Restrictions on Use and Disclosure of Confidential Birth Information for Research Purposes

Any person who is granted temporary use of confidential birth information for research purposes pursuant to M.G.L. c. 111, §§ 24A and 24B, and 105 CMR 305.000 shall comply with the following restrictions on the use and disclosure of such information and any other restrictions or conditions imposed by the Commissioner in any particular case: (A) Birth information shall be considered confidential. No person who is granted temporary use of confidential birth information for research purposes shall re-disclose, in any manner, any confidential birth information, except to: (1) Other individuals named in the application to the Department and only for the purposes of furthering the research study as described in the application for temporary use of confidential birth information; or (2) Individuals conducting authorized oversight of the research project, provided that the principal investigator obtains prior approval from the Commissioner. (B) Confidential birth information shall be used only for the purposes described in the application for temporary use of confidential birth information or any amendment to that application that is approved by the Commissioner. (C) The principal investigator is responsible for limiting access to the confidential birth information to only those persons listed on the original or amended application as authorized persons to maintain or use confidential birth information or any other person authorized access to confidential birth information by the Commissioner. All individuals who will receive or use confidential birth information shall sign a pledge of confidentiality, on a form prescribed by the Commissioner, which the principal investigator shall submit to the Department as a condition for approval. (D) No database linkages utilizing any confidential birth information shall be permitted unless authorized by the Commissioner. (E) If the Commissioner approves temporary use of only de-identified confidential birth information, no person participating in the research study shall in any way attempt to identify or contact any of the data subjects or allow anyone else to identify or contact any of the data subjects. (F) The Commissioner at all times retains an exclusive property interest in the ownership and control of confidential birth information that it may from time to time provide to researchers on a temporary basis for the purposes of conducting a time-limited study or research as approved by the Commissioner. Upon the completion of the research project, or at an earlier time specified by the Commissioner, the principal investigator shall ensure that all confidential birth information and any linked files derived from confidential birth information are destroyed and no copies are made or retained, unless otherwise authorized by the Commissioner. (G) All publications or reports of analyses shall involve only aggregate data. No personally identifying information or other information which could foreseeably lead to the identification of any data subject shall ever be published or disclosed. No report of confidential birth information containing statistical cells with fewer than five subjects shall be disclosed, except with prior written approval from the Commissioner. No maps which could foreseeably lead to the identification of a data subject shall be published or disclosed. (H) Initial approvals issued by the Commissioner to researchers for temporary use of confidential birth information shall expire one year from the date of initial approval. The principal investigator may submit a request for renewal of authorization to extend temporary use of confidential birth information for an additional year. Any renewal request shall contain the following information and any other information required by the Commissioner: (1) A brief summary of current project status; (2) An explanation of any proposed changes to the protocol or a statement affirming that the protocol has not changed; (3) A current copy of any Institutional Review Board approval; and (4) A current listing of staff who have access to study data. (I) The Commissioner, at his/her sole discretion, may require a principal investigator to submit a new application for access to confidential birth information every five years throughout the duration of the study. (J) As a condition for the disclosure of confidential birth information by the Commissioner, the principal investigator shall sign an agreement containing, at a minimum, the conditions listed in 105 CMR 305.080 and any other conditions considered appropriate by the Commissioner in order to ensure the confidentiality of birth information.