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PARRIS N. GLENDENING, Governor
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Ch. 552
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(B) A PERSON MAY NOT CONDUCT RESEARCH USING A HUMAN SUBJECT
UNLESS THE INSTITUTIONAL REVIEW BOARD HAS DETERMINED THAT;
(1) IN ACCORDANCE WITH THE PRINCIPLES AND REQUIREMENTS FOR
THE PROTECTION OF HUMAN SUBJECTS ADOPTED BY THE INSTITUTION, THE RIGHTS
AND WELFARE OF HUMAN SUBJECTS IN THE RESEARCH ARE PROTECTED; AND
(2) ALL COMPONENTS OF THE RESEARCH COMPLY WITH FEDERAL AND
STATE LAW.
(C) (1) AN INSTITUTIONAL REVIEW BOARD SHALL INVITE AN INDIVIDUAL
WITH SPECIAL KNOWLEDGE ABOUT AN AREA OF RESEARCH TO ASSIST THE
INSTITUTIONAL REVIEW BOARD IN THE REVIEW OF ISSUES THAT, AS DETERMINED
BY THE INSTITUTIONAL REVIEW BOARD, REQUIRE EXPERTISE IN ADDITION TO THAT
AVAILABLE ON THE INSTITUTIONAL REVIEW BOARD.
(2) THE INDIVIDUAL WHO ASSISTS THE INSTITUTIONAL REVIEW BOARD
UNDER PARAGRAPH (1) OF THIS SUBSECTION MAY NOT VOTE WITH THE
INSTITUTIONAL REVIEW BOARD.
(D) AN INSTITUTIONAL REVIEW BOARD SHALL REVIEW RESEARCH IN
ACCORDANCE WITH THE FEDERAL REGULATIONS ON THE PROTECTION OF HUMAN
SUBJECTS.
13-1605.
(A) THE MINUTES MAINTAINED BY AN INSTITUTIONAL REVIEW BOARD SHALL
BE OPEN TO PUBLIC INSPECTION IN THE INSTITUTION DURING BUSINESS HOURS.
(B) THE INSTITUTIONAL REVIEW BOARD SHALL REDACT ANY CONFIDENTIAL
OR PRIVILEGED INFORMATION FROM THE MINUTES MAINTAINED BY THE
INSTITUTIONAL REVIEW BOARD.
(C) FOR EACH RESEARCH PROTOCOL SUBMITTED TO AN INSTITUTIONAL
REVIEW BOARD, THE MINUTES SHALL:
(1) IDENTIFY THE ATTENDEES OF THE MEETING OF THE
INSTITUTIONAL REVIEW BOARD;
(2) SUMMARIZE THE DISCUSSION OF THE INSTITUTIONAL REVIEW
BOARD CONCERNING RISKS TO SUBJECTS, INFORMED CONSENT, AND OTHER
MATTERS DETERMINED BY THE INSTITUTIONAL REVIEW BOARD TO BE MATERIAL TO
THE INSTITUTIONAL REVIEW BOARD'S DECISION CONCERNING THE RESEARCH
PROTOCOL;
(3) DOCUMENT ANY FINDINGS OF THE INSTITUTIONAL REVIEW BOARD
REQUIRED UNDER ANY PROVISION OF FEDERAL OR STATE LAW; AND
(4) DOCUMENT THE ACTION TAKEN BY THE INSTITUTIONAL REVIEW
BOARD WITH RESPECT TO THE RESEARCH PROTOCOL, INCLUDING THE NUMBER OF
MEMBERS VOTING FOR OR AGAINST THE RESEARCH PROTOCOL, OR THAT HAVE
ABSTAINED FROM VOTING.
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- 4167 -
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