Elements of Informed Consent

From the Code of Federal Regulations Title 21, Section 50.25

Eight Basic Elements of Informed Consent

• Statement explaining the purpose of the research, the procedures to be followed, the duration of participation and any investigational treatments or procedures
• Description of foreseeable risks and discomforts to volunteers
• Description of benefits that the volunteers can reasonably expect
• Disclosure of any alternative treatments or procedures that might be advantageous to the volunteers
• Statement about how volunteer confidentiality will be maintained
• Explanation of compensation and whether medical treatments are available if injury occurs
• List of contacts to answer study-related questions and to help with research-related injuries
• Statement that participation is voluntary and that there is no penalty or loss of benefits for refusing to participate

Additional Elements on Informed Consent Forms When Appropriate

• Statement of unforeseeable risks to the volunteer, embryo or fetus- if the volunteer is or may become pregnant
• List of anticipated circumstances under which the investigator may terminate a volunteer’s participation
• Description of additional costs to the volunteer
• Explanation of the consequences and the procedures if a volunteer decides to withdraw
• Statement about informing volunteers of significant new findings that might affect their willingness to participate
• Description of the number of volunteers participating in the study

Source: CenterWatch. Informed Consent: The Consumer’s Guide to the Risks and Benefits for Clinical Trials. Boston; 2002. For more information, visit CenterWatch on the web. Reprinted with permission.

Sample Consent Forms

• For the Consent Language
  This document contains a sample consent form for all participants over 18 years of age. If children are involved between the ages of 13-17, this document must be used in conjunction with a Parental consent form.
• For Parental Consent
  This document provides a sample form that should be given to parents when involving participants under the age of 18. This document should be used in conjunction with the regular consent form above.
• For Child Assent
  This document is a sample/script that should be used when working with children 12 and under when providing them with informed consent. Parental Permission is needed prior to asking the child for participation. This document should be used in conjunction with the Parental consent form above.