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- If an individual is not determined to be capable of consent with regard to even one of the standards, a legally authorized representative should be consulted and the individual should be asked to provide assent, rather than consent.
www.tc.columbia.edu/institutional-review-board/irb-blog/2022/assessing-potential-research-participants-capacity-to-consent/Assessing Potential Research Participants’ Capacity to Consent
If participants will be provided the choice to opt in or out of certain research elements, consent for those should be sought separately from overall study participation. Clearly indicate that participants can still participate in the study if they do not consent to the optional elements.
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.
We identified three main categories of arguments for the acceptability of a consent waiver: data validity and quality, major practical problems, and distress or confusion of participants. Approval by a medical ethical review board always needs to be obtained.
G. Potential Research Risks or Discomforts to Participants. In order to approve the research, the IRB must consider the risks posed to participants by the research and any efforts to mitigate those risks.
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Mar 25, 2024 · Informed consent is a process of communication between a researcher and a potential participant in which the researcher provides adequate information about the study, its risks and benefits, and the participant voluntarily agrees to participate.
Aug 2, 2022 · Researchers should carefully assess an individual’s capacity to consent using evidence-based standards that are relevant to their population of interest and are based on a list of justifiable and reasonable standards.
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In order for participants to give meaningful consent, they should be able to understand the intent of the research, be clear about what they are being asked to do and if any risks are involved, and know how their information will be used. Consent may be documented in many ways.
