知情同意重点及问题解决.ppt

2010-08-18 Thank you * * * * * * * * * * * * * * * * * * * * * * * * * Informed Consent Vera Han QA Specialist Informed Consent 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 subjects decision to participate. Informed consent is documented by means of a written, signed, and dated informed consent form. – ICH Guidance for Industry, Good Clinical Practice Consolidated Informed Consent Definition? Webster Says Informed consent: n. consent obtained from a patient for the performance of a specific medical, surgical, or research procedure after the procedure and risks involved have been fully explained in nontechnical terms and understood What rules do We follow? ICH Good Clinical Practice Guidelines E6 4.8 Institutional Policy Declaration of Helsinki Federal Regulations 21CFR Part 50 45CFR Part 46 Good Clinical Practice Who Can Obtain Informed Consent? PI may delegate to appropriate members of the research teamAuthorization List Those obtaining informed consent must be knowledgeable about the specific study and the process of informed consentCV and Training record Who Can Obtain Informed Consent? The PI is not required to obtain consent, but is responsible for the process and any required documentation. The person conducting the consent interview is the “person obtaining consent” INFORMED CONSENT PROCESS Steps in Informed Consent Process Informed Consent Form Documenting the Consent Process Consent Revision Re-consenting Steps in Informed Consent Process Starts with an interview Is an exchange of essential information about the research Allows an opportunity for subject to ask questions and have them answered Is evidenced by the signing of informed consent document Is documented in record Requires giving a copy of the Informed Consent form to the subject Continues at each interaction by providing t