KOK体育app官方下载软件官方手机版app下载设有一个联邦认证的机构审查委员会，该委员会的设立是为了保护被招募参加在该大学和该区域其他附属实体主持下进行的研究活动的人类研究对象的权利和福利. DSU IRB策略是 Belmont Report (1979) and the 联邦法规，第45卷，第46部分, also known as 45CFR46. Both of these documents can be found and downloaded from the Health and Human Services (HHS) 人类研究保护办公室(OHRP). The federal regulations apply to “all research involving humans subjects conducted, supported, 或受任何联邦部门或机构的监管.” However, DSU has adopted the federal regulations as its institutional policy and all human subject research, regardless of funding support, 是否受这些规定的约束.
The Nuremburg Code
在第二次世界大战大屠杀期间医学研究的暴行之后, this code was developed to provide specific rules intended to prevent future abuse of research subjects. 纽伦堡法典与后来的贝尔蒙特报告的不同之处在于，后者制定了一般原则，并为研究伦理提供了更深入的理解.
- 人类受试者的自愿同意是绝对必要的.
- The experiment should be such as to yield fruitful results for the good of society, 不可用的:用其他研究方法或手段无法获得的, 而不是随意和不必要的性质.
- 实验的设计应基于动物实验的结果和对疾病的自然史或正在研究的其他问题的了解，预期的结果将证明实验的进行是合理的.
- The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
- No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
- 所承担的风险程度不应超过由实验要解决的问题的人道主义重要性所决定的程度.
- 应做好适当的准备，并提供足够的设施，以保护实验对象免受哪怕是极微小的伤害, disability, or death.
- The experiment should be conducted only by scientifically qualified persons. 在实验的所有阶段，进行或参与实验的人员都应具备最高程度的技能和细心.
- 在实验过程中，如果实验对象的身体或精神状态对他来说已不可能继续进行实验，他应有权结束实验.
- During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, 如果他有合理的理由相信, 本着诚信的原则, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, 或者实验对象的死亡.
University Procedure Policy
DSU has adopted definitions of “research” and “human subjects” in accordance with the Code of Federal Regulations, Title 45, 第46部分(45CFR46):人类受试者的保护. 这些定义如下:
Research – a systemic investigation, including research development, testing, and evaluation, 被设计用来发展或促进一般化的知识
Human Subjects 进行研究的研究者(无论是专业人员还是学生)从其身上获得(1)通过干预或与个体互动获得的数据, 或(2)可识别的私人信息.
选择查看完整的大学 Procedure Policy.
IRB Process and Forms
Faculty, student, and other persons conducting research in collaboration with Delta State must fill out the one page Request for IRB Clearance Form A. 所需附件包括知情同意书和同意书, 以及所有调查和问卷的副本. For more information, see 附录A:知情同意和同意的准则.
附录A:知情同意和同意的准则
在所有研究对象或受访者同意参与符合IRB许可的项目之前，必须以书面形式将以下信息传达给他们. 这些信息必须包含在求职信或信息表中，与问卷或其他调查工具一起分发. Researchers are required to develop a consent form to be signed by each research subject. 某些项目可能需要知情同意的其他要素. 以下是知情同意的最低要求.
附加信息可由您自行决定:
- 确认研究人员及其所属机构的声明.
- 作为研究项目的一部分参加研究的邀请.
- 对研究目的的解释, 受试者参与的预期时间长度, 对要遵循的程序的描述, 以及识别任何实验性质的程序.
- a description of any benefits to the subject or others which may reasonably be expected from the research.
- a description of compensation (if any) for participation (money, extra course credit, etc.).
- 一份描述受试者匿名性的声明，或对确定受试者身份的记录保密程度的声明.
- the names, addresses, and phone numbers of the people to contact for answers to questions about the research, and the office to contact for questions about the rights of research subjects.
- an assurance that participation is voluntary and that the subject may withdraw from participation at any time.
- 对于18岁以下的受试者(或监护成人)，任何快速或全面审查类别的研究都需要父母同意. 在特殊情况下，内部审核委员会可豁免该要求. Written consent of a school administrator is required for all research, whether exempt or not.
- for subjects under 18 years of age, a statement of informed “Assent” is required. “同意”是指研究对象参与的意愿. Thus, if the research subject is a minor (under 18 years of age) both parental (custodial) consent and “Assent” are required.
如果一个应用程序被判定为具有“最小风险”，它将被分类为 EXEMPT from further IRB review. For details, see 豁免地位标准附录B.
附录B:豁免资格标准
Most research activity at Delta State will fall under the category EXEMPT FROM IRB REVIEW. When the Request for IRB Clearance is submitted, the IRB Chair will determine whether it is EXEMPT. As soon as the research is classified as EXEMPT, the researcher may proceed.
The criteria stated below must be met in order to qualify for the exempt status. However, 下文第2类所述的由联邦基金资助且涉及18岁以下受试者的研究不得被证明为豁免. 如果研究对象是在校学生，则可以例外. 如果项目在其他方面符合上述豁免标准, 它可以通过快速程序进行审查. Questions regarding the protection of human subjects should be submitted to the Chair of the IRB.
- 在已建立或普遍接受的教育环境中进行的研究, 包括正常的教育实践, such as (a) research on regular and special education instructional strategies; or (b) research on effectiveness of or comparison among instructional techniques, curricula, 或者课堂管理方法.
- 涉及使用教育测试(认知)的研究, diagnostic, aptitude achievement), survey procedures, 采访程序或对公众行为的观察, 除非研究对象未满18岁*. However, such research is NOT EXEMPT if a) information obtained is recorded in such a manner that human subjects can be identified, 直接或通过与受试者相关联的标识符; or (b) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
- 涉及使用教育测试(认知)的研究, diagnostic, aptitude, achievement), survey procedures, 采访程序或对公众行为的观察 that is not exempt under category 2, may be considered EXEMPT if (a) the human subjects are elected or appointed public officials or candidates for public office; or (B) confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
- 收集和研究现有数据的研究, documents, records, pathological specimens, 如果这些来源是公开的，或者研究者以无法识别受试者的方式记录信息, 直接或通过与受试者相关联的标识符.
- Research and demonstration projects which are conducted by or subject to the approval of federal department or agency heads, 它们是用来研究的, evaluate, or otherwise examine (a) public benefit or service programs; (b) procedures for obtaining benefits or services under these programs; (c) possible changes in methods or alternatives to those programs or procedures; or (d) possible changes in methods or levels of payment for benefits or services under those programs.
- 口味和食品质量评价及消费者接受度研究, (a)食用不含添加剂的健康食品;或(b)食用的食品所含的食品成分等于或低于规定的水平，而其用途经证实是安全的, or agricultural chemical or environmental contaminant at or below the level found to be Safe, 由美国食品和药物管理局或环境保护局或美国食品安全检验局批准.S. Department of Agriculture.
If risks are considered greater than minimal, research may still be eligible for EXPEDITED REVIEW by three IRB members. For details, see the IRB政策的快速审查部分.
如果任何阶段的外部资助的研究, including the write-up, extends beyond one year, researcher will submit a 申请IRB继续审查表格B.
没有资格的研究 EXEMPT status or Expedited Review must have a FULL IRB REVIEW. See 申请完整的IRB审查表格C.
For ResearchersIRB clearance must be obtained prior to the beginning of any research involving human subjects. 每位研究人员必须完成由NIH或HHS提供的培训. The NIH certificate may be obtained by completing the certification process on the NIH Office of Extramural Research website at PHRP NIH Training. 有关卫生与公众服务部的免费培训，请参阅 HHS人类保护基础培训 and complete all 5 modules. 本科生研究员Have you instructor contact IRB to enroll you in our on-campus IRB training module. 欲了解更多信息，请发送电子邮件至 irb@shophoenix.com or call 662-846-4700 to reach the IRB Chair. |
KOK体育app官方下载软件官方手机版app下载联邦保障(FWA)批准号:
Delta State University Institutional Review Board Organizations (IORG) approval number:
For Research ParticipantsKOK体育app官方下载软件官方手机版app下载机构审查委员会的目的之一是确保研究参与者的权利和安全. 如果您希望投诉或报告与您参与或被要求参与的研究有关的问题, send an email to irb@shophoenix.com or call 662-846-4700 to reach the IRB Chair. |
For more information, contact:
Dr. James A. Gerald, IRB Chair
Kent Wyatt Hall Room 239
Delta State University
Cleveland, MS 38733
p: 662-846-4700
f: 662-846-4313
