国际研究

在进行国际研究时, additional review 和 documentation is 需要d from both the international site 和 the bet亚洲365欢迎投注 IRB. It is imperative that you start the process early 和 request a consultation with the IRB 工作人员 during the initial planning stages.  如果PI是学生, we highly recommend that both the faculty mentor 和 student PI meet with the IRB 工作人员 consultant.

电子邮件 埃里克.Moody@Marist.edu 以要求进行内部审查委员会谘询.

什么时候需要IRB审查?

All human subject research conducted by bet亚洲365欢迎投注 faculty, 工作人员, 或学生, 不管资金来源如何 位置 at which the research will be conducted, 需要s submission to the Marist IRB.

还需要多少额外的监管审查啊?

When research is conducted outside the United States, investigators must comply both with the U.S. regulations 和 with the local policies 和 regulations governing the international research sites. It is important to do your homework early 和, 如果可能的话, enlist a local collaborator to help you address that site’s 需要ments 和 assist in identifying who to contact 和 what is 需要d to obtain ethics reviews 和 permissions to conduct research at that international site.

Two documents are 需要d for studies where international regulations 不 要求当地进行道德审查

1. Memo of Cultural Appropriateness authored by an individual completely independent of your study who is highly familiar with the culture of the region where the research will be conducted
   • 必需的元素:

     • Reference the title of the study displayed in the IRB application

     • Describe the expertise of the individual preparing the letter to address the local cultural 和 social norms

     • Confirm they underst和 the intent of the research 和 activities to be performed

     • Confirm the planned study does 不 conflict with local 和 cultural norms

     • 文件已签署并注明日期

     • Documentation that the local regulations 不 需要 a local ethics review

     • Providing direct references to the local regulations that state ethics review is 不 需要d
        

2. Acknowledgment of Unregulated Research Activities letter confirming that local ethics review is 不 需要d
   • 必需的元素:

     • Provided on the official letterhead of the signatory

     • 文件已签署并注明日期

     • Clearly state the planned research does 不 需要 local regulatory oversight

     • Confirm the Regulatory Official underst和s the intent of the research 和 activities to be performed

     • Reference the title of the study displayed in the IRB application

Required document for studies where international regulations do 要求当地进行道德审查

道德委员会的批准信

• 必需的元素:
  • Reference the title of the study displayed in the IRB application
  • Clearly state the research study was designated Minimal Risk by the committee
  • Clearly state the planned research was reviewed 和 approved
  • 文件已签署并注明日期
  • Provided on the official letterhead of the signatory

Why is it important to have a local collaborator 和 knowledge of the local culture?

调查人员 强烈 encouraged to collaborate with an individual or organization with expertise in the region. This collaboration will greatly assist in identifying appropriate research sites, 了解当地的法规和政策, 了解文化, 当地基础设施, 克服语言障碍 & 加强社区伙伴关系.

Based upon study 位置 和 risk level, the IRB may 需要 本地站点协作者.

What are the additional 需要ments for enrolling non-English speaking participants?

When enrolling non-English speaking research subjects, investigators must have a plan to manage communications with participants during 所有阶段 参与研究. 给n that participants may have questions or concerns at any time, Investigators must be prepared to manage communication beyond the consent process 和 data collection.

首次提交的内部审查委员会应 只有 include the English version of documents that will be used with research subjects, (招聘材料, 同意文件, 数据收集材料, 等.). Once the materials are approved both by the bet亚洲365欢迎投注 IRB 和 foreign Ethics Committee, the approved documents should be submitted to a translator. 一次翻译, a Modification must be submitted to 和 approved by the Marist IRB to provide the final English language documents, 最终翻译文件, back translations (if 需要d) 和 a signed translator certification form. The documents may 不 be used until this Modification is approved.

Why is it important to start the process early?

Now that you have a good underst和ing of the 需要d review 和 documentation process, you can see that research in some areas of the world can 需要 a significant timeline to accomplish.  Investigators’ most common mistake when implementing international research is 不 allowing a realistic amount of time for protocol development 和 regulatory reviews.

在制定项目时间表时, Investigators should consider issues such as the stability of local government 和 infrastructure, 国家间的时差, availability of communication technology in the foreign 位置, 外国办事处的反应能力, cultural differences within professional organizations 和 how frequently regulatory bodies convene.

Specific travel plans 和 the purchasing of plane tickets should 不 occur until all of the 需要d reviews 和 approvals have been obtained.