i ", Puge 16 (a) “Children arc persons whe hoy. cas attaines the decal ape ton consent to treatments or procedures involved in the research, under the applicable law of the jusisdiction in which the research will be conducted. (b) “Assent” means a child's affirmptive agrcenicni 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 guardian to the participation of their child or ward in research. (d) “Parent” means a child’s biological or adoptive parent. (¢) “Guardian” means an individual who is authorized under applicable state or local law to consent on behalf of a child to general medical care. 846.403 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. involving 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. 946.405 Research involving greater than minima! risk but presenting the prospect of direct benefit to the individual subjects, HHS wil! 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 ovt the prospect of direct benefit for the individual subjeci, or by a Approved For Release 2003/09/10 : CIA-RDP96-00789R003000020002-5 moot procedure that is likely to conhinoute to the solgots wol-beoing only if the PRB finds that: (8) The risk to 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 avuilable 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. §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, 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 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 assent of the children and permission of their parents or guardians, as sct forth in § 46.408. 45 CFR 46 § 46.407 Research not otherwise approvable which preseiis an opportunity to understand, prevent, or- eleviste 2 sericus problem affecting the hesith or welfare of children. HHS will conduct or fund research that the IRB does not believe meets the requirements of - $5 46.404, 46.405, or 46.406 only if: (a) The IRB finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of chiidren; and (t) 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 determined cither: (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; (it) The research will be conducted in accordance with sound ethical principles; (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 Requirements for permission by parents or guardians and for asseat by children. (a) In addition to the determinations required under other applicable sections of this subpart, the IRB shall 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 assent. In determining whether children are capable of assenting, the IRH shal! take into account the ages, ; Maturity, and psychological state of the children involved. This judgment Approved For Release 2003/09/10 : CIA-RDP96-00789R003000020002-5
“e made for all children to be Ava resessch under a ; _ ular protocol, or for each child, * ts ERB deems appropriate. If the dctermines thet the canebiliy cf > or all of the children 1s so ‘ed that they cannot reasonably <onsulted or that the intervention *. - :ocedure involved in the ch holds out a prospect of ‘cet benefit that is important to the ‘vaith or well-being of the children is available only in the context of “++ research, the assent of the idren is not a necessary condition proceeding with the research. ~- tn where the IRB determines that tls. subjects are capable of assenting, Ts. [RD may still waive the assent \+\uirement under circumstances in * och consent may be waived in ‘vord with § 46.116 of Subpart A. d. 4.) In addition to the “I+ erminations required under other th. ‘icable sections of this subpart, *'- IRB shall determine, in ‘-. ordance with and to the extent SU: Consent is required by § 46.116 of aT hoart A, that adequate provisions ot ~ made for soliciting the permission W: sch child's parents or guardian. OO: + cre parental permission is to be PS ained, the IRB may find that the fOr. ission of one parent is sufficient ‘research to be conducted under ~ IS - 46.404 of 46.405. Where research an! Svered by §§ 46.406 and 46.407 permission is to be obtained from FR Approved For Release 2003/09/10 : CIA-RDP96-00789R003000020002-5 parents, both paretas musi give their PUoeus On Uiitss one Pare ts deceased, unknown, woompetent, or only one parent has lepal 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 IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonabie requirement to protect the subjects (for example, neglected or abused children), it 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 subjects, 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. (e) When the IRB determines that assent is required, it shall also Page 17 detcrmnitie whether and how assent rises B, PELs? Do geKtumentoc. § 46.409 Wards, (a) Children who are wards of the state or any other agency, institution, or entity can be included in research anproved under 88 46.406 of 46.407 only if such research is: (1) Related to their svatus 2s wards; or (2) Conducted in schools, camps, 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 (a) of this section, the IRB shall require appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loca parentis. One individual may serve as advocate for more than one child. The advocate shall 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 is 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 Organization. Approved For Release 2003/09/10 : CIA-RDP96-00789R003000020002-5
. Page 18 Approved For Release 2003/09/10 : CIA-RDP96-00789R003000020002-5 45 CFR 46 HUMAN SUBJECTS Minimum Criteria Identifying the Viable Fetus On March 13, 1975, reguiations were published in the FEDERAL K EGISTER(4U FR £}854) relating to the protection of human subjects in research, development, and related activities supported by Department of Health, Education, and Welfare grants and contracts. These regulations are codified at 45 CF Part 46. ° NOTICES Elsewhere in this issue of the Pebewat REGISTER, the Secretary is emending 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 FEDERAL REGISTER <a Ruidelines to assist on determining whether z ¢ fetus is viable for purposes of this subpart. This notice is published in ccordance with § 46.20%d). For purposes of Subpart B, the guidelines indicating that a fetus other than 2 dead fetus within the meaning of § 46.203(f) is viable include the following: - an cstimated gestational age of 20 weeks or mote and a body weight of $00 grams or more. FEDERAL REGISTER, VOL 40, AUGUST 8, 1975 U.S. GOVERNMENT PRINTING OFFICE : 1983 0 = 406-756 Approved For Release 2003/09/10 : CIA-RDP96-00789R003000020002-5
x rn ee mt TE ate eta wee ES a Approved For Release 2003/09/10 : CIA-RDP96-00%89R003000020002-5 - ed PROCEDURE 13. EXPERIMENTATION ON HUMAN SUBJECTS FOR INTELLIGENCE PURPOSES A. APPLICABILITY This procedure applies to experimentation on human sub- jects L1£ 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 a 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 damage 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 con- ponent regardless of the existence of a contractual rela- tionship. ~ ee Approved For Release 2003/09/10 : CIA-RDP96-00789R003000020002-5
sew ae ahs dome Pee Approved For Release 2003/09/10 : CIA-RDP96-00789R003000020002-5 Co . 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 ee 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 Army intelligence components will be addressed through command channels to HQDA (DAMI-CIC), WASH DC 20310.] Approved For Release 2003/09718-: CIA-RDP96-00789R003000020002-5