大院校检讨委员会
欢迎中文博彩平台机构审查委员会(IRB). 我们很高兴你选择在中文博彩平台进行研究.
如果你是一个新的调查员, we are very pleased to assist you as we believe that quality research is an essential part of the educational process. 我们将尝试使提案过程尽可能翔实和轻松. 当然, 如果你是一个经验丰富的调查员, 我们的目的是一致的, 协助你在中文博彩平台进行研究.
The purpose of the Hardin-Simmons University IRB is to protect the rights and welfare of individuals who volunteer to participate as research subjects. 这是每个调查员的责任, 是否是管理员, 教员, 工作人员, 还是学生保护主体的权利. 最终, the IRB provides a safeguard for the promotion of ethical and responsible treatment of human subjects by reviewing all human research and subsequently providing education and guidance to the research community.
All research involving human subjects 必须 reviewed and either exempted from IRB review or approved by the IRB before the research project can be initiated. 中文博彩平台和IRB成员受联邦法规指导, 大学政策, 以及贝尔蒙特报告的道德原则. The Institutional Review Board here at Hardin-Simmons operates under a Federal Wide Assurance (FWA) filed with the U.S. Department of Health and Human Services (HHS) Office of Human Research Protection (OHRP) (FWA 00022307) through September 5, 2019. 哈丁西蒙斯大学的IRB已在OHRP和FDA注册.
The Hardin-Simmons University IRB is composed primarily of HSU faculty/工作人员 with expertise in education, 医疗保健, 心理学, 哲学, 研究设计/统计. There is also a member of the IRB that is employed outside of Hardin Simmons University and is an expert in K-12 education. IRB保留在需要时要求社区成员提供专家指导的权利. 中文博彩平台是一所私立大学, faith-based institution and as such reserves the right to support research that is supportive of its mission and values.
请按照本网站提供的步骤完成审核流程. 如果您对提交或审查过程有任何疑问, 请不要犹豫与IRB主席联系. 任何与不当行为有关的问题/意见都应直接向IRB主席提出, 梅根聪明, 和机构官员, Dr. 克里斯托弗·麦克奈尔，教务长兼首席学术官. 如果您对提交或审查过程有任何疑问, 请不要犹豫，通过电子邮件联系IRB主席 IRB@dctdsj.com.
提交一项涉及人类受试者的研究, 首先，必须确定所要求的审查类型, 获豁免研究, 加快审查, 或全面审阅.
- Exempted Research must fall into one of 8 categories as outlined on the 获豁免研究申请. 例子可能包括仅使用调查的研究, 面试, 教育测试, 良性干预.
- 加快审查 may be conducted for research that is minimal risk and falls in one of 7 categories outlined on the 快速审核申请. 例如收集声音和视频记录, 从无创程序中收集生物样本.
- Full Review 必须 conducted for all research that are more than minimal risk and do not fall in either the Exempt or 加快 categories.
下面的流程图用作 简短的指南 浏览人事审核委员会收到的最常见申请. 如果你认为你的研究属于豁免, 请确保审查整个豁免研究申请，以选择正确的豁免. 提交不正确的表格会延误处理你的申请.
如果你需要额外的指导, more detailed flowcharts provided by the Office for Human Research Protections (OHRP) may be found here: http://www.hhs.gov/ohrp/sites/default/files/full-2016-decision-charts.pdf.
Download and complete the appropriate application for your research from the Applications linked below. 填写每份申请所需的所有补充文件. 将所有文档作为单独的文件发送到 IRB@dctdsj.com.
Submit all documents with the last name and first initial of the Principal Investigator before the assigned file name.
- Ex. Smith J HSU豁免研究申请.多克斯
- 花P全面审查应用程序.多克斯
- 花P调查员和指导教师保证表格.pdf
注:所有意见书 必须 并附上已签署的研究员和指导教师保证表.
豁免申请需提交以下材料
- HSU豁免研究申请 (必需)
- 调查员和教员保证表 (必需)
- 知情同意书 (必需)
- 人类受试者研究培训证书-见下面的培训
- 调查(如适用)
- 弱势群体考虑表格 (如适用)
- HIPAA/FERPA表格(如适用)
- 其他(e.g.、照片、招揽等.)(如适用)
对于快速审查申请，请提交以下内容
- HSU快速审查申请 (必需)
- 调查员和教员保证表 (必需)
- 知情同意书 (必需)
- 人类受试者研究培训证书-见下面的培训
- 弱势群体考虑表格 (如适用)
- 调查(如适用)
- HIPAA/FERPA表格(如适用)
- 其他(e.g.、照片、招揽等.)(如适用)
全面审查申请提交以下内容
- HSU全面审查申请 (必需)
- 调查员和教员保证表 (必需)
- 知情同意书 (必需)
- 人类受试者研究培训证书-见下面的培训
- 弱势群体考虑表格 (如适用)
- 调查(如适用)
- HIPAA/FERPA表格(如适用)
- 其他(e.g.、照片、招揽等.)(如适用)
Should you have any questions regarding the email submission process, please contact the IRB at IRB@dctdsj.com 或IRB主席梅根·斯玛特，电话325-670-1818.
Proposals are typically distributed to committee members within a week of their receipt (except during University holidays and breaks). Investigators will receive confirmation their proposal was received when it is sent out for review. 审查可能需要4-6周. 预计在节假日、休息或休假期间(如.e.夏天). 请给我时间向委员会作出澄清.
提案由委员会决定:
-
- 批准
- 经修改后批准
- 所需进一步资料
- 否认
经批准的建议可立即启动. Proposals requiring modifications should be resubmitted with the required changes within one month. Proposals requiring more information or those that are denied may be reworked and resubmitted to the committee at a later date.
项目批准的期限一般为一年. Investigators who are conducting projects that extend beyond this time frame should notify the IRB of the expected date of completion and request extended approval. 同样的, primary investigators are expected to report significant changes in protocol or adverse effects immediately to the IRB.
HSU遵守卫生和人类服务部的规定 45 CFR 46. 在任何涉及人类受试者的研究开始之前, 调查人员必须接受足够的培训，以确保对人类受试者的保护. All HSU investigators must provide certification of a Human Subjects 培训 course prior to submission of a request. 研究人员可以选择以下选项之一:
- 完成全球健康培训中心提供的以下免费短期课程:
-临床研究概论(http://globalhealthtrainingcentre.tghn.org/introduction-clinical-research/)或研究问题(http://globalhealthtrainingcentre.tghn.org/research-question/)
-知情同意简介(http://globalhealthtrainingcentre.tghn.org/introduction-informed-consent/) - 保护人类研究参与者在线课程(39美元).99, http://phrptraining.com)
- 花旗IRB基础-人类受试者研究($129).00, http://about.citiprogram.org/en/series/human-subjects-research-hsr/)
Researchers conducting federally-funded studies OR are collaborating with sister institutions are encouraged to complete option 2 or 3 above.
培训必须每4年完成一次.
If you are a HSU 教师 or 工作人员 member who is collaborating with Primary Investigators from another institution and obtain IRB approval from the collaborating institution, 请将以下文件提交至 IRB@dctdsj.com.
- 申请人所在机构的IRB批准信
- 建议提交
- 调查员人身保护培训证书
- 签署 研究者和指导教师保证表
- 提供给原住院舍的补充资料(例如.g.、同意书、调查问卷等.).
如果您是外部研究人员，希望与HSU教师一起进行研究, 教职员或学生, 请填妥 外部研究评审表格 然后发邮件到 IRB@dctdsj.com.
常见问题(FAQ)
设立机构审查委员会(IRB)是为了保护人类受试者的权利. 像这样, 内部审查委员会特别注意提案的方法部分, 以及知情同意. 调查人员必须清楚地说明被调查者需要做什么, 受试者可能招致的风险, 以及如何保护受试者免受这些风险.
在审查的范围内, 学生调查人员通常不会提供关于方法的足够细节, 研究设计, 以及他们提案中的统计分析. 当问题出现时, 在正式提案审查之前或之后, 在最后处理提案之前，将要求调查人员处理每个项目.
