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By:
Andy Parkhurst
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Decks in this class (23)
Historical Background
Nuremberg code historical context...,
Nuremberg code the basic elements...,
Wichita jury study 3
21
cards
Belmont Principles
Belmont report date of occurrence 1,
Belmont report the three principl...,
Belmont report respect for persons 3
15
cards
Regulatory Criteria for Approval
Criteria for irb approval of rese...,
Criteria for irb approval of rese...,
Criteria for irb approval of rese...
10
cards
Levels of Review
Exempt from irb review 1,
Limited irb review 2,
Expedited review 3
9
cards
Random Definitions
Research 1,
Human subject 2,
Minimal risk 3
6
cards
Exempt Categories
Exempt category 1 1,
Exempt category 2 2,
Exempt category 3 3
8
cards
Expedited Categories
Expedited category 1 1,
Expedited category 2 2,
Expedited category 3 3
9
cards
Basic Elements of Informed Consent
Basic elements of informed consen...,
Basic elements of informed consen...,
Basic elements of informed consen...
10
cards
Additional Elements of Informed Consent
Additional elements of informed c...,
Additional elements of informed c...,
Additional elements of informed c...
9
cards
Broad Consent Requirements
When someone gives broad consent ...,
Broad consent is not what 4 things 2,
Where are the requirements for br...
10
cards
FDA and Other Agencies
Unlike the common rule the fda do...,
What s considered an fda regulate...,
When are ind s required 3
16
cards
IRB Membership and Authority
What s the minimum composition of...,
What is required for irb quorum 2,
True or false members with a conf...
6
cards
Privacy and Confidentiality
What s the difference between pri...,
What does privacy mean in a resea...,
What does confidentiality mean in...
9
cards
Vulnerable populations
What are the key protections for ...,
What are the key protections for ...,
Who consents in research involvin...
7
cards
Monitoring and Review of Reportable Events
What are the three major reportab...,
Define an unanticipated problems ...,
Define noncompliance 3
7
cards
Meeting Minutes
What are the required elements of...,
Are verbatim transcripts required...,
Must vote tallies be included in ...
3
cards
Cooperative Research
What is cooperative research 1,
When did the nih begin requiring ...,
When is sirb not required 3
6
cards
Policies, Procedures, and IRB Records
Per 45 cfr 46103 b 4 and 21 cfr 5...,
Required by 45 cfr 46115 and 21 c...,
How long must irb records be reta...
3
cards
Conflict of Interest
When does a conflict of interest ...,
Do policies need to be in place a...,
What should happen if an irb memb...
8
cards
Regulatory Reporting Obligations
The irb must report the following...,
In terms of reporting requirement...,
What other entities might need to...
8
cards
Document Management and Retention
Per 45 cfr 46115 b and 21 cfr 561...,
How long must records be retained 2,
Records may be paper or electroni...
7
cards
Educational Programs
Are irbs required by regulation t...,
Who is typically required to comp...,
What topics are covered in typica...
3
cards
Random Flashcards to make it to 200
What ethical principle requires t...,
Can a legally authorized represen...,
What must the irb do when researc...
9
cards
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CIP Prep
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