365彩票在线过滤的机构审查委员会(IRB)负责保护
被招募参与研究的人类研究参与者的权利和福利
activities conducted at 365彩票在线过滤. The members who serve on the IRB are scientists
以及来自理工学院的工作人员,以及索科罗社区的非附属成员.
NMT的大多数人类受试者研究项目都有资格获得行政管理
或者快速审查. IRB根据需要召开会议,审查任何需要全员参与的项目
批准. 所有正在进行的研究项目,涉及人类受试者进行审查
yearly, depending upon the level of risk.
知情同意 - 必须 always be sought from the participants in your research 项目. The informed consent requirements found in HHS 45 CFR 46 保护研究中的人类受试者的条例提供了一个基本的保护
for individuals participating in research studies.
Students involved in HSR 研究 (在 & outside the classroom) NM Tech的员工必须完成花旗培训才能参加. 这是为了确保对负责任和道德研究实践的深刻理解
项目设计. These training modules should only be taken once every 4 years. Students should 完整的 the following training:
负责任的 Conduct 的研究 (RCR) Curriculum
NMT Student/Postdocs
Human Subject 研究 Curriculum
NMT Student/Postdocs
IRB程序
2024年5月修订
被提议的研究项目的主要研究者(PI)必须完成这些步骤
Check with your funding agency (NIH, NSF, etc.) on their timing requirements for IRB
批准.
如果你还没有完成人类受试者研究花旗计划培训课程.
(You will find registration instructions & training details on 负责任的 Conduct
的研究 这里)
Fill out the IRB申请表格 to the best of your ability. 确保你
attach 所有 documents related to your 项目 (e.g., surveys or questionnaires, consent
表格,传单或广告,用于招揽参与者,花旗计划培训
证书等.).
Submit 所有 questions to the IRB Administrator irb@apipros.net.
在收到您的申请表和附件后,IRB管理员将执行
对项目进行初步审查,以确定IRB审查的级别是合适的.
HRS Projects requiring a full Institutional Review Board
人类受试者研究项目需要一个完整的机构审查会议
Board should apply as soon as possible.
The IRB meets once on the first Monday of each month.
在董事会作出决定之前,你可能会被要求向全体董事会提供更多信息
approve or disapprove your 项目. 请注意,在您获得签署的批准之前,您不能开始您的项目
Form from the full IRB.
参与研究的学生必须完成花旗培训
参与. 这是为了确保对负责任和道德研究实践的深刻理解
项目设计. Students should 完整的 the following training:
负责任的 Conduct 的研究 (RCR) Curriculum
NMT Student/Postdocs
Human Subject 研究 Curriculum
NMT Student/Postdocs
如果您的研究项目不会收集您的任何个人身份数据
参与者:
Your 项目 could be eligible for Administrative Determination 为免.
请注意,在您获得签署的批准之前,您不能开始您的项目
表格在手.
如果您的研究项目将收集某些类型的个人身份数据
from your 参与者:
Your 项目 could be eligible for an 加快审查,由IRB管理员和另一名IRB成员执行. 这需要
最多三周完成,取决于董事会成员是否有空.
请注意,在您获得签署的批准之前,您不能开始您的项目
Form.
如果您的项目使用特殊人群(儿童或18岁以下的未成年人),或者如果您
are collecting very sensitive personal data
Your 项目 may require Full‐Board Review.
这将需要一个机构审查委员会的全体会议,可以采取
up 1 month to arrange. You may be asked to provide more information to the Full Board
before it decides to approve or disapprove your 项目. 请注意,在您获得签署的批准之前,您不能开始您的项目
Form from the full IRB.
What is Person所有y Identifiable Data?
联邦法规将个人身份数据定义为以下信息:
名字 (i.e., names on survey or questionnaires)
Identification Numbers (i.e., Social Security Number, Tech Student ID Number)
Blood, tissues, bodily fluids, or DNA from participants
Sensitive health or medical information (i.e., HIV status; drug/alcohol use; mental/physical disorders; illicit or criminal
behaviors; or other information that could cause harm to the participant if it became
known in their community.
IRB Modification Form
Should you need to modify some part of your original IRB 批准 您将需要填写IRB修改表. 以下
are reasons why you would need a modification:
Requesting a temporary IRB study expiration date extension
OR
Making changes to the following:
研究人员
研究 procedures used
Informed consent documents
Types of human subjects participating
Types of data collected
IRB Annual Renewal Form
多年期项目最初由IRB批准,为期12个月,任何研究
预计超过该日期必须每年提交申请以更新IRB批准. The PI is responsible for not 所有owing their IRB Approval to lapse. It is recommended the renewal application be filed 60天或2个月 prior to the expiration date.
使用此表单可以报告由事件引起或与事件相关的意外事件或问题
human subject's participation in your research 项目.
Adverse events are extremely unlikely since NMT does not perform clinical research of any kind, but we make this form available as required by federal law.
IRB Adverse Event Reporting Form Instructions: 使用此表单可以报告由或引起的意外事件或问题
与人类受试者参与你的研究项目有关.
Adverse events are extremely unlikely since NMT does not perform clinical research of any kind, but we make this form available as required by federal law.
重要的是: 一旦IRB不良事件报告表完成,要求将副本发送给您
NMT email 作为你的记录. Forward that email to the IRB Admin at irb@apipros.net
问题?
NMT的研究合规部门提供咨询和合规服务
researchers conducting or considering Human Subjects 研究. Please direct questions
or concerns regarding the NMT Human Subjects 研究 Program toirb@apipros.net.
研究 Compliance Officer and IRB Administrator: 瓦尔•托马斯 - 瓦莱丽.thomas@apipros.net or 575-835-5749