Policy and Governance

The following is the Code of Conduct that research investigators agree to abide by as an Approved User of data received through the Data Management Resource (DMR). Failure to abide by any term within this Code of Conduct may result in revocation of approved access to any or all datasets obtained through DMR.

The elements of the DMR Code of Conduct for Phenotypic and Genotypic Data Use include:

1. Investigator(s) will use requested data solely in connection with the research project described in the approved Data Access Request for each data;
2. Investigator(s) will make no attempt to identify or contact individual participants from whom these data were collected without appropriate approvals from the relevant IRBs;
3. Investigator(s) will not distribute these data to any entity or individual beyond those specified in the approved Data Access Request;
4. Investigator(s) will adhere to computer security practices that ensure that only authorized individuals can gain access to data files;
5. Investigator(s) will not submit for publication or any other form of public dissemination analyses or other reports on work using or referencing DMR data prior to the embargo release date listed for the data (or dataset version) on DMR;
6. Investigator(s) acknowledge the Intellectual Property Policies as specified in the Data Use Certification; and,
7. Investigator(s) will report any inadvertent data release in accordance with the terms in the Data Use Certification, breach of data security, or other data management incidents contrary to the terms of data access.

1. The biological samples will be submitted to a Repository, with all identifying information removed.
2. The data will be submitted to a database, with all identifying information removed (it will be anonymous).
3. The samples will be stored indefinitely.
4. No personal identifiers will be sent to the Repository or the database.
5. The specimens may be used for preparation of DNA, and may be used for cell culture from which DNA will be prepared.
6. Samples and data will be distributed to scientists for use in research and teaching only.
7. Because all samples and data are de-identified, no results will be returned to donors.
8. The sample could be used for research into any type of disease.
9. The sample and unidentified data will be available to researchers at hospitals, universities, and commercial organizations.
10. There is a risk that someone could use information from the sample you submitted, via DNA, to identify you if it were matched with another DNA sample provided by you. However, any user of this sample must agree not to use it for that purpose, and the risk, while real, is small.
11. You have the right to withdraw from this research project at any time. If possible, any samples and data you have contributed will be discarded if you request this; however, because of the sample and data-masking, we may not always be able to identify which samples were donated by you.Your withdrawal from the study will in no way affect access to medical care for which you are otherwise eligible.

*This policy is based on the NIH Genomic Data Sharing Policy

*NIH Informed Consent Guidance for Data and Biospecimens: Informed Consent for Secondary Research with Data and Biospecimens

1. Clinical data will be entered by PDBP sites in real time via the PDBP DMR
2. All clinical data, including imaging data used for clinical evaluation (i.e., DAT scanning, anatomic imaging) should be made immediately available to all PDBP consortium investigators.
3. Embargo period: During the first year of the PDBP, data cannot be viewed by those outside the consortium.
4. As of November 2013, an up to twelve month embargo period for PDBP has been established. Generally, during this timeframe only PDPB investigators can publish on findings from analysis of PDBP data. However, it may be possible during this embargo period that some approved researchers with a valid institutional affiliation (academic and industry) outside of the PDBP consortium, and with a research request that addresses the goals of the PDBP, can request and receive access to both the clinical data and the biospecimens for analysis, as long as they agree to respect any specified embargo period.
5. Following the embargo period which begins in November 2013, all clinical data will be available to the general research community (via a controlled and tracked approval process, i.e. Data Access Committee Approval). Data updates will be made on a regular basis to the controlled access PDBP database.
6. Aggregate (non-individual level) data will be released immediately and publicly available (on website, no application or approval process required).
7. Analyzed data including laboratory and hypothesis testing imaging data will be made available per the individual project milestones.

PDBP Steering Committee

The PDBP Steering Committee is composed of NINDS staff and project PIs. A chair and vice-chair will be selected by the PDBP PIs and the positions will be rotated on an annual basis. The Steering Committee will have monthly calls and annual in person meetings to assure the smooth running of the program.

Parkinson's Disease Biospecimen Resource Access Committee (PD BRAC)

Requests for access to PD Biospecimens collected via the PDBP, Michael J. Fox Foundation (MJFF) cohorts and the Harvard Biomarker Study will be administrated and reviewed by the Parkinson's Disease BRAC. This committee is composed of Parkinson's disease scientists, clinicians and statisticians. For questions, email NINDS-PD-BRAC@ninds.nih.gov.

PDBP Data Access Committee (DAC)

The DAC will be composed of NINDS staff and PDBP operation staff. Requests for access to PDBP data requires completion of a Data Use Request form and compliance with the PDBP Data Use Certification Agreement. Requests will be reviewed in a timely fashion by the DAC.