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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.
Build your form Identify required information. You will need to identify the required information for your consent form. ... Create a digital form. ... Set field validation rules. ... Identify required fields. ... Save and publish. ... Pick your tool. ... Distribute your form. ... Set completion date, enable reminders, track status.
Implied Consent. Participation in a certain situation is sometimes considered proof of consent. ... Explicit Consent. ... Active Consent. ... Passive Consent. ... Opt-Out Consent. ... Key Takeaway.
The main purpose of the informed consent process is to protect the patient. A consent form is a legal document that ensures an ongoing communication process between you and your health care provider.
A waiver is legal document releasing or relinquishing a known right, claim, or privilege. In this context, it is the relinquishment to pursue a claim in a certain set of defined circumstances. Informed consent is a written acknowledgement that a participant understands the risks inherent in a particular activity.

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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. ... Key Takeaway.
Build your form Identify required information. You will need to identify the required information for your consent form. ... Create a digital form. ... Set field validation rules. ... Identify required fields. ... Save and publish. ... Pick your tool. ... Distribute your form. ... Set completion date, enable reminders, track status.
A statement that the study involves research, an explanation of the purposes of the research, the expected duration of a subject's participation, a description of the procedures to be followed, and if applicable identification of any experimental procedures.
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.
A waiver of informed consent completely waives the requirement to obtain informed consent. The IRB may approve a consent procedure which does not include some or all of the required elements of informed consent provided all of the following are true: The research involves no more than minimal risk.

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