Lecture 3: chapter 4 Flashcards
what are the elements of ethical research?
1) protecting human rights
2) understanding informed consent
3) understanding institutional review of research
4) balancing benefits/ risks in a study
what are the unethical researches mentioned?
1) Nazi Medical Experiments
2) Tuskegee Syphilis Study
3) Willowbrook Study
4) Jewish Chronic Disease Hospital Study
what are two documents associated with the Nazi Medical experiments?
Nuremberg Code and Declaration of Helsinki
what are the critiquing guidelines for problems and purposes?
what are things to consider when critiquing guidelines of research (problems and purposes)?
- is it clear and concise?
- limited in scope?
- is it narrowed to the focus of the study?
- does it identify variables, population, and setting?
- does this allow for generation of knowledge?
- feasible?
- ethical?
what were the ethical violations of the Nazi Medical Experiments?
subjects were given poison, surgery w/o anasthesia, involuntary participation, freezing temperatures, and permanent damage
who were the subjects of the Nazi Medical Experiments?
Jewish prisoners of war
what was the goal of Tuskegee Syphilis Study (TSS)?
to examine the natural course of syphilis in adult black men w/o treatment
what made TSS unethical?
withheld information of effective treatment (Penicillin)
what roles did the CDC play in TSS?
they reviewed it and determined it should be continued for the next 40 years
what are the long-term implications of unethical research in the past?
severe mistrust by subjects of the researchers
what was the purpose of the Willowbrook Study (WS)?
examined the course of hepatitis in the body using mentally impaired children
on what grounds was WS defended at that time?
cleaner environment, better supervision, higher nurse-patient ratio
what was the purpose of the Jewish Chronic Disease Study (JCDS)?
determine the patient’s rejection response to live cancer cells
who were the subject of JCDS?
patients with dementia
what made JCDS unethical?
researchers did not inform subjects they were taking part in a study (no informed consent)
doctors who were caring for the patients with dementia did not know about the study
true
what is the focus of the Declaration of Helsinki?
clarifies the difference between therapeutic and nontherapeutic research
therapeutic research
gives patients an opportunity to receive experimental treatment
nontherapeutic research
is conducted to generate knowledge for science and the benefit of future patients
3 ethical principles (Belmont Report)
1) respect of persons (autonomy)
2) beneficence (promote good)
3) justice (fairness)
what are the ways autonomy is applied in research?
informed consent
ability to withdraw
confidentiality
what are the ways beneficence is applied in research?
minimize risks
assure benefits
maintain integrity of the study
how do you maintain the integrity of the study?
report true results and finish the study
what are the ways fairness is applied in research?
establishing inclusion and exclusion criteria
translated consent and surveys
5 human rights considered for research
1) self-determination
2) privacy
3) anonymity
4) protection from harm and discomfort
5) fair selection and treatment
right to self-determination
humans are autonomous agents with freedom to conduct their lives as they choose
how do you violate the right to self-determination?
coercion
covert data collection
deception
coercion
intentional threat of harm to subject to obtain compliance
covert data collection
subjects are unaware of the research data being collected
deception
actual misinforming of subject for research purposes
example of deception
Milgram Study
administering electric shocks to another person (who was actually an actor)
when is deception acceptable?
it is not expected to cause any long-lasting harm
benefit-risk ratio
expected benefits balances high risks
who are persons with diminished autonomy?
legally and mentally incompetent subjects
neonates and children
terminally ill
people confined to an institution
pregnant women and fetuses
right to privacy
the freedom people have to determine the time, extent and general circumstances under which private information will be kept or shared
what is considered discomfort and harm?
no anticipated effects
temporary discomfort
unusual levels of temporary discomfort
risk of permanent damage
certainty of permanent damage
which right prevents coercion of subjects?
right to fair selection and treatment
elements of informed consent
disclosure (essential information for consent)
comprehension
competence to give consent
voluntary agreement
functions of the Institutional Review Board
protection of rights and welfare
voluntary informed consent
benefits exceeds risks
what is the focus of the IRB?
the safety of the subjects
note they have nothing to do with the study itself (if it was valid)
levels of reviews by the IRB
1) exempt
2) expedited
3) full/ complete
studies that are exempt from review
they pose no apparent risks to the research subjects
studies that will receive expedited review
they have minimal risks
studies that will receive a full review
carries greater than minimal risks
(but it needs to present how they will actively minimize risks, ensure equitable selection of subjects, protect the privacy, make accommodations)
