TCPS 2

Which of the following statements is/are true (select all that apply)?

A) Research involving secondary use of identifiable information requires REB review, but not consent.

B) REBs may waive the consent requirement for research involving secondary use of identifiable information, at their discretion.

C) REBs may waive the consent requirement for research involving secondary use of identifiable information if the researcher satisfies six conditions.

D) Where research involves the secondary use of non-identifiable information, neither consent nor REB review is required.

E) Secondary use research involves using data that was originally collected for another purpose.

C) REBs may waive the consent requirement for research involving secondary use of identifiable information if the researcher satisfies six conditions

E) Secondary use research involves using data that was originally collected for another purpose.

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.

All of the above

Who has responsibility for safeguarding the privacy of research participants (select the most appropriate answer):

1) Researchers alone.

2) Researchers and REBs.

3) Researchers, REBs, and institutions.

4) Researchers, REBs, institutions, and funders.

3) Researchers, REBs, and institutions.

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?

1) Indirectly identifying information.

2) Anonymized information.

3) Coded information.

4) Secret information.

5) Anonymous information.

4) Secret information.

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.

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

Which one of the following statements best describes the status of an REB?

1) A committee accountable in all respects to the institution that created it.

2) A committee accountable to the institution that created it with respect to its operations, but independent with respect to its decisions on research proposals.

3) A committee independent in all respects from the institution that created it.

2) A committee accountable to the institution that created it with respect to its operations, but independent with respect to its decisions on research proposals.

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.

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.

4) Conducting an initial assessment of the level of risk to determine what level of scrutiny the review requires.

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”.

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.

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.

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.

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.

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.

4) Addressing a community priority related to research.

5) Knowledge transfer to researchers.

1) Knowledge gained from the research.

3) Skills training opportunities for community members.

4) Addressing a community priority related to research.

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.

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.

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.

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.

Which of the following activities constitute(s) research involving human participants (select all that apply)?

1) Interviews of experts in genetics by a journalist.

2) Market survey involving potential consumers.

3) Research involving human bones found in an archeological site.

4) Performance review of a human resource department.

5) Research involving the secondary use of human cell lines.

5) Research involving the secondary use of human cell lines.

Research ethics boards are composed of (select all that apply):

1) At least one senior administrator who works for the institution.

2) At least one community member who has no affiliation with the institution.

3) At least one lawyer whose role is to safeguard the institution’s legal interests.

4) At least one member who is knowledgeable in ethics.

5) At least two members who have expertise in relevant research disciplines.

2) At least one community member who has no affiliation with the institution.

4) At least one member who is knowledgeable in ethic

5) At least two members who have expertise in relevant research disciplines.

Which of the following statements is/are true (select all that apply):

1) Research involving human participants is generally not recommended in the medical emergency setting.

2) Research involving medical emergencies does not require the consent of the patient because the potential benefits to others in similar situations outweigh the risks to the participant.

3) Publicly declared emergencies may raise new or additional risks to participants requiring a reconsideration of the protocol by the REB.

4) For research involving individuals who temporarily lack the capacity to decide for themselves whether to participate, a member of the research team can act as an authorized third party.

2, 3

Which of the following statements is/are true (select all that apply)?

1) In research involving minors, the parents always have the final word about their participation.

2) In the great majority of cases, consent should be obtained prior to a participant’s involvement in the research.

3) There are circumstances that permit a departure from the requirement to document the consent process.

4) There are circumstances that permit a departure from the general principles of consent.

5) According to TCPS 2, consent should be voluntary, informed, and ongoing.

2) In the great majority of cases, consent should be obtained prior to a participant's involvement in the research.

4) There are circumstances that permit a departure from the general principles of consent.

5) According to TCPS 2, consent should be voluntary, informed, and ongoing.

Tri-council Policy Statement is based on respect for human ______________, which is expressed through three core principles: Respect for Persons; Concern for Welfare; Justice.

Dignity

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.

1,2,4,5

What is the fundamental value upon which the TCPS 2 is based?

1) Do no harm.

2) All persons are created equal.

3) Respect for human dignity

4) Autonomy

3

Research that is exempt from REB review

- Information that is legally or publicly accessible, with no expectation of privacy

- Observation of people in public places

- Secondary use of anonymous information or human biological materials

TCPS 2 sets out two categories of activity that do not require REB review:

- Quality assurance/quality improvement/program evaluation/performance reviews

- Creative practice activities

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.

2,4

Under TCPS 2, it is the role of the REB to review:

1) The ethics of mandated quality assurance activities.

2) The ethics of animal and human research.

3) The ethics of research involving humans

3

respect for person: consent consists of what three key elements:

1) voluntary, 2) informed, and 3) ongoing.

If research is based exclusively on the secondary use of non identifiable information, is REB and consent required?

only REB

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.

Answers: 2, 4, 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.

1,4

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.

all the above

an individual's right to be free from intrusion or interference by others

privacy

the information identifies a specific individual through direct identifiers (e.g., name, social insurance number, personal health number)

Directly identifying information:

the information can reasonably be expected to identify an individual through a combination of indirect identifiers (e.g., date of birth, place of residence or unique personal characteristic)";

Indirectly identifying information

direct identifiers are removed from the information and replaced with a code. Depending on access to the code, it may be possible to re-identify specific participants (e.g., the principal investigator retains a list that links the participants' code names with their actual names so data can be re-linked if necessary)";

Coded information

the information is irrevocably stripped of direct identifiers, a code is not kept to allow future re-linkage, and risk of re-identification of individuals from remaining indirect identifiers is low or very low

Anonymized information

the information never had identifiers associated with it (e.g., anonymous surveys) and risk of identification of individuals is low or very low" (Chapter 5, Section A).

Anonymous information

Who has responsibility for safeguarding the privacy of research participants (select the most appropriate answer):

1) Researchers alone.

2) Researchers and REBs.

3) Researchers, REBs, and institutions.

4) Researchers, REBs, institutions, and funders.

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.

all the above

What is the primary role of the community member on an REB?

1) To bring diversity to the REB.

2) To provide an independent perspective on the proposed research.

3) To represent the research participant perspective.

4) To ensure that not all REB members are academics.

3

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.

It is up to the researcher to determine the nature and extent of community engagement appropriate to the research.

4) Community engagement is required where Indigenous Peoples make up a sizeable proportion of the study or community and where Indigenous-specific conclusions are intended.

1,2,5