105. Mass. Code Regs. 305.080. - Restrictions on Use and Disclosure of Confidential Birth Information for Research Purposes

“Restrictions on Use and Disclosure of Confidential Birth Information for Research Purposes”
 
Imposes restrictions on the use and disclosure of confidential birth information for any person who is granted temporary use of confidential birth information for research purposes.  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 for the purposes of furthering the research study to an individual already named in the application or to an individual conducting authorized oversight of the research project provided they’ve been authorized by the Commissioner.
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. All individuals who will receive or use confidential birth information must sign a pledge of confidentiality. There cannot be any database linkages utilizing any confidential birth information unless authorized by the Commissioner.If the Commissioner approves temporary use of only de-identified confidential birth information, no person participating in the research study can in any way attempt to identify or contact any of the data subjects.
Upon the completion of the research project, or at an earlier time specified by the Commissioner, the principal investigator must ensure that all confidential birth information and any linked files derived from confidential birth information are destroyed and no copies are retained. All publications or reports of analyses shall involve only aggregate data. 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 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.As a condition for the disclosure of confidential birth information by the Commissioner, the principal investigator shall sign an agreement containingconditionsin order to ensure the confidentiality of birth information.