How does the PMAP work with IRB and Data Trust Risk Tiers?add
The Johns Hopkins School of Medicine IRB has worked with the Data Trust (http://intranet.insidehopkinsmedicine.org/data_trust/) to streamline review processes for study protocols which use highly secure environments. The Precision Medicine Analytic Platform (PMAP) and Secure Analytic Framework Environment (SAFE) virtual desktop is the preferred platform for managing larger data sets as these tools provide a powerful and secure analytic environment for large and small data sets. Using the PMAP and SAFE platforms permits greater flexibility in specifying the research dataset for big data projects looking at correlations, as such flexibility is often required for such projects. For example, projects may choose to look at all labs for a set of patients with a specific disease rather than specifying the exact labs of interest.
The document listed below describes three tiers of risk for research and quality projects, with Tier A representing projects with the lowest level of risk and Tier C representing projects with the highest level of risk, requiring additional scrutiny. Sensitive data, viz. psychotherapy notes, substance abuse data, and HIV data, have special legal protections, and as such, require a higher level of review. Even when using preferred practices for managing data, projects seeking to use sensitive data fall into Tier B or higher. Tier A: Requires no Data Trust review by default. ORA, IRB, or data steward may request Data Trust review for a specific concern. More flexibility is allowed in the IRB application to enable larger scale exploration. Tier B: May or may not require Data Trust review. More specificity may be required in the IRB application. The Data Trust may consider projects for Executive review (see Research Data Subcouncil – Executive Review Process) Tier C: Requires IRB Data management review and or IT security review. Likely to require Data Trust review. More specificity required in the IRB application. For more information about Risk Tiers, please refer to:
In order to estimate the risk tier, please use the following risk calculator. This risk calculator will eventually be incorporated into the eIRB workflow.
How do I find the data I want in the Data Catalog, if I don't know exact table names?add
The PMAP Data Catalog uses tags to assist with catalog searching, so that users of the catalog do not need to know exact table and field names in order to find entries of interest. Example tags include: Demographics. Labs, Medication, Vital, Biospecimen.
How does the PMAP handle restricted data?add
PMAP Data Management team experts will provision data based on certain aspects of the data sets. These include restricting access to research data collected as part of an active protocol, only provisioning Protected Health Information (PHI) with prior approval, and restricting access to sensitive data elements (e.g. HIV, psychiatric, and opioid use) unless the requestor has prior permission to receive these sensitive data elements.
How is Protocol-specific data handled in the PMAP?add
Data collected as part of an active study protocol is kept in its own secure segment in PMAP separate from other data. Data from that protocol will only be provisioned to other investigators with approval from the PI of the protocol as well as approval from the IRB. Once the study protocol is no longer active, restrictions on accessing the data set will be removed and the data will be treated just like any other data in PMAP.