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This document serves as an informed consent form for parents or legal guardians allowing their child to participate in the TrialNet Natural History Study to screen for the development of Type 1 Diabetes,
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How to fill out Parent or Legally Authorized Representative Informed Consent Document for Research

01
Begin by reading the entire informed consent document to understand its contents.
02
Complete the participant's information section with the child's name, date of birth, and any other identifying details.
03
Fill out your name as the parent or legally authorized representative.
04
Provide your contact information in the designated area.
05
Review the purpose of the research study, ensuring you understand what it involves.
06
Go through the risks and benefits section, and ask questions if anything is unclear.
07
Indicate your consent by signing and dating the document in the provided spaces.
08
Keep a copy of the signed consent document for your records.

Who needs Parent or Legally Authorized Representative Informed Consent Document for Research?

01
The Parent or Legally Authorized Representative Informed Consent Document for Research is needed for any research involving minors or individuals who are unable to consent for themselves.
02
This includes situations where the participant is a child, or when their legal guardian or representative must provide consent on their behalf.
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A legally authorized representative is an individual who, under law, has the ability to act on behalf of another person (such as a minor study participant). The LAR may be a parent, grandparent, caregiver who has the legal authority to grant consent on behalf of another who has been invited to participate in research.
The LAR may be a parent, grandparent, caregiver who has the legal authority to grant consent on behalf of another who has been invited to participate in research.
The Key Differences between a POA and a PR: Purpose: A Power of Attorney is often used for incapacity planning or to facilitate decision making during the individual's lifetime, while a PR is appointed to handle the affairs of a deceased individual's estate after their death.
The physician ordering or providing the care, is responsible for obtaining the patient's informed consent prior to the provision of the care.
Unless written consent has been waived as a requirement for the study, the participants who do not speak English must be provided with: A written consent document in a language understandable to them AND. An interpreter fluent in both English and the participant's spoken language to aid in the consent process.
In general, permission should be obtained from both parents before a child is enrolled in research. However, the Institutional Review Board (IRB) may find that the permission of one parent is sufficient for research to be conducted under 46.404 or 46.405.
Legally authorized representative (LAR) means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research (45 CFR 46.102(c)).
“LAR means an individual, or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.” 45CFR.

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It is a document designed to inform parents or legally authorized representatives about a research study involving a minor or individuals unable to provide consent themselves, ensuring they understand the study's purpose, procedures, risks, and benefits before agreeing to participate.
Researchers or institutions conducting studies that involve minors or individuals who are not capable of giving informed consent are required to file this document.
To fill out the document, the person responsible should read the entire consent form, ensuring all sections are completed, including participant details, study description, risks and benefits, and signature from the parent or legal representative, along with the date.
The purpose is to ensure that parents or legally authorized representatives are adequately informed about the research, allowing them to make an educated decision regarding the participation of the minor or individual in the study.
The document must include information such as the study's title, purpose, procedures, potential risks and benefits, and the right to withdraw from the study, as well as contact information for the research team.
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