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Considerations in preparing the informed consent document: Elements of consent present. Complete explanations. Lay language. Protection of confidentiality. No unproven claims of effectiveness. Device studies include a statement that the study includes an evaluation of the safety of the test article.

The consent form should describe if/when identifiable data will be destroyed and how such data will be protected and how it will be used or shared. Language - Consent forms should be written in the 2nd person (i.e., "you are") and in a language that is clear, concise, and understandable to the subject population.

In law, countersignature refers to a second signature onto a document. For example, a contract or other official document signed by the representative of a company may be countersigned by their supervisor to verify the authority of the representative.

Take the photocopied document and the original and ask the person to certify the copy by: writing 'Certified to be a true copy of the original seen by me' on the document. signing and dating it. printing their name under the signature. adding their occupation, address and telephone number.

What to include in a consent form? a name and contact details of a client/participant. detailed description for the activity, including both sides' responsibilities. terms and conditions that a person consents to. a personal signature.

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.

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 subject's 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.