Depending on availability and the nature of the proposed project, investigators may request:

• Clinical and demographic data

• Longitudinal study data

• Neuropsychological and clinical assessment data

• Neuroimaging data

• Polysomnography (PSG) data

• Biospecimens, including blood specimens and cerebrospinal fluid

• Derived datasets or other study-specific measures

Availability varies by participant, study visit, specimen type, and data modality. Not all resources are available for every NAPS participant.

Investigators should complete the NAPS Data and Biospecimen Request Form and provide sufficient information for the committee to evaluate the proposed project.

Requests should generally include:

• Project title

• Principal investigator and institutional affiliation

• Study objectives and scientific rationale

• Specific data and/or biospecimens requested

• Participant population and sample size

• Proposed analyses

• Funding source, if applicable

• Regulatory or IRB status

• Plans for publication and dissemination of results

Clearly defining the requested variables, participant groups, specimen types, volumes, and study visits can help streamline the review process.

Requests are reviewed by the NAPS Data and Biospecimen Committee, which meets every other month during odd-numbered months (January, March, May, July, September, and November). Depending on the scope or complexity of the request, additional review by NAPS leadership, Core investigators, or other subject-matter experts may be necessary.

The review considers factors such as:

• Scientific significance and feasibility

• Appropriateness of the requested NAPS resources

• Availability of data and biospecimens

• Potential overlap with ongoing NAPS analyses or approved projects

• Adequacy of the proposed sample size and analysis plan

• Regulatory requirements

• Impact of biospecimen use on limited or nonrenewable resources

• Alignment with NAPS data-sharing and publication policies

Most requests are reviewed at the next available Data and Biospecimen Committee meeting. Investigators should allow additional time for requests that are complex, require clarification, involve limited biospecimens, or require review by NAPS leadership or individual Cores.

Biospecimen requests may take longer than data-only requests because specimen availability, volume, prior use, and preservation of limited resources must be considered.

The committee may request additional information before making a final determination. Common reasons include the need to clarify:

• Phenoconversion or diagnostic groups

• Specific variables or time points requested

• Biospecimen type or volume

• Sample-size justification

• Proposed assays or analytic methods

• Regulatory approval status

For biofluid requests, NAPS may also request additional evidence that a proposed assay is sufficiently validated before approving use of limited biospecimens. For requests involving more than approximately 20–30 samples, investigators may be asked to provide pilot data from an RBD population or another pertinent neurodegenerative disease population. Alternatively, investigators may be asked to provide a published manuscript or other supporting documentation demonstrating that the assay has been validated for the proposed application.

Providing these details promptly can help move the request forward.

No. NAPS biospecimens are finite research resources, and availability varies substantially by specimen type, participant, and study visit.

Some specimen types are available only in small quantities. Requests involving limited specimens may therefore receive additional scrutiny, and the committee may recommend a smaller volume, alternative specimen type, or modified sample set when appropriate.

If a proposed assay has not yet been evaluated in an RBD population or a relevant neurodegenerative disease population, NAPS may initially approve and provide a smaller number of biospecimens for pilot testing. The investigator may then be asked to provide pilot data demonstrating assay feasibility and performance before the committee considers approval of the full biospecimen request.

Approval of a scientific request does not guarantee that every requested specimen will be available.

Available volumes depend on the specimen type and existing inventory. Investigators should request only the amount necessary to complete the proposed analyses and should provide justification for requested volumes when appropriate.

The NAPS team may work with investigators to determine whether the requested volume can be accommodated.

Investigators may submit a request while their local IRB review or determination is pending. However, applicable IRB approval, exemption, or other institutional determination may be required before identifiable or coded data and/or biospecimens can be released.

Providing documentation as soon as it becomes available can help prevent delays after scientific approval.

Not necessarily. Committee approval is one step in the process.

Before release, additional steps may include:

• Finalizing the requested cohort or variables

• Confirming specimen availability

• Completing IRB or regulatory requirements

• Executing a Data Use Agreement, Material Transfer Agreement, or other institutional agreement

• Preparing and quality-checking the requested dataset

• Coordinating biospecimen distribution, which can take up to a few months

• Obtaining data from an approved external repository

The NAPS team will provide instructions regarding the next steps applicable to each approved request.

The method of data distribution depends on the type of data requested and applicable data-sharing requirements.

Some datasets may be prepared by the NAPS Data Management and Statistics Core, while certain specialized data types are distributed through established repositories.

Investigators will receive instructions regarding access after their request is approved and all required agreements and regulatory documentation are complete.

NAPS polysomnography data, including available EDF files, are distributed through the National Sleep Research Resource (NSRR) as datasets become available.

Investigators requesting EDF files may need to wait until the relevant files have been uploaded and released through NSRR. Availability of PSG files may therefore differ from the availability of other NAPS data.

Yes. Investigators may request defined subsets of participants based on scientifically justified criteria.

Examples might include participants with isolated RBD, participants who have phenoconverted to a neurodegenerative disorder, controls, or participants with specific longitudinal assessments or biospecimens available.

Requests should define the population as precisely as possible.

Yes, when appropriate for the proposed research question and when the relevant data are available.

Because the term “phenoconversion” can refer to different clinical outcomes, requests should clearly specify the intended diagnostic group (i.e. Parkinson disease, dementia with Lewy bodies, multiple system atrophy, or mild cognitive impairment).

Yes. Industry-sponsored requests may be considered. These requests may require additional contractual, regulatory, intellectual property, or data-sharing review depending on the nature of the collaboration.

Costs depend on the nature of the request. Investigators are responsible for expenses associated with specimen processing and shipping. Potentially, costs could be incurred for certain specialized dataset preparation, repository access, assays, or other project-specific activities.

Any anticipated costs will be discussed before materials are distributed whenever possible.

Investigators may be required to return assay results, derived variables, or other data generated from NAPS biospecimens to the NAPS Consortium so that these resources can contribute to the broader NAPS research program.

Requirements for data return, timing, format, and any applicable embargo period will be communicated as part of the approval and agreement process.

Yes. Investigators using NAPS resources are expected to comply with NAPS publication, acknowledgment, authorship, and data-sharing policies.

Depending on the project, this may include:

• Appropriate acknowledgment of the NAPS Consortium and funding sources

• Inclusion of appropriate NAPS collaborators or investigators when warranted by their contributions

• Notification of NAPS before manuscript submission

• Compliance with applicable publication or data embargo periods

• Return of resulting datasets or derived measures to NAPS

Specific requirements will be communicated to investigators as part of the approval process.

Potential overlap does not automatically prevent approval. The committee may recommend coordination with investigators already working in the same area to minimize duplication and encourage productive collaboration.

Yes, but substantive changes may require additional review.

Investigators should contact NAPS before changing the:

• Scientific aims

• Participant population

• Sample size

• Data elements

• Biospecimen type or volume

• Assay platform

• Collaborating institutions

• Intended use of the requested resources

The NAPS team will determine whether the modification can be handled administratively or requires committee review.

Investigators will be notified after committee review. Approved requests are assigned a NAPS data request identification number, which should be referenced in future correspondence.

If additional information is needed, the NAPS team will contact the investigator before or following committee review.

Questions regarding data and biospecimen requests may be directed to the NAPS Consortium administrative team at info@naps-rbd.org

When contacting NAPS about an existing request, please include the assigned data request ID whenever possible.