§241. Research and investigations generally
(a) Authority of Secretary
The Secretary shall conduct in the Service, and encourage, cooperate with, and render assistance to other appropriate public authorities, scientific institutions, and scientists in the conduct of, and promote the coordination of, research, investigations, experiments, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of physical and mental diseases and impairments of man, including water purification, sewage treatment, and pollution of lakes and streams. In carrying out the foregoing the Secretary is authorized to-
(1) collect and make available through publications and other appropriate means, information as to, and the practical application of, such research and other activities;
(2) make available research facilities of the Service to appropriate public authorities, and to health officials and scientists engaged in special study;
(3) make grants-in-aid to universities, hospitals, laboratories, and other public or private institutions, and to individuals for such research projects as are recommended by the advisory council to the entity of the Department supporting such projects and make, upon recommendation of the advisory council to the appropriate entity of the Department, grants-in-aid to public or nonprofit universities, hospitals, laboratories, and other institutions for the general support of their research;
(4) secure from time to time and for such periods as he deems advisable, the assistance and advice of experts, scholars, and consultants from the United States or abroad;
(5) for purposes of study, admit and treat at institutions, hospitals, and stations of the Service, persons not otherwise eligible for such treatment;
(6) make available, to health officials, scientists, and appropriate public and other nonprofit institutions and organizations, technical advice and assistance on the application of statistical methods to experiments, studies, and surveys in health and medical fields;
(7) enter into contracts, including contracts for research in accordance with and subject to the provisions of law applicable to contracts entered into by the military departments under sections 2353 and 2354 of title 10, except that determination, approval, and certification required thereby shall be by the Secretary of Health and Human Services; and
(8) adopt, upon recommendations of the advisory councils to the appropriate entities of the Department or, with respect to mental health, the National Advisory Mental Health Council, such additional means as the Secretary considers necessary or appropriate to carry out the purposes of this section.
The Secretary may make available to individuals and entities, for biomedical and behavioral research, substances and living organisms. Such substances and organisms shall be made available under such terms and conditions (including payment for them) as the Secretary determines appropriate.
(b) Testing for carcinogenicity, teratogenicity, mutagenicity, and other harmful biological effects; consultation
(1) The Secretary shall conduct and may support through grants and contracts studies and testing of substances for carcinogenicity, teratogenicity, mutagenicity, and other harmful biological effects. In carrying out this paragraph, the Secretary shall consult with entities of the Federal Government, outside of the Department of Health and Human Services, engaged in comparable activities. The Secretary, upon request of such an entity and under appropriate arrangements for the payment of expenses, may conduct for such entity studies and testing of substances for carcinogenicity, teratogenicity, mutagenicity, and other harmful biological effects.
(2)(A) The Secretary shall establish a comprehensive program of research into the biological effects of low-level ionizing radiation under which program the Secretary shall conduct such research and may support such research by others through grants and contracts.
(B) The Secretary shall conduct a comprehensive review of Federal programs of research on the biological effects of ionizing radiation.
(3) The Secretary shall conduct and may support through grants and contracts research and studies on human nutrition, with particular emphasis on the role of nutrition in the prevention and treatment of disease and on the maintenance and promotion of health, and programs for the dissemination of information respecting human nutrition to health professionals and the public. In carrying out activities under this paragraph, the Secretary shall provide for the coordination of such of these activities as are performed by the different divisions within the Department of Health and Human Services and shall consult with entities of the Federal Government, outside of the Department of Health and Human Services, engaged in comparable activities. The Secretary, upon request of such an entity and under appropriate arrangements for the payment of expenses, may conduct and support such activities for such entity.
(4) The Secretary shall publish a biennial report which contains-
(A) a list of all substances (i) which either are known to be carcinogens or may reasonably be anticipated to be carcinogens and (ii) to which a significant number of persons residing in the United States are exposed;
(B) information concerning the nature of such exposure and the estimated number of persons exposed to such substances;
(C) a statement identifying (i) each substance contained in the list under subparagraph (A) for which no effluent, ambient, or exposure standard has been established by a Federal agency, and (ii) for each effluent, ambient, or exposure standard established by a Federal agency with respect to a substance contained in the list under subparagraph (A), the extent to which, on the basis of available medical, scientific, or other data, such standard, and the implementation of such standard by the agency, decreases the risk to public health from exposure to the substance; and
(D) a description of (i) each request received during the year involved-
(I) from a Federal agency outside the Department of Health and Human Services for the Secretary, or
(II) from an entity within the Department of Health and Human Services to any other entity within the Department,
to conduct research into, or testing for, the carcinogenicity of substances or to provide information described in clause (ii) of subparagraph (C), and (ii) how the Secretary and each such other entity, respectively, have responded to each such request.
(5) The authority of the Secretary to enter into any contract for the conduct of any study, testing, program, research, or review, or assessment under this subsection shall be effective for any fiscal year only to such extent or in such amounts as are provided in advance in appropriation Acts.
(c) Diseases not significantly occurring in United States
The Secretary may conduct biomedical research, directly or through grants or contracts, for the identification, control, treatment, and prevention of diseases (including tropical diseases) which do not occur to a significant extent in the United States.
(d) Protection of privacy of individuals who are research subjects
The Secretary may authorize persons engaged in biomedical, behavioral, clinical, or other research (including research on mental health, including research on the use and effect of alcohol and other psychoactive drugs) to protect the privacy of individuals who are the subject of such research by withholding from all persons not connected with the conduct of such research the names or other identifying characteristics of such individuals. Persons so authorized to protect the privacy of such individuals may not be compelled in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings to identify such individuals.
(e) Preterm labor and delivery and infant mortality
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall expand, intensify, and coordinate the activities of the Centers for Disease Control and Prevention with respect to preterm labor and delivery and infant mortality.
(July 1, 1944, ch. 373, title III, §301,
Amendments
2006-Subsec. (e).
1993-Subsec. (b)(4).
1988-Subsec. (d).
1986-Subsec. (a)(3).
Subsec. (c).
1985-Subsec. (a)(3).
Subsec. (a)(8).
1978-
1976-Subsecs. (c), (h).
1974-Subsec. (c).
Subsec. (d).
Subsecs. (e), (f).
Subsec. (g).
Subsecs. (h), (i).
1972-Subsecs. (d), (i).
1971-Subsecs. (d), (i).
1970-Subsec. (d).
Subsec. (h).
1967-Subsec. (h).
1965-Subsecs. (h), (i).
1962-Subsec. (d).
1960-Subsec. (d).
1956-Subsecs. (g), (h). Act July 3, 1956, added subsec. (g) and redesignated former subsec. (g) as (h).
1948-Subsec. (d). Acts June 16, 1948, §4(e), and June 24, 1948, §4(e), made provisions applicable to the National Advisory Heart Council and the National Advisory Dental Research Council, respectively.
Subsec. (d). Act June 25, 1948, continued in basic legislation the authority to purchase penicillin and other antibiotic compounds for use in research projects.
Subsec. (g). Acts June 16, 1948, §4(f), and June 24, 1948, §4(f), made provisions applicable to the National Advisory Heart Council and the National Advisory Dental Research Council, respectively.
1946-Subsec. (d). Act July 3, 1946, made the National Advisory Mental Health Council the body to make recommendations to the Surgeon General on awarding of grants-in-aid for research projects with respect to mental health.
Subsec. (g). Act July 3, 1946, gave National Advisory Health Council the right to make recommendations to carry out purposes of this section.
Change of Name
"Secretary of Health and Human Services" substituted for "Secretary of Health, Education, and Welfare" in subsec. (a)(7), and "Department of Health and Human Services" substituted for "Department of Health, Education, and Welfare" in subsec. (b)(1), (3), and (4)(D)(I), (II), pursuant to section 509(b) of
Effective Date of 1978 Amendment
Sections 261 and 262 of
Effective Date of 1974 Amendment
Section 104(b) of
Effective Date of 1972 Amendment
Amendment by
Effective Date of 1971 Amendment
Amendment by
Coordination of Data Surveys and Reports
Female Genital Mutilation
"(a) Congress finds that-
"(1) the practice of female genital mutilation is carried out by members of certain cultural and religious groups within the United States; and
"(2) the practice of female genital mutilation often results in the occurrence of physical and psychological health effects that harm the women involved.
"(b) The Secretary of Health and Human Services shall do the following:
"(1) Compile data on the number of females living in the United States who have been subjected to female genital mutilation (whether in the United States or in their countries of origin), including a specification of the number of girls under the age of 18 who have been subjected to such mutilation.
"(2) Identify communities in the United States that practice female genital mutilation, and design and carry out outreach activities to educate individuals in the communities on the physical and psychological health effects of such practice. Such outreach activities shall be designed and implemented in collaboration with representatives of the ethnic groups practicing such mutilation and with representatives of organizations with expertise in preventing such practice.
"(3) Develop recommendations for the education of students of schools of medicine and osteopathic medicine regarding female genital mutilation and complications arising from such mutilation. Such recommendations shall be disseminated to such schools.
"(c) For purposes of this section the term 'female genital mutilation' means the removal or infibulation (or both) of the whole or part of the clitoris, the labia minor, or the labia major.
"(d) The Secretary of Health and Human Services shall commence carrying out this section not later than 90 days after the date of enactment of this Act [Apr. 26, 1996]."
Sentinel Disease Concept Study
Section 1910 of
Study of Thyroid Morbidity for Hanford, Washington
Section 161 of
National Commission on Sleep Disorders Research
Section 162 of
Research With Respect to Health Resources and Services Administration
Section 632 of
Continuing Care for Psychiatric Patients in Former Clinical Research Center at National Institute on Drug Abuse
Analysis of Thyroid Cancer; Creation and Publication of Radioepidemiological Tables
"(a) In carrying out section 301 of the Public Health Service Act [this section], the Secretary of Health and Human Services shall-
"(1) conduct scientific research and prepare analyses necessary to develop valid and credible assessments of the risks of thyroid cancer that are associated with thyroid doses of Iodine 131;
"(2) conduct scientific research and prepare analyses necessary to develop valid and credible methods to estimate the thyroid doses of Iodine 131 that are received by individuals from nuclear bomb fallout; and
"(3) conduct scientific research and prepare analyses necessary to develop valid and credible assessments of the exposure to Iodine 131 that the American people received from the Nevada atmospheric nuclear bomb tests.
"(b)(1) Within one year after the date of enactment of this Act [Jan. 4, 1983], the Secretary of Health and Human Services shall devise and publish radioepidemiological tables that estimate the likelihood that persons who have or have had any of the radiation related cancers and who have received specific doses prior to the onset of such disease developed cancer as a result of these doses. These tables shall show a probability of causation of developing each radiation related cancer associated with receipt of doses ranging from 1 millirad to 1,000 rads in terms of sex, age at time of exposure, time from exposure to the onset of the cancer in question, and such other categories as the Secretary, after consulting with appropriate scientific experts, determines to be relevant. Each probability of causation shall be calculated and displayed as a single percentage figure.
"(2) At the time the Secretary of Health and Human Services publishes the tables pursuant to paragraph (1), such Secretary shall also publish-
"(A) for the tables of each radiation related cancer, an evaluation which will assess the credibility, validity, and degree of certainty associated with such tables; and
"(B) a compilation of the formulas that yielded the probabilities of causation listed in such tables. Such formulas shall be published in such a manner and together with information necessary to determine the probability of causation of any individual who has or has had a radiation related cancer and has received any given dose.
"(3) The tables specified in paragraph (1) and the formulas specified in paragraph (2) shall be devised from the best available data that are most applicable to the United States, and shall be devised in accordance with the best available scientific procedures and expertise."
Termination of Advisory Committees
Ex. Ord. No. 13435. Expanding Approved Stem Cell Lines in Ethically Responsible Ways
Ex. Ord. No. 13435, June 20, 2007, 72 F.R. 34591, provided:
By the authority vested in me as President by the Constitution and the laws of the United States of America, and to provide leadership with respect to research on pluripotent stem cells derived by ethically responsible techniques so that the potential of pluripotent stem cells can be explored without violating human dignity or demeaning human life, it is hereby ordered as follows:
(b) Within 90 days of this order, the Secretary, after such consultation with the Director of the National Institutes of Health (Director), shall issue a plan, including such mechanisms as requests for proposals, requests for applications, program announcements and other appropriate means, to implement subsection (a) of this section, that:
(i) specifies and reflects a determination of the extent to which specific techniques may require additional basic or animal research to ensure that any research involving human cells using these techniques is clearly consistent with the standards established under this order and applicable law;
(ii) prioritizes research with the greatest potential for clinical benefit;
(iii) takes into account techniques outlined by the President's Council on Bioethics, and any other appropriate techniques and research, provided they clearly meet the standard set forth in subsection (a) of this section;
(iv) renames the "Human Embryonic Stem Cell Registry" the "Human Pluripotent Stem Cell Registry;" [sic] and
(v) adds to the registry new human pluripotent stem cell lines that clearly meet the standard set forth in subsection (a) of this section.
(c) Not later than December 31 of each year, the Secretary shall report to the President on the activities carried out under this order during the past fiscal year, including a description of the research carried out or supported by the Department of Health and Human Services, including the National Institutes of Health, and other developments in the science of pluripotent stem cells not derived from human embryos.
(a) the purposes of this order are (i) to direct the Department of Health and Human Services, including the National Institutes of Health, to intensify peer reviewed research that may result in improved understanding of or treatments for diseases and other adverse health conditions, and (ii) to promote the derivation of human pluripotent stem cell lines from a variety of alternative sources while clearly meeting the standard set forth in section 1(a) of this order;
(b) it is critical to establish moral and ethical boundaries to allow the Nation to move forward vigorously with medical research, while also maintaining the highest ethical standards and respecting human life and human dignity;
(c) the destruction of nascent life for research violates the principle that no life should be used as a mere means for achieving the medical benefit of another;
(d) human embryos and fetuses, as living members of the human species, are not raw materials to be exploited or commodities to be bought and sold; and
(e) the Federal Government has a duty to exercise responsible stewardship of taxpayer funds, both supporting important medical research and respecting ethical and moral boundaries.
(b) For purposes of this order, the term "subjecting to harm a human embryo" shall mean subjecting such an embryo to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.204(b) and section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)) as of the date of this order.
(c) Nothing in this order shall be construed to affect any policy, guideline, or regulation regarding embryonic stem cell research, human cloning by somatic cell nuclear transfer, or any other research not specifically authorized by this order, or to forbid the use of existing stem cell lines deemed eligible for other federally funded research in accordance with the presidential policy decision of August 9, 2001, for research specifically authorized by this order.
(b) This order is not intended to, and does not, create any right, benefit, or privilege, substantive or procedural, enforceable at law or in equity, by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
George W. Bush.