Objective 4: Explain informed decision-making and the informed consent process

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 2 Belmont Report Issued in 1979 by a national commission Sets forth three principles for the ethical conduct of research: 1.Respect for persons 2.Beneficence 3.Justice

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 3 Privacy What is a definition of “privacy” Privacy is defined in terms of having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others What are examples of “private” information? Your name, address, tribal affiliation

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 4 “Confidentiality” Participants give information about themselves to the research team in a relationship of trust. Participants expect that the information will be shared only as necessary. The research team must respect the participant's trust and not betray the confidence placed in them.

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 5 What is the difference between “privacy” and “confidentiality? Confidential means the research staff do not discuss or share any private, personal information about the “client” with anyone else Confidential extends beyond the time when the individual is employed Years after no longer working, the information STILL can NOT be shared

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 6 Purposes of the IRB Institutional Review Board (IRB) reviews research and consent forms to determine if the rights and welfare of subjects are protected. Works for the benefit and respect of the community Multiple legal and ethical roles and responsibilities

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 7 Purposes of the IRB IRB shares responsibility with the research investigator for protecting the: Privacy Safety Confidentiality of the people who participate in the study

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 8 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 8 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 8 The Purpose of the “Informed Consent” Process QUESTION: What is the purpose of the informed consent process? To ensure that the patient has sufficient knowledge to make an informed choice regarding study participation Do you want to hear Dana’s story?

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 9 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 9 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 9 What is Informed Consent? More than a form or a signature An ongoing process for information exchange that typically includes: Verbal instructions Written materials Question and answer session Agreement documented by signature

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 10 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 10 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 10 What “Informed Consent” is NOT: A legal contract Binding on the part of the participant Simply a set of instructions on how medications are given Protect the researcher from malpractice QUESTION: Why is it mandatory to adhere to informed consent process today? Making a choice versus being a guinea pig Tuskeegee, Involuntary sterilization of Indian women (1960’s), Havasupai

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 11 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 11 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 11 Informed Consent Process -- Clarified Who administers, when, where, how What information shared Understandable by potential participant Voluntary participation and withdrawal

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 12 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 12 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 12 What is Informed Consent? More than a document It is an agreement and a process that the participant will NOT be taken advantage of It Should: Provide adequate information Ensure participant understands information Include voluntary consent Includes how to withdraw from the study Patient cannot be denied care if withdraw