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- Alterations to the consent process are possible if all the following are met: (i) there exists no more than a minimal risk to participants; (ii) participants’ welfare will not be adversely affected; (iii) obtaining consent would render answering the research question impos-sible or impracticable; (iv) the nature and extent of the consent alteration are defined; and (v) participants may refuse consent or withdraw data/biological specimens during a poststudy debrief-ing.
www.queensu.ca/vpr/sites/vprwww/files/uploaded_files/Ethics/InformedConsentPaper.pdfInformed consent practices in clinical research: present and ...
Nov 6, 2023 · Alterations to consent requirements may include providing prospective participants with only partial disclosure about the purpose of the study, deceiving prospective participants entirely about the purpose of the study, and not informing participants that they (or their data or biological materials) are involved in a study.
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This template is a guide to assist researchers applying to the Health Canada-PHAC REB. It should not be interpreted as a standard for other institutions. This template follows the guidance provided in TCPS 2 (Chapter 3: The Consent Process) which is the official human research ethics policy of the Canadian federal research granting agencies. Resear...
This template is a guide to assist researchers applying to the Health Canada-PHAC REB. It should not be interpreted as a standard for other institutions. This template follows the guidance provided in TCPS 2 (Chapter 3: The Consent Process) which is the official human research ethics policy of the Canadian federal research granting agencies. Resear...
These forms were created using the REB Secretariat's consent form template as a guide. They are meant to assist researchers applying to the Health Canada-PHAC REB and should not be interpreted as a standard for other institutions. The forms follow the guidance provided in TCPS 2 (Chapter 3: The Consent Process) which is the official human research ...
This form was created using the REB Secretariat's assent form template as a guide. It is meant to assist researchers applying to the Health Canada-PHAC REB and should not be interpreted as a standard for other institutions. The form follows the guidance provided in TCPS 2 (Chapter 3: The Consent Process) which is the official human research ethics ...
What does this all mean for researchers preparing an intervention study with a consent waiver? First, it is important to keep in mind that situations justifying consent waiver are always an exception to the rule. Informed consent should always remain the standard in research with an intervention.
Certain types of research require alternate processes for seeking consent. These are also described in this chapter. Researchers may request an alteration to consent requirements if they can meet the criteria of Article 3.7A.
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
standard processes for obtaining informed consent. Alterations to the consent process are possible if all the following are met: (i) there exists no more than a minimal risk to participants; (ii) participants’ welfare will not be adversely affected; (iii) obtaining consent would render answering the research question impos-
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Re-signing consent forms should be reserved for ethically compelling reasons, such as protecting human subjects from harm or promoting their autonomy. Legally defective consent documents can raise ethical concerns and can have an impact on research subjects, however.
