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Informed Consent Process for Patient Participation in Rare Disease Registries Linked to Biorepositories Summary: As plans are moving ahead to establish the Global Rare Disease Patient Registry- Data Repository
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The informed consent process is for ensuring that individuals are fully informed about a medical procedure or research study before deciding to participate.
Researchers, healthcare providers, or institutions conducting medical procedures or research studies are required to file informed consent processes.
Informed consent forms should be filled out by providing detailed information about the procedure or study, potential risks and benefits, and obtaining the individual's signature indicating their understanding and agreement.
The purpose of the informed consent process is to protect individuals' rights, autonomy, and well-being by ensuring they have the necessary information to make an informed decision about participating in a medical procedure or research study.
Informed consent forms must include details about the procedure or study, potential risks and benefits, confidentiality, alternatives, and the right to withdraw at any time.
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