Characteristics of the Adult Consent Form for Non-Therapeutic Research that is Greater than Minimal Risk
- If the study is classified as greater than minimal risk, the consent form format required by federal law should be used. All elements of consent are identified by required subheadings.
- The consent form should be written in the 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.
- Define all technical terms.
- Because the study is classified as greater than minimal risk, the consent form must include the elements titled, “In Case of Emergency Contact Procedure” and “Emergency Care and Compensation in Case of Injury.”
- The Documentation of Informed Consent contains the concluding consent statements required for research of minimal risk or greater. A witness of the informed consent procedure is required because the study is classified as greater than minimal risk.
- 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 must be placed below the Identification of Investigators section.
- Because the study is classified as greater than minimal risk, the day and night phone numbers of the investigators must be listed.
SAMPLE OF THE ADULT CONSENT FORM FOR NON-THERAPEUTIC RESEARCH THAT IS GREATER THAN MINIMAL RISK.
Characteristics of the Adult Consent Form for Non-Therapeutic Research that is Greater than Minimal Risk
