Understanding Informed Consent Components in Research Studies
Explore the essential components of informed consent in research studies, including study description, risks, benefits, confidentiality, and more. Learn about the importance of conveying understanding and agreement before participating.
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Presentation Transcript
Informed Consent and Assent In the Global Early Adolescent Study 1 1 The Global Early Adolescent Study: Informed Consent and Assent
What is Informed Consent? Consent is: Conveys understanding of the research and agreement to participate Gives complete information about the study Required from every study participant before they begin contributing to research Recorded on an IRB-approved written document 2 2 The Global Early Adolescent Study: Informed Consent and Assent
Informed Consent Components Study description Risks Benefits Alternatives Confidentiality Compensation Contacts Voluntary participation and ability to stop 3 3 The Global Early Adolescent Study: Informed Consent and Assent
Informed Consent Components: Research Name of study Name and contact information of lead researcher Research goals Responsibilities of participants Required tasks Length of study 4 4 The Global Early Adolescent Study: Informed Consent and Assent
Informed Consent Components: Risks and Benefits Physical, social, and mental Anything expected or possible Likelihood of risks or benefits Severity and duration of risks or benefits Factual- do not exaggerate 5 5 The Global Early Adolescent Study: Informed Consent and Assent
Informed Consent Components: Confidentiality Amount of privacy that can be promised Varies depending on the type of study Specify who can have access to the information If in a group setting, information should remain private within the group 6 6 The Global Early Adolescent Study: Informed Consent and Assent
Informed Consent Components: Contact Research team members IRB 7 7 The Global Early Adolescent Study: Informed Consent and Assent
Informed Consent Components: Voluntary Participation Own choice to decide to participate Able to stop participating at any time No penalty for withdrawing 8 8 The Global Early Adolescent Study: Informed Consent and Assent
Consent Vs. Assent Informed consent gives researchers permission to include an eligible adult in the research study Informed assent gives researchers permission to include an eligible minor (under age 18) in the research study When recruiting adolescents, need both parental or legal guardian consent and teen assent for research participation 9 9 The Global Early Adolescent Study: Informed Consent and Assent
