II

105TH CONGRESS

1ST SESSION S. 193

To provide protections to individuals who are the human subject of research.

IN THE SENATE OF THE UNITED STATES

JANUARY 22, 1997

Mr. GLENN introduced the following bill; which was read twice and referred

to the Committee on Labor and Human Resources

A BILL

To provide protections to individuals who are the human

subject of research.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Human Research Sub5 ject Protections Act of 1997’’.

6 SEC. 2. FINDINGS AND PURPOSES.

7 (a) FINDINGS.—Congress makes the following find8 ings:

9 (1) The Constitution guarantees the right of

10 the people to be secure in their persons, and the

11 Declaration of Independence asserts as self-evident
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1 that all men have certain unalienable rights among

2 these are life, liberty and the pursuit of happiness.

3 (2) The first principle of the Nuremberg code

4 states that with respect to human research, the vol5 untary consent of the human subject is absolutely

6 essential. The Nuremberg code further asserts that

7 such consent must be competent, informed and com8 prehending.

9 (3) In 1974, the Department of Health, Edu10 cation and Welfare published regulations (45 CFR

11 46) governing the protection of human subjects in

12 research. These regulations applied only to research

13 sponsored by the Department. In 1991 these regula14 tions were adopted by 16 additional Federal agencies

15 to apply to any research which these agencies may

16 sponsor.

17 (4) Between 1974 and 1983, Congress enacted

18 2 Public Laws that established ethical advisory bod19 ies. Public Law 91–348 established the National

20 Commission for the Protection of Human Subjects

21 of Biomedical Research and Public Law 95–622 es22 tablished the President’s Commission for the Study

23 of Ethical Problems in Medicine and Biomedical and

24 Behavioral Research. Each of these advisory bodies
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1 made recommendations to the President and Con2 gress to expand protections for human research sub3 jects. Some of these recommendations have been in4 corporated into the Federal regulation (45 CFR 46).

5 (5) In 1995, the President’s Advisory Commit6 tee on Human Radiation Experiments found that

7 there are significant deficiencies in some aspects of

8 the current system for the protection of human sub9 jects. In particular, the Committee found that some

10 consent forms currently in use are flawed in morally

11 significant aspects.

12 (6) The President’s Advisory Committee on

13 Human Radiation Experiments recommended the

14 adoption of a Federal policy requiring the informed

15 consent of all human subjects of classified research

16 and that this requirement not be subject to exemp17 tion or waiver. The Committee further recommended

18 that in all cases, potential subjects should be in19 formed of the identity of the sponsoring Federal

20 agency and that the project involves classified infor21 mation.

22 (7) Some agencies of the Federal government

23 sponsor research involving human subjects, but these
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1 agencies have not adopted the Common Rule as pro2 vided for in part 46 of title 45, Code of Federal

3 Regulations.

4 (8) Private individuals or institutions that do

5 not receive any Federal funding or that are not

6 seeking the approval of the Food and Drug Adminis7 tration for a drug or device, and that sponsor re8 search involving human subjects, do not need to

9 abide by the requirements of part 46 of title 45,

10 Code of Federal Regulations.

11 (9) Many, but not all, research institutions that

12 receive Federal sponsorship for research involving

13 human subjects may voluntarily apply the protec14 tions of the Common Rule to all research conducted

15 at the research institution.

16 (10) Notwithstanding paragraphs (1) through

17 (9), no provision of United States law explicitly re18 quires that informed consent and independent review

19 of research involving human subject be obtained.

20 (11) The human research subject activities de21 scribed in this section are either in interstate (or

22 foreign) commerce or substantially affect such com23 merce or the free flow thereof, and the regulation of

24 those activities as provided for in this Act is nec25 essary to prevent and eliminate burdens upon such
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1 commerce and to effectively regulate such commerce,

2 in order to insure that the rights and welfare of

3 human research subjects are protected.

4 (b) PURPOSE.—The purposes of this Act are—

5 (1) to apply common rule protections to all

6 human subject research and provide for criminal

7 sanctions for violations of this Act;

8 (2) to prohibit the provision of Federal support

9 for classified research that is not reviewed by an in10 stitutional review board and require disclosure to

11 human research subjects of certain information re12 garding classified research; and

13 (3) to address any potential regulatory conflict

14 of interest within the Department of Health and

15 Human Services and the National Institutes of

16 Health, and establish an Office for Protection of Re17 search Subjects within the Office of the Secretary of

18 Health and Human Services.

19 SEC. 3. DEFINITIONS.

20 In this Act:

21 (1) ASSURANCE.—The term ‘‘assurance’’ means

22 a written agreement between the Secretary and a re23 search facility, or an institution supporting the re24 search facility, that such research facility will comply

25 with all Federal ethical standards regarding human
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1 subject research, including the common rule protec2 tions. Such term includes a ‘‘single project assur3 ance’’, ‘‘multiple project assurance’’, and ‘‘coopera4 tive project assurance’’.

5 (2) BOARD.—The term ‘‘board’’ means an insti6 tutional review board established in accordance with

7 and for the purposes expressed in this Act.

8 (3) CLASSIFIED RESEARCH.—The term ‘‘classi9 fied research’’ means research involving human sub10 jects that is specifically authorized under criteria es11 tablished by an Executive Order to be kept secret in

12 the interest of national defense of foreign policy.

13 (4) COMMON RULE PROTECTIONS.—The term

14 ‘‘common rule protections’’ means the requirements

15 and protections provided under part 46 of title 45,

16 Code of Federal Regulations, as in effect on the date

17 of enactment of this Act.

18 (5) HUMAN SUBJECT.—The term ‘‘human sub19 ject’’ means a living individual about whom an inves20 tigator (whether professional or student) conducting

21 research obtains—

22 (A) data through intervention or inter23 action with the individual; or

24 (B) individually identifiable private infor25 mation.
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1 (6) INTERSTATE COMMERCE.—The term ‘‘inter2 state commerce’’ has the meaning given the term in

3 section 201(b) of the Federal Food, Drug, and Cos4 metic Act (21 U.S.C. 321(b)).

5 (7) OFFICE.—The term ‘‘Office’’ means the Of6 fice for Protection of Research Subjects established

7 under section 102(a) or the Office designated under

8 section 102(b).

9 (8) RESEARCH.—The term ‘‘research’’ means a

10 systematic investigation, including research develop11 ment, testing and evaluation, designed to develop or

12 contribute to generalizable knowledge, and those ac13 tivities for which a Federal department or agency

14 has specific responsibility for regulating as research

15 activities.

16 (9) RESEARCH FACILITY.—The term ‘‘research

17 facility’’ means any public or private entity, agency

18 (including Federal, State, and other agencies) or

19 person that—

20 (A) uses human subjects in research in21 volving interstate commerce; or

22 (B) receives support under a grant, loan,

23 contract, or other award from a department,

24 agency, or instrumentality of the United States
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1 for the purpose of carrying out research using

2 human subjects.

3 (10) SECRETARY.—The term ‘‘Secretary’’

4 means the Secretary of Health and Human Services.

5 (11) STATE.—The term ‘‘State’’ means a State

6 of the United States, the District of Columbia, the

7 Commonwealth of Puerto Rico, the Virgin Islands,

8 Guam, American Samoa, or any other territory or

9 possession of the United States.

10 TITLE I—GENERAL RESEARCH

11 REQUIREMENTS

12 SEC. 101. APPLICATION OF COMMON RULE REQUIREMENTS

13 AND PROTECTIONS.

14 (a) IN GENERAL.—Except as provided in subsection

15 (b), the requirements and protections provided under part

16 46 of title 45, Code of Federal Regulations, as in effect

17 on the date of enactment of this Act, shall apply to re18 search conducted by research facilities using human sub19 jects.

20 (b) EXCEPTION WHEN IN CONFLICT WITH ACT.—

21 The provisions of this Act shall supersede any provision

22 of part 46 of title 45, Code of Federal Regulations, if such

23 provisions are in conflict.
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1 SEC. 102. OFFICE FOR PROTECTION OF RESEARCH SUB2 JECTS.

3 (a) ESTABLISHMENT.—Not later than 90 days after

4 the date of enactment of this Act, the Secretary shall es5 tablish within the Office of the Secretary an office to be

6 known as the ‘‘Office for Protection of Human Research

7 Subjects’’ or make the designation described in subsection

8 (b).

9 (b) DESIGNATION.—Not later than 90 days after the

10 date of enactment of this Act, the Secretary may reassign

11 the Office for Protection from Research Risks to the Of12 fice of the Secretary and designate such Office to carry

13 out the duties of the Office under this Act.

14 (c) FUNDING.—The Secretary shall ensure the avail15 ability of such sums as may be necessary to enable the

16 Office to conduct all activities under this Act, as well as

17 to conduct appropriate oversight and implementation ac18 tivities.

19 SEC. 103. REGISTRATION OF FACILITIES.

20 (a) IN GENERAL.—To conduct research using human

21 subjects, a research facility shall have in effect a valid reg22 istration with the Secretary in accordance with this section

23 and with such regulations as the Secretary may promul24 gate.

25 (b) REQUIREMENTS.—An application for registration

26 under subsection (a) shall include—
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1 (1) a statement of the principles of the appli2 cant research facility with respect to the protection

3 of the rights and welfare of humans subjects of re4 search conducted or supported by the research facil5 ity;

6 (2) a designation of the official responsible for

7 all human subject research conducted or supported

8 by the applicant research facility;

9 (3) a designation of, and membership roster or

10 rosters for, each board that is responsible for review11 ing human subject research conducted or supported

12 by the applicant research facility; and

13 (4) an assurance that the applicant research fa14 cility is complying and will continue to comply with

15 the requirements for—

16 (A) board membership;

17 (B) the functions and operations of the

18 board;

19 (C) the review of research by the board;

20 (D) the approval of research by the board;

21 (E) the suspension or termination of board

22 approval of research;

23 (F) the maintenance of records by the

24 board; and
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1 (G) obtaining and documenting informed

2 consent from human subjects, consent from

3 children, and permission from parents or guard4 ians as provided for in the common rule protec5 tions.

6 (c) PERIOD OF REGISTRATION.—The registration of

7 a research facility shall be valid for the 3-year period be8 ginning on the date on which the Secretary approves the

9 application for registration, except that such registration

10 may be suspended, revoked or deemed to be incomplete

11 or otherwise insufficient by the Secretary.

12 (d) AFFECT OF ASSURANCES.—Upon the notification

13 of the Secretary by the official designated under sub14 section (b)(2), a research facility shall be deemed to be

15 in compliance with the registration provisions of this sec16 tion, if that research facility has in effect a valid assurance

17 negotiated with the Department of Health and Human

18 Services.

19 (e) FAILURE TO REGISTER.—A research facility may

20 not conduct an activity covered by this Act if the facility

21 is not registered with the Secretary under this section or

22 an assurance described in subsection (d) is not in effect.

23 SEC. 104. INSPECTION AND INVESTIGATION.

24 (a) IN GENERAL.—The Secretary may carry out such

25 inspections or investigations as may be necessary to enable
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1 the Secretary to determine whether any research facility

2 has violated or is violating any provision of this Act.

3 (b) ACCESS TO FACILITIES AND RECORDS.—To en4 able the Secretary to carry out subsection (a), the Sec5 retary shall, after providing reasonable notice, be provided

6 with access to a research facility and the records required

7 to be kept by the facility pursuant to section 103(b)(4)

8 and the common rule protections.

9 (c) PENALTIES.—Title 18, United States Code, is

10 amended by inserting after chapter 89 the following:

11 ‘‘CHAPTER 90—PROTECTION OF HUMAN

12 SUBJECTS BY RESEARCH FACILITIES

13 ‘‘§ 1841. Protection of human subjects

14 ‘‘(a) IN GENERAL.—Whoever forcibly assaults, re15 sists, opposes, impedes, intimidates, or interferes with any

16 person while such person is engaged in the performance

17 of his or her official duties under the Human Research

18 Subject Protections Act of 1997, or because such person

19 has carried out such duties, shall be fined not more than

20 $10,000, or imprisoned not more than 3 years, or both.

21 ‘‘(b) USE OF WEAPON.—Whoever in the commission

22 of an act that is a violation of subsection (a), uses a deadly

23 or dangerous weapon shall be fined not more than

24 $25,000, or imprisoned not more than 10 years, or both.
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1 ‘‘(c) HOMICIDE.—Whoever kills any human being

2 while that human being is engaged in the performance of

3 his or her official duties under the Human Research Sub4 ject Protections Act of 1997, or because such human being

5 has carried out such duties, shall be fined or imprisoned

6 as provided for under sections 1111 and 1114.’’.

7 SEC. 105. ENFORCEMENT.

8 (a) SUSPENSION OF REGISTRATION.—If the Sec9 retary has reason to believe that any research facility reg10 istered under section 103 has violated or is in violation

11 of any provision of this Act, or of any of the rules or regu12 lations or standards promulgated by the Secretary under

13 this Act, the Secretary may suspend the registration of

14 that research facility for a period of not to exceed 30 days,

15 and after notice and opportunity for a hearing, may sus16 pend such registration for any additional period as the

17 Secretary may determine appropriate. Upon a determina18 tion by the Secretary that such a violation has occurred

19 the Secretary may continue such suspension or revoke the

20 registration.

21 (b) PENALTIES.—Any employee of a research facility

22 that knowingly violates any provision of this Act shall, on

23 conviction thereof, shall be fined not more than $10,000,
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1 or imprisoned not more than 3 years, or both. Such viola2 tion shall be referred by the Secretary to the United States

3 Department of Justice for prosecution.

4 SEC. 106. REGULATIONS.

5 The Secretary may promulgate such regulations as

6 the Secretary determines to be necessary to carry out this

7 Act.

8 TITLE II—CLASSIFIED

9 RESEARCH

10 SEC. 201. PROHIBITION.

11 Notwithstanding any other provision of law, no Fed12 eral funds shall be expended for the conduct of any classi13 fied research where a board has waived informed consent

14 as defined in the common rule protections or where a de15 termination has been made that the research is exempt

16 from review by such a board.

17 SEC. 202. ADDITIONAL REQUIREMENTS.

18 In addition to the requirements applicable under the

19 common rule protections, the human subjects involved in

20 any classified research that receives Federal funding shall

21 be provided with the following additional information:

22 (1) The identity of the Federal agency provid23 ing funds in connection with the conduct of such re24 search.
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1 (2) A statement that the research involves clas2 sified information.

3 (3) An unclassified description of the purpose

4 of the research.

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