105. Mass. Code Regs. 305.070. - Application for Access to Confidential Birth Information for Research Purposes

Confidential birth information may be used in the conduct of approved research including birth related medical and demographic data obtained pursuant to M.G.L.A.111 §24B.  The investigator requesting use of the confidential birth information for research must submit an application to the Department of Public Health outlining the following:

• Purpose of the study;
• Public health benefits of the study;
• How the study will reduce mortality and morbidity in Massachusetts;
• Study design;
• Specific birth information that is required;
• If the study requires contact with the patients;
• Whether informed consent will be obtained from the patients;
• Information on any decisions by an Institutional Review Board;
• Measures undertaken to ensure the confidentiality and security of the birth information;

The applicant must submit supporting materials to the Department of Public Health.  The Department must take into account the factors above, and decide whether the confidential birth information is required for the feasibility of the research project