» te CBR SEE In SA TAA OE: 2 TRA Bas Se EAS BW a TR fC RS A ere wom aint Bie ‘ 45 €FR#broved For Release 2000/08/08 : CIA-RDP96-00788R001500140003-9 1 ia aaa 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 subjects must be selected: randomly from the group of available presaners who mect the characteristics needed for that particular research project; {5) The information is presented in language which is understandable to the subject population; (4) Adequate assurance exists that parole baanda, gill aot feka. into, account # prisoner's paricipation 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 follaw-up exgminauion or care of participants after the end of their participaiion, adequate provision bas been made for such examination 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 mantier as the Secretary may require, that the duties of the Board under this secuion have been fulfilled. §46.106 Peeritied research ; involving prisoners.. "” (a} Dhomedical or behavioral research conducted or supported by DHEW may involve prisoners ag subjects only if: (1) The institution responsibls for the.conduct of the research has certified to the Secretary that the Insiitutional Review Board has approved the research under § 46.305 of this subpart: and (2) In the judgment of the PA REEL AH ee ire Secretary the proposed research involves solely the following: (A) Study of the posstble 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 structures 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 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, in the FEDERAL REGISTER, of his intent to approve such research: or (9) 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 cansistent 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 ethies, and published nutice, 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 or suppurted by DHEW shail not involve prisoners as subjects. aT ACN AEN ON rN ure t V ekaw enbe BRT ARTE RL CL 2 PS lg RT, ES SMS C9 A AA ch lites adi «on le a dea alee Page 15 Cee talecanl Subpart D-- Additional Protections for Cilldraa Lwralved as Subjects tu Research, Source: 48 FR 9818, March 8, 1993 846.401 To what do these regulations apply? (a) This subpart applies to all research involving children ag 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 an 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 (¢) 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 $46.101(b), is applicable to this subpart where the investigator(s) does not participate in the activities being observed. Exemption (3), research involving survey or interview procedures, listed at § 46. 101(b) does not apply to research covered by this subpart. (c) The exceptions, additions, and provisions for waiver as they appear in paragraphs (c) through (i) of §46.101 of Subpart A are applicable to this subpart. 846.402 Definitions. The definitions in §$ 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-RDP96-00788R001500140003-9 |
‘ d es fee a ii daatecalalartinandiasir hnmeebubieeweiiucaneatininainaisnireinaranih hove A UREA Se RT. SH Rs FO REELS ERE ARE A CoE LS ; eens iamrebiaieentivanneeitl inv phoeerone t 45 CFR 46 . Pagkp proved For Release 2000/08/08 : CIA-RDP96-00788R001500140003-9 ‘ene parte ene a wei re eee tate a adn k= mer Ammo (a) “Children” are persons who | Shave not attained the legal age for consent to treaiments 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 guardian to the participation of their child or ward in research. (4) “Parent” means a child’s biological or adoptive parent, (e) “Guardian” ‘means an individual who is authorized under applicable state or local law to consent on behalf of a child to feneral medical care, #46403 IRB duties, ; In addition to other responsibilities assigned to IRBs under this part, each IRB shall review research covered by this subpart and apprave only research which satisfies the conditions of all applicable sections of this subpart. $45.404 Research not. javolving greater than miniwal risk, HHS will conduct or fuad 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 creater tus minimal risk but presenting 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 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; (6) The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presenied by available alternative approaches; and (c) Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians, a3 set forth in § 46.408. $46.406 Research involving greater than minimal risk and no prospect of direct bencfit to individual subjects, but likely to yield Rencralizable knowledge about the subject's disorder or condition. HHS will conduct or fund research in which the IRB finds that more than minima! risk to 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 presen{s 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 o¢ amelioration of the subjects’ disorder or condition; and (4) Adequate provisions are made for soliciting assent of the children and permission of their parents or guardians, as set forth in § 46.408. § 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, 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 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 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 determined 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; (ti) The research will be conducted in accordance with sound ethical principles: (ili) Adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians, as set forth in § 46.408, § 46.403 Roquirements for Perimission by parents or guardians and for sasent by children, (a) {n addition to the determinations required under other applicable sections of this subpart, the IR5 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 IRB shall take into account the ages, ; maturity, and Piychological state of the children involved. This judgment Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140003-9
45 CE’ RSoroved For Release 2000/08/08 : CIA-RDP96-00788R001500140003-9 thay be made for all children to be itvolved in research under a particular protocol, or for each child, @is the ERB deems appropriate. If the N IRD determines that the capability of some or all of the children is so limited that they cannot 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 the research, the assent of the cluldren is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRD may still waive the assent requirement under circumstances in which consent may be waived in accord with § 46.116 of Subpart A. (b) tn addition to the determinations required under other applicable sections of this subpart, the IRB shall determine, in accordance with and to the extent that consent is required by § 46.116 of , Subpart A, that adequate provisions are inade for soliciting the permission of each child’s parents or guardian, Where parental permission is to be obtained, the IRB may find that the permission of one parent is sufficient for research to be conducted under 38 46.464 of 46.405. Where research is covered by §§ 46.406 and 46.407 and permission is to be obtained from ee ar He ma parents, both parents must give their permission uniess one parent is deceased, unknown, incompetent, or not reasonubly available, or when only one parent has 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 IRB determines that a 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), 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 siate 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 Subnart A. (¢) When the IRB 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, or entity can be included in research approved under §§ 46.406 or 46.407 only if such research is: (1) Related to theiy scatus as wards; or (2) Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not warils. (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 loco 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 2000/08/08 : CIA-RDP96-00788R001500140003-9
‘ HUMAN SUBJECTS Minimum Criteria Identifying the Viable Fetus On March 13, 1975, regulations were published in the FEDERAL REGISTER(40 FR 11854) relating to the protection of human subjects in fescarch, development, and related activities supported by Department of Health, Education, and Welfare grants and contracts. These regulations are codified at 45 CFR Part 46. TE LT Elsewhere in this issue of the FEDERAL REGISTER, the Secretary is arnending 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 im the FEDERAL REGISTER U.S. GOVERNMENT PRINTING OFFICE : 45 CFR 46 | ~“Mpproved-For Release_2000/08/08 : CIA-RDP96-00788R001500140003-9 ot a = Se en A CFR 46 —_ NOTICES . Ruidelings 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 estimated gestational age of 20 weeks of More and a body weight uf $00 grams or more FEDERAL REGISTER, VOL 4Q, AUGUST 5, 1975 1983 0 - 406-756 Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140003-9