Informed Consent: General & Basic Elements

4. Informed consent must include a description of the ____________ to be followed.
5. Informed consent must include an explanation of ____________.
9. Informed consent must include a disclosure of appropriate ____________ procedures or courses of treatment.
12. For research involving more than ____________ risk, informed consent must include an explanation of whether compensation or medical treatment is available if injury occurs.
13. No informed consent can include ____________ language appearing to waive participant legal rights.
14. Sufficient opportunity to discuss and consider whether to participate must be provided to minimize the possibility of ____________ or undue influence.
15. The ____________ elements of informed consent must be provided to each subject or legally authorized representative unless the IRB has approved a waiver or alteration of informed consent>
16. Informed consent must include a statement describing the extent to which confidentiality of records _____________ subjects will be maintained.

1. Informed consent must include an explanation of whom to ____________ for answers to questions about research, subject’s rights, and research-related injury to subject.
2. Informed consent must include a description of any reasonably ____________ risks or discomforts.
3. Informed consent must include a __________ use statement about any research that involves the collection of identifiable information or identifiable biospecimens.
6. Informed consent must include the expected ____________ of the subject’s participation.
7. Informed consent must include a statement that the study involves ____________.
8. Informed consent must include a statement that participation is ____________.
10. Informed consent must begin with a concise and focused presentation of ____________ information.
11. Informed consent must include a description of ____________ to subject/other.