[PART V.]  BIRTH DEFECTS STUDIES

     [§324-41]  Definitions.  As used in this part, unless the context requires otherwise:

     "Adverse reproductive outcome" means a birth defect, stillbirth, infant death up to one year of age, or spontaneous or medical termination of pregnancy for a birth defect.

     "Birth defect" means an abnormality of structure, function, or body metabolism present at birth that adversely affects a child's health and development, results in a physical or mental disability, or is fatal.

     "Institutional review board" means an institutional review board established in accordance with 7 Code of Federal Regulations 1c.107, 10 Code of Federal Regulations 745.107, 14 Code of Federal Regulations 1230.107, 15 Code of Federal Regulations 27.107, 16 Code of Federal Regulations 1028.107, 21 Code of Federal Regulations 56.107, 22 Code of Federal Regulations 225.107, 24 Code of Federal Regulations 60.107, 28 Code of Federal Regulations 46.107, 32 Code of Federal Regulations 219.107, 34 Code of Federal Regulations 97.107, 38 Code of Federal Regulations 16.107, 40 Code of Federal Regulations 26.107, 45 Code of Federal Regulations 46.107, 45 Code of Federal Regulations 690.107, or 49 Code of Federal Regulations 11.107.

     "Registry" means a collection of data organized so that the information can be processed and made available for research.

     "Research" means a systematic investigation designed to develop or contribute to generalizable knowledge.

     "Researcher" means a person who is conducting research which has been approved or declared exempt by an institutional review board. [L 2002, c 252, pt of §2]