Ethics In Research Flashcards

1
Q

should arise out of our commitment to ethical practice and to improve client outcomes

A

EBP

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2
Q

can be used to bring about change for one patient, across a system, or for the profession

A

Evidence

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3
Q

True/False: Commitment to the protection of patients’ rights and dignity must be the most important aspect when designing and conducting clinical research.

A

True

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4
Q

Research with human subjects requires adherence to 3 basic principles:

A
  1. Autonomy
  2. Beneficence
  3. Justice
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5
Q

the capacity of the individual to make decisions affecting their lives and to act on those decisions

A

Autonomy

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6
Q

When must an individual have a surrogate decision maker

A

For Children and patients with cognitive difficulties may be unable to understand their involvement in the research

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7
Q

the obligation to attend to the well-being of individuals

A

Beneficence

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8
Q

refers to the fairness in the research process

A

Justice

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9
Q

Examples of abuse in research

A

Tuskegee Study
Nazi Experiments

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10
Q

Clearly emphasized that every individual should voluntarily consent to participate as a research subject.

A

Nuremberg Code of 1949

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11
Q

“the research should be conducted only by scientifically qualified persons”

A

Nuremberg Code of 1949

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12
Q

declares that reports of research that has not been conducted according to stated principles should not be accepted for publication

A

Declaration of Helsinki

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13
Q

first document that addressed the concept of independent review of research

A

Declaration of Helsinki

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14
Q

Developed to ensure the protection and rights of human subjects in research and are now considered “standard” throughout the United States

A

National Research Act 1974

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15
Q

National Research Act 1974 demands

A

research have a fully developed research proposal

Informed consent MUST be obtained

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16
Q

Governs conduct of research ion United States

A

Belmont Report

17
Q

DHHS regulations protect individual confidentiality is known as

A

The common rule

18
Q

IRB

A

Institutional Review Board

19
Q

IRB is composed of 5 members:

A

Cannot be all males or all females
Cannot be all members of one professional group
At least one member must be concerned primarily with nonscientific issues and may be a lawyer, clergyman, etc.
One member must be a ”public” member and must not be associated with the institution (university or hospital, etc.) where the research is to be completed

20
Q

Responsibility of IRB

A

Review research proposals at convened meetings.
The decision to approve, require modifications in, defer or deny approval of a proposal must be that of a majority
Must consider the scientific merit of the project, the competence of the investigators, the risk to subjects, and the feasibility based on identified resources.

21
Q

3 elements of informed consent

A
  1. Information Elements
  2. Consent Elements
  3. Authorization
22
Q

Subjects must be fully informed:
1. a written statement of the purpose of the study
2. a fair explanation of the procedures to be used & how they are to be applied
3. The explanation must be complete and there must be NO deception

A

Information elements

23
Q

Consent must be voluntary

Vulnerable Subjects – special considerations must be given to children, subjects with mental illness, diminished mental capacity, or developmental disability. In these cases, consent must be given by a legal guardian or advocate.

A

Consent elements

24
Q

This allows or authorizes the researcher to use data in a manner specified in the protocol

A

Authorization

25
Q

9 Elements of Informed Consent

A
  1. Purpose of the research project
    2.Procedures
    3.Risks and discomforts
    4.Benefits
    5.Alternatives to participation
    6.Confidentiality
    7.Request for more information
    8.Refusal or withdrawal
    9.Injury statement
    10.Consent statement
    11.Signatures
26
Q

CITI

A

The Collaborative Institutional Training Initiative (CITI Program)

27
Q

dedicated to promoting the public’s trust in the research enterprise.

A

CITI

28
Q

CITI was founded in

A

2000

29
Q

5 unethical principles of research

A
  1. Data falsification
  2. Data fabrication
  3. Unintentional plagiarism
  4. Intentional plagiarism
  5. Conflict of interest
30
Q

Ways to address unethical research

A

Be up to date on ethical guideline’s
Don’t be afraid
See something, say something
Educate others