Section 305.070 - Application for Access to Confidential Birth Information for Research Purposes(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.