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

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Belmont Report

Issued in 1979 by a national commissionSets forth three principles for the ethical conduct of research:

1. Respect for persons2. Beneficence3. Justice

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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

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“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.

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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 elseConfidential extends beyond the time when the individual is employed

Years after no longer working, the information STILL can NOT be shared

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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 communityMultiple legal and ethical roles and responsibilities

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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]

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Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605]

http: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.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 / http:///www.NatAmCancerInitiatives.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 participationDo you want to hear Dana’s story?

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Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605]

http: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org 9

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http: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.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

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Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605]

http: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.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 / http:///www.NatAmCancerInitiatives.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 pigTuskeegee, Involuntary sterilization of Indian women (1960’s), Havasupai

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Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605]

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Informed Consent Process -- Clarified

Who administers, when, where, how What information shared Understandable by potential participant Voluntary participation and withdrawal

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Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605]

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http: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.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 ofIt Should:

Provide adequate information Ensure participant understands informationInclude voluntary consentIncludes how to withdraw from the studyPatient cannot be denied care if withdraw