The consent form should include the following statements: I confirm that I have had the project explained to me, and have read the participant information sheet, which I may keep for my records. I have been given the opportunity to ask questions and have had them answered to my satisfaction.
Obtaining Written or Verbal Informed Consent. Obtaining consent involves explaining the research and assessing participant comprehension using a consent document, usually a written consent form or information sheet, as a guide for the verbal explanation of the study.
To create a consent form, you need to list the consenting parties and specify the activities or data covered by the consent. It should also state the parties' rights and responsibilities and include dates, contact information, and other necessary details.
The subject or the subject's legally authorized representative or the parent(s) must sign the short form, and the person actually obtaining the consent must sign the copy of the summary (45 CFR 46.117(b)(2)).
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.
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 include the following statements: I confirm that I have had the project explained to me, and have read the participant information sheet, which I may keep for my records. I have been given the opportunity to ask questions and have had them answered to my satisfaction.
What Is Informed Consent? There are 4 components of informed consent including decision capacity, documentation of consent, disclosure, and competency. Doctors will give you information about a particular treatment or test in order for you to decide whether or not you wish to undergo a treatment or test.
If you prefer to write your own consent document, you may do so, but be sure to include all required elements of informed consent.