Parental Consent Form for Non-Therapeutic Research, Less than Minimal Risk
- If a study is classified as less than minimal risk, the narrative consent form format can be used. This means that the elements of consent are not identified by subheadings except for the Documentation of Informed Consent.
- The consent form should be written in proxy style that clearly indicates the child as the subject. Elements of Informed Consent should be arranged sequentially.
- The Purpose of the Study should be restricted to a statement of scientific purpose.
- Because the research poses less than minimal risk, the Documentation of Informed Consent should contain the simplified parental concluding consent statements.
- A place for the parents 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.
SAMPLE OF THE PARENTAL CONSENT FORM FOR NON-THERAPEUTIC RESEARCH THAT IS LESS THAN MINIMAL RISK.
