- A statement that the study involves research.
- An explanation of the purpose of the research.
- A description of the procedures to be followed.
- The expected duration of the study.
- A description of any foreseeable risks or discomforts.
- A description of the benefits to the subjects or others that may result from the research.
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and reported.
- An explanation that participation is voluntary and that the subject may discontinue at any time.
An explanation about what will be done with information alreay collected if subjects decide to discontinue participation.
- Terms of payment and conditions under which subjects will receive partial or no payment. Note: Subjects must be told during the informed consent process if they must provide their social security numbers in order to receive payment. See the model Payment Verification Form with sample consent form language.
- An explanation of whom to contact with questions about the research.
- An explanation of whom to contact for questions about subjects' rights.
Additional Elements (These elements are included in the regulations, but apply primarily to biomedical research and are rarely needed in research in the social and behavioral sciences.)
- Identification of pocedures that are experimental, rather than providing standard treatment. A description of appropriate alternative procedures or courses of treatment that might be advantageous to the subject.
- For research involving more than minimal risk, an explanation about whether any compensation is offered and/or whether medical treatments are available in injury occurs, and where further information may be obtained.
- For research involving more than minimal risk, an explanation of whom to contact in the event of research-related injury.