Accessing mHealth Data onSage Bionetworks’ Synapse

May 6, 2016

Sage Bionetworks | 1100 Fairview Ave N, M1-C108 | Seattle WA 98109t: (206) 667-2102 | f: (206) 667-2062 | w: www.sagebase.org

Introduction:

Sage Bionetworks sponsors a number of app-mediated research studies to advance human health. To enroll, prospective participants self-guide through a visually engaging and robust informed consent process. As part of this process, participants specify if the data they donate to the study can also be used for secondary research purposes by “qualified researchers worldwide.” The requirements for becoming a qualified researcher are designed to honor the magnitude of participants’ donation as well as safeguard these data sets against inappropriate use; researchers may not see, access or work with these donated “public” data sets without meeting the qualified researcher requirements. mHealth studies like mPower would not be possible without the generous participation of thousands of research volunteers; we thank them for their partnership.

Access procedure for mPower data

Background:

mPower is an app-mediated research study piloting new approaches to monitoring key indicators of Parkinson Disease progression and diagnosis by supplementing traditional behavioral symptom measurements with novel metrics gleaned from sensor-rich mobile devices. As a scalable, inexpensive, and non-invasive method for frequent measurement and tracking of symptoms, the Parkinson mPower app has been able to survey a large, longitudinal cohort of volunteers with PD and controls. Due to the novel nature and collection method of this data, we have instituted governance structures that balance sharing this data for secondary research with commensurate privacy protections for participants.

Overview of data access procedure:

mPower Public Researcher PortalmPower data is accessed through the mPower Public Researcher Portal (https://www.synapse.org/#!Synapse:syn4993293/wiki/247859). This portal serves as a hub for all research activities relating to mPower. The portal houses background on mPower, links to webinars and publications about/resulting from these data, high level data descriptions, a FAQ, and contact information for our team.

The specific instructions for how to become a qualified researcher, illustrated with graphics and hyperlinks, are found on the mPower Public Researcher Portal. Further, the mPower Research Community registry of qualified researchers’ intended data use statements is maintained on the portal.

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Access instructions overviewTo gain access to mPower data, researchers must complete a five-step researcher qualification process:1. Register for a Synapse account and agree to Synapse’s governance policies (https://www.synapse.org/#!Help:Governance).2. Become Certified Synapse users by passing a knowledge quiz reinforcing key governance terms and applied research ethics.3. Submit their Synapse profile for validation to Sage’s Access and Compliance Team (ACT). The validation process is designed to create transparency within the mPower research community.4. Submit an Intended Data Use statement covering the what, why, and how of their planned research using mPower data. These statements are listed publically in the mPower Research Community registry on the mPower Public Researcher Portal (https://www.synapse.org/#!Synapse:syn4993293/wiki/392026).5. Agree to any data-set specific Conditions for Use via click wrap prior to downloading the data set.Researchers must complete additional steps for access to data covered by independent copyright (i.e., MDS-UPDRS and PDQ-8 survey results). These steps involve review and approval of the researcher’s Intended Data Use statement and assessment for commercial fees.

Illustration of data access procedure steps

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Detailed data access description:

Access to mPower data sets is granted only to qualified researchers who agree to specific Conditions for Use designed to protect the privacy of study participants, create transparency within the mPower researcher community, and serve as a hurdle to those who might abuse the privilege of access to these data. In short, qualified researchers are Synapse Certified users with validated profiles who have submitted an Intended Data Use statement and agreed to data-specific Terms of Use. The process steps for researcher qualification are detailed below.

First, prospective researchers must register for a Synapse account. Account creation requires users to provide a user name and email address. Additionally, researchers are required to agree to the Synapse governance policies and procedures, including the Terms and Conditions of Use, Privacy Policy, Awareness and Ethics Pledge ((https://www.synapse.org/#!Help:Governance). The Terms and Conditions of Use for Synapse include agreement to use data ethically and responsibly, to protect the privacy and confidentiality of all sample contributors, not to re-identify individuals, and to comply with all applicable laws and regulations.

Once registered, researchers are asked to become Certified Synapse users. Certified users are authorized to use the full Synapse functionality. In order to ensure that users wishing to interact more freely within Synapse are familiar with the Synapse governance policies and procedures, users must pass a knowledge quiz on the content of the Synapse tutorial to become Certified. Once verified, a badge appears on the researcher’s Synapse profile page (Figure 1).

Following Certification, researchers are able to submit their profiles to Sage’s Access and Compliance Team (ACT) for validation. From their Synapse profile page, researchers follow prompts to:

Confirm their user profile is complete, including their full name, current affiliation, and city/country. This information is permanently snapshotted and listed publically to enhance transparency. (Figure 1)

Submit identity attestation in the form of a signing official letter, notary letter, or copy of a professional license (Figure 2a).

Link their public profile to their ORCID profile, creating a persistent digital identifier for themselves as researchers (Figure 2b).

Sign and initial an illustrated copy of the Synapse Oath, further reinforcing the ethical code that governs the use of mPower data (Figure 2c).

Once verified, a “Profile Validated” button appears on the researcher’s Synapse profile page (Figure 1).

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Figure 1: Synapse Certified user with a validated profile

Figure 2a: Identity attestation via signing official letter

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Link to researcher’s ORCID

Synapse Certification badge

Figure 2b: ORCID profile showing unique digital identifier

Figure 2c: Completed Synapse Oath

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Each researcher requesting access to mPower data must submit an Intended Data Use statement. The Intended Data Use statement presents the researcher’s overarching research goal, main testable hypothesis or focus, and how they will proceed with their investigation. These statements are listed publically in the mPower Research Community registry on the mPower Public Researcher Portal (https://www.synapse.org/ - !Synapse:syn4993293/wiki/392026) (Figure 3).

Figure 3: Intended Data Use statement on the mPower Public Researcher Portal

After this statement has been reviewed and accepted by the Sage Bionetworks Access and Compliance Team, and posted to the Community registry, researchers are notified that they qualify for access to the mPower data. Initial access requires acknowledgement of the data-specific Terms of Use, presented via click wrap prior to download (Figure 4).

Figure 4: Data-specific Terms of Use click wrap

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Link to researcher’s Synapse profileLink to researcher’s ORCID

Researchers must complete additional steps for access to data covered by independent copyright (e.g., MDS-UPDRS survey results). These steps involve review and approval of the researcher’s Intended Data Use statement and assessment for commercial fees. This process is facilitated by an automated token exchange between Synapse and these external groups to ensure that only Synapse qualified researchers are eligible to apply for access to these independently copyrighted data.

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