A statement explaining the trial’s purpose, the procedures to be followed, the duration of participation, and any investigational treatments or procedures
A description of foreseeable risks and discomforts to participants
A description of benefits that the participant can reasonably expect
A disclosure of any alternative treatments or procedures that might be advantageous to participants
A statement about how participant confidentiality is maintained
An explanation of compensation and whether medical treatments are available if injury occurs
A list of contacts to answer trial-related questions and to help with research-related injuries
A statement that participation is voluntary and that there is no penalty and no loss of benefits for refusing to participate
Other Elements When Appropriate
A statement that there may be unforeseeable risks to the participant, embryo, or fetus—if the participant is or may become pregnant
A list of circumstances under which the investigator may terminate a participant’s enrollment
A description of additional costs to the participant
An explanation of the consequences and procedures if a participant decides to withdraw
A statement that participants will be informed of significant new findings that might affect their willingness to participate
The approximate number of participants enrolled in the trial
Adapted from The Food and Drug Administration, Code of Federal Regulations, Title 21, Section 50.25 (www.fda.gov).
