豁免类别

To qualify for review at the exempt level, the research must not be greater than minimal risk* and must fall into one or more of the exempt categories described below.

*Minimal risk is defined by the federal regulations as the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.

豁免类别:

  • 教育研究
  • 调查、访谈、教育测试、
  • 公众观察（不涉及儿童）
  • 良性行为干预
  • 对先前收集的可识别信息/标本进行分析
  • 联邦研究/示范项目
  • 味觉和食物评价研究

豁免类别详情

第一类-教育研究

Research conducted in established or commonly accepted educational settings, involving normal educational practices that are not likely to adversely impact students’ opportunity to learn or assessment of educators

例子:

  • 评估已接受或修订的标准化测试的使用情况
  • 测试或比较课程或课程
  • 药学继续教育项目评价

第2类-调查、访谈、教育测试、公众观察

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior 和:

  • 记录的信息不能轻易识别主体（直接或间接/关联） 或
  • Any disclosure of responses outside of the research would NOT reasonably place subject at risk (criminal, civil liability, financial, employability, educational advancement, reputation)

例子:

  • 调查教师、护士或医生的技术或结果
  • 就管理风格或最佳实践对经理进行面试
  • 就社区项目的经验或意见进行焦点小组讨论

类别3 -良性行为干预

Research involving benign behavioral interventions through verbal, written responses, (including data entry or audiovisual recording) from adult subjects who prospectively agrees and 下列之一 met:

  • 记录的信息不能轻易识别主体（直接或间接/关联） 或
  • Any disclosure of responses outside of the research would NOT reasonably place subject at risk (criminal, civil liability, financial, employability, educational advancement, reputation)

例子:

  • 在各种噪音条件下解决难题
  • 玩经济游戏
  • 暴露于颜色、光线或声音等刺激（在安全水平下）
  • 执行认知任务

For this category a benign behavior intervention is brief in duration (less than 2 hours), harmless, painless, not physically invasive, not likely to have adverse lasting impact, and not be offensive or embarrassing.

Category 4 – Secondary Research Uses of Identifiable Private Information or Identifiable Biospecimens

Secondary research with identifiable Information/specimens collected for some other initial activity, if 下列之一:

  • 生物标本或信息是公开的
  • 记录的信息使受试者无法轻易识别（直接或间接/关联）； 研究者不会联系受试者，也不会重新识别受试者
  • Collection and analysis involving Investigators Use of identifiable health information when use is regulated by HIPAA “health care operations” or “research” or “public health activities and purposes”
  • Research information collected by or on behalf of federal government using government generated or collected information obtained for non-research activities

例子:

  • Analyzing existing tissue samples or data set which are recorded by the investigator without identifiers

第5类-联邦研究或示范项目

由联邦机构/部门支持的研究和示范项目。 和 designed to study, public benefit or service programs.

  • Federal agencies must publish a list of projects covered by this exemption prior to research commencing

类别6 -口味和食品质量评价研究

口味和食品质量评估以及消费者接受度研究，

  • 如果食用了不含添加剂的健康食品
  • if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

不属于豁免范畴的研究

如果研究活动不属于豁免类别，该怎么办？

The research is not exempt and must be submitted for 加急或全餐 review