Specimens
Request Specimens Process
PPMI encourages interested investigators (from academia or industry) to apply for use of PPMI biospecimens to verify potential PD progression biomarkers.
PPMI samples are reserved for verification studies and not available for assay development work or biomarker discovery. An inventory of PPMI biospecimens — including peripheral blood mononuclear cells, urine, blood, and cerebrospinal fluid — is available here.
Comprehensive clinical and imaging data is also available to correlate biospecimen analyses with relevant subject data.
Please note, data generated from the use of PPMI biospecimens must be returned to the data repository at LONI.
Interested in requesting biospecimens for other biomarker research? View our complimentary resources.
An instructional template on requesting specimens can be found here.
Procedure to apply for access to biospecimens
review
Submit pre-proposal
Agree to Use Policies
The first step of the specimen request process requires all investigators to agree to the PPMI Biospecimen Use Agreement, Data Use Agreement, and Publication Policy.
Complete pre-proposal application
Prospective applicants are then invited to submit a Pre-Proposal through the MJFF grants portal. This is a brief two-page summary outlining the rationale for the proposed study, data on assay validation, associated data indicating that the biomarker(s) has the potential to track PD progression, and the number and type of samples requested. Click on this link to access the Pre-Proposal template.
Pre-proposal review
Biospecimen Review Committee will review based on the following evaluation criteria:
Biomarker and Assay Rationale
Is there sufficient evidence indicating that the biomarker can track with PD progression? Is the biomarker truly ready to be verified?
Experimental Plan and Feasibility
Has sufficient technical groundwork been performed to justify the use of this valuable material?
In addition to the criteria outlined above, the number of samples available in the PPMI repository and overlap with ongoing efforts will be taken into account when deciding whether to allocate the requested biospecimens.
Invitation to submit full proposal
Complete & submit full proposal
Following BRC review of the Pre-Proposal, applicants will be informed whether they are invited to submit a Full Proposal via email. Instructions and all information necessary for submitting full proposals through the MJFF grant portal will be included. Any feedback from the BRC will also be included. The BRC may choose to work closely with invited applicants in shaping the final experimental design of the Full Proposal and thus include suggestions for altering the study design.
The 5 page PPMI Full Proposal template is available here. The Full Proposal requests information on the goal/hypothesis of the proposed work, as well as the impact on how evaluation in PPMI would impact the field. Preliminary data (ideally generated under the same conditions as the PPMI biosamples) including the utility of the biomarker to monitor PD progression, longitudinal assessment, and correlation with disease severity/duration is important. Detailed information on the number/type of samples, as well as a clear project plan inclusive of timelines and key milestones should be included.
Review & Committee decision
Biospecimen Review Committee will evaluate:
- The readiness of the biomarker assay(s) (feasibility under PPMI storage conditions, volume required, assay validation and performance)
- Evidence indicating the biomarker can track with PD progression
- Whether sufficient technical groundwork has been performed to justify use of this valuable material
- Justification of sample size (based on power analysis)
- Expertise of the investigator(s) to carry out the proposed work
Applicant will receive a decision:
- Approval of application: After a positive review by the BRC, applicants will be informed and contacted to provide additional information to facilitate the logistics of transferring the specimens
- Approval with revisions: The BRC may conditionally approve the samples based on requested revisions to the sample request/analysis plan. Pending agreement between the BRC and the applicant, additional information to facilitate the logistics of transferring the specimens will be shared.
- Disapproval of the application: Application was not deemed to be of significant merit and/or the proposed assays were not of sufficient quality to justify use of the limited PPMI samples.
Biospecimens released
Prior to sample shipment of the PPMI biosamples from the Biorepository Core at Indiana University, the following are required:
- Signed Material Transfer Agreement (MTA)
- Signed MJFF Grant Agreement (even if no associated funding is requested)
- Completion of an introductory call with the PPMI Biorepository Core to review sample selection, box design, and shipping procedures
Biospecimens shipped to investigator
Biospecimens will be shipped from the PPMI Biorepository Core to the receiving investigator in a blinded fashion. The samples are matched to a unique biorepository identification number.
Submit results
After analysis completed, investigator submits Methods Document and Results file to LONI
The applicant should use the provided templates to provide information about the assay(s) and the results to LONI. Results must be submitted for every shipped sample.
LONI provides code to unblind specimens
Upon review of the returned data, LONI will provide a ‘code’ that matches the unique biorepository ID with the PPMI ID so the specimens can then be unblinded and investigators can match their data to the clinical data in the PPMI database.
The submitted results are embargoed for a period of 45 days to allow for quality control by the investigator. After that time, data are available for download from the LONI website for use by the Research Community.
Start the Specimen Request Process
Once you've understood the process outlined above, you're ready to start to make a request. The link below will take you to the first step, registering on MJFF's Grant Portal. You can view an instructional template for help in navigating the portal.
GO NOWThe PPMI Biospecimen Review Committee (BRC)
The PPMI Biospecimen Review Committee (BRC) The BRC was established to review applications seeking access to PPMI biospecimens and is convened on a rolling basis. Following evaluation of a Pre-Proposal, the BRC may invite an applicant to submit a Full Proposal or decline the request. All proposals submitted to the PPMI BRC are treated confidentially. Click here to read our Conflict of Interest statement.
Confidentiality
MJFF and the BRC treats all Pre-Proposal, Full Proposals, research projects and associated research information (collectively, the 'Confidential Information') in confidence using no less than reasonable care in protecting such Confidential Information from disclosure to third parties who do not participate in the grant review process and MJFF assessments. All Confidential Information will be used by the BRC, MJFF and its grant reviewers ('Reviewers') only internally for the purposes of reviews and assessments, and will be shared only in accordance with its sharing policy stated herein. Notwithstanding Reviewers obligations regarding such Confidential Information, such obligations cover any information retained in their unaided memories and may not be used without the permission of the disclosing party. Notwithstanding the foregoing, the obligations governing the disclosure and use of Confidential Information do not apply with respect to Confidential Information that it can be demonstrated:
(a) was generally known to the public prior to the effective date when the Pre-Proposal was submitted; or
(b) becomes generally known to the public through no unlawful or unauthorized act of omission by any recipient of Confidential Information, or in violation of this review process; or
(c) was independently developed by any recipient prior to the effective date of this review process; or
(d) was disclosed to a recipient by a third party who has the right to make such disclosure.
If any recipient of Confidential Information is requested to produce any of the Confidential Information pursuant to a legal or governmental proceeding, such recipient shall give the applicant or other owner of such Confidential Information (the 'Discloser') as much prior notice of such requirement as is reasonably practicable under the circumstances and shall use its reasonable efforts to assist the Discloser of such Confidential Information in objecting to such request. If a recipient is compelled to disclose any of the Confidential Information pursuant to such legal or governmental proceeding, such recipient shall use its reasonable efforts to assist Discloser in obtaining confidential treatment for such Confidential Information, will disclose only that portion of the Confidential Information which is responsive to the order, and will provide the Discloser with any copies of Confidential Information so disclosed; provided that such Confidential Information shall remain confidential until it falls into one of the categories specified in this Section entitled 'CONFIDENTIALITY'.