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Senate and House of Representatives Proposed Legislation on adding and expanding Clinical Research Programs

[S. 1421 Clinical Research Enhancement Act of 1997; H.R. 3001 Clinical Research Enhancement Act of 1997]

Friday, November 7, 1997

Mr. KENNEDY (for himself, Mr. Cochran, Mr. Durbin, Mr. Faircloth, and Ms. Mikulski):
S. 1421. A bill to amend the Public Health Service Act to provide additional support for and to expand clinical research programs, and for other purposes; to the Committee on Labor and Human Resources.

THE CLINICAL RESEARCH ENHANCEMENT ACT OF 1997

Mr. KENNEDY: Mr. President, the promise of new biomedical research is boundless. As impressive as the progress of the past has been, it pales in comparison to future opportunities. We stand on the threshold of stunning advances in medicine. Supporting biomedical research is among the wisest possible investments we can make in our Nation's future.

Support for clinical research is central to biomedical research. Clinical research is essential for the advancement of scientific knowledge and the development of cures and improvement treatments of disease. Tremendous advances in basic biological research are opening doors to new insights into all aspects of medicine. As a result, there are extraordinary opportunities for cutting-edge clinical research to translate breakthroughs in the laboratory to the bedsides of patients.

Improvements in patient care and diagnosis and prevention of disease depend upon clinical research that brings basic research discoveries to the bedside. In addition, the results of clinical research are incorporated by industry and developed into new drugs, vaccines, and health care products. These developments strengthen the economy and create jobs.

Advances in biomedical research may also prove to be the most effective way to reduce the country's health care costs in the long run. As our Nation's demographics change and the baby boomers move toward retirement, financing Medicare has become an increasing concern. A Duke University study released earlier this year suggests that a small improvement in the disability rate of older Americans can bring large cost savings for Medicare. Investment in medical research will result in healthier older Americans and lower costs to Medicare.

Despite these clear benefits, clinical research is in crisis. The resources dedicated to such research, particularly at the NIH, have fallen to a level that places the United States at a serious international disadvantage.

Studies by the Institute of Medicine, the National Research Council, the National Academy of Sciences, and the National Institutes of Health have highlighted significant problems in the Nation's clinical research efforts. A 1994 report by the Institute of Medicine, for example, characterized the current level of training and support for health research professionals as "fragmented, frequently undervalued and potentially underfunded."

The legislation we are introducing today seeks to enhance support of clinical research by addressing the issues that have caused this crisis in clinical research.

First, it will implement the longstanding recommendations regarding the merit review process for clinical research proposals at NIH.

Second, it will provide greater support for general clinical research centers.

Third, it will create new opportunities to pursue clinical research. A Clinical Research Career Enhancement Award will enable a clinical researcher to pursue research projects with a mentor prior to independent pursuit of research. For more established researchers, the Innovative Medical Science Award will provide funds to apply basic scientific discoveries to medical treatment. Both awards will generate the protected time which is so valuable to physician-scientists.

Fourth, the bill provides support for individuals seeking advanced degrees in clinical investigation.

Fifth, it expands the Loan Repayment Program for clinical researchers to encourage the recruitment of new investigators.

A solid infrastructure is essential to any research program. In clinical research, that infrastructure is provided by the general clinical research centers at academic health centers throughout the country. Support for these centers was once largely provided by academic health centers. Today, academic health centers provide approximately $1 billion annually from clinical revenues to support clinical research. However, academic health centers are confronted with heavy competition from nonteaching institutions and are increasingly obligated to emphasize patient care over research to minimize costs. In the face of these changes, clinical researchers have become more dependent on NIH for infrastructure support.

In spite of the expanding need, NIH support for the general clinical research centers has barely kept up with inflation. The centers are consistently funded at 75 percent of the funding level recommended by the NIH's own Advisory Council. This level is not adequate for the backbone of the Nation's clinical research efforts. Clearly we need to do more.

The number of physicians choosing careers in clinical investigation is in serious decline. Between 1985 and 1997, the number of physicians increased by 34 percent, while the number of physicians pursuing research decreased by 37 percent. Fewer young physicians are choosing careers in research, and we need to reverse that decline.

Student debt is a major barrier to pursuing clinical research. Young physicians graduate from medical school with an average debt burden of $80,000. Limited financial opportunity in clinical research has caused many young physicians to choose more lucrative medical practice. NIH has acknowledged this problem and has established a loan repayment subsidy to encourage the recruitment of clinical researchers to NIH. Our legislation expands the current program.

Many of today's young clinical investigators are unfamiliar with research methodology. Dr. Harold Varmus, the Director of NIH, has articulated the need for individuals seeking careers in clinical research to have access to clinical research-specific training programs after they graduate from medical school. The NIH already supports a postgraduate training for those pursuing basic research. This legislation will support a comparable program for clinical investigators.

Clinical researchers at academic health centers are also increasingly urged to turn their attention away from research to generate greater revenues. This loss of protected time has a significant adverse impact on their ability to compete for NIH research grants. This problem is particularly difficult for young researchers still seeking mentored research experience during the early years of clinical investigation. The NIH currently has awards to provide mentored career development experiences for basic scientists. Our legislation creates career development awards to help meet this need.

Less than a third of all NIH grantees are physicians. Only a fraction of them receive awards for clinical investigation. The funding gap for clinical research is most severe in the earliest phases of clinical investigation, where basic scientific discoveries are tested on a small scale in studies involving few patients. Industry will not support such research in non-product-oriented studies and often regard such efforts as too speculative. The medical science awards in our bill will ensure funding for these important research initiatives.

The need for reform of the peer review system has been documented by studies by the Institute of Medicine and an outside review committee of the NIH Division of Research Grants, which is responsible for the peer review process. So far, their recommendations have not been implemented, and the bias against clinical research persists. Our legislation will implement these recommendations and provide effective evaluation of clinical research proposals.

The funds authorized by our legislation to support clinical research do not target specific diseases. The funds would go to peer-reviewed proposals to translate basic scientific discoveries into treatment and prevention of disease. Without such legislation, clinical research will continue to decline to a point where advances in medicine will no longer come from this country but from abroad.

Mr. President, our bill is supported by more than a hundred and forty biomedical associations and organizations. I would like to thank the American Federation for Medical Research for their efforts to support this legislation and ask unanimous consent that the list of supporters, the letters of support be and a copy of the bill be included in the Record.

I look forward to working with my colleagues as we move this important legislation through Congress.

There being no objection, the material was ordered to be printed in the Record, as follows:

Supporters of Clinical Research Enhancement Act

Alliance for Aging Research
Alzheimer's Association
Ambulatory Pediatric Association
American Academy of Child and Adolescent Psychiatry
American Academy of Dermatology
American Academy of Neurology
American Academy of Optometry
American Academy of Ophthalmology
American Academy of Otolaryngology-Head and Neck Surgery
American Academy of Physical Medicine and Rehabilitation
American Association for Cancer Research
American Association for the Surgery of Trauma
American Association of Anatomists
American Association of Colleges of Nursing
American Association of Neurological Surgeons
American Cancer Society
American Celiac Society--Dietary Support Coalition
American College of Chest Physicians
American College of Clinical Pharmacology
American College of Medical Genetics
American College of Neuropsychopharmacology
American Diabetes Association
American Federation for Medical Research
American Gastroenterological Association
American Geriatrics Society
American Heart Association
American Kidney Fund
American Liver Foundation
American Lung Association
American Neurological Association
American Optometric Association
American Pediatric Society
American Psychiatric Association
American Skin Association
American Society for Bone and Mineral Research
American Society for Clinical Nutrition
American Society for Clinical Pharmacology and Therapeutics
American Society for Reproductive Medicine
American Society of Addiction Medicine
American Society of Adults with Pseudo-Obstruction, Inc.
American Society of Clinical Nutrition
American Society of Hematology
American Society of Nephrology
American Thoracic Society
American Urological Association
Americans for Medical Progress
Arthritis Foundation
Association for Medical School Pharmacology
Association for Research in Vision and Ophthalmology
Association of Academic Health Centers
Association of Academic Physiatrists
Association of American Cancer Institutes
Association of American Medical Colleges
Association of American Veterinary Medical Colleges
Association of Behavorial Sciences and Medical Education
Association of Departments of Family Medicine
Association of Medical and Graduate Departments of Biochemistry
Association of Medical School Pediatric Department Chairmen
Association of Pathology Chairs
Association of Professors of Dermatology
Association of Professors of Medicine
Association of Program Directors in Internal Medicine
Association of Schools and Colleges of Optometry
Association of Schools of Public Health
Association of Subspecialty Professors
Association of University Radiologists
American Urogynecologic Society
Center for Ulcer Research and Education Foundation
Citizens for Public Action
Cooley's Anemia Foundation
Crohn's and Colitis Foundation of America
Cystic Fibrosis Foundation
Dean Thiel Foundation
Digestive Disease National Coalition
East Carolina University School of Medicine
Ehlers-Danlos National Foundation
Ermory University School of Medicine
The Endocrine Society
Epilepsy Foundation of America
Foundation for Ichthyosis and Related Skin Types
Gay Men's Health Crisis
General Clinical Research Center Program Directors' Association
Gluten Intolerance Group
Hemochromatosis Research Foundation
Hepatitis Foundation International
Inova Institute of Research and Education
Institute for Asthma and Allergy
International Foundation for Functional Gastrointestinal Disorders
Jeffrey Modell Foundation
Joint Council of Allergy, Asthma and Immunology
Juvenile Diabetes Foundation International
Lawson Wilkins Pediatric Endocrine Society
Lupus Foundation of America, Inc.
Medical Dermatology Society
Mount Sinai Medical Center
National Caucus of Basic Biomedical Science Chairs
National Committee to Preserve Social Security and Medicare
National Health Council
National Marfan Foundation
National Multiple Sclerosis Society
National Organization for Rare Disorders
National Osteoporosis Foundation
National Perinatal Association
National Tuberous Sclerosis Association
National Vitiligo Foundation, Inc.
National Vulvodynia Association
North America Society of Pacing and Electrophysiology
Oley Foundation for Home Parenteral and Enteral Nutrition
The Orton Dyslexia Society
Osteogenesis Imperfecta Foundation
PXE International
RESOLVE
Schepens Eye Research Institute
Scleroderma Research Foundation
Society for Academic Emergency Medicine
Society for the Advancement of Women's Health Research
Society for Inherited Metabolic Disorders
Society for Investigative Dermatology
Society for Pediatric Research
Society of Gastroenterology Nurses and Associates, Inc.
Society of Gynecologic Oncologists
Society of Medical College Directors of Continuing Medical Education
Soviety of University Urologists
St. Jude Children's Research Hospital
Tourette Syndrome Association, Inc.
United Ostomy Association
United Scleroderma Foundation
University of Rochester School of Medicine and Dentistry
Wound, Ostomy and Continence Nurses Society
Yale University School of Medicine.

American Federation for Medical Research

November 7, 1997.
Hon. Thad Cochran
The Honorable Edward Kennedy,
U.S. Senate, Washington, DC.

Dear Senators Cochran and Kennedy:

I write to express the strong support of the American Federation for Medical Research for the legislation you will introduce to enhance clinical research programs at the National Institutes of Health. The AFMR is a national organization of 6,000 physician scientists engaged in basic, clinical, and health services research. Most of our members receive NIH support for their basic research but are finding it increasingly difficult to obtain public or private funding for translational or clinical research--studies through which basic science discoveries are translated to the care of patients. In the past, academic medical centers provided institutional support for this research through revenues generated by patient care activities. However, as the health care marketplace has become increasingly competitive, academic centers have all but eliminated internal subsidizes clinical research or the training of clinical investigators. In fact, the Association of American Medical Colleges has estimated that these institutions have lost approximately $800 million in annual "purchasing power" for research and research training within their institutions. In this context, the $60 million in spending entailed in your legislation (representing less than one-half of one percent of the NIH budget) would seem an extremely modest investment in a much-needed program to reinvigorate our nation's clinical research capabilities.

The Clinical Research Enhancement Act is a conservative approach to a severe problem. The Institute of Medicine (IOM) expressed alarm about the challenges confronting clinical research in a 1994 report, and your bill is based on the initiatives recommended by the IOM:

The IOM recommended that the General Clinical Research Centers program be strengthened. Your bill would codify this program, which has existed since the late 1950's, so that the Congress will have greater discretion over GCRC funding.

The IOM recommended enhanced career development in clinical investigation, and your bill proposes such awards.

The IOM noted problems with the NIH peer review of clinical research. Your bill directs the NIH to improve the peer review process for such research and establishes "innovative science awards" that will be reviewed by scientists knowledgeable in clinical investigation.

The IOM recommended programs to relieve the tuition debt of physicians pursuing clinical research careers. Your bill would expand an existing NIH intramural program for this purpose to the extramural community.

The IOM recommended structured, didactic training in clinical investigation. Your bill authorizes funding for advanced degree (master's and Ph.D.) training in clinical research as successfully initiated at several institutions around the country.

The list of almost 150 organizations that support the Clinical Research Enhancement Act indicates the consensus of scientific, medical, consumer, and patient organizations that steps must be taken as soon as possible to stop the deterioration of the U.S. clinical research capacity, to reinvigorate the clinical research programs of academic medical centers, and to assure that the American people and the American economy benefit from the translation of basic science breakthroughs to improved clinical care and new medical products. The American Federation for Medical Research is pleased to have the opportunity to express its strong support for your legislation.

Sincerely,
Jeffrey Kern, MD.,
President.

As a coalition of organizations concerned about improving the quality of health care, the National Health Council strongly supports the Clinical Research Enhancement Act. As you know, it has been more than three years since the Institute of Medicine (IOM) documented the major challenges confronting clinical research in our country. Your bill would implement a number of the IOM recommendations for addressing these problems. It is critically important that the NIH move forward as rapidly as possible with these initiatives.

The NIH is the major funding source in the United States for basic biomedical research. However, the major dividends from this investment are discoveries that improve our ability to prevent, effectively treat, and cure disease and disability. The NIH must foster not only the basic research that begins this process but also the translational research through which a basic science discovery is applied to a medical problem. There is generous industry support for clinical research and clinical trials aimed at the development of new products. However, private funding is extremely limited for initial translational research that may have little or no commercial product potential. Examples of such research include studies of nutritional therapies, new approaches to disease prevention, transplantation techniques, behavioral interventions, and studies of off-label uses of approved drugs. In the past, such research was often subsidized from patient care revenues to academic medical centers. However, competition in the health care marketplace has begun to erode this source of funding; therefore, NIH must play an expanded role in providing support for this research. The Clinical Research Enhancement Act would foster NIH funding opportunities for this type of research through the establishment of "innovative medical science awards." Such studies will focus on translating basic research discoveries into tools that health care professionals can use to cure disease and relieve suffering.

In addition, we support provisions of the bill that would foster opportunities for physicians to pursue careers in clinical research. There is ample evidence that American physicians are opting out of careers in science for a variety of reasons. Steps must be taken to rebuild our nation's supply of well-trained physician scientists if the United States is to continue its leadership of the world in medical science.

Finally, the bill would direct the NIH to improve the peer review of patient-oriented research. Studies have documented the fact that clinical research proposals are at a disadvantage when reviewed by NIH study sections because of NIH's primary focus on basic biomedical research. This must be changed, as proposed in your bill, so that scientific opportunities to improve medical care are not lost.

The undersigned organizations are extremely grateful for your leadership in addressing the problems confronting clinical research. We support your initiative to assure that the NIH invests in the translational research that holds the key for patients around the country who are waiting for a cure. We are pleased to endorse the clinical Research Enhancement Act.

Alzheimer's Association
American Autoimmune Related Diseases Association
American Diabetes Association
American Kidney Fund
American Paralysis Association
Digestive Diseases National Coalition
Epilepsy Foundation of America
Foundation Fighting Blindness
Juvenile Diabetes Foundation International
Glaucoma Research Foundation
Myasthenia Gravis Foundation
National Alopecia Areata Foundation
National Multiple Sclerosis Society
National Osteoporosis Foundation
National Tuberous Sclerosis Association
Paget Foundation
Sjogren's Syndrome Foundation
Tourette Syndrome Association.



105th CONGRESS
  1st Session
                                S. 1421

 To amend the Public Health Service Act to provide additional support 
 for and to expand clinical research programs, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            November 7, 1997

 Mr. Kennedy (for himself, Mr. Cochran, Mr. Durbin, Mr. Faircloth, and 
 Ms. Mikulski) introduced the following bill; which was read twice and 
         referred to the Committee on Labor and Human Resources

_______________________________________________________________________

                                 A BILL


 
 To amend the Public Health Service Act to provide additional support 
 for and to expand clinical research programs, and for other purposes.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Clinical Research Enhancement Act of 
1997''.

SEC. 2. FINDINGS AND PURPOSE.

    (a) Findings.--Congress makes the following findings:
            (1) Clinical research is critical to the advancement of 
        scientific knowledge and to the development of cures and 
        improved treatment for disease.
            (2) Tremendous advances in biology are opening doors to new 
        insights into human physiology, pathophysiology and disease, 
        creating extraordinary opportunities for clinical research.
            (3) 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.
            (4) The United States will spend more than $1 trillion on 
        health care in 1997, but the Federal budget for health research 
        at the National Institutes of Health was $12.7 billion, only 1 
        percent of that total.
            (5) 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.
            (6) The Director of the National Institutes of Health has 
        recognized the current problems in clinical research and has 
        through the use of an advisory committee begun to evaluate 
        these problems.
            (7) The current level of training and support for health 
        professionals in clinical research is fragmented, frequently 
        undervalued, and potentially underfunded.
            (8) 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:
                    (A) The number of young investigators applying for 
                grants dropped by 54 percent between 1985 and 1993.
                    (B) The number of federally funded research (R01) 
                grants awarded to persons under the age of 36 have 
                decreased by 70 percent from 1985 to 1993.
                    (C) Newly independent life-scientists are expected 
                to raise funds to support their new research programs 
                and a substantial proportion of their own salaries.
            (9) The following have been cited as reasons for the 
        decline in the number of active clinical researchers, and those 
        choosing this career path:
                    (A) A medical school graduate incurs an average 
                debt of $80,000, as reported in the Medical School 
                Graduation Questionnaire by the American Association of 
                Medical Colleges (AAMC).
                    (B) The prolonged period of clinical training 
                required increases the accumulated debt burden.
                    (C) The decreasing number of mentors and role 
                models.
                    (D) The perceived instability of funding from the 
                National Institutes of Health and other Federal 
                agencies.
                    (E) The almost complete absence of clinical 
                research training in the curriculum of training grant 
                awardees.
                    (F) 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.
            (10) 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.
            (11) Appropriations for general clinical research centers 
        in fiscal year 1997 equaled $153,000,000.
            (12) In fiscal year 1997, there were 74 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.
            (13) The average annual amount allocated for each general 
        clinical research center is $1,900,000, establishing a current 
        funding level of 75 percent of the amounts approved by the 
        Advisory Council of the National Center for Research Resources.
    (b) Purpose.--It is the purpose of this Act to provide additional 
support for and to expand clinical research programs.

SEC. 3. INCREASING THE INVOLVEMENT OF THE NATIONAL INSTITUTES OF HEALTH 
              IN CLINICAL RESEARCH.

    Section 402 of the Public Health Service Act (42 U.S.C. 282) is 
amended by adding at the end the following:
    ``(l)(1) The Director of NIH shall undertake activities to support 
and expand the involvement of the National Institutes of Health in 
clinical research.
    ``(2) In carrying out paragraph (1), the Director of NIH shall--
            ``(A) design test pilot projects and implement the 
        recommendations of the Division of Research Grants Clinical 
        Research Study Group and other recommendations for enhancing 
        clinical research, where applicable; and
            ``(B) establish an intramural clinical research fellowship 
        program and a continuing education clinical research training 
        program at NIH.
    ``(3) The Director of NIH, 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.
    ``(4) The Director of NIH shall establish peer review mechanisms to 
evaluate applications for--
            ``(A) clinical research career enhancement awards;
            ``(B) innovative medical science awards;
            ``(C) graduate training in clinical investigation awards;
            ``(D) intramural clinical research fellowships.
Such review mechanisms shall include individuals who are exceptionally 
qualified to appraise the merits of potential clinical research 
training and research grant proposals.''.

SEC. 4. GENERAL CLINICAL RESEARCH CENTERS.

    Part B of title IV of the Public Health Service Act (42 U.S.C. 284 
et seq.) is further amended by adding at the end the following:

``SEC. 409B. GENERAL CLINICAL RESEARCH CENTERS.

    ``(a) Grants.--The Director of the National Center for Research 
Resources shall award grants for the establishment of general clinical 
research centers to provide the infrastructure for clinical research 
including clinical research training and career enhancement. Such 
centers shall support clinical studies and career development in all 
settings of the hospital or academic medical center involved.
    ``(b) Activities.--In carrying out subsection (a), the Director of 
NIH shall expand the activities of the general clinical research 
centers through the increased use of telecommunications and 
telemedicine initiatives.
    ``(c) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section, such sums as may be necessary.

``SEC. 409C. ENHANCEMENT AWARDS.

    ``(a) Clinical Research Career Enhancement Award.--
            ``(1) In general.--The Director of the National Center for 
        Research Resources shall make grants (to be referred to as 
        `clinical research career enhancement awards') to support 
        individual careers in clinical research at general clinical 
        research centers or at other institutions that have the 
        infrastructure and resources deemed appropriate for conducting 
        patient-oriented clinical research. The Director of the 
        National Center for Research Resources shall, where 
        practicable, collaborate or consult with other Institute 
        Directors in making awards under this subsection.
            ``(2) Applications.--An application for a grant under this 
        subsection shall be submitted by an individual scientist at 
such time as the Director may require.
            ``(3) Limitations.--The amount of a grant under this 
        subsection shall not exceed $125,000 per year per grant. Grants 
        shall be for terms of 5 years. The Director shall award not 
        more than 20 grants in the first fiscal year, and not more than 
        40 grants in the second fiscal year, in which grants are 
        awarded under this subsection.
            ``(4) Authorization of appropriations.--There is authorized 
        to be appropriated to make grants under paragraph (1), 
        $3,000,000 for fiscal year 1998, and such sums as may be 
        necessary for each subsequent fiscal year.
    ``(b) Innovative Medical Science Award.--
            ``(1) In general.--The Director of the National Center for 
        Research Resources shall make grants (to be referred to as 
        `innovative medical science awards') to support individual 
        clinical research projects at general clinical research centers 
        or at other institutions that have the infrastructure and 
        resources deemed appropriate for conducting patient-oriented 
        clinical research. The Director of the National Center for 
        Research Resources shall, where practicable, collaborate or 
        consult with other Institute Directors in making awards under 
        this subsection.
            ``(2) Applications.--An application for a grant under this 
        subsection shall be submitted by an individual scientist at 
        such time as the Director requires.
            ``(3) Limitations.--The amount of a grant under this 
        subsection shall not exceed $175,000 per year per grant.
            ``(4) Authorization of appropriations.--There is authorized 
        to be appropriated to make grants under this subsection, 
        $52,500,000 for fiscal year 1998, and such sums as may be 
        necessary for each subsequent fiscal year.
    ``(c) Graduate Training in Clinical Investigation Award.--
            ``(1) In general.--The Director of the National Center for 
        Research Resources shall make grants (to be referred to as 
        `graduate training in clinical investigation awards') to 
        support individuals pursuing master's or doctoral degrees in 
        clinical investigation.
            ``(2) Applications.--An application for a grant under this 
        subsection shall be submitted by an individual scientist at 
        such time as the Director may require.
            ``(3) Limitations.--The amount of a grant under this 
        subsection shall not exceed $75,000 per year per grant. Grants 
        shall be for terms of 2 years or more and will provide stipend, 
        tuition, and institutional support for individual advanced 
        degree programs in clinical investigation.
            ``(4) Definition.--As used in this subsection, the term 
        `advanced degree programs in clinical investigation' means 
        programs that award a master's or Ph.D. degree after 2 or more 
        years of training in areas such as the following:
                    ``(A) Analytical methods, biostatistics, and study 
                design.
                    ``(B) Principles of clinical pharmacology and 
                pharmacokinetics.
                    ``(C) Clinical epidemiology.
                    ``(D) Computer data management and medical 
                informatics.
                    ``(E) Ethical and regulatory issues.
                    ``(F) Biomedical writing.
            ``(5) Authorization of Appropriations.--There is authorized 
        to be appropriated to make grants under this subsection, 
        $3,000,000 for fiscal year 1998, and such sums as may be 
        necessary for each subsequent fiscal year.''.

SEC. 5. CLINICAL RESEARCH ASSISTANCE.

    (a) National Research Service Awards.--Section 487(a)(1)(C) of the 
Public Health Service Act (42 U.S.C. 288(a)(1)(C)) is amended by 
striking ``50 such'' and inserting ``100 such''.
    (b) Loan Repayment Program.--Section 487E of the Public Health 
Service Act (42 U.S.C. 288-5) is amended--
            (1) in the section heading, by striking ``from 
        disadvantaged backgrounds'';
            (2) in subsection (a)(1)--
                    (A) by striking ``who are from disadvantaged 
                backgrounds''; and
                    (B) by striking ``as employees of the National 
                Institutes of Health'' and inserting ``as part of a 
                clinical research training position'';
            (3) in subsection (a), by striking paragraph (3) and 
        inserting the following:
            ``(3) Applicability of certain provisions regarding 
        obligated service.--With respect to the National Health Service 
        Corps Loan Repayment Program established under subpart III of 
        part D of title III, the provisions of such subpart shall, 
        except as inconsistent with this section, apply to the program 
        established in this section in the same manner and to the same 
        extent as such provisions apply to such loan repayment 
        program.'';
            (4) in subsection (b)--
                    (A) by striking ``Amounts'' and inserting the 
                following:
            ``(1) In general.--Amounts''; and
                    (B) by adding at the end the following:
            ``(2) Disadvantaged backgrounds set-aside.--In carrying out 
        this section, the Secretary shall ensure that not less than 50 
        percent of the contracts involve those appropriately qualified 
        health professionals who are from disadvantaged backgrounds.''; 
        and
            (5) by adding at the end the following:
    ``(c) Definition.--As used in subsection (a)(1), the term `clinical 
research training position' means an individual serving in a general 
clinical research center or in clinical research at the National 
Institutes of Health, or a physician receiving a clinical research 
career enhancement award, an innovative medical science award, or a 
graduate training in clinical investigation award.
    ``(d) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section such sums as may be necessary 
for each fiscal year.''.

SEC. 6. DEFINITION.

    Section 409 of the Public Health Service Act (42 U.S.C. 284d) is 
amended--
            (1) by striking ``For purposes'' and inserting ``(a) Health 
        Service Research.--For purposes''; and
            (2) by adding at the end the following:
    ``(b) Clinical Research.--As used in this title, the term `clinical 
research' means patient oriented clinical research conducted with human 
subjects, or research on the causes and consequences of disease in 
human populations involving material of human origin (such as tissue 
specimens and cognitive phenomena) for which an investigator or 
colleague directly interacts with human subjects in an outpatient or 
inpatient setting to clarify a problem in human physiology, 
pathophysiology, or disease; or epidemiologic or behavioral studies, 
outcomes research, or health services research, or developing new 
technologies or therapeutic interventions.''.



INTRODUCTION OF THE CLINICAL RESEARCH ENHANCEMENT ACT OF 1997

______

HON. NITA M. LOWEY

of new york

in the house of representatives

Sunday, November 9, 1997

Mrs. LOWEY: Mr. Speaker, I am pleased to introduce today the Clinical Research Enhancement Act of 1997. This legislation will better enable us to translate basic science discoveries into improvements in medical treatment. I am pleased to be joined by Congresswoman Nancy Johnson as the primary cosponsor of this important legislation.

The difficulties faced by clinical researchers and their patients threaten progress in medicine and our country's international competitive edge in biomedical science. We are losing a generation of physician scientists because of limited research funding, medical tuition indebtedness, and obstacles created by our increasingly competitive health care system. While the Clinical Research Enhancement Act of 1997 cannot address all these problems, it can help us to recruit and retain talented clinical investigators to insure that advances in basic biomedical science are more readily translated into improvements in patient care.

In 1994, the Institute of Medicine [IOM] issued a groundbreaking report outlining the crisis facing clinical research. The IOM report found that numerous obstacles confront clinical researchers at various points in their careers. Furthermore, the IOM concluded that we simply are not training the number of clinical scientists necessary to address the rapid discoveries occurring in basic biomedicine. Studies by the National Research Council, National Academy of Sciences, and the National Institutes of Health have also highlighted the problems facing clinical research.

The Clinical Research Enhancement Act of 1997 will improve Federal support of clinical research by:

Improving the peer review process for clinical research grants and establishing innovative science awards that will be reviewed by scientists who are particularly knowledgeable about clinical research;

Strengthening the general clinical research centers [GCRC's] which now serve as the hub of NIH-supported extramural clinical research activity;

Enhancing the career development of clinical scientists by creating new awards that will be similar to existing NIH career awards but focused on clinical investigators who pursue initial research projects with a mentor prior to independent pursuit of research;

Creating innovative medical science awards for more established researchers in order to improve funding for projects involving potential clinical applications of a basic discovery which are tested on a small number of patients;

Providing support for scientists seeking advanced degrees in clinical investigation in order to address the need for structured, academic training in clinical investigation; and

Expanding the existing loan repayment program available to clinical researchers who are based at the NIH campus to make it available to NIH-supported clinical scientists at centers around the country.

The Clinical Research Enhancement Act of 1997 has the support of over 100 medical, scientific, and academic organizations. I want to especially commend the American Federation for Medical Research for their leadership on this important issue.

I urge my colleagues to cosponsor this legislation which will help to ensure that our Federal investment in basic biomedical science is translated into improvements in medical care.

I request that the accompanying materials be included in the Record.

    As a coalition of organizations concerned about improving the quality of health care, the National Health Council strongly supports the Clinical Research Enhancement Act. As you know, it has been more than three years since the Institute of Medicine (IOM) documented the major challenges confronting clinical research in our country. Your bill would implement a number of the IOM recommendations for addressing these problems. It is critically important that the NIH move forward as rapidly as possible with these initiatives.

    The NIH is the major funding source in the United States for basic biomedical research. However, the major dividends from this investment are discoveries that improve our ability to prevent, effectively treat, and cure disease and disability. The NIH must foster not only the basic research that begins this process but also the translational research through which a basic science discovery is applied to a medical problem. There is generous industry support for clinical research and clinical trials aimed at the development of new products. However, private funding is extremely limited for initial translational research that may have little or no commercial product potential. Examples of such research include studies of nutritional therapies, new approaches to disease prevention, transplantation techniques, behavioral interventions, and studies of off-label uses of approved drugs. In the past, such research was often subsidized from patient care revenues to academic medical centers. However, competition in the health care marketplace has begun to erode this source of funding; therefore, NIH must play an expanded role in providing support for this research. The Clinical Research Enhancement Act would foster NIH funding opportunities for this type of research through the establishment of "innovative medical science awards." Such studies will focus on translating basic research discoveries into tools that health care professionals can use to cure disease and relieve suffering.

    In addition, we support provisions of the bill that would foster opportunities for physicians to pursue careers in clinical research. There is ample evidence that American physicians are opting out of careers in science for a variety of reasons. Steps must be taken to rebuild our nation's supply of well-trained physician scientists if the United States is to continue its leadership of the world in medical science.

    Finally, the bill would direct the NIH to improve the peer review of patient-oriented research. Studies have documented the fact that clinical research proposals are at a disadvantage when reviewed by NIH study sections because of NIH's primary focus on basic biomedical research. This must be changed, as proposed in your bill, so that scientific opportunities to improve medical care are not lost.

    The undersigned organizations are extremely grateful for your leadership in addressing the problems confronting clinical research. We support your initiative to assure that the NIH invests in the translational research that holds the key for patients around the country who are waiting for a cure. We are pleased to endorse the Clinical Research Enhancement Act.

    Alzheimer's Association, American Autoimmune Related Diseases Association, American Diabetes Association, American Kidney Fund, American Paralysis Association, Digestive Diseases National Coalition, Epilepsy Foundation of America, Foundation Fighting Blindness, Juvenile Diabetes Foundation International.

    Glaucoma Research Foundation, Myasthenia Gravis Foundation, National Alopecia Areata Foundation, National Multiple Sclerosis Society, National Osteoporosis Foundation, National Tuberous Sclerosis Association, Paget Foundation, Sjogren's Syndrome Foundation, Tourette Syndrome Association.

____

American Federation for

Medical Research,

Washington, DC, November 7, 1997.
Hon. Nancy Johnson,
Hon. Nita Lowey,
U.S. House of Representatives, Washington, DC.

    Dear Representatives Johnson and Lowey:

    I write to express the strong support of the American Federation for Medical Research for the legislation you will introduce to enhance clinical research programs at the National Institutes of Health. The AFMR is a national organization of 6,000 physician scientists engaged in basic, clinical, and health services research. Most of our members receive NIH support for their basic research but are finding it increasingly difficult to obtain public or private funding for translational or clinical research--studies through which basic science discoveries are translated to the care of patients. In the past, academic medical centers provided institutional support for this research through revenues generated by patient care activities. However, as the health care marketplace has become increasingly competitive, academic centers have all but eliminated internal subsidies, clinical research or the training of clinical investigators. In fact, the Association of American Medical Colleges has estimated that these institutions have lost approximately $800 million in annual "purchasing power" for research and research training within their institutions. In this context, the $60 million in spending entailed in your legislation (representing less than one-half of one percent of the NIH budget) would seem an extremely modest investment in a much-needed program to reinvigorate our nation's clinical research capabilities.

    The Clinical Research Enhancement Act is a conservative approach to a severe problem. The Institute of Medicine (IOM) expressed alarm about the challenges confronting clinical research in a 1994 report, and your bill is based on the initiatives recommended by the IOM:

    The IOM recommended that the General Clinical Research Centers program be strengthened. Your bill would codify this program, which has existed since the late 1950's, so that the Congress will have greater discretion over GCRC funding.

    The IOM recommended enhanced career development in clinical investigation, and your bill proposes such awards.

    The IOM noted problems with the NIH peer review of clinical research. Your bill directs the NIH to improve the peer review process for such research and establishes "innovative science awards" that will be reviewed by scientists knowledgeable in clinical investigation.

    The IOM recommended programs to relieve the tuition debt of physicians pursuing clinical research careers. Your bill would expand an existing NIH intramural program for this purpose to the extramural community.

    The IOM recommended structured, didactic training in clinical investigation. Your bill authorizes funding for advanced degree (master's and Ph.D) training in clinical research as successfully initiated at several institutions around the country.

    The list of almost 150 organizations that support the Clinical Research Enhancement Act indicates the consensus of scientific, medical, consumer, and patient organizations that steps must be taken as soon as possible to stop the deterioration of the U.S. clinical research capacity, to reinvigorate the clinical research programs of academic medical centers, and to assure that the American people and the American economy benefit from the translation of basic science breakthroughs to improved clinical care and new medical products. The American Federation for Medical Research is pleased to have the opportunity to express its strong support for your legislation.

Sincerely,

Jeffrey Kern, M.D.,
President.



105th CONGRESS
  1st Session
                                H. R. 3001

 To amend the Public Health Service Act to provide additional support 
 for and to expand clinical research programs, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            November 9, 1997

 Mrs. Lowey (for herself, Mrs. Johnson of Connecticut, Mr. Hoyer, Mrs. 
Morella, Mr. Nadler, Mr. Stearns, Ms. DeLauro, Mr. Leach, Mr. Lewis of 
  Georgia, Mr. Wicker, and Mr. Cardin) introduced the following bill; 
            which was referred to the Committee on Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend the Public Health Service Act to provide additional support 
 for and to expand clinical research programs, and for other purposes.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Clinical Research Enhancement Act of 
1997''.

SEC. 2. FINDINGS AND PURPOSE.

    (a) Findings.--Congress makes the following findings:
            (1) Clinical research is critical to the advancement of 
        scientific knowledge and to the development of cures and 
        improved treatment for disease.
            (2) Tremendous advances in biology are opening doors to new 
        insights into human physiology, pathophysiology and disease, 
        creating extraordinary opportunities for clinical research.
            (3) 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.
            (4) The United States will spend more than $1 trillion on 
        health care in 1997, but the Federal budget for health research 
        at the National Institutes of Health was $12.7 billion, only 1 
        percent of that total.
            (5) 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.
            (6) The Director of the National Institutes of Health has 
        recognized the current problems in clinical research and has 
        through the use of an advisory committee begun to evaluate 
        these problems.
            (7) The current level of training and support for health 
        professionals in clinical research is fragmented, frequently 
        undervalued, and potentially underfunded.
            (8) 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:
                    (A) The number of young investigators applying for 
                grants dropped by 54 percent between 1985 and 1993.
                    (B) The number of federally funded research (R01) 
                grants awarded to persons under the age of 36 have 
                decreased by 70 percent from 1985 to 1993.
                    (C) Newly independent life-scientists are expected 
                to raise funds to support their new research programs 
                and a substantial proportion of their own salaries.
            (9) The following have been cited as reasons for the 
        decline in the number of active clinical researchers, and those 
        choosing this career path:
                    (A) A medical school graduate incurs an average 
                debt of $80,000, as reported in the Medical School 
                Graduation Questionnaire by the American Association of 
                Medical Colleges (AAMC).
                    (B) The prolonged period of clinical training 
                required increases the accumulated debt burden.
                    (C) The decreasing number of mentors and role 
                models.
                    (D) The perceived instability of funding from the 
                National Institutes of Health and other Federal 
                agencies.
                    (E) The almost complete absence of clinical 
                research training in the curriculum of training grant 
                awardees.
                    (F) 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.
            (10) 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.
            (11) Appropriations for general clinical research centers 
        in fiscal year 1997 equaled $153,000,000.
            (12) In fiscal year 1997, there were 74 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.
            (13) The average annual amount allocated for each general 
        clinical research center is $1,900,000, establishing a current 
        funding level of 75 percent of the amounts approved by the 
        Advisory Council of the National Center for Research Resources.
    (b) Purpose.--It is the purpose of this Act to provide additional 
support for and to expand clinical research programs.

SEC. 3. INCREASING THE INVOLVEMENT OF THE NATIONAL INSTITUTES OF HEALTH 
              IN CLINICAL RESEARCH.

    Section 402 of the Public Health Service Act (42 U.S.C. 282) is 
amended by adding at the end the following:
    ``(l)(1) The Director of NIH shall undertake activities to support 
and expand the involvement of the National Institutes of Health in 
clinical research.
    ``(2) In carrying out paragraph (1), the Director of NIH shall--
            ``(A) design test pilot projects and implement the 
        recommendations of the Division of Research Grants Clinical 
        Research Study Group and other recommendations for enhancing 
        clinical research, where applicable; and
            ``(B) establish an intramural clinical research fellowship 
        program and a continuing education clinical research training 
        program at NIH.
    ``(3) The Director of NIH, 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.
    ``(4) The Director of NIH shall establish peer review mechanisms to 
evaluate applications for--
            ``(A) clinical research career enhancement awards;
            ``(B) innovative medical science awards;
            ``(C) graduate training in clinical investigation awards;
            ``(D) intramural clinical research fellowships.
Such review mechanisms shall include individuals who are exceptionally 
qualified to appraise the merits of potential clinical research 
training and research grant proposals.''.

SEC. 4. GENERAL CLINICAL RESEARCH CENTERS.

    Part B of title IV of the Public Health Service Act (42 U.S.C. 284 
et seq.) is further amended by adding at the end the following:

``SEC. 409B. GENERAL CLINICAL RESEARCH CENTERS.

    ``(a) Grants.--The Director of the National Center for Research 
Resources shall award grants for the establishment of general clinical 
research centers to provide the infrastructure for clinical research 
including clinical research training and career enhancement. Such 
centers shall support clinical studies and career development in all 
settings of the hospital or academic medical center involved.
    ``(b) Activities.--In carrying out subsection (a), the Director of 
NIH shall expand the activities of the general clinical research 
centers through the increased use of telecommunications and 
telemedicine initiatives.
    ``(c) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section, such sums as may be necessary.

``SEC. 409C. ENHANCEMENT AWARDS.

    ``(a) Clinical Research Career Enhancement Award.--
            ``(1) In general.--The Director of the National Center for 
        Research Resources shall make grants (to be referred to as 
        `clinical research career enhancement awards') to support 
        individual careers in clinical research at general clinical 
        research centers or at other institutions that have the 
        infrastructure and resources deemed appropriate for conducting 
        patient-oriented clinical research. The Director of the 
        National Center for Research Resources shall, where 
        practicable, collaborate or consult with other Institute 
        Directors in making awards under this subsection.
            ``(2) Applications.--An application for a grant under this 
        subsection shall be submitted by an individual scientist at 
such time as the Director may require.
            ``(3) Limitations.--The amount of a grant under this 
        subsection shall not exceed $125,000 per year per grant. Grants 
        shall be for terms of 5 years. The Director shall award not 
        more than 20 grants in the first fiscal year, and not more than 
        40 grants in the second fiscal year, in which grants are 
        awarded under this subsection.
            ``(4) Authorization of appropriations.--There is authorized 
        to be appropriated to make grants under paragraph (1), 
        $3,000,000 for fiscal year 1998, and such sums as may be 
        necessary for each subsequent fiscal year.
    ``(b) Innovative Medical Science Award.--
            ``(1) In general.--The Director of the National Center for 
        Research Resources shall make grants (to be referred to as 
        `innovative medical science awards') to support individual 
        clinical research projects at general clinical research centers 
        or at other institutions that have the infrastructure and 
        resources deemed appropriate for conducting patient-oriented 
        clinical research. The Director of the National Center for 
        Research Resources shall, where practicable, collaborate or 
        consult with other Institute Directors in making awards under 
        this subsection.
            ``(2) Applications.--An application for a grant under this 
        subsection shall be submitted by an individual scientist at 
        such time as the Director requires.
            ``(3) Limitations.--The amount of a grant under this 
        subsection shall not exceed $175,000 per year per grant.
            ``(4) Authorization of appropriations.--There is authorized 
        to be appropriated to make grants under this subsection, 
        $52,500,000 for fiscal year 1998, and such sums as may be 
        necessary for each subsequent fiscal year.
    ``(c) Graduate Training in Clinical Investigation Award.--
            ``(1) In general.--The Director of the National Center for 
        Research Resources shall make grants (to be referred to as 
        `graduate training in clinical investigation awards') to 
        support individuals pursuing master's or doctoral degrees in 
        clinical investigation.
            ``(2) Applications.--An application for a grant under this 
        subsection shall be submitted by an individual scientist at 
        such time as the Director may require.
            ``(3) Limitations.--The amount of a grant under this 
        subsection shall not exceed $75,000 per year per grant. Grants 
        shall be for terms of 2 years or more and will provide stipend, 
        tuition, and institutional support for individual advanced 
        degree programs in clinical investigation.
            ``(4) Definition.--As used in this subsection, the term 
        `advanced degree programs in clinical investigation' means 
        programs that award a master's or Ph.D. degree after 2 or more 
        years of training in areas such as the following:
                    ``(A) Analytical methods, biostatistics, and study 
                design.
                    ``(B) Principles of clinical pharmacology and 
                pharmacokinetics.
                    ``(C) Clinical epidemiology.
                    ``(D) Computer data management and medical 
                informatics.
                    ``(E) Ethical and regulatory issues.
                    ``(F) Biomedical writing.
            ``(5) Authorization of appropriations.--There is authorized 
        to be appropriated to make grants under this subsection, 
        $3,000,000 for fiscal year 1998, and such sums as may be 
        necessary for each subsequent fiscal year.''.

SEC. 5. CLINICAL RESEARCH ASSISTANCE.

    (a) National Research Service Awards.--Section 487(a)(1)(C) of the 
Public Health Service Act (42 U.S.C. 288(a)(1)(C)) is amended by 
striking ``50 such'' and inserting ``100 such''.
    (b) Loan Repayment Program.--Section 487E of the Public Health 
Service Act (42 U.S.C. 288-5) is amended--
            (1) in the section heading, by striking ``from 
        disadvantaged backgrounds'';
            (2) in subsection (a)(1)--
                    (A) by striking ``who are from disadvantaged 
                backgrounds''; and
                    (B) by striking ``as employees of the National 
                Institutes of Health'' and inserting ``as part of a 
                clinical research training position'';
            (3) in subsection (a), by striking paragraph (3) and 
        inserting the following:
            ``(3) Applicability of certain provisions regarding 
        obligated service.--With respect to the National Health Service 
        Corps Loan Repayment Program established under subpart III of 
        part D of title III, the provisions of such subpart shall, 
        except as inconsistent with this section, apply to the program 
        established in this section in the same manner and to the same 
        extent as such provisions apply to such loan repayment 
        program.'';
            (4) in subsection (b)--
                    (A) by striking ``Amounts'' and inserting the 
                following:
            ``(1) In general.--Amounts''; and
                    (B) by adding at the end the following:
            ``(2) Disadvantaged backgrounds set-aside.--In carrying out 
        this section, the Secretary shall ensure that not less than 50 
        percent of the contracts involve those appropriately qualified 
        health professionals who are from disadvantaged backgrounds.''; 
        and
            (5) by adding at the end the following:
    ``(c) Definition.--As used in subsection (a)(1), the term `clinical 
research training position' means an individual serving in a general 
clinical research center or in clinical research at the National 
Institutes of Health, or a physician receiving a clinical research 
career enhancement award, or a graduate training in clinical 
investigation award.
    ``(d) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section such sums as may be necessary 
for each fiscal year.''.

SEC. 6. DEFINITION.

    Section 409 of the Public Health Service Act (42 U.S.C. 284d) is 
amended--
            (1) by striking ``For purposes'' and inserting ``(a) Health 
        Service Research.--For purposes''; and
            (2) by adding at the end the following:
    ``(b) Clinical Research.--As used in this title, the term `clinical 
research' means patient oriented clinical research conducted with human 
subjects, or research on the causes and consequences of disease in 
human populations involving material of human origin (such as tissue 
specimens and cognitive phenomena) for which an investigator or 
colleague directly interacts with human subjects in an outpatient or 
inpatient setting to clarify a problem in human physiology, 
pathophysiology, or disease; or epidemiologic or behavioral studies, 
outcomes research, or health services research, or developing new 
technologies or therapeutic interventions.''.



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