Human Subjects |  | Risks |
|  |  | Psychological Risks 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?
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