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."