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Participation in research is a choice, based on information about the risks and potential benefits of the research.
A1-1. Which one of the following statements reflects the TCPS 2 core principle of Respect for Persons?
- Participation in research is a choice, based on information about the risks and potential benefits of the research.
- Research should be designed so as to avoid exposing participants to unnecessary risks.
- Research studies should be designed so that the burdens and the potential benefits of the research are distributed fairly.
- A graduate student at an eligible Canadian college conducting self-funded research on political protest groups by interviewing members of those groups.
- A professor at an eligible Canadian university who is conducting research in Brazil on educational initiatives involving Indigenous Peoples.
- A researcher at an eligible academic institution conducts research within that institution that is funded by their department, not the Agencies;
- A master's student at an eligible institution conducts their research with street youth, not on the premises of the institution;
A1-2. Which of the following researchers must follow the TCPS 2 (select all that apply)?
- A graduate student at an eligible Canadian college conducting self-funded research on political protest groups by interviewing members of those groups.
- A professor at an eligible Canadian university who is conducting research in Brazil on educational initiatives involving Indigenous Peoples.
- An independent researcher hired by a private company to conduct research on consumer brand loyalties.
- A researcher at an eligible academic institution conducts research within that institution that is funded by their department, not the Agencies;
- A master's student at an eligible institution conducts their research with street youth, not on the premises of the institution;
- 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.
- The researcher's institution may take action under the institution's policies.
- 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.
A1-3. What happens if a researcher with a SSHRC grant breaches the TCPS 2 when conducting their research (select all that apply)?
- The TCPS 2 is a voluntary set of guidelines, so there are no consequences for a breach.
- The researcher's institution may take action under the institution's policies.
- 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.
Respect for human dignity
A1-4. What is the fundamental value upon which the TCPS 2 is based?
- Do no harm.
- All persons are created equal.
- Respect for human dignity
- Autonomy
- Consult with colleagues, disciplinary associations, or lawyers, to determine how best to resolve the conflict
- Anticipate potential conflicts and design research to avoid them, where possible.
A1-5. How should a researcher resolve a potential conflict between ethics considerations and legal obligations (select all that apply)?
- Consult with colleagues, disciplinary associations, or lawyers, to determine how best to resolve the conflict
- Fulfil the ethical obligations - they have more moral weight.
- Follow the law - it always takes precedence over ethics
- Anticipate potential conflicts and design research to avoid them, where possible.
- Professor A designs a pilot study to address that research question, and gets a small group of individuals to take part in the study.
- 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.
A2-1. 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)?
- Professor A meets with colleagues in their department to discuss a research question of interest to them, with a view to refining the question.
- Professor A meets with representatives of a community to discuss conducting research within that community on the topic they discussed with their colleagues.
- Professor A designs a pilot study to address that research question, and gets a small group of individuals to take part in the study.
- 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 patient with a particular condition whose tissue was removed to help scientists better understand that condition and how to treat it.
- 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.
A2-2. which of the following person is considered a research participant (select all that apply)?
- A patient whose tissue was removed to determine whether they had a condition requiring treatment.
- A patient with a particular condition whose tissue was removed to help scientists better understand that condition and how to treat it.
- An employee of a college who must fill out a job satisfaction survey anonymously for the Human Resources department.
- 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.
- Is exempt from REB review.
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 _________."
- Requires REB review.
- Is exempt from REB review.
- May require REB review, depending on the circumstances.
- The ethics of research involving humans.
A2-4. Under TCPS 2, it is the role of the REB to review:
- The ethics of mandated quality assurance activities.
- The ethics of animal and human research.
- The ethics of research involving humans.
- Direct benefits to the participants
- Benefits to the group or community to which the participant belongs
- Benefits to society in the form of increased knowledge
A3-1. REBs may consider the following as potential benefits of research (select all that apply).
- Direct benefits to the participants
- Benefits to the researcher in terms of career advancement
- Benefits to the group or community to which the participant belongs
- Benefits to society in the form of increased knowledge
- All the risks associated with the research
A3-2. Choose the correct description of research-attributable risks, according to TCPS 2:
- All the risks a participant is exposed to during the period of the research
- All the risks a participant is ordinarily exposed to, plus any risks specific to the research
- All the risks associated with the research
- Economic harm
- Social harm
- Psychological harm
- Physical harm
A3-3. Which types of possible harms may be considered research risks (select all that apply)?
- Economic harm
- Social harm
- Psychological harm
- Physical harm
- The distinction helps the REB to determine the appropriate level of ethics review.
A3-4. What is the purpose of distinguishing between minimal risk research and research that is more than minimal risk?
- Minimal risk research does not require REB review.
- The distinction helps the REB to determine the appropriate level of ethics review.
- The distinction serves only to categorize the types of research proposal the REB receives.
- Voluntary, informed, ongoing.
A4-1. What are the general principles of consent?
- Informed, ongoing, documented.
- Voluntary, informed, ongoing.
- Voluntary, informed, free.
- Voluntary, informed, documented.
- Prior to commencing participation in the research.
A4-2. In general, when should researchers seek consent from individuals to participate in research?
- At any time during the course of the research.
- After the participant has completed the research activity.
- Prior to commencing participation in the research.
- Whenever the researcher chooses.
- Through any form that can serve as evidence of consent and that complies with applicable legal requirements.
A4-3. Which of the following best describes how consent should be documented?
- Only through a signed consent form
- Only through a video recording of consent
- Only through a researcher's notes of a verbal consent.
- Through any form that can serve as evidence of consent and that complies with applicable legal requirements.
- When a prospective participant lacks decision-making capacity.
- In medical emergencies
- For certain types of public health research.
A4-4. Under which of the following circumstances may a researcher depart from the general principles of consent (select all that apply)?
- When obtaining consent would delay the conduct of the research.
- When a prospective participant lacks decision-making capacity.
- Under no circumstances.
- In medical emergencies
- For certain types of public health research.
- Secondary use research involves using data that was originally collected for another purpose.
- REBs may waive the consent requirement for research involving secondary use of identifiable information if the researcher satisfies six conditions.
A4-5. Which of the following statements is/are true (select all that apply)?
- Secondary use research involves using data that was originally collected for another purpose.
- Research involving secondary use of identifiable information requires REB review, but not consent.
- REBs may waive the consent requirement for research involving secondary use of identifiable information, at their discretion.
- REBs may waive the consent requirement for research involving secondary use of identifiable information if the researcher satisfies six conditions.
- Where research involves the secondary use of non-identifiable information, neither consent nor REB review is required.
- Ethically unacceptable, unless the exclusion is related to the nature and scope of the research question.
A5-1. Complete the following sentence in accordance with the guidance in TCPS 2: "Excluding women from research is ___________."
- Never ethically acceptable.
- Ethically acceptable because this protects women from the risks of research.
- Ethically unacceptable, unless the exclusion is related to the nature and scope of the research question.
- Ethically necessary when a woman is pregnant or breastfeeding.
- It is important to communicate research results to participants, in a format suitable to them.
- 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.
A5-2. Which of the following statements reflect TCPS 2 guidance (select all that apply)?
- Publication in an academic journal is the only acceptable form of research dissemination.
- It is important to communicate research results to participants, in a format suitable to them.
- 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.
- It is ethically acceptable for sponsors to prohibit the dissemination of results at their discretion, since they paid for the research.
- Yes, so long as their participation is necessary to the research and additional protective measures are in place.
A5-3. Under TCPS 2, can individuals who are in vulnerable circumstances participate in research?
- Yes, so long as their participation is necessary to the research and additional protective measures are in place.
- No, it is wrong to include vulnerable individuals in research.
- Yes, all that matters is that they have the capacity to consent.
- No, those in vulnerable circumstances cannot participate in research even if the research focus is on people in their circumstances.
- This helps to maintain public trust in research.
- 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.
- This avoids disadvantaged or marginalized groups from bearing a disproportionate share of research risks.
A5-4. The principle of Justice requires an equitable distribution of the benefits and burdens of research because (select all that apply):
- This helps to maintain public trust in research.
- 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.
- This avoids disadvantaged or marginalized groups from bearing a disproportionate share of research risks.
- Researchers have an ethical duty to maintain the confidentiality of information they collect during the course of research.
- A researcher's duty of confidentiality extends to human biological materials collected during the course of research.
- Researchers may have legal obligations to maintain the privacy of research participants.
A6-1. Which of the following statements is correct (select all that apply)?
- Researchers have an ethical duty to maintain the confidentiality of information they collect during the course of research.
- A researcher's duty of confidentiality extends to human biological materials collected during the course of research.
- Researchers may have legal obligations to maintain the privacy of research participants.
- Research that relies on information originally collected for a purpose other than the current research purpose.
A6-2. Secondary use research is:
- Research that generates at least two publications.
- Original research that is copied by a second researcher.
- Research that relies on information originally collected for a purpose other than the current research purpose.
- Researchers, REBs, and institutions.
A6-3. Who has responsibility for safeguarding the privacy of research participants (select the most appropriate answer):
- Researchers alone.
- Researchers and REBs.
- Researchers, REBs, and institutions.
- Researchers, REBs, institutions, and funders.
- Secret information.
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?
- Indirectly identifying information.
- Anonymized information.
- Coded information.
- Secret information.
- Anonymous information.
- Researchers, REB members, and institutions.
A7-1. In research, conflict of interest is an issue that can affect (select the most appropriate answer):
- Researchers
- Researchers and REB members.
- Researchers, REB members, and institutions.
- Researchers and institutions.
- REB members and institutions.
- Conflicts of interest may be real, potential, or perceived.
- 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.
A7-2. Which of the following statements is/are true (select all that apply)?
- Conflicts of interest may be real, potential, or perceived.
- Only real conflicts of interest need to be managed.
- A research study cannot proceed if a researcher has disclosed a conflict of interest.
- 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.
- Researchers may choose whether or not to disclose conflicts of interest.
- REB members supervise the researcher submitting the protocol for REB review.
- REB members sit on the board of the company that is sponsoring the research.
- REB members are collaborating with the research applicant on another research project.
- The research applicant is their sister-in-law.
- The research applicant is their supervisor.
- REB members own shares in the company that is sponsoring the research.
A7-3. Which of the following would be a conflict of interest for REB members (select all that apply)?
- REB members supervise the researcher submitting the protocol for REB review.
- REB members sit on the board of the company that is sponsoring the research.
- REB members are collaborating with the research applicant on another research project.
- The research applicant is their sister-in-law.
- The research applicant is their supervisor.
- REB members own shares in the company that is sponsoring the research.
- Develop a plan to minimize the effect of the conflict.
- Disclose to the REB and to participants.
A7-4. Which of the following is/are an acceptable way for a researcher to manage a conflict of interest (select all that apply)?
- Disclose the conflict to a colleague at another institution.
- Develop a plan to minimize the effect of the conflict.
- Decide to remain impartial.
- Disclose to the REB and to participants.
- Keep silent, but be prepared to step off the research team if the conflict is discovered.
- It helps to protect the integrity of research.
- It is part of the process of ensuring that prospective research participants make informed decisions regarding their consent to participate.
A7-5. Addressing conflicts of interest in research involving humans is important because (select all that apply):
- It helps to protect the integrity of research.
- It is part of the process of ensuring that prospective research participants make informed decisions regarding their consent to participate.
- It makes researchers feel virtuous.
- All conflicts of interest can and must be eliminated.
- To provide advice about alternative methods to answer the research question.
A8-1. Which of the following activities is not a primary responsibility of an REB?
- To review the ethical acceptability of the methods of a research proposal.
- To review the ethical acceptability of the design of a research proposal.
- To review substantive changes made to the research during the course of a study.
- To provide advice about alternative methods to answer the research question.
- To communicate their decisions in a timely and efficient manner.
- A committee accountable to the institution that created it with respect to its operations, but independent with respect to its decisions on research proposals.
A8-2. Which one of the following statements best describes the status of an REB?
- A committee accountable in all respects to the institution that created it.
- A committee accountable to the institution that created it with respect to its operations, but independent with respect to its decisions on research proposals.
- A committee independent in all respects from the institution that created it.
- To represent the research participant perspective.
A8-3. What is the primary role of the community member on an REB?
- To bring diversity to the REB.
- To provide an independent perspective on the proposed research.
- To represent the research participant perspective.
- To ensure that not all REB members are academics.
- Applying delegated review to minimal risk research and full board review to more than minimal risk research.
- Considering the foreseeable risks, the potential benefits and the ethics implications of the research.
- Conducting an initial assessment of the level of risk to determine what level of scrutiny the review requires.
A8-4. Which of the following statements describe(s) a proportionate approach to assessing the ethical acceptability of research (select all that apply)?
- Applying delegated review to minimal risk research and full board review to more than minimal risk research.
- Considering the foreseeable risks, the potential benefits and the ethics implications of the research.
- Having only the vice-president of research review minimal risk research.
- Conducting an initial assessment of the level of risk to determine what level of scrutiny the review requires.
- Institutions and REBs should develop preparedness plans for how to review research during public declared emergencies.
- Any exceptional procedures put in place during a publicly declared emergency remain in force only as long as the emergency continues.
A8-5. Which of the following statements is/are correct (select all that apply)?
- Due to the extraordinary circumstances, research cannot take place during a publicly declared emergency.
- Institutions and REBs should develop preparedness plans for how to review research during public declared emergencies.
- No exceptions to TCPS 2 procedures can occur during a publicly declared emergency, regardless of the justification provided.
- Any exceptional procedures put in place during a publicly declared emergency remain in force only as long as the emergency continues.