September 2006
What is the JHHC Data Sharing Committee? This committee is composed of the directors (or their delegates) of the principal departments within JHHC. The Committee will review the scientific merit, potential impact of the study and appropriateness of the study for the mission of JHHC. The Committee will assess the amount of JHHC resources that will be necessary to provide the data requested. It will also ensure that protected health information (PHI) in its custody is managed according to the HIPAA Privacy Rule and the data concerns of the individual plans with whom JHHC has contracted are respected. How should an investigator initiate a research project using clinical or administrative claims data (a.c.d.) residing at Johns Hopkins HealthCare LLC (JHHC)? The first step is to obtain IRB approval for the study. In the course of completing the eIRB application, the investigator will prompted to complete the JHHC Data Request Application. The JHHC will be notified when a new application involving its clinical or a.c.d. has been submitted. When IRB approval for the study is granted, an automatic notification from eIRB will be sent to the Chair of the JHHC Data Sharing Committee. Approval to obtain/access the clinical or a.c.d. must then be granted by the JHHC Data Sharing Committee. What are the steps of the review process at JHHC? Step 1 The Committee will review the Data Request Application and documentation. Generally, the investigator requesting the data will be asked to present the study to the JHHC Data Sharing Committee before a final decision is made. Based upon the assessment of the study’s scientific merit, potential impact and correspondence to the JHHC mission, one of following three actions may be taken: 1) Approve; 2) Pending – further information required, and the PI will be contacted; or 3) deny. If the DSC denies access to the data, the IRB will be notified of this action. Step 2 When approved, the request will be forwarded to the Director(s) of the health plans whose enrollee data is requested: Priority Partners, Employers Health Program (EHP), and/or Uniform Services Family Health Plan (USFHP). Permission of the health plans whose data is requested must be obtained prior to any release. The investigator requesting the data need not be active in this step. Step 3 With the approvals of the Data Sharing Committee and the health plans involved, the final approval for the request must come from either from the Director of Decision Support Services or the Vice President of Care Management. Prior to making a final decision, they will assess in detail the amount of resources, e.g. data analyst time, which will be required to fulfill the request for data. During Step 3 the investigator may be involved in communication with the data analyst about the definition of the data being sought.
Throughout these steps the Chair of the Data Sharing Committee will communicate the status of the request to the investigator. How can I get further information about this process? A copy of the JHHC Data Sharing policy is available at: http://irb.jhmi.edu/Forms/jhhcdatarequestapplication.doc For further information about the JHHC go to http://ppmco.org/Providers/research.htm Or Contact : The Data Sharing Administrative Assistant, 410 762-5283 or Peter J. Fagan, PhD
The Chair of the Data Sharing Committee
410 424-4958
pfagan@jhmi.edu
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