Respect for Persons, Beneficence, Justice
Three core ethical principles that are relevant to research involving
human subjects
Respect for Persons
treating persons as autonomous agents and protecting those with
diminished autonomy
Beneficence
is the duty to protect research subjects from harm
Justice
selection of research subjects should be fair
Phases of Pharmaceutic Research
Pre-clinical trials, Human clinical experimentation (Phase 1-4), Clinical
research study design (Independent Variable & Dependent variable)
Pre-clinical trials
initial trial of a chemical thought to have therapeutic potential; uses
laboratory animals, not human subjects
Genotoxicity
the ability of a compound to damage genetic information in a cell, in
addition to drug absorption, distribution, metabolism, and excretion
Drug discovery
Test drug compounds in animals & tissue
Phase I
testing of 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
Phase II
treatment is given to a larger group of people to see if it is effective and
to further evaluate its safety
Phase III
, treatment is given to large groups of people to confirm its effectiveness,
monitor side effects, compare it to commonly used treatments, and
collect information that will allow the drug or treatment to be used safely
Phase IV
Studies are done after the drug or treatment has been marketed to
gather information on the drug's effect in various populations and any
side effects associated with long-term use.
Independent variable
treatment, such as with a drug
Dependent variable
outcome, such as clinical effect
ANA (American Nurses Association)
Association who deals with the professional nursing scope and
standards of practice; standards of practice and professional
performance; all RNs are a part; mission is to advance nursing
profession
ANA Code of Ethics
A guide for carrying out nursing responsibilities in a manner consistent
with quality in nursing care and the ethical obligations of the profession
(1950). Revised in 2015.
Nurse's role in clinical research
responsible for both safety of the patient and the integrity of the research
protocol.
Selected Drug Standards and Legislation
Drug Standards and Federal Legislation
Drug standards in the US
United States Pharmacopeia (USP)
US Pharmacopeia and the National Formulary
the authoritative source for drug standards; dosage, forms, drug
substances, excipients, biologics, compounded preparations, and dietary
supplements.
Federal legislation
protects the public from drugs that are impure, toxic, ineffective, or not
tested before public sale. Its purpose is to ensure safety.
Food and Drug Act of 1906
America's first law to regulate drugs. This law prohibits the sale of
misbranded and adulterated drugs but did not address drug
effectiveness and safety.
Three core ethical principles that are relevant to research involving
human subjects
Respect for Persons
treating persons as autonomous agents and protecting those with
diminished autonomy
Beneficence
is the duty to protect research subjects from harm
Justice
selection of research subjects should be fair
Phases of Pharmaceutic Research
Pre-clinical trials, Human clinical experimentation (Phase 1-4), Clinical
research study design (Independent Variable & Dependent variable)
Pre-clinical trials
initial trial of a chemical thought to have therapeutic potential; uses
laboratory animals, not human subjects
Genotoxicity
the ability of a compound to damage genetic information in a cell, in
addition to drug absorption, distribution, metabolism, and excretion
Drug discovery
Test drug compounds in animals & tissue
Phase I
testing of 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
Phase II
treatment is given to a larger group of people to see if it is effective and
to further evaluate its safety
Phase III
, treatment is given to large groups of people to confirm its effectiveness,
monitor side effects, compare it to commonly used treatments, and
collect information that will allow the drug or treatment to be used safely
Phase IV
Studies are done after the drug or treatment has been marketed to
gather information on the drug's effect in various populations and any
side effects associated with long-term use.
Independent variable
treatment, such as with a drug
Dependent variable
outcome, such as clinical effect
ANA (American Nurses Association)
Association who deals with the professional nursing scope and
standards of practice; standards of practice and professional
performance; all RNs are a part; mission is to advance nursing
profession
ANA Code of Ethics
A guide for carrying out nursing responsibilities in a manner consistent
with quality in nursing care and the ethical obligations of the profession
(1950). Revised in 2015.
Nurse's role in clinical research
responsible for both safety of the patient and the integrity of the research
protocol.
Selected Drug Standards and Legislation
Drug Standards and Federal Legislation
Drug standards in the US
United States Pharmacopeia (USP)
US Pharmacopeia and the National Formulary
the authoritative source for drug standards; dosage, forms, drug
substances, excipients, biologics, compounded preparations, and dietary
supplements.
Federal legislation
protects the public from drugs that are impure, toxic, ineffective, or not
tested before public sale. Its purpose is to ensure safety.
Food and Drug Act of 1906
America's first law to regulate drugs. This law prohibits the sale of
misbranded and adulterated drugs but did not address drug
effectiveness and safety.
