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- Researchers may request an alteration to consent requirements if they can meet the criteria of Article 3.7A. These include a requirement to satisfy the research ethics board (REB) that it is impossible, impracticable (see Glossary) or inappropriate to address the research question without the requested alteration.
ethics.gc.ca/eng/tcps2-eptc2_2018_chapter3-chapitre3.html
Nov 6, 2023 · Researchers must adhere to all applicable regulations and guidelines when seeking an alteration of consent requirements to ensure the protection of research participants' rights and well-being. Criteria for alterations of consent requirements.
- Introduction
- A. General Principles
- B. Departures from General Principles of Consent
- C. Decision-Making Capacity
- Reference
This chapter sets out the ethical requirements for consent in research involving humans. Throughout this Policy, the term “consent” means “free, informed and ongoing consent.” For the purpose of this Policy, “free” and “voluntary” are used interchangeably. Respect for Persons implies that individuals who participate in research should do so volunta...
Incidental Findings
An “incidental finding” is a discovery about research participants or prospective participants that is made in the course of research, but is outside the objectives of the research study. Incidental findings are considered to be material incidental findings if they are reasonably determined to have significant welfare implications for the participant or prospective participant. Material incidental findings may appear at any stage of the research. For example, material incidental findings can...
Articles 3.1 to 3.5set out the default requirements for seeking the consent of individuals to participate in research. However, there are some research questions that cannot be answered without an alteration to these consent requirements. For example, the question of what factors influence whether people will choose to return a wallet dropped by so...
Decision-making capacity refers to the ability of prospective or actual participants to understand relevant information presented about a research project and to appreciate the potential consequences of their decision to participate or not participate. This ability may vary according to the complexity of the choice being made, the circumstances sur...
Centre of Genomics and Policy (CGP), Maternal Infant Child and Youth Research Network (MICYRN), Best Practices for Health Research Involving Children and Adolescents [ PDF (1.16 MB) - external link ], 2012. Retrieved on June 29, 2018. 1. Previous 2. Table of contents 3. Next Date modified: 1. 2020-01-22
research questions that cannot be answered without an alteration to these consent requirements. Under specified circumstances, given a satisfactory rationale by the researcher, an REB may approve the waiver of a consent requirement, or a partial waiver of some elements of a consent requirement.
Researchers should consider the following criteria when determining whether participants can provide their own consent, or whether an authorized third party should be involved: The risk level associated with the research project; The legal requirements for age of consent in that jurisdiction
In some circumstances, an alteration of the standard consent procedures (i.e., partial disclosure/deception or an exception to requirement to seek prior consent) may be permissible. Studies requesting an alteration of consent must meet a rigorous set of criteria outlined in the TCPS 2, including providing a debriefing plan for participants ...
If there was an alteration to the requirement for prior consent in a study involving partial disclosure, then the participants must be able to indicate their consent or refusal following the post-study debriefing.
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Nov 17, 2009 · Alterations to Consent Requirements (TCPS 2 (2022), Chapter 3, Article 3.7A) The Research Ethics Board (“REB”) may approve research that involves an alteration to the requirements for consent if the REB is satisfied, and documents, that all of the following apply:
