Ethical Considerations for Research Involving Prisoners (2007) / Chapter Skim
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Appendix D Code of Federal Regulations Title 45: Public Welfare Part 46: Protection of Human Subjects
Appendix D Code of Federal Regulations Title 45: Public Welfare Part 46: Protection of Human Subjects
Pages 205-238
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46.102 Definitions 46.103 Assuring compliance with this policy -- research con ducted or supported by any federal department or agency 46.104– [Reserved] 46.106 46.107 IRB membership 46.108 IRB functions and operations 46.109 IRB review of research 46.110 Expedited review procedures for certain kinds of research involving no more than minimal risk and for minor changes in approved research 46.111 Criteria for IRB approval of research 46.112 Review by institution 205
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46.201 To what do these regulations apply? 46.202 Definitions 46.203 Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates 46.204 Research involving pregnant women or fetuses 46.205 Research involving neonates 46.206 Research involving, after delivery, the placenta, the dead fetus, or fetal material 46.207 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects Sec.
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46.402 Definitions 46.403 IRB duties 46.404 Research not involving greater than minimal risk 46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects 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 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 46.408 Requirements for permission by parents or guardians and for assent by children 46.409 Wards The authority for these federal regulations can be found in 5 U.S.C.
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Part 11 Department of Transportation Subpart A: Basic DHHS Policy for Protection of Human Research Subjects Authority: 5 U.S.C.
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(b) Unless otherwise required by department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy: (1)
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[An example is a foreign institution which complies with guidelines consistent with the World Medical Assembly Declaration (Declaration of Helsinki amended 1989) issued either by sovereign states or by an organization whose function for the protection of human research subjects is internationally recognized.]
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Except when otherwise required by statute or Executive Order, the department or agency head shall forward advance notices of these actions to the Office for Human Research Protections, Department of Health and Human Services (DHHS) , or any successor office, and shall also publish them in the Federal Register or in such other manner as provided in department or agency procedures.1 §46.102 Definitions.
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(g) IRB means an institutional review board established in accord with and for the purposes expressed in this policy.
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required by this policy to be made to department and agency heads shall also be made to the Office for Human Research Protections, DHHS, or any successor office.
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of this policy, the existence of an DHHS-approved assurance is accepted. In this case, change in IRB membership shall be reported to the Office for Human Research Protections, DHHS, or any successor office.
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The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and
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(b) Except when an expedited review procedure is used (see §46.110)
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The list will be amended, as appropriate, after consultation with other departments and agencies, through periodic republication by the Secretary, DHHS, in the Federal Register. A copy of the list is available from the Office for Human Research Protections, DHHS, or any successor office.
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some or all of the research appearing on the list and found by the reviewer(s) to involve no more than minimal risk, (2)
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(4) Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by §46.116.
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§46.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the sub
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A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained; (6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained; (7)
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The research involves no more than minimal risk to the subjects; (2) The waiver or alteration will not adversely affect the rights and welfare of the subjects; (3)
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That the research presents no more than minimal risk of harm to sub
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or (i) , no human subjects may be involved in any project supported by these awards until the project has been reviewed and approved by the IRB, as provided in this policy, and certification submitted, by the institution, to the department or agency.
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of this section and whether the applicant or the person or persons who would direct or has/have directed the scientific and technical aspects of an activity has/have, in the judgment of the department or agency head, materially failed to discharge responsibility for the protection of the rights and welfare of human subjects (whether or not the research was subject to federal regulation)
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226 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS the time of approval when in the judgment of the department or agency head additional conditions are necessary for the protection of human subjects. Subpart B: Additional Protections for Pregnant Women, Human Fetuses, and Neonates Involved in Research Source: 66 FR 56778, Nov.
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227 APPENDIX D (e) Nonviable neonate means a neonate after delivery that, although living, is not viable.
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If the research holds out the prospect of direct benefit to the pregnant woman, the prospect of a direct benefit both to the pregnant woman and the fetus, or no prospect of benefit for the woman nor the fetus when risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means, her consent is obtained in accord with the informed consent provisions of Subpart A of this part; (e) If the research holds out the prospect of direct benefit solely to the fetus then the consent of the pregnant woman and the father is obtained in accord with the informed consent provisions of Subpart A of this part, except that the father's consent need not be obtained if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest; (f)
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The purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means; and (5) The legally effective informed consent of both parents of the neonate is obtained in accord with Subpart A of this part, except that the waiver and alteration provisions of §46.116(c)
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Informed consent will be obtained in accord with the informed consent provisions of Subpart A and other applicable subparts of this part.
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(a) The regulations in this subpart are applicable to all biomedical and behavioral research conducted or supported by the Department of Health and Human Services involving prisoners as subjects.
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26, 1981] §46.305 Additional duties of the institutional review boards where prisoners are involved.
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§46.306 Permitted research involving prisoners.
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of this section, biomedical or behavioral research conducted or supported by DHHS shall not involve prisoners as subjects. Subpart D: Additional Protections for Children Involved as Subjects in Research Source: 48 FR 9818, March 8, 1983, unless otherwise noted §46.401 To what do these regulations apply?
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§46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. DHHS 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
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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)
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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 principles; (iii)
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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.
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