DETAILED ANSWERS|LATEST UPDATE!!!!!!2026|GUARANTEED
CORRECT = 100
100
INCORRECT=0
STUDY MATERIALS.......DESIGNED TO HELP YOU SUCCEED
SPOTLIGHT 1
1
, WELL DETAILED ANSWERS|LATEST
UPDATE!!!!!!2026|GUARANTEED PASS|GRADED
Investigator should (qualifications/agreements) - ANSWER Be qualified by
training/education and expertise
Be familiar with the product investigational
Be aware and comply with GCP and regulatory requirements
Permit auditing/monitoring
Delegate authority and maintain a log
Be responsible for the training of the staff
Nuremberg Code - ANSWER (1947) Ten guidelines for the ethical treatment of
human subjects in research - Came about after Nuremberg trial in Germany during world
war II
Legal force of the document was NOT established or incorporated directly into the American
or German law
Nuremberg Code 10 Ethical Guidelines - ANSWER 1. Voluntary consent of the
human subject is absolutely essential.
2. The experiment should be such as to productive results for the good of society
unprocuable by other methods or means and not ransom and unnecessary in nature.
3. The experiment should be so designed and based on the results of animal
experimentation and a knowledge of the natural history of the disease.
4. The experiment should be so conducted as to avoid all unnecessary physical and mental
suffering and injury.
2
, 5. No experiment should be conducted where there is an a prior reason to believe that
death or disabling injury will occur.
6. The degree of risk to be taken should never exceed that determined by the humanitarian
importance of the
problem to be solved by the experiment.
7. Proper preparations should be made and adequate facilities provided to protect the
experimental subject against even remote possibilities of injury, disability, or death.
8. The experiment should be conducted only by scientifically qualified persons. The highest
degree of skill and care.
9. During the course of the experiment the human subject should be at liberty to bring the
experiment to an end.
10. During the course of the experiment the scientist in charge must be prepared to
terminate the experiment at any stage.
Nuremberg Code - Key Principles - ANSWER 1. Voluntary participation
2. Informed Consent
3. Minimization of risk
The Nuremberg Code and the Declaration of Helsinki are the basis for the... -
ANSWER Code of Federal Regulations Title 45 Volume 46 which are regulations
issued by the United states department of heath and human services
Declaration of Helsinki - ANSWER (1964) Is a set of ethical principles regarding
human experimentation developed for the medical community by the WMA (World Medical
Association).
Declaration is addressed primarily to physicians.
The WMA (World Medical Association) encourages others who are involved in medical
research involving human subjects to adopt these principles. Not legally mandated
3
CORRECT = 100
100
INCORRECT=0
STUDY MATERIALS.......DESIGNED TO HELP YOU SUCCEED
SPOTLIGHT 1
1
, WELL DETAILED ANSWERS|LATEST
UPDATE!!!!!!2026|GUARANTEED PASS|GRADED
Investigator should (qualifications/agreements) - ANSWER Be qualified by
training/education and expertise
Be familiar with the product investigational
Be aware and comply with GCP and regulatory requirements
Permit auditing/monitoring
Delegate authority and maintain a log
Be responsible for the training of the staff
Nuremberg Code - ANSWER (1947) Ten guidelines for the ethical treatment of
human subjects in research - Came about after Nuremberg trial in Germany during world
war II
Legal force of the document was NOT established or incorporated directly into the American
or German law
Nuremberg Code 10 Ethical Guidelines - ANSWER 1. Voluntary consent of the
human subject is absolutely essential.
2. The experiment should be such as to productive results for the good of society
unprocuable by other methods or means and not ransom and unnecessary in nature.
3. The experiment should be so designed and based on the results of animal
experimentation and a knowledge of the natural history of the disease.
4. The experiment should be so conducted as to avoid all unnecessary physical and mental
suffering and injury.
2
, 5. No experiment should be conducted where there is an a prior reason to believe that
death or disabling injury will occur.
6. The degree of risk to be taken should never exceed that determined by the humanitarian
importance of the
problem to be solved by the experiment.
7. Proper preparations should be made and adequate facilities provided to protect the
experimental subject against even remote possibilities of injury, disability, or death.
8. The experiment should be conducted only by scientifically qualified persons. The highest
degree of skill and care.
9. During the course of the experiment the human subject should be at liberty to bring the
experiment to an end.
10. During the course of the experiment the scientist in charge must be prepared to
terminate the experiment at any stage.
Nuremberg Code - Key Principles - ANSWER 1. Voluntary participation
2. Informed Consent
3. Minimization of risk
The Nuremberg Code and the Declaration of Helsinki are the basis for the... -
ANSWER Code of Federal Regulations Title 45 Volume 46 which are regulations
issued by the United states department of heath and human services
Declaration of Helsinki - ANSWER (1964) Is a set of ethical principles regarding
human experimentation developed for the medical community by the WMA (World Medical
Association).
Declaration is addressed primarily to physicians.
The WMA (World Medical Association) encourages others who are involved in medical
research involving human subjects to adopt these principles. Not legally mandated
3
