Convert To Word Legal Maryland Consent Forms For Free

If you prefer to write your own consent document, you may do so, but be sure to include all required elements of informed consent.

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.

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. US federal regulations require a full, detailed explanation of the study and its potential risks.

Consent documents are more understandable if they are written just as the clinical investigator would give an oral explanation to the subject, that is, the subject is addressed as "you" and the clinical investigator as "I/we." This second person writing style also helps to communicate that there is a choice to be made ...

The Common Rule requires the informed consent form to be focused and understandable per 45 CFR 46.166(a)(4). To accomplish this, there is now a requirement that a concise summary explaining the research precede the body of the consent form. For examples of concise summaries, see Template Concise Summary Document.

To ensure informed consent, a consent form must include the following: A statement of activity. The purpose of the activity. Procedures. Risks to the participant. Benefits to the participant. Cost of participation. Confidentiality. Voluntary participation.