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风险/利益评估清单Federal regulations, based on the ethical principle of beneficence, require that risks associated with research are reasonable in relation to the anticipated benefits. 受试者必须被告知研究的潜在风险。
风险/利益评估清单
To use the checklist for assessing risk, begin with the federal regulatory definition of
minimal risk. Once you have completed the checklist, refer to the type of IRB review
your research will require.
在评估风险时，请记住有五种主要类型的风险：
- physical risk (for example, pain, bruising and infection associated with venipuncture,
muscle soreness and pain as a consequence of exercise testing, heart attack induced
by maximal exercise tests) - psychological risk (for example, stress associated with experiments and testing,
feelings of guilt or discomfort because of sensitive survey topics) - 社会风险（例如，侵犯隐私、丧失社区地位）
- 法律风险（例如刑事起诉或撤销假释）
- 经济风险（例如，失去工作，失去潜在的金钱收益）
风险/利益评估清单
最小风险的定义: Minimal risk means that the probability and magnitude of
harm or discomfort anticipated in the research are not greater in and of themselves
than those ordinarily encountered in daily life or during the performance of routine
physical or psychological examinations or tests (45 CFR 46.102 (h) (i)).
风险类别
检查你研究的适当风险类别：
- 这项研究对受试者的风险不超过最小。
- ___这项研究对受试者的风险最小。
- _____这项研究对受试者的风险超过最小。
a. ___The risk(s) represents a minor increase over minimal risk, or
b. ___The risk(s) represents more than a minor increase over minimal risk, or
c. ___The risk(s) represents a major increase over minimal risk.
福利定义： A research benefit is considered to be something of a health-
related,psychosocial, or other value to an individual research subject, or something
that will contribute to the acquisition of generalizable knowledge. Money or other
compensation for participating in research is not considered to be a benefit. A great
deal of research in the social and behavioral sciences offers little potential for direct
benefits to the subjects themselves. Rather, the benefits often encompass the
importance of the knowledge to be gained, and/or to the contributions the research
makes to science or society.
福利类别
检查您的研究的适当利益类别：
- ___ The research provides no prospect of direct benefit to individual subjects, but
likely will yield generalizable knowledge about subject’s disorder or condition. - ___ The research provides no prospect of direct benefits to individual subjects, but
likely will yield generalizable knowledge to further society’s understanding of
the disorder or condition under study. - 该研究为个体受试者提供了直接受益的前景。
- ___ The research provides no prospect of direct benefits to individual subjects, to
science, or to society.
If you checked numbers 1 or 2 under Risks Categories, and numbers 1, 2, or 3, in the
福利类别, your protocol will generally be reviewed as Exempt unless the
research involves one of the categories of vulnerable subjects; refer to children,
prisoners, mentally disabled persons, economically or educationally disadvantaged
persons, pregnant women, fetuses and neonates.
如果你检查了3。A或3。b under Risks Categories, and numbers 1, 2, or 3, in the
福利类别, your protocol will be reviewed as Expedited or require a full-board review.
如果你检查了3。c under Risks Categories, and/or number 4, in the Benefits
Categories, your protocol will not receive IRB approval, and you will be unable to
conduct your research.
