Section 144-280-7 - CONFIDENTIALITY OF ALL REPORTING DATA1. All data reported to the Maine Birth Defects Program, which contains either direct or indirect individually identifiable information, shall be confidential.2. Except as otherwise provided in these Rules, individually identifiable information submitted to the Birth Defects Program shall only be available to qualified organizations with a documented history of scientific research or other researchers determined to be appropriate by the Program. In any event, disclosure of any individually identifiable information will be in conformity with applicable state and federal law.3. Any organization or individual which requests individually identifiable information from the Birth Defects Program may be required to execute such confidentiality agreements as the Program deems appropriate.4.Institutional Review Board approval is required for any research plan which involves either the use or release of any information contained in the Birth Defects Program. Any such Institutional Review Board must be established in conformity with applicable regulations established by the U.S. Department of Health and Human Services including but not limited to 45 CFR, Subtitle A, Part 46, §§ 46.101-46.409. (Revised as of Oct. 1, 2002).5. In the event a proposed research plan involves contacting family members, written consent of the parent or guardian of any infant or fetus will be required as a predicate for use or release of any information from the Birth Defects Program.10- 144 C.M.R. ch. 280, § 7