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Required Elements of Informed Consent

Informed consent is the process of communicating to a prospective participant, in easy-to-understand language (usually sixth- to eighth-grade level), all that he or she needs to know about participating in a research project, and then obtaining the prospective participant's agreement to participate. The following ten elements of consent are widely recognized and, except under certain specific conditions, must be included in all consent processes and forms:

1. An explanation of the study, including goals, procedure, and a statement that the study is research.

2. A description of what participants are expected to do and expected length of participation.

3. A description of any likely risks or discomforts for the participants. Potential harm should be explained in language that participants can understand and that relate to everyday life.

4. A description of any likely benefits to the participant or to others.

5. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant.

6. A statement describing the level of privacy assured for collected information (anonymous, confidential) and how private information and information security will be managed.

7. An explanation of whom to contact for answers to questions about the research. When an Alverno student is the principal investigator, the name and phone number of a supervising faculty member is required.

8. An explanation of whom to contact for concerns generally about the participant’s privacy and rights, which for Alverno College is its acting IRB Chair (Dr. Paul Smith, 382-6363) but for student investigators, may be the supervising faculty member.

9. 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 participant that is no greater than the risk encountered in normal, day-to-day activities or during routine physical or psychological examinations.)

10. A statement that research participation is voluntary and the participant may withdraw from participation at any time, without penalty or loss of benefits to which the participant is otherwise entitled. If the participant is a patient or client receiving medical, 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 participant is currently receiving or may receive in the future. Participants 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 participants should be told they may refuse to answer individual questions.

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