NATIONAL RESEARCH ACT PUBLIC LAW 93-348 JULY 12, 1974 INSTITUTIONAL REVIEW BOARDS, ETHICS GUIDANCE PROGRAM Sec. 212. (a) Part f of tide [V 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 thal 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 shail 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 TO THE PUBLIC HEALTH SERVICE ACT. salus ubi multi consiliarti Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140003-9 | "
7 ’ Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140003-9 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 Oy Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140003-9 ee cecal cnc gab ta etree cas oe Ma Ree ed HS TE Hak er
FR aS RES RE SSR: RE A HR LR EE Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140003-9 Page 4 -PART 46-—-PROTECTION OF ; HUMAN SUBJECTS Subpart A-—Basic HHS Policy for Protection of Human Research Subjects See. 4h 101 4.402 46 103 46 108 $5105 ot 106 46.107 46,108 To what do these regulations apply? Definitions. Assurances. Section reserved. Sectinn reserved. Section reserved. {AB membership. IRB functions and operstions. 46.109 JAB review of research. 46.01) Expedited review procedures for certain kinds of research involving no more than minimal cisk, and for minor changes in approved research. 46 131 Criteria for IRB approval of research. 46.142 Review by instiuution. 46.013 Suspenston of terminanoe of IRB approval of research, 40.14 Cooperative research. 46.515 IRB records. 46916 Generai requirements for informed eonsenl,. 45 117 Documentation of informed consent, 45.118 Applications and proposals lacking definite plans for invetvement of human subjects. 460.019 Research undertaken without the intention of involving human subjecis. 40.120 Evatuahon and disposirion af applecations and proposals. 46 $21 lavestigacional new drug or device 30-day delay requirement. 46.122 Use of federal funds. 40.123 Early termination of research fundin?, evaluation of subsequent applications and proposals. a6 [24 Conditions. Subpart B—Additional Protections Pertaining to Research, Development, and Related Activities lnvelving Fetuses, Pregnant Women, and Human ta Vitro Fertilization Sec. 46.201 46 202 46.203 Applicability. Purpose. Defininens. 46.204 Ethical Advisory Boards. 46.205 Addivional duties of the Instututional Review Buards in connection with a TCT AIMEE MME AN ROH A CORR RUORL TARR ANS activities involving fetuses, pregnant women, of human in vitro fertilizacon. 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 wlero, including nonviahle fetuses, as subjects. 46.210 Activities involving the dead fetus, fetal material, or the placenta. 46.211 Madification or waiver of specific requirements. Subpart C-—Additlonal Protections Pertaining to Biomedical and Behavioral Research lavoiving Prisoners as Subjects Sec. 46.301 46.302 Applicability. Purpose. 46.303 Definitions. 46.304 Composition of Institutional Review Boards where prisoners are involved. 46.305 Additional duuies 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 46.401 46,402 To what do these regulations apply? Definitions. 46.403 IRB duties. 46.404 Research not involving greater than minimal risk. 46.405 Research involving greater than mininaal risk bul presenting the prospect of direct benefit to the individual subjects, 46.406 Research involving greater than ‘minimal risk aud 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 approvahle which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. 46.408  Requiremests for permission by Parents or guardians and for assent by childrens. 46.409 Wards. Authority: $U8S.C. VOL, sec. 474(a), 88 Stat, 342 (42 US... T8913 ay. 1A RE NH A ERS EON it 45 CFR 46 Subpart A-~Basic HHS Policy for Protection of Human Research Subjects # Source: 46 FR 8386, January 26, 1961, 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 whale or in part by a Departinent grant, contract, cooperative agreement or fellowship, (ht) This includes research conducted by Departnent employees, except cach Principal Operating Component head may adopt such nonsubstantive, procedural modifications as may be appropriate from an administrative standpoint. (2) it also ineludes 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 («) 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: i (1} Research conducted in established or commonly accepted educational setlings, involving norinal educational practices, such as (i) research on regular and special education instructional strategies, or (i) 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 @ Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140003-9
e “48 cApRroved For Release 2000/08/08 : CIA-RDP96-00788R001500140003-9 information taken from these sources is feeorded in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. (3) Research involving survey or interview procedures, except where all of the following conditions exist: ii) responses are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects, (ii) the subject's responses, if they became known outside the research, could reasonably place the subject at risk of criminal or civil liability or be | damaging to the subject's financial standing or employability, and (Hi) the research deals with sensitive aspects of the subject’s own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol, All research involving survey or interview procedures is exempt, without exception, when the respondents are elected or appointed public officials or candidates for publee office, (4) Research involving the voservation (including observation by participants) of public behavior, except where all of the following conditions exist: (i) observations are recorded in such a manner that the huntan subjects can be identified, divecdy or through identifiers Linked to the subjects, (1) the observations recorded about the individual, if they became known outside the research, coud reasonably place the subject at risk of criminal or civil Hability or be damaying to the subject's financial standing or employability, and Ciii) the vesearch deals with sensitive aspects of the subject's own behavior such as iHegal conduct, drug use, sexual behavior, or use of alcohol, (5) Research iavolving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, Wf these sources are publicly available or if the information is recorded by the mvestigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. (6) Unless specifically required by statute (and except to the extent specified in paragraph (i)), research and demonstration projects which are conducted by or subject to the approval of the Department of Health and Hutnan Services, and which are designed to study, evaluate, or otherwise examine: (i) programs under the Social Security Act, or other public benefit or service programs; (ti) procedures for obtaining benefits or services under those programs; (iii) possible changes in or allernatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services uader those programs. (c) The Secretary has final authority to determine whether a particular activity is covered by these regulations, (d) The Secretary may require that specific research activities or classes of research activities conducted or funded by the Department, but not otherwise covered hy these regulations, comply with some or all of these regulations. (e) The Secretary may alsa waive applicability of these regulations to specific reseaich activities or classes of research activities, otherwise covered by these regulations. Notices ot these actions will be published in the Federal Register as they occur. (f) No individual may receive Departinent funding for research covered by these regulations untess the individual is affiliated with or sponsored by an institution which assumes responsibility for the research under an assurance gatislying ihe requirenvents of this part, or the individual makes other arrangements with the Department, (g) Coniphanee wath these regulattaas will in ao way render inapplicable pertinent federal, state, of local laws or regulations. <A manne ee me Nahe ts i Mange 8 ALANNA a LEO LeY th) Each subpart of these regulations contains a separate seclion describing to what the subpart applies, Research which is covered by more than one subpurt shall comply with all applicable subparts. () Lf, following review of proposed research activities that are exempt from these regulations under paragraph (b)(6), the Secretary determines that a research or demonstration project presents a danger to the physical, mental, or emotional well-being of a participant or subject of the research or demonstration project, then federal funds may not be expended for such a project without the written, informed consent of each participant ar subject. § 46.102 Definitions. (a) ‘Secretary '' means the Secretary of Healih and Human Services and any other officer or employee of the Department of Health and Human Services to whom authority has been delegated. (b) “Department’’ or "HHS" means the Department of Health and Human Services, ic) *Enstitution’’ means any public or private entity ov agency (including federal, state, and other agencies). (A) ‘Legally authorized . representative’ means an individual or judicial or other tbody authorized under applicable jaw to consent on hehall of a prospective subject to the subject's participation in the procedure(s) involved in the research (e) **Research"* means a systematic investigation designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute ‘research’ for purposes of these regulations, whether or not they are supported or funded under a program which is considered research for other purposes. For example, some demonstration’ and “service'’ Programs may include research activities. Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140003-9
ABE RRR 5g 8 Oi A Sd EER Se OE e——————ee———— AA TO nt Pugs 6proved For Release 2000/08/08 : CIA-RDP96-00788R001500140003-9 __ 4° CFR 46 (f) ‘Human subject!’ means a living individual about whom an iave'stigator (whether professional or student) conducting research obtains (i) data through intervention or interaction with the tadividual, or (2) identifiable private information. “Intervention Y includes both physical procedures by which Jata are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes, “interaction ‘ includes conimunication or interpersonal contact between investigator and subject. Private infermation”™ includes information about behavior that occurs in a context in which an individual can reasonably expect that ng observation oc recording is taking place, and information which has been provided for specific purposes py an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information mast be individually identufiable (ie., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) ia order for obtaining the infurmation to constitule research involving human subjects. (gy) “Minimal risk" gmicans that the tisks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. (h) **Cestification!’ means the official notification by the institution to the Department in accordance with the requirements of this part that a research project or activity involving human subjects has been reviewed and approved by the Institutianal Review Board (IRB) ia accordance with the approved assurance on file at HHS. (Cerufication is required when the research is funded by the Department and not otherwise exempt in accordance with § 46.101(b)). 846.103 Assurances. (a) Each in.titution engaged in research covered by these regulations shail provide written assurance satistactory to the Secretary that it will comply with the requirements set forth in Giese regulauons. (b) The Department will conduct or fund research covered by these regulations only if the institution has an assuragce approved as provided in this section, and only if the institution has certified to the Secretary that the research has been reviewed and approved by an IRB provided for in the assurance, and will be subject to continuing review by the IRB. This “assurance shall at a minimum include: (1) A statement of principles governing the institution in the discharge of its responsibilities for protecting the rights and weltare of human subjects of research conducted ator sponsored by the institution, regardless of source of funding. This may inclide an appropriate existing code, declaration, or statement of ethical principles, of a statement formulated by the instituton itself, This requirement does not preempt provisions of these regulations applicable to Department-funded research and is not applicable to any research in an exempt catevory listed in § 46.101. (2) Designanon of one or more IRBs established in accordance with the requirements of this subpart. and for which provisions are made for meeting space and sufficient staff to support the IRB 's review and recordkeeping duties, (3) A list of the IRB members identified by name: earned deprees: representative capacity; indications of experience such as beard certifications, licenses, ete., sufficient to deseribe each member's chief anticipated contributions to IRB deliberations, and any employment or other relationship between each member and the institution, for example: full-time employee, part- ume employee, member of poverning panel or board, stockholder, paid or unpeid consultant. Changes in IRB membership shall be reported to the Secrstary.! (4) Written procedures which the IRB will follow (i) for conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution; (ii) for determining which projects require review more often than annually aad which projects need verification from sources other than the investigators that no matertal changes have occurred since previous IRB review, (ili) for insuring prompt reporting to the IRB of proposed changes in a research activity, and for msuring that changes ia approved research, during the period for which IRB approval has already been given, may not be initiated without [IRB review and approval except where necessary to climinate apparent immediate hazards to the subject; and (iv) for insuring prompt reporting to the IRB and to the Secretary! of unanticipated problems involving risks to subjects or others, (c) The assurance shall be executed by an individual authorized to act for the institution and to assume on behalf of the institudion the obligations imposed by these regulations, and shall be filed in such form and manner as the Secretary may prescribe, (d) The Secretary will evaluate all assurances submitted in accordance with these regulations through such officers and ernployees of the Department and such experts or consullants engaged for this purpose as the Secretary determines to be appropriate. The Secretary's evaluation, will take into consideration the adequacy of the proposed IRB in light of the anticipated scope of the institution's research activities and the types of subject populations likely to be ' Repons should be filed with the Office for Protection fram Research Risks, National Institutes of Healta, Department of Health and Human Services, Bethesda, Maryland 20205 Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140003-9