Section 144-175-4 - REGISTRY DATA APPLICATION REQUIREMENTSA researcher may request Registry data by submitting to the Department a complete application on the form prescribed and furnished by the Department. The Department will only release Registry data after the Department's designee(s) responsible for managing data requests has reviewed the request and determined the applicant is eligible to receive the data.
A.Eligibility. To be eligible, the applicant must submit the following: 1. Contact Information: The researcher's full name, organizational affiliation and title (if any), mailing address, telephone number and email address. When the application is submitted on behalf of an organization, it must also include the name, title, and contact information of the official authorized to execute agreements on the organization's behalf.2. Research protocol; purpose and use statement: A detailed explanation of the purpose and scope of the data request and any preliminary plans for presentation and/or publication of results of any study, research, or analysis using the requested Registry data.3. Documentation of successful completion of the research disclosure approval process (e.g. Institutional Review Board (IRB) approval or exemption determination letter). a. If the governing IRB determines that a request for consumer information is part of a human subject research process, then the applicant must obtain IRB approval.b. If the matter requires use of HIPAA-covered protected health information, a waiver of authorization must be obtained from a HIPAA Privacy Board.c. If the governing IRB approves a protocol or determines that the applicant is not engaged in research, then the requested information may be disclosed to the applicant pursuant to a "Data Sharing and Protection Agreement."4. Any other information reasonably requested by the Department to serve the purpose of the Registry, ensure that the privacy of consumer information is protected, and understand how the data release benefits the public.B.Application review. The Department will review the complete application to determine the applicant's eligibility to receive Registry data and the type and extent of Registry data that may be released. 1. The research for which Registry data is requested must be a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.2. The Department may disclose the minimum information necessary to accomplish a specified research purpose. If it is determined that part or all of a data request can be accomplished through in-house analysis, use of unrestricted data, or the creation of proxy variables, the Department reserves the right to create such products to fill a request, rather than release the restricted data.C.Application approval. Registry data release is limited to the purpose(s) for which the information is furnished. Any further disclosure or unlawful use may result in penalties pursuant to 22 MRS §42(5). Upon determination of eligibility, the Department will notify the applicant of the approval or denial and any cost estimate associated with completing the request. 1. The Department may disclose Registry data that may directly or indirectly identify registrants only after approval of a researcher's application outlined in subsection D, which includes a signed confidentiality statement and/or data sharing agreement, and IRB approval or exemption determination letter.2. The Department may require the approved applicant to enter into a data-sharing agreement regarding the use of the Registry data before it is released.10-144 C.M.R. ch. 175, § 4