| Term | Meaning |
|---|---|
| Ad hoc advisor | An individual with relevant and competent knowledge and expertise consulted by a Research Ethics Board (REB) for a specific research ethics review, and for the duration of that review in the event that the REB members lack specific expertise or knowledge to review with competence the ethical acceptability of a research proposal. The ad hoc advisor is not a formally appointed member of the REB and is not counted in quorum or allowed to vote on REB decisions. |
| Adverse event (AE) | Any untoward medical or study related occurrence with a research participant, administered investigational product, including an occurrence which does not have a causal relationship with this product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of an investigational product, whether or not it is related to the investigational product. |
| Alternate member | A formally appointed voting member of the Research Ethics Board (REB) who may substitute for a regular member of the REB but who is not expected to attend every REB meeting. An alternate REB member’s presence at the REB meeting in the place of an absent regular REB member is used to establish quorum. |
| Amendment | A written description of a modification or change(s) to the previously approved research study. Amendments include any changes to the protocol or related research documents, such as changes to the consent form, revisions to the Investigator Brochure, updated participant material, etc. |
| Assent | Affirmative agreement to participate in research by an individual unable to provide consent. |
| Authorized signatory | Individual(s) authorized to sign documents on behalf of an organization. |
| Authorized third party | Any person with the necessary authority to make decisions on behalf of the prospective participant who lacks the capacity to consent to participate, or to continue to participate, in a particular research project. (Also known as a “legally acceptable representative” or “substitute decision-maker”). |
| Confidentiality | Refers to the agreement between the Researcher and the participant as to how personal data will be managed and used, and an ethical and/or legal responsibility to safeguard information from unauthorized use, disclosure, modification, loss or theft. The term also refers to the ethical and/or legal responsibility of the Reseach Ethics Board (REB) to safeguard information in its custody from unauthorized use, disclosure, modification, loss or theft. |
| Conflict of Interest (COI) |
Circumstance of a person (e.g., Researcher or Research Ethics Board (REB) member) or organization in a real, perceived, or potential conflict between their duties or responsibilities related to research and their personal, institutional or other (secondary) interests. Example: COI may occur when an individual’s judgments and actions or an organization’s actions in relation to research are, or could be, affected by personal, organizational or other interests, including, but not limited to, business, commercial or financial interests, whether of individuals, their family members, their friends, or their former, current or prospective professional associations or of the organization itself.
Examples of secondary interests for an REB member include the following:
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| Continuing research ethics review (also referred to as “continuing 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. |
| Controlled forms | Documents that require formal change control, and that form part of the permanent record of Research Ethics Board (REB) operations and processes. |
| Data and Safety Monitoring Board (DSMB) | 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 research procedures, and monitoring the overall conduct of the research. |
| 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 review (also referred to as expedited review) | The level of Research Ethics Board (REB) review assigned to minimal risk research studies, to minor changes in approved research and to continuing review applications that meet the delegated review criteria. Delegated reviewers are selected from among the REB membership to conduct the review. |
| Designee | Refers to a member of the Research Ethics Board (REB) or to the REB Office Personnel depending on the context of the statement and the accompanying requirements of the organization. |
| Expiry date | The first day that the Research Ethics Board (REB) approval of the research is no longer valid without further review and approval by the REB. When the REB determines that review more than annually is required, the expiration date will be determined by the REB (e.g., six months from the date of the approval). |
| Full Research Ethics Board (REB) review | The level of Research Ethics Board (REB) review assigned to above minimal risk research studies. Conducted by the full membership of the REB, it is the default requirement for the ethics review of research involving human participants. |
| 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. |
| Impartial | Without prejudice or bias, fair; a principle of justice holding that decisions should be based on objective criteria, rather than on the basis of bias, prejudice, or preferring the benefit to one person over another. |
| 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 research participants, monetary or otherwise, to encourage participation in research. |
| Incidental findings | Unanticipated discoveries made during the course of research that are outside the scope of the research project. Material incidental findings are findings that have been interpreted as having significant welfare implications for the participant, whether health- related, psychological or social. If, in the course of research, material incidental findings are discovered, Researchers have an obligation to inform the participant. |
| Indigenous peoples | In Canada, the term “Indigenous peoples” refers to persons of First Nations, Inuit, or Metis descent, regardless of where they reside and whether their names appear on an official register. In Canada, a comparable term, “Aboriginal peoples,” is also used in certain contexts. |
| Inspection | A systematic examination and evaluation of study-related activities and documents in comparison to specified requirements and standards. |
| 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 |
| Investigational product | Refers to new or new uses of drugs, biologics, medical devices or natural health products. |
| Local adverse event | Those adverse events experienced by research participants enrolled by the Researcher at the centre(s) under the jurisdiction of the Research Ethics Board (REB). |
| Mature minor | An individual who demonstrates adequate understanding and decision- making capacity. |
| 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. |
| Minimal risk | 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 those aspects of their everyday life that relate to the research. |
| Minor change | Any change that would not materially affect an assessment of the risks and benefits of the research or the integrity of the data and does not substantially change the specific aims or design of the study. |
| Multi-centred | Research is reasonably expected to be conducted at more than one centre. |
| Natural health product (NHP) trial | A clinical trial testing the safety and/or efficacy of one or more nNHPs, is used to describe substances such as vitamins, minerals, herbal medicines, homeopathic preparations, energy drinks, probiotics, and many alternative and traditional medicines. |
| Non-compliance | Failure to follow applicable guidelines and regulations governing human participant research; failure to follow the protocol approved by the Research Ethics Board (REB), or failure to follow stipulations imposed by the REB as a condition of approval. |
| Non-controlled forms | Documents that are not part of the permanent record of Research Ethics Board (REB) operations and processes. Non-controlled forms also will contain version dates. |
| Non-local (external) adverse event (EAE): | Those adverse events experienced by research participants enrolled by Researchers at other centres/organizations outside the REB’s jurisdiction. |
| Ongoing research | Research that has received Research Ethics Board (REB) approval and has not yet been completed. |
| Organizational Official | A senior official who can authorize an organization's human participants’ assurance, making a commitment on behalf of the organization to comply with 45 CFR Part 46, the US Code of Federal Regulations covering protection of human participants, and with Health Canada regulations. |
| 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.” |
| Periodic safety update or summary report | A summary report, created by the sponsor, listing all reported unexpected serious adverse events that have occurred during a given reporting period, and which includes any significant areas of concern and the evolving safety profile of the investigational product. |
| Personal health information |
PHI, is a subset of Personal information which is identifiable information about an individual. (See “Identifiable information” which also is “personal information”) PHI is identifying information about an individual in either an oral or in a recorded form, if the information:
Any other information about an individual that is included in a record containing personal health information is also included in this definition. This definition does not include information about an individual if the information could not reasonably be used to identify the individual. |
| Personal information (also referred to as “identifiable information”) |
Information that identifies an individual and/or for which it is foreseeable that may reasonably be expected to identify an individual, alone or in combination with other available information. Directly identifying information: Information that identifies a specific individual through direct identifiers (e.g., name, social insurance number, personal health number). |
| Privacy | An individual’s right to be free from intrusion or interference by others, including and their interest in controlling the access of others to themselves (their personal information). |
| Privacy breach | The unauthorized collection, use, or disclosure of personal information or personal health information (PHI) in the custody and control of an individual or a Health Information Custodian (HIC) or in the custody and control of the organization or its affiliated partners. |
| Proportionate approach to research ethics review | The assessment of foreseeable risk to determine the level of scrutiny the research will receive (i.e., delegated review for minimal risk research or full Research Ethics Board (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. |
| Protocol deviation | Are identified as any unplanned or unforeseen change to a Research Ethics Board (REB) approved protocol or protocol procedures. Deviations are different from amendments in that they generally apply to a single occurrence or participant and are not intended at the time to modify the entire protocol. |
| Quorum |
Shall include at least five (5) voting members, including (at minimum):
For research subject to the US Code of Federal Regulations, quorum shall also include a majority (50%+1) of voting members. |
| Reportable event | Any circumstance that could significantly impact the conduct of the research or alter the Research Ethics Board’s (REB) approval or favourable opinion to continue the research. |
| Research | An undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation. |
| 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 organization to review the ethical acceptability of all research involving humans conducted within the organization’s jurisdiction or under its auspices. |
| Research Ethics Board (REB) of record | The Research Ethics Board (REB) that has been granted ultimate authority for the ethics review and oversight of a research study. |
| Researcher | 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. (Also known as “Qualified Investigator”). |
| 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. |
| Secondary Use | The use in research of information or human biological materials originally collected for a purpose other than the current research purpose. |
| Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (ADR): | Any untoward medical occurrence that at any dose: results in death, is life threatening, requires inpatient hospitalization of prolongation of existing hospitalization, results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect. |
| Suspension | Temporary or permanent halt to all research activities pending future action by the Research Ethics Board (REB), by the sponsor and/or by the Researcher. |
| Termination | Permanent halt by the Research Ethics Board (REB), by the sponsor and/or by the Researcher to all or some research activities. |
| Tools for Research at Queen's (TRAQ) | An e-submission system designed to streamline research-related administrative processes. |
| 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. |
| University Animal Care Committee (UACC) | Is responsible for the review of all protocols proposing the use of animals in research, teaching, or testing at or indirect affiliation with Queen's University. |
| Vulnerability | 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. |
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