[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]