Characteristics of the Adult Consent Form for Non-Therapeutic Research That is Less Than Minimal Risk
- 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.
SAMPLE OF THE ADULT CONSENT FORM FOR NON-THERAPEUTIC RESEARCH THAT IS LESS THAN MINIMAL RISK.
