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133.

A physician who coordinates a medical experiment is carrying out a procedure for obtaining informed consent from the study participants. The participants are minors who have attained the age of 13 years but have not attained the age of 16 years. The physician has an obligation to obtain informed consent:

A. only from the statutory representative of the minor age participants.
B. only from the minor age participants who have acquired full legal capacity on their completing the age of 13 years.
C. both from the statutory representatives and the minor age participants.
D. from the guardianship court as the only body that has capability to make an objective assessment of the risk related to the minor’s participation in the trial and to protect his/her welfare.
E. from the statutory representative of the minor as well as from his primary care physician who knows best his/her health condition and is able to evaluate the risk versus benefits related to participation.

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