will not be developing model organisms or producing GWAS data, and our budget is not in excess of $500,000/year), we recognize that study will result in a valuable data set and biospecimen collection. We do plan to make the study data available to qualified scientific collaborators, especially basic scientists who wish to test findings from cell culture or animal models in a human cohort. The following guidelines will govern our data and biospecimen sharing with outside investigators.
Guidelines for use of the [Study name]data by external collaborators
A. Submitting a proposal to the [Study name] investigators
1.Any investigator wishing to develop a collaboration with the [STUDY NAME] investigators to use the [Study name] data should send a two-page description (maximum) of the proposed analysis to the Principal Investigator [name, e-mail]. The project description will then be reviewed by the study investigators. If the proposed project is deemed feasible (e.g. can be adequately addressed using the available data and/or stored specimens), of substantial scientific interest, and is not currently under consideration by an [STUDY NAME] investigator as a specific aim of a funded, submitted or planned grant or manuscript, the investigator will be invited to submit a detailed proposal to the [STUDY NAME] investigators for full review.
2.Proposal format. The full proposal’s format should be similar to an NIH grant (i.e. specific aims, background and significance, approach), but should be no longer than 5 pages in length (including references). The proposal should briefly outline the hypothesis being proposed, the reason for proposing use of the [STUDY NAME] data, and the required data and/or biospecimens. The reasons for proposing use of [STUDY NAME] data must be clearly described. The proposal should include a proposed timeline for the project, including deadlines related to grant submissions, if appropriate.
3.Review of study proposals. Proposals will be reviewed by the [STUDY NAME] investigators who will decide to accept, accept pending revisions, or reject a proposal. For either of the latter two outcomes, a summary of the reasons for the [STUDY NAME] investigators’ decision will be provided. An “acceptable pending revisions” will be given if the proposal has considerable scientific merit, yet one or more issues need to be addressed before the project can proceed. Arrangements will be made to provide an expedited review of a revised proposal, which addresses the concerns of the [STUDY NAME] investigators.
4.Project funding. Since no funds have been allocated to manage the development of these outside collaborative arrangements, all costs for proposed projects must be borne by the external collaborator(s) or through research funding obtained jointly the [STUDY NAME] investigators and the external collaborator(s). For projects that require application for funding from an external funding agency (e.g. NIH), the approval process described above must be factored into the timing of any grant application. The [STUDY NAME] investigators do not take responsibility for missed deadlines.
At least one [STUDY NAME] investigator must be included as a co-investigator (with appropriate time commitment and salary support) on any project where use of [STUDY NAME] data or biospecimens is proposed. Any nonacademic external collaborator (e.g. from a private company) similarly must be able to provide salary support for an investigator. The level of effort will vary according to the size and complexity of the project, but will be expected to be at least 5% FTE per year. External collaborators must also provide funding to support the [STUDY NAME] programmer’s time and effort to create the necessary data set(s) for the project.
The arrangement for payments will be through formal subcontracts with the George Washington University Sponsored Projects Administration.
Outside collaborators must provide a draft of any grant proposal (e.g. NIH grant) to the collaborating [STUDY NAME] investigator at least six weeks prior to the application due date. This will allow the [STUDY NAME] investigator an opportunity to provide feedback, and will allow time to provide any available preliminary data that will maximize the probability of funding for the proposal. The final grant proposal must be reviewed by the [STUDY NAME] Principal Investigator, at least 10 business days before submission. Failure to meet this deadline will result in delay of submission. The primary [STUDY NAME] investigator will provide a letter of support to the external investigator to be included in the application indicating the interest of the [STUDY NAME] investigators in collaborating on the proposed study.
B. Conducting studies using the [STUDY NAME] data
1.Collaborative agreement. Prior to the initiation of any data analysis, the exact nature and scope of the project must be described in a written collaborative agreement and signed by the external collaborator, the primary [STUDY NAME] investigator for the project, and a representative from each investigator’s institution. Use of data from the [STUDY NAME] cohort is limited to the defined, specific project outlined in the proposal that was approved by the [STUDY NAME] investigators. If further research or analytic activities develop from the original project, the external collaborator must obtain appropriate approval for such activities. In signing the collaborative agreement, external collaborators also will be confirming that they have read these guidelines (“Guidelines for use of the [STUDY NAME] data by external collaborators”), and both understand and agree to comply by them.
2.Data security. To ensure the integrity of the [STUDY NAME] data, it is the policy of the [STUDY NAME] that only de-identified data will leave the George Washington University. Data is de-identified if, in accordance with the de-identification standard, 45 C.F.R. §164.514(a)(b), a person with appropriate knowledge and skill uses accepted scientific principles and methods to determine the risk is very small that information could be used to identify the individual and documents the method used to justify such a conclusion.
3.Human subjects considerations: All projects must receive approval from the George Washington University Institutional Review Board and the home institution (if an IRB is operational) prior to implementation.
4.Progress reports: The external collaborator must agree to keep the [STUDY NAME] investigators updated on the progress of the project by providing a written report at least every 6 months. Failure to adhere to a reasonable progress schedule (as assessed by the [STUDY NAME] investigators) could lead to termination of the collaborative relationship.
C. Data analysis and Publication of studies using [STUDY NAME] data
The external collaborating investigator(s) should forward all analysis results to the collaborating [STUDY NAME] investigator. At least one member of the [STUDY NAME] investigator team must be included as a co-author on any manuscript resulting from this collaboration, and, as such, will need to sign off on any manuscript prior to its submission for publication. External investigators should plan on the entire process taking at least 4 weeks (and longer if there are issues to be resolved concerning analysis or interpretation of the data). Any initial presentation of these data at meetings also must receive sign off from the designated [STUDY NAME] collaborating investigator(s).
Any dispute regarding data interpretation may be brought to the entire [STUDY NAME] investigator team for consideration. Where appropriate, the [STUDY NAME] investigator team will seek additional consultation from independent experts. Final decisions rest with the [STUDY NAME] Principal Investigator, in consultation with the entire [STUDY NAME] investigator team.