[PART V.] BIRTH DEFECTS STUDIES

 

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

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

"Birth defect" means an abnormalityof structure, function, or body metabolism present at birth that adverselyaffects a child’s health and development, results in a physical or mentaldisability, or is fatal.

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

"Registry" means a collection of dataorganized so that the information can be processed and made available forresearch.

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

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