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INFORMED CONSENT WITH HIPAA AUTHORIZATION TEMPLATEUpdated 9/14/2020 Instructions for Research Team:This document must be written in commonly used, easily understood language (not above 8th grade reading
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01
Start by reading the informed consent form thoroughly to understand the purpose, risks, benefits, and procedures involved in the study.
02
If you have any questions or concerns, consult with the researcher or a medical professional before signing the form.
03
Provide your personal information accurately on the form, such as your name, contact details, age, and any relevant medical history.
04
Make sure to clearly understand and acknowledge your voluntary participation in the study, knowing that you have the right to withdraw at any time without penalty.
05
If there are any specific requirements or actions you need to take during the study, ensure that you comprehend and agree to them.
06
If you are agreeing to participate on behalf of someone else, ensure that you have the legal authority to do so and understand the responsibilities involved.
07
Sign and date the informed consent form to indicate your understanding, agreement, and willingness to participate.

Who needs informed consent - only?

01
Informed consent is typically required for individuals who participate in research studies, clinical trials, medical treatments, or any situation where their personal information or well-being may be involved. This includes patients, volunteers, and individuals who are part of a specific target group identified for the study or treatment.

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Informed consent is a process through which a patient or participant voluntarily confirms their willingness to participate in a particular procedure or research study after being informed of all relevant facts, risks, and potential benefits.
Researchers and healthcare providers who conduct clinical trials or medical procedures involving human participants are required to file informed consent.
To fill out informed consent, one must provide the participant with comprehensive information regarding the study or procedure, then have them read and sign the consent form, ensuring they understand and agree to the terms.
The purpose of informed consent is to ensure that individuals are fully aware of what participation entails and to protect their autonomy by allowing them to make informed choices regarding their involvement.
The informed consent must report information including the purpose of the research, procedures involved, potential risks and benefits, the right to withdraw, and confidentiality assurances.
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