The following eight elements of consent are widely recognized and, except under certain specific conditions, must be included in all consent processes:
- An explanation of the study, including goals, procedures, expected length of participation, and a statement that the study is research.
- A description of any likely risks or discomforts for the subjects. Potential harm should be explained in language that subjects can understand and that relate to everyday life.
- A description of any likely benefits to the subject or to others.
- A statement describing how private information and information security (e.g., questionnaire shredded following the study) will be managed.
- For research involving more than minimal risk, a statement describing any compensation for injuries and contact information. (Minimal risk is a risk of harm to the subject that is no greater than the risk encountered in normal, day-to-day activities or during routine physical or psychological examinations). Please keep in mind that the IRB will utilize stringent procedures to protect that the subject’s welfare.
- An explanation of whom to contact for answers to questions about the research and subject's rights. The name and phone number of the responsible faculty member and the UW-Stout IRB Administrator (see site: http://www.uwstout.edu/rs/documents/cform.doc) must be included for this purpose. If the project involves student research, the name and phone number of the student's advisor must also be included.
- A statement that research participation is voluntary and the subject may withdraw from participation at any time, without penalty or loss of benefits to which the subject is otherwise entitled must be included in the consent form. If the subject is a patient or client receiving psychological, counseling, or other treatment services, there should be a statement that withdrawal from the study will not jeopardize or otherwise affect any treatment or services the subject is currently receiving or may receive in the future. Subjects also should be told whether their data will be destroyed should they withdraw from the study. If a survey instrument or interview questions are used and some questions deal with sensitive issues, the subjects should be told they may refuse to answer individual questions.