Transcript Objective 4: Explain informed decision

Objective 4:
Explain informed
decision-making
and the informed
consent process
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
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EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605]
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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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EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605]
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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 else
Confidential 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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EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605]
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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
community
Multiple legal and ethical roles and
responsibilities
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EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605]
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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
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EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605]
http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org
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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]
http://www.NativeAmericanPrograms.org
http: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org
/ http://www.NatAmCancerInitiatives.org
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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]
http://www.NativeAmericanPrograms.org
http: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org
/ http://www.NatAmCancerInitiatives.org
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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]
http://www.NativeAmericanPrograms.org
http: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org
/ http://www.NatAmCancerInitiatives.org
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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]
http://www.NativeAmericanPrograms.org
http: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org
/ http://www.NatAmCancerInitiatives.org
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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
Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of
EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605]
http://www.NativeAmericanPrograms.org
http: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org
/ http://www.NatAmCancerInitiatives.org
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