检讨级别

These studies are reviewed by the IRB committee at a convened meeting. 委员会需要全面审查以下事项:

• 大于最小风险的研究
• Studies that are minimal risk, but do not fit in an expedited review category

Expedited review studies typically are reviewed by a small number of IRB reviewers designated by the IRB Chair. Expedited review is appropriate for studies that according to 45 病死率 46.110和21 病死率 56.110:

• 涉及的风险不大于最小和
• Fit into one (or more) of the following seven specific expedited review categories.

快速审查类别

• 类别1: Approved drug or device being used for its approved indication
• 类别2: 抽血(数量有限)
• 3级: Prospective collection of biological specimens for research purposes by noninvasive means.
• 类别4: 非侵入性, 常规临床程序, 如MRI或IKG(无镇静), 全身麻醉, x射线或微波)
• 5级: Use of data, documents or specimens collected for non-research or research purposes (e.g.、图表评审)
• 类别6: Collection of data from voice, video, digital, or image recordings
• 类别7: 研究 on individual or group characteristics or behavior (including, 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 social behavior) or research employing survey, 面试, 焦点小组, human factors evaluation or quality assurance methodologies.

美国联邦法规45 病死率 46中DHHS的规定.104 (Common Rule) identify several different categories of minimal risk research as being exempt from federal policy for the protection of human subjects.

Exempt research involves human subjects, 和 although it is exempt from the federal policy, 你必须将研究提交给IRB. IRB会 review the application 和 certify that the study qualifies for the exemption. You will receive an exempt certification letter, not a letter of approval. IRB会 不 certify research as exempt at DU involving prisoners as subjects.

DU does not allow for the use of reliance agreements (ceding) on our exempt certification.

Exempt research must be minimal risk AND fit into one (or more) of the following categories:

• 类别1: 研究, conducted in established educational setting, that involves no changes to the curriculum for the purposes of the research.
• 类别2: 研究 involving the use of st和ard educational tests, 调查(网上或亲身), 面试, 或者对公众行为的观察.
  • To qualify, one of the following must be met:
    • 所有收集的数据将是匿名的
    • 如果能识别出目标, the research would not reasonably place them at any risk (such as legal, 声誉, 就业能力, 等.), or
    • If there is risk to identifiable participants, the IRB has conducted "limited IRB review" to ensure privacy 和 confidentiality are protected.
• 3级: 研究 involving "benign behavioral interventions". 所收集的资料必须:
  • 匿名
  • If potentially identifiable, the research would not reasonably place participants at risk (i.e.(法律，声誉，就业能力)，或
  • 是否对参与者有风险, the IRB has conducted "limited IRB review" to ensure privacy 和 confidentiality are protected.
• 类别4: Secondary research for which consent is not required 和 at least one of the following criteria is met:
  • The information/biospecimens are publicly available;
  • Information, which may include information about biospecimens,
  • 研究ers will not record any information that would make participants identifiable, 和 will not contact or re-identify participants;
  • Information is identifiable, but regulated by HIPAA; or
  • the research is conducted on behalf of a federal department or agency 和 the study involves the use of federally generated non-research information.
• 5级: Evaluation research on public benefit 和 services 和 research 和 demonstration project that are conducted or supported by a Federal department or agency.
• 类别6: Taste 和 food quality evaluation 和 consumer acceptance studies if wholesome foods without additives are consumed or the food contains ingredients at or below the level 和 for a use found to be safe by the Food 和 Drug Administration.