Objective: The Parkinson Progression Markers Initiative (PPMI) is a multinational, longitudinal observational study that collects clinical, imaging, biologic, and genetic data from participants with or at risk of Parkinson’s disease (PD) and healthy controls. The objective is to ascertain site experiences to inform the development of disclosure processes.

Background: Disclosure of personal research information to participants in observational studies remains controversial due to ethical and logistical challenges. Projects to ascertain participant interest in learning personal research information, evaluate methods of disclosure, and review impact on study outcomes are needed.

Method: A two-part mixed methods approach was developed to ascertain existing practices of research information disclosure and gather key stakeholder input. A novel survey was developed by all authors and disseminated to investigators across PPMI sites (31 in US, 20 international). Questions asked if, how, by whom, and what PPMI research information was being disclosed. Current practices were evaluated and informed the design for a centralized online disclosure model. Website content for this model, including pre- and post-disclosure education, was developed. In parallel, a centralized support model was established to address participant questions.

Results: Surveys were disseminated to 51 site investigators and responses were collected between September 22, 2023 and October 13, 2023. 23 sites completed the survey (44% of all sites). 16 (70%) sites reported returning some research information, while seven (30%) did not return research information. Clinical data, MRI, and DAT scan information is returned by 12 (75%) of those reporting yes to returning any research information, while blood (9, 56%), CSF (6, 38%), and genetic (4, 25%) information were returned by fewer sites.

Conclusion: Educational content developed by experts and key stakeholders will be evaluated in future studies to determine best practices and can serve as a model for research information disclosure beyond PPMI. This work has previously been presented at the Planning for the Prevention of Parkinson’s 2024 Meeting.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/research-information-disclosure-in-the-ppmi-study-development-of-a-disclosure-process/