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NURS 3550 - Research > Week 7 > Flashcards

Week 7 Flashcards

1
Q

what is ethics

A
  • involves systematizing, defending, and recommending concepts of right & wrong behavior
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2
Q

what are 3 forms of ethics

A
  • meta ethics
  • normative ethics
  • applied ethics
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3
Q

what is meta ethics

A
  • the attempt to understand the metaphysical, epistemological, semantic, and psychological presuppositions and commitments of moral thought, talk, and practice
  • asks what morality actually is
  • the attempt to answer questions about ethics (not so much concerned with what people or acts in particular are ethical) –> the where, when, why, how, and what r/t ethics & morality
  • studies the meaning of moral language and the metaphysics of moral facts
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4
Q

what is normative ethics? who is the decision usually made by

A
  • investigates the questions that arise regarding how one OUGHT to act, in a moral sense
  • the study of ethical behaviour
  • decision usually made by the majority (ex. in the past is was determined by old white males)
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5
Q

what is applied ethics (3)

A
  • refers to the practical application of moral considerations w respect to real-world considerations in the areas of private & public life
  • builds from meta-ethics
  • determines how ethical principles are realistically applied
  • application of ethics to real-world problems
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6
Q

research ethics closely relates to which form of ethics

A
  • applied ethics (it produces research guidelines)
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7
Q

define research ethics

A
  • involves the application of fundamental ethical principles to a variety of topics involving research
  • set of ethical guidelines that guides us on how scientific research should be conducted and disseminated
  • governs the standards of conduct for scientific researchers
  • must prevade and guide all aspects of the research process
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8
Q

why is it important to adhere to ethical principles w research

A
  • in order to protect the dignity, rights, and welfare of research participants
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9
Q

in research involving human subjects, what needs to be obtained prior to starting the study?

A
  • ethics approval
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10
Q

who approves a research study? what are they?

A

tri-council:

  • made up of three major funding bodies which back human trials
  • together they create the tri-council policy statements on ethics –> attempt to apply a standard set of ethical principles across all sorts of health research
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11
Q

which funding body is most relevant to nursing

A
  • Canadian Institute for Health Research
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12
Q

describe the tri-council policy statement (5)

A
  • the purpose of the TCPS is to establish principles to guide the design, ethical conduct and ethics review process of research involving humans
  • expresses the Agencies’ continuing commitment to the people of Canada to promote the ethical conduct of research involving humans
  • only research adhering to the standards of the Counsil will receive funding in Canada
  • used by research ethical boards across Canada
  • avoids any one disciplinary perspective, aims to provide a shared ethical framework for funding agencies and clinical institutions
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13
Q

why are research ethics important? (8)

A
  • protects study participants, including vulnerable groups
  • establishes risk-benefit ratio
  • ensures full respect of dignity, privacy, disclosure, and fair treatment of participants
  • builds capacity of
    participants to accept or reject study participation
  • promotes the aims of research (knowledge, truth, avoidance of error)
  • promotes values essential to collaborative work
  • supports researcher accountability
  • builds public trust in research findings

applied to both conducting & applying research

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14
Q

what are some examples of breaches of research ethics throughout history (2)

A
  • Nazi experiments on Jewish prisoners

- the Tuskegee Syphilis Study

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15
Q

what are some general breaches of research ethics (3)

A
  • confidentiality *
  • informed consent*
  • accurate reporting of study findings
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16
Q

what is the Belmont report and what are the 3 pillars of ethics?

A

Bellmont report is a federal document that provides the ethical principles and guidelines that must be followed in research involving human participants

  • respect for persons
  • beneficence
  • justice
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17
Q

what is included in the Respect for Persons pillar of the Belmont report (3)

A
  • right to self-determination & autonomy
  • voluntary participation
  • freedom from coercion
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18
Q

what is included in the Beneficence pillar of the Belmont Report (5)

A
  • freedom from exploitation and harm
  • risk/benefit ratio
  • do good
  • do no harm
  • links to the concept of fiduciary relationships (nurses have an obligation as part of this relationship to put the needs of our clients first)
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19
Q

what is included in the Justice pillar of the Belmont Report (5)

A
  • right to fair and non-prejudical treatment
  • right to privacy
  • anonymity
  • confidentiality
  • all individuals in the population of interest should have equal opportunity to participate in health research
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20
Q

Box 261 on pg 382 describes 15 guiding principles in making ethical decisions

A

…

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21
Q

what are some modern ethical dilemmas in the research area (4)

A
  • stem cell research
  • the human genome project
  • influence of big pharma
  • clinical research vs quality improvement/EBQI
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22
Q

what are some ethical dilemmas associated w stem cell research (3)

A
  • who should have access to stem cells
  • who consents to give stem cells
  • how is stem cell research contributing to inequities (rich people can afford to bank stem cells)
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23
Q

what are some ethical dilemmas associated w human genome projects

A
  • ethical challenge is editing out things like down syndrome, genetic diseases –> should this be allowed?
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24
Q

what are some ethical dilemmas associated w big pharma (2)

A
  • conducts expensive, large RCTs which produce the majority of our meds
  • research findings may be biased (researchers what to prove the drug works, may not look as closely at adverse effects
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25
Q

see textbook for clinical research vs quality improvement/EQBI (exam Q)

A
  • research = uses a scientific process to generate new knowledge and research utilization
  • quality improvement = systematic process used by healthcare systems to improve their processes and outcomes for a specific population once a problem is identified
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26
Q

describe some examples of ethical tension (4)

A
  • issues of consent, control, and justice
  • questions of fairness, privacy, confidentiality, impact on genetic counselling, and prediction of future disease
  • funding from a biased source, privacy, and confidentiality, equitable access to clinical trials
  • need for ethics review board (REB) approval
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27
Q

describe access equity as an ethical issue

A
  • many groups are regularly excluded from studies
    ex. minorities, LBGTQ, women, the disables, those w mental illness, individuals living in poverty, the homeless
  • majority of clinical research is conducted on middle aged white males
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28
Q

know difference between sex & gender in Yackerson article

A

…

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29
Q

describe intersectionality and how it relates to research

A
  • A variety of factors coming together to influence your life/opportunities
  • People with a variety of minorities are less likely to be included in a research study even if the research question involves them

ex. Historically, medical residents were only trained to respond to cardiac symptoms which are experienced by males (women present with neck pain, jaw pain, nausea, feeling of impending doom instead of the radiating arm pain men experience) = women were often misdiagnosed with panic attacks or anxiety disorders when presenting with a heart attack

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30
Q

what are 7 TCPS ethical principles

A
  • respect for human dignity
  • respect for free & informed consent
  • respect for vulnerable persons & groups
  • respect for privacy & confidentiality
  • respect for justice & inclusiveness
  • balancing harms & benefits
  • minimizing harms & maximizing benefits
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31
Q

describe the TCPS ethical principle of respect for human dignity

A
  • moral imperative to not treat humans as a means to an end, regardless of the benefits to research
32
Q

describe the TCPS ethical principle of respect for free & informed consent

A
  • participants have the right to make a decision regarding participation in research
33
Q

describe the TCPS ethical principle of respect for vulnerable persons and groups

A
  • respect for those w a diminished capacity for decision making
34
Q

describe the TCPS ethical principle of respect for privacy and confidentiality

A
  • protect the access, control, and dissemination of personal info
35
Q

describe the TCPS ethical principle of respect for justice & inclusiveness (2)

A
  • ethical review must be fair & independent

- no segment of the population should be unduly burdened by the harms of research or denied access to benefits

36
Q

describe the TCPS ethical principles of balancing harms and benefits (2)

A
  • harms of research should not outweigh the benefits

- embedded in research design & study conduction

37
Q

describe the TCPS ethical principle of minimizing harm & maximizing benefits (3)

A
  • non-maleficence
  • minimize harm throughout fewest number of participants and tests/instruments
  • includes both physical & psychological harm
38
Q

what is the purpose of research ethics boards (REBs)

A
  • to protect participants involved in human research and to ensure ethical standards are upheld prior to the conduction of funded research that have undergone scientific peer review or clinical non-funded studies
39
Q

what is the purpose of research ethics boards (REBs)

A
  • to protect participants involved in human research and to ensure ethical standards are upheld prior to the conduction of funded research that have undergone scientific peer review or clinical non-funded studies
  • review new & revised study protocols and monitor clinical trials
40
Q

what are some criticisms of ethics review systems (3)

A
  • committee members review and critque methodology of the study and not the impact this will have on human participants
  • the only methodological question these boards should be looking at is if the study is adequately powered (if the study will not have validity or reliability then you are wasting the money and time of the public and research participants)
  • there is no public representation on these boards –> no one to represent the actual population which this study will be conducted on (ex. if its a study about anxiety, you dont have a spokeperson w anxiety)
41
Q

if you want to research specific populations (ex. children, Indigenous population), you may have to??

A
  • go through additional ethical approval (in addition to REBs)
42
Q

informed consent addresses which ethical principles? (3)

A
  • respect for human dignity
  • respect for free & informed consent
  • respect for privacy & confidentiality
43
Q

informed consent is a …. what does this mean?

A
  • process that occurs throughout a study = can withdraw at any time, may only choose to take part in certain parts of the study
44
Q

informed consent must include the following: (4)

A
  • voluntary
  • informed (written in lay language, ensure you explain everything the study entails)
  • legal capacity & competence (statutory age of majority, mentally competent)
  • valid (can withdraw at any time)
45
Q

what should be considered w the voluntary aspect of consent? (4)

A
  • incentives
  • dependancy
  • control
  • unequal power relationships
46
Q

describe some concerns r/t incentives & informed consent? what are examples of incentives ?

A
  • includes money & prizes
  • people may consent to something they don’t want to do if there is financial compensation involved
  • offering money can be seen as coercion
47
Q

what is dependancy r/t informed consent? (2)

A
  • concern that refusal to participate will impact care

- belief that participation may lead to improved care

48
Q

describe some things to consider r/t dependancy & informed consent (2)

A
  • typically, being in a study will improve care –> either getting special access to an intervention
  • if a drug has actual benefits, all participants (including the control) will receive it at the end of a trial
49
Q

what populations are considered r/t control & informed consent (4)

A
  • incarcerated persons
  • members of the military
  • personal care home residents
  • students
    ex. consider being asked to participate in a study done by a prof you will have in a later year of study
50
Q

describe unequal power relationships r/t informed consent

A
  • fiduciary relationship between patients and care providers
51
Q

describe lay language r/t informed consent (2)

A
  • study descriptions should be at 6th grade lvl or lower

- consent forms are becoming longer & longer –> can result in fatigue and skimming

52
Q

what is the difference between consent & assent

A
  • consent = ability of participants to give informed consent in accord w their fundamental values, must have the capacity & competency to give legal consent
  • assent = agreement to participate in research given by those without the capacity to provide full & legal consent
53
Q

what is assent typically used in

A
  • research involving children
54
Q

assent requires that participants have: (3)

A
  • a basic understanding of what research participation will entail
  • comprehension of the basic purpose of research
  • the ability to express preference regarding participation
55
Q

what forms are used for assent? who signs them? which trumps which?

A
  • consent form fill out by a child’s parent or guardian
  • assent form signed by child
  • assent should trump consent –> if a child refuses to participate but the parent says to force them, you can’t
56
Q

describe consent forms for assent? (3)

A
  • describe if procedures are painful, invasive
  • mention if what a child says will be disclosed to their parent or guardian
  • outline what the time requirements may be
57
Q

describe the tri-council policy r/t consent & incompetent individuals (2)

A
  • include incompetent individuals if research question can only be answered w the identified group
  • stipulates that incompetent individuals should not be automatically excluded from research that may be beneficial
58
Q

describe anonymity r/t research participants (5)

A
  • participants’ responses should not be able to be linked to their identity
  • use ID #s and keep linked information separate from data
  • remove identifying info from transcripts
  • report aggregate data only in published reports
  • should only be 1 document which links the pt’s name and participant ID number, which is separate from the raw data
59
Q

describe confidentiality r/t research (4)

A
  • no unauthorized individuals should have access to data that includes identifying info
  • data stored in locked cabinets; password protected
  • email not used to share confidential info
  • change descriptions of individuals in published reports
60
Q

describe privacy r/t research (3)

A
  • participants have a right to control access to personal info
  • new privacy legislation has made contacting pts for study recruitment difficult (social, clinical, and epidemiological researchers)
  • what are the implications for researchers, clinicians, and completion of research in a timely manner ?
61
Q

researchers must justify focusing on specific populations (“vulnerable” populations). what are they? (6)

A
  • age (children or elderly)
  • legal/mental capacity
  • terminal illness
  • confined to population (only including those w specific demographics or lived experience)
  • specific cultural groups
  • individuals w stigmatized diseases
62
Q

describe research w indigenous individuals, groups, or communities (7)

A
  • indigenous people have historically been treated in an unethical fashion by researchers
  • researchers have lacked respect for Indigenous ways of knowing, cultural practices, and spiritual beliefs
  • research become part of the colonizing of Indigenous people
  • there are examples of studies which have applied inhummane methods
  • researchers tend to focus on their own priorities and not those of the communities
  • communities may have felt compelled to participate in researcher in order to continue to receive funding
  • data was at time not communicated back to communities
  • past projects have violated some or all of the basic principles of ethical research as laid out in the Belmont Report
63
Q

the treatment of Indigenous individuals & communities has result in? define this?

A

helicopter research:

  • Any investigation within the community in which a researcher collects data, leaves to disseminate it, and never again has contact with the community
  • To conduct study activities with only the researcher’s or an external entity’s benefits in mind
  • scientists collect data from marginalised communities without the involvement of local researchers and community members
64
Q

describe the principles of OCAP (3)

A
  • developed by Indigenous leaders in 1990 but preceded by decades of consultation
  • not a checklist, doctrine, or prescription for conducting research w Indigenous populations
  • its a guiding principle and set of values which each Indigenous community can define in their own way (although there is a good deal of consensus on the interpretation of OCAP)
65
Q

what are the four principles of OCAP

A

Ownership
Control
Access
Possession

66
Q

describe the ownership princple of OCAP

A
  • refers to the relationship of First Nations to their cultural knowledge, data, and info
  • a community or group owns info collectively in the same way that an individual owns his or her personal info
67
Q

describe the control principle of OCAP (2)

A
  • affirms that First Nations are within their rights in seeking to control over all aspects of research and info management processes that impact them
  • includes all stages of a research project, from initial planning to final dissemination
  • extends to the control of resources and review processes, the planning process, management of the information and so on
68
Q

describe the Access principle of OCAP (2)

A
  • First Nations must have access to info and data about themselves and their communities regardless of where it is held
  • refers to the right of First Nations communities and organizations to manage and make decisions regarding access to their collective info
69
Q

describe the Possession principle of OCAP

A
  • while ownership identifies the relationship between a people and their info in principle, possession or stewardship is more concrete –> refers to the physical control of data
  • possession is the mechanism by which ownership can be asserted and protected
70
Q

how does ethics relate to the practicing nurse (5)

A
  • nurses as a participant in research
  • nurses as caregivers to pts involved in researcher
  • nurses as consumers of health & nursing research
  • nurses as research assistant
  • nurses as researcher
71
Q

what do you do if a pt who has been enrolled in a study asks you a question about the study?

A
  • you cannot give info

- only refer them to the researcher in a timely fashion

72
Q

when does ethical research end?

A
  • does not end once the review board has given ethical approval –> must be maintained throughout the whole thing
73
Q

REB approval does not mean…

A
  • the study is ethical

- the researcher must be constantly aware of the potential for a breach in ethics

74
Q

what are examples of serious breaches in ethics (3)

A
  • falsifying data or results
  • coercing participants
  • continuing w interventions once they are known to be ineffective or harmful
75
Q

what are more subtle, insidious breaches in ethics

A
  • privacy & confidentiality breachers
  • participants who experience distress due to some aspect of the research process
  • inadequately powered studies

NURS 3550 - Research (12 decks)

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