<section xmlns="http://xml.house.gov/schemas/uslm/1.0" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:dcterms="http://purl.org/dc/terms/" style="-uslm-lc:I80" id="ida4a86a00-09a0-11eb-a85b-f5cef3d06f4d" identifier="/us/usc/t42/s284k"><num value="284k">§ 284k.</num><heading> Clinical research</heading><subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ida4a86a01-09a0-11eb-a85b-f5cef3d06f4d" identifier="/us/usc/t42/s284k/a"><num value="a" class="bold">(a)</num><heading class="bold"> In general</heading><content><p style="-uslm-lc:I11" class="indent0">The Director of National Institutes of Health shall undertake activities to support and expand the involvement of the National Institutes of Health in clinical research.</p>
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</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ida4a86a02-09a0-11eb-a85b-f5cef3d06f4d" identifier="/us/usc/t42/s284k/b"><num value="b" class="bold">(b)</num><heading class="bold"> Requirements</heading><chapeau style="-uslm-lc:I11" class="indent0">In carrying out subsection (a), the Director of National Institutes of Health shall—</chapeau><paragraph style="-uslm-lc:I12" class="indent1" id="ida4a86a03-09a0-11eb-a85b-f5cef3d06f4d" identifier="/us/usc/t42/s284k/b/1"><num value="1">(1)</num><content> consider the recommendations of the Division of Research Grants Clinical Research Study Group and other recommendations for enhancing clinical research; and</content>
</paragraph>
<paragraph style="-uslm-lc:I12" class="indent1" id="ida4a86a04-09a0-11eb-a85b-f5cef3d06f4d" identifier="/us/usc/t42/s284k/b/2"><num value="2">(2)</num><content> establish intramural and extramural clinical research fellowship programs directed specifically at medical and dental students and a continuing education clinical research training program at the National Institutes of Health.</content>
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</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ida4a86a05-09a0-11eb-a85b-f5cef3d06f4d" identifier="/us/usc/t42/s284k/c"><num value="c" class="bold">(c)</num><heading class="bold"> Support for the diverse needs of clinical research</heading><content><p style="-uslm-lc:I11" class="indent0">The Director of National Institutes of Health, in cooperation with the Directors of the Institutes, Centers, and Divisions of the National Institutes of Health, shall support and expand the resources available for the diverse needs of the clinical research community, including inpatient, outpatient, and critical care clinical research.</p>
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</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="ida4a89116-09a0-11eb-a85b-f5cef3d06f4d" identifier="/us/usc/t42/s284k/d"><num value="d" class="bold">(d)</num><heading class="bold"> Peer review</heading><content><p style="-uslm-lc:I11" class="indent0">The Director of National Institutes of Health shall establish peer review mechanisms to evaluate applications for the awards and fellowships provided for in subsection (b)(2) and section 284<i>l</i> of this title. Such review mechanisms shall include individuals who are exceptionally qualified to appraise the merits of potential clinical research training and research grant proposals.</p>
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</subsection>
<sourceCredit id="ida4a89117-09a0-11eb-a85b-f5cef3d06f4d">(<ref href="/us/act/1944-07-01/ch373">July 1, 1944, ch. 373</ref>, title IV, § 409G, formerly § 409C, as added <ref href="/us/pl/106/505/tII/s203">Pub. L. 106–505, title II, § 203</ref>, <date date="2000-11-13">Nov. 13, 2000</date>, <ref href="/us/stat/114/2326">114 Stat. 2326</ref>; renumbered § 409G, <ref href="/us/pl/107/109/s3/1">Pub. L. 107–109, § 3(1)</ref>, <date date="2002-01-04">Jan. 4, 2002</date>, <ref href="/us/stat/115/1408">115 Stat. 1408</ref>.)</sourceCredit>
<notes type="uscNote" id="ida4a89118-09a0-11eb-a85b-f5cef3d06f4d">
<note style="-uslm-lc:I75" topic="referencesInText" id="ida4a89119-09a0-11eb-a85b-f5cef3d06f4d">
<heading class="centered smallCaps">References in Text</heading><p style="-uslm-lc:I21" class="indent0">Section 284<i>l</i> of this title, referred to in subsec. (d), was in the original “section 409D”, and was translated as meaning section 409D of <ref href="/us/act/1944-07-01/ch373">act July 1, 1944, ch. 373</ref>, as added by <ref href="/us/pl/106/505/s204/b">section 204(b) of Pub. L. 106–505</ref>. Such section 409D was renumbered section 409H of <ref href="/us/act/1944-07-01/ch373">act July 1, 1944, ch. 373</ref>, by <ref href="/us/pl/107/109/s3/2">Pub. L. 107–109, § 3(2)</ref>, <date date="2002-01-04">Jan. 4, 2002</date>, <ref href="/us/stat/115/1408">115 Stat. 1408</ref>. Another section 409D of <ref href="/us/act/1944-07-01/ch373">act July 1, 1944, ch. 373</ref>, as added by <ref href="/us/pl/106/310/s1001">section 1001 of Pub. L. 106–310</ref>, is classified to <ref href="/us/usc/t42/s284h">section 284h of this title</ref>.</p>
</note>
<note style="-uslm-lc:I74" topic="miscellaneous" id="ida4a8911a-09a0-11eb-a85b-f5cef3d06f4d"><heading class="centered smallCaps">Findings and Purpose</heading><p><ref href="/us/pl/106/505/tII/s202">Pub. L. 106–505, title II, § 202</ref>, <date date="2000-11-13">Nov. 13, 2000</date>, <ref href="/us/stat/114/2325">114 Stat. 2325</ref>, provided that:<quotedContent origin="/us/pl/106/505/tII/s202">
<subsection style="-uslm-lc:I21" class="indent0"><num value="a">“(a)</num><heading> <inline class="small-caps">Findings</inline>.—</heading><chapeau>Congress makes the following findings:</chapeau><paragraph style="-uslm-lc:I22" class="indent1"><num value="1">“(1)</num><content> Clinical research is critical to the advancement of scientific knowledge and to the development of cures and improved treatment for disease.</content>
</paragraph>
<paragraph style="-uslm-lc:I22" class="indent1"><num value="2">“(2)</num><content> Tremendous advances in biology are opening doors to new insights into human physiology, pathophysiology and disease, creating extraordinary opportunities for clinical research.</content>
</paragraph>
<paragraph style="-uslm-lc:I22" class="indent1"><num value="3">“(3)</num><content> Clinical research includes translational research which is an integral part of the research process leading to general human applications. It is the bridge between the laboratory and new methods of diagnosis, treatment, and prevention and is thus essential to progress against cancer and other diseases.</content>
</paragraph>
<paragraph style="-uslm-lc:I22" class="indent1"><num value="4">“(4)</num><content> The United States will spend more than $1,200,000,000,000 on health care in 1999, but the Federal budget for health research at the National Institutes of Health was $15,600,000,000 only 1 percent of that total.</content>
</paragraph>
<paragraph style="-uslm-lc:I22" class="indent1"><num value="5">“(5)</num><content> Studies at the Institute of Medicine, the National Research Council, and the National Academy of Sciences have all addressed the current problems in clinical research.</content>
</paragraph>
<paragraph style="-uslm-lc:I22" class="indent1"><num value="6">“(6)</num><content> The Director of the National Institutes of Health has recognized the current problems in clinical research and appointed a special panel, which recommended expanded support for existing National Institutes of Health clinical research programs and the creation of new initiatives to recruit and retain clinical investigators.</content>
</paragraph>
<paragraph style="-uslm-lc:I22" class="indent1"><num value="7">“(7)</num><content> The current level of training and support for health professionals in clinical research is fragmented, undervalued, and underfunded.</content>
</paragraph>
<paragraph style="-uslm-lc:I22" class="indent1"><num value="8">“(8)</num><chapeau> Young investigators are not only apprentices for future positions but a crucial source of energy, enthusiasm, and ideas in the day-to-day research that constitutes the scientific enterprise. Serious questions about the future of life-science research are raised by the following:</chapeau><subparagraph style="-uslm-lc:I23" class="indent2"><num value="A">“(A)</num><content> The number of young investigators applying for grants dropped by 54 percent between 1985 and 1993.</content>
</subparagraph>
<subparagraph style="-uslm-lc:I23" class="indent2"><num value="B">“(B)</num><content> The number of physicians applying for first-time National Institutes of Health research project grants fell from 1226 in 1994 to 963 in 1998, a 21 percent reduction.</content>
</subparagraph>
<subparagraph style="-uslm-lc:I23" class="indent2"><num value="C">“(C)</num><content> Newly independent life-scientists are expected to raise funds to support their new research programs and a substantial proportion of their own salaries.</content>
</subparagraph>
</paragraph>
<paragraph style="-uslm-lc:I22" class="indent1"><num value="9">“(9)</num><chapeau> The following have been cited as reasons for the decline in the number of active clinical researchers, and those choosing this career path:</chapeau><subparagraph style="-uslm-lc:I23" class="indent2"><num value="A">“(A)</num><content> A medical school graduate incurs an average debt of $85,619, as reported in the Medical School Graduation Questionnaire by the Association of American Medical Colleges (AAMC).</content>
</subparagraph>
<subparagraph style="-uslm-lc:I23" class="indent2"><num value="B">“(B)</num><content> The prolonged period of clinical training required increases the accumulated debt burden.</content>
</subparagraph>
<subparagraph style="-uslm-lc:I23" class="indent2"><num value="C">“(C)</num><content> The decreasing number of mentors and role models.</content>
</subparagraph>
<subparagraph style="-uslm-lc:I23" class="indent2"><num value="D">“(D)</num><content> The perceived instability of funding from the National Institutes of Health and other Federal agencies.</content>
</subparagraph>
<subparagraph style="-uslm-lc:I23" class="indent2"><num value="E">“(E)</num><content> The almost complete absence of clinical research training in the curriculum of training grant awardees.</content>
</subparagraph>
<subparagraph style="-uslm-lc:I23" class="indent2"><num value="F">“(F)</num><content> Academic Medical Centers are experiencing difficulties in maintaining a proper environment for research in a highly competitive health care marketplace, which are compounded by the decreased willingness of third party payers to cover health care costs for patients engaged in research studies and research procedures.</content>
</subparagraph>
</paragraph>
<paragraph style="-uslm-lc:I22" class="indent1"><num value="10">“(10)</num><content> In 1960, general clinical research centers were established under the Office of the Director of the National Institutes of Health with an initial appropriation of $3,000,000.</content>
</paragraph>
<paragraph style="-uslm-lc:I22" class="indent1"><num value="11">“(11)</num><content> Appropriations for general clinical research centers in fiscal year 1999 equaled $200,500,000.</content>
</paragraph>
<paragraph style="-uslm-lc:I22" class="indent1"><num value="12">“(12)</num><content> Since the late 1960s, spending for general clinical research centers has declined from approximately 3 percent to 1 percent of the National Institutes of Health budget.</content>
</paragraph>
<paragraph style="-uslm-lc:I22" class="indent1"><num value="13">“(13)</num><content> In fiscal year 1999, there were 77 general clinical research centers in operation, supplying patients in the areas in which such centers operate with access to the most modern clinical research and clinical research facilities and technologies.</content>
</paragraph>
</subsection>
<subsection style="-uslm-lc:I21" class="indent0"><num value="b">“(b)</num><heading> <inline class="small-caps">Purpose</inline>.—</heading><content>It is the purpose of this title [see Short Title of 2000 Amendments note set out under <ref href="/us/usc/t42/s201">section 201 of this title</ref>] to provide additional support for and to expand clinical research programs.”</content>
</subsection>
</quotedContent>
</p>
</note>
<note style="-uslm-lc:I74" topic="miscellaneous" id="ida4a8b82b-09a0-11eb-a85b-f5cef3d06f4d"><heading class="centered smallCaps">Oversight by GAO</heading><p style="-uslm-lc:I21" class="indent0"><ref href="/us/pl/106/505/tII/s207">Pub. L. 106–505, title II, § 207</ref>, <date date="2000-11-13">Nov. 13, 2000</date>, <ref href="/us/stat/114/2330">114 Stat. 2330</ref>, provided that, not later than 18 months after <date date="2000-11-13">Nov. 13, 2000</date>, the Comptroller General was to submit to Congress a report describing the extent to which the National Institutes of Health had complied with the amendments made by title II of <ref href="/us/pl/106/505">Pub. L. 106–505</ref>.</p>
</note>
</notes>
</section>