SOCRA - CCRP Problem Solving Exam Questions and With Distinction level Marking scheme updated 2024/2025
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CCRP SOCRA
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CCRP SOCRA
SOCRA - CCRP Problem Solving Exam Questions and With Distinction level Marking scheme updated 2024/2025
Jewish Chronic Disease Hospital study (1963) - correct answer Live cancer cells were injected into 22 cognitively impaired patients.
National Research Act (1974) - correct answer Congress p...
SOCRA - CCRP Problem Solving Exam
Questions and With Distinction level Marking
scheme updated 2024/2025
Jewish Chronic Disease Hospital study (1963) - correct answer
Live cancer cells were injected into 22 cognitively impaired
patients.
National Research Act (1974) - correct answer Congress passed
this act in response to the concern on prior studies (PHS
Syphilis, prisoner research, willow brook etc.)
- est. National Commission to identify basic ethical principles +
guidelines
- required IRBs at organizations receiving funding
The National Commission (1975-1978) - correct answer Created
recommendations for regulating human subject research -
vulnerable populations, psychosurgery, IRBs, etc.
Final report published 1979 - Ethical Principles and Guidelines
for the Protection of Human Subjects of Research
-> Belmont Report
The Belmont Report - correct answer Based on National
Commission deliberations.
,1. Respect for Persons
2. Beneficence
3. Justice
Analytical framework guiding the resolution of problems arising
from human subject research.
Belmont: Respect for Persons - correct answer Subjects are
autonomous agents - informed consent
If diminished autonomy, need additional protection.
- Condition (age, health, cognition)
- Circumstances (poverty, lack of education, social status)
Also respect person's right to privacy (not directly addressed in
Belmont).
Belmont: Beneficence - correct answer Strive to do no harm
while maximizing benefits + minimizing harm.
Systematic Assessment - account for probability and magnitude
of potential harm
Benefit - to individual or advancement of scientific knowledge
Minimize risk - risks in research should be the minimum to
achieve the research objective. Researchers + IRBs should
,carefully consider alternative, less risky procedures /
modifications to reduced magnitude or probability of harm.
Belmont: Justice - correct answer Injustice is when benefit is
denied from a person without good reason, and some the burden
is imposed unduly.
Example: research on prisoners or institutionalized children -
both will not see the benefit and must bear the burden.
Subject selection - are some selected due to availability,
compromised position, or manipulatability? Must be based on
scientific need, not convenience.
Do not exclude so they do not derive benefit (i.e. not speaking
english). Undue influences from real or perceived pressures -
financial, power, implied benefits.
45 CFR 46 - correct answer PHS policy raised to regulatory
status for "Regulations for the Protection of Human Subjects of
Biomedical and Behavior Research) in anticipation of the
National Research Act.
First set of federal regulations detailing requirement of
organizational assurances, IRB review, ICF, and ethical conduct.
Revised in 1981
, 21 CFR 50 + 21 CFR 56 - correct answer Adopted by FDA on
ICF in 1980, IRBs in 1981 respectively
21 CFR 812 + 21 CFR 312 - correct answer Adopted by FDA in
1980 and 1981 for investigational medical devices + drugs &
biologics respectively.
45 CFR 46, Subpart A - correct answer 1991 - 17 federal
agencies that conduct, support, or otherwise regulate human
subjects research issued uniform regulations - "The Federal
Policy for the Protection of Human Subjects." = Common Rule
Updated -> 2018 Requirements: strengthen human subject
protections, reduce administrative burdens, add flexibility. Major
changes to IRB operations, ICF, definitions, and exemptions.
Declaration of Helsinki - correct answer International codes +
standard in response to Nuremberg Trials
1964 - World Medical Assembly meeting in Helsinki Finland
adopted "Recommendations Guiding Medical Doctors in
Biomedical Research Involving Human Subjects."
Has been revised multiple times (1975, 1983, 1989, 1996, 2000,
2008, and 2013).
CIOMS guidelines - correct answer International codes +
standard in response to Nuremberg Trials
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