(a) “Chiltren’ are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted, (b) “Assent” means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. {c) “Permission” means the agreement of parent(s) or guardiau to the participation of their child or ward in research, (d) “Parent” means a child’s biological or adoptive parent. (e) “Cyuardien” 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 IRB 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 ail applicable sections of this subpart, § 46.404 Research not.iavolving greater thaa minimal risk, HHS will conduct or fund research in which the IRB finds that HO greater than minimal risk to children is presented, only if the IRB finds that adequate provisions are inade for soliciting the assent of the children and the permission of their parents or guardians, as set forth in § 46.406, 445.405 Research involving greater than minimal risk but presenting the prospect af 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 prospéct of direct benefit for the individual subject, or by a | Pura dbproved For Release 2000/08/08 : CIA-RDP96-00788R001700250001-7 A OME SFE ee no me: monitoring procedure that is likely to contribute to the subject’s well-being only if the IRB finds that: (a) The risk is justified 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 § 46.408. 946.406 Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yleld generaiizable knowledge about the subject's disorder or condition, HHS will conduct or fund research in which the IRB finds that more than minimal risk w children is presented by an intervention or procedure that does aot 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 subject;' disorder or condition which is of vital importance for the understanding or amelioration of the subjecis’ disorder or condition; and (d) Adequate provisions are made for soliciting assent of the children and permission of their parents or Suardians, as set forth in § 46.408. noes Leak he SME DARS Btah SR IERTe iny can ihe SS ES Es ‘ 45 CFR 46 “ oon ten nun retcnnnesunersserepreneane oe $ 46.407 Research not Otherwise = 5 approvable which presexts an alleviate a serious problera affecting the healih or welfare of children, HHS will conduct or fund research that the IRB does not believe meets the requirements of - ‘ $§ 46.404, 46.405, or 46.406 only if: (a) The IRS finds that the research presenis a reasonable opportunity to further the understanding, prevention, o¢ alleviation of a serious problem affecting the health or welfare of children; and (b) The Secretary, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, education, ethics, law) and following Opportunity for public review and comment, has deterinined either: (1) That the research in fact satisfies the conditions of §§ 46.404, 46.405, or 46.406, as applicable, or (2) the following: (i) The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children: (ii) The research will be conducted in accordance with sound ethical Priaciples; (iii) Adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians, as set forth in § 46.408. $ 46.408 Requireaents for Permisaloa by parents or guardians aad for assent by children, {a) In addition to the determinations required under other applicabie sections of this subpart, the IRB shali determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing asseat. In determining whether children are capable of assenting, the IRB shall take into account the ages, ; maturity, and psychological state of @ the children involved. This judgment Opportunity to understand, prevent, or- ¢3 { @* Approved For Release 2000/08/08 : CIA-RDP96-00788R001700250001-7
RAE Wake 9. HIRES eae. e . 96-00788R001700250001-7 Page 17 sR © mma a He Se Hs omrterdite etal tate CN ENE HE ETERNAL Bt ", » #5 CPR AB. oved For Release 2000/08/08 : CIA-RDP tnay be made for all children to be involved in research under a yparticular protocol, or for each child, OF the IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they cannat reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of ihe research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IND may still waive the assent requirement under Circumatances in which cousent may be waived in accord with § 46.116 of Subpart A. (b) In addition to the determinations required under other applicable sections of this subdpari, the IRB shall determine, in accordance with and to the extent that consent is required by $ 46.116 of aes Subpart A, that adequate provisions are made for soliciting the permission of each child's parents or guardian. Where parental permission is to be obtained, the IRD may find that the permission of one parent is sufficient ior research to be conducted under $§ 46.404 or 46.405. Where research is covered by $§ 46.406 and 46.407 and permission is to be obtained from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent hes legal responsibility for the care and custody of the child. {c) In addition to the provisions for waiver contained in § 46.116 of Subpart A, if the (RB determines that & research protocol is designed for conditions or for 2 subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), ie may waive the consent requirements in Subpart A of this part and paragraph (b) of this section, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with federal state or local law. The choice of an appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjecis, and their age, maturity, status, and condition. (d) Permission by parents or guardians shall be documented in accordance with and to the extent required by § 46.117 of Subpart A. {c) When the IRS determines that assent is required, it shall also determine whether and how assent must be documented. § 46.409 Wards, (a) Children who are wards of the State or any other agency, institution, oF entity can be included in research approved under §§ 46.406 or 46.407 only if such research is: (1) Related to their siatus ag wards: or (2) Conducted in schools, campa, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards. (b) If the research is approved under paragraph (2) of this section, the IRG shall require appointment of an advocate for cach child who is a ward, in addition to any other individual acting on dchalf of the child as guardian or in loco parentis. One individual may serve as advocate for more than one child. The advocate shail be an individual who has the background and experience to act in, and agrees to act in, the best interests of the child for the duration of the child's participation in the research and who i$ NOt associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian Orgaiization. Approved For Release 2000/08/08 : CIA-RDP96-00788R001700250001-7
|. | Page 8 ved Eor Release 2000/08/08 : CIA-RDP96-00788R001700250001-7 HUMAN SUBJECTS Minimum Criteria Identifying the Viahle Fetus On March 13, 1975, regulations were published in the FEDERAL REGISTER (40 FR 11854) relating to the protection of human subjects in tesearch, development, and relate activities supported by Department of Heaith, Education, and Welfare grants and contracts. These regulations are codified at 45 CFR Pan 46. NOTICES Elsewhere in this issue of the FEDERAL REGISTER, the Secretary is amending 45 CFR Part 46 by, among other things, adding a new Subpart B to provide additional Protections pertaining to research, development, and related activities involving fetuses, pregnant women, and in vitro fertilization. Section 46.203(d) of Subpart B provides inter alia as follows: The Secretary may from time to time, taking into account medical advances, Publish in the Fepemar REGISTER U.S. GOVERNMENT PRINTING OFFICE ; guidelines to assist in determining whether a ¢ fetus is viable for purposes of this subpart. This notice is published in accordance with § 46.20%d). For purposes of Subpart B, the guidelines indicating that a fetus other than a dead fetus within the meaning of § 46.203(f) is viable include the following: . an csfimated gestational age of 20 weeks or more and a body weight of 500 grams or More. FEOERAL REGISTER, VOL 40, AUGUST &, 1975 1983 0 =~ 406~756 Approved For Release 2000/08/08 : CIA-RDP96-00788R001700250001-7
EE EE A A A I OS I) an eee ees ee ads WTR ak hee cw A tcl FP aha i Approved For Release 2000/08/08 : CIA-RDP96-00788R001700250001-7~ . wets PROCEDURE 13. EXPERIMENTATION ON HUMAN SUBJECTS FOR INTELLIGENCE PURPOSES A. APPLICABILITY This procedure applies to experimentation on human sub- jects Lf such experimentation is conducted by or on behalf of a DoD intelligence component, This procedure does not apply to experimentation on animal subjects. B. EXPLANATION OF UNDEFINED ‘TERMS 1. Experimentation in this context means any research or testing activity involving human subjects that may expose such subjects to the possibility of permanent or temporary injury (including physical or psychological danage and damage to the reputation of such persons) beyond the risks of injury to which such subjects are ordinarily exposed in their daily lives, 2. Experimentation is conducted on behalf of a Dod intelligence component if it is conducted under contract to that component or to another DoD component for the benefit of the intelligence component or at the request of such a com- ” ponent regardless of the existence of a contractual rela- tionship. = r Approved For Release 2000/08/08 : {iaRp96-00788R001700250001-7
EE BS ES ON IEE IE a EI. 5: RIE ra Deans ties Tera. Sse ee enna. aie S gm SF OL. Po ale RET NN “ _ Approved For Release 2000/08/08 : CIA-RDP96-00788R001700250001-7 (© 3. Human subjects in this context includes any person whether or not such person is a United States person. C. PROCEDURES 1. Experimentation en human subjects conducted by or on behalf of a DoD intelligence component may be undertaken only with the informed consent of the subject, and in accordance with guidelines issued by the Department of Health and Human Services, setting out conditions that safeguard the welfare of such subjects, 2. DoD intelligence components may not engage in or 4 contract for experimentation on human subjects without appro- val of the Secretary or Deputy Secretary of Defense, or the Secretary or Under Secretary of a Military Department, as appropriate. [Requests for such approval submitted by Aruy - . intelligence components will be addressed through command channels to HQDA (DAMI-CIC), WASH DC 20310.) Cc Approved For Release 2000/08/08 ~CtAeRDP96-00788R001700250001-7