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SOCRA Questions > Title 45 Part 46 > Flashcards

Title 45 Part 46 Flashcards

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

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

A

46.124 - Conditions

25
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart B

A

Subpart B—Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research

26
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart B—Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
46.201

A

46.201 - To what do these regulations apply

27
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart B—Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
46.202

A

46.202 - Definitions

28
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart B—Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
46.203

A

46.203 - Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates

29
Q

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

A

46.204 Research involving pregnant women or fetuses

30
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart B—Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
46.205

A

46.205 - Research involving neonates

31
Q

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

A

46.206 - Research involving, after delivery, the placenta, the dead fetus or fetal material

32
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart B—Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
46.207

A

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
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart C

A

Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects

34
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
46.301

A

46.301 - Applicability

35
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
46.302

A

46.302 - Purpose

36
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
46.303

A

46.303 - Definitions

37
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
46.304

A

46.304 - Composition of Institutional Review Boards where prisoners are involved

38
Q

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

A

46.305 - Additional duties of the Institutional Review Boards where prisoners are involved

39
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
46.306

A

46.306 - Permitted research involving prisoners

40
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart D

A

Subpart D—Additional Protections for Children Involved as Subjects in Research

41
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart D—Additional Protections for Children Involved as Subjects in Research
46.401

A

46.401 - To what do these regulations apply

42
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart D—Additional Protections for Children Involved as Subjects in Research
46.402

A

46.402 - Definitions

43
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart D—Additional Protections for Children Involved as Subjects in Research
46.403

A

46.403 - IRB duties

44
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart D—Additional Protections for Children Involved as Subjects in Research
46.404

A

46.404 Research not involving greater than minimal risk

45
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart D—Additional Protections for Children Involved as Subjects in Research
46.405

A

46.405 - Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects

46
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart D—Additional Protections for Children Involved as Subjects in Research
46.406

A

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
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart D—Additional Protections for Children Involved as Subjects in Research
46.407

A

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
Q

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

A

46.408 - Requirements for permission by parents or guardians and for assent by children

49
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart D—Additional Protections for Children Involved as Subjects in Research
46.409

A

46.409 - Wards

50
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart E

A

Subpart E—Registration of Institutional Review Boards

51
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart E—Registration of Institutional Review Boards
46.501

A

46.501 - What IRBs must be registered?

52
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart E—Registration of Institutional Review Boards
46.502

A

46.502 - What information must be provided when registering an IRB?

53
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart E—Registration of Institutional Review Boards
46.503

A

46.503 - When must an IRB be registered?

54
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart E—Registration of Institutional Review Boards
46.504

A

46.504 - How must an IRB be registered?

55
Q

Title 45 Part 46 - Protection of Human Subjects
Subpart E—Registration of Institutional Review Boards
46.505

A

46.505 - When must IRB registration information be renewed or updated?

SOCRA Questions (6 decks)

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