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Guidelines for the Preparation of Informed Consent Forms

Consent Form Preparation Checklist

Is the consent form written in lay language?
Is it free of language which waives or appears to waive the subject's legal rights?
Does it include the following basic elements of informed consent?
- An introductory paragraph stating the purpose of the study and naming the investigators and sponsoring agencies.
- A statement of the purpose of the study.
- An explanation of the procedures to be followed and the nature and duration of the subject's participation in the research study.
- A description of any anticipated risks or discomforts.
- A description of any benefits to the participant or to others
- A disclosure of alternative procedures, treatments or resources that might be appropriate and advantageous to the participant.
- A statement describing the extent to which confidentiality will be maintained.
- A statement disclosing any additional costs for treatment, testing, therapy or counseling for which the volunteer will be responsible.
- A statement of the amount and method of any payment to subjects.
- A statement regarding compensation for injury.
- A statement that participation in the study is voluntary, and refusal to participate or withdrawal from the study will involve no penalty or loss of benefits.
- A statement providing the name and work telephone number of the person who is available to answer questions about the research.
- A signed statement of informed consent to participate in the study.
If children or persons who are not competent to give proper informed consent are included as research subjects, does the consent form make provisions for securing the informed consent of the individual's parents or legal guardians?
If Saint Xavier University students or employees are included as volunteers, does the consent form make additional provisions to ensure the voluntary nature of their participation?
If prisoners are included as volunteers, does the consent form make special provisions to ensure the circumstances of their participation are completely voluntary and non coercive?

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