Tiêu đề 14. INFORMED CONSENT PROCESS.pdf ✅

PHARMD GURU Page 1 DEFINITION: A process by which a subject, voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed Consent is documented by means of a written, signed and dated informed consent form. INTRODUCTION: 1) Informed Consent is about people's understanding and willingness to participate in a study or not about signing a form. 2) Even though the consent document that gives information is a vital part of the process, the discussion regarding any questions or concerns with a knowledgeable research team member is also necessary. 3) Investigators have to understand that the informed consent involves - educating prospective subjects & not just disclosing information that is just a part of the process. 4) Before, during, and even after the trial, the study subjects should have the opportunity to ask questions and raise concerns. 5) Thus informed consent is an ongoing interactive process rather than a one time information session. STEPS FOR CONDUCTING INFORMED CONSENT PROCESS: In all clinical studies, the investigators should follow all the essential steps for conducting informed consent. These include: 1) Obtaining informed consent from each studies subject. 2) Obtain the informed consent before the start of the subject. 3) The person receiving the information and giving consent (study subject) must sign the consent form. 4) In some situations, the study subject is incapable of providing informed consent. [Example: subset is unable to write or understand the consent document] or the study subject is in a vulnerable population [Example, children, elderly], then the INFORMED CONSENT PROCESS
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.

PHARMD GURU Page 4 INFORMED CONSENT IN EMERGENCY SITUATIONS:  There is a provision within the regulations for an emergency use of an investigational product.  If the investigator has determined that there is insufficient time to obtain informed consent from the subject/legally authorities representative, the investigator should have the determination reviewed by another physician, who is not a part of the study.  The investigator should obtain a written certification of the following before the use of the product: 1) That the subject is facing a life threatening situation, hence, necessitating the use of the investigational product. 2) That informed consent cannot be obtained due to inability to communicate with the subject. 3) That, there is insufficient time to obtain consent from the legally acceptable representative of the subjects. 4) That there is no alternative method of approval or generally recognized therapy that could provide, at least an equal likelihood of saving the subject's life.