Informed Consent
¡Written at appropriate level for intended audience ¡Anticipates and answers questions of participants
¡Clear picture of risks and benefits
¡Free of errors
¡Contain no exculpatory or coercive language
¡Contains required elements (8)
1. Statement that study is research and information on purposes/duration/procedures/experimental procedures
2. Reasonably foreseeable risks or discomforts
3. Benefits which may be reasonably expected
4. Alternative procedures
5. How confidentiality will be maintained
6. For more than minimal risk, information on compensation for injury
7. Contact names -- at least one person not associated with the research is recommended
8. Statement that participation is voluntary and able to withdraw at any time