Research Law

Maryland Law Making All Research Follow the Federal Regulations

HOUSE BILL 917

Unofficial Copy                                                                                                                    2002 Regular Session

J1                                                                                                                                                                                                                                                                                    2lr0821

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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

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Committee Report: Favorable with amendments

House action: Adopted

Read second time: March 23, 2002

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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.