Table 3.

Required elements of an informed consent document

Statements that indicate:
1. Study involves research; purposes, expected duration, description of study procedures and identification of experimental procedures
2. Description of foreseeable risks or discomforts
3. Description of reasonably expected benefits to subjects or others
4. Disclosure of procedures or treatments
5. Extent of confidentiality of records that can be expected
6. Explanation of availability of treatment and/or compensation for injuries from the research
7. Contact information for research questions, subjects rights and research-related injury
8. Statement that participation is voluntary, no penalty or loss of benefits for refusal, ability to discontinue participation at any time