Characteristics of the Adult Consent Form for Non-Therapeutic Research That is Minimal Risk

Characteristics of the Adult Consent Form for Non-Therapeutic Research That is Minimal Risk
Federal law requires that a specific format be followed in the consent form for research that poses minimal risk.

If the study is classified as minimal risk, the consent form format required by federal law should be used. All elements of consent should be identified by required subheadings.

The consent form should be written in second person. The Elements of Informed Consent should be arranged sequentially.

The Purpose of the Study should be restricted to a statement of scientific purpose.

The Documentation of Informed Consent should contain the concluding consent statement required for research of minimal risk or greater.

A place for the subject to initial each page of the consent form should be provided.

The date of final IRB approval of the consent form should be placed below the Identification of Investigators section.