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How to Reorder Pages Detailed Medical Consent

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Misti Ault Anderson: Hello, everyone, and welcome to our session today on Simplifying Informed Consent. My name is Misti Ault Anderson, and I am here with my colleague, Yvonne Lau. We both work in the Division of Education and Development in the HHS Office for Human Research Protections. And we are looking forward to talking with you today about the informed consent process, the new requirements and how to use these to get a really meaningful informed consent in a more simplified manner to make it easier for you and for your research participants to understand and join your study. So thank you for joining us today. This session is scheduled for an hour and 45 minutes. We will talk for probably 75 to 90 minutes of that, and then well be opening it up for questions. If you have questions that youd like to submit for us to answer, please enter them into the Q and A portion of the Zoom so that we can address them all through the Q and A as opposed to the chat. So again, please use the Q

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What are the criteria needed to satisfy valid consent?

3 key elements: it must be voluntary. the patient must have the capacity to consent. the patient must be properly informed.

How do you document the informed consent process?

Informed consent is documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subjects legally authorized representative at the time of consent. A copy of the signed and dated consent form must be given to the person signing the form.

What information needs to be included in a consent form?

The consent form must identify the subjects alternatives to participation in the protocol and should offer a discussion of their relative advantages and disadvantages. It is usually not necessary to provide a full account of the risks and benefits of alternative treatments in the research consent form.

What are the 4 components of consent?

Four core criteria must be met: the patient giving consent must have capacity the consent must be freely given the consent must be sufficiently specific to the procedure or treatment proposed the consent must be informed.

What are the 5 elements of informed consent?

Informed Consent Checklist (1998) A statement that the study involves research. An explanation of the purposes of the research. The expected duration of the subjects participation. A description of the procedures to be followed. Identification of any procedures which are experimental.

What are the 7 elements of informed consent?

B. Basic Elements of Informed Consent Description of Clinical Investigation. Risks and Discomforts. Benefits. Alternative Procedures or Treatments. Confidentiality. Compensation and Medical Treatment in Event of Injury. Contacts. Voluntary Participation.

What are the 6 elements of informed consent?

Elements of Informed Consent Title of the Study. Names and Affiliations of the Primary Investigator. If a student is conducting the study, state the students information first. Purpose of the Study. Subject Selection Criteria. Study Procedures. Potential Risks and Discomforts. Potential Benefits. Cost and Compensation.

What are 5 pieces of information that must be on a consent form?

Obtaining informed consent in medicine is process that should include: (1) describing the proposed intervention, (2) emphasizing the patients role in decision-making, (3) discussing alternatives to the proposed intervention, (4) discussing the risks of the proposed intervention and (5) eliciting the patients

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