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免除豁免审查用于对非易感受试者的风险小于最小的研究。
免除
- Research, conducted in established or commonly accepted educational settings, that specifically 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和特殊教育教学策略的研究，以及关于教学技术、课程或课堂管理方法的有效性或比较的研究。
Impact at 太阳城娱乐官网: Now includes a statement that the research 不能 “adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. 提供风险说明。
- Research that only includes interactions involving educational tests (cognitive, diagnostic aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if 至少一个 of the following criteria is met:
i. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects 不能 be readily be ascertained, directly or through identifiers linked to the subjects;
二世。 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, employability, education advancement or reputation; or
三世。 The information obtained is recorded by the investigator in such a manner that the identity of the human 可以 readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a 有限内部审查委员会审查 to make the determination required by §_____.111(a)(7).
Impact at 太阳城娱乐官网: Includes a clarification that the data may involve visual or audio recording as well as a “carve-out” that allows for the collection of sensitive, identifiable data to be collected as long as a “limited review” is conducted by the IRB. 允许敏感的、可识别的数据被确定为豁免。 - Research 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 and 至少一个 of the following criteria is met:
A. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects 不能 be readily be ascertained, directly or through identifiers linked to the subjects;
B. 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, employability, education advancement or reputation; or
C. The information obtained is recorded by the investigator in such a manner that the identity of the human 可以 readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a 有限内部审查委员会审查 to make the determination required by §_____.111(a)(7).
i.就本条款而言，良性行为干预是指持续时间短、无害、无痛、无身体侵入性、不太可能对受试者产生重大的不利持久影响，研究者没有理由认为受试者会觉得干预令人反感或尴尬。 如果满足所有这些标准，这种良性行为干预的例子包括让受试者玩网络游戏，让他们在各种噪音条件下解决谜题，或者让他们决定如何在自己和他人之间分配收到的名义金额的现金。
二世。 如果研究涉及在研究的性质或目的上欺骗受试者，则此豁免不适用，除非受试者在被告知他或她将不知道或被误导有关研究的性质或目的的情况下，通过预期协议授权进行欺骗以参与研究。
Impact at 太阳城娱乐官网: This is a new category specific to “benign interventions” involving adults that allows for deception under certain conditions. Data may also be sensitive and identifiable as long as a “limited review” is conducted by the IRB. “Benign interventions” are currently reviewed as expedited review, as there is no current exempt category that this activity would fit in with the Final Rule, this type of research would be permitted as an exempt review. - Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if 至少一个 of the following criteria is met:
i. The identifiable private information or identifiable biospecimens are publicly available;
二世。 信息，可能包括生物标本的信息，由研究者以这样一种方式记录，即人类受试者的身份不能轻易地直接确定或通过与受试者相关的标识符确定，研究者不联系受试者，研究者也不会重新识别受试者；
三世。 The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E [HIPPA], for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities ad purposes” as described under 45 CFR 164.512(b); or
iv. The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, 或作为活动的一部分产生的信息将根据1974年《隐私法》第5编第552a条的规定保存在记录系统中，并且，如果适用，研究中使用的信息是根据1995年《文书工作减少法》第44编第3501条及其后的规定收集的。
对太阳城娱乐官网的影响：该类别已修订，还包括生物标本，以及hipaa覆盖的数据，联邦政府进行的研究和联邦政府生成的数据的特殊雕刻。 这就更清楚地说明了在此类别下允许的内容。 - 由联邦部门或机构进行或支持的研究和示范项目，或以其他方式获得部门或机构负责人批准的项目（或获得授权进行研究和示范项目的局或其他下属机构负责人的批准），旨在研究，评估，改进或以其他方式检查公共利益或服务计划； 包括在这些计划下获得福利或服务的程序，这些计划或程序的可能变化或替代方案，或这些计划下福利或服务的支付方法或水平的可能变化。 此类项目包括但不限于联邦雇员的内部研究，以及根据合同或咨询安排、合作协议或赠款进行的研究。 豁免项目还包括使用经修订的《社会保障法》第1115和1115A条等权威机构对其他强制性要求的豁免。
i.执行或支持研究与示范项目的每个联邦部门或机构必须在可公开访问的联邦网站上，或以该部门或机构负责人确定的其他方式，建立一份联邦部门或机构根据本规定执行或支持的研究与示范项目清单。 研究或示范项目必须在开始涉及人体受试者的研究之前在此列表上公布。
Impact at 太阳城娱乐官网: The revisions provides further clarification about what are “research and demonstration projects that are conducted or supported by Federal department or agency. 值得注意的是，在这一类别下进行审查的研究一直非常罕见。 - Taste and food quality evaluation and consumer acceptance studies:
i. If wholesome foods without additives are consumed; or
二世。 如果一种食品中所含的食品成分达到或低于FDE或EPA或美国农业部食品安全检验局批准的安全水平或低于安全水平的食品成分或低于安全水平的食品成分或低于安全水平的农业化学品或环境污染物。 - Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a 有限内部审查委员会审查 and makes the determination required by §_____.111(a)(8).
Impact at 太阳城娱乐官网: This new category is specifically for identifiable data and/or biospecimen repositories as long as a “limited review” is conducted by IRB. 存储库目前是作为加速审查进行审查的，因为当前没有此活动适合的豁免类别。 根据最终规则，这类研究将被允许作为豁免审查。 - Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met:
i. Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with §_____.116(a)(1)至(4)、(a)(6)和(d)；
二世。 Documentation of informed consent or waiver of documentation of consent was obtained in accordance with §_____.117;
三世。 An IRB conducts a 有限内部审查委员会审查 and makes the determination required by §_____.111(a)(7)并确定将进行的研究在本条(d)(8)(i)段所述的广泛同意范围内； and
iv. The investigator does not include returning individual research results to subjects as a part of the study plan. 这一规定并不妨碍研究者遵守任何法律要求返回个人研究结果。
对太阳城娱乐官网的影响：这个新类别涉及到只要满足某些条件，就可以使用存储库中的可识别数据和/或生物标本。 对可识别数据的二次使用的审查目前作为快速审查进行审查，因为目前没有该活动适合的豁免类别。 根据最终规则，这类研究将被允许作为豁免审查。
Note: If broad consent is not adopted, exempt categories 7 and 8 不能 be used.
