The Informed Consent Process - University of Arkansas for 知情同意的过程-阿肯色大学.pptVIP

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The Informed Consent Process - University of Arkansas for 知情同意的过程-阿肯色大学.ppt

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The Informed Consent Process - University of Arkansas for 知情同意的过程-阿肯色大学

The Informed Consent Process Danna K. Carver Director UAMS Office of Research Compliance 501-526-6875 carverdannaK@uams.edu AHEC Seminar 4/25/03 Informed Consent Objectives Informed Consent Process Informed Consent Interview Informed Consent Document Informed Consent and Vulnerable Populations Research?Medical Practice Patients vs. Subjects When a person volunteers to participate in a research trial, his or her status changes from patient to subject Subjects may not be receiving “standard of care”. The risks may be higher Documentation for subjects is MORE EXTENSIVE than regular clinical documentation The subject is the ultimate decision maker and must have complete information to assure his participation remains voluntary The Informed Consent Process Informed consent is information exchange including subject recruitment materials, verbal instructions, written materials, questions and answer sessions and signature documenting consent with date. Subjects are given opportunity to choose involvement based on information, comprehension and voluntariness. – Protecting study volunteers in research Cynthia McGuire Dunn, MD Gary Chadwick, PHARM.D, mph 1999. The Informed Consent Process Is the key to respecting autonomy Provides a reasonable assurance that the subject has not been deceived or coerced Cannot be obtained from those who are vulnerable, dependent or cognitively impaired O O’Neil J Med Ethics 2003:29:4-7 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 the subject new information as it develops Informed Consent Interview Interview Choose a quiet, private, non-intimidating place to talk to the prospective subject A