SOCRA CCRP EXAM 160 QUESTIONS & CORRECT
ANSWERS LATEST 2025
When was the Nuremberg Code created? - ANSWER-1947
What did the Nuremberg Code establish? - ANSWER-Worldwide requirement for
informed consent with properly formulated experimentation with beneficence
towards participants.
When was Belmont report established? - ANSWER-1979
What does the Belmont report do? - ANSWER-- Establish boundaries between
practice and research
- created ethical principles: Respect for persons, Beneficence, and Justice
- ensure applications of informed consent, risk/benefit assessment, and selection
of research subjects
When was the Declaration of Helsinki established? - ANSWER-1964
What is the Declaration of Helsinki? - ANSWER-- developed by World Medical
Association
- provides basic principles for medical research
- binds the physician with the words, "The health of my patient will be my first
consideration,"
,Which country follows the Declaration of Helsinki? - ANSWER-The U.S.
What are the 8 required elements of an informed consent? - ANSWER-1. Study
description- research acknowledgment, purpose, expected duration, procedures,
and specify which procedures are experimental
2. Foreseeable risks and discomforts
3. Benefits
4. Alternative procedures/treatments
5. Confidentiality of records
6. Compensation and treatment for injury
7. Contact information
8. Voluntary participation
What education level must an informed consent be written in? - ANSWER-6th-8th
grade level
What are the additional elements of informed consent? - ANSWER-- Risks are
unforeseeable
- Investigators may terminate participation
- Additional costs
- Consequences of subject's withdrawal
- Significant new findings
- Number of subjects participating
, What are the regulations for informed consent? - ANSWER-- Subject must be
given adequate time to read prior to signing
- Signature of witness/LAR
- Signature of person obtaining consent
- Date
- Signed copy must be given to the subject
- Must be current and IRB approved
When is a short form ICF needed? - ANSWER-For subjects whose first language is
not English
What are the 10 points of the Nuremberg Code? - ANSWER-- Required voluntary,
informed consent
- Experiment aims at positive results for society
- Based on previous knowledge that justifies the experiment
- Study design avoids unnecessary physical and mental suffering and injuries
- Not conducted if there is any reason to believe it implies a risk of death or
disabling injury
- Risks < Benefits
- Preparations and facilities must be provided to protect subjects against risks
- Staff must be fully trained and qualified
- Subject must be free to quit at any time
- Medical staff stop the experiment at any time if they observe continuation
would be dangerous.
ANSWERS LATEST 2025
When was the Nuremberg Code created? - ANSWER-1947
What did the Nuremberg Code establish? - ANSWER-Worldwide requirement for
informed consent with properly formulated experimentation with beneficence
towards participants.
When was Belmont report established? - ANSWER-1979
What does the Belmont report do? - ANSWER-- Establish boundaries between
practice and research
- created ethical principles: Respect for persons, Beneficence, and Justice
- ensure applications of informed consent, risk/benefit assessment, and selection
of research subjects
When was the Declaration of Helsinki established? - ANSWER-1964
What is the Declaration of Helsinki? - ANSWER-- developed by World Medical
Association
- provides basic principles for medical research
- binds the physician with the words, "The health of my patient will be my first
consideration,"
,Which country follows the Declaration of Helsinki? - ANSWER-The U.S.
What are the 8 required elements of an informed consent? - ANSWER-1. Study
description- research acknowledgment, purpose, expected duration, procedures,
and specify which procedures are experimental
2. Foreseeable risks and discomforts
3. Benefits
4. Alternative procedures/treatments
5. Confidentiality of records
6. Compensation and treatment for injury
7. Contact information
8. Voluntary participation
What education level must an informed consent be written in? - ANSWER-6th-8th
grade level
What are the additional elements of informed consent? - ANSWER-- Risks are
unforeseeable
- Investigators may terminate participation
- Additional costs
- Consequences of subject's withdrawal
- Significant new findings
- Number of subjects participating
, What are the regulations for informed consent? - ANSWER-- Subject must be
given adequate time to read prior to signing
- Signature of witness/LAR
- Signature of person obtaining consent
- Date
- Signed copy must be given to the subject
- Must be current and IRB approved
When is a short form ICF needed? - ANSWER-For subjects whose first language is
not English
What are the 10 points of the Nuremberg Code? - ANSWER-- Required voluntary,
informed consent
- Experiment aims at positive results for society
- Based on previous knowledge that justifies the experiment
- Study design avoids unnecessary physical and mental suffering and injuries
- Not conducted if there is any reason to believe it implies a risk of death or
disabling injury
- Risks < Benefits
- Preparations and facilities must be provided to protect subjects against risks
- Staff must be fully trained and qualified
- Subject must be free to quit at any time
- Medical staff stop the experiment at any time if they observe continuation
would be dangerous.
