ch 7 ethics Flashcards
do research actions require full pt consent and IRB authorization
ye, requires both
_______ defined ethical principles for the protection of human subjects of research and in doing so provided guideleins for deciding whether an action is research or practice
the Belmont Commission of 1979
which 3 documents help healthcare researchers make dcision about ethics in research
what ethical principles do they focus on
international council of nurses has ICN code of ethics for nurses. ANA (American) also has doc. These docs focus on 3 ethical principles of autonomy, beneficence and justice.
what is beneficence and how does it relate to research
o Beneficence –ability of healthcare memer to act in best interest of the research subjuest and always fx in advocacy role
what is justice and how does it relate to research
o Justice-fundamental in research and identifies how subject should be recruited and treated fuin the research study. Ensures that research subjects always selected from wide array of the pop and aren’t recruited in coercive ways
autonomy in r/t research
o Autonomy in r/t research =right to self-det and right of every person to informed consent
If pt is asked to participate in research that holds great risk is it unethical?
what would make it un/ethical?
o Pt may be asked to participate in research that holds great risk but the research isn’t inherently unethical so long as pts autonomy rights have been address and theyve made fully informed decision
is there a requirement that researchers only propose studies that involve no risk?
no, but they must disclose those risks
what are the three components of the informed consent form
- Description of the study, including specifically what the subject will be asked to do as a participant
- Description of potential risks or benefits to participant
- Description of sunjects rights if he or she chooses to participate
american nurses assoc deemed what rights to be the 5 human rights in research
- Right to self-det-free from coercion
- Right to privacy and dignity-can choose what they do, what is done to them nd contro when and how info about them is shared with others
- Right to anonymity and confidentiality
- Right to fair Tx-nondiscriminatory selection of participants, nonjudgemental Tx
- Right to protection from discomfort and harm-and potential benefits of study should be maximized
what is an institutional review boards purpose
o IRB are created for sole purpose of reviewing any proposed research study to be implemented by institution or employees of institton. Most hospitals have one while clinics will share an IRB with hosp or school
o IRB wil have diverse members some w special knowledge or interest in ethics (eg ministers) and one or two lay members
why were IRBs created
o IRBs est as response to unethical research eg Nazi medical experiements (Nuremberg War Crimes Trial after WWII), Tuskegee Syphilis study (withheld Tx in south from African amer men)
o 1974 the National Commision for Protection of Human Subjects of biomedical and Behavioural Research did what
what did thi pave the way for
- Identified the diff between research and activiesthatre routine care practices
- Establishing the importance of reviewing the risk benefit ratio
- Est guidelines for selection of human subjects for participation in research
- ID whats required in the informed consent process for various types f research
o The finding of this commission were released in the Belmont report (the most imp modern doc that identifies basic ethical principles and guidelines)
what obligations do researchers have in regards to risk to participatns in a study
o Researchers are obligated to identify any potential risksto participation in their study, describe how theyll try and prevent the risks, monitor for their occurrence and what theyll do if they occur
t or f it is illegal to implement research on humans or animals without IRB approval
True
t or f a subject is considered anonymous if no one but the researcher can link them to the research
FALSE
o Anonymity is considered so imp thats its a separate right (the person is considered anonymous if no one, including the researcher can link tem to the research)
is anonymity possible with a study that follows someone forward in time
o Study that follows indiv over time cant guarantee anonymity until study complete because researcher must know who participants are to stay in touch w them
is it ethical to target poor, unemployed people because they are easier to access to be in your study
NO
o Subject recruitment plan must give all members of pop o interest an opportunity to participate and may not taget vulnerable groups simply because its easier to get
is it acceptable to sample only those who are easy to recruit or those with lower risk profiles?
eg if youre doing a drug trial theres the possibility that the woman might get pregnant and harm could be caused so you dont want to use women in your study?
o Cant avoid inclusion of indiv who are harder to recuit or have more risk considerations eg women (esp in reproductive years)
o Because women were avoided in past research its imp toincude them
t or f
the right to withdrawal should be on the consent form.
the right to withdrawal is part of which right?
o The partic has right to withdrawal at any time without penalty, theconsent form should carify that they have this right
(part of right to self-det)
are patients more or less likely to feel comfortable declining to be in a study. what right is this a part of?
o Another part of self-det is right to decline partic without consequences. Esp relevant for pts inhealthcare who might feel coerced to participate
what should be specified on form to prevent patients feeling coercion
o Consent forms should include that whether or not they participate, Tx and care wont be influenced
what do patients get in case of some negative effect from the study
how wuld they contact the researcher
o Last part of informed consent is a statement of rights of partic to care whether some neg effect should occur from participating in research and the provision of the specific names and # of researcher and IRB rep. They now have access to IRB and researcher if theyve questions
o Partic gets copy of consent forms so they can contact people after research if nec
if a research participant has a cognitive disorders, is a kid, mental or physical illness then the researcher is obligated to seek consent from who
a legal representative
