Essentials of Informed Consent

Essentials of Informed Consent

Title: Show the heading of “Informed Consent Form.” You may want to add the full title of the project.

Involvement: Identify the investigator, faculty sponsor (if relevant), and any funding or sponsoring organizations. Identify Methodist University as the responsible institution or as one of the responsible institutions.

Overview: Invite subjects to participate and tell them the purposes of the study. Give a brief description of the procedures to be used and the time required, providing enough detail to enable subjects to make an informed decision. It might be helpful to ask yourself what information you would need to have as a naïve potential subject in order to feel that you could make such an informed decision.

Risks and benefits: Describe any reasonable foreseeable risks or discomforts associated with the study. If there are no known risks, this should be stated. Also, give a description of the likely benefits to subjects or to others.

Compensation: Provide a statement of any compensation available to subjects, along with information on how it can be obtained.

Handling discomfort or injury: If appropriate, tell subjects what treatment will be available and how it can be obtained.

Confidentiality: Specify the procedure for maintaining the confidentiality of records that identify subjects.

For more information: Tell subjects how to obtain more information about the project.

Voluntary participation: Explicitly state that subject may refuse to participate or may withdraw for any reason without penalty. Describe the procedures for both electing to participate and for declining, along with a statement regarding the disposition of data which may have already been collected from subjects who later elect to withdraw.

Signature: Provide a space for signatures indicating consent, and remember to include a second copy for the subject to keep when obtaining consent.

Miscellaneous: Include the following statement: “This project has been approved by the Methodist University Institutional Review Board for the Protection of Human and animal subjects (Phone: 910.480.8494).”