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PARRIS N. GLENDENING, Governor
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Ch. 552
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Annotated Code of Maryland
(2000 Replacement Volume and 2001 Supplement)
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF
MARYLAND, That the Laws of Maryland read as follows:
Article - Health - General
SUBTITLE 16. HUMAN SUBJECT RESEARCH.
13-1601.
(A) IN THIS SUBTITLE THE FOLLOWING WORDS HAVE THE MEANINGS
INDICATED.
(B) "FEDERAL REGULATIONS ON THE PROTECTION OF HUMAN SUBJECTS"
MEANS:
(1) TITLE 45, PART 46 OF THE CODE OF FEDERAL REGULATIONS, AND
ANY SUBSEQUENT REVISION OF THOSE REGULATIONS; AND
(2) WITH RESPECT TO RESEARCH THAT IS SUBJECT TO THE
JURISDICTION OF THE FEDERAL FOOD AND DRUG ADMINISTRATION, TITLE 21, PARTS
50 AND 56 OF THE CODE OF FEDERAL REGULATIONS, AND ANY SUBSEQUENT
REVISION OF THOSE REGULATIONS.
(C) "HUMAN SUBJECT" MEANS A LIVING INDIVIDUAL ABOUT WHOM AN
INVESTIGATOR CONDUCTING RESEARCH OBTAINS;
(1) DATA THROUGH INTERVENTION OR INTERACTION WITH THE
INDIVIDUAL; OR
(2) IDENTIFIABLE PRIVATE INFORMATION HAS THE MEANING STATED
IN THE FEDERAL REGULATIONS ON THE PROTECTION OF HUMAN SUBJECTS.
(D) "INSTITUTIONAL REVIEW BOARD" MEANS ANY BOARD, COMMITTEE, OR
OTHER GROUP FORMALLY DESIGNATED BY AN INSTITUTION TO APPROVE THE
INITIATION OF, AND TO CONDUCT PERIODIC REVIEW OF, RESEARCH INVOLVING A
HUMAN SUBJECT HAS THE MEANING STATED IN THE FEDERAL REGULATIONS ON
THE PROTECTION OF HUMAN SUBJECTS.
(E) "RESEARCH" MEANS A SYSTEMATIC INVESTIGATION, INCLUDING
RESEARCH DEVELOPMENT, TESTING, AND EVALUATION, DESIGNED TO DEVELOP OR
CONTRIBUTE TO GENERAL KNOWLEDGE HAS THE MEANING STATED IN THE
FEDERAL REGULATIONS ON THE PROTECTION OF HUMAN SUBJECTS.
(F) "RESEARCH PROTOCOL" MEANS A WRITTEN EXPLANATION OF THE
OBJECTIVES AND METHODS OF PROPOSED RESEARCH.
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- 4165 -
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