Pitfalls 3-4m

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The following suggestions will help you avoid common pitfalls in the risks and benefits section.
  • Avoid underestimating risks: a rule of thumb to follow is "if the experiment exposes the subject to risks greater than what might be expected during the course of a normal day, state it."
  • Do not state that risks are "unknown" because this is interpreted as "none." State that "the risks are not known at this time" or use another qualifier.
  • Avoid insufficient explanations, e.g., "blood drawing may cause bruising." Include less frequent side effects as well, such as nausea, light-headedness, etc.
  • Do not exaggerate or overstate facts, e.g., "this product is safe and has been extensively used...."
  • Avoid overestimated benefits and lofty statements, such as "the betterment of humanity, advancement of science or knowledge."

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