ACRP CCRC Exam - CITI GCP UPDATED
ACTUAL Exam Questions and CORRECT
Answers
Belmont Report (1979) - CORRECT ANSWER - Created to summarize basic ethical
principles for research.
Pharmacodynamics (PD) - CORRECT ANSWER - Describes the effects of the agent on
the body.
3 basic ethical principles of Belmont Report - CORRECT ANSWER - 1. Respect for
Persons
2. Beneficence
3. Justice
Respect for Persons - CORRECT ANSWER - Treating persons as autonomous agents and
protecting those with diminished autonomy.
Ex: Providing informed consent (accurate information about the study and its procedures),
ensuring comprehension and that patients' participation is voluntary in research.
Beneficence - CORRECT ANSWER - Obligation to secure persons' wellbeing, "do good",
maximize possible benefits and minimize possible harms.
Justice - CORRECT ANSWER - Fairness in distribution.
Distribution of benefits and burdens to each person:
1. an equal share
2. according to individual need
3. according to individual effort
, 4. according to societal contribution
5. according to merit
Informed Consent - CORRECT ANSWER - Document voluntarily signed by patient that
clearly describes purpose, methods, procedures, anticipated benefits, and risks of a diagnostic or
treatment procedure.
Incomplete Disclosure - CORRECT ANSWER - Withholding some information in order to
conduct an unbiased study when informing patients of some pertinent aspect(s) of the study is
likely to impair the validity of the research.
Justifications for Incomplete Disclosure - CORRECT ANSWER - Incomplete Disclosure
is only justified when:
1. it is truly necessary to accomplish goals of the research
2. there are no undisclosed risks to subjects that are more than minimal risk
3. there is an adequate plan for debriefing subjects when appropriate and for dissemination of
research results to them
Coercion - CORRECT ANSWER - An overt threat or harm is intentionally presented by
one person to another to obtain compliance.
Undue Influence - CORRECT ANSWER - Occurs through offer of an excessive,
unwarranted, inappropriate, or improper reward in order to obtain compliance.
Risk - CORRECT ANSWER - Possibility that harm may occur, includes chance
(probability) and severity (magnitude) of envisioned harm.
Benefit - CORRECT ANSWER - Something of positive value related to health or welfare.
ACTUAL Exam Questions and CORRECT
Answers
Belmont Report (1979) - CORRECT ANSWER - Created to summarize basic ethical
principles for research.
Pharmacodynamics (PD) - CORRECT ANSWER - Describes the effects of the agent on
the body.
3 basic ethical principles of Belmont Report - CORRECT ANSWER - 1. Respect for
Persons
2. Beneficence
3. Justice
Respect for Persons - CORRECT ANSWER - Treating persons as autonomous agents and
protecting those with diminished autonomy.
Ex: Providing informed consent (accurate information about the study and its procedures),
ensuring comprehension and that patients' participation is voluntary in research.
Beneficence - CORRECT ANSWER - Obligation to secure persons' wellbeing, "do good",
maximize possible benefits and minimize possible harms.
Justice - CORRECT ANSWER - Fairness in distribution.
Distribution of benefits and burdens to each person:
1. an equal share
2. according to individual need
3. according to individual effort
, 4. according to societal contribution
5. according to merit
Informed Consent - CORRECT ANSWER - Document voluntarily signed by patient that
clearly describes purpose, methods, procedures, anticipated benefits, and risks of a diagnostic or
treatment procedure.
Incomplete Disclosure - CORRECT ANSWER - Withholding some information in order to
conduct an unbiased study when informing patients of some pertinent aspect(s) of the study is
likely to impair the validity of the research.
Justifications for Incomplete Disclosure - CORRECT ANSWER - Incomplete Disclosure
is only justified when:
1. it is truly necessary to accomplish goals of the research
2. there are no undisclosed risks to subjects that are more than minimal risk
3. there is an adequate plan for debriefing subjects when appropriate and for dissemination of
research results to them
Coercion - CORRECT ANSWER - An overt threat or harm is intentionally presented by
one person to another to obtain compliance.
Undue Influence - CORRECT ANSWER - Occurs through offer of an excessive,
unwarranted, inappropriate, or improper reward in order to obtain compliance.
Risk - CORRECT ANSWER - Possibility that harm may occur, includes chance
(probability) and severity (magnitude) of envisioned harm.
Benefit - CORRECT ANSWER - Something of positive value related to health or welfare.
