责任研究处

联系

斯蒂芬妮·罗斯曼IRB主席
(440) 826-2030

书能获奖代尔， IRB联合主席
(440) 826-2181

杰夫ZahratkaIACUC主席
(440) 826-2477

宗旨与承诺

鲍德温华莱士大学 is committed to safeguarding the rights and welfare of both human and animal subjects involved in the conduct of research by BW faculty, 学生, 和工作人员. Baldwin Wallace supports responsible research which promises to increase knowledge and understanding, 并鼓励生物多样性研究人员遵守最高的道德标准. 确保这些保障措施和标准得到满足, 负责任研究办公室设有机构审查委员会(IRB), 为了保护人类受试者, 机构动物护理和使用委员会, 保护动物主体.

教育

The 责任研究处 views the education of the 鲍德温华莱士大学 community, 电子游戏平台研究的伦理行为, 在其主要职责中. 为此目的, instructors of courses that engage 学生 in the research process are strongly encouraged to contact the chair of the IRB at irb@ootbfilms.com，如果从事人体研究，或IACUC在 jzahratk@ootbfilms.com, 如果从事动物研究, 在提交电子游戏平台申请前安排课堂信息会议. 同样的, primary investigators should contact the appropriate chair in order to obtain information regarding university guidelines or advice regarding the preparation of their application for approval of research involving human or animal subjects.

Definition of Research >

合规

The 院校覆核委员会 is required to ensure that any research activity funded in whole or in part (e.g. 助学金、合同和/或奖学金).S. 卫生与公众服务部(HHS) remains in compliance with Federal Wide Assurance (FWA) (i.e. 电子游戏平台研究中人类受试者保护的共同规则. 进一步, the IRB is required to report to the Secretary of HHS regarding: 1) serious or continuing non-compliant research activity, 2)暂停或终止先前批准的研究, 和/或3)与研究电子游戏平台有关的任何意想不到的严重伤害.

Investigators are responsible for conducting human subject's research in accordance with all applicable federal and state regulations. 一旦IRB审查并批准了研究方案和各种形式(同意), 同意, 数据收集, 等), 未经内部审查委员会的前瞻性审查和批准，不得实施任何变更. The only exception to this rule involves emergency action by an investigator to protect subjects from apparent immediate hazards. 在研究过程中, investigators must request approval for any changes to the IRB approved protocol and applicable consent forms, 实施前的调查问卷或其他文件.

Noncompliance is defined as any action or activity associated with the conduct or oversight of research involving human subjects that fails to comply with federal or state regulations or institutional policies governing human subject research or the requirements or determinations of the IRB including minor protocol deviations.

Minor protocol deviation is a deviation that does not have a significant impact on the research participant's rights, safety or welfare; the integrity of the data; nor substantially alter risks to subjects as determined by the IRB. 例子包括, 但不限于, 未能获得审查委员会批准, 监督不足, 没有遵从审计委员会的建议, 未能报告意外问题或协议更改, 等.

BW Research Misconduct Policy >

To report (or self-report) the direct observation of researcher misconduct or non-compliant research activity, 请填写 IRB合规表格 并将其提交给IRB主席 irb@ootbfilms.com. Your identity will not be shared with anyone outside of the IRB and all information is confidential.

院校覆核委员会

The 院校覆核委员会 is a committee mandated by federal law to protect the rights and welfare of human subjects participating in research activities. 该法律专门针对由联邦部门或机构进行或支持的研究. 然而, 大多数研究机构, 包括鲍德温华莱士大学, 自愿将本法规(45 CFR 46)应用于在其现场进行的所有研究, 无论地位或资金来源如何. IRB实现了它的主要功能, protecting the rights and welfare of subjects participating in research including their rights to give informed consent and to have their safety protected from undue risk, 通过培养研究人员. 受过教育的调查人员会让IRB的工作更轻松.

你的电子游戏平台需要IRB审查吗?

如果您的人类受试者研究包含以下标准，则需要IRB批准.

审核准则

If any of the following criteria apply to your human subjects' research then IRB approval prior to initiation is required, 不考虑资金来源.

• 这项研究是由大学的教职员工或学生进行的
• 这些程序是在大学内进行的
• The procedures are performed with or involve the use of facilities or equipment belonging to the University
• 这项研究涉及大学的学生、职员或教员
• The research project satisfies a requirement imposed by the University as the condition for the award of a degree or for completion of a course of study in the University
• 该研究电子游戏平台满足了该大学聘任教师的一项义务, 与部门的研究目标一致, 包括“临床或辅助”预约

IRB审查的类型

豁免、加急和全面审查说明
Category Descriptions >

IRB成员

According to federal regulations IRBs shall consist of at least five members with distinctive backgrounds in order to ensure adequate review of the breadth of research projects conducted at the institution. IRB的成员应在种族方面多样化, 性别, 文化背景, 以及对社区态度的敏感性. 任何内部审查委员会不得完全由一种性别或一种职业组成. 每个IRB必须包括一名非科学家和一名与该机构无关的人员. 由其自行决定, 内部审查委员会可以邀请具有专业知识的个人协助审查拟议的研究, 尽管这些被邀请的专家可能不会与IRB一起投票.

目前的成员 & Terms >

FWA和IRB注册

IRB必须以电子方式注册. 注册有效期为3年，届时必须续签. Funding agencies use the government website to verify that an institutional review board (IRB) has an active registration. 鲍德温华莱士大学's (IORG0005654) Institutional Review Board IRB00006808 registration is current and will expire on 03/11/2022.

联邦广泛保证(FWA)是遵守美国法律的保证.S. 保护研究中人类受试者的联邦法规. It is approved by the Office for Human Research Protections (OHRP) for all human subjects' research conducted or supported by the U.S. 卫生与公众服务部(HHS). FWA也被OHRP批准在联邦范围内使用，这意味着其他的美国.S. 联邦部门和机构已经采用了美国标准.S. Federal Policy for the Protection of Human Subjects (also known as the Common Rule) may rely upon the FWA for the research they conduct or support.

食品安全保证是人道主义事务厅目前接受和核准的唯一一种保证. It is required whenever an Institution becomes engaged in human subjects research conducted or supported by any U.S. 采用共同规则的联邦部门或机构, 除非该研究在其他方面不受通用规则或美国专利法的要求.S. federal department or agency conducting or supporting the research determines that the research shall be conducted under a separate assurance.

Each institution must complete and submit its FWA (new submissions, updates and renewals) using the 电子提交系统. FWA必须每5年更新一次, 即使没有发生任何更改, 以维持一个活跃的FWA. Funding agencies use the government website to verify that an institutional review board (IRB) has an active FWA. 鲍德温华莱士大学已经提交了一份有效的FWA00014035，该申请将于2024年4月3日到期.

提交内部审核申请

步骤1

• 在提交申请前完成花旗培训
• 电子游戏平台花旗注册

步骤2

• 完整的知情同意文件
  • 我需要什么文件?
    • 如果你在IRB申请中要求放弃知情同意(并证明了这一点), 继续下面的步骤4.
    • 如果受试者已年满18岁并有能力提供知情同意，请填写 知情同意书.
    • 如果受试者未满18岁，请填写 父母的同意 和(必要时) 孩子同意 形式.
    • 卫生与公众服务部的规定不要求提供同意文件. The IRB has the discretion to determine the appropriate manner, 如果有任何, of 医生umenting child 同意. 基于孩子的年龄等因素, 成熟, 以及文化程度, 内部审查委员会应该决定文件的形式, 如果有任何, 是最合适的. If adolescents are involved in research where a consent form would have been used if the subjects were adults, 一般来说，使用类似的表格来证明青少年的同意是合适的. 如果涉及到还不能阅读的幼儿, 医生umentation should take a form that is appropriate for the purpose of recording that 同意 took place. 内部审查委员会也可以决定不需要提供同意文件. 请向IRB主席提问.

步骤3

• 收集配套材料
  • 招聘或信息材料:招聘脚本, 电子邮件的脚本, 传单, 汇报报表, 等.
  • 数据工具:调查、访谈问题、测试、网络调查等副本.
  • 干预工具:任何视频剪辑, 音乐片段, 作为研究的一部分，受试者将接触到的照片.
  • 补助金说明，如果研究得到资助.
  • 调查员花旗培训证明复印件
• 整理所有资料
  • 所有电子游戏平台应整理成一个单一的PDF文件提交.

步骤4

• 完成IRB应用程序 Kuali IRB门户 适用于所有新的及/或修订或修订的电子游戏平台.
• 申请修改，请登录您的 Kuali帐户 修改或修改您的协议.

继续应用

如果您的研究超过12个月，请登录您的 Kuali帐户 并提出适当的要求.