Quality Improvement

Elements of Informed Consent Source: 45 CFR 46, 21 CFR 50

 General Requirements

• The individual is given sufficient opportunity to consider whether or not to participate in the study without coercion or undue influence.
• Information is provided in an understandable manner without use of exculpatory language.

Required Elements

• Statement which indicates the study involves research.
• Explanation of the purpose of the research.
• Expected duration of participation in the study.
• Description of procedures.
• Identification of experimental procedures.
• Description of reasonably foreseeable risks or discomforts.
• Description of reasonably expected benefits.
• Identification of alternative procedures available.
• Description of the level of confidentiality of records identifying the participant.
• If research is greater than minimal risk: description of compensation and/or medical treatment available in case of injury.
• Identification of whom to contact with questions about the study, the participant’s rights and in case of injury.
• Statement that participation in the study is voluntary.
• Statement that the individual is free to refuse and/or withdraw without penalty or loss of benefits.

Additional Elements

• Potential for unforeseeable risks to the individual or an embryo or fetus if the individual is or may become pregnant.
• Circumstances in which the individual’s participation may be terminated by the investigator without regard to the individual’s consent.
• Any additional costs the individual may incur due to participation in the study.
• The consequences of the individual’s decision to withdraw from the study and procedures to terminate from the study.
• Statement which indicates that significant new findings, which may affect the individual’s willingness to continue participation in the study, will be provided.
• The approximate number of individuals who will participate in the study.

v. 01/17/07