Characteristics of the Adult Consent Form for Non-Therapeutic Research That is Less Than Minimal Risk
A study is classified as less than minimal risk if no known risk is associated with any of the study procedures.
- If the study is classified as less-than-minimal risk the narrative consent form format should be used. The elements of consent are not identified by subheadings except for the Documentation of Informed Consent.
- The consent form should be written in the second person and include all the elements of informed consent arranged sequentially.
- The Purpose of the Study should be restricted to a statement of the scientific purpose.
- The Documentation of Informed Consent should contain the subject’s concluding consent statement.
- A place for the subject to initial each page of a consent should be provided.
- The date of final IRB approval of the consent form should be placed below the Identification of Investigators in the Documentation of Informed Consent section.
CLICK HERE FOR A SAMPLE OF THE ADULT CONSENT FORM FOR NON-THERAPEUTIC RESEARCH THAT IS LESS THAN MINIMAL RISK.