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PHARMACOLOGY > Drug Development and Ethical Considerations (OBJECTIVES 1-4) > Flashcards

Drug Development and Ethical Considerations (OBJECTIVES 1-4) Flashcards

1
Q

Three core ethical principles are relevant to research involving human subjects:

A

respect for persons, beneficence, and justice

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2
Q

integral to the issues of informed consent and risk-benefit ratio in such research

A

Core Ethical Principles

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3
Q

Patients should be treated as independent persons capable of making decisions in their own best interests.

A

Respect for Persons

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4
Q

Respect for Persons

Patients with diminished decision- making capacity are entitled to _____-.

A

protection

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5
Q

Respect for Persons

When making health care decisions, patients should be made aware of _________ to them as well as the _______ that stem from those alternatives.

A

alternatives available; consequences

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6
Q

Respect for Persons

The patient’s choice should be _______ whenever possible

A

honored

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7
Q

Respect for Persons

It is imperative that _____ recognize when patients are not capable of making decisions in their own best interest and are therefore entitled to ______.

A

nurses; protection

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8
Q

Respect for Persons

The nurse can assist with the determination of decision-making capacity through ______________.

A

frequent assessment of the patient’s cognitive status

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9
Q

is an integral component of respect for persons.

is the right to self-determination.

A

Autonomy

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10
Q

Respect for Persons

In health care se ttings,
_________ must _____ the patient’s right to make decisions in their own best interest, even if the decision is ___________ for the patient.

A

health care personnel; respect; not what the health care personnel want or think is best

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11
Q

Respect for Persons

Generally, patients can _____ any and all treatments (right of _____) except when the decision poses a threat to others.

A

refuse; autonomy

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12
Q

is as relevant to the conduct of research as it is in health care decision making

A

Autonomy

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13
Q

Respect for Persons

patients have the right to ______ to participate in a research study and may _____ from studies at any time without penalty.

A

refuse; withdraw

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14
Q

has its roots in the 1947 Nuremberg Code

A

Informed Consent

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15
Q

The two most relevant aspects of the Code are:

A

(1) the right to be informed and (2) that participation is voluntary, without coercion

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16
Q

Informed Consent

If ______ is suspected, the nurse is obligated to _____ this suspicion promptly

A

coercion; report

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17
Q

Informed consent has dimensions beyond protection of the individual patient’s choice:

  • It is a _____ of information, a process of _____.
  • It expresses _______.
  • It gains the patient’s _______ in their care.
  • It respects the patient’s ________.
A
  • It is a mutual sharing of information, a process of communication.
  • It expresses respect for the person.
  • It gains the patient’s active involvement in their care. * It respects the patient’s right to self-determination.
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18
Q

Informed Consent

It is the role of the _________, not the _____, to explain the study to the patient, what is expected of the patient, and to respond to questions from the patient.

A

health care provider; nurse

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19
Q

Informed Consent

When giving ________, the patient must be ____ and able to _______.

A

written consent; the patient must be alert and able to comprehend

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20
Q

Informed Consent

consent forms should be writt en at or below the _______, and words should be kept to
_______.

A

eighth-grade reading level; fewer than three syllables

21
Q

Informed Consent
_____ are patient advocates

A

Nurses

22
Q

Informed Consent

In collaboration with the health care provider and the pharmacist, the nurse must be knowledgeable about all aspects of a drug study—including all _____ and _____ for participants, _______, and _______—to promote participant safety and quality study results.

A

inclusion and exclusion criteria, study protocol, and study-related documentation

23
Q

is the duty to protect research subjects from harm. It involves ensuring the risks and possible benefits from participating in a research study are clearly defined, and ensuring the benefits are greater than the risk.

A

Beneficence

24
Q

is one of the most complex problems faced by the researcher.

A

Risk-Benefit Ratio

25
Q

Risk-Benefit Ratio

All possible _____ of a clinical study must be _____ and ______ against the _______ and the ________.

A

consequences; analyzed and balanced; inherent risks; anticipated benefits

26
Q

Risk-Benefit Ratio

_____, _______, and ____ risks must be identified and weighed against the benefits.

A

Physical, psychological, and social risks

27
Q

Risk-Benefit Ratio

A requirement of the ___________ is that ________ determine that risks to subjects be reasonable in relation to the anticipated benefits, if any, for subjects.

A

Department of Health and Human Services (DHHS); institutional review boards (IRBs)

28
Q

Risk-Benefit Ratio

No ma er how noble the intentions, the calculation of risks and benefits by the researcher _________.

A

cannot be totally accurate or comprehensive

29
Q

requires that the selection of research subjects be fair. Research must be conducted so that the distribution of benefits and burdens is equitable.

A

Justice

30
Q

The FDA requires clinical research to follow the ___________, an international ethical and scientific quality standard for designing, conducting, monitoring, auditing, recording, analyzing, and reporting clinical research.

A

Good Clinical Practice (GCP) Consolidated Guideline

31
Q

It is the foundation of clinical trials that involve human subjects.

A

Good Clinical Practice (GCP) Consolidated Guideline

32
Q

Before the implementation of clinical research, the FDA requires ________ to determine a drug’s toxic and pharmacologic effects through in vitro and in vivo animal testing in the laboratory.

A

preclinical trials

33
Q

Preclinical Trials

Through these trials, drug developers are able to determine ______, the ability of a compound to damage genetic information in a cell, in addition to drug absorption, distribution, metabolism, and excretion.

A

genotoxicity

34
Q

Human Clinical Experimentation

Historically, drug research was done only with _________, causing uncertainty as to the validity of research results for people of other ethnicities and for women and children.

A

Caucasian males

35
Q

Human Clinical Experimentation

In _________ passed the ___________, which helped establish guidelines to include women and minorities in clinical research.

A

1993 Congress; National Institutes of Health (NIH) Revitalization Act

36
Q

Human Clinical Experimentation

Additionally, the _________ and the _________ encourage pharmaceutical companies to study their drugs in children.

A

Best Pharmaceuticals for Children Act (BPCA) of 2002; Pediatric Research Equity Act (PREA) of 2003

37
Q

Human Clinical Experimentation

A ________ approach that includes nurses, physicians, pharmacologists, statisticians, and research associates is required to ensure safety and quality in all phases of clinical research.

A

multidisciplinary team

38
Q

Identify which phase of clinical experimentation:

Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

A

Phase I

39
Q

Identify which phase of clinical experimentation:

The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

A

Phase II

40
Q

Identify which phase of clinical experimentation:

The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it with commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

A

Phase III

41
Q

Identify which phase of clinical experimentation:

Studies are done after the drug or treatment has been marketed to gather information on the drug’s effects in various populations and to assess any side effects associated with long- term use.

A

Phase IV

42
Q

Human Clinical Experimentation

To reduce delays in the FDA approval process, in ________ passed the _________, which provided the FDA with funds to expedite the review process. As a result, the average drug approval time has decreased from __ months to __.

A

1992 Congress; Prescription Drug User Fee Act; from 30 months to 12.

43
Q

“was developed as a guide for carrying out nursing responsibilities in a manner consistent with quality in nursing care and the ethical obligations of the profession.”

A

American Nurses Association (ANA) Code of Ethics

44
Q

American Nurses Association (ANA) Code of Ethics

It was first adopted in ____ and most recently was revised with interpretive statements in ____.

A

1950; 2015

45
Q

American Nurses Association (ANA) Code of Ethics

is founded on the principles first identified by _______.

A

Florence Nightingale

46
Q

Florence Nightingale believed that a nurse’s ethical duty was first and foremost _______.

A

to care for the patient

47
Q

are at the forefront of clinical research.

A

Nurses

48
Q

are likely to encounter patients eligible to participate, considering participation, or actively participating in clinical research.

A

Nurses

PHARMACOLOGY (11 decks)

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