ch 7 ethics

Question 1

do research actions require full pt consent and IRB authorization

Answer 1

ye, requires both

Question 2

_______ 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

Answer 2

the Belmont Commission of 1979

Question 3

which 3 documents help healthcare researchers make dcision about ethics in research
what ethical principles do they focus on

Answer 3

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.

Question 4

what is beneficence and how does it relate to research

Answer 4

o Beneficence –ability of healthcare memer to act in best interest of the research subjuest and always fx in advocacy role

Question 5

what is justice and how does it relate to research

Answer 5

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

Question 6

autonomy in r/t research

Answer 6

o Autonomy in r/t research =right to self-det and right of every person to informed consent

Question 7

If pt is asked to participate in research that holds great risk is it unethical?
what would make it un/ethical?

Answer 7

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

Question 8

is there a requirement that researchers only propose studies that involve no risk?

Answer 8

no, but they must disclose those risks

Question 9

what are the three components of the informed consent form

Answer 9

1. Description of the study, including specifically what the subject will be asked to do as a participant
2. Description of potential risks or benefits to participant
3. Description of sunjects rights if he or she chooses to participate

Question 10

american nurses assoc deemed what rights to be the 5 human rights in research

Answer 10

1. Right to self-det-free from coercion
2. 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
3. Right to anonymity and confidentiality
4. Right to fair Tx-nondiscriminatory selection of participants, nonjudgemental Tx
5. Right to protection from discomfort and harm-and potential benefits of study should be maximized

Question 11

what is an institutional review boards purpose

Answer 11

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

Question 12

why were IRBs created

Answer 12

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)

Question 13

o 1974 the National Commision for Protection of Human Subjects of biomedical and Behavioural Research did what

what did thi pave the way for

Answer 13

1. Identified the diff between research and activiesthatre routine care practices
2. Establishing the importance of reviewing the risk benefit ratio
3. Est guidelines for selection of human subjects for participation in research
4. 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)

Question 14

what obligations do researchers have in regards to risk to participatns in a study

Answer 14

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

Question 15

t or f it is illegal to implement research on humans or animals without IRB approval

Answer 15

True

Question 16

t or f a subject is considered anonymous if no one but the researcher can link them to the research

Answer 16

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)

Question 17

is anonymity possible with a study that follows someone forward in time

Answer 17

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

Question 18

is it ethical to target poor, unemployed people because they are easier to access to be in your study

Answer 18

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

Question 19

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?

Answer 19

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

Question 20

t or f
the right to withdrawal should be on the consent form.

the right to withdrawal is part of which right?

Answer 20

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)

Question 21

are patients more or less likely to feel comfortable declining to be in a study. what right is this a part of?

Answer 21

o Another part of self-det is right to decline partic without consequences. Esp relevant for pts inhealthcare who might feel coerced to participate

Question 22

what should be specified on form to prevent patients feeling coercion

Answer 22

o Consent forms should include that whether or not they participate, Tx and care wont be influenced

Question 23

what do patients get in case of some negative effect from the study

how wuld they contact the researcher

Answer 23

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

Question 24

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

Answer 24

a legal representative

Question 25

under these circumstances: if a research participant has a cognitive disorders, is a kid, mental or physical illness then the researcher is obligated to seek consent from legal representative

is it enough that they are just the legal representative

Answer 25

no they should also be the legal gaurdian
o The legal rep must understand the implications of consent and NOT have a personal stake in the interest of the subjects participation in the research

Question 26

when would you use assent instead of consent and what is it?

who do you have to gain assent from

Answer 26

o Assent mean to agree or concur and in research reflects a lower level of understanding about t emeaning f particip in a study than concent. Its often sought in studies involving older kids or indiv w some minor level of impairment
o if using assent should tell kid and the legal guardian. Legal guardian is the one making the official decision

Question 27

what are the 5 basic right of the informed consent form

Answer 27

• right to self determination
• right to privacy and dignity
• right to anonymity and confidentiality
• right to fair treatment
• right to protection from discomfort and harm

Question 28

what does it mean whe research is exempt

exmples of this

Answer 28

o when research is exempt the study falls under a category of research thats free from some of the constraints that are normally imposed upon research involving human subjects

o egs of this-research on educational curriculum efficacy, research involving human behaviour (without contact with the indivs observed), and research involving collection of publically avail data where the subjects cant be identified

Question 29

if research is exempt does it mean that an IRB borad isnt necessary

Answer 29

no. still should be sent to them for consideration

Question 30

what is the most common error r/t ethics of the sampling section

Answer 30

o the most common error found in a sampling report r/t ethics of a study is the failure to tell us enough to let us judge the occurrence of potetnital problems

Question 31

who is usually best equipped to recognize when the IRB protection is limited or if the study sample accurately reflects the real pt population

Answer 31

o Often its the practicing healthcare team member who most readily recog the limits to IRB protection and sampling processes bc those in practice understand their pts needs, functionality, characteristics
o Once a team meber understands the sampling langage and the IRB process theyre likely the best judges of whether the study sample accurately relflects real pt pop and is appropriate to a particular research question