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Ch. 552
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2002 LAWS OF MARYLAND
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13-1602.
THIS SUBTITLE DOES NOT APPLY TO RESEARCH THAT IS EXEMPT UNDER TITLE
15, § 16.101(B) OF THE CODE OF FEDERAL REGULATIONS FROM FEDERAL
REGULATIONS ON THE PROTECTION OF HUMAN SUBJECTS.
(A) A PERSON MAY NOT CONDUCT RESEARCH USING A HUMAN SUBJECT
UNLESS THE PERSON CONDUCTS THE RESEARCH IN ACCORDANCE WITH THE
FEDERAL REGULATIONS ON THE PROTECTION OF HUMAN SUBJECTS.
(B) NOTWITHSTANDING ANY PROVISION IN THE FEDERAL REGULATIONS ON
THE PROTECTION OF HUMAN SUBJECTS THAT LIMITS THE APPLICABILITY OF THE
FEDERAL REGULATIONS TO CERTAIN RESEARCH, SUBSECTION (A) OF THIS SECTION
APPLIES TO ALL RESEARCH USING A HUMAN SUBJECT.
13-1603.
(A) THIS SECTION DOES NOT APPLY IF, UNDER THE FEDERAL REGULATIONS
ON THE PROTECTION OF HUMAN SUBJECTS, RESEARCH MAY BE CONDUCTED
WITHOUT INFORMED CONSENT.
(B) SUBJECT TO THE GRANT OF A WAIVER BY AN INSTITUTIONAL REVIEW
BOARD UNDER SUBSECTION (C) OF THIS SECTION, A PERSON MAY NOT CONDUCT
RESEARCH USING A HUMAN SUBJECT UNLESS, IN ACCORDANCE WITH FEDERAL
REGULATIONS ON THE PROTECTION OF HUMAN SUBJECTS, THE PERSON HAS
OBTAINED.
(1) THE VOLUNTARY WRITTEN INFORMED CONSENT OF THE HUMAN
SUBJECT;
(2) IF THE HUMAN SUBJECT IS A MINOR WHO DOES NOT HAVE THE
AUTHORITY UNDER STATE LAW TO CONSENT TO A TREATMENT OR PROCEDURE
INVOLVED IN THE RESEARCH, THE VOLUNTARY WRITTEN INFORMED CONSENT OF A
PARENT OR GUARDIAN OF THE MINOR; OR
(3) IF THE HUMAN SUBJECT IS INCAPABLE OF GIVING INFORMED
CONSENT, THE VOLUNTARY WRITTEN INFORMED CONSENT OF A LEGALLY
AUTHORIZED REPRESENTATIVE ON BEHALF OF THE HUMAN SUBJECT.
(C) IN ACCORDANCE WITH FEDERAL REGULATIONS ON THE PROTECTION OF
HUMAN SUBJECTS, AN INSTITUTIONAL REVIEW BOARD MAY WAIVE;
(1) INFORMED CONSENT;
(2) CERTAIN ELEMENTS OF INFORMED CONSENT; OR
(3) WRITTEN DOCUMENTATION OF INFORMED CONSENT.
13-1604.
(A) THIS SECTION DOES NOT APPLY IF, UNDER FEDERAL REGULATIONS ON
THE PROTECTION OF HUMAN SUBJECTS, RESEARCH MAY BE CONDUCTED WITHOUT
INSTITUTIONAL REVIEW BOARD REVIEW.
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- 4166 -
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