TCPS 2

Participant consent may be obtained in ways other than in writing.

False

True

true

The dynamics of how a new virus transmits through human populations are not well understood. One theory is that it is being transmitted from human to human through exposure to mosquitoes at workplaces. If this proves to be true, installing mosquito nets at workplaces would provide employees with sufficient protection against the new virus. The scientific evidence does not yet indicate whether this hypothesis is correct. During an epidemic in a foreign country, a Canadian researcher working under the auspices of an institution eligible for Agency funding proposes a research protocol that aims to test this hypothesis. The methodology essentially consists of recruiting employees working for different employers, randomly assigning them to Group A (using mosquito nets) or Group B (control group not using mosquito nets), and assessing the relative effectiveness of mosquito nets by observing the incidence of the virus in these two groups.

In order to facilitate the recruitment of participants, the researcher plans to invite the employers to be part of the research team. By doing so, the researcher hopes that the research will be better publicized, that the employees will feel more engaged in the research, and that recommendations based on the research results will be implemented. Do you agree that such collaboration is advisable from an ethical standpoint?

Yes

No

no

conflict of interest

As the main policy document for research ethics in Canada, TCPS 2 supersedes provincial and territorial legislation.

True

False

false

A large research team of biologists, social scientists, epidemiologists and statisticians from Canada and around the world wish to conduct research aiming to identify biological and social predispositions to chronic diseases amongst Indigenous Peoples in Canada. This research includes in-depth interviews with individuals living in First Nations, Inuit and Métis territories, as well as the collection of blood and saliva samples, which will be used to perform genomic analyses.

Please select the correct answer:

Community engagement and REB review should be initiated simultaneously.

Researchers should seek REB review prior to initiating community engagement.

Researchers should initiate community engagement prior to seeking REB review.

Researchers should initiate community engagement prior to seeking REB review.

A researcher at a Canadian institution eligible to receive Agency funding wishes to determine the frequency of cannabis consumption among high school students in Canada. The researcher will create a website that includes a secure link to a survey for students wishing to participate in the research. For scientific reasons, only students who have already used cannabis will be invited to participate and respond anonymously to the survey (please answer all questions by YES or NO).

The researcher believes that some of the high school students who will respond to the survey may come from an Indigenous community. However, the researcher does not intend to make Indigeneity an element of their analysis of the findings. Moreover, it will not be possible for the researcher to know which participants are from Indigenous communities, because the survey does not include socio-demographic questions that would allow such description. In this case, is the researcher required to do community engagement?

Yes

No

no

If students coming from an Indigenous community are not expected to be a major proportion of the population investigated, they are not the focus of this research, and their responses will not be compared to the responses of other students, community engagement is not required.

A researcher at a Canadian institution eligible to receive Agency funding wishes to determine the frequency of cannabis consumption among high school students in Canada. The researcher will create a website that includes a secure link to a survey for students wishing to participate in the research. For scientific reasons, only students who have already used cannabis will be invited to participate and respond anonymously to the survey (please answer all questions by YES or NO).

The REB administrator sees the proposed study as minimal risk research and decides to do a delegated review instead of a full board REB review. Is the REB administrator correct in thinking this is minimal risk research and that delegated review is acceptable in this case?

No

Yes

no

A full board review would be preferable in this case, because it involves minors, and the research questions may reveal personal and sensitive information as well as illegal activity. In some jurisdictions, involving minors in the research may also be illegal.

Program evaluation activities do not constitute research for the purposes of TCPS 2

False

True

true

Some activities may resemble research, but do not fall within the scope of REB review. Where researchers are uncertain about whether an activity is research or includes research elements, they should consult the REB to help make that determination.

A researcher at a Canadian institution eligible to receive Agency funding wishes to determine the frequency of cannabis consumption among high school students in Canada. The researcher will create a website that includes a secure link to a survey for students wishing to participate in the research. For scientific reasons, only students who have already used cannabis will be invited to participate and respond anonymously to the survey (please answer all questions by YES or NO).

If the REB determines that the targeted population and prospective participants have the capacity to decide for themselves to participate in this study, must the REB also require that the researcher seek the authorization of a parent or authorized third party prior to the participation of minors in this context?

Yes

No

no

In this case, minors have been determined to have the capacity to decide for themselves. Requiring the authorization of a parent or authorized third party may negatively impact the protection of the privacy of students who wish to participate in the study.

The dynamics of how a new virus transmits through human populations are not well understood. One theory is that it is being transmitted from human to human through exposure to mosquitoes at workplaces. If this proves to be true, installing mosquito nets at workplaces would provide employees with sufficient protection against the new virus. The scientific evidence does not yet indicate whether this hypothesis is correct. During an epidemic in a foreign country, a Canadian researcher working under the auspices of an institution eligible for Agency funding proposes a research protocol that aims to test this hypothesis. The methodology essentially consists of recruiting employees working for different employers, randomly assigning them to Group A (using mosquito nets) or Group B (control group not using mosquito nets), and assessing the relative effectiveness of mosquito nets by observing the incidence of the virus in these two groups.

Consider the situation where, in the course of the research, definitive scientific evidence becomes available that the virus can be transmitted from human to human, but not through mosquitos. Do you believe that the researcher should continue the study as initially approved by the REB?

No

Yes

no

The study should be terminated, because there are no potential benefits of continuing the study.

A researcher at a Canadian institution eligible to receive Agency funding wishes to determine the frequency of cannabis consumption among high school students in Canada. The researcher will create a website that includes a secure link to a survey for students wishing to participate in the research. For scientific reasons, only students who have already used cannabis will be invited to participate and respond anonymously to the survey (please answer all questions by YES or NO).

The researcher wishes to compare the frequency of cannabis consumption depending on the sex and gender of the students. Is such an analysis ethically acceptable?

No

Yes

yes

Given that sex and gender analyses are relevant to addressing the study objectives, they are ethically acceptable.

A researcher at a Canadian institution eligible to receive Agency funding wishes to determine the frequency of cannabis consumption among high school students in Canada. The researcher will create a website that includes a secure link to a survey for students wishing to participate in the research. For scientific reasons, only students who have already used cannabis will be invited to participate and respond anonymously to the survey (please answer all questions by YES or NO).

A. Some REB members do not agree with the methodological decision of the researcher to exclude from the study students who have never used cannabis, because they believe that it will diminish the likelihood that the researcher can publish the results in a prestigious journal. Based on this reason, should the REB require that the researcher change the protocol?

Yes

No

no

It is not within the mandate of the REB to assess a study based on the likelihood of publication. However, REBs may require changes to the protocol if the method is not likely to answer the research question, and therefore does not present a favorable balance between the risks and potential benefits.

The dynamics of how a new virus transmits through human populations are not well understood. One theory is that it is being transmitted from human to human through exposure to mosquitoes at workplaces. If this proves to be true, installing mosquito nets at workplaces would provide employees with sufficient protection against the new virus. The scientific evidence does not yet indicate whether this hypothesis is correct. During an epidemic in a foreign country, a Canadian researcher working under the auspices of an institution eligible for Agency funding proposes a research protocol that aims to test this hypothesis. The methodology essentially consists of recruiting employees working for different employers, randomly assigning them to Group A (using mosquito nets) or Group B (control group not using mosquito nets), and assessing the relative effectiveness of mosquito nets by observing the incidence of the virus in these two groups.

Consider the situation where, prior to the research, some prospective participants had already installed mosquito nets at their workplaces as a precautionary measure. In this situation, the researcher is aware that some participants will be reluctant to be randomly assigned to the group working in a workplace without mosquito nets. In order to convince them to participate, the researcher proposes to provide these prospective participants with a monetary incentive that is significant for them. Is this approach ethically acceptable?

No

Yes

no

Under TCPS 2, the provision of monetary incentives should not create undue influence, undermine voluntary consent and lead individuals to take risks they otherwise would not have.

Canadian researchers who plan to recruit participants only from outside Canada are not required to seek REB approval from their institution because the mission of TCPS 2 is to protect Canadian research participants.

False

True

false

According to Chapter 9 of TCPS 2, researchers cannot conduct critical inquiries of the governance of Indigenous institutions.

True

False

false

Some research projects involving Indigenous communities may include critical inquiry of a public institution, a policy or other social phenomena. When it is the case, engagement with formal leadership may not be required.

The dynamics of how a new virus transmits through human populations are not well understood. One theory is that it is being transmitted from human to human through exposure to mosquitoes at workplaces. If this proves to be true, installing mosquito nets at workplaces would provide employees with sufficient protection against the new virus. The scientific evidence does not yet indicate whether this hypothesis is correct. During an epidemic in a foreign country, a Canadian researcher working under the auspices of an institution eligible for Agency funding proposes a research protocol that aims to test this hypothesis. The methodology essentially consists of recruiting employees working for different employers, randomly assigning them to Group A (using mosquito nets) or Group B (control group not using mosquito nets), and assessing the relative effectiveness of mosquito nets by observing the incidence of the virus in these two groups.

In order to facilitate the consent process, the researcher plans to exclude all employees who are minors and may need parental consent to participate. Based on the provided reason, would the exclusion of this group from the study be ethically acceptable?

No

Yes

no

Facilitating the consent process is not a sufficient reason to ethically justify the exclusion of certain groups from research.

A large research team of biologists, social scientists, epidemiologists and statisticians from Canada and around the world wish to conduct research aiming to identify biological and social predispositions to chronic diseases amongst Indigenous Peoples in Canada. This research includes in-depth interviews with individuals living in First Nations, Inuit and Métis territories, as well as the collection of blood and saliva samples, which will be used to perform genomic analyses.

The researchers plan to conduct in-depth interviews that ask members of Indigenous communities to provide information about their diet and lifestyle. Please select the correct answer:

Some research projects involving Indigenous communities can meet the criteria for minimal risk research and be evaluated in delegated review.

In the context of research involving Indigenous communities, it is the responsibility of the REB to determine whether a given research project should be considered minimal risk research

.

In the context of research involving Indigenous communities, the distinction between minimal risk and above minimal risk research is relevant.

All of the above.

None of the above.

all of the above

In keeping with the principle of proportionate review, it is the REB's responsibility to determine whether the research meets the criteria for minimal risk research. REBs make this determination on a case-by-case basis, taking into account the specificities of the research, and using the same criteria for research involving Indigenous communities as for research not involving Indigenous communities.

A researcher at a Canadian institution eligible to receive Agency funding wishes to determine the frequency of cannabis consumption among high school students in Canada. The researcher will create a website that includes a secure link to a survey for students wishing to participate in the research. For scientific reasons, only students who have already used cannabis will be invited to participate and respond anonymously to the survey (please answer all questions by YES or NO).

The researcher proposes to ask teachers to inform their students that the study exists, and to tell them where they can access the link to the survey, in case they wish to complete it, at home or anywhere outside the classroom. The schoolboard has approved the proposal, the teachers are not members of the research team and the context is not likely to exercise coercive pressure on students to participate in the study. Is the proposal ethically acceptable?

Yes

No

yes

Based on the information provided in this case, the voluntariness of consent is being protected and therefore the proposal is acceptable.

In order to identify prospective participants who may be in a position to help answer specific research questions, it can be ethically acceptable to engage with some individuals or their community before seeking REB review and approval of the research project.

True

False

true

Engaging with individuals or their communities (exploratory work) before seeking REB review and approval of the research can be acceptable. In some cases, it is also recommended. However, it is not acceptable to recruit research participants before REB approval of the research.

A large research team of biologists, social scientists, epidemiologists and statisticians from Canada and around the world wish to conduct research aiming to identify biological and social predispositions to chronic diseases amongst Indigenous Peoples in Canada. This research includes in-depth interviews with individuals living in First Nations, Inuit and Métis territories, as well as the collection of blood and saliva samples, which will be used to perform genomic analyses.

Please select the correct answer:

If the proposed research involved Indigenous communities only in regions outside Canada, Chapter 9 of TCPS 2 could not apply.

The guidance found in Chapter 9 of TCPS 2 may be relevant and apply to non-Indigenous communities.

Chapter 9 is the sole chapter of TCPS 2 providing guidance to researchers when they conduct research involving Indigenous communities.

All of the above.

None of the above.

The guidance found in Chapter 9 of TCPS 2 may be relevant and apply to non-Indigenous communities.

The respectful research practices designed with Indigenous Peoples, for research involving Indigenous Peoples in Canada, may also serve as guidance for research in Indigenous communities abroad, and other specific communities, where appropriate.

According to TCPS 2, what is minimal risk research (select the most appropriate definition)?

Research that does not involve any invasive interventions.

Research that involves a risk level that most prospective participants are likely to accept.

Research in which the possible harms are no greater than those encountered by participants in their everyday life.

Research that can be conducted without any risk for participants.

Research that adopts a methodological approach that is known to be the least risky available.

Research in which the possible harms are no greater than those encountered by participants in their everyday life.

The dynamics of how a new virus transmits through human populations are not well understood. One theory is that it is being transmitted from human to human through exposure to mosquitoes at workplaces. If this proves to be true, installing mosquito nets at workplaces would provide employees with sufficient protection against the new virus. The scientific evidence does not yet indicate whether this hypothesis is correct. During an epidemic in a foreign country, a Canadian researcher working under the auspices of an institution eligible for Agency funding proposes a research protocol that aims to test this hypothesis. The methodology essentially consists of recruiting employees working for different employers, randomly assigning them to Group A (using mosquito nets) or Group B (control group not using mosquito nets), and assessing the relative effectiveness of mosquito nets by observing the incidence of the virus in these two groups.

Consider the case where one of the members of the researcher’s family works for a company that produces, commercializes, and distributes mosquito nets. Should the researcher disclose a potential conflict of interest to the REB?

Yes

No

yes

A researcher at a Canadian institution eligible to receive Agency funding wishes to determine the frequency of cannabis consumption among high school students in Canada. The researcher will create a website that includes a secure link to a survey for students wishing to participate in the research. For scientific reasons, only students who have already used cannabis will be invited to participate and respond anonymously to the survey (please answer all questions by YES or NO).

The researcher proposes to ask participants to provide minimal information about themselves, such as sex, gender, age, and postal code (indirect identifiers). However, the participants will not be required to provide direct identifiers such as their name and the researcher will not collect their IP address. Considering the information that will be collected, can the data be considered anonymous?

Yes

No

no

Because the combination of indirect identifiers (sex, gender, age and postal code) makes it possible to re-identify the participant.

The dynamics of how a new virus transmits through human populations are not well understood. One theory is that it is being transmitted from human to human through exposure to mosquitoes at workplaces. If this proves to be true, installing mosquito nets at workplaces would provide employees with sufficient protection against the new virus. The scientific evidence does not yet indicate whether this hypothesis is correct. During an epidemic in a foreign country, a Canadian researcher working under the auspices of an institution eligible for Agency funding proposes a research protocol that aims to test this hypothesis. The methodology essentially consists of recruiting employees working for different employers, randomly assigning them to Group A (using mosquito nets) or Group B (control group not using mosquito nets), and assessing the relative effectiveness of mosquito nets by observing the incidence of the virus in these two groups.

The research involves collaborators working in the country of the study. They have obtained all the necessary ethics certifications required to conduct the research in that country. Does the REB of the Canadian researcher also need to approve the research?

Yes

No

yes

Research conducted by a researcher from a Canadian institution is conducted under the auspices of that institution.

A large research team of biologists, social scientists, epidemiologists and statisticians from Canada and around the world wish to conduct research aiming to identify biological and social predispositions to chronic diseases amongst Indigenous Peoples in Canada. This research includes in-depth interviews with individuals living in First Nations, Inuit and Métis territories, as well as the collection of blood and saliva samples, which will be used to perform genomic analyses.

Please select the correct answer:

In the context of research involving Indigenous communities, the three core principles of TCPS 2 do not apply.

In the context of research involving Indigenous communities, community agreement is more important than the individual consent of participants.

In the context of research involving Indigenous communities, obtaining a signed research agreement is more important than the individual consent of participants.

All of the above.

None of the above.

none of the above

According to TCPS 2, the amount of financial compensation or an incentive that is offered to participants must be directly proportional to the level of risk imposed on them by the research.

False

True

false

TCPS 2 does not provide an algorithm for determining the appropriate amounts of financial compensation or incentives. However, it states explicitly that these should not be so large that they impede the voluntary nature of consent, and lead participants to accept research-attributable risks that they otherwise would not have.