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1) State the 10 sections that should be included in an informed consent form
1) State the 10 sections that should be included in an informed consent form.
2)Describe the various levels of review: exempt review, expedited review, full board review.
Expert Solution
Answer:
1)
-A statement that the study involves research
-An explanation of the purposes of the research
-The expected duration of the subject's participation
-A description of the procedures to be followed
-Identification of any procedures which are experimental
-A description of any reasonably foreseeable risks or discomforts to the subject
-A description of any benefits to the subject or to others which may reasonably
be expected from the research
-A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
-A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
-For research involving more than minimal risk, an explanation as to whether any compensation, and an explanation as to whether any medical treatments are available, if injury occurs and, if so, what they consist of, or where further information may be obtained
2)
Exempt Review: research that involves very minimal to no risk.
Expedited Review: involves no more than minimal risk to participants and not intentional deception.
Full Board Review: research that involves projects that place human subjects At more than minimal risk, or involves a vulnerable population.
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