All consents must include the following information. See below a sample consent. Consents must be written at a 6th grade level and must be obtained from the appropriate individual (participant, parent/guardian; assent for children).
• Title of the Study
• Name of the researcher, department, contact information (phone/e-mail)
• A short description and justification of the study, including those who are eligible to participate in the study
• Procedures
• What the participant can expect
• How long it will take
• The place and time of the study
• A brief description of the questionnaires, surveys or instruments OR interview or experiment (In clinical studies involving experimental treatments, identify the new or experimental elements and possible deception.)
• Potential benefits of participating in the study
• Potential risks (physical, psychological, social, or legal), discomforts or stresses that may be faced
• If risk, discomfort or stress is identified, include resources that the participant may access
• Confidentiality/how data will be collected and stored
• If names are not necessary and there is no identifying information, then data can be considered anonymous
• If names are needed or there is potentially identifiable information included, then the data should be considered confidential
• Data must be kept safe such as in either a locked file cabinet or in a password protected computer
• Statement of voluntary participation and withdrawal without penalty
• Signatures of participants or guardian/parent (For online consent, a statement with related link (e.g., I agree)
• Name and contact information of the IRB chair
Sample Consent Form
