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NURS 344 > Ethics TCPS2 > Flashcards

Ethics TCPS2 Flashcards

1
Q

A1 -1. Which one of the following statements reflects the TCPS 2 core principle of Respect for Persons?

a) Participation in research is a choice, based on information about the risks and potential benefits of the research.

b) Research should be designed so as to avoid exposing participants to unnecessary risks.

c) Research studies should be designed so that the burdens and the potential benefits of the research are distributed fairly.

A

A) Participation in research is a choice, based on information about the risks and potential benefits of the research.

From my notes:

Respect for Persons
* Informed consent
* Protecting those that lack capacity for informed consent

Concern for Welfare
* Do no harm

Justice
* Fair
o Must ensure we treat everyone with respect
o May need to treat some people differently to reduce inequalities
* Equitable
o Fair distribution of burdens and benefits
* Careful considering of inclusion/exclusion criteria
* Consider power imbalance between researcher and participants

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2
Q

A1-2. Which of the following researchers must follow the TCPS 2 (select all that apply)?

1) A graduate student at an eligible Canadian college conducting self-funded research on political protest groups by interviewing members of those groups.

2) A professor at an eligible Canadian university who is conducting research in Brazil on educational initiatives involving Indigenous Peoples.

3) An independent researcher hired by a private company to conduct research on consumer brand loyalties.

4) A researcher at an eligible academic institution conducts research within that institution that is funded by their department, not the Agencies;

5) A master’s student at an eligible institution conducts their research with street youth, not on the premises of the institution;

6) A graduate student at an eligible Canadian university who has a grant from NSERC to conduct research on the link between climate change and the bee population.

A

1) A graduate student at an eligible Canadian college conducting self-funded research on political protest groups by interviewing members of those groups.

2) A professor at an eligible Canadian university who is conducting research in Brazil on educational initiatives involving Indigenous Peoples.

4) A researcher at an eligible academic institution conducts research within that institution that is funded by their department, not the Agencies;

5) A master’s student at an eligible institution conducts their research with street youth, not on the premises of the institution;

WRONG ANSWERS:

3 is private
6 is not on people

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3
Q

A1-3. What happens if a researcher with a SSHRC grant breaches the TCPS 2 when conducting their research (select all that apply)?

1) The TCPS 2 is a voluntary set of guidelines, so there are no consequences for a breach.

2) The researcher’s institution may take action under the institution’s policies.

3) SSHRC may take recourse that can range from a letter of awareness to a denial of eligibility for funding, depending on the seriousness of the breach.

A

2) The researcher’s institution may take action under the institution’s policies.

3) SSHRC may take recourse that can range from a letter of awareness to a denial of eligibility for funding, depending on the seriousness of the breach.

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4
Q

A1-4. What is the fundamental value upon which the TCPS 2 is based?

a) Do no harm.
b) All persons are created equal.
c) Respect for human dignity
d) Autonomy

A

c) Respect for human dignity

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5
Q

A1-5. How should a researcher resolve a potential conflict between ethics considerations and legal obligations (select all that apply)?

1) Consult with colleagues, disciplinary associations, or lawyers, to determine how best to resolve the conflict

2) Fulfil the ethical obligations – they have more moral weight.

3) Follow the law – it always takes precedence over ethics

4) Anticipate potential conflicts and design research to avoid them, where possible.

A

1) Consult with colleagues, disciplinary associations, or lawyers, to determine how best to resolve the conflict

4) Anticipate potential conflicts and design research to avoid them, where possible.

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6
Q

A2-1. The TCPS 2 defines research as “an undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation”. Which of the following activities fall within this definition (select all that apply)?

1) Professor A meets with colleagues in their department to discuss a research question of interest to them, with a view to refining the question.

2) Professor A meets with representatives of a community to discuss conducting research within that community on the topic they discussed with their colleagues.

3) Professor A designs a pilot study to address that research question, and gets a small group of individuals to take part in the study.

4) Professor A revises the study based on their experience with the pilot study participants, and administers the full study to a group of 100 participants.

A

3) Professor A designs a pilot study to address that research question, and gets a small group of individuals to take part in the study.

4) Professor A revises the study based on their experience with the pilot study participants, and administers the full study to a group of 100 participants.

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7
Q

A2-2. Which of the following person is considered a research participant (select all that apply)?

1) A patient whose tissue was removed to determine whether they had a condition requiring treatment.

2) A patient with a particular condition whose tissue was removed to help scientists better understand that condition and how to treat it.

3) An employee of a college who must fill out a job satisfaction survey anonymously for the Human Resources department.

4) That same college employee responding to a survey from a labour relations professor aimed at measuring job satisfaction in unionized vs non-unionized academic staff.

A

2) A patient with a particular condition whose tissue was removed to help scientists better understand that condition and how to treat it.

4) That same college employee responding to a survey from a labour relations professor aimed at measuring job satisfaction in unionized vs non-unionized academic staff.

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8
Q

A2-3. Complete the following sentence: “Under TCPS 2, research that relies exclusively on information that is publicly accessible and for which there is no reasonable expectation of privacy _________.”

a) Requires REB review.

b) Is exempt from REB review.

c) May require REB review, depending on the circumstances.

A

b) Is exempt from REB review.

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9
Q

A2-4. Under TCPS 2, it is the role of the REB to review:

a) The ethics of mandated quality assurance activities.

b) The ethics of animal and human research.

c) The ethics of research involving humans.

A

c) The ethics of research involving humans.

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10
Q

A3-1. REBs may consider the following as potential benefits of research (select all that apply).

1) Direct benefits to the participants

2) Benefits to the researcher in terms of career advancement

3) Benefits to the group or community to which the participant belongs

4) Benefits to society in the form of increased knowledge

A

1) Direct benefits to the participants

3) Benefits to the group or community to which the participant belongs

4) Benefits to society in the form of increased knowledge

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11
Q

A3-2. Choose the correct description of research-attributable risks, according to TCPS 2:

a) All the risks a participant is exposed to during the period of the research

b) All the risks a participant is ordinarily exposed to, plus any risks specific to the research

c) All the risks associated with the research

A

c) All the risks associated with the research

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12
Q

A3-3. Which types of possible harms may be considered research risks (select all that apply)?

1) Economic harm

2) Social harm

3) Psychological harm

4) Physical harm

A

All of the above

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13
Q

A3-4. What is the purpose of distinguishing between minimal risk research and research that is more than minimal risk?

a) Minimal risk research does not require REB review.

b) The distinction helps the REB to determine the appropriate level of ethics review.

c) The distinction serves only to categorize the types of research proposal the REB receives.

A

b) The distinction helps the REB to determine the appropriate level of ethics review.

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14
Q

Why were ethical standards developed?

A

Violations of human rights

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15
Q

What are some studies that were discussed that violated human rights on which ethical standards were developed?

A

Nazi medical experiments

Tuskegee Syphilis Study (1932-1972) - they just watched black men with syphilis to see the end stage of disease, didn’t tell them they had it and didn’t treat them for it, even after we developed antibiotics

Cameron’s LSD and brainwashing studies (Montreal, 1957-1964) - using drugs and ECT in an attempt for mind control

Willowbrook State School (1963-1966) - mentally handicapped children kept in deplorable conditions where they would contract hepatitis A and experimented with inoculation

Henrietta Lacks - her cancer cells were used in all manner of studies and genome sequencing all without the consent of her family

Indigenous blood - Blood taken in Vancouver, BV, and used for genetic studies, and continues to be used, even though there was no consent given for it

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16
Q

Describe the Tuskegee Syphilis Study (1932-1972)

A

 Untreated syphilis in African American males
 Were enrolled without being told they had the disease or that they were enrolled and were not treated even though we had antibiotics
 Established the USA office for human research protections
 Lead to federal regulations requiring review boards

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17
Q

Describe Cameron’s LSD and brainwashing studies (Montreal, 1957-1964)

A

 Project MKUltra, was a CIA mind control project
 Were working to develop drug induced mind control
 LSDs, barbiturates, and ECT were used

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18
Q

Describe the Willowbrook State School (1963-1966)

A

 Hepatitis studies
 Mentally handicapped children kept in deplorable conditions
 Most children developed hepatitis A within a short period of time
 Healthy children were intentionally inoculated with hep A and then monitored to gauge the affects of gamma globulin in combating the virus

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19
Q

Who was Henrietta Lacks and what was done that was unethical in her case?

A

 Developed cancer in the 60s and cancer cells were retained without her consent and are the source of the Hela cell line
 The Hela cell line contributed to development of drugs for polio, Parkinsons, leukemia and others and are still in use
 They published the entire genome sequence without asking for the family’s consent violating her privacy
 Anyone that uses Hela cells, it has be approved by a board that includes at least 2 family members

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20
Q

What happened in Canada to the indigenous population that impacted ethics?

A

 Blood taken from Vancouver Island indigenous people were used for unauthorized genetic studies in the US and England, only returned to BC after controversy was voiced
 Experts continued to use the blood without consent
 Studies were funded by health Canada
 Similar has happened in Australia

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21
Q

What are some major events that advanced the development of ethical standards? (policy changes, not the studies that incited them)

A

Nuremburg Code 1949 - Trial of the Nazi’s experiments and formally outlined protecting human rights of participants

WMA Declaration of Helsinki 1964 - physicians must protect participants from harm and must publish regardless of results

Belmont Report 1978 - US policy, emphasized informed consent and identified the ethical principles of research

Hong Kong Manifesto for Assessing Researchers 2020 - rewarding researchers for behaviours that strengthen research integrity

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22
Q

Describe how the Nuremburg Code advanced the development of ethical standards

A

o Developed in 1949 after the Nuremberg trials of Nazis
o First document to formally outline strategies for protecting the rights of human research participants

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23
Q

Describe how the WMA Declaration of Helsinki advanced the development of ethical standards

A

o Adopted in 1964, then revised in 2008 and 2013
o Focuses on physicians
o Maintains that particular care is required to protect subjects who participate in non-therapeutic research from harm
o Addresses use of placebo and can be used when there is no appropriate treatment
o Researchers must make the outcomes of research publicly available
o First time they have ethical results to publish, positive results or not

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24
Q

Describe how the Belmont Report advanced the development of ethical standards

A

Created in the US by the national commission for the protection of human subjects of biomedical and behavioural research

Emphasized informed consent

Identified the guiding ethical principles for research
 Beneficence
 Respect for human dignity (respect for persons)
 Fair treatment (aka justice)

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25
Q

Describe how the Hong Kong Manifesto for Assessing Researchers advanced the development of ethical standards

A

Result of 6th world conference on research integrity

Focuses on ensuring researchers are rewarded for behaviours that strengthen research integrity

5 principles - VALOR
V - Valuing different types of research
A - All contributions to research and scholarly activities need to be recognized
L - legitimately transparent reporting
O - open science
R - responsible research practices

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26
Q

What are the main principles of bioethics?

A

MEMORY: Justice Always Needs Balance

J - Justice

A - Autonomy

N - Non-maleficence (do not harm)

B - Beneficence (doing good)

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27
Q

What is the bioethics principle of autonomy?

A

o Individual has right to make decisions based on full disclosure by the researcher

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28
Q

What is the bioethics principle of non-malficence?

A

o Do no harm

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29
Q

What is the bioethics principle of beneficence?

A

o Performing a deed that benefits someone
o Obligation to take action that maintains or enhances the dignity of others when those actions do not place an undue burden on the healthcare provider
o Duty on researchers to prevent or minimize harm with humans

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30
Q

What is the bioethics principle of justice?

A

o Fair distributions of benefits
o Greatest good for the greatest number

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31
Q

What are the 5 rights according to the Canadian Nurses Association?

A

MEMORY: we have rights from previous SPATS

S - self determination
P - privacy and dignity
A - anonymity and confidentiality
T - treatment that is fair
S - safety (protection from harm)

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32
Q

What regulations/policies regarding ethics impacts nurses?

A

CNA - Code of Ethics and it’s 5 rights

Health Canada - Good Clinical Practice Guidelines (1997)

Tri-Council Policy Statement (1998)

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33
Q

Who developed the tri-council policy statement TCPS)?

A

Canadian Institutes of Health Research (CIHR)

National Sciences and Engineering Research Council of Canada (NSERC)

Social Sciences and Humanities Research Council of Canada (SSHRC)

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34
Q

What are the 3 guiding principles established in the Tri-Council Policy Statement?

A

Respect for persons
Concern for welfare
Justice

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35
Q

An essential component of the TCSP is that research ethics board (REB) should first review and approve each study that involves _______.

A

Human subjects

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36
Q

In Canada, compliance with the TCPS is a condition of ______ and a requirement for all research conducted under the auspices of a(n) ___________

A

agency funding

eligible institution

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37
Q

Where TCPS applies, it does so regardless of _______, _________, and _________.

A

o Who carries out the research
o What the source of funding is, if any
o Where the research is conducted

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38
Q

What should a researcher anticipate and attempt to resolve prior to beginning a study?

A

Conflicts that arise between ethical considerations and legal obligations

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39
Q

What may be the result if a researcher fails to follow the TCPS?

A

recourse taken by the researcher’s institution, and by the Agencies

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40
Q

What TCPS ethical principle recognizes the intrinsic value of human beings and the respect and consideration that they are due?

A

Respect for persons

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41
Q

How is respect for persons demonstrated?

A

o Informed consent
o Respect for privacy

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42
Q

Describe autonomy, an important aspect of respect for persons

A

o Ability to deliberate about a decision and act on that deliberation
o Recognize a persons judgment and ensuring they are free to make those choices without influence

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43
Q

With regard to respect for persons, who must the researcher endeavor to protect?

A

Must protect those with developing, impaired, or diminished autonomy

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44
Q

Consent must be _____, ______, and _______.

A

Voluntary (cannot use coercion or incentives)

Informed

Ongoing

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45
Q

What must researchers do to embody the respect for persons TCPS ethical principle?

A

o Treat individuals as autonomous agents
o Do not use a person as a means to an end
o Allow people to choose for themselves
o Give extra protection to those with limited autonomy

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46
Q

What TCPS ethical principle focuses on the obligation to treat people fairly and equitably?

A

Justice

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47
Q

What are the 2 main principles of justice?

A

Fairness
o Must ensure we treat everyone with respect and concern
o May need to treat some people differently to reduce inequalities

Equitable
o Fair distribution of burdens and benefits
o No segment of the population should be unduly burdened by the harms or research
o Nobody should be denied benefits of the knowledge generated by the study

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48
Q

What part of ethics requires that we treat everyone with respect but understand we may have to treat some differently to reduce inequalities?

A

Fairness, an important aspect of justice, which is one of the 3 main principles of the TCPS

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49
Q

What part of ethics requires the fair distribution of both the burdens and the benefits of a study and that everyone should be able to benefit from the knowledge generated by a study?

A

Equitable, an important aspect of justice, which is one of the 3 main principles of the TCPS

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50
Q

Which ethical principle is threatened by the possible imbalance of power between the researcher and participants?

A

justice, which is one of the 3 main principles of the TCPS

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51
Q

How do we demonstrate justice as we perform a study?

A

o Correct selection of study participants
o Representing a cross section of the entire population
o No favouritism of the sharing of benefits or risks. All must be distributed equally
o All data must be reported in the study’s findings. Data should not be held back or discarded

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52
Q

The concern for welfare, one of the ethical principles of TCPS, is based on the obligations derived from _____ and _____.

A

Beneficence - promote good

Non-maleficence - do no harm

These are bioethical principles

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53
Q

How do we demonstrate concern for welfare during a study?

A

o Sound research design
o Competent investigations
o Favorable risk-benefit ratio
o Researcher must be available to all participants to answer questions and to intervene in case harm occurs

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54
Q

The concern for welfare, one of the ethical principles of TCPS, is concerned about which risks?

A

Those that are attributable to the research

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55
Q

The concern for welfare, one of the ethical principles of TCPS, ________ should outweigh the ________ associated with the study.

A

Potential benefits

foreseeable risks

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56
Q

The concern for welfare, one of the ethical principles of TCPS, revolves around the benefits of the study. Who may these benefit?

A

The participants, communities, or society

They do not include any benefits for the researcher

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57
Q

The concern for welfare, one of the ethical principles of TCPS, involves the risk of harm. What harms may be experienced from a study?

A

social, behavioural, psychological, physical, or economic

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58
Q

Describe minimal risk research

A

A part of concern for welfare, an ethical principle of TCPS.

Research in which the probability and magnitude of possible harms implied by participation in the research are no greater than those encountered by participants in those aspects of their everyday life that relate to the research

i.e. asking participants to run 5k, minimal risk for someone who regularly runs 10k but more than minimal risk for someone who doesn’t exercise

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59
Q

The concern for welfare, one of the ethical principles of TCPS, involves the risk of harm. As researchers we should protect the participants from _________. Our design should ______, ______, or _______ risks

A

unnecessary risks

avoid, eliminate, or minimize

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60
Q

What are the contributing factors to concern for welfare, an ethical principle of the TCPS?

A

o Privacy and control of information about the person
o Treatment of human biological materials

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61
Q

The concern for welfare, one of the ethical principles of TCPS, requires that researchers and REBs aim to __________. We have to provide participants with ________.

A

protect the welfare of participants

enough information about the risks and benefits of participation

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62
Q

What research requires a REB review?

A

Any research involving human participants needs and ethics review and REB approval before recruitment

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63
Q

How does the TCPS define research?

A

An undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation

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64
Q

John is performing some exploratory work prior to actually recruiting for his study. He is spending his time asking members in his community some questions and some of his collegues to refine what he really wants to study. Does he need a REB review for this?

A

No.

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65
Q

John is performing a small pilot study of 5 people just to work out some of the kinks in his study design. Does he need a REB review for this?

A

Yes.

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66
Q

The TCPS requires a REB approval prior to recruitment for any research involving human participants. How does it define human participants?

A

o Individuals whose data, biological materials, or responses to interventions, stimuli or questions by the researcher, are relevant to answering the research question(s)
o Alive or deceased
o Human tissues such as embryos, stem cells, gametes etc.

67
Q

What are exemptions to requiring a REB approval prior to a study and what are some examples of this?

A

Research with human participants that are considered ethically justified because the participants are adequately protected through other means

Includes
o Information that is legally or publicly accessible, with no expectation of privacy
o Observation of people in public areas (no interventions)
o Secondary use of anonymous information or human biological materials - so material was already collected for another purpose, anonymity is important, this is difficult in today’s electronic world)

68
Q

What activities involving human participants does NOT require a REB review?

A

QA/QI/program evaluation/performance reviews

Creative practice activities
o Like an interactive art display

Can be mandated by company/government etc.

Is not for the purpose of expanding knowledge (because it is no longer considered research to the TCPS)

69
Q

What is an activity that is not research but is going to be used for research purposes called?

An example might be an interactive art display that monitors the patron’s response/interactions

Does this need a REB review?

A

Dual purpose

Yes

70
Q

What is a dual purpose activity according to TCPS? Does it need a REB review?

A
  • Activity that is not research but used for research purposes
  • I.e. an interactive art display that monitors the patrons responses/interactions
  • Requires a REB review
71
Q

What is a purpose of a Research Ethics Board?

A

o Protect and respect the best interests of research participants
o Protect participants from any undue harm
o Ensure appropriate standards are followed in accordance with TCPS

72
Q

Ethics review and approval by an REB before research begins is required for what types of research?

A

Research involving living human participants

Research involving human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive materials, and stem cells. This applied to materials derived from living and deceased individuals

73
Q

Publicly available information is legally accessible and appropriately protected with no expectation of privacy issues.

If the research relies solely on publicly available information, does it require a REB review?

A

No

74
Q

REB guidelines tend to be ________ research focused, so there are some issues with _______ research studies.

A

Quantitative

Qualitative

75
Q

What are the approval criteria for a REB review?

A
  • Risks minimized
  • Benefits balanced risks
  • Subject selection equitable
  • Procedures for obtaining informed consent
  • Procedures for consent documentation
  • Data monitoring provisions
  • Privacy and confidentiality
  • Safeguards for vulnerable subjects
76
Q

Describe informed consent

A

An ongoing process of communication and mutual understanding

Shared responsibility for protection

It is not
o A piece of paper
o Moment in time
o Legal contract

77
Q

Is a signed piece of paper considered informed consent?

A

No, because it has to be an ongoing process. It might be included, but it is not the end of informed consent.

78
Q

What are the elements of informed consent?

A
  • Purpose of research
  • Expected duration for subject
  • Description of procedures
  • Reasonably foreseeable risks of discomforts
  • Reasonably foreseeable benefits for subjects or others
  • Confidentiality - who has access to the data, will it be used in the future
  • Compensation
  • Who can answer questions
  • Voluntary participation
  • Transparency
  • Comprehension - they have to actually understand it
79
Q

Who are considered vulnerable subjects in a research study according to TCSP?

A
  • Children
  • Prisoners
  • Mentally disabled persons
  • Economically disadvantaged
  • Educationally disadvantaged
80
Q

What is subtle vulnerability according to the TCSP?

A
  • Language
  • Culture
  • Pregnancy
  • Students
  • Employees
81
Q

What are some special considerations for using vulnerable subjects as participants in a study? i.e. children

A

Individuals with vulnerabilities should be involved in decision making whenever possible

May include asking about their feelings regarding participation

May include asking for consent

Ascent
o Too young to give informed consent but old enough to understand the research in general and what is expected of them and risks/benefits
o Children 7+ can sign assent forms and the parent signs the consent form (may be the same form)

82
Q

What is ascent? When may it be given? Is this the same as consent? Who would sign the consent forms in these cases?

A

Too young to give informed consent but old enough to understand the research in general and what is expected of them and risks/benefits

Not the same as consent

Children 7+ can sign assent forms and the parent signs the consent form (may be the same form)

83
Q

What is scientific integrity?

A

“The researcher’s commitment to the advancement of knowledge also implies duties of honest and thoughtful inquiry, rigorous analysis, and accountability for the use of professional standards.” – Tri-Council Policy Statement

84
Q

What are the 3 types of research misconduct?

A

Fabrication - lying, making up results

Falsification - manipulation of an aspect of the study so that it is not accurately represented

Plagiarism - using another’s work without giving them credit

85
Q

John makes an honest, unintentional error during his research project that he does not notice until others see it in his paper. Is this considered research misconduct?

A

No.

86
Q

Describe fabrication

A

A type of research misconduct

Lying, making up results

87
Q

Describe falsification

A

A type of research misconduct

Manipulation of research materials, equipment, or process, or changing, omitting, or distorting results that the research is not accurately represented

i.e. Andrew Wakefield – 1998 Study of link between MMR and autism

88
Q

Describe plagiarism

A

A type of research misconduct

Taking others ideas, process, results, or words without giving proper credit and can happen at any step of the research such as
* Proposing
* Performing the study
* Reviewing research
* Reporting research results

89
Q

Why does research misconduct occur?

A

Desire to “get ahead”

Publish or perish
 Might lose job if you’re not publishing research articles

Cultural issues
 May be appropriate to take other ideas as you are expressing admiration for someone else

Personal/character issues

90
Q

What type of research misconduct involves lying?

A

Fabrication

91
Q

What type of research misconduct involvfes the manipulation of some part of the research process that results in research that is not accurately represented?

A

Falsification

92
Q

What type of research misconduct did Andrew Wakefield perform when he developed a study that “proved” the link between the MMR vaccine and autism

A

Falsification

93
Q

What type of research misconduct involves taking someone else’s work without crediting the original person?

A

Plagiarism

94
Q

What can the desire to “get ahead” as a researcher result in?

A

Research misconduct

95
Q

What is part of the nurses role to upholding ethical standards when working as part of a study with human participants?

A

The nurse can advocate for the patient in a research study
o Informed consent
o Monitor participants responses during the study
o Reporting adverse effects
o Protecting confidential information
o Preventing misuse of research findings

Nurses working on research teams have a direct responsibility to protect study participants from harm
o Nurses who collect data can protect participants from harm by recognizing untoward side effects and respond appropriately
o Nurses functioning as research team members can offer debriefing or referrals as needed for participants
o We have to be aware of the parameters of the study and be able to explain the study to participants

96
Q

A4-1. What are the general principles of consent?

a) Informed, ongoing, documented.
b) Voluntary, informed, ongoing.
c) Voluntary, informed, free.
d) Voluntary, informed, documented.

A

B

97
Q

A4-2. In general, when should researchers seek consent from individuals to participate in research?
a) At any time during the course of the research.
b) After the participant has completed the research activity.
c) Prior to commencing participation in the research.
d) Whenever the researcher chooses.

A

C

98
Q

A4-3. Which of the following best describes how consent should be documented?
a) Only through a signed consent form
b) Only through a video recording of consent
c) Only through a researcher’s notes of a verbal consent.
d) Through any form that can serve as evidence of consent and that complies with applicable legal requirements.

A

D

99
Q

A4-4. Under which of the following circumstances may a researcher depart from the general principles of consent (select all that apply)?
1) When obtaining consent would delay the conduct of the research.
2) When a prospective participant lacks decision-making capacity.
3) Under no circumstances.
4) In medical emergencies
5) For certain types of public health research.

A

2, 4, 5

100
Q

A4-5. Which of the following statements is/are true (select all that apply)?
1) Secondary use research involves using data that was originally collected for another purpose.
2) Research involving secondary use of identifiable information requires REB review, but not consent.
3) REBs may waive the consent requirement for research involving secondary use of identifiable information, at their discretion.
4) REBs may waive the consent requirement for research involving secondary use of identifiable information if the researcher satisfies six conditions.
5) Where research involves the secondary use of non-identifiable information, neither consent nor REB review is required.

A

1, 4

101
Q

A4-6. Which of the following statements is/are true (select all that apply)?
1) Blanket consent and broad consent can be used interchangeably.
2) Broad consent requires the researcher to directly contact participants when future research is being conducted.
3) Broad consent is sought prior to data collection.
4) Only the researcher is responsible for ensuring that the terms of participant consent are respected when data is stored in a repository.
5) Broad consent implies the storage and use of data and/or human biological materials for future unspecified research, subject to specific restrictions.

A

3, 5

102
Q

A5-1. Complete the following sentence in accordance with the guidance in TCPS 2: “Excluding women from research is ___________.”
a) Never ethically acceptable.
b) Ethically acceptable because this protects women from the risks of research.
c) Ethically unacceptable, unless the exclusion is related to the nature and scope of the research question.
d) Ethically necessary when a woman is pregnant or breastfeeding.

A

C

103
Q

A5-2. Which of the following statements reflect TCPS 2 guidance (select all that apply)?
1) Publication in an academic journal is the only acceptable form of research dissemination.
2) It is important to communicate research results to participants, in a format suitable to them.
3) Researchers have a responsibility to disseminate the results of their research, even if those results do not confirm (or run counter to) their original hypothesis.
4) It is ethically acceptable for sponsors to prohibit the dissemination of results at their discretion, since they paid for the research.

A

2, 3

104
Q

A5-3. Under TCPS 2, can individuals who are in vulnerable circumstances participate in research?
a) Yes, so long as their participation is necessary to the research and additional protective measures are in place.
b) No, it is wrong to include vulnerable individuals in research.
c) Yes, all that matters is that they have the capacity to consent.
d) No, those in vulnerable circumstances cannot participate in research even if the research focus is on people in their circumstances.

A

A

105
Q

A5-4. The principle of Justice requires an equitable distribution of the benefits and burdens of research because (select all that apply):
1) This helps to maintain public trust in research.
2) This contributes to the legitimacy of research results by ensuring that research findings are drawn from the full range of those to whom the research applies.
3) This avoids disadvantaged or marginalized groups from bearing a disproportionate share of research risks.

A

1, 2, 3

106
Q

Consent must be _______, ________, and _________

A

Voluntary, informed, and ongoing

107
Q

When must a researcher obtain consent for primary research?

A

consent must proceed collection of data or biological materials

108
Q

When must a researcher obtain consent for secondary research?

A

consent must proceed access to existing data or biological materials

109
Q

What can undermine consent being voluntary?

A

o Coercion or undue influence
o Incentives (large enough they can lead to reckless disregard for risks)

110
Q

Can participants withdraw from a study? What is the researchers responsibility with this?

A

o Participants can do so at anytime and without providing a reason
o Researchers may ask questions about the reasons but they cannot pressure them to justify their decision to withdraw

111
Q

What should happen if, during the research project, there is a change that impacts the risks or benefits to the participants?

A

The changes need to be disclosed to the participant and if there is any change to the ethical acceptability, the REB must be notified too

112
Q

Who must be notified if there is any change in the research that has an impact on it’s ethical acceptability?

A

REB

113
Q

Should vulnerable subjects be excluded from research projects?

A

No, they should not be unfairly excluded from research but also should not be included where participation is inappropriate

114
Q

When is partial consent or deception used in research rather than informed consent?

A
  • Used when research question cannot be answered without an alteration to general requirements for consent
115
Q

In what types of research would partial consent or deception be used?

A
  • knowing that they are involved in research may alter their behaviour
  • Also includes some public health and emergency medicine research
116
Q

What is an incidental finding?

A

o Discovery about research participants or prospective participants that is made in the course of research, but is outside the objectives of the research study

117
Q

What are material incidental findings?

A

o Reasonably determined to have significant welfare implications for the participant or prospective participant

118
Q

When doing genetics research, it is reasonably expected to have a material incidental finding. What should the participant be informed of prior to commencing the study? What if they do not want to know?

A

o Likelihood of discovering material incidental findings
o How these findings are disclosed to them

Autonomy and the right not to know
o Communication will only be done if participants have consented to receiving them

119
Q

What criteria must exist for the REB to waive the requirement for consent of secondary use information?

A

MEMORY: drop dead if you don’t want to follow the rules - SUPINE

S - Safeguard information
U - Unlikely to adversely affect welfare of participants
P - Preferences previously expressed are followed
I - Impossible to seek consent
N - Necessary permissions for everything else has already been obtained
E - Essential - identifiable information is essential to research

120
Q

If the research is based exclusively on secondary use of non-identifiable information, is consent required? Is a REB review?

A

consent - no

REB review - yes

121
Q

What is broad consent?

A

o Consent for future unspecified research with stored data/materials without direct contact or intervention with participants at that time
o Includes specific reservations (i.e. specific field of study, etc.)
o Encouraged to sperate this from regular consent when recruiting participants

122
Q

Where is data or biological materials stored?

A

Repositories

123
Q

In terms of a repository, what must the Researcher, repository, and future researchers ensure?

A

 Terms of participant consent are respected
 Participant privacy and confidentiality protected

124
Q

What is appropriate includsion?

A

o Participant population fully reflects target population under study

125
Q

What is the cost of not having appropriate inclusion?

A

o Responses not reflecting full range of views undermines validity

126
Q

What is inappropriate exclusion?

A

Exclusion not justified by research question or risks to prospective participants

127
Q

What is the cost of inappropriate exclusion?

A

o Violates principle of justice by denying excluded groups from potential benefits of participation

128
Q

Who are most likely to be excluded inappropriately from a research study?

A

Pregnancy, women, children, elderly, and those lacking capacity

129
Q

What might vulnerable people need in order to participate?

A
  • Vulnerable participants may need additional measures to ensure their participation is justified and that they are adequately protected
  • May need substitute decision-makers for those that lack capacity for example
130
Q

A6-1. Which of the following statements is correct (select all that apply)?
1) Researchers have an ethical duty to maintain the confidentiality of information they collect during the course of research.
2) A researcher’s duty of confidentiality extends to human biological materials collected during the course of research.
3) Researchers may have legal obligations to maintain the privacy of research participants.

A

1, 2, 3

131
Q

A6-2. Secondary use research is:
a) Research that generates at least two publications.
b) Original research that is copied by a second researcher.
c) Research that relies on information originally collected for a purpose other than the current research purpose.

A

C

132
Q

A6-3. Who has responsibility for safeguarding the privacy of research participants (select the most appropriate answer):
a) Researchers alone.
b) Researchers and REBs.
c) Researchers, REBs, and institutions.
d) Researchers, REBs, institutions, and funders.

A

C

133
Q

A6-4. The level of privacy protection required is based on the identifiability of the information. Which of the following is not a category of identifiability set out in the TCPS 2?
a) Indirectly identifying information.
b) Anonymized information.
c) Coded information.
d) Secret information.
e) Anonymous information.

A

D

134
Q

What is privacy?

A

o Individuals right to be free from intrusion or interference by others
o May include their body, personal information, expressed thoughts/opinions, personal communication, spaces they occupy
o How this information is collected, used, and disclosed is covered in consent process

135
Q

What is confidentiality?

What is this essential to?

A

o Obligation of an individual/organization to safeguard entrusted information
o Essential to research integrity and trust between researchers and participants

136
Q

What is identifiable information?

A

o Information that is reasonably expected to identify an individual, alone, or in combination with other information available

137
Q

What are the categories of identifiable information?

A

Directly identifying
Indirectly identifying
Coded
Anonymized
Anonymous

138
Q

What is directly identifying information?

A

o Identifies a specific individual through direct identifiers i.e. name, ULI etc.

139
Q

What is indirectly identifying information?

A

o Reasonably be expected to identify an individual through a combination of indirect identifiers i.e. DOB, unique personal characteristics etc.

140
Q

What is coded information?

A

o Direct identifiers removed from information and replaced with a code
o Accessing the code may make it possible to re-identify specific participants

141
Q

What is anonymized information?

A

o Information irrevocably stripped of direct identifiers
o No code is kept linking to the original information and risk of re-identifying individuals is low or very low

142
Q

What is anonymous information?

A

o Information never had identifiers associated with it and risk of identification is low or very low
o Includes anonymous surveys

143
Q

What is a conflict of interest?

A
  • An incompatibility of two or more duties, responsibilities or interests of an individual or institution as they relate to the ethical conduct of research, such that one cannot be fulfilled without compromising another
144
Q

What are the 3 types of conflicts of interest?

A

Real
Potential
Perceived

145
Q

What is a conflict of interest in which the two duties, responsibilities, or interests are indisputably contradictory?

A

Real

146
Q

What is a conflict of interest that does not presently exist but can reasonably be foreseen to occur?

A

Potential

147
Q

What is a conflict of interest that is not an undisputable real conflict but appears to be one in the eyes of external observers?

A

Perceived

148
Q

All real, potential, and perceived conflicts must be reported to _______.

A

The REB

149
Q

A7-1. In research, conflict of interest is an issue that can affect (select the most appropriate answer):
a) Researchers
b) Researchers and REB members.
c) Researchers, REB members, and institutions.
d) Researchers and institutions.
e) REB members and institutions.

A

C

150
Q

A7-2. Which of the following statements is/are true (select all that apply)?
1) Conflicts of interest may be real, potential, or perceived.
2) Only real conflicts of interest need to be managed.
3) A research study cannot proceed if a researcher has disclosed a conflict of interest.
4) A conflict of interest in research is an incompatibility between all of one’s duties, responsibilities, or interests, as they relate to the ethical conduct of research.
5) Researchers may choose whether or not to disclose conflicts of interest.

A

1, 4

151
Q

A7-3. Which of the following would be a conflict of interest for REB members (select all that apply)?
1) REB members supervise the researcher submitting the protocol for REB review.
2) REB members sit on the board of the company that is sponsoring the research.
3) REB members are collaborating with the research applicant on another research project.
4) The research applicant is their sister-in-law.
5) The research applicant is their supervisor.
6) REB members own shares in the company that is sponsoring the research.

A

All of these

152
Q

A7-4. Which of the following is/are an acceptable way for a researcher to manage a conflict of interest (select all that apply)?
1) Disclose the conflict to a colleague at another institution.
2) Develop a plan to minimize the effect of the conflict.
3) Decide to remain impartial.
4) Disclose to the REB and to participants.
5) Keep silent, but be prepared to step off the research team if the conflict is discovered.

A

2, 4

153
Q

A7-5. Addressing conflicts of interest in research involving humans is important because (select all that apply):
1) It helps to protect the integrity of research.
2) It is part of the process of ensuring that prospective research participants make informed decisions regarding their consent to participate.
3) It makes researchers feel virtuous.
4) All conflicts of interest can and must be eliminated.

A

1, 2

154
Q

A8-1. Which of the following activities is not a primary responsibility of an REB?
a) To review the ethical acceptability of the methods of a research proposal.
b) To review the ethical acceptability of the design of a research proposal.
c) To review substantive changes made to the research during the course of a study.
d) To provide advice about alternative methods to answer the research question.
e) To communicate their decisions in a timely and efficient manner.

A

D

155
Q

A8-2. Which one of the following statements best describes the status of an REB?
a) A committee accountable in all respects to the institution that created it.
b) A committee accountable to the institution that created it with respect to its operations, but independent with respect to its decisions on research proposals.
c) A committee independent in all respects from the institution that created it.

A

B

156
Q

A8-3. What is the primary role of the community member on an REB?
a) To bring diversity to the REB.
b) To provide an independent perspective on the proposed research.
c) To represent the research participant perspective.
d) To ensure that not all REB members are academics.

A

C

157
Q

A8-4. Which of the following statements describe(s) a proportionate approach to assessing the ethical acceptability of research (select all that apply)?
1) Applying delegated review to minimal risk research and full board review to more than minimal risk research.
2) Considering the foreseeable risks, the potential benefits and the ethics implications of the research.
3) Having only the vice-president of research review minimal risk research.
4) Conducting an initial assessment of the level of risk to determine what level of scrutiny the review requires.

A

1, 2, 4

158
Q

A8-5. Which of the following statements is/are correct (select all that apply)?
1) Due to the extraordinary circumstances, research cannot take place during a publicly declared emergency.
2) Institutions and REBs should develop preparedness plans for how to review research during public declared emergencies.
3) No exceptions to TCPS 2 procedures can occur during a publicly declared emergency, regardless of the justification provided.
4) Any exceptional procedures put in place during a publicly declared emergency remain in force only as long as the emergency continues.

A

2, 4

159
Q

A8-6. Which of the following statements is/are true (select all that apply)?
1) Multi-jurisdictional minimal risk research requires official agreements between institutions.
2) The single REB review model is an optional, but a preferred approach for multi-jurisdictional minimal risk research.
3) Any REB can act as the single reviewing REB.
4) It is possible for institutions to adopt their own approaches for streamlining the ethics review of multi-jurisdictional minimal risk research.
5) The more REBs that review a research project, the greater the participant protections.

A

2, 4

160
Q

A9-1. How is the concept of community defined in Chapter 9 of the TCPS 2 (select all that apply)?
1) A community is defined by territory.
2) TCPS 2 adopts the definition of community in the Constitution of Canada.
3) A community may be territorial, organizational, or interest-based.
4) A community describes a group of people with a shared identity or interest that has the capacity to act or express itself as a collective.
5) It is up to the parties to a research project to define the term “community”.

A

3, 4

161
Q

A9-2. Which of the following statement(s) describe community engagement (select all that apply)?
1) Community engagement is required where the research is likely to affect the welfare of an Indigenous community to which the prospective participants belong.
2) Community engagement is a process that establishes a respectful relationship between a researcher or research team, and an Indigenous community relevant to the research project.
3) Community engagement is not required if the research does not take place on First Nations, Inuit or Métis lands.
4) It is up to the researcher to determine the nature and extent of community engagement appropriate to the research.
5) Community engagement is required where Indigenous Peoples make up a sizeable proportion of the study or community and where Indigenous-specific conclusions are intended.

A

1, 2, 5

162
Q

A9-3. What are possible benefits of research for a community (select all that apply)?
1) Knowledge gained from the research.
2) Helping the researcher get a publication in an academic journal.
3) Skills training opportunities for community members.
Addressing a community priority related to research.
4) Knowledge transfer to researchers.

A

1, 3, 4

163
Q

A9-4. Which of the following statement(s) about research agreements is/are correct (select all that apply)?
1) Research agreements are required for any research involving First Nations, Inuit and Métis participants.
2) Researchers should draft research agreements so communities can just sign on.
3) Community customs and codes of practice should be integrated into research agreements.
4) Research agreements should set out how disputes between the parties will be resolved.
5) Only researchers have responsibilities under research agreements.

A

3, 4

164
Q

A9-5. Which of the following statement(s) is true (select all that apply)?
1) The guidance in Chapter 9 may also apply to non-Indigenous communities.
2) For some research projects including critical inquiry of a public institution, engagement with formal leadership may not be required.
3) It is not ethically acceptable to conduct research involving critical inquiry of Indigenous institutions, polices or social phenomena.
4) In the context of research involving Indigenous communities, individual consent is less important than community approval of the research.

A

1, 2

NURS 344 (7 decks)

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