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SOCRA - CCRP (High Level) Exam With 100% Correct And Verified Answers
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SOCRA - CCRP (High Level) Exam With 100% Correct And Verified Answers
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SOCRA - CCRP (High Level) Exam With100% Correct And Verified Answers
Nuremberg Code (1947) - Correct Answer-A research ethics code that
arose in response to the Nazis' inhumane experimentation (nuremberg
trials) - holocaust, racial hygiene / eugenics / master race.
The Nuremberg Code - 10 points - Correct Answer-1. voluntary
2. necessary for results
3. logical design and results
4. avoid unnecessary harm
5. cannot result in death or disablement
6. risk assessment
7. protect subjects against harm
8. qualified investigators
9. right to withdrawal
10. right to end trial if needed
Belmont Report (1979) - Correct Answer-Three core principles are
identified: respect for persons, beneficence, and justice.
Arose in response to Tuskegee Syphilis Study - studying untreated
syphilis on African-American men unaware of their true condition and tx
plan.
Belmont Report - definitions of core - Correct Answer-1. Respect for
persons: informed consent + no deception
2. Beneficence: maximize benefits and minimize risk
3: Justice: fair procedures considering risk analysis.
Belmont Report - current role - Correct Answer-Serves as a historical
document and provides the moral framework for understanding
regulations in the United States on the use of humans in experimental
methods.
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,Belmont Report - review of 7 items for research trials - Correct Answer-1.
IRB approved
2. Obtain informed consent
3. Ensure understanding
4. No coercion
5. Monitor adverse events
6. Maintain privacy
7. Ensure patients receive minimal care for their condition
Declaration of Helsinki (1964, 1975) - Correct Answer-Set of ethical
principles regarding human experimentation developed for the medical
community by the World Medical Association (WMA)
Good Clinical Practice (GCP) - Correct Answer-ICH-GCP and ISO-GCP
(medical device) enforces guidelines on ethical aspects of a clinical trial.
Covers human rights, standards on trial conduct, roles and
responsibilities (IRB, PI, sponsor, monitors).
GCP v Declaration of Helinski - Correct Answer-GCP lacks moral
principles and guidance surrounding COI, study design, benefits, result
reporting.
Also restricts placebo in control group v effective alternative tx
Common Rule - Correct Answer-US federal policy that specifies ethics
regulations for human subjects research
1. ICF in reasonable language, reasons why they would not want to
participate in research
2. Disclosure of use of de-identified data /
specimens for future studies, commercial profit,
clinically relevant results disclosed, genome
sequencing
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,3. Consent waiver only if research could not be
carried out without accessing / using information /
specimens in an identifiable format. Pre-screening
for trial permitted if able to obtain oral or written
communication OR access records / stored
biospecimens.
4. Exempt / Limited IRB if
- record review both retrospectively AND propectively
- benign behavioral interactions
- collect identifiable sensitive data via adults in surveys/interviews
5. Continuing review - not required if expedited level
6. Multi-instituitional research studies required to use 1 IRB
(effective 01-19-2020)
Title 21 US Code of Federal Regulations (11, 50, 56, 312, 812) -
Correct Answer-Title 21 is part of the code of federal regulations
governing good and drugs for the FDA, DEA, and ONDCP (office of
national drug control policy)
11 - e-records + e-signatures
50 - protection human subjects
56 - IRB that oversee trials
312 - drug trial requirements
812 - controlled substances
Title 21 CFR Part 11 - Correct Answer-1. Controls - audits,
validators, audit trails, e-sigs, documentation for software + systems
processing e-data.
2. E-records cannot be illegible, inaccessible, or corrupted
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, 3. "Hard copies" are authoritative documents for regulatory
purposes
Title 21 CFR Part 50 - Correct Answer-
The National Research Act of 1974 - Correct Answer-Established
the National Commission.
Issued in 1974, 45 CFR 46 raised to regulatory status: - Correct
Answer-US Public Health Service Policy
Henry K. Beecher Article (1966) - Correct Answer-Detailed 22
published medical studies presenting risk to subjects without their
knowledge or approval.
Beecher's article clearly demonstrated that unethical research was
not confined to Nazi atrocities.
U.S. Public Health Service (PHS) Study of Untreated Syphilis /
Tuskegee Syphilis Study (1932-1972) - Correct Answer-Examined
the natural course of untreated syphilis in Black American men.
All were impoverished sharecroppers from Macon County,
Alabama, were unknowing subjects in the study; they were not told
that they had syphilis, nor were they offered effective
treatment when it became available in the late
1940s with the availability of penicillin.
Willowbrook studies (1956-1970) - Correct Answer-
Children with intellectual disabilities were
deliberately infected with the hepatitis virus
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