Risk/Benefit Assessment Checklist-bet36365体育

Risk/Benefit Assessment Checklist
Federal regulations, based on the ethical principle of beneficence, require that risks associated with research are reasonable in relation to the anticipated benefits. Subjects must be informed about the potential risks of a study.

Risk/Benefit Assessment Checklist

To use the checklist for assessing risk, begin with the federal regulatory definition of
最小的风险. Once you have completed the checklist, refer to the type of IRB review
你的研究需要.

When assessing risk, bear in mind there are five major types of risk:

physical risk (for example, pain, bruising and infection associated with venipuncture,
muscle soreness and pain as a consequence of exercise testing, heart attack induced
通过最大运动测试)

psychological risk (for example, stress associated with experiments and testing,
feelings of guilt or discomfort because of sensitive survey topics)

social risk (for example, invasion of privacy, loss of community standing)

legal risk (for example, criminal prosecution or revocation of parole)

economic risk (for example, loss of employment, loss of potential monetary gain)

Risk/Benefit Assessment Checklist

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

Check the appropriate risk category of your research:

___ The research involves no more than 最小的风险 to subjects.

___ The research involves 最小的风险 to subjects.

___ The research involves more than 最小的风险 to subjects.

        a. ___The risk(s) represents a minor increase over 最小的风险, or
        b. ___The risk(s) represents more than a minor increase over 最小的风险, or
        c. ___The risk(s) represents a major increase over 最小的风险.

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. 金钱或其他
compensation for participating in research is not considered to be a benefit. 一个伟大的
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
对科学或社会有益.

福利类别

Check the appropriate benefits category (ies) of your research:

___ 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.

___ The research provides the prospect of direct benefits to individual subjects.

___ The research provides no prospect of direct benefits to individual subjects, to
科学，还是社会.

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还是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
进行你的研究.