Glossary of Terms
TPH research ethics approval is valid for one year from the date of the approval letter. Four weeks prior to this anniversary date a Continuing Research Renewal Form is sent to the Principal Investigator if the research project is still ongoing (i.e., An End of Research Reporting Form has not been submitted to the REB through firstname.lastname@example.org).
Research projects which have not deviated from the approved proposal will usually receive a Renewal of REB Approval Letter. This process will continue annually until the project is complete.
Anonymous Information or Human Biological Material
Anonymous Information (and/or human biological material) is information/human biological material which never had identifiers associated with it and the process of data linkage or recording or dissemination of results will not generate identifiable information.
Not Anonymous (Information/Human Biological Material)
All of the following types of information (human biological materials) are not anonymous and have the potential to identify one or more individuals.
1. Directly Identifying Information
The information identifies a specific individual through direct identifiers (e.g., name, social insurance number, personal health number).
2. 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, unique personal characteristic).
3. 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 names so data can be re-linked if necessary).
4. 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.
Authorized Third Party
Delegated REB Review
Projects which are considered to be minimal risk receive a Delegated REB Review. Generally two REB members conduct Delegated Reviews. The results of the assessment are documented and reported to the Full REB.
An epidemiological investigation is a focused examination into the cause(s) of, and risks for, a health condition experienced by a defined population for the specific purpose of intervention, where possible.
A research application is feasible if it can be completed using available TPH resources, to the degree requested, relative to program priorities and other research priorities. Feasibility takes into consideration:
- Ability to provide requested data
- Accessibility of existing records and documents
- Direct and indirect impacts on service delivery or TPH resources
- Timing and duration relative to service delivery
- Demands on potential project participants
- Risk to clients or services
- Relationships between TPH and its clients
Full REB Review
Projects which are considered to be more than minimal risk receive a Full REB Review at a REB meeting where quorum is maintained. Two reviewers, a Primary Reviewer and a Secondary Reviewer, conduct in-depth written reviews of the proposal. The remaining REB Members contribute to the review.
An Investigator(s) is a member of the Research Team who is responsible and accountable for the scientific and/or ethical conduct of at least one component of the research project.
Research is considered to be minimal risk if the probability and magnitude of possible harms associated with the research are no greater than those encountered by the participant in those aspects of his or her everyday life that relate to the research.
Monitoring refers to the continuing review of research projects following approval to determine if they are implemented as approved.
The Principal Investigator(s) (PI) is the leader of the Research Team. The PI has primary responsibility and accountability for the scientific and ethical conduct of the research project, including ensuring that the actions of all members of the Research Team are consistent with the approved research application. The PI also has primary responsibility and accountability for the legal and administrative aspects of the research project.
Policy analysis is the process of assessing situations, defining problems, clarifying values and goals, and developing and recommending options and frameworks for implementing and/or evaluating outcomes.
Policy evaluation is a systematic process for assessing the design, implementation and outcomes of public policies.
Privacy and Information Management Assessment
Research proposals submitted to TPH must comply with the Personal Health Information Protection Act (PHIPA) and the Municipal Freedom of Information and Protection of Privacy Act (MFIPPA) and all relevant regulations. The TPH Privacy and Information Management Liaison Officer is responsible for assessing research proposals to ensure compliance with these statutes and other information management related issues.
Program evaluation is the systematic gathering, analysis, and reporting of data about a program to assist in decision-making. It includes quantitative, qualitative, and/or mixed-method approaches
A proportionate assessment approach to research ethics review involves the consideration of foreseeable risks, the potential benefits, and ethical implications of the proposed research. The level of scrutiny of the research proposal is determined by the level of risk presented by the proposed research.
Quality Improvement (QI)
Quality improvement initiatives are conducted on an ongoing basis and used exclusively for program/service assessment, management and improvement. They include, but are not limited to: identifying measures, standards, and benchmarks related to outcomes; identifying processes used to achieve goals/outcomes; documenting processes; changing processes; and monitoring results.
A research application is assessed as relevant if it is appropriate or significant to the work or mandate of TPH. Relevance takes into consideration the:
- Degree to which the proposed research addresses TPH strategic directions
- Ways in which the results of the proposed research will be useful for planning and/or providing programs and services
- Ways in which the findings of the proposed research will further the understanding of emerging public health issues/new policy developments
- Degree to which the proposed research supports the Ontario Public Health Standards goals and requirements
Research is a systematic investigation designed to develop or establish principles, facts or generalizable knowledge, or any combination of them, and includes the development, testing and evaluation of research. Research may involve the collection of new data using quantitative, qualitative or mixed methods. Research also may involve the analysis or synthesis of existing data or research findings.
The TPH Research Ethics Review Policy has operationalized the term research to further outline distinctions between projects that are, are not, or may be considered to be research. A screening tool has been developed to help the Research Coordinator, in consultation with the Research Ethics Board (REB) Chair and/or Principal Investigator(s) as necessary, determine if a project is research according to this policy.
A project is research if it meets one or more of the following criteria:
- REB review is required as part of the funding arrangements or legislation requirements
- The primary purpose is to contribute to the body of knowledge regarding health and/or health systems that is generally accessible through academic (peer reviewed) literature
- The project is primarily designed to answer a specific research question or to test/generate an explicit hypothesis using qualitative or quantitative methodologies
- The project involves randomization or other systematic sampling techniques to divide participants into different comparison groups
- The project has already been reviewed by another REB
A project is likely to be research if it meets one or more of the following criteria:
- The project is designed to support generalizations that go beyond the particular sample included in the project
- The project imposes additional burdens or collection of additional data on participants beyond what would be expected during standard program/service delivery or role expectation
A project is not research if it does not meet any of the above criteria and if it meets either of the following criteria:
- A routine reporting or investigative practice outlined within an existing approved policy and procedure
- Activities to manage outbreaks by identifying and understanding risks associated with an incident to inform timely public health action
According to the TPH Research Ethics Review Policy, quality improvement initiatives, routine surveillance initiatives, activities to obtain session feedback, staff performance reviews, and student course evaluations are not research. Program evaluation initiatives, epidemiological investigations and projects related to policy analysis and policy evaluation may be research.
Routine surveillance is the (mandatory) systematic and ongoing collection, collation, and analysis of health-related information that is communicated in a timely manner to all who need to know, so that action can be taken. Dissemination of surveillance analyses may take the form of reports, advisories, healthy public policy recommendations, alerts, or warnings.
As part of the organizational assessment, TPH assesses the design and methods of the research to determine if they are capable of answering the research question. TPH will generally avoid duplicating previous assessments of scientific merit.
End of session forms that collect information on topics such as: meeting objectives, presenter(s) knowledge, and educational strategies or approaches used.
TPH Research Ethics Review Criteria
All projects that meet the following TPH research ethics review criteria must undergo a TPH research ethics review:
- The project meets the definition of research as set out in the TPH Research Ethics Review Policy; and
- The project involves human participants (including but not limited to, biological samples) or data related to human participants; and
- The project involves or relates to TPH in at least one of the following ways regardless of who initiates the project (internal, external, collaborative, student):
- The project involves TPH staff or clients as project participants
- The project uses TPH provided information about individuals/their biological materials which is not anonymous.
- The project involves TPH staff, students, or others as delegated, including contract service providers, as Principal Investigator(s) or Investigator(s), as part of their TPH role, accessing participants and/or data related to individuals/their biological materials outside of TPH (if the data/biological materials are not anonymous).