If I may be of any assistance to the subcommittee, please contact me at any time. Sincerely, Tow!) Regen. Paul D. Keeper PDK:kp OPRR Reports PROTECTION HUMAN SUBJECTS CODE OF FEDERAL REGULATIONS 45 CFR 46 Revised as of March 8, 1983 NATIONAL RESEARCH ACT PUBLIC LAW 93-348 INSTITUTIONAL REVIEW BOARDS; ETHICS GUIDAnce progrAM SEC. 212. (a) Part I of title IV of the Public Health Service Act, as amended by section 103 of this Act, is amended by adding at the end the following new section: **INSTITUTIONAL REVIEW BOARDS; ETHICS GUIDANCE PROGRAM "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 involves the conduct of biomedical or behavioral research involving human subjects submit in or with its application for such grant or contract assurances satisfactory to the Secretary that it has established (in accordance with regulations which the Secretary shall prescribe) a board (to be known as an 'Institutional Review Board') to review biomedical and behavioral research involving human subjects 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 raised in connection with biomedical or behavioral research involving human subjects are responded to promptly and appropriately." (b) The Secretary of Health, Education, and Welfare shall within 240 days of the date of the enactment of this Act promulgate such regulations as may be required to carry out section 474(a) of the Public Health Service Act. Such regulations shall apply with respect to applications for grants and contracts under such Act submitted after promulgation of such regulations. THE CODE OF FEDERAL REGULATIONS, 45 CFR 46, IMPLEMENTS THESE AMENDMENTS salus ubi multi consiliarii CODE OF FEDERAL REGULATIONS TITLE 45 PUBLIC WELFARE DEPARTMENT OF HEALTH AND HUMAN SERVICES NATIONAL INSTITUTES OF HEALTH OFFICE FOR PROTECTION FROM RESEARCH RISKS PART 46-PROTECTION OF HUMAN SUBJECTS REVISED AS OF MARCH 8, 1983 activities involving fetuses, pregnant women, or human in vitro fertilization. 46.206 General limitations. 46.207 Activities directed toward pregnant women as subjects. 46.208 Activities directed toward fetuses in utero as subjects. 46.209 Activities directed toward fetuses ex utero, including nonviable fetuses, as subjects. 46.210 Activities involving the dead fetus. fetal material, or the placenta. 46.211 Modification or waiver of specific requirements. Subpart C-Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects Sec. 46.301 Applicability. 46.302 Purpose. 46.303 Definitions. 46.304 Composition of Institutional Review Boards where prisoners are involved. 46.305 Additional duties of the Institutional Review Boards where prisoners are involved. 46.306 Permitted activities involving prisoners. Subpart D-Additional Protections for Children Involved as Subjects in Research Sec. 46.401 To what do these regulations apply? 46.402 Definitions. 46.403 IRB duties. 46.404 Research not involving greater than minimal risk. 46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. 46.406 Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition. 46.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. 46.408 Requirements for permission by parents or guardians and for assent by children. 46.409 Wards. Authority: 5 U.S.C. 301; sec. 474(a), 88 Stat. 352 (42 U.S.C. 2891-3(a)). 45 CFR 45 Subpart A-Basic IIHS Policy for Protection of Human Research Subjects Source: 46 FR 8386, January 26, 1981, 48 FR 9269, March 4, 1983. § 46.101 To what do these regulations apply? (a) Except as provided in paragraph (b) of this section, this subpart applies to all research involving human subjects conducted by the Department of Health and Human Services or funded in whole or in part by a Department grant, contract, cooperative agreement or fellowship. (1) This includes research conducted by Department employees, except each Principal Operating Component head may adopt such nonsubstantive, procedural modifications as may be appropriate from an administrative standpoint. (2) It also includes research conducted or funded by the Department of Health and Human Services outside the United States, but in appropriate circumstances, the Secretary may, under paragraph (e) of this section waive the applicability of some or all of the requirements of these regulations for research of this type. (b) Research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from these regulations unless the research is covered by other subparts of this part: (1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. (2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), if |