院校检讨委员会

什么是院校覆核委员会?

An 院校覆核委员会 is a group of people formally designated to review 和 monitor research involving human subjects. The purpose of the IRB is to protect the rights 和 welfare of individuals who are participating as subjects in the research. IRB有权批准, 不赞成, 和 require modifications to research projects involving human subjects. 一旦获得批准, 内部审查委员会必须监督正在进行的研究的进展, 预期批准修改, 和, 如果有必要保护受试者, 暂停一项研究计划.

为什么IRB?

The bet365中文大学 院校覆核委员会 is endorsed with the responsibility of overseeing that all research involving the use of human subjects are conducted under ethical 和 scientific sound principles that ensure the rights 和 welfare of human subjects recruited to participate in such studies are safeguarded, 和 that the study will yield outcomes that are to the good of society, 遵守联邦法规及其经营方针. 有关IRB起源的更多信息,请访问网站 贝尔蒙特报告OHRP指南

会员

The board comprises individuals of varying disciplines from within the university 和 community, who are experienced 和 knowledgeable of the kinds of research done at the university. Such diversity ensures a comprehensive approach to protecting the rights 和 welfare of human participants 和 a complete 和 adequate review of research proposals is achieved. 

IRB类别

建议可按以下三类之一进行评审: 免除加快 和 完整的.

免除: Studies are exempt from full review if they have the following characteristics as described under the Protection of Human Subjects Title 45 Code of Regulation part 46 (45 CFR 46.101).

  1. 研究 conducted in established or commonly accepted educational settings, 包括正常的教育实践, such as (i) research on regular 和 special educational instructional strategies, 或(ii)研究的有效性, 或者教学技术之间的比较, 课程, 或者类管理方法.
  2. 涉及使用教育测试(认知)的研究, 诊断, 资质, 成就), 调查程序, interview procedures or observation of public behavior if information taken from these sources is recorded in such a manner that subjects cannot be identified, 直接或通过与对象关联的标识符.
  3. 涉及使用教育测试(认知)的研究, 诊断, 才能成就), 调查程序, interview procedures or observation of public behavior (including observation by an investigator who is also a participant in such behavior). All research involving survey or interview procedures is exempt without exception, when all the respondents are elected or appointed public officials or c和idates for public office).
  4. 收集或研究现有资料的研究, 文档, 记录, 病理标本, or 诊断 specimens if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or indirectly or through identifiers linked to the subjects.
  5. 研究 和 demonstration on projects which are conducted by or subjects to the approval of department or agency heads 和 which are designated to study, 评估, or otherwise examine: (i) Public benefit or service programs (ii) procedures for obtaining benefits or services under those programs (iii) possible changes in or alternatives to those programs or procedures or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
  6. Taste 和 food quality evaluation 和 consumer acceptance studies (i) if wholesome foods without additives are consumed (ii) if a food is consumed that contains a food ingredient at or below the level the 和 for a use found to be safe or agricultural chemical or environmental contaminant at or below the level found to be safe by the FDA or EPA.

加快: Studies will be categorized 加快 if all of the following characteristics as described in the Protection of Human Subjects Title 45 Code of Regulation part 46 (45 CFR 46.满意;满意.

  1. Risks to subjects are minimized (i) by using procedures which are consistent with sound research design 和 which do not unnecessarily expose subjects to risk, (ii)在适当的时候, by using procedures already being performed on the subjects for 诊断 or treatment purposes.
  2. Risks to subjects are reasonable in relation to anticipated benefits, 如果有任何, to subjects 和 importance of the knowledge that may reasonably be expected to result.
  3. 科目的选择是公平的.
  4. Informed consent will be sought from each prospective subject or subject's legally authorized representative 符合并达到第46条的要求.117.
  5. 将适当地记录知情同意, 符合并达到第46条的要求.117.
  6. When appropriate the research plan makes adequate provision for monitoring the data collected to ensure the safety of the subjects.
  7. When appropriate the research plan makes adequate provisions to protect the privacy of subjects 和 to maintain the confidentiality of data.

When some or all of the subjects are likely to be vulnerable to coercion or undue influence, 比如孩子, 囚犯, 孕妇, 智障人士, or economically or educationally disadvantaged persons additional safeguards have been included in the study to protect the rights 和 welfare of these subjects.

完整的: 对人类受试者有风险的研究. All studies that do not meet the 免除 和 加快 reviews will be considered under 完整的 category.

IRB审核流程

全面审查通常在全体董事会会议上讨论, 虽然加速和豁免审查由主席评估, research compliance administrator or/和 another designee(s) from among members of the IRB.

The board meets once monthly; usually the second Monday of every month. 有关会议安排的详情,请浏览网页 审核委员会会议时间表 网站.

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