CHAPTER SIX: HUMAN RESEARCH

clinical trial

scientific study designed to test a medical intervention in humans

_____ ____ are to determine effects on human body

clinical trials

For clinical trials to be morally permissible:

• Must be informed voluntary consent

• Must be designed to minimize risks, must be balance of risks and benefits

• Fair selection of subjects to avoid exploitation or unjust excluding

• Privacy protection, confidentiality of data must be preserved

• Research must be approved by independent panel before conducted

True or False: clinical trials provide the strongest and most trustworthy evidence of treatments impact on human health

True

A clinical trial is divided into two subject groups:

1. group that gets the treatment

2. group closely resembling, not getting treatment

The two groups of subjects are known as the:

an experimental group; control group

placebo

inactive or sham treatment

this part of the experiment is used as a control group used to assess the worth of the treatment

placebo

For a treatment to be judged genuinely effective, subjects in the treatment group must show significantly greater improvement than those in the placebo group. Studies using placebos in this way are called _______ trials.

placebo-controlled

In an active control group, subjects get the standard treatment, one already proven to work. The results in the treatment group can then be compared to those in the active control group to see if the new treatment outperforms the old. Studies that use this type of control group are known as ________ trials.

active-controlled

In general, ________ trials are more trustworthy than other types of clinical trials

placebo-controlled

blinding

procedure for ensuring subjects and researchers do not know which interventions subjects receive

True or False: When it comes to blinding it is NOT applied to standard, new, or placebo research

False

double-blinded

when both subject and researches are unaware of what treatments the subjects get

single-blinded

only subjects are unaware of what treatments the subject gets

good clinical trials testing for treatment efficacy are blinded; preferably ______

double-blinded

randomization

assigning of subjects randomly to both experimental and control groups

____ is a must for reliable date and also minimizes bias

randomization

by law, drugs must involve several clinical trials in _______ stages

three

stage in clinical trial that is non therapeutic with few people, there is no try to evaluate efficacy and focuses on safety

phase one

stage in clinical trial where preliminary indication of effectiveness in larger groups, more assessments of safety

phase two

stage in clinical trial that establishes effectiveness, compares efficacy with proven treatments, where learning to employ in the safest way occurs, therapeutic, and when passed approved for widespread use

phase three

phase in clinical trial that is after the drug is marketed and assess effectiveness and side effects long term

phase four

horrific experiments that included infecting, shooting, freezing, starving, sterilizing and mutilating

WWII

occured in 1932 when poor black men were targeted for research on syphilis; never told they had syphilis, nature of the study and never treated

Tuskegee Study

what study led to Nuremberg Code (set of minimal principles governing human experiment) added to the Declaration of Helsinki in 1964

Tuskegee

human research has to do with ____ because it is an act for people’s good

beneficence

______, _____, and _______ are important in human research standards

beneficence, autonomy, and justice

True or False: therapeutic trials and non-therapeutic (if informed consent) can NOT be justified by the potential good to the subjects and future patients of society

False

The use of control groups touch on most issues of _______

beneficence

who are the most vulnerable in society?

• children

• women

• those with intellectual disabilities

• prisoners

• minorities

• people in developing countries

what is the essential argument of conflict between the research and vulnerable?

1. duty to shield vulnerable from abuse

2. aspiration to benefit them or society through needed research

Most policies assume properly designed research in children is or is not morally acceptable if conducted for their sake, to generate needed therapies ?

is

even if parent gives informed consent, _______ is required to research by child

assent

a feminist ethics approach would support:

women ought to be represented proportionately to their health risk in any clinical study likely to benefit women, not only men

when it comes to research on the vulnerable, issues like gender or race fall into which principle of biomedical ethics? what specifically?

justice, distributive justice

applying major theories: ______ accepts clinical trials as long as their is below a certain level of risk and maximize good consequences, minimizing bad

utilitarianism

“The Tuskegee study revealed more about the pathology of racism than it did about the pathology of syphilis”

Allan M. Brandt