免除 and expedited reviews require that a research project is of no more than minimal risk to the subjects participating in the project and that the project f所有s under a category identified by OHRP as acceptable for exempt or expedited review. 当您以豁免或加急方式提交IRB申请时, you must identify which category your project f所有s under and give a brief explanation of why this category fits your project. 这项研究对受试者的风险也必须不超过最低限度.
部分46.104 of 45 CFR 46 identifies eight categories under which a research project may be submitted for 免除 IRB review, 和 1998年OHRP加速审查类别 notice identifies nine categories under which a research project may be submitted for 加快 IRB review. 这些类别列在下面.
如果您的项目不符合豁免或快速审查的任何类别, 或者你的项目对参与者的风险大于最小, 你必须提交你的项目以供全面审查. 如果您不确定您的项目适合哪个类别, 请透过西北税务局的电邮地址(IRBNWMS@fc-daudenzell.com).
更多的 information related to categories of IRB review can be found in the Northwest IRB Submission Guide and within the current OHRP rules and regulations, 可以在 这个链接.
Within category descriptions, most information is taken directly from the OHRP 45 CFR 46 regulations. 在某些情况下, additional information is provided beyond that of the official regulations; this information is presented in italics.
研究, 在已建立的或普遍接受的教育环境中进行的, that specific所有y involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. 这包括大多数关于常规教育和特殊网上赌博网站十大排行策略的研究, 并对教学方法的有效性进行了比较研究, 课程, 或者课堂管理方法.
仅包括涉及教育测试(认知)的互动研究, 诊断, 资质, 成就), 调查程序, 面试程序, 或观察公众行为(包括视觉或听觉记录).
有 三个子类 第2类. If you believe your project is 第二类 免除, you must specify which subcategory it fits within:
Subcategory 2-I: The information obtained is recorded by the investigator in such a manner that the 身份 of the human subjects cannot readily be ascertained, 直接或通过与受试者相关联的标识符.
Subcategory 2-II: Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, 就业能力, 教育的进步, 或声誉.”
Subcategory 2-III: The information obtained is recorded by the investigator in such a manner that the 身份 of the human subjects can readily be ascertained, 直接或通过与受试者相关联的标识符, IRB进行有限的IRB审查，以作出§46所要求的决定.111(a)(7).
重要的是: 涉及儿童的项目不能作为第2-III类的豁免提交, 和y may only be submitted as exempt under subcategories 2-I or 2-II if the investigator does not participate in data collection or observation.
如果您的项目不符合上述标准, 但其他方面都属于这一类, 见下文第6类和第7类加急申请.
研究 involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection.
至少一个 还必须符合下列标准之一:
如果您的项目不符合上述标准, 但其他方面都属于这一类, 见下文第7类加急.
请注意, category 3 does not apply for projects where subjects will be deceived about the true nature of the study, 除非实验对象事先知道他们会被欺骗. 第三类也不适用于儿童研究.
Examples of benign behavioral interventions provided by OHRP include “…having the subjects play an online game, 让他们在各种噪音条件下解决谜题, or having them decide how to 所有ocate a nominal amount of received cash between themselves and someone else.”
不需要同意的二次研究, 包括涉及可识别的私人信息的二次研究.
至少一个 还必须符合下列标准之一:
如果您的项目不符合上述任何标准, 但其他方面都属于这一类, 见下文第5类加急.
研究 and demonstration projects that are conducted or supported by a Federal department or agency, 或者需要部门或机构负责人的批准，这些都是为了研究而设计的, 评估, 改善, 或以其他方式审查公共利益或服务项目…这些项目包括, 但不限于, 联邦雇员的内部研究, 根据合同或咨询安排进行研究, 合作协议, 或赠款.
口味和食品质量评价及消费者接受度研究, as long as wholesome foods without additives are consumed or a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, 或农业化学品或环境污染物达到或低于安全水平, by the Food and Drug Administration or approved by the Environmental Protection Agency o the Food Safety and Inspection Service of the US Department of Agriculture.
Storage or 维护 for secondary research for which 广泛的同意 is required: Storage or 维护 of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by §46.111(a)(8).
需要广泛同意的二次研究，只要 所有 符合下列条件之一:
请注意, 广泛的同意 不是一样的吗 知情同意. Broad consent is a special form of consent that applies to storage and usage of data for possible secondary research projects. Broad consent is not covered in this document or in the Northwest IRB Submission Guide; if you believe your study f所有s under this category or that you wish to obtain 广泛的同意, 参见第46节.有关更多信息，请参阅OHRP准则第116条.
In 1998, OHRP outlined a list of nine approved categories of research that may be considered with an expedited IRB review. Most information within category descriptions is taken from this policy document which can be read in full at 这个链接. 在某些情况下, additional information is provided beyond that of the official regulations; this information is presented in italics.
Clinical studies of drugs and medical devices that are no more than minimal risk and f所有 into one of two approved categories:
用指棒、足棒、耳棒或静脉穿刺采集血样;
通过非侵入性手段为研究目的而前瞻性地收集生物标本.
The policy document provides a specific set of examples for this category; while this set is not exhaustive, 它应该提供有关OHRP认为的“非侵入性”和不超过最低风险的信息.
Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided 收款程序 is not more invasive than routine prophylactic scaling of the teeth 和 process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, 皮肤拭子, or mouth washings; (j) sputum collected after saline mist nebulization.
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. 在使用医疗器械的地方，它们必须经过审批/批准才能上市. (Studies intended to 评估 the safety and effectiveness of the medical device are not gener所有y eligible for expedited review, 包括已获批准用于新适应症的医疗器械的研究).
和第3类一样, the policy document provides several examples of noninvasive clinical practices that would be appropriate; again, 这个列表并不详尽.
Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject’s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, 脑电描记法, 温度记录, 放射性检测:对自然发生的放射性的检测, electroretinography, 超声波, 诊断性红外成像, 多普勒血流, and echocardiography; (e) moderate exercise, 肌力测试, 身体成分评估, 考虑到年龄，适当的时候进行柔韧性测试, 重量, 以及个人的健康.
涉及材料(数据)的研究, 文档, 记录, (或标本)已收集, 或仅用于非研究目的(如医疗或诊断). (Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4).
快速第5类适用于本应符合豁免第4类的研究, 但豁免第4类的四项标准均未达到.
为研究目的而从声音、视频、数字或图像记录中收集数据.
This is similar to 免除 第二类, except that the criteria 所有owing for exemption cannot be met. 通常, 这将适用于可以确定主体身份的记录数据, 如果身份被确定, 这些资料可能以某种方式使当事人处于危险之中.
对个人或群体特征或行为的研究(包括, 但不限于, 知觉研究, 认知, 动机, 身份, 语言, 沟通, 文化信仰或习俗, 和社会行为)或研究雇用调查, 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. (Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2)及(b)(3). 此列表仅指未被豁免的研究).
与上述第6类一样，这一类别与豁免第2类(和第3类)重叠。. 因此, 只有当被试者的身份能够被确定并且, 如果确定, 实验对象的反应可能会在某种程度上使他们处于危险之中.
继续审查先前由召集的内部审查委员会批准的研究如下, 该研究是永久禁止新受试者入组的, 所有受试者完成了所有与研究相关的干预措施, 和 research remains active only for long-term follow-up of subjects; or where no subjects have been enrolled and no additional risks have been identified; or where the remaining research activities are limited to data analysis.
持续的研究回顾, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
