A brief description of the purpose, methods, and time-frame of the research. A detailed explanation of how the welfare and rights of subjects, whose competency to give informed consent is compromised, are to be protected if such subjects are to be involved in the research. A description of the risks and discomforts, if any, to the subjects. Such deleterious effects may be physical, psychological, or social.
Some research involves neither risks nor discomforts, but rather violations of normal expectations.
Such violations, if any, must be specified. A description of the means to be taken to minimize each such deleterious effect or violation, including the means by which the subject s personal privacy is to be protected and confidentiality of information is received and maintained. A copy of the consent-form that is to be used with the subjects. Information as to the investigator's ethical responsibilities to the subjects.