
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 23, 2000]
[Document not affected by Public Laws enacted between
  January 23, 2000 and December 4, 2001]
[CITE: 42USC300v-1]

 
                 TITLE 42--THE PUBLIC HEALTH AND WELFARE
 
                    CHAPTER 6A--PUBLIC HEALTH SERVICE
 
SUBCHAPTER XVI--PRESIDENT'S COMMISSION FOR THE STUDY OF ETHICAL PROBLEMS 
            IN MEDICINE AND BIOMEDICAL AND BEHAVIOR RESEARCH
 
Sec. 300v-1. Duties of Commission


(a) Studies and investigations; priority and order; report to President 
        and Congress

    (1) The Commission shall undertake studies of the ethical and legal 
implications of--
        (A) the requirements for informed consent to participation in 
    research projects and to otherwise undergo medical procedures;
        (B) the matter of defining death, including the advisability of 
    developing a uniform definition of death;
        (C) voluntary testing, counseling, and information and education 
    programs with respect to genetic diseases and conditions, taking 
    into account the essential equality of all human beings, born and 
    unborn;
        (D) the differences in the availability of health services as 
    determined by the income or residence of the persons receiving the 
    services;
        (E) current procedures and mechanisms designed (i) to safeguard 
    the privacy of human subjects of behavioral and biomedical research, 
    (ii) to ensure the confidentiality of individually identifiable 
    patient records, and (iii) to ensure appropriate access of patients 
    to information continued \1\ in such records,\2\ and
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    \1\ So in original. Probably should be ``contained''.
    \2\ So in original. The comma probably should be a semicolon.
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        (F) such other matters relating to medicine or biomedical or 
    behavioral research as the President may designate for study by the 
    Commission.

The Commission shall determine the priority and order of the studies 
required under this paragraph.
    (2) The Commission may undertake an investigation or study of any 
other appropriate matter which relates to medicine or biomedical or 
behavioral research (including the protection of human subjects of 
biomedical or behavioral research) and which is consistent with the 
purposes of this subchapter on its own initiative or at the request of 
the head of a Federal agency.
    (3) In order to avoid duplication of effort, the Commission may, in 
lieu of, or as part of, any study or investigation required or otherwise 
conducted under this subsection, use a study or investigation conducted 
by another entity if the Commission sets forth its reasons for such use.
    (4) Upon the completion of each investigation or study undertaken by 
the Commission under this subsection (including a study or investigation 
which merely uses another study or investigation), it shall report its 
findings (including any recommendations for legislation or 
administrative action) to the President and the Congress and to each 
Federal agency to which a recommendation in the report applies.

(b) Recommendations to agencies; subsequent administrative requirements

    (1) Within 60 days of the date a Federal agency receives a 
recommendation from the Commission that the agency take any action with 
respect to its rules, policies, guidelines, or regulations, the agency 
shall publish such recommendation in the Federal Register and shall 
provide opportunity for interested persons to submit written data, 
views, and arguments with respect to adoption of the recommendation.
    (2) Within the 180-day period beginning on the date of such 
publication, the agency shall determine whether the action proposed by 
such recommendation is appropriate, and, to the extent that it 
determines that--
        (A) such action is not appropriate, the agency shall, within 
    such time period, provide the Commission with, and publish in the 
    Federal Register, a notice of such determination (including an 
    adequate statement of the reasons for the determination), or
        (B) such action is appropriate, the agency shall undertake such 
    action as expeditiously as feasible and shall notify the Commission 
    of the determination and the action undertaken.

(c) Report on protection of human subjects; scope; submission to 
        President, etc.

    The Commission shall biennially report to the President, the 
Congress, and appropriate Federal agencies on the protection of human 
subjects of biomedical and behavioral research. Each such report shall 
include a review of the adequacy and uniformity (1) of the rules, 
policies, guidelines, and regulations of all Federal agencies regarding 
the protection of human subjects of biomedical or behavioral research 
which such agencies conduct or support, and (2) of the implementation of 
such rules, policies, guidelines, and regulations by such agencies, and 
may include such recommendations for legislation and administrative 
action as the Commission deems appropriate.

(d) Annual report; scope; submission to President, etc.

    Not later than December 15 of each year (beginning with 1979) the 
Commission shall report to the President, the Congress, and appropriate 
Federal agencies on the activities of the Commission during the fiscal 
year ending in such year. Each such report shall include a complete list 
of all recommendations described in subsection (b)(1) of this section 
made to Federal agencies by the Commission during the fiscal year and 
the actions taken, pursant \3\ to subsection (b)(2) of this section, by 
the agencies upon such recommendations, and may include such 
recommendations for legislation and administrative action as the 
Commission deems appropriate.
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    \3\ So in original. Probably should be ``pursuant''.
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(e) Publication and dissemination of reports

    The Commission may at any time publish and disseminate to the public 
reports respecting its activities.

(f) Definitions

    For purposes of this section:
        (1) The term ``Federal agency'' means an authority of the 
    government of the United States, but does not include (A) the 
    Congress, (B) the courts of the United States, and (C) the 
    government of the Commonwealth of Puerto Rico, the government of the 
    District of Columbia, or the government of any territory or 
    possession of the United States.
        (2) The term ``protection of human subjects'' includes the 
    protection of the health, safety, and privacy of individuals.

(July 1, 1944, ch. 373, title XVIII, Sec. 1802, as added Pub. L. 95-622, 
title III, Sec. 301, Nov. 9, 1978, 92 Stat. 3439; amended Pub. L. 96-32, 
Sec. 4, July 10, 1979, 93 Stat. 82.)


                               Amendments

    1979--Subsec. (f). Pub. L. 96-32 redesignated definitions subsection 
following subsec. (e) as (f), which in original was designated as 
``(b)''.
