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The informed consent process involves three key features: (1) disclosing to potential research subjects information needed to make an informed decision; (2) facilitating the understanding of what has been disclosed; and (3) promoting the voluntariness of the decision about whether or not to participate in the research.
There are two types of consent that a patient may give to their medical provider: express consent and implied consent. Express consent is typically done in writing, while implied consent is typically conveyed through a patients actions or conduct.
Types of Consent/Assent Written Informed Consent Document: Waiver of Signed Documentation of Informed Consent: Waiver or Alteration of SOME Informed Consent Elements: Waiver of ALL Informed Consent Document Elements: Oral Informed Consent Script:
Simply put, enthusiastic consent means looking for the presence of a yes rather than the absence of a no. Enthusiastic consent can be expressed verbally or through nonverbal cues, such as positive body language like smiling, maintaining eye contact, and nodding.
Valid informed consent for research must include three major elements: (1) disclosure of information, (2) competency of the patient (or surrogate) to make a decision, and (3) voluntary nature of the decision.

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Implied Consent. Participation in a certain situation is sometimes considered proof of consent. Explicit Consent. Active Consent. Passive Consent. Opt-Out Consent.
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.
The informed consent document should succinctly describe the research as it has been presented in the IRB application. Use the second (you) or third person (he/she) to present the study details. Avoid use of the first person (I). Include a statement of agreement at the conclusion of the informed consent document.
The consent form provides potential research subjects sufficient written information to decide whether to participate in a research study or not based on an explanation of the proposed research and the nature of the participation that is requested of them.
I voluntarily agree to take part in this study. I understand I will receive a copy of this consent form. I understand that photographs (audio/video recordings) may be taken during the study. I consent to use of my photograph (audio/video) in presentations related to this study.

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