Policies

Data is defined as all information pertaining to, but not limited to, the following: demographic, clinical, family history, neuropsychological, neuroimaging, and biofluid measures. This includes the raw data and data derived from analyses of clinical, neuropsychological, neuroimaging, as well as biofluid samples and measures.

All data requests should be submitted using the Online FPI-MDS Data Request Form (anticipated availability Fall 2024). This standardized application process asks the prospective authors to specify the principal hypotheses, the variables needed, and the analytic plan.

For each request, approvals from each FPI contributing consortium (whose data has been requested) will be facilitated by the FPI Data Team. When a request is approved, and data use agreements have been established between each contributing consortium and the requestor’s institution, de-identified data will be made available to investigators to conduct analyses. These shared datasets will be prepared, cleaned and frozen on a regular basis.

All industry data requests should be submitted using the Online FPI-MDS Industry Data Request Form (anticipated availability Fall 2024). This standardized application process asks for the list of individuals who will have access to the data and for a description of the intended data use.

For each request, approvals from each FPI contributing consortium (whose data has been requested) will be facilitated by the FPI Data Team. When a request is approved, and data use agreements have been established between each contributing consortium and the requestor de-identified participant level data will be made available. These shared datasets will be prepared, cleaned and frozen on a regular basis.

The individual level FPI-MDS data may not be shared without additional approvals from the FPI. Collaborations that span multiple companies or institutions will require a separate data request per organization. Aggregate data and analyses may be included in regulatory filings or published with clear acknowledgement of the data source as the FTD Prevention Initiative.

Raw biospecimens and MRI images obtained through each consortium are not available for request at this time.

New data generated through analyses of FPI datasets must be returned to the FPI Executive Committee for possible inclusion in the project database. A six-month embargo will be placed on returned data to allow publication of results. Notification of negative findings need to be returned to the FPI Executive Committee within one year of dataset distribution.

If a data request is approved, the requestors must Agree to the following Data Use Policies:

For FPI Investigators:

• Prepare a manuscript in a timely manner, as determined by the lead author and the FPI Executive Committee.
• Share preliminary analysis results upon request, either via email or on a publications call.
• Agree to follow FPI Authorship policies.
• Notify the FPI Executive Committee upon acceptance for publication.

For External Investigators:

• Agree to follow FPI data use policies and data display guidelines to protect participant confidentiality.
• Acknowledge the FPI and contributing consortia as a data source.
• Provide results of analyses to the FPI Executive Committee upon request.
• Notify the FPI Executive Committee upon acceptance for publication.

The FPI Executive Committee reserves the right to require changes in the manuscript to avoid substantial conflict or overlap with other publications, and to ensure proper description of:

• informed consent
• approach to confidentiality
• acknowledgements of FPI investigators and funding sources
• disclosure of potential and actual conflicts of interest

All precautions to ensure confidentiality must be taken by recipients of FPI data. The final dataset will be stripped of identifiers prior to release for sharing and be transferred only with encryption and password protection by the FPI Data Team. The code linking a subject’s identity to their consortium-specific de-identifiers will be maintained securely with restricted access. 

To mitigate potential deductive disclosure of participant identity we will make the data and associated documentation available to users only under the following prerequisites:

• Recipients of data will provide assurance of ability to secure the dataset in compliance with the data protection policies of the FPI and the data contributing consortia as defined in the data sharing agreements.
• Recipients of data will provide a signed code access agreement for data usage (code access agreements are a simple statement declaring that the data recipient will use the data only for research purposes and will not attempt to identify any individual participant).
• Recipients of data will guarantee that any mutation data shared will be destroyed when analyses are complete.

Collaborative engagement is a key to deciding upon authorship. The following are the FPI Authorship Policy Guidelines:

• The person who generates the first draft of the manuscript and takes principal responsibility for crafting the final version should be the first author on any FPI publication.
• All named co-authors must meet appropriate standards for authorship (see below).
• All primary FPI Investigators must be invited to participate as named co-authors. Investigator information will be provided to the corresponding author upon request.
• All publications from FPI investigators or collaborators based on FPI data must also include “on behalf of the FPI Investigators” as an author.
• For publications based on a single consortium’s data (i.e. ALLFTD, GENFI, ReDLat, etc.) please contact the consortium for guidance.

Co-authors must:

• Make substantial contributions to the study data.
• Make meaningful contributions to the intellectual content of the manuscript during analysis, drafting, or revision.
• Acknowledge participation as a named co-author.
• Complete journal authorship forms in a timely fashion. Repeated delays in completing these forms will jeopardize co-authorship.

• Should publication(s) result from the use of FPI data — now or in the future — the recipient must notify the FPI Executive Committee with details (reference or PubMedCentral ID#) and provide a copy of the publication. This information will be used to report FPI productivity to funding agencies and governmental bodies.
• Should funding result from this research now or in the future, please notify the FPI Executive Committee (contact information below) with the details, including the grant title, sponsor, number, total cost, and dates. This information will only be used for productivity reporting to funding agencies.
• As described in the “Returning Results” section, new data created through analysis of FPI data must be provided to the FPI Executive Committee for possible inclusion in the FPI database. Such data may be distributed in future FPI datasets. Returning results also includes notification of negative findings (e.g., a manuscript will not be forthcoming).
• No sharing of data with a third party is allowed without permission of the FPI Executive Committee.

Required acknowledgement language

Please include the following language in the acknowledgment section: “Data presented in this manuscript were derived from multiple consortium comprising the FTD Prevention Initiative. The authors acknowledge the invaluable contributions of the study participants and families as well as the assistance of the support staff at each of the participating sites.”