ch 4 examining ethics in nursing research Flashcards
things included nazi medical experiments
-high altitudes
-freezing temps
-malaria
-poisons
-typhus
-untested drugs
-surgery w/o anesthetic
type research: Provides patients with an opportunity to receive and experimental
treatment that might have beneficial results
therapeutic research
type research: conducted to generate knowledge for a discipline; the
results of the study might benefit future patients but probably will not benefit those acting
as research subjects
nontherapeutic research
developed from the nuremberg code that defined two types of research
declaration of helsinki
what provided the basis for the declaration of helsinki
nuremberg code (trial of nazi experiments for mistreatment of humans)
intentional infection with hepatitis of mentally handicapped children from 1950-1970
willowbrook study
intentional lack of treatment of syphilis for african american men from 1932-1972
tuskegee syphilis study
injection of 22 patients with live cancer cells by dr chester southam
jewish chronic disease hospital study
report that is a statement of basic ethical principles and guidelines that should assist in
resolving the ethical problems that surround the conduct of research with human
subjects
-identified by commission for the protection of human subjects of biomedical and behavioral research
belmont report
3 ethical principles included in protection of human subjects (included in belmont report)
- principle of respect for persons
- principle of beneficence
- principle of justice
principle of belmont report: People should be treated as autonomous agents with the right to self determination. They have the right to choose to participate or not participate in research
principle of respect for persons
principle of belmont report: Do good, and above all, do no harm. Minimize risks and maximize benefits
principle of beneficence
principle of belmont report: Human subjects should be treated fairly in terms of the benefits and risks of research
principle of justice
5 human rights
-self determination
-privacy
-anonymity and confidentiality
-fair treatment
-protection from discomfort and harm
human right: Humans are autonomous agents who can choose to participate in research.
self determination
occurs when a person intentionally presents an overt threat of harm or
excessive reward to obtain compliance
coercion
occurs when subjects are unaware that
research data are being collected.
covert data collection
actual misinforming of subjects for research purposes that can
violate a subject’s right to self-determination.
deception
people with diminished autonomy
-minors
-pregnant women and fetuses
-mentally impaired individuals
-unconscious people
the freedom people have to determine the time, extent, and general circumstances under which their private information will be shared with or withheld from others
privacy
occurs when private information is shared without a person’s knowledge or consent, or against their will
invasion of privacy
covered entities that can use/disclose pt information
-health care providers
-health care plans
-employees
-health care clearinghouses
researcher must refrain from sharing
information without the authorization of the research subject
confidentiality
occurs when
there is unauthorized access to raw data
breach of confidentiality
No one, not even the researcher, knows the
identity of the subjects
anonymity
4 highly publicized projects that are known for their unethical treatment of human subjects
-nazi medical experiments
-tuskegee syphilis study
-willowbrook study
-jewish chronic disease hospital study
when someone changes their behavior because they know they are being observed
hawthorne effect
12 critical components of informed consent
-introduction of research activities
-statement of research purpose
-selection of research subjects
-explanation of procedures
-description of risks and discomforts
-description of benefits
-disclosure of alternatives
-assurance of anonymity and confidentiality
-offer to answer questions
-voluntary participation
-option to withdraw
-consent to incomplete disclosure
purpose of institutional review board (IRB) (with informed consent)
have a committee examine the study for ethical concerns
-must have no less than 5
members of various backgrounds to promote
complete, scholarly and fair reviews of
research for the institution
3 levels of review for institutional review board
-exempt from review
-expedited review
-complete review
level of review for IRB: study poses no apparent risk for research subject
exempt from review
level of review for IRB: study poses minimal risk to subject
expedited review
level of review for IRB: anything outside of exempt or expedited reviews; criteria must be met to obtain approval
complete review
criteria that must be met for complete review from IRB (6)
-Risk to the subject minimized
-Risks to the subject are reasonable in relation to the anticipated benefits
-Informed consent will be sought
-Informed consent will be appropriately documented
-There is adequate provision for monitoring the data collection
-There is adequate provision for protection of the privacy and confidentiality of the data under HIPAA
