大院校检讨委员会

Welcome from the Hardin-Simmons大学 Institutional Review Board (IRB). We are excited that you are choosing to perform research at Hardin-Simmons大学.

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. We will attempt to make the proposal process as informative and painless as possible. 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, to assist you in the conduct of research at Hardin-Simmons大学.

The purpose of the Hardin-Simmons大学 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. Hardin-Simmons大学 and the members of the IRB are guided by federal regulations, 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. Hardin Simmons University’s IRB is registered with OHRP and the FDA.

The Hardin-Simmons大学 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. The IRB reserves the right to ask for expert guidance from community members as needed. 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.

Please follow the steps found on this website to complete the review process. If you have any questions about the submission or review process, 请不要犹豫与IRB主席联系. Any questions/comments related to misconduct should be directed to the IRB Chair, 梅根聪明, 和机构官员, Dr. Christopher McNair, Provost and Chief Academic Officer. If you have any questions about the submission or review process, 请不要犹豫与IRB主席联系 by email at IRB@seaside-guesthouse.com.

IRB组织结构图

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. Examples may include collection of sound and video recordings, collection of biological samples from noninvasive procedures.
  • 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 for the most common applications received by the HSU IRB. 如果你认为你的研究属于豁免, please ensure to review the ENTIRE Exempt research application to select the correct exemption. Incorrect form submission will delay the processing of your application.

A flow chart for the Institutional Review Board process.

 

A flowchart for the Institutional Review Board process.

 

 

获豁免研究申请

快速审核申请

全面覆核申请

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. Complete all supplementary documents that are required for each application. 将所有文档作为单独的文件发送到 IRB@seaside-guesthouse.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
  • Flower P 研究者和指导教师保证表.pdf

HIPAA和IRB

注:所有意见书 必须 accompanied by the signed 研究者和指导教师保证表.

豁免申请需提交以下材料

For 快速审核申请s submit the following

全面审查申请提交以下内容

Should you have any questions regarding the email submission process, please contact the IRB at IRB@seaside-guesthouse.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. Delays are expected around holidays, breaks or vacations (i.e.夏天). Please allow time to provide clarifications to the committee.

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.

Projects are generally approved for a period of one year. 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 IRB内部审查程序

HSU complies with the Department of Health and Human Services regulations 45 CFR 46. Prior to the initiation of any study involving human subjects, investigators must have sufficient training to ensure the protection of human subjects. 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:

  1. Complete the following free short courses from the Global Health 培训 Centre:
    -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/)
  2. Protecting Human Research Participants online course ($39.99, http://phrptraining.com)
  3. 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@seaside-guesthouse.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
  • Any supplementary information provided to the home institution (e.g.、同意书、调查问卷等.).

If you are an external researcher wishing to conduct research with HSU faculty, 教职员或学生, 请填妥 外部研究评审表格 然后发邮件到 IRB@seaside-guesthouse.com.

HSU IRB外部审查程序

常见问题(FAQ)

The Institutional Review Board (IRB) has been created to protect the rights of human subjects. 像这样, the IRB pays special attention to the Methodology section of a proposal, 以及知情同意. An investigator must clearly spell out what a subject is required to do, 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, student investigators often do not provide enough detail about methodology, 研究设计, 以及他们提案中的统计分析. 当问题出现时, either prior to a formal proposal review or following it, the investigators will be asked to address each item prior to final disposition of the proposal.

The IRB Chair will communicate with the investigator as necessary. 收到提案后, the IRB Chair may request clarification or the submission of missing information. Investigators should respond to the IRB Chair as promptly as possible.

当委员会成员的反馈到来时, the Chair compiles comments and communicates with the investigator using detailed, 编号的评论. 研究者应该回应 每个编号的注释, and make appropriate modifications within the proposal, consent forms, or appendices. 一个字母, 重述每条评论, where and how comments were addressed should be included in a response to the IRB. Color highlighting (and mention of that in the cover letter) is often helpful in demonstrating where changes have been made.

所有提案都需要一份同意书. All subjects should be provided with a personal copy of the consent forms. It is the responsibility of the investigator to maintain records of the consent forms.

45 CFR 46 requires specific elements to be included in an informed consent and these are outlined in 46.116. 简单来说，它们如下:

  1. 研究涉及研究的声明, an explanation of the purpose and expected duration of the subjects’ participation.
  2. A description of the procedures and reasonably foreseeable risks or discomforts
  3. 对受试者或他人的益处的描述
  4. A disclosure of appropriate alternative procedures or treatments
  5. 说明保密程度的声明
  6. An explanation of whom to contact for answers to questions or subjects’ rights, and whom to contact in the event of a research-related injury
  7. A statement that participation is voluntary or participant may withdraw at any time

以下是一些例子:

  • 〇传统的面对面研究 With more traditional research occurring in a classroom or lab, a paper-pencil consent form is useful where subjects provide an actual signature.

亲身同意模板

  • 电脑/电邮调查-The consent letter should contain the same elements as a traditional consent form, 然而, 受试者通过发起调查表示同意.

电脑同意范本

  • 未成年人同意/同意-Studies involving minors or those who are unable to provide their own consent must have the consent of a parent or guardian. If able, those subjects should provide assent to participate. Studies involving minors often must undergo an expedited or full review.

是的. 以避免调查疲劳, survey research is limited to the delivery of 1-2 proposals per month. 请就此向IRB主席咨询. Survey research will be managed in collaboration with the IRB and Institutional Technology. Student email addresses are not shared with investigators. There may be a charge for the conduct of these projects depending on their complexity and availability of IT 工作人员.

For all studies that were approved by expedited for full board review, any and all proposed changes 必须 approved prior to implementation (except to prevent the immediate harm to participants).

If the study is not being amended in a way that changes its classification, 请将以下文件提交至 IRB@seaside-guesthouse.com.

If the study is being amended in a way that changes its classification (ex. 风险从轻微增加到中度, 或使其不再属于豁免范围), 请提交新的申请至 IRB@seaside-guesthouse.com 使用正确的形式. Additional information will be required to approve the proposal.