Does the study involve sensitive issues (e.g. sexuality, victimization, alcohol, or drug use) that may create emotional upset, anxiety, distress, precipitate a behavioral disorder, or raise questions for subjects? Is there a referral path readily available for subjects who need it (e.g., free mental health counseling)?
Social Risks
Could participation or a breach in confidentiality create embarrassment,
ostracism, stigmatization, loss of status, or precipitate personal conflict
for the subject?
Economic Risks
Could participation or a breach in confidentiality cause the subject to
lose their job, be passed over for advancement, or lose income, existing
resources, or benefits? Could a business be negatively impacted?
Physical Risks
Does the study involve blood draws, the placement of electrodes, or maximal
exercise? Could physical harm requiring treatment, initial or recurrent,
be caused by participation in the study? How likely is it that discomfort,
illness, injury, or death may occur?
Legal Risks
Is the information gathered subject to subpoena? Are subjects asked to
report illegal behaviors? Could a breach in confidentiality put subjects
at risk of arrest, prosecution, civil or criminal liability, or punishment?
Could subjects be identified through demographics or other means?
Risks to Quality of
Life
Could participation negatively change the subjects' perceived or real
life status or ability to achieve desired goals and objectives?
