|Ad hoc advisor||a person with relevant and competent knowledge and expertise consulted by an 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 member of the REB and is not counted in the quorum or allowed to vote on REB decisions.|
|Adverse event (AE)||any untoward medical occurrence in 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 related to the investigational product.|
|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).|
|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.|
|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”).|
|Canadian Collaboration for Child Health: Efficiency and Excellence in the Ethics Review of Research (CHEER)||a cross-province streamlined ethics review process for multi-site studies to achieve a single ethics review for child health studies in Canada.|
|Clinical Trials Ontario (CTO)||CTO Stream, our Ontario-built online system, enables all research sites participating in a clinical trial to undergo a single ethics review rather than separately applying to their local research ethics boards, reducing the time and labour required to obtain research ethics approval.|
|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 REB’s ethical and/or legal responsibility 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.
Examples of secondary interests for a Researcher include the following:
|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||may refer 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.|
|General Research Ethics Board (GREB)||has the authority to review any proposed research involving human participants that is conducted under the auspices of Queen's University.|
|Health Sciences and Affiliated Teaching Hospitals Research Ethics Board (HSREB)||has the authority to review proposed research involving human participants that are being conducted under the auspices of Queen's University.|
|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 in the course of research that are outside the scope of the research. 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 Indian (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.|
|Mature minor||is 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||multi-centre means that the 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 natural health products (NHP). The term NHP is used to describe substances such as vitamins and 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.|
|Ongoing research||research that has received Research Ethics Board (REB) approval and has not yet been completed.|
|Organizational Official||a senior official who signs 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.|
|Ontario Cancer Research Ethics Board (OICR)||a collaborative research institute that conducts and enables high-impact translational cancer research.|
|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 of the reported unexpected serious adverse events that have occurred in a given reporting period, and which includes any significant areas of concern and the evolving safety profile of the investigational product.|
|Personal health information||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”)
Personal health information is identifying information about an individual in either an oral or in a recorded form, if the information:
|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: 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 Researcher retains a list that links the participant’s code name 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.
|Privacy||an individual’s right to be free from intrusion or interference by others. Privacy refers to persons 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||the term protocol deviation is not well defined by regulations or guidelines, but deviations 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||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||includes anything 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.|
|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”).|
|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.|
|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.|
|Suspension||a 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||a 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.|
|Unanticipated problem||any incident, experience, or outcome (including an adverse event) that meets all of the following criteria:
|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||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.