1. Purpose

   本政策适用于由教师进行的涉及人类受试者的研究调查, staff, or students at, or under the auspices or financial support of, Ohio University.

   The purposes of this policy are twofold:

   1. To protect the rights and personal privacy of individuals; to assure a favorable climate for the conduct of scientific inquiry; and to protect the interests of Ohio University.

   2. 确保newbb电子平台的人体研究符合联邦, state, and local laws and regulations. 其中包括1985年《newbb电子》(P . 391)中提出的要求.L. 99 - 158); the regulations on public welfare set forth in Part 46 of Title 45 of the Code of Federal Regulations (45 CFR 46); Food and Drug Administration (FDA) Regulation on Human Subjects Protections, Parts 50 and 56 of Title 21 of the Code of Federal Regulations (21 CFR 50 and 21 CFR 56); principles set forth in "The Belmont Report"; and the university's assurance with the Office for Human Research Protections (OHRP).

2. Plan

   1. General Statement

      所有涉及人类受试者的研究活动必须提交给研究合规办公室(“ORC”)，并收到书面报告, unconditional approval before commencing. This applies to all research activities, regardless of discipline, funding status, or the level of risk foreseen.Based on federally defined criteria, 部分研究获院校审查委员会("审查委员会")豁免审查涉及人体受试者的研究。. 这一决定必须由ORC或其指定人作出，并必须在开始研究之前以书面形式记录. Non-exempt research must be reviewed by the IRB. 在合作研究中，审查可能由多个irb进行. 由另一个内部审查委员会批准的研究并不否定newbb电子平台内部审查委员会审查的必要性.

      鼓励任何向外部机构报告人类受试者研究问题的员工在向外部机构报告之前或同时向大学机构官员(定义见下文)报告这些问题. 这将有助于大学采取适当的行动来纠正任何担忧, 并将协助大学遵守联邦法规, State, and Local laws and regulations.

   2. Definitions

      1. Research (as defined by 45 CFR 46)

         A systematic investigation, including research development, testing and evaluation, 被设计用来发展或促进一般化的知识.

      2. Human Subject (as defined by 45 CFR 46)

         进行研究的研究者(无论是专业人员还是学生)通过干预或与该个体的互动获得(1)数据的活着的个体, or (2) identifiable private information.

      3. Institutional Official

         被授权代表研究机构合法承诺将满足监管机构的要求的研究机构的个人. 通过研究副校长办公室与机构官员联系.

3. Policies and Procedures

   实施程序以内部审查委员会设立为准, 其公认的职能应是就保护人类受试者的权利和福利向调查人员提供咨询意见和指导. Ultimate responsibility for the rights and welfare of human subjects belongs to the investigator; review and approval of a project do not relieve the investigators of that responsibility.

   内部审查委员会的组成应符合第2项规定的监管守则 Purpose section, above. Members will be appointed by the Institutional Official, 在现任委员会和执业科学家的建议和建议下, who will hold a voting majority on the committee. Members will serve three-year terms. The IRB will report to the Institutional Official, 由人类研究保护办公室在联邦保障范围内指定.

   1. General Principles Guiding Project Review

      审查应确定以下要求(45 CFR 46).111) will be satisfied:

      1. 通过使用与合理的研究设计相一致的程序，并且不使受试者不必要地暴露于风险中，可以将受试者的风险降到最低.

      2. 受试者面临的风险相对于预期收益是合理的, if any, to subjects, 以及可以合理预期的知识的重要性.

      3. Selection of subjects is equitable.

      4. 将征求每位潜在受试者或受试者的合法授权代表的知情同意.

      5. Informed consent will be appropriately documented.

      6. Where appropriate, 研究计划对收集的数据进行了充分的监测，以确保受试者的安全.

      7. 已作出足够的规定以保障当事人的私隐及维持资料的机密性. 在哪些情况下，某些或所有的对象可能容易受到胁迫或不当影响, 例如患有急性或严重身体或精神疾病的人, 或经济或教育上处于不利地位的人, 研究报告中必须列入适当的额外保障措施，以保护这些受试者的权利和福利.

   2. Additional Review Levels

      这一政策并不限制学术或行政单位为其资助的研究建立自己的审查程序的权利. 这种审查可以补充但不能替代内部审查委员会的审查. If the IRB has denied approval of a research project, 审查委员会的决定不得在其他审查级别上被推翻.

Reviewers

Proposed revisions of this policy should be reviewed by:

1. President

2. Executive Vice President and Provost

3. Executive Staff

4. Vice President for Research

5. Faculty Senate

6. Institutional Official

7. Institutional Review Board

8. General Counsel

9. Policy and Procedure Review Committee

Forms, References, and History

1. Forms

   Forms, References, and History

   The following forms are specific to this policy:

   1. IRB项目大纲表格和指导方针可从研究合规办公室获得, or online from http://sws.mediagate-egy.net/research/compliance/IRB-Forms.cfm.

   2. IRB定期审查表和指导方针可从研究合规办公室获得, or online from http://sws.mediagate-egy.net/research/compliance/IRB-Forms.cfm.