Legal and ethical considerations Flashcards
respect for persons
right to self determination
beneficence
do no harm
justice
all subject must be treated fairly
important required elements of informed consent
basis for selection, purpose, explanation of procedures, description of risk or discomforts, potential benefits, alternatives to participation, subject to withdraw, etc.
informed consent
everything is laid out for the person to agree to
implied consent
Patients is agreeing but doe not know exactly what is happening, EX: “by clicking continue you are consenting to a terms and conditions”
what does institutional review boards do
review studies to ensure ethical standards for protection of human subjects are met
T/F any one can be a committee member
False, need to be qualified and complete training
T/F research has to be approved by IRB before beginning a study
True
who are the vulnerable populations in studies
children, pregnant women, prisoners, elderly
Assent
basic understanding of the purpose of the study and what will be done; ability to express a preference about participation, Childs consent
T/F a child must also agree to the study even though their parents already consented
True
