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SUPPLEMENT 2 NATIONAL RESEARCH SERVICE AWARD AUTHORITY Public Law 93-34B, as amended LEMON RICH sumacs AWARDS SEC. 472. (a) (1) The Secretary shall- 289~^C. (A) provide National Research Service Awards for (i) biomedical and behavioral research at the National Institutes of Health and the Alcohol, Drug Abuse, and Mental Health A~nmistra- tion or under programs administered by the Division of Nursing of the Health Resources Administration, in matters relating to the cause, diagnosis, prevention, and treatment of the diseases or other health problems or Division of ~ ursin,. (ii) framing at the Institutes and Adminis- tration of ~ndiw~uals to undertake such re- search, (iii) biomedical and behavioral research at public institutions and at nonprofit private in- StitUtiOnS, and (iv) pre- and post doctoral training at such public and private institutions of in~i`-iduals to undertake such research; and (B) make grants to public institutions and to nonprofit private institutions to enable such in- stitutions to make to individuals selected by them National Research Service Awards for research (and training to undertake such research) in the matters described In subparagraph (A) (i). A reference in this subsection to the National Institutes of Health or the Alcohol, Drug Abuse, and Mental Health Administration shall be considered to include the insti- tutes, divisions, and bureaus included in the Institutes or under the Administration, as the case may be. (~) National Research Service Awards may not be used to support residencies. (3) Effective July 1, 1975, National Research Service Awards may be made for research or research training in only those subject areas for which, as determined under section 473, there is a need for personnel. (b) (1) No National Research Service Award may be made by the Secretary to any individual unless (A) the individual has submitted to the Secretary an application therefor and the Secretary has ap- proved the application; (B) the individual provides, in such form and manner as the Secretary shall by regulation pre- scr~be, assurances satisfactory to the Secretary that the individual will meet the service requirement of subsection (c) (1~; and (C) in the case of a National Research Service Award for a purpose described in subsection (a) (1) (A) (iii) or (a) (1) (A) (iv), the individual has been sponsored (m such manner as the Secretary may by 80.727 o - 77 - vote ~ - u 199

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regulation require) by the institution at which the research or training under the Award will be conducted. An application for an Award shall be in such form, sub- mitted in such manner, and contain such "formation, as the Secretary may by regulation prescribe. (2) The award of National Research Service Award by the Secretary under subsection (a) and the making of grants for such Award shad be subject to review and approval by the appropriate advisory councils within the Department of Health, Education, and Welfare (A) whose activities relate to the research or training under the Awards, or (B) at which such research or training will be concluctM. (3) No grant may be made under subsection (a) (1) (B) unIem an application therefor has Men sub- mitted to and approved by the Secretary. Such applica- tion shall be in such form, submitted in such manner, and contain such information, as the Secretary may by re~u- lation prescribe. Subject to the provisions of this section other than paragraph (1) of this subsection, National Research Service Awards made under a grant under sum section (a) (1) (B) shall be made in accordance with such regulations as the Secretary shall prescribe. (~) The period of any National Research Service Award made to any ~ndindua] under subsection (a) may not exceed three years in the aggregate unless the Secre- tary for good cause shown waives the application of the three-year limit to such ~n~v~dual. (5) National Research Service Awards shall pronde for such stipends and allowances (including travel and subsistence expenses and dependency allowances) for the recipients of the Awards as the Secretary may deem necessary. A National Research Service Award made to an individual for research or research training at a non- Federal public or nonprofit private institution shall also provide for payments to be made to the institution for the cost of support services (including the cost of faculty salaries, supplies, equipment, general research support, and related Items) provided such Individual by such institution. The amount of any such payments to any institution shall be determined by the Secretary and shall bear a direct relationship to the reasonable costs of the institution for establishing and maintaining the quality of its biomedical and behavioral research and training programs. (c) (1) (A) Each individual who receives a National Research Service Award shall, In accordance with para- graph (3), engage it (i) health research or teaching or any combination thereof which is in accordance with usual patterns Of academic employment, 200

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(ii) if authorized under subparagraph (B), serve as a member of the National Health Service Corps or serve in his specialty, or (iii) if authorized unpiler subparagraph (C),serve in a health related activity approved under that sub- paragraph, for a period computed in accordance with paragraph (B) Any individual who receive a National Research Service Award and who is a physician, dentist, nurse, or other ~nd~v~dua] trained to provide health care directly to individual patients may, upon application to the Sec- retary, be authorized by the Secretary to . (i) serve as a member of the national Health Service Corps, (ii) serve in his specialty in private practice in a geographic area designated by the Secretary as re- quiring that specialty, or (iii) provides services in his specialty for a health maintenance organization to which payments may be made under section 1876 of title XVIll of the Social Security Act and which serves a medically underserved population (as defined in section 1302 (7)ofthisAct), in lieu of engaging in health research or teaching if the Secretary determines that there are no suitable health research or teaching positions available to such . no .~v~dual. (C) Where appropriate the Secretary may, upon application, authorize a recipient of a National Research Service Award, who is not trained to provide health care directly to individual patients, to engage in a health- reiated activity in lieu of engaging in health research or teaching if the Secretary determines that there are no suitable health research or teaching positions available to such individual. (2) For each year for which an individual receives National Research Service Award he shall- (A) for twelve months engage in health research or teaching or any combination thereof which is in accordance with the usual patterns of academic em- ployment. or, if so authorized, serve as a member of the National Health Service Corps, or (B) if authorized under paragraph (1) (B) or (1) (C), for twenty months serve In his specialty or engage in a health-related activity. (3) The requirement of paragraph (1) shall be com- piled with by any individual to whom it applies within such reasonable period of time, after the completion of such individual's Award, as the Secretary shall by regu- lation prescribe. The Secretary shall (A) by regulation prescribe (i) the type of research and teaching which an 201

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individual may end n to comply with such require- ment, and (ii) suc other requirements respecting such research and teaching and alternative service authorized under paragraphs (1) (B) and (1) (C) as he deems neces- sary; and (B) to the extent feasible, provide that the members of the National Health Service Corps who are serving in the Corps to meet the requirement of para- graph (1) shall be assigned to patient care and to post tions which utilize the clinical training and experience of the members. (4) (A) If any individual to whom the requirement of paragraph (1) is applicable fails, within the period Arm scribed by paragraph (3), to comply with such require meet, the United States shall be entitled to recover from such individual an amount determined in accordance with the formula A .~ (t I/ ~) in which "A" is the amount the United States is entitled to recover; "09, is the sum of the total amount paid under one or more National Research Service Award to such individual; "t" is the total number of months In such individual's service obligation; and "s" is the number of months of such obligation served by him in accordance with paragraphs (1) and (2) of this subsection. (B) Any amount which the United States is entitled to recover under subparagraph (A) shall, within the three-year per od begs ng on the date the United States becomes entitled to recover such amount, be Paid to the United States. Until any amount due the United States under subparagraph it? on accost of any National Research Service Award Is paid, there shall accrue to the IJnited States interest on such amount at a rate fixed by the Secretary of the Treasury after taking into considera- tion private consumer rates of interest prep ailing on the date the United States becomes entitled to such amount. (5) (it) Any obligation of any individual under para- graph (3) shall be canceled upon the death of such individual. (B) The Secretary shall by regulation pronde for the waiver or suspension of any such obligation applicable to any individual whenever compliance~by such ~ndindual is impossible or would involve extreme hardship to such individual and if enforcement of such obligation with respect to an,, Lingual would be again; equity and goo OCR for page 199
centum shall be made available for payments under Na- tional Research Service Awards pronded by the Secre- tary under subsection (a) (1) (A). 8TDDn:8 RE8pEcrING BIO1~DICAI, AND BEHAVIORS RESEARCH PER80N~ SEC. 473. (a) The Secretary shall, in accordance with 48,U~C subsection (b), arrange for t e conduct of a continuing study to (1) establish (~) the Nation's overall need for biomedical and behavioral research personnel, (B) the subject areas in which such personnel are needed and the number of such personnel needed in each such area, and (C) the kincis and extent of training which should be provided such personnel; (2) assess (A) current training programs avail- able for the training of biomedical and behavioral research personnel which are conducted under this Act at or through institutes under the National Institutes of Health and the Alcohol, Drum Abuse, and Mental Health Administration, and (~) other current training programs available for the train- ~ng of such personnel; (3) identify the kinds of research positions avail- able to and held by individuals completing such programs; (4) determine, to the extent feasible, whether the programs referred to in clause (B) of paragraph (2) would be adequate to meet the needs established under paragraph (1) if the programs referred to In clause (A) of paragraph (2) were terminated; and (5) determine what modifications in the programs referred to ~ paragraph (2) are required to meet the needs established under paragraph (1) (b) (1) The Secretary shall request the National Academy of Sciences to conduct the study required by subsection (a) under an arrangement under which the actual expenses incurred by such Academy In conducting such study will be paid by the Secretary. If the Nationa] Academy of Sciences is willing to do so, the Secretary shall enter into such an arrangement with such Academy for the conduct of such study. (2) If the National Academy of Sciences is unwilling to conduct such study under such an arrangement, then the Secretary shall enter into a similar arrangement with other appropriate nonprofit private groups or associa- tions under which such groups or associations will con- duct such study and prepare and submit the reports thereon as pros bled In subsection (c). (3) The National Academy of Sciences or other group or association conducting the study required by subsec- tion (a) shall conduct such study In consultation with the Director of the National Institute of Health. 203

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42 U.. 2891 ~ 42 U^C 2~} - (c) A report on the resulb of such study Mall be Bun misted by the Secretary to the Committee on Interstate and Foreign Commerce of the House of Representatives and the Committee on I~abor and Public Welfare of the Senate not later than September 30 of each year. INBT~ONAT- RB~W BOARDS; ET=C8 GUIDANCE Croats SEC. 474. (a) The Secretary shall by regulation require that each entity which applies for a grant or contract under this Act for any ,project or program which Evolves the conduct of biomedical or behavioral research mvolv- ing human subjects submit in or with its application for such grant or contract assurances satisfactory to the Sec- retary that it has established {m accordance with re~ula- tions which the Secretary shall prescribe) a board To be known as an "Institutional Renew Board") to review biomedical and behaviors research involving human sum jects conducted at or sponsored by such entity in order to protect the rights of the human subjects of such research. (b) The Secretary shall establish a program within the Department under which requests for clarification and guidance with respect to ethical issues raped in connec- tion with biomedical or behavioral research ~nvoInng human subjects are Sponged to promptly and appro- pr~ately. PEER Ik;~w OF MAT APPLICATION8 AD CONTRACT ~OJ~8 Sac. 475. (a) The Secretary, after consultation with the Director of the National Institutes of Health, and, where appropriate, the Directors of the National Insti- tute of Mental Health, the National Institute on Alcohol Abuse and Alcoholic, and the National Institute on Drug Abuse, shall by regulation require appropriate scientific peer review of . .. . (1) applications made after the effective date of such regulations for "ants under this Act for bin medical ardbehanoral research; and (2) biomedical and behavioral research and de" velopment contract projects to be administered after such effective date through an institute established Under this title, the National Institute on Alcohol Abuse and Alcoholism, or the National Institute on Drug IBM (b) Regulations promulgated under subsection (a) shall, to the extent practicil, require that the renew of grant applications required by the regulations be con- duc~d (1) ~ a manner consistent with the system for scientific peer review applicable on the date of the enactment of this section to applications for grants 204

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under this Act for biomedical and behavioral re- search, and (2) by peer review groups performing such review on or before such date. (c) The members of any peer review group established under such regulations shall be individuals who by vir- tue of their training or experience are eminently quali- fied to perform the review functions of the group and not more than one-fourth of the members of any peer review group established under such regulations shall be officers or employees of the United Stated vIsrr~-a SCIENTIST AWARDS SEC. 476. (a) The Secretary may make awards (re- 42U~C 2801 ferred to as "Visiting Scientist Rewards") to outstanding scientists who agree to serge as visiting scientists at insti- tutions of post-secondary education which have signifi- cant enrollments of disadvantaged students. Visiting Scientist Awards shall be made by the Secretary to enable the faculty and students of such institutions to draw upon the special talents of scientists from other institutions for the purpose of receiving guidance advice, and instruc- tion with regard to research, teaching. and curriculum development in the biomedical and behavioral sciences and such other aspects of these sciences as the Secretary shall deem appropriate. (b) The amount of each Visiting Scientist.\ward shall include such sum as shall be commensurate with the. sal- ary or remuneration which the individual recei`-ing the award wouId have been entitled to receive e from the insti- tution with which the individual has, or had. a permanent or immediately prior affiliation. Eligibility for and terms of Visiting Scientist Awards shall be determined in ac- cordance with regulations the Secretary shall prescribe. 205