The ethical appropriateness of clinical research depends on protecting participants from excessive risks. Yet no systematic framework has been developed to assess research risks, and as a result, investigators, funders, and review boards rely only on their intuitive judgments. Because intuitive judgments of risk are subject to well-documented cognitive biases, this approach raises concern that research participants are not being adequately protected. To address this situation, we delineate a method called the systematic evaluation of research risks (SERR), which evaluates the risks of research interventions by comparing these interventions with the risks of comparator activities that have been deemed acceptable. This method involves a 4-step process: (1) identify the potential harms posed by the proposed research intervention; (2) categorize the magnitude of the potential harms into 1 of 7 harm levels on a harm scale; (3) quantify or estimate the likelihood of each potential harm; and (4) compare the likelihood of each potential harm from the research intervention with the likelihood of harms of the same magnitude occurring as a result of an appropriate comparator activity. By explicitly delineating, quantifying, and comparing the risks of research interventions with the risks posed by appropriate comparator activities, SERR offers a way to minimize the influence of cognitive biases on the evaluation of research risks and thereby better protect research participants from excessive risks.
Estimated risks of epicutaneous allergy skin testing (per 100 000): transient pain (negligible), approximately 100 000; local allergic reaction (negligible), approximately 50 000; mild systemic allergic reaction (small), 11 to 30; moderate or severe systemic allergic reaction (moderate or significant), 2 to 5; and death (catastrophic), approximately 0 (1 case report).45- 52 Daily life risks in the United States (per 100 000): bruise (negligible), approximately 100 000 (all age groups); common cold (1 day [small]), approximately 22 000 (children); bone fracture or dislocation (surfing contest [moderate]), approximately 70 (adults); complete ligament tear of knee (sports practice [significant]), approximately 8 (adolescents); loss of 1 finger (workday in service sector [major]), approximately 0.008 (adults); paraplegia (day of skiing [severe]), approximately 0.03 (all age groups); and death (riskier car trip [catastrophic]), approximately 0.2 (adolescents/adults).38- 44aSpan of elongated data markers indicates range of estimated risk.
Estimated risks of percutaneous liver biopsy (per 100 000): anxiety (small), 31 000; transient mild pain (negligible), approximately 100 000; immediate postprocedure pain (small), approximately 3000; postprocedure pain (small), approximately 10 000 to 20 000; superficial kidney puncture (small), 3; subcutaneous emphysema (small), 1; pleural effusion (moderate), 21; hematothorax (moderate), 18 to 63; pneumothorax (moderate), 8 to 35; major hemorrhage requiring transfusion (moderate), 160 to 733; hemobilia requiring conservative treatment (moderate), 6 to 50; sepsis requiring antibiotic treatment (moderate), 9; major hemorrhage requiring interventional radiography/surgery (significant), 67; hemobilia requiring interventional treatment (significant), 6 to 50; sepsis requiring intensive care unit (ICU) treatment (significant), 9; gallbladder perforation (significant), 12 to 22; colon perforation (significant), 4; death (catastrophic), 0 to 40.53- 64 For daily life risks see Figure 1 legend.aSpan of elongated data markers indicates range of estimated risk.
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