IRB裁定表格

我的项目需要什么样的IRB审查?

To assist us in making a determination of whether your project constitutes Human Subject 研究, 请填写这份简短的问卷. You should also consult with your faculty advisor/dissertation chair/faculty project chair/scholarly project advisor, 等. 在填写此表格前.

注:所有Ed.D. students should complete this form to determine level of review but will be expected to complete the IRB application process. 

人体受试者判定表

NOTE: HUMAN SUBJECT DETERMINATION FORM DOES NOT CONSTITUTE IRB APPROVAL. YOU MUST OBTAIN OFFICAL IRB APPROVAL PRIOR TO BEGINNING ANY DATA COLLECTION.

定义:45 CFR 46.102

人类的主题 - a living individual about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information.

干预 includes both physical procedures by which information is gathered (for example, venipuncture) 和 manipulations of the subject or the subject's environment that are performed for research purposes.

交互 includes communication or interpersonal contact between investigator 和 subject.

私人信息 includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, 和 information which has been provided for specific purposes by an individual 和 which the individual can reasonably expect will not be made public (for example, 医疗记录信息). 私人信息必须是可单独识别的.

可识别的 is where the identity of the subject is or 五月 be ascertained by the researcher, 或者将与信息相关联. 这项研究可能涉及使用编码数据/标本.

编码 means a living individual's identifiable information such as name or social security number has been replaced by a code, 比如一个数字, 信, or combination thereof 和 there is a key to link the code to the identifiable information of that individual. 根据通用规则，编码数据被认为是可识别的.

研究 系统的调查, 包括研究开发, 测试与评估, 被设计用来发展或促进一般化的知识.

最小的风险 means that the probability 和 magnitude of harm or discomfort anticipated in the research are not greater in 和 of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

IRB批准 means the determination of the IRB that the research has been reviewed 和 五月 be conducted at an institution within the constraints set forth by the IRB 和 by other institutional 和 federal requirements.

评审级别解释:

豁免(45 CFR 46).104) - 研究 五月 如属下列类别之一，可获豁免:

  1. 教育研究
  2. Surveys, 面试s, educational tests, 和 public observations (that do not involve children)
  3. 良性行为干预
  4. Secondary research uses of identifiable private information or identifiable biospecimens
  5. 联邦研究或示范项目
  6. 口味和食品质量评价研究

研究不能豁免，如果它:

是否大于最小风险
or;
包括药物或器械的管理或使用

加急(45 CFR 46).110) – 研究 involves no more than minimal risk, 和 for minor changes in previously approved research. 研究 五月 qualify for expedited review if it falls within one of the below categories:

  1. Clinical studies of drugs 和 medical devices only when certain conditions are met
  2. 用手指棒采集血样, 跟贴, 耳朵贴, 或者在一定数量的人群中进行静脉穿刺
  3. Prospective collection of biological specimens for research purposes by noninvasive means
  4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, 不包括涉及x射线或微波的手术.
  5. 涉及材料(数据)的研究, 文档, 记录, (或标本)已收集, 或将只收集作非研究用途
  6. Collection of data from voice, video, digital, or image recordings made for research purposes
  7. 研究 on individual or group characteristics or behavior or research employing survey, 面试, 口述历史, 焦点小组, 项目评估, 人为因素评价, 或者质量保证方法

全面董事会(45 CFR 46).110) - The probability 和 magnitude of harm or discomfort anticipated in the research are greater in 和 of themselves from those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests, 或者不属于加速研究的类别. 研究 that does not qualify for 免除 or expedited (presents more than minimal risks to subjects) will require review at a fully convened IRB committee meeting.

注:考虑的项目 免除 仍须向税务局提交 和 内部审查委员会将证明豁免加急审查或全面审查.

填写我的 在线表单.