CODE OF FEDERAL REGULATIONS TITLE 45 PUBLIC WELFARE PART 46--PROTECTION OF HUMAN SUBJECTS

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CIA-RDP96-00789R003000020002-5
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RIFPUB
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U
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18
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November 4, 2016
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June 17, 2003
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2
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Publication Date: 
March 8, 1983
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REGULATION
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Approved For Release 2003/09/10 : CIA-RDP96-00789R003000020002-5 CODE OF FEDE F AFL REGULATIONS T!T1 rfir 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 Approved For Release 2003/09/10 : CIA-RDP96-00789R003000020002-5 Approved For Release 2003/09/10 : CIA-RDP96-00789R003000020002-5 Page 4 45 CFR 46 PART 4~-- HUMAN SUBJECTS 6ubpart A-Basic HITS 1'oiicy for 4`rotectlon of Human _Research subjects r Se,. 46 101 To what do these regulations apply? 46.102 Definitions, 46.103 Assurances 46 104 Section reserved 46.105 Section reserved, 46.106 Section reserved. 46 107 IRB membership. 46.108 IRB functions and operations. 46.109 IRB review of research. 46.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. 46 111 Criteria for IRB approval of research. 46. 112 Review by institution. 46. 113 Suspension or termination of IRB approval of research. 46.114 Cooperative research. 46.115 IRB records. 46 116 General requirements for informed consent. 46. 1 17 Documentation of informed consent. 46. 118 Applications and proposals lacking definite plans for involvement of human subjects. 46.119 Research undertaken without the intention of involving human subjects. 46.120 Evaluation and disposition of applications and proposals. 46.121 Investigational new drug or device 30-day delay requirement. 46.122 Use of federal funds. 46.123 Early termination of research funding; evaluation of subsequent applications and proposals. 46 124 Conditions. Subpart B-Additional Protections Pertaining to Research, Development, and Related Activities Involving Fetuses, Pregnant Women, and Human In Vitro Fertilization Sec. 46.201 Applicability. 46.202 Purpose., 46.203 Definitions. 46.204 Ethical Advisory Boards. 46 205 Additional duties of the Institutional Revicw Boards in connection with c.1 .. it', ,, L. r wun,cri, ur bur an in vet.: lcri~i~,ai;ur.. 46.201: General lrrritaiiur:s Jo.:u ! i.ilSiiics tiireCtec in-aro p:rgr m women as subjects. -it).,: VO Activities directed toward tctuscs iii uteri) as subjects. 46.209 Activities directed toward fetuses ex uteri:, including nonviable louses. a; subn:cts, 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 "C'. . 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 RescArch 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 Requircinenss for permission by parents or guardians and for assent by children. 46.409 Wards. Authority: S US C 30!, sec. 474(al, 88 F,tat. 1 5~2 (42 U,S.C. 2891-3(511. lei;:viii A --L;sic IllS folic) for P'toicction of Human Research irttrir' -fc _n 46 FR 6386, January 26, 1981, 48 Ff. 9265, March 4, 1981. 146. 101 To what do these te;;taiations 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 art 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'ategories are exempt from these regulations unless the research is covered by other subparts of this part: (I) 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, dta,nostic, aptitude. achievement), if Approved For Release 2003/09/10 : CIA-RDP96-00789R003000020002-5 . . Approved For Release 2003/09/10 : CIA-RDP96-00789R003000020002-5 ' 45 (:FR 46 m ti ,, tak:. t;,r.:L. is recorded in such a manner that suh-Iects cannot he identified, directly or-through it'entific?rs linked to it', subjects. (3) Research involving survey or interview procedures, except where all of the following conditions extsr: fir en lr~ ?tn'j iti,? or ~...~:.... t, rF. it responses are recorded in such it approval of the Department of manner that the human subjects can Health and Human Services, and be identified, directly or through which are designed to study. identifiers linked to the subjects, (ii) evaluate, or otherwise examine: (i) the subject's responses, if they programs under the Social Security hc',.ame known outside the research. Act, or other public benefit or could reasonably place the subject at service programs; (ii) procedures for i k s r of criminal or civil liability or be obtaining benefits or services under damaging to the subject's financial standing or employability, and (iii) the research deals with sensitive aspects of the subject's own behavior, such as illegal conduct, drug use, sexual behavior, or we 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 public office. (4) Research involving the observation (including observation participants) of public behavior. except where all of the following by conditions exist: (i) observations are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects, (ii) the observations recorded about the individual. 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 (iii) the research deals with sensitive aspects of the subject's own behavior such as illegal conduct, drug use. sexual behavior, or use of alcohol. (5) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, it these sources are publicly available or if the information is recorded by the investigator in such a manner that or through Identifiers linkeu to tht' sU3jeels. (6) Uniess specifically required by statute (t.rt? 4 ,,_ .; to the extent specified in paragraph (i)), research and demonstration projects which those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under 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 by these regulations, comply with some or all of these regulations. Page 5 sUL,;; Ft of these rcr t itions caniainc a separate ;', ?h,r:t, to v:hat the su,pari JP11110. Research which is covered by nil!--` than one subpart shall ct}ir ~iy wtt)i all applicable subparts. (i) if, following review of .r;1nr1 ST (Certification is required when the research is funded by the Department and not otherwise exempt in accordance with ? 46.101(b)). 4::.i; I nneez. (a) Loch In !i:i i r, er;r'a, . to shall provide written assurance crlli%t" 'tars' h, t!'.t Sc,,: Ct:.'` ;}.St tt will comply with the reyuireinents tint furilt tit ("ies, regulations. (b) The Department will conduct or fund research covered by these ?Irt:.,.... . c)nrr.; if tut iiraiitiliruai IM, an assurance 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 1RB. 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 welfare of human subjects of research conducted at or sponsored by the institution, regardless of source of funding. This may include an appropriate existing code, declaration, or statement of ethical principles, or a statement formulated by the institution 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 category listed in ? 46.101. (2) Designation 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 degrees; representative capacity; indications of .experience such as board certifications, licenses, etc., sufficient to describe 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- time employee, member of governing panel or board, stockholder, paid or urp-;d consultant f'h_t.r,, it, litB i tt itii+Cr'htr ~)I;'H (',t r,.?t,r... t t. rl i (4) Wiitten procedutes which tn: r its initial and continuing review of research and for rept,i trop its findings and actions to the investigator and the institution: (ii) for determining which pr.-ic:: rcy; if,, idle st r,-.Pic t,ftc,r than annually and which projects need verification from s..urces other than the investigators that no material changes have occurred since previous IRB review; (iii) for insuring prompt reporting to the IRB of proposed changes in a research activity, and for insuring that changes in 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 eliminate 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 institution 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 employees of the Department and such experts or consultants 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 ' Reports should be filed with the Office for Protection from Research Risks, National Institutes of Health. Dcparmeni vt Health and Human Services, Be:he4da, M_rylaed 20205 Approved For Release 2003/09/10 : CIA-RDP96-00789R003000020002-5 44 CFR 46 Approved For Release 2003/09/10 : CIA-RDP96-00789R003000020002-5 I;;volved, 01C ahproptiatc;. review procedures in light of the probable risks, and the stet- an f complexity of the institution. (c) On the basis of this rvalua!ion, the Secretary may approve or disapprove the assurance, or enter into r, e0niationc to d:?vclon an approvahle one. The Secretary may, limit the period during which any particular approved assurance or class Of approved assurances shall remain effective or otherwise condition or restrict approval. (f) Within 60 days after the date of submission to HHS of an application or proposal, an institution with an approved assurance covering the proposed research shall certify that the application or proposal has been reviewed and approved by the IRB. Other institutions shall certify that the application or proposal has been approved by the IRB within 30 days after receipt of a request for such a certification from the Department. If the certification is not submitted within these time limits, the application or proposal may be returned to the institution. ? 46.104 [Reserved] ? 46.105 [Reserved) ? 46.106 [Reserved) ? 46.107 IRB membership. (a) Each IRD shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members' backgrounds including consideration of the racial and cultural backgrounds of members and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessinc: the prc,fession;t! C %V specific research activities, the IRB shall hr- ^+!,- to -ccrt,,.;n t!% aeveptahility of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and praCtii i:. ii1G IRB shad tliciefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a vulnerable category of subjects, including but not limited to subjects covered by other subparts of this part, the IRB shall include one or more individuals who are primarily concerned with the welfare of these subjects. (b) No IRB may consist entirely of men or entirely of women, or entirely of members of one profession. (c) Each IRB shall include at lcabt one member whose primary concerns are in nonscientific areas; for example: lawyers, ethicists, members of the clergy. (d) Each IRB shall include at least one member who is,not otherwise affiliated with the institution and who is not pan of the immediate family of a person who is affiliated with the institution. (e) No IRB may have a member participating in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the 1R13. (f) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of complex issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB. ? 46.108 IRB functions and operations. In order to fulfill the requirements of these regulations each IRB shall: (a) Follow written procedures as provided in ? 46.103(h)(4). Page 7 rh) Fxccp: zi, ex),:.,.ftt- reslcvww pr,kcdurc is used t.scc ? 46.110), review proposed research at convened meetings at which a maJority of the members of the 1RB ate present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting. (c) Be responsible for reporting to the appropriate institutional officials and the Secretary' any serious or continuing noncompliance by investigators with the requirements and determinations of the 1RB. ? 46.109 IRB review of research. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by these regulations. (b) An IRB shall require that information given to subjects as part of informed consent is in accordance with ? 46.116. The lRB may require that information, in addition to that specifically mentioned in ? 46.116, be given to the subjects when in the iRB's judgment the information would meaningfully add to the protection of the rights and welfare of subjects. (c) An IRB shall require documentation of informed consent or may waive documentation in accordance with ? 46.117. (d) An IRB shall notify investigators and the institution in writing of its decision.to approve or disapprove. the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification ' Reports should he filed with the Office for Protcction from Research Risks. National institutes of health, Department of Health and Flumars Ser' tccs. Bethesda. Maryland 202^5 Approved For Release 2003/09/10 : CIA-RDP96-00789R003000020002-5 Page8 a statement of the resson? f,,r it:, t+.CCtsron turd give t`tc imrsiig for an ol., : n.,istt? to r 'pu:. 1 it, p crsoi or in writing. ;c) An IRB shsl1 conduct conLncing review of research covered by these regulations at intervals appropriate to the degree of risk, but not less than once per year, and shall lla'vt aud-loiity to obtiCiYC Ur havc a third party observe the consent process and the research. ?46.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes In approved research. (a) The Secretary has established, and published in the Federal Register, a list of categories of research that may be reviewed by the 1RS through an expedited review procedure. The list will be amended. as appropriate, through periodic republication in the Federal Register. (bl An IRB may review some or all of the research appearing on the list through an expedited review procedure, if the research involves no more than minimal risk. The IRB may also use the expedited review procedure to review minor changes in previously approved research during the period for which approval is authorized. Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRS except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the non-expedited procedure set forth in ? 46.108(b). (c) Each IRB which uses an expedited review procedure shall adopt a method for keeping all members advised of research proposals which have been under U c nru cdurc (d) 1 is 5rcretar' may fc;tiltt, suspend, or terminate an institution's or 1};h''s use of the cxpe.l;ik :-4 re?.ie,k procedure when necessary to protect the rights or welfare of subjects. ?46.11! Criteria for IRR approval of research. (a) In order to approve research covered by these regulations the IRB shall determine that all of the following requirements are satisfied: (I) Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes. (2) Risks to subjects are reasonable in relation to anticipated benefits. if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks.and benefits, the IRB should consider only. those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRS should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility. (3) Selection of subjects is equitable. In making this assessment the IRS should take into account th e 45 CFR 46 (5) infonned consent will be a ..,rd:+nce wit!'., and to the extent required by ? 46-117. (6) Wircrc appropriate, the resca;ch plan makes adequate provision for monitoring the data collected to insure the safety of subjects. (7) Where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. (b) Where some or all of the subjects are likely to be vulncrablt to coercion or undue influence, such as persons with acute or severe physical or mental illness, or persons who arc economically or educationally disadvantaged. sppropriatc edditional- safeguards have been included in the study to protect the rights and welfare of these subjects. ? 46.112 Review by institution. Research covered by these regulations that has been approved by an IRS may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those officials may not approve the research if it has not been approved by an IRB. f 46.1113 Suspension or termination of IRS approval of research. An IRB shall have y.uthi r ty_toll suspend or terminate approval of research that is not being conducted in accordance with the IRB 's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the -IRS's actiolt and shad be reported purposes of the research and the setting in which the research will be promptly to the investigator, conducted. appropriate institutional officials, and (4) Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by ? 46.116. I Reports should be filed with the office for Protection from Research Risks, National Institutes of Health. Department of Health and Human Services, Bethesda, Maryland 20205. Approved For Release 2003/09/10 : CIA-RDP96-00789R003000020002-5 ;45.CFR 46 App-o -d-d Fo~Release 2003/09/10 : CIA-RDP96-00789R003000020002-5 t, 46.114 Cooperative res.~arcft. Cooperhtrvc research proicct'. ;rr( :) oS(' ilii)Jeets, nOrili) Jirk poIIca through grants, contracts, or similar ..; gcmcret:~, ''.Bich invclvc institutions in addition to the grantee or prime contractor (such as a contractor with the grantee, or a subcontractor with the prime c4pnrraciori in such instances., the grantee or prime contractor remains responsible to the Department for safeguarding the rights and welfare of human subjects, Also, when cooperatir.~ institutions conduct some or all of the research involving some or all of these subjects, each cooperating institution shall comply with these regulations as though it received funds for its participation in the project directly from the Department, except that in complying with these regulations institutions rna~ use ioint review, reliance upon the review of another qualified IRR, or siniiies arrangements aimed at avoidance of duplication of effort. 46.115 IRB records. (a) An institution, or where appropriate an IRB, shall prepare and maintain adequate documentation of IRB activities, including the following: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to subjects. (2) Minutes of IRB meetings which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution. (3) Records of continuing review activities. (4) Cn ic, (Ft all cnrrr,,ponderkec hcts+e r tl?- JRl: anJ the in e Li LT a!or`.. (5) A list of lRB members tcquircu by ? 4o. iu3(b)(i). sc,t ing. informed conscat the Page 9 provided to each subject: (b A statement that the study involves rescar,li, an explanation of the purposes of the rese^reh and the expected duration of the subject's participation, a description of the procedures to be followed, and 4 identification of any procedures which are experimental; i1 t A description of any reasonably foreseeable risks or discomforts to the subject; (M A description of any benefits to the subject or to others which may .reasonably be expected from the r!reseach; 4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; ?A statement describing the extent, if any, to which (6) Written procedures for the IRIS as required by ? 46,103(h)(4). (7) Statements of significant new findings providc(l to subjects, as required by ? 46.116(b)(5). (b) The records required by this regulation shall be retained for at least 3 years after completion of the research, and the records shall be accessible for inspection and copying by authorized representatives of the Department at reasonable times and in a reasonable manner. * 46.1116 General requirements for informed consent. Except as provided elsewhere in this or other subparts, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has UUMMEMCftidly e fft t r . ative, An investigator shall seek such consent only under circumstances that provide the prospective subject or the confidentiality of records identifying the subject will be maintained; For research involving more than minimal risk, an explanation as to whether any compensation and an It) explanation as to whether any medical treatments are available if injury occurs and, if so, what they representative sufficient opportunity inf anon niay be obtained; to consider whether or not to An explanation of who participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative Shad be in language understandable to_14C,.subject or the representative,r.$odinformed consent, whether oral or. written, may include any exculpatory language through which the subject or the m to contact for answers to pertinent questions about the research and .research subjects' rights, and whom to contact in the event of a research- related injury to the subject; and ,A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits .to which the subject is otherwise representative is made to waive or discontinue participation at any time appear to waive any of the subject's without penalty or loss of benefits to legal rights, or releases or appears to ,which the subject is otherwise release the investigator, the sponsor, entitled. the institution or its agents from I (b) Additional elements of liability for negligence. informed consent. When appropriate, (a) Basic elements of informed one or more of the following elements consent. Except as provided in of information shall also be provided paragraph (c) or (d) of this section, in to each subject: Approved For Release 2003/09/10 : CIA-RDP96-00789R003000020002-5 1'11' wrr,c cr s1i of the cc't:srrt 6r! a-.rvr " or waive the .plc nts to obtain informed piovideii the IRB t.inds and .-nix that: r' tic research involves no more "iininlal risk to the subjects; 'I he waiver or alteration will +-~ecly ailed the rights and :c u1 the subjects; f'ht: research could not .t 111ly be carried out without the Of alteration; and Whenever appropriate, the -t: will be provided with ca~;ti pertinent information after ._ipulion. t hr informed consent :cements in these regulations are r r :tended to preempt any cable federal, state, or local laws t require additional information di%closed in order for informed Ott to be legally effective. Nothing in these regulations is ded to limit the authority of a -clan to provide emergency s t,J .gal Care, to the extent the trtr'? ician is permitted to do so under till/ '-cable federal, state, or local law. 17 Documentation of wd consent. ?.t Except as provided in graph (c) of this section, li t ruicd consent shall be lttr atfentcd by the use of a written ent form approved by the lRB igned by the subject or the ec-'s legally authorized '' t nentative. t Me 1 1.1't` .Except -as provided in raph (c) of this section, the qtt,,! y'~~~ !'r'1 ,`cpt form may be either of the t:ttt winlt: li~lf t f A written consent document t`Intktics the elements of t!'aa lpcd consent required by "ti}' , 116, This form may be read to I It ; object or the subject's legally rlt riz.ed representative, but in any "'& t. the investigator shall give the ,object or the representative adequate opp,:trtur.ity to read it before it i d: car (2) A','short form" written consent document stating that the elements of informed consent required by $ 46,116 have beer presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the-short form and a copy of the ?"fmmary, and the person actually ootatning consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the "short for " 3-ants.1RB may waive tie' jlNWj1jffii"r- tote investigatorio Igtteconse' arm Tire to (1) That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subj ct's wishes will govern; or ( - ~. ~ ~~rsscgts ~o requirement is waived, the IRS may require the investigator to provide subjects with a written statement regarding the research. 4 46.118 Applications and proposals lacking definite plans for Involvement of human subjects. Certain types of applications for grants, cooperative agreements. or contracts are submitted to the Department with the knowledge that subjects may be involved within the Approved For Release 2003/09/10 : CIA-RDP96-00789R003000020002-5 45, f_I R Ott Atiaroved For Release 2003/09/10 CIA-RDP96-00789R003000020002-5 i C1 duii0 but dcclinjte plans the Suhlt;is and otiierc:, and the w;;t ;1. Jt.On or proposal. These Page 1 t res!Lvatrons, incluclinr ,ti cut regulations, hzvc h-cn satis;;ca. 46.123 Early termination of research funding; evaluation of subsequent applications and proposals. include activities such as institutional ,; LXcalse* ao Subject* tn; Research. 1146.401 To what do these reg=ddations apply? (a) This subpart applim to all research involving children as sub; cts, conducted or supported by the Department of Health and Human Services. (I - This includes research conducted by Department. C. ::oyees, except that each (?cad of an Operating Divininn of the Department may adopt such nonsubstantive, procedural modifications as may be appropriate from an administrative standpoint. (2) It also includes research conducted or supported by the Department of Health and Human Services outside the United States, but in appropriate circumstances, the Secretary may, under paragraph (e) of ?46.101 of Subpart A. waive the applicability of some or all of the requirements of these regulations for research of this type. (b) Exemptions (1), (2), (5) and (6) as listed in Subpart A at ?46.101(b) are applicable to this subpart. Exemption (4), research involving the observation of public behavior, listed at ? 46.101(b), is applicable to this subpart where the investigator(s) does not participate in the activities being observed. Exemption (3), research involving survey or interview procedures, listed at ?46.101(b) does not apply to research covered by this subpart. (c) The exceptions, additions, and provisions for waiver as they appear in paragraphs (c) through (i) of ?46.101 of Subpart A are applicable to this subpart. ?46.402 Definitions. The definitions in ? 46.102 of Subpart A shall be applicable to this subpart as well. In addition, as used in this subpart: Approved For Release 2003/09/10 : CIA-RDP96-00789R003000020002-5 l'irgc 16 . Approved For Release 2003/09/10 : CIA-RDP96-00789R003000020002-5 "Cl ildceii"src' IR:r_:..lns A h consent to treatments of procedures involved in the research, under the ap ricah!c law Of the ju,asdiction in which the rest?srrh wif h; conducted. (b) "Assent" means a child's affirmative agrccn,ciit to narticinatr in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. (c) "Permission" means the agreement of parent(s) or guardian to the participation of their child or ward in research. (d) "Parent" means a child's biological or adoptive parent. (e) "Gupian".means an individual who is authorized under applicable state or local law to consent on behalf of a child to general medical care. ? 46.403 IRD duties. In addition to other responsibilities assigned to IRBs under this part, each IRB shall review research covered by this subpart and approve only research which satisfies the conditions of all applicable sections of this subpart. ? 46.404 Research. not. tivolviag greater than minimal risk, HHS will conduct or fund research in which the IRB finds that no greater than minimal risk to children is presented, only if the IRB finds that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in ? 46.406. ?46.405 Research involving greater than minimal risk bit preaeating the prospect of direct benefit to the Individual subjects, HHS will conduct or fund research in which the IRB finds that more than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a muwto u,}, prtu:edurc that is likely to only if the 1R1 finds that. by the anticipated benefit to the subjects; (b) The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches; and (c) Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians, as set forth in ? 46.40f8. ? 46.406 Research ip,;olving 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. HHS will conduct or fund research its which the IRB finds that more than minimal risk to children is presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or by a monitoring procedure which is not likely to contribute to the well-being of the, subject, only if the IRB finds that: (a) The risk represents a minor increase over minimal risk; (b) The intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations; (c) The intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or condition which is of vital importance for the understanding or amelioration of the subjects' disorder or condition; and (d) Adequate provisions are made for soliciting i s