The PD-DOC Database contains coded private information collected from patients at PD-DOC user sites. According to current Office of Human Research Protections (OHRP) and Department of Health and Human Services (HHS) guidelines, submission of data to the PD-DOC Database requires that prior permission be provided by the subject. This should occur as part of the usual informed consent process for the subject’s participation in research. All HIPPA-designated protected health information will be deleted before it is shared with other researchers. The following PD-DOC Model Consent Form Language has been approved by the Research Subjects Review Board (RSRB) at the University of Rochester and can be incorporated into the informed consent forms used at participating sites:
PD-DOC Proposed language to be inserted into individual site’s informed consents:
MODEL
CONSENT FORM LANGUAGE
TITLE: Parkinson’s Disease Data and Organizing Center (PD-DOC)
INVESTIGATORS: PD-DOC has been established by the PD Neuroscience faculty at the University of Rochester with the financial support of the NIH.
Study Chair: Roger Kurlan, MD
University of Rochester
Movement and Inherited Neurological Disorders Unit
1351 Mt Hope Avenue Suite 100
Rochester Ny 14620 Usa
Work Phone: 585-275-7937
Fax Number: 585-473-4678
PD-DOC proposed language to be inserted into individual site’s informed consents:
Another component of the [insert study name] is the possibility of sharing some of the data collected about you and your health condition with the Parkinson’s Disease Data and Organizing Center (PD-DOC) at the University of Rochester in Rochester, NY which is supported by the National Institutes of Health (NIH). Your data will be added to other data contributed by individuals from across the country, and may be used to develop future studies of PD and related disorders. This is an optional requirement, so you may choose whether to participate. Your decision whether to participate will have no impact on your participation in the rest of the [insert study name].
Confidentiality of Records and HIPAA Authorization
The Federal Health Insurance Portability and Accountability Act (HIPAA) requires us to get your permission to use protected health information about you that we either create or use as part of the research. This permission is called an Authorization. We may use your research record, related information from your medical records, results of laboratory tests, screening logs, case report forms, and both clinical and research observations made while you take part in the research. The research data submitted to the PD-DOC at the University of Rochester in Rochester, NY will either 1) have all HIPPA-designated protected health information deleted before it is sent, or 2) the PD-DOC will delete all HIPPA-designated protected health information before it is shared with other researchers. Also, the PD-DOC will label your data with a confidential identification code, which will be different from the one used for the information collected during this study. Therefore your identity cannot be disclosed to any researchers using this data in the future.
Results of the research may be presented at meetings or in publications, but your identity will remain private.
Those with access to data submitted to the PD-DOC by [institution name] while you participate in [study name]:
· Staff from the PD-DOC at the University of Rochester, Rochester, NY (representatives that manage and monitor the data)
· The Institutional Review Boards (committees at the University of Rochester and the [NAME OF INSTITUTION] that make certain your rights are protected)
· National Institute of Health (NIH)
· Investigators that have approval to use data from the PD-DOC for future research.
If you decide to take part, your Authorization for this study will not expire unless you cancel (revoke) it. The information collected during your participation will be kept indefinitely. You can always cancel this Authorization by writing to the study investigator. If you cancel your Authorization, you will also be removed from the study. Canceling your Authorization only affects uses and sharing of information after the study investigator gets your written request. Information gathered before then may need to be used and given to others.
As stated in the section on Voluntary Participation, you can also refuse to sign this consent/Authorization and not be part of the study. You can also tell us you want to leave the study at any time without canceling the Authorization. By signing this consent form, you give us permission to use and/or share your health information as stated above.
I give my permission and my HIPPA authorization for the submission of my data collected as part of the [insert study] to the PD-DOC for use in future research.
Yes No
End of Consent Language
It is each investigator's responsibility to be sure that appropriate institutional human subjects approvals are in place at the time data is gathered and submitted to the PD-DOC.
Linked Databases and Databases for Sharing will have all HIPPA-designated protected health information deleted before being received by the PD-DOC or before being shared with other researchers.