Current through 2024-38, September 18, 2024
A 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.
