Current through Register 1518, March 29, 2024
(A) Any person may
submit a request to the Department for temporary use of confidential birth
information for research purposes. Information that may be available for
approved research studies includes birth related medical and demographic data
collected pursuant to M.G.L. c. 111, § 24B, and
105 CMR 305.000, and
certain information related to non-marital births restricted by c. 46, §
2A, but available for research purposes pursuant to M.G.L. c. 111, § 24B,
and
105 CMR 305.000. Access to
confidential birth information is limited to researchers who have been approved
by the Commissioner pursuant to M.G.L. c. 111, §§ 24A and 24B and
105 CMR 305.000. The
Commissioner may restrict use or disclosure to certain confidential birth
information or may restrict use or disclosure to certain data
elements.
(B) The principal
investigator who is requesting temporary use of confidential birth information
for research purposes shall complete an application for temporary use of
confidential birth information on a form prescribed by the Commissioner. The
applicant shall provide a detailed study protocol describing, at a minimum:
(1) The purpose of the study;
(2) The public health benefits of the
study;
(3) The applicability of the
results of the study to the reduction of morbidity or mortality in the
Commonwealth;
(4) The study design,
including the methods of data collection, plans for analysis, and expected time
frame;
(5) The specific birth
information variables required for the study with justification for each
variable;
(6) Whether the study
involves contact with the data subjects;
(7) Whether informed consent will be obtained
from the data subjects for use of confidential birth information or other
information;
(8) Information on any
review and decision by an Institutional Review Board;
(9) The measures that will be taken to ensure
the confidentiality and security of confidential birth information;
and
(10) The names and titles of
all individuals who will have access to confidential birth information for
purposes of conducting the study.
(C) The applicant shall include all related
documentation required by the Commissioner including, but not limited to:
(1) A copy of any consent forms;
(2) A copy of any questionnaires, telephone
interview scripts, and research subject contact materials;
(3) A copy of any application to an
Institutional Review Board along with any decision of the Institutional Review
Board with regard to the study; and
(4) Copies of resumes or curriculum vitae of
the principal investigator and all co-applicants.
(D) The Commissioner shall designate a
Department review committee consisting of the Registrar and senior Department
staff with experience in epidemiology, public health surveillance, public
health policy, law, or privacy protection for research subjects. The Department
review committee shall meet on a regular basis to review applications
requesting temporary use of confidential birth information. The Department
review committee shall review each application submitted to the Department for
temporary use of confidential birth information and make a recommendation to
the Commissioner regarding the application based on the review criteria
specified in 105 CMR 305.070(E). The Commissioner may approve or deny the
application, or request revisions to the application.
(E) The Department review committee shall
consider the following criteria in deciding whether to recommend approval of an
application for temporary use of confidential birth information:
(1) The application demonstrates that:
(a) The proposed study addresses a topic of
substantial public health and/or medical importance;
(b) The Department holds a present
programmatic interest or possible future programmatic interest in the results
of the proposed study; and
(c) The
purpose of the proposed study relates to the reduction of morbidity and
mortality in the Commonwealth;
(2) The application demonstrates that the
proposed study has sufficient scientific and methodological rigor to yield
results which can be used to reduce morbidity and mortality in the
Commonwealth;
(3) The study is not
feasible unless the researcher is able to have access to the requested
confidential birth information;
(4)
The researcher has limited the request to only those data elements that are
absolutely necessary to complete the proposed research study;
(5) The study has been reviewed and approved
by an Institutional Review Board at the applicant's institution and/or by the
Department's Institutional Review Board, or the applicant has provided
documentation indicating the study is exempt from such review;
(6) There are adequate written assurances
that confidential birth information will be used only for the approved research
study and that confidential birth information will be protected from improper
use or disclosure in accordance with
105
CMR 305.080;
(7) The preparation of the birth information
for the study is administratively feasible within the Department;
(8) Informed consent of the data subject for
the use or disclosure of personal or medical information is obtained whenever
required by law or whenever feasible;
(9) The researcher has provided the
Commissioner with assurances and the researcher's application demonstrates that
no individual-level data which could affect employment or eligibility for
health or insurance benefits will be provided to employers or insurers, without
the informed consent of the data subject;
(10) If the study involves contact with a
data subject:
(a) Appropriate contact
protocols are in place; and
(b)
Contact protocols have been reviewed and approved by an Institutional Review
Board that meets the requirements of 45 CFR Part 46; and
(11) The study protocol and any conditions
the Commissioner imposes on the applicant provide adequate and appropriate
safeguards to ensure the confidentiality of the birth information requested for
the study.
