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.
CLICK HERE FOR A SAMPLE OF THE ADULT CONSENT FORM FOR NON-THERAPEUTIC RESEARCH THAT IS MINIMAL RISK.