Page 12 EN AAO Rig na ON ra grants and contract supporting research, development, and related activities involving: (1) The fetus, (2) pregnant women, and (3) human ta vitro fertilization. (b} Nothing in this subpart shall be construed as indicating that compliance with the procedures set forth herein will in any way render inapplicable pertinent State or local laws bearing upon activities covered by this subpart. (c) The requirements of this subpart are in addition to those imposed under the other subparts of this part. § 46.202 Purpose. it is the purpose of this subpart to provide additional safeguards in reviewing activities to which this subpart is applicable to assure that they conform to appropriate ethical Standards and relate to important societal needs. $ 46.203 Definitions. As used in this subpar: {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 becn delegated. (b) **Pregnancy'’ encompasses the period of time from confirmation of implantation (through any of the presumptive signs of pregnancy, such as missed menses, or by a medically acceptable pregnancy test), until expulsion or extraction of the fetus. (c) ‘‘Fetus’* means the product of conception from the time of implantation (as evidenced by any of the presumptive signs of pregnancy, such as missed menses, or a medically acceptable pregnancy test), until a determination is made, following explusion or extraction of the fetus, that it is viable. (d) *‘Viable'" as it pertains to the tctus means being able, after either spontaneous or induced delivery, to survive (given the benefit of available medical therapy) to the paint of independently maintaining heart ten etme mere resmannaN AERA in * Approved For Release 2000/08/08 : CIA-RDP96-00788R001700250001-7 ee rere beat and respiration. The Secretary may from Gme to time, taking into account medical advances, publish in the FEDERAL REGISTER guidelines to assist in determining whether a fetus is viable for purposes of this subpart. If a fetus is viable after delivery, it is @ premature infant. {e) ‘‘Nonviable fetus’ means a fetus ex utero which, although living, is not viable, (f) **Dead fetus" means a fetus ex utero which exhibits neither hearibeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord (if still attached). (g) ‘Jn vitre fertilization’ means any fertilization of human ova which occurs outside the body of a female, either through admixture of donor human sperm and ova or by any other means. § 46.204 Ethical Advisory” Boards. | (a) One or more Ethical Advisory Hoards shall be established by the Secretary, Members of these board(s) shall be so selected that the board(s) will be competent to deal with medical, legal, social, ethical, and related issues and may include, for example, research scientists, physicians, psychologists, sociologists, educators, lawyers, and ethicists, as well as representatives of the general public. No board member may be 4 regular, full-time employee of the Department of Health, Education, and Welfare. (b) At the request of the Secretary, the Ethical Advisory Board shall render advice consistent with the policies and requirements of this Part as to ethical issues, involving activities covered by this subpart, raised by individual applications or Proposals. in addition, upon request by the Secretary, the Board shail render advice as to classes of applications or proposals and general policies, guidelines, and procedures. (c) A Board may establish, with the approval of the Secretary, classes of applications or proposals which: reine oni (i) Must be submitted to the Board, or (2) need not be submitted 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 its acceptability from an ethical standpoint. $ 46.205 Additional duties of the institutional Review Boards in connection with activities inveiving 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 ail 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 cither by approving induction of each individual into the activity or Approved For Release 2000/08/08 : CIA-RDP96-00788R001700250001-7 45 CFR 46
ee es | ASCE, eaamomncas verifying, perhaps through sampling, that approved procedures for induction of individuals into the activily are being followed, and (i) monitoring the progress of the activity and intervening as necessary through such steps as visits to the acuvity 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 paragraph (a) of this section and the Secretary has approved these delerminations, 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 for the designation of an Institutional 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 heen completed: (2) Except where the purpose of the activity is to meet the heaith 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 activity. (3) Individuals engaged in the activity will have no part in: Gi) Any decisions as to the timing, method, and procedures used to terminate the pregnancy, and (ia) determining the viability of the fetus at the termination of the pregnancy: and (4) No procedural changes which May cuuse greater (han minimal risk to the fetus or the pregnant woman will he introduced into the procedure oved For Release 2000/08/08 : CIA-RDP96-007 eed ee tam tan for terminating the pregnancy solely in the interest of the activity. (5) No inducemenis, monetary or otherwise, may be offered to terminate pregnancy for purposes of the activity. (40 FR 33528. Aug. 8. 1975, as amended at 40 FR 51638. Nov. 6, 1975} § 46.207 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 minimum extent necessary to meet such needs, or (2) the risk ta the fetus is minimal. (b) An activity permitted under paragraph (a) of this section may be conducied only if the mother and father are legally competent and have given their informed consent alter 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 reasonally 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 to meet such aceds, or (2) the risk to the fetus imposed by the research is minimal and the pucpose of the activity is the development of important biomedical knowledge which cannot be obtained by other meuns. (b) An activity permitted under Paragraph (a) of this section may be conducted only if the mother and ES wre 88R001700250001-7 Page 13 Cae OR father are legally competent and have given their informed consent, except that the father's consent need 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, 23 subjects. (a) Until it has been ascertained whether or not a fetus ex 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 uther 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 noaviable 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 part. {d) An activity permitted under paragraph (a) or (b) of this section may be conducted only if the mother and father are leg4lly competent and have given their informed consent, except that the father's informed consent need nat be secured if: (1) his identity or whereabouts cannot reasonably be ascertained, (2) he is Approved For Release 2000/08/08 : CIA-RDP96-00788R001700250001-7 ee RE a a NS TI ar FEE IE OME MERE TTR RC,
fe aA ER ie BU Bi a et AE LO TET aE, Approved For Release 2000/08/08 : CIA-RDP96-00788R001700250001-7 ' Pane 44 owes. craic te ma aaa not reasonably available, or (3) the pregnancy resulted from rape. § 46.210 Activities involving the dead fetus, fetal material, or the placenta. Activities involving the dead fetus, mascerated fetal material, or cells, tissue, of organs excised from a dead fetus shall be conducted only in accordance with any applicable State or local laws regarding such activities. § 46.211 Modificstion ar waiver of specific requiremenis. Upon the request of an applicant or offeror (with the approval of its Institutional Review Board), the Secretary may modify or waive specific requirements of this subpar, 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 witl consider whether the risks to the subject are so ourwerghed by the sum of the benefit to the subsect and the importance of the knowledie to be gained as to warrant such madification or waiver und tat such benefits cannot be gained except through a modification or warver, Any such moditicuuions or waivers wHl be published as notices in the FEDERAL REGISTER Subpart C---Additional Protections Pertaining ta Biomedical and Rehavioral Research Involving Prisuners aa Subjects Source: 43 FR $3655. Nov 16, 1978 § 46.301 Applicability. (a} The regulations in this subpart are applicable to all biomedicai and behavioral research conducted or supported by the Department of Health, Education, and Welfare invelving prisoners as subjects, (bi Nothing in this subpast shall be construed as indicating that compliance with the procedures set focth herein will authorize research involving prisoners as subjects, to the! extent such research is limited or eect Riche RO wing EAR barred by applicable State or local law. (c) The requirements of this subpart are in addition to those imposed under the oiher subparts of this part. § 46.302 Purpuse. Inasmuch as prisoners may be under constraints because of their incarceration which could affect 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 to provide additional safeguards for the protection of prisoners involved in activities to which this subpart is applicable. $ 46.303 Definitions. As used in this subpart: (a) ““Secretary’” means the Secretary of Health, Education, Welfare and any other officer or employee of the Department of Health, Education, and Welfare to whom authority has been delegated. ib) “DHEW' means the Department of Health, Educadon, and Welfare. (c) Prisoner’ and Y * meana any ‘tidividual involuntarily confined of detained i in a penal | institution. The term is intended ‘ta encompass ° ° ‘individuals sentenced to such an institution under a criminal or civil - statute, individuals “detained in “other facilities by? virtue of staqutes oF, : commitment procedures. which . "provide: alternatives toeriminal: prosecution ; Or incarceration in 2 : 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 af healthy persons. § 46.304 Compesition of Institutional Review Boards where prisoners are involved, In addition to satisfying the te en nm cy Me cee im 45 CFR 46 requirements in § 46.107 of this pan, an Institutional 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. af the Board... «4 (exclusive o ‘of f prisoner “ members) rer) have no association with the prison(s, involved, apart from their”, fe tee 4: membership on the Board: By) (b) At least one member of f the? Board | shall be bea 8 | prisorier, or a pridoaer. feprescatative ¥ with: appropriate background 5 and 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. ep ter $ 46.305 Additiunal duties of the Institutional Review Boards where prisoners are involved. (a) In addition ta all other responsibilities prescribed for Institutional Review Boards under this part, the Board shal} 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 § 46.306fa)(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, umenities and opportunity for earnings in the prison, are not of such a magnitude. that bis or her ability to. , weigh thevisks of the research against, the value of such advantages in the limited choice environment of the prison is impaired: 0 (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 2000/08/08 : CIA-RDP96-00788R001700250001-7
"3 CFR SS roved For Release 2000/08/08 : CIA-RDP96-00788R001700250001-7 LET I EE SOS ERE STIS OENENS: PEE I MERA RITT TE PPS * a all prisoners and immune from arbitrary intervention by prison authorities or prisoners. Uniess the principal investigator provides to the Board justification in writing for following some other procedures, control subjectz. must be selected randomly from the group of available prisoners who meet the characteristics needed for that particular research project; (3) The information is presented in language which is understandable to the subject population: (6) Adequate assurance exists that parole. boards, wil aos fake. 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 on his or her parole; and (7) Where the Board finds there may be a need for follow-up exanunation or care of participants after the end of their participation. . adequate provision has been made tor such exXaminalion or care, taking into account the varying lengths of individual prisoners’ sentences, and for informing participants of this fact. (>) The Board shall carry out such other duties as may be assigned by the Secretary. ic} The institution shall certify to the Secretary, in such form and maser as the Secretary may require, that the duties of the Board under this section have been fulfilled. §$ 46.206 Permitted research iavoiving 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 cerufied to the Secretary that the Institutional Review Board has approved the research under § 46.305 _of Utis subpart: and Tw (2) In the judgement of the SME: EMI A Tg SERRE TERI CE be a Secretary the proposed research invoives solely the following: (A) Seudy of the possible causes, effects, and processes of incarceration, and of criminal behavior, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects: (B) Study of prisons as institutional struciures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risk and ao 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 prevaient 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 penvlogy medicine and ethics, and published nolice, in the FEDERAL REGISTER, of his intent to approve such research: or (D) Research un practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well- being of the subject. In eases 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 fram the research, the study may proceed only after the Secretary bas consulted with appropriate experts, including experts in penology medicine and ethics, and Published notice, in the FEDERAL REGISTER, of his intent to approve such Tesearch, (b) Except as provided in paragraph (a) of this section, biomedical or behavioral research conducted or supported by DHEW shall not involve prisoners as subjects. Pape 15 ~ Anh Ah NC RARDIN ith eat Sabpart D— Additional Protections for Catidron Devolved as Sebjects in Research, Source: 48 FR 9818, March 8, 1983 846.401 To what da these regulations apply? (a) This subpart applies to all research involving children as subjects, conducted or supported by the Department of Health and Human Services. (1) This includes research conducted by Department employees, except that each head of at Operating Division 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 (&) 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 2000/08/08 : CIA-RDP96-00788R001700250001-7