Tiêu đề 14. INFORMED CONSENT PROCESS.pdf ✅

PHARMD GURU Page 2 informed consent document should be signed by the "study subject`s legally acceptable representative". 5) The person who provides the information and obtain the consent [The investigator] should sign the consent form. The investigator must be qualified enough to inform the study subjects of all the aspects of the study. The signatories [study subject, investigator, and any other person involving in the consent process] should personally date the informed consent document. 6) If a subject is unable to read, or if a legally acceptable representative is unable to read, then, an "impartial witness" will ensure that there was no coercion [force or threats] in obtaining the informed consent. The witness should be independent of the study subject. The relationship of the witness to the study subject, and to the investigator, or to the study should be documented. After the written informed consent form and any other written information to be provided to the subjects is read and explained to the subjects or subject's legally acceptable or representative & the subject has orally consented to the participation in the trial and if capable of doing so, has signed, and personally dated the informed consent form, the witness should sign, and personal data consent form. By signing the consent form, the witness attests that information in the consent form, and any other written information was accurately explained to, and apparently understood by the subject or the subject's legally acceptable representative, and that informed consent was freely given by subject, or subject's legally acceptable representative. STEPS IN OBTAINING THE INFORMED CONSENT:  Obtain approval of the informed consent from the IRB.  Present the prospective subjects, with the consent document.  Explain significant points about the research or participation to the study subjects.  Prompt the subject to ask questions and answer all or any questions. Make sure to discuss the risks, benefits, and alternatives therapies, in addition to purpose and procedures.  Give the prospective subject, a copy of the consent document.