(pproved For Release 2003/09/10 : CIA-RDP96-00789R003000020002-5 Cosgubetton The Sevbotirs i “nouime to time, taking tnto tae medical advances. publish in “UPRAL REGISTER guidelines . ‘in determining whether a a “< waable for purposes of this ‘ott Ifa fetus is viable after "atts @ premature infant Nonviable fetus’’ means a \ + utero which, although living, H., viable. 4 he Dead fetus*' means a fetus ex a. which exhibits neither ¥... Lal, Spontaneous respiratory ih \, Spontaneous movement of \. ify muscles, nor pulsation of ay -bilical cord (if still attached). 0... "In vitro fertilization’’ means ¢ii,  ctilization of human ova which hu:. outside the body of a female, ius.” through admixture of donor 8 sperm and ova or by any other By. , wo M "Ethical Advisory’ Bu. ot. 7 , Se. | “ne or more Ethical Advisory sh...” , shall be established by the will \ “-y, Members of these boards) Mee a * so selected that the board(s) rela. \ competent to deal with eka. * |, legal, social, ethical, and phy. . | issues and may include, for SOWA - vie, research scientists, eth. ins, psychologists, the 4. “vrists, educators, lawyers, and may -y. “', as well as representatives of wf th srval public. No board member Edu. + a regular, full-time employce (& Oepartment of Health, the} ‘sn, and Welfare. fend, the request of the Secretary, Poli “cal Advisory Board shall aste .. ‘advice consistent with the aus.” > and requirements of this Part aaiscS CO lival issues, involving PROPS, 1" covered by this subpart, by Ux O°) individual applications or gendy © his, In addition, upon request appli. “ecretary, the Board shall poli... ivice as to classes of fc: +... wns or proposals and general the, . puidelines, and procedures. toy “oard may establish, with al of the Secretary, classes ‘ors or proposals which: 45 CFR 46 (i) Must be su miutted to the Board, or (2) need not be submitied to the Board. Where the Board so establishes a class of applications or proposals which must be submitted, no application or proposal within the class may be funded by the Department or any component thereof until the application or proposal has been reviewed by the Board and the Board has rendered advice as to its acceptability from an ethical standpoint. (d) No application or proposal involving human in vitro fertilization may be funded by the Department or any component thereof until the application or proposal has been reviewed by the Ethical Advisory Board and the Board has rendered advice as to ifs acceptability from an ethical standpoint. $ 46.205 Additional duties of the Institutional Review Boards in connection with activities involving fetuses, pregnant women, or human in vitro fertilization. (a) In addition to the responsibilities prescribed for Institutional Review Boards under Subpart A of this part, the applicant's or offeror's Board shall, with respect to activities covered by this subpart, carry out the following additional duties: (1) Determine that all aspects of the activity meet the requirements of this subpart; (2) Determine that adequate consideration has been given to the manner in which potential subjects will be selected, and adequate . provision has been made by the applicant or offeror for monitoring the actual informed consent Process (e.g., through such mechanisms, when appropriate, as participation by the Institutional Review Board or subject advocates in: (i) Oversecing the actual process by which individual consents required by this subpart are secured either by approving induction of each individual into the activity or Approved For Release 2003/09/10 : CIA-RDP96-00789R003000020002-5
Approved For Release 2003/09/10 : CIA-RDP96-00789R003000020002-5 45 CFR 46° Sere veri ing, peibaps througn sampling, 9 for terminating the pregnancy solcis eofenerayee prose dpres for ithe intss tof the sc tvite. mnidictlud of activity are berne fallowed, and (il) monitoring the progress of the acbvitly and intervening as necessary throuyh such steps as vinits to the activity site and continuing evaluation to determine if any unanticipated risks have arisen), (3) Carry out such other responsibilities as may be assigned by the Secretary. (b) No award may be issued until the applicant or offeror has certified to the Secretary that the Institutional Review Board has made the determinations required under tdi viduals into the paragraph (a) of this section and the Secretary has approved these determinations, as provided in § 46.120 of Subpart A of this part. (c) Applicants or offerors seeking support For activities covered by this subpart must provide ror the designation of an (nstitutional Review Board, subject to approval by the Secretary, where no such Board has been established under Subpart A of this part. $ 46.206 General limitations. (a) No activity to which this subpart is applicable may be undertaken unless: (1) Appropriate studies on animals and nonpregnant individuals have been completed, (2) Except where the purpose of the activity is to meet the health needs of the mother or the particular fetus, the risk to the fetus is minimal and, in all cases, is the least possible risk for achieving the objectives of the acuivily. (3) Individuals engaged in the activity will have no part in: (i) Any decisions as to the timing, method, and procedures used to terminate the pregnancy, and (ii) determining the viability of the fetus at the termination of the pregnancy; and (4) No procedural changes which to the fetus or the pregnant womun will he intraduced into the procedure (b) No inducements, monetary or otherwise, may be offered to terminate pregnancy for purposes of the activity. [46 FR 33528, Aug. 8, 1975, as amended at 40 FR 51638. Nov. 6, 1975] § 460.207 Activities directed toward pregnant women as subjects. (a) No pregnant woman may be involved as a subject in an activity covered by this subpart unless: (1) The purpose of the activity is to meet the health needs of the mother and the fetus will be placed at risk only to the minituum extent necessary to meet such needs, or (2) the risk to the fetus is minimal. (b) An activity permitted under paragraph (a) of this section may be conducted only if the mother and father are legally competent and have given their informed consent after having been fully informed regarding possible impact on the fetus, except that the father's informed consent need not be secured if: (1) The purpose of the activity is to meet the health needs of the mother; (2) his identity or whereabouts cannot reasonably be ascertained; (3) he is not reasonably available: or (4) the pregnancy resulted from rape. § 46.208 Activities directed toward fetuses in utero as subjects. (a) No fetus in utero may be involved as a subject in any activity covered by this subpart unless: (1) The purpose of the activity is to meet the health needs of the particular fetus and the fetus will be placed at risk’ only to the minimum extent necessary fo meet such needs, or (2) the risk to the fetus imposed by the research is minimal and the purpose of the activity is the development of impoctant biomedical knowledge which cannot be obtained by other means. (b) An activity permitted under paragraph (a) of this section may be conducted only if the mother and Pape 13 futher are lecally competent anu have given there infurnicd consent, except that the father’s consent nced not be secured if: (1) His identity or whereabouts cannot reasonably be ascertained, (2) he is not reasonably available, or (3) the pregnancy resulted from rape. § 46.209 Activities directed toward fetuses ex utero, including nonviable fetuses, as subjects. (a) Until it has been ascertained whether or not a fetus ¢x utero is viable, a fetus ex utero may not be involved as a subject in an activity covered by this subpart unless: (1} There will be no added risk to the fetus resulting from the activity, and the purpose of the activity is the development of important biomedical knowledge which cannot be obtained by other means, or (2) The purpose of the activity is to enhance the possibility of survival of the particular fetus to the point of viability. (b) No nonviable fetus may be involved as a subject in an activity covered by this subpart unless: (1) Vital functions of the fetus will not be artificially maintained, (2) Experimental activities which of themselves would terminate the heartbeat or respiration of the fetus will not be employed, and (3) The purpose of the activity is the development of important biomedical knowledge which cannot be obtained by other means. (c) In the event the fetus ex utero is found to be viable, it may be included as a subject in the activity only to the extent permitted by and in accordance with the requirements of other subparts of this pan. (d) An activity permitted under paragraph (a) or (b) of this section may be conducted only if the mother and father are legally competent and have given their informed consent, except that the father's informed consent need not be secured if: (1) his identity or whereabouts cannot reasonably be ascertained, (2) he is Approved For Release 2003/09/10 : CIA-RDP96-00789R003000020002-5
_ Pan As pproved For Release 2003/08/40 : C1A-RDP96-00789R003000020002-5 45 CFR 46 nat reasonably available, or (3¥ the prepnancy rosulted from rane. § 46.210 Activities involving the dead fetus, fetal muteri-!, ar ihe placenta. Activides involving the dead fetus, mascerated fetal material, o° cells, tissue, Or organs excised from a dead fetus shall be conducted antes accordance with any applicable State or local laws regarding such activities, § 46.211 Modification or waiver of specific requirements. Upon the request of an applicant or offeror (with the approva! of its Institutional Review Board), the Secretary may modify or waive specific requirements of this subpart, with the approval of the Ethical Advisory Board after such opportunity for public comment as the Ethical Advisory Board considers appropriate in the particular instance, In making such decisions, the Secretary will consider whether the risks to the subject are so outweighed by the sum of the benefit to the subject and the importance of the knowledge to be gained as to warrant such modification or waiver and that such benefits cannot be gained except through a modification or waiver. Any such modifications or waivers will be published as notices in the F EDURAL REGISTER Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects : Svurce: 43 FR $3655, Nov 16, 1974 § 46.301 Applicability. (a) The regulations in this subpart are applicable to all biomedical and behavioral research conducted or supported by the Department of Health, Education, and Welfare involving prisoners as subjects. (b) Nothing in this subpart shall be construed as indicating that compliance with the procedures set forth herein will authorize research invelving prisoners as subjects, to the eatent such research is limited or barred by applicable State or focal haw (ed Tae requirements of this subpart are in addition to those imposed under the uiher subparts of this part § 46.302 Purpose, Inastnuch as prisoners may he under constraints because ol their incarceration which could atfect their ability to make a truly voluntary and uncoerced decision whether or not to Participate as subjects in research, it is the purpose of this subpart ts provide additional safeguards for the Protection of prisoners invalved in activities to which this subpart is applicable, $ 46.303 Definitions. As used in this subpart: {a) *‘Secretary’’ means the Secretary of Health, Education, and Welfare and any other officer or employee of the Department of Health, Education, and Welfare to whom authority has been delegated. (b) “DHEW"' means the Department of Health, Education, and Welfare. _(c) **Prisoner”’ ” means any | ‘itidividual involuntarily confined of detained i in a penal institution.’ The .ferm is intended to encompass * individuals sentenced to such an institution under a criminal or civil | “Statute, individuals s detained i in “other facilities “by § virtue of statutes or . ‘commitment, procedures, which . ‘provide alternatives: to ‘criminal Prosecutfon or incarceration ina :penal institution, and individuals detained pending arraignment, trial, or sentencing. (d) “Minimal risk’’ is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons. § 46.304 Composition of institutional Review Boards Where prisoners are involved. In addition ta satisfying the requirements in § 46.107 of this part, an Insuttonal Review Board, carrying out responsibilities under this part with respect to research covered by this subpart, shall also - meet the following specific requirements: (a) A majority of the Board... abt (exclusive ¢ Of prisoner members) shal? have no association with the prison(s)’ involved, apan from their” wa adie membership onthe Board) 4 (b) At least ohe member of f the! Board Shall b be. a i prisoner, or r te pridoner. fepresentative with appropriate background and xy experience to serve in that capacity, except that where a particular research project is reviewed by more than one Board only one Board need satisfy this requirement. $ 46.305 Additional duties of the Institutional Review Boards where prisoners are involved. (a) In addition to all other responsibilities prescribed for Institutional Review Boards under this part, the Board shall review research covered by this subpart and approve such research only if it finds that: (1) The research under review represents one of the categories of research permissible under § 46.306(a)(2); (2) Any possible advantages accruing to the prisoner through his or her participation in the research, when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison, are not of such @ Magnitude that bis or her ability ta. , weigh the risks of the research against. the value of such: advantages i in the limited choice environment of the prison is impaired: (3) The risks involved in the research are commensurate with risks that would be accepted by nonprisoner volunteers: ¢@) (4) Procedures for the selection of Subjects within the prison are fair to @ Approved For Release 2003/09/10 : CIA-RDP96-00789R003000020002-5
' all prisoners and immune fron: cero inioeverdion by prison authorities or prisoners. Uniess the principal investigator provides tc the Board justificauon in writing for following some other procedures, control subjects must be selected tandomly trom the group of available pnsoness who meet the characteristics needed for that particular research project: (5) The information is presented in language which is understandable to the subject population; (6) Adequate assurance exists that “parole boards will not take. into, account a prisoner's participation in the research in making decisions regarding parole, and each prisoner is clearly informed in advance that Participation in the research will have no effect om his or her parole; and (7) Where the Board finds there may be a need for follow-up examination of care of participants after the end of their participation, adequate provision has been made for such examination or care, taking into account the varying lengths of individual prisoners’ sentences, and for informing participants of this fact. (b) The Board shall carry out such other duties as may be assigned by the Secretary. (c) The institution shall certify to the Secretary, in such form and manner as the Secretary may require, that the duties of the Board under this secuion have been fulfilled. § 46.306 Permitted research | involving prisoners.." * (a) Biomedical or behavioral research conducted or supported by DHEW may involve prisoners as subjects only if: (1) The institution responsible for the-conduct of the research has certified to the Secretary that the Institutional Review Board has approved the research under § 46.305 of this subpart, and (2) In che judgment of the Sectetary the proposed research mroses sstely the fotlowine (A} Study of the posstble causzs, clfects, and processes of incarceration, and of criminal behavior. pravided that the study presents no more than minimal risk and no more than inconvenience to the subye cis: (B) Study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects: (C) Research on conditions particularly affecting prisoners as a class (for example, vaccine trials and other research on hepatitis which is much more prevalent in prisons than elsewhere; and research on social and psychological problems such as alcoholism, drug addiction and sexual assaults) provided that the study may proceed only atter the Secretary has consulted with appropriate experts including experts in penology medicine and ethics, and published notice, inthe FEDERAL REGISTER, of his intent to approve such research; or (D) Research on practices, both innovative and accepted, which have the intent-and reasonable probability of improving the health or well- being of the subject. In cases in which those studies require the assignment of prisoners in a manner consistent with protocols approved by the IRB to control groups which may not benefit from the research, the study may proceed only after the Secretary has consulted with appropriate experts, including experts in penology medicine and ethics, and published notice, in the FEDERAL REGISTER, of his intent to approve such research. -(b) Except as provided in paragraph (a) of this section, biomedical or behavioral research conducted cr supported by DHEW shall not involve prisoners as subjects. 09/10 : CIA-RDP96-00789R003000020002-5 . 45 CF R 4 . Approved For Release 2003/ Page 15 eee eee oe Subpsat D—Additionad Protections fis CiGdron Leralved a3 Subjects ig Research, Source: 48 FR 9618, March 8 1983 846.401 To what do these reguistions apply? {a} This subpart applies to all research involving children as subjects, conducted or supported by the Department of Health and Human Services. (i) This includes research conducted by Department emjnoyees, except that each head of an Operating Divinion 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