Ethics TCPS2 Flashcards
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) 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
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.
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
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.
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.
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
c) Respect for human dignity
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.
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.
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.
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.
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.
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.
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.
b) Is exempt from REB review.
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.
c) The ethics of research involving humans.
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
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
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
c) All the risks associated with the research
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
All of the above
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.
b) The distinction helps the REB to determine the appropriate level of ethics review.
Why were ethical standards developed?
Violations of human rights
What are some studies that were discussed that violated human rights on which ethical standards were developed?
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
Describe the Tuskegee Syphilis Study (1932-1972)
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
Describe Cameron’s LSD and brainwashing studies (Montreal, 1957-1964)
Project MKUltra, was a CIA mind control project
Were working to develop drug induced mind control
LSDs, barbiturates, and ECT were used
Describe the Willowbrook State School (1963-1966)
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
Who was Henrietta Lacks and what was done that was unethical in her case?
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
What happened in Canada to the indigenous population that impacted ethics?
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
What are some major events that advanced the development of ethical standards? (policy changes, not the studies that incited them)
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
Describe how the Nuremburg Code advanced the development of ethical standards
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
Describe how the WMA Declaration of Helsinki advanced the development of ethical standards
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
Describe how the Belmont Report advanced the development of ethical standards
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)
Describe how the Hong Kong Manifesto for Assessing Researchers advanced the development of ethical standards
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
What are the main principles of bioethics?
MEMORY: Justice Always Needs Balance
J - Justice
A - Autonomy
N - Non-maleficence (do not harm)
B - Beneficence (doing good)
What is the bioethics principle of autonomy?
o Individual has right to make decisions based on full disclosure by the researcher
What is the bioethics principle of non-malficence?
o Do no harm
What is the bioethics principle of beneficence?
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
What is the bioethics principle of justice?
o Fair distributions of benefits
o Greatest good for the greatest number
What are the 5 rights according to the Canadian Nurses Association?
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)
What regulations/policies regarding ethics impacts nurses?
CNA - Code of Ethics and it’s 5 rights
Health Canada - Good Clinical Practice Guidelines (1997)
Tri-Council Policy Statement (1998)
Who developed the tri-council policy statement TCPS)?
Canadian Institutes of Health Research (CIHR)
National Sciences and Engineering Research Council of Canada (NSERC)
Social Sciences and Humanities Research Council of Canada (SSHRC)
What are the 3 guiding principles established in the Tri-Council Policy Statement?
Respect for persons
Concern for welfare
Justice
An essential component of the TCSP is that research ethics board (REB) should first review and approve each study that involves _______.
Human subjects
In Canada, compliance with the TCPS is a condition of ______ and a requirement for all research conducted under the auspices of a(n) ___________
agency funding
eligible institution
Where TCPS applies, it does so regardless of _______, _________, and _________.
o Who carries out the research
o What the source of funding is, if any
o Where the research is conducted
What should a researcher anticipate and attempt to resolve prior to beginning a study?
Conflicts that arise between ethical considerations and legal obligations
