DHS 116.05(2)(c)1.1. The department may release child-identifiable information to a person requesting, in writing, information for the purpose of demographic, epidemiological, health or social services research specific to birth defects prevention and surveillance. The person proposing to conduct the research shall submit an application to the department that includes a written protocol for proposed research, the researcher’s professional qualifications, a signed agreement to ensure data confidentiality and subject privacy, and any other information requested by the department. If the proposed research involves direct contact with a child or the child’s family, the requester shall provide proof of approval by a certified institutional review board or a committee for the protection of human subjects in accordance with the regulations for research involving human subjects required by the federal department of health and human services for projects supported by that agency. The contact may only be made with the written informed consent of the parent or guardian of the subject of the report and the department shall determine whether such contact is necessary to meet the research objectives.

DHS 116.05(2)(c)2.2. The department shall acknowledge the request within 10 calendar days after receiving the request, review the request and, if the request is approved, furnish the information within 30 calendar days after receipt of the approved request.

DHS 116.05(2)(c)3.3. Any person requesting information under this paragraph shall agree in writing to all of the following:

DHS 116.05(2)(d)(d) Any informed consent required under this subsection shall contain the name of the requestor, the name of the child whose record is to be disclosed, the purpose of or need for the disclosure, the specific information to be disclosed, the time period for which the consent is effective, the date on which the consent document is signed and the signature of a parent or guardian.