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TCPS 2 - Glossary

 This glossary is intended to assist readers in their understanding of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS), also referred to as “the Policy.” Definitions that have been provided in the main text of the Policy are also repeated here. Additional terms are defined in accordance with the purposes of the Policy. For more detailed descriptions of many terms it is best to read them in the context of the chapters in which they appear – consult the Index for the appropriate reference.

A

Aboriginal peoples – Persons of Indian (First Nations), Inuit, or Métis descent, regardless of where they reside and whether or not their names appear on an official register. In the international context, the term comparable to Aboriginal peoples is Indigenous peoples.

Academic freedom – The collective freedom of faculty and students to conduct research, and to disseminate ideas or facts without religious, political, or institutional restrictions. It includes freedom of inquiry, freedom to challenge conventional thought, freedom to express one’s opinion about the institution, its administration, or the system in which one works,and freedom from institutional censorship.

Ad hoc advisor – A person with relevant and competent knowledge and expertise consulted by a research ethics board for a specific research ethics review, and for the duration of that review. The ad hoc advisor is not a member of the research ethics board.

Agencies, the – Canada’s three federal research agencies: the Canadian Institutes of Health Research (CIHR); the Natural Sciences and Engineering Research Council of Canada (NSERC); and the Social Sciences and Humanities Research Council of Canada (SSHRC).

Agreement, the – The agreement between the Agencies and institutions eligible to receive and manage research funding from the Agencies. A commitment to adhere to the TCPS is a part of the Agreement.

Appeal – A process that allows a researcher to request a review of a research ethics board (REB) decision when, after reconsideration, the REB has refused ethics approval of the research.

Appeal mechanism – A procedure established by an institution to promptly handle a researcher’s appeal of a research ethics board (REB) decision. An ad hoc or permanent appeal committee, which reflects a range of expertise and knowledge similar to that of the REB, is established or appointed by the same authority that established the REB.

Authorized third party – Any person with the necessary legal authority to make decisions on behalf of a prospective participant who lacks the capacity to decide whether or not to participate, or to continue to participate, in a particular research project. In other policies/guidance they are also known as “authorized third party decision makers.”

Autonomy – The capacity to understand information and to be able to act on it voluntarily; the ability of individuals to use their own judgement to make decisions about their own actions, such as whether or not to participate in research.

B

Biobank – A collection of human biological materials. It may also include associated information about individuals from whom biological materials were collected.

C

Clinical equipoise – The existence of a genuine uncertainty on the part of the relevant expert community about what therapy or therapies are most effective for a given condition.

Clinical trial – Any investigation involving participants that evaluates the effects of one or more health-related interventions on health outcomes.

Coercion – An extreme form of undue influence, involving a threat of harm or punishment for failure to participate in research. See “Undue influence.”

Collaborative research – Research that involves the cooperation of researchers, institutions, organizations and/or communities, each bringing distinct expertise to a project, and that is characterized by respectful relationships. See “Community-based research” and “Participatory research.”

Community – A group of people with a shared identity or interest that has the capacity to act or express itself as a collective. A community may be territorial, organizational, or a community of interest.

Community-based research – Research conducted at a community site that focuses not only on individuals but on the community itself. Community-based research may be initiated by the community independently or in collaboration with a researcher. See “Collaborative research” and “Participatory research.”

Community engagement – A process that establishes an interaction between a researcher (or a research team) and a community with regard to a research project. It signifies the intent of forming a collaborative relationship between researchers and communities, although the degree of collaboration may vary depending on the community context and the nature of the research.

Concern for Welfare – A core principle of this Policy that requires researchers and research ethics boards to aim to protect the welfare of participants, and, in some circumstances, to promote that welfare in view of any foreseeable risks associated with the research. See “Risk” and “Welfare.”

Confidentiality – An ethical and/or legal responsibility of individuals or organizations to safeguard information entrusted to them, from unauthorized access, use, disclosure, modification, loss or theft.

Conflict of interest – The incompatibility of two or more duties, responsibilities, or interests (personal or professional) of an individual or institution as they relate to the ethical conduct of research, such that one cannot be fulfilled without compromising another.

Consent – An indication of agreement by an individual to become a participant in a research project. Throughout this Policy, the term “consent” means “free (also referred to as voluntary), informed and ongoing consent.”

Continuing research ethics review (also referred to as “Continuing ethics review”) – Any review of ongoing research conducted by a research ethics board (REB) occurring after the date of initial REB approval and continuing throughout the life of the project to ensure that all stages of a research project are ethically acceptable in accordance with the principles in the Policy.

Core principles – The three core principles of the Policy that together express the overarching value of respect for human dignity: Respect for Persons, Concern for Welfare and Justice. See “Respect for persons,” “Concern for Welfare” and “Justice.”

Creative practice – A process through which an artist makes or interprets a work, or works, of art. It may also include a study of the process of how a work of art is generated.

Critical inquiry – The analysis of social structures or activities, public policies, or other social phenomena for research purposes.

Cultural heritage – A dynamic concept which includes, but is not limited to, First Nations, Inuit and Métis peoples’ relations with particular territories, material objects, traditional knowledge and skills, and intangibles that are transmitted from one generation to the next, such as sacred narratives, customs, representations or practices.

Cyber-material – Documents, images, audio or video recordings, records, performances, or on-line archival materials available in digital form on the Internet.

D

Data linkage – The merging or analysis of two or more separate data sets (e.g. health information and education information about the same individuals) for research purposes. See also “Data set.”

Data safety monitoring board – A multi-disciplinary, expert advisory group established by a research sponsor, that is responsible for safeguarding the interests of participants by reviewing emerging data, assessing the safety and efficacy of clinical trial procedures, and monitoring the overall conduct of a trial.

Data set – A collection of information to be used for research purposes, including human biological materials.

Decision-Making Capacity – Data stewards are responsible for data definition (i.e., defining the characteristics of the elements in a database) and access authorization, particularly data access and disclosure to third parties.

Debriefing – The full disclosure of the research purpose and other pertinent information to participants who have been involved in research employing partial disclosure or deception. Debriefing is typically done after participation has ended, but may be done at any time during the study.

Delegated research ethics board (REB) review – The level of REB review assigned to minimal risk research projects. Delegated reviewers are selected from among the REB membership, with the exception of the ethics review of student course-based research which can be reviewed by delegates from the student’s department, faculty, or an equivalent level. Delegated reviewers who are non-members or non-voting members of the REB must have experience, expertise and knowledge comparable to what is expected of an REB member.

Differentiation – The process by which cells acquire new characteristics and form more specialized cell types.

Disciplined inquiry – an inquiry that is conducted with the expectation that the method, results, and conclusions will be able to withstand the scrutiny of the relevant research community.

E

Embryo – A human organism during the first 56 days of its development following fertilization or creation, excluding any time during which its development has been suspended. It also includes any cell derived from such an organism that is used for the purpose of creating a human being.

Embryonic germ (EG) cells – Pluripotent stem cells derived from the cells in the fetal gonad that would normally develop into mature gametes.

Embryonic stem (ES) cell – A cell derived from the inner cell mass of developing blastocysts. An embryonic stem cell is self-renewing (can replicate itself) and pluripotent.

Embryonic stem cell line – An embryonic stem cell line is derived from one embryo that has been propagated indefinitely in culture.

Emergency preparedness plans – Plans that detail an institution’s policies and procedures for addressing research ethics review during public health outbreaks, natural disasters, and other publicly declared emergencies. See “Publicly declared emergency.”

Emergent design – A research method in which data collection and analyses can evolve over the course of a research project in response to what is learned in earlier parts of the study.

F

Fetal tissue – Membranes, placenta, umbilical cord, amniotic fluid, and other tissue that contains genetic information about the fetus.

Fetus – A human organism during the period of its development beginning on the 57th day following fertilization or creation, excluding any time during which its development has been suspended, and ending at birth.

Full research ethics board (REB) review – The level of REB review assigned to above minimal risk research projects. Conducted by the full membership of the research ethics board, it is the default requirement for the ethics review of research involving humans.

G

Gamete – The sex cell (sperm or egg). The functional, mature, male gamete is called a “sperm” while the female gamete is called the “ovum” or “egg.”

Gender - Gender refers to the socially constructed roles, behaviours, expressions and identities of girls, women, boys, men, and gender diverse people. It influences how people perceive themselves and each other, how they act and interact, and the distribution of power and resources in society. Gender is usually conceptualized as a binary (girl/woman and boy/man) yet there is considerable diversity in how individuals and groups understand, experience, and express it.

Gene alteration – The transfer of genes into cells to induce an altered capacity of the cell.

Genetic counselling – The explanation of the meaning and implication of information revealed in genetic research to a participant by someone with the experience or training to provide the appropriate context and support .

H

Harm – Anything that has a negative effect on participants’ welfare, broadly construed. The nature of the harm may be social, behavioural, psychological, physical or economic. See “Welfare.”

Human biological materials – Tissues, organs, blood, plasma, skin, serum, DNA, RNA, proteins, cells, hair, nail clippings, urine, saliva, and other body fluids. The term also includes materials related to human reproduction, including embryos, fetuses, fetal tissues and human reproductive materials.

Identified human biological materials – The materials are labelled with a direct identifier (e.g. name, personal health number). Materials and any associated information are directly traceable back to a specific individual.

Coded human biological materials – Direct identifiers are removed from the materials and replaced with a code. Depending on access to the code, it may be possible to re-identify specific individuals (e.g. a principal investigator retains a key that links the coded material with a specific individual if re-linkage is necessary).

Anonymized human biological materials – The materials are 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.

Anonymous human biological materials – The materials never had identifiers attached to them and risk of identification of individuals is low or very low.

Human embryonic stem cell (hESC) – An embryonic stem cell derived from a human embryo.

Human genetic research – The study of genetic factors responsible for human traits and the interaction of those factors with each other, and with the environment.

Human participant – See “Participant.”

Human reproductive materials – A sperm, ovum, or other human cell, or a human gene, including a part of any of them.

I

Identifiable human biological materials – Human biological materials that may reasonably be expected to identify an individual, alone or in combination with other available information.

Impracticable – Incapable of being put into practice due to a degree of hardship or onerousness that jeopardizes the conduct of the research; it does not mean mere inconvenience.

Incentive – Anything offered to participants, monetary or otherwise, to encourage participation in research.

Incidental findings – Unanticipated discoveries made in the course of research that are outside the scope of the research.

Indigenous knowledge – See “Traditional knowledge.”

Indigenous peoples – See “Aboriginal peoples.”

Induced pluripotent stem cell (iPSC) – A type of pluripotent stem cell, similar to an embryonic stem cell, formed by the introduction of certain embryonic genes into a somatic cell.

Information (Types)

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

Indirectly 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).

Coded 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 name so data can be re-linked if necessary).

Anonymized 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.

Anonymous information – The information never had identifiers associated with it (e.g., anonymous surveys) and risk of identification of individuals is low or very low.

Institutional conflicts of interest – An incompatibility between two or more substantial institutional obligations that cannot be adequately fulfilled without compromising one or another of the obligations.

Institutions – The universities, hospitals, colleges, research institutes, centres and other organizations eligible to receive and manage Agency grant funds on behalf of the grant holders and the Agencies.

Intermediary – An individual with the necessary language skills to ensure effective communication between the research team and participants, should any language barriers exist.

J

Justice – A core principle of this Policy that refers to the obligation to treat people fairly and equitably. Fairness entails treating all people with equal respect and concern. Equity requires distributing the benefits and burdens of research participation in such a way that no segment of the population is unduly burdened by the harms of research or denied the benefits of the knowledge generated from it.

M

Medical device trials – Clinical trials that test the safety and/or efficacy of one or more instruments used in the prevention, diagnosis, mitigation, or treatment of a disease or abnormal physical condition or the restoration, correction or modification of body function or structure.

Medical emergency – A situation in which one or more individuals requires urgent medical care.

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

Multi-jurisdictional research – research involving multiple institutions and/or multiple REBs. It is not intended to apply to ethics review mechanisms for research involving multiple REBs within the jurisdiction or under the auspices of a single institution.

N

Natural Health Product (NHP) Trial – A clinical trial testing the safety and/or efficacy of one or more natural health products. The term natural health product is used to describe substances such as vitamins and minerals, herbal medicines, homeopathic preparations, energy drinks, probiotics, and many alternative and traditional medicines.

O

Observational research – The study of behaviour in a natural environment in which people involved in their normal activities are observed whether with or without their knowledge. This term does not include observational methods used in epidemiological research.

Ongoing research – Research that has received REB approval and has not yet been completed.

P

Participant – An individual whose data, or responses to interventions, stimuli, or questions by a researcher are relevant to answering a research question; also referred to as “human participant,” and in other policies/guidance as “subject” or “research subject.”

Participatory research – Research that includes the active involvement of those who are the subject of the research. Participatory research is usually action-oriented, where those involved in the research process collaborate to define the research project, collect and analyze the data, produce a final product and act on the results. See “Community-based research” and “Collaborative research.”

Principal investigator – The leader of a research team who is responsible for the conduct of the research, and for the actions of any member of the research team.

Personal information – Identifiable information about an individual. See “Identifiable information.”

Pharmaceutical trial – A clinical trial designed to test the safety and/or efficacy of a pharmaceutical product.

A pharmaceutical product is any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease, disorders, or other illness.

Placebo-controlled trials – A clinical trial in which the safety or efficacy of one or more interventions are compared with a placebo control group.

A placebo is an inactive substance or intervention that resembles the comparable active substance or intervention.

Pluripotent stem cell – A cell that can become all the cell types that are found in an implanted embryo, fetus, or developed organism, but not embryonic components of the trophoblast and placenta. Pluripotent stem cells include embryonic stem cells, induced pluripotent stem cells and embryonic germ cells.

Possible/Impossible – If an action can be done, regardless of the level of difficulty required to do it, it is possible. If an action cannot be done under any circumstances, it is impossible. For example, it is possible to offer debriefing to participants who have participated anonymously in an online survey by providing them with the researchers’ email for the purpose of requesting debriefing information at the point of exit from the survey. In the case of secondary use of data or materials that have been stored for decades  without any identifiers or contact information  it is impossible to offer a consent process or a debriefing to the original providers of these data or materials (see Chapter 5, Key Concepts).

Practicable/Impracticable – An action is practicable if it is possible and it is reasonable to expect the action to be done. For example, it is practicable to offer consent materials and task instructions in multiple languages when members of the desired participant population speak different languages and there is no common language understood by all participants. An action is possible but not practicable when circumstances render a possible action unreasonably difficult to execute, or, the action will jeopardize the ability of the researcher to address the research question. For example, in a study examining the effect of two types of exit signage (alternated daily for two weeks) on crowd behaviour in a stadium, it would be impracticable to seek prior consent without affecting the behaviour under observation. It may be practicable to offer debriefing once the study is concluded, by advertising the availability of information about the study to the community that makes use of the stadium.

Privacy – An individual’s right to be free from intrusion or interference by others.

Privacy risks – The potential harms that participants, or the groups to which they belong, may experience from the collection, use, and disclosure of personal information for research purposes.

Proportionate approach to research ethics review – The assessment of foreseeable risk to determine the level of scrutiny a research proposal will receive (i.e. delegated review for minimal risk research or full REB review for research above minimal risk), as well as the consideration of foreseeable risks, potential benefits, and ethical implications of the research in the context of initial and continuing review.

Psychotherapy trials – A clinical trial testing the safety and/or efficacy of one or more psychotherapeutic approaches to behavioural disorders or other mental illness.

Publicly declared emergency – An emergency situation which, due to the extraordinary risks it presents, has been proclaimed as such by an authorized public office (in accordance with legislation and/or public policy). Publicly declared emergencies are extraordinary events that arise suddenly or unexpectedly, and require urgent or quick responses to minimize devastation. Examples include hurricanes and other natural disasters, large communicable disease outbreaks, catastrophic civil disorders, bio-hazardous releases, environmental disasters, and humanitarian emergencies.

Publicly available information – Any existing stored documentary material, records or publications, which may or may not include identifiable information, and that has no restrictions on its use or distribution, or that may be released under certain legal conditions.

Q

Qualitative research – An approach that aims to understand how people think about the world and how they act and behave in it. This approach requires researchers to understand phenomena based on discourse, actions, and documents, and how and why individuals interpret and ascribe meaning to what they say and do, and to other aspects of the world (including other people) they encounter.

R

Reciprocal research ethics board (REB) review – An official agreement between two or more institutions, in which they accept, with an agreed level of oversight, the research ethics reviews of each other’s REBs.

Reimbursement – Payment to participants to ensure that they are not put at a direct, or indirect, financial disadvantage for the time and inconvenience of participation in research. Direct expenses refer to the costs incurred, and indirect expenses refer to losses that arise, because of research participation.

Research – An undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation.

Research agreement – A document that serves as a primary means of clarifying and confirming mutual expectations and, where appropriate, commitments between researchers and communities.

Research directive – Written instructions used to express an individual’s preferences for participation in future research, in the event that the individual loses decision-making capacity. It is intended to guide the individual’s authorized third party in deciding whether or not to give substitute consent for the individual to participate in research.

Research ethics board (REB) – A body of researchers, community members, and others with specific expertise (e.g. in ethics, in relevant research disciplines) established by an institution to review the ethical acceptability of all research involving humans conducted within the institution’s jurisdiction or under its auspices.

Research ethics education and training – The provision of materials and corresponding instruction by an institution to research ethics board (REB) members or researchers with regard to the core principles and understanding of this Policy, basic ethics standards, applicable institutional policies, and legal or regulatory requirements. This term also includes an understanding of the role and mandate of REBs and responsibilities of REB members.

Research involving partial disclosure or deception – A type of research, in which the participant may not know that they are part of a project until it is over or is not informed of the true purpose of the research in advance. See “Debriefing.”

Respect for Persons – A core principle of this Policy that recognizes the intrinsic value of human beings and the respect and consideration that they are due. It incorporates the dual moral obligations to respect autonomy and to protect those with developing, impaired, or diminished autonomy.

Risk – The possibility of the occurrence of harm. The level of foreseeable risk posed to participants by their involvement in research is assessed by considering the magnitude or seriousness of the harm and the probability that it will occur, whether to participants or to third parties.

S

Secondary use – The use in research of information or human biological materials originally collected for a purpose other than the current research purpose.

Security – Measures taken to protect information. It includes physical, administrative, and technical safeguards.

Sex – Refers to a set of biological attributes in humans and animals. It is primarily associated with physical and physiological features including chromosomes, gene expression, hormone levels and function, and reproductive/sexual anatomy. Sex is usually categorized as male or female but there is variation in the biological attributes that comprise sex and how those attributes are expressed.

Shall – Indicates a mandatory provision.

Should – Indicates guidance for the interpretation of the core principles.

Somatic cell – Any body cell other than gametes (egg or sperm); sometimes referred to as "adult" cells.

Somatic (adult) stem cell – A relatively rare undifferentiated cell found in many organs and differentiated tissues with a limited capacity for both self-renewal (in the laboratory) and differentiation. Such cells vary in their differentiation capacity, but it is usually limited to cell types in the organ of origin. These are stem cells with a more restricted differentiation capacity than pluripotent stem cells.

Stem cell – A cell that has the ability to divide for indefinite periods in culture and to give rise to specialized cells.

Stopping rules – Statistically significant end points and safety considerations for a clinical trial that are determined in advance, and, once reached, dictate that the trial must be terminated.

Surgical trials – A clinical trial which compares the safety and/or efficacy of different surgical techniques.

T

Therapeutic misconception – A misunderstanding, on the part of participants, of the purpose, benefits, and/or risks of clinical trials. Often participants do not understand that research is aimed primarily at producing knowledge and may not provide any therapeutic benefit to them.

Traditional knowledge – The knowledge held by First Nations, Inuit and Métis peoples, the Aboriginal peoples of Canada. Traditional knowledge is specific to place, usually transmitted orally, and rooted in the experience of multiple generations. It is determined by an Aboriginal community’s land, environment, region, culture, and language. It may also new knowledge transmitted to subsequent generations.

U

Unanticipated issues – Issues that: occur during the conduct of research; may increase the level of risk to participants or have other ethical implications that may affect participants’ welfare; and were not anticipated by the researcher in the research proposal submitted for research ethics review.

Undue influence – The impact of an unequal power relationship on the voluntariness of consent. This may occur when prospective participants are recruited by individuals in a position of authority over them (e.g. doctor/patient, teacher/student, employer/employee). See “Coercion.”

V

Vulnerability – A diminished ability to fully safeguard one’s own interests in the context of a specific research project. This may be caused by limited decision-making capacity or limited access to social goods, such as rights, opportunities and power. Individuals or groups may experience vulnerability to different degrees and at different times, depending on their circumstances. See also “Autonomy.”

W

Welfare – The quality of a person’s experience of life in all its aspects. Welfare consists of the impact on individuals and/or groups of factors such as their physical, mental and spiritual health, as well as their physical, economic and social circumstances.

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