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The consent form should include the following statements: I understand that my participation is voluntary, that I can choose not to participate in part or all of the project, and that I can withdraw at any stage of the project without being penalized or disadvantaged in any way. I agree to take part in this study.

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.

The informed consent documentation should be friendly, straightforward, and conversational. Ideally, the adult informed consent documents should be written at or below an 8th grade reading level, with a readability score of more than 50 (the higher the score, the easier your document is to read).

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

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.

A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.

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.

4-Step Guide: How to Make a Consent Form Choose a sample consent form to customize. To begin, choose from a selection of sample consent forms and customize them easily to suit your specific needs. Adjust the form's design. Publish your form online. Get consent and print the documents if needed.

A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.