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Weekly GCP Challenge

Answer the questions below and then click the button. The next page will mark your answers and show you how well you have done compared with the previous people who have taken the tests.


Challenge: Declaration of Helsinki

Question Number 1:

The 1996 Declaration of Helsinki states:

"Biomedical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person. The responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, .................."

A
even though the subject has given his or her consent
B
the monitor or the legal guardian
C
or the legal guardian
D
or the impartial witness

Question Number 2:

The 1996 Declaration of Helsinki states:

"When obtaining informed consent for the research project the physician should be particularly cautious if the subject is ........... In that case the informed consent should be obtained by a physician who is not engaged in the investigation and who is completely independent of this official relationship."

A
in a dependent relationship to him or her
B
in a dependent relationship to him or her or may consent under duress
C
under duress
D
unaware of the risk to benefit profile of the project

Question Number 3:

The 1996 Declaration of Helsinki states:

"Biomedical research involving human subjects cannot legitimately be carried out unless the importance of the objective is in proportion to the ..............."

A
financial compensation to the subject
B
duration of potential clinical benefit
C
inherent risk to the subject
D
potential hazards to the patient

Question Number 4:

The 1996 Declaration of Helsinki states:

"The research protocol should always contain a statement of the ........ and should indicate that the principles enunciated in the present Declaration are complied with."

A
financial benefit to the investigator
B
ethical considerations involved
C
commercial objectives of the trial
D
inherent risks

Question Number 5:

The 1996 Declaration of Helsinki States:

"The ................ must never interfere with the physician-patient relationship."

A
commercial responsibilities
B
financial compensation
C
withdrawal of a patient from a study
D
refusal of the patient to participate in a study

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