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SOCRA Questions > Title 45 Part 46 > Flashcards

Title 45 Part 46 Flashcards

(55 cards)

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1
Q

Title 45

A

Title 45 - Public Welfare

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2
Q

Title 45 Public Welfare
Part 46

A

Part 46 - Protection of Human Subjects

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3
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart A

A

Subpart A—Basic HHS Policy for Protection of Human Research Subjects

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4
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart A—Basic HHS Policy for Protection of Human Research Subjects
46.101

A

46.101 - To what does this policy apply

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5
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart A—Basic HHS Policy for Protection of Human Research Subjects
46.102

A

46.102 - Definitions for purposes of this policy

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6
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart A—Basic HHS Policy for Protection of Human Research Subjects
46.103

A

46.103 - Assuring compliance with this policy—research conducted or supported by any Federal department or agency

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7
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart A—Basic HHS Policy for Protection of Human Research Subjects
46.104

A

46.104 - Exempt research

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8
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart A—Basic HHS Policy for Protection of Human Research Subjects
46.107

A

46.107 - IRB membership

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9
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart A—Basic HHS Policy for Protection of Human Research Subjects
46.108

A

46.108 - IRB functions and operations

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10
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart A—Basic HHS Policy for Protection of Human Research Subjects
46.109

A

46.109 - IRB review of research

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11
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart A—Basic HHS Policy for Protection of Human Research Subjects
46.110

A

46.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research

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12
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart A—Basic HHS Policy for Protection of Human Research Subjects
46.111

A

46.111 - Criteria for IRB approval of research

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13
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart A—Basic HHS Policy for Protection of Human Research Subjects
46.112

A

46.112 - Review by institution

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14
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart A—Basic HHS Policy for Protection of Human Research Subjects
46.113

A

46.113 - Suspension or termination of IRB approval of research

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15
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart A—Basic HHS Policy for Protection of Human Research Subjects
46.114

A

46.114 - Cooperative research

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16
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart A—Basic HHS Policy for Protection of Human Research Subjects
46.115

A

46.115 - IRB records

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17
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart A—Basic HHS Policy for Protection of Human Research Subjects
46.116

A

46.116 - General requirements for informed consent

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18
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart A—Basic HHS Policy for Protection of Human Research Subjects
46.117

A

46.117 - Documentation of informed consent

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19
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart A—Basic HHS Policy for Protection of Human Research Subjects
46.118

A

46.118 - Applications and proposals lacking definite plans for involvement of human subjects

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20
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart A—Basic HHS Policy for Protection of Human Research Subjects
46.119

A

46.119 - Research undertaken without the intention of involving human subjects

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21
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart A—Basic HHS Policy for Protection of Human Research Subjects
46.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal department or agency

A

46.120 - Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal department or agency

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22
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart A—Basic HHS Policy for Protection of Human Research Subjects
46.122

A

46.122 - Use of Federal funds

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23
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart A—Basic HHS Policy for Protection of Human Research Subjects
46.123

Study These Flashcards
A

46.123 - Early termination of research support: Evaluation of applications and proposals

24
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart A—Basic HHS Policy for Protection of Human Research Subjects
46.124

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A

46.124 - Conditions

25
Title 45 Part 46 - Protection of Human Subjects Subpart B
Subpart B—Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
26
Title 45 Part 46 - Protection of Human Subjects Subpart B—Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research 46.201
46.201 - To what do these regulations apply
27
Title 45 Part 46 - Protection of Human Subjects Subpart B—Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research 46.202
46.202 - Definitions
28
Title 45 Part 46 - Protection of Human Subjects Subpart B—Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research 46.203
46.203 - Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates
29
Title 45 Part 46 - Protection of Human Subjects Subpart B—Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research 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
46.204 Research involving pregnant women or fetuses
30
Title 45 Part 46 - Protection of Human Subjects Subpart B—Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research 46.205
46.205 - Research involving neonates
31
Title 45 Part 46 - Protection of Human Subjects Subpart B—Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research 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
46.206 - Research involving, after delivery, the placenta, the dead fetus or fetal material
32
Title 45 Part 46 - Protection of Human Subjects Subpart B—Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research 46.207
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
33
Title 45 Part 46 - Protection of Human Subjects Subpart C
Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
34
Title 45 Part 46 - Protection of Human Subjects Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects 46.301
46.301 - Applicability
35
Title 45 Part 46 - Protection of Human Subjects Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects 46.302
46.302 - Purpose
36
Title 45 Part 46 - Protection of Human Subjects Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects 46.303
46.303 - Definitions
37
Title 45 Part 46 - Protection of Human Subjects Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects 46.304
46.304 - Composition of Institutional Review Boards where prisoners are involved
38
Title 45 Part 46 - Protection of Human Subjects Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects 46.305 Additional duties of the Institutional Review Boards where prisoners are involved 46.306 Permitted research involving prisoners
46.305 - Additional duties of the Institutional Review Boards where prisoners are involved
39
Title 45 Part 46 - Protection of Human Subjects Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects 46.306
46.306 - Permitted research involving prisoners
40
Title 45 Part 46 - Protection of Human Subjects Subpart D
Subpart D—Additional Protections for Children Involved as Subjects in Research
41
Title 45 Part 46 - Protection of Human Subjects Subpart D—Additional Protections for Children Involved as Subjects in Research 46.401
46.401 - To what do these regulations apply
42
Title 45 Part 46 - Protection of Human Subjects Subpart D—Additional Protections for Children Involved as Subjects in Research 46.402
46.402 - Definitions
43
Title 45 Part 46 - Protection of Human Subjects Subpart D—Additional Protections for Children Involved as Subjects in Research 46.403
46.403 - IRB duties
44
Title 45 Part 46 - Protection of Human Subjects Subpart D—Additional Protections for Children Involved as Subjects in Research 46.404
46.404 Research not involving greater than minimal risk
45
Title 45 Part 46 - Protection of Human Subjects Subpart D—Additional Protections for Children Involved as Subjects in Research 46.405
46.405 - Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects
46
Title 45 Part 46 - Protection of Human Subjects Subpart D—Additional Protections for Children Involved as Subjects in Research 46.406
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
47
Title 45 Part 46 - Protection of Human Subjects Subpart D—Additional Protections for Children Involved as Subjects in Research 46.407
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.
48
Title 45 Part 46 - Protection of Human Subjects Subpart D—Additional Protections for Children Involved as Subjects in Research 46.408 Requirements for permission by parents or guardians and for assent by children
46.408 - Requirements for permission by parents or guardians and for assent by children
49
Title 45 Part 46 - Protection of Human Subjects Subpart D—Additional Protections for Children Involved as Subjects in Research 46.409
46.409 - Wards
50
Title 45 Part 46 - Protection of Human Subjects Subpart E
Subpart E—Registration of Institutional Review Boards
51
Title 45 Part 46 - Protection of Human Subjects Subpart E—Registration of Institutional Review Boards 46.501
46.501 - What IRBs must be registered?
52
Title 45 Part 46 - Protection of Human Subjects Subpart E—Registration of Institutional Review Boards 46.502
46.502 - What information must be provided when registering an IRB?
53
Title 45 Part 46 - Protection of Human Subjects Subpart E—Registration of Institutional Review Boards 46.503
46.503 - When must an IRB be registered?
54
Title 45 Part 46 - Protection of Human Subjects Subpart E—Registration of Institutional Review Boards 46.504
46.504 - How must an IRB be registered?
55
Title 45 Part 46 - Protection of Human Subjects Subpart E—Registration of Institutional Review Boards 46.505
46.505 - When must IRB registration information be renewed or updated?

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