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Research Law

Maryland Law Making All Research Follow the Federal Regulations

HOUSE BILL 917

Unofficial Copy 2002 Regular Session

J1 2lr0821

____________________________________________________________________________________

By: Delegates Hubbard, Oaks, D. Davis, Owings, Billings, Nathan-Pulliam,

Cane, Boutin, Sher, Mohorovic, Schisler, Klausmeier, Stull, Elliott, R.

Baker, Bobo, and Grosfeld

Introduced and read first time: February 8, 2002

Assigned to: Environmental Matters

_____________________________________________________________________________________

Committee Report: Favorable with amendments

House action: Adopted

Read second time: March 23, 2002

_____________________________________________________________________________________

CHAPTER_______

1 AN ACT concerning

2 Human Subject Research - Institutional Review Boards

3 FOR the purpose of requiring a person conducting human subject research to obtain

4 certain consent from the human subject under certain circumstances; requiring

5 a person conducting human subject research to obtain institutional review board

6 approval under certain circumstances; requiring an institutional review board

7 to invite certain individuals to assist the institutional review board under

8 certain circumstances; providing for the exemption of certain research; comply

9 with federal regulations on the protection of human subjects; defining certain

10 terms; providing that the minutes of an institutional review board shall be open

11 to public inspection at certain times and shall contain certain information; made

12 available upon request within a certain period of time; authorizing the Attorney

13 General to seek injunctive or other relief under certain circumstances related to

14 research in violation of this Act; and generally relating to human subject

15 research and institutional review boards.

16 BY adding to

17 Article - Health - General

18 Section 13-1601 through 13-1606 13-1604, inclusive, to be included under the

19 new subtitle "Subtitle 16. Human Subject Research"

20 Annotated Code of Maryland

21 (2000 Replacement Volume and 2001 Supplement)

22 SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF

23 MARYLAND, That the Laws of Maryland read as follows:


2 HOUSE BILL 917

1 Article - Health - General

2 SUBTITLE 16. HUMAN SUBJECT RESEARCH.

3 13-1601.

4 (A) IN THIS SUBTITLE THE FOLLOWING WORDS HAVE THE MEANINGS

5 INDICATED.

6 (B) "FEDERAL REGULATIONS ON THE PROTECTION OF HUMAN SUBJECTS"

7 MEANS:

8 (1) TITLE 45, PART 46 OF THE CODE OF FEDERAL REGULATIONS, AND

9 ANY SUBSEQUENT REVISION OF THOSE REGULATIONS; AND

10 (2) WITH RESPECT TO RESEARCH THAT IS SUBJECT TO THE

11 JURISDICTION OF THE FEDERAL FOOD AND DRUG ADMINISTRATION, TITLE 21, PARTS

12 50 AND 56 OF THE CODE OF FEDERAL REGULATIONS, AND ANY SUBSEQUENT

13 REVISION OF THOSE REGULATIONS.

14 (C) "HUMAN SUBJECT" MEANS A LIVING INDIVIDUAL ABOUT WHOM AN

15 INVESTIGATOR CONDUCTING RESEARCH OBTAINS:

16 (1) DATA THROUGH INTERVENTION OR INTERACTION WITH THE

17 INDIVIDUAL; OR

18 (2) IDENTIFIABLE PRIVATE INFORMATION HAS THE MEANING STATED

19 IN THE FEDERAL REGULATIONS ON THE PROTECTION OF HUMAN SUBJECTS.

20 (D) "INSTITUTIONAL REVIEW BOARD" MEANS ANY BOARD, COMMITTEE, OR

21 OTHER GROUP FORMALLY DESIGNATED BY AN INSTITUTION TO APPROVE THE

22 INITIATION OF, AND TO CONDUCT PERIODIC REVIEW OF, RESEARCH INVOLVING A

23 HUMAN SUBJECT HAS THE MEANING STATED IN THE FEDERAL REGULATIONS ON

24 THE PROTECTION OF HUMAN SUBJECTS.

25 (E) "RESEARCH" MEANS A SYSTEMATIC INVESTIGATION, INCLUDING

26 RESEARCH DEVELOPMENT, TESTING, AND EVALUATION, DESIGNED TO DEVELOP OR

27 CONTRIBUTE TO GENERAL KNOWLEDGE HAS THE MEANING STATED IN THE

28 FEDERAL REGULATIONS ON THE PROTECTION OF HUMAN SUBJECTS.

29 (F) "RESEARCH PROTOCOL" MEANS A WRITTEN EXPLANATION OF THE

30 OBJECTIVES AND METHODS OF PROPOSED RESEARCH.

31 13-1602.

32 THIS SUBTITLE DOES NOT APPLY TO RESEARCH THAT IS EXEMPT UNDER TITLE

33 45, 46.101(B) OF THE CODE OF FEDERAL REGULATIONS FROM FEDERAL

34 REGULATIONS ON THE PROTECTION OF HUMAN SUBJECTS.


3 HOUSE BILL 917

1 (A) A PERSON MAY NOT CONDUCT RESEARCH USING A HUMAN SUBJECT

2 UNLESS THE PERSON CONDUCTS THE RESEARCH IN ACCORDANCE WITH THE

3 FEDERAL REGULATIONS ON THE PROTECTION OF HUMAN SUBJECTS.

4 (B) NOTWITHSTANDING ANY PROVISION IN THE FEDERAL REGULATIONS ON

5 THE PROTECTION OF HUMAN SUBJECTS THAT LIMITS THE APPLICABILITY OF THE

6 FEDERAL REGULATIONS TO CERTAIN RESEARCH, SUBSECTION (A) OF THIS SECTION

7 APPLIES TO ALL RESEARCH USING A HUMAN SUBJECT.

8 13-1603.

9 (A) THIS SECTION DOES NOT APPLY IF, UNDER THE FEDERAL REGULATIONS

10 ON THE PROTECTION OF HUMAN SUBJECTS, RESEARCH MAY BE CONDUCTED

11 WITHOUT INFORMED CONSENT.

12 (B) SUBJECT TO THE GRANT OF A WAIVER BY AN INSTITUTIONAL REVIEW

13 BOARD UNDER SUBSECTION (C) OF THIS SECTION, A PERSON MAY NOT CONDUCT

14 RESEARCH USING A HUMAN SUBJECT UNLESS, IN ACCORDANCE WITH FEDERAL

15 REGULATIONS ON THE PROTECTION OF HUMAN SUBJECTS, THE PERSON HAS

16 OBTAINED:

17 (1) THE VOLUNTARY WRITTEN INFORMED CONSENT OF THE HUMAN

18 SUBJECT;

19 (2) IF THE HUMAN SUBJECT IS A MINOR WHO DOES NOT HAVE THE

20 AUTHORITY UNDER STATE LAW TO CONSENT TO A TREATMENT OR PROCEDURE

21 INVOLVED IN THE RESEARCH, THE VOLUNTARY WRITTEN INFORMED CONSENT OF A

22 PARENT OR GUARDIAN OF THE MINOR; OR

23 (3) IF THE HUMAN SUBJECT IS INCAPABLE OF GIVING INFORMED

24 CONSENT, THE VOLUNTARY WRITTEN INFORMED CONSENT OF A LEGALLY

25 AUTHORIZED REPRESENTATIVE ON BEHALF OF THE HUMAN SUBJECT.

26 (C) IN ACCORDANCE WITH FEDERAL REGULATIONS ON THE PROTECTION OF

27 HUMAN SUBJECTS, AN INSTITUTIONAL REVIEW BOARD MAY WAIVE:

28 (1) INFORMED CONSENT;

29 (2) CERTAIN ELEMENTS OF INFORMED CONSENT; OR

30 (3) WRITTEN DOCUMENTATION OF INFORMED CONSENT.

31 13-1604.

32 (A) THIS SECTION DOES NOT APPLY IF, UNDER FEDERAL REGULATIONS ON

33 THE PROTECTION OF HUMAN SUBJECTS, RESEARCH MAY BE CONDUCTED WITHOUT

34 INSTITUTIONAL REVIEW BOARD REVIEW.

35 (B) A PERSON MAY NOT CONDUCT RESEARCH USING A HUMAN SUBJECT

36 UNLESS THE INSTITUTIONAL REVIEW BOARD HAS DETERMINED THAT:


4 HOUSE BILL 917

1 (1) IN ACCORDANCE WITH THE PRINCIPLES AND REQUIREMENTS FOR

2 THE PROTECTION OF HUMAN SUBJECTS ADOPTED BY THE INSTITUTION, THE RIGHTS

3 AND WELFARE OF HUMAN SUBJECTS IN THE RESEARCH ARE PROTECTED; AND

4 (2) ALL COMPONENTS OF THE RESEARCH COMPLY WITH FEDERAL AND

5 STATE LAW.

6 (C) (1) AN INSTITUTIONAL REVIEW BOARD SHALL INVITE AN INDIVIDUAL

7 WITH SPECIAL KNOWLEDGE ABOUT AN AREA OF RESEARCH TO ASSIST THE

8 INSTITUTIONAL REVIEW BOARD IN THE REVIEW OF ISSUES THAT, AS DETERMINED

9 BY THE INSTITUTIONAL REVIEW BOARD, REQUIRE EXPERTISE IN ADDITION TO THAT

10 AVAILABLE ON THE INSTITUTIONAL REVIEW BOARD.

11 (2) THE INDIVIDUAL WHO ASSISTS THE INSTITUTIONAL REVIEW BOARD

12 UNDER PARAGRAPH (1) OF THIS SUBSECTION MAY NOT VOTE WITH THE

13 INSTITUTIONAL REVIEW BOARD.

14 (D) AN INSTITUTIONAL REVIEW BOARD SHALL REVIEW RESEARCH IN

15 ACCORDANCE WITH THE FEDERAL REGULATIONS ON THE PROTECTION OF HUMAN

16 SUBJECTS.

17 13-1605.

18 (A) THE MINUTES MAINTAINED BY AN INSTITUTIONAL REVIEW BOARD SHALL

19 BE OPEN TO PUBLIC INSPECTION IN THE INSTITUTION DURING BUSINESS HOURS.

20 (B) THE INSTITUTIONAL REVIEW BOARD SHALL REDACT ANY CONFIDENTIAL

21 OR PRIVILEGED INFORMATION FROM THE MINUTES MAINTAINED BY THE

22 INSTITUTIONAL REVIEW BOARD.

23 (C) FOR EACH RESEARCH PROTOCOL SUBMITTED TO AN INSTITUTIONAL

24 REVIEW BOARD, THE MINUTES SHALL:

25 (1) IDENTIFY THE ATTENDEES OF THE MEETING OF THE

26 INSTITUTIONAL REVIEW BOARD;

27 (2) SUMMARIZE THE DISCUSSION OF THE INSTITUTIONAL REVIEW

28 BOARD CONCERNING RISKS TO SUBJECTS, INFORMED CONSENT, AND OTHER

29 MATTERS DETERMINED BY THE INSTITUTIONAL REVIEW BOARD TO BE MATERIAL TO

30 THE INSTITUTIONAL REVIEW BOARD'S DECISION CONCERNING THE RESEARCH

31 PROTOCOL;

32 (3) DOCUMENT ANY FINDINGS OF THE INSTITUTIONAL REVIEW BOARD

33 REQUIRED UNDER ANY PROVISION OF FEDERAL OR STATE LAW; AND

34 (4) DOCUMENT THE ACTION TAKEN BY THE INSTITUTIONAL REVIEW

35 BOARD WITH RESPECT TO THE RESEARCH PROTOCOL, INCLUDING THE NUMBER OF

36 MEMBERS VOTING FOR OR AGAINST THE RESEARCH PROTOCOL, OR THAT HAVE

37 ABSTAINED FROM VOTING.


5 HOUSE BILL 917

1 13-1603.

2 (A) AN INSTITUTIONAL REVIEW BOARD SHALL MAKE THE FINAL MINUTES OF

3 A MEETING AVAILABLE FOR INSPECTION WITHIN 30 DAYS OF RECEIPT OF A REQUEST

4 FOR THE MINUTES FROM ANY PERSON.

5 (B) PRIOR TO MAKING THE MINUTES OF A MEETING AVAILABLE FOR

6 INSPECTION UNDER SUBSECTION (A) OF THIS SECTION, AN INSTITUTIONAL REVIEW

7 BOARD MAY REDACT CONFIDENTIAL OR PRIVILEGED INFORMATION.

8 (C) THE MINUTES OF A MEETING OF AN INSTITUTIONAL REVIEW BOARD ARE

9 NOT PUBLIC RECORDS UNDER TITLE 10, SUBTITLE 6 OF THE STATE GOVERNMENT

10 ARTICLE.

11 13-1606. 13-1604.

12 (A) THE OFFICE OF THE ATTORNEY GENERAL MAY SEEK APPROPRIATE

13 INJUNCTIVE OR OTHER RELIEF TO PREVENT THE CONDUCT OF RESEARCH IN

14 VIOLATION OF HUMAN SUBJECT RESEARCH IN VIOLATION OF THE FEDERAL

15 REGULATIONS ON THE PROTECTION OF HUMAN SUBJECTS OR THIS SUBTITLE.

16 (B) IN EXERCISING THE AUTHORITY GRANTED UNDER SUBSECTION (A) OF

17 THIS SECTION, THE OFFICE OF THE ATTORNEY GENERAL MAY NOT:

18 (1) SHALL AVOID DUPLICATION OF DUPLICATE THE INVESTIGATORY,

19 COMPLIANCE, OR ENFORCEMENT ACTION UNDERTAKEN BY AN AGENCY OF THE

20 FEDERAL GOVERNMENT; AND OR

21 (2) MAY NOT BRING AN ACTION UNDER SUBSECTION (A) OF THIS

22 SECTION IF AN AGENCY OF THE FEDERAL GOVERNMENT HAS DETERMINED THAT AN

23 INVESTIGATION IS NOT WARRANTED.

24 SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect

25 October 1, 2002.

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