Process for Requesting Specimens

Investigators should read all of the following information prior to submitting a request for samples. Click the button below to begin the submission process.

Overview

The goal of the Parkinson’s Progression Markers Initiative (PPMI) is to identify, test and verify markers of progression for early-stage Parkinson’s disease. To accomplish this goal, PPMI is collecting biospecimens, including urine, blood and cerebrospinal fluid (CSF) from participants (early stage Parkinson’s disease (PD) subjects and healthy subjects). An inventory of PPMI biospecimens available through the PPMI biorepository core and will be maintained on the PPMI website. Comprehensive clinical and imaging data collected from PPMI research participants will also be available on the PPMI website to enable researchers to develop studies that might correlate biospecimen analysis with relevant subject data.

Several analyses of already identified analytes will be performed by PPMI investigators. Results of these studies will be made available on the PPMI website as soon as laboratory analyses are complete. Planned analyses will investigate the following analytics:

• Alpha-synuclein levels in CSF
• Urate levels in plasma
• DJ-1 levels in blood and CSF
• Tau, Phosphorylated tau, and beta-amyloid 1-42 in CSF

The PPMI study encourages interested investigators, whether associated with PPMI or not, to apply for use of PPMI biospecimens to verify potential PD progression biomarkers. Please note: Stored samples are reserved for verification studies; samples should not be used for biomarker discovery work.

The PPMI Biospecimen Review Committee (BRC)
The BRC has been established to review applications seeking access to PPMI biospecimens. Following evaluation of a Letter of Intent, the BRC will accept and invite for Full Proposal or decline a proposal. The BRC will meet every other month to review all Letters of Intent and Full Proposals received in time for the meeting. All proposals submitted to the PPMI BRC will be treated confidentially. Click here to read our Conflict of Interest statement.

Procedure to apply for access to Biospecimens

Please read the following section carefully to understand the process to apply for use of biospecimens (serum, plasma, DNA, RNA/miRNA, urine, CSF) collected as part of the PPMI study. In addition to applying for access to PPMI biospecimens, please note that applicants may also apply to MJFF for funding to perform the proposed studies. The review procesess for biospecimen access and funding are separate; PPMI biospecimen access is determined by the PPMI BRC while MJFF will review all funding requests. Approval for use of PPMI biospecimens does not guarantee MJFF funding.

Letter of Intent (LOI)

The first step of the specimen request process requires all investigators to agree to the PPMI Biospecimen Use Agreement. Prospective applicants must then submit a LOI online. This is a brief two-page summary outlining the rationale for the proposed biomarker, the current evidence for testing of this biomarker, the current experience with the proposed assay as well as the number and type of samples the investigator is requesting. Click here to access a template for the LOI.

LOIs are not formal proposals per se but will act as the basis for selecting the most relevant and promising projects to be invited for a Full Proposal.

Full Proposals

Following BRC review of the LOI, applicants will be informed whether they are invited to submit a Full Proposal via email. Instructions and all information necessary for submitting full proposals online will be included. Any feeback 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.

Evaluation Criteria

1. 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’? The following information on the proposed biomarker/assay should be discussed:

• Stability of the biomarker in the current PPMI storage conditions

• polypropylenetubes used in the PPMI study
• multiple freeze/thaw cycles
• without preservatives or additional reagents in sample processing

• Reproducibility of the assay
• Volume of sample required
• Range of biomarker
• Test-retest reliability of the assay
• Previous use of assay in human samples

2. Experimental Plan and Feasibility: Has sufficient technical groundwork been performed to justify the use of this valuable material? Are sample sizes justified based on power analyses? A data analysis plan incorporating analysis of the relevant aspects of the PPMI dataset (clinical, neuroimaging, etc) should be discussed.

3. Collaborative Team and Environment: Do the investigator and collaborators possess the appropriate expertise to carry out the proposed work? Are all key areas of expertise adequately supported as needed? Does the organizational/institutional environment in which the work will be done contribute to the probability of success? Are materials, technologies and additional support personnel available to ensure progress? Do the proposed experiments take advantage of unique features of the environment or employ useful collaborative arrangements? Is there evidence of institutional support? Has the team agreed to the PPMI Data Sharing Policy and IP Guidelines?

In addition to the criteria outlined above, the number of samples in the entire PPMI repository will be taken into account when deciding whether to allocate the number of specimens being requested to a particular applicant.

Post Review

A Full Proposal will receive one of the following decisions from the BRC:

1. Approval of application: After a positive review by the BRC, applicants will informed of their selection and be contacted to provide additional information to facilitate the logistics of accessing the specimens
2.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.

Approved projects will obtain the biospecimens from the PPMI biorepository core. Before any biospecimens or data will be released to the investigator(s) the following administrative items must be completed:

• Acknowledgment and acceptance of PPMI Biospecimen Use Agreement by the investigator(s), including compliance with the IP policy/guidelines outlined within the Agreement
• Receipt of regulatory approval (i.e. IRB) by the relevant institution(s) to handle/work with the biospecimens
• Signed Material Transfer Agreement between PPMI biorepository core and the investigator’s institution.

To ensure that experiments occur on a timely basis, investigators will be required to complete the administrative necessities outlined above within three months of receipt of BRC approval. Failure to complete these items in a timely manner will result in forfeit of the approval to use PPMI samples.

Data Obtained from PPMI Samples

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. When the analyses are completed the investigator will submit a report of the analyses by subject to the BRC. Upon approval, the BRC will provide a “code” that will match the unique biorepository ID with the PPMI ID so the specimens can then be unblinded and investigators can match the data to the clinical data in the PPMI database. Within two months of unblinding, all investigators who use PPMI samples must resubmit his/her data/analyses to the BRC. Upon submission, the BRC has the right but not the obligation to deposit these analyses in the PPMI study database for use by the Research Community.

Confidentiality

MJFF and the BRC treats all Letters of Intent (LOI), 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 LOI 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.”.

Questions

Contact us with questions about the specimen request process.