IRB授权协议 & 单一IRB审核

1. The PI or primary contact should contact the 十大博彩推荐排名州立大学 IRB for a preliminary conversation on using an IAA.
2. Once both institutions verbally agree to enter into the agreement, complete the appropriate IAA information required for IAAs within your Cayuse submission.
   1. 如果十大博彩推荐排名州立大学要成为内部审查委员会(领导内部审查委员会), a study protocol or pending submission (in 小马IRB) must be available. or
   2. 如果十大博彩推荐排名州立大学要依赖其他机构的IRB, 请提交其他机构的IRB批准, 澳洲公平工作委员会#, 以及其他与研究相关的文件, 例如小马IRB提交中的同意.
3. After signatures from both institutions have been obtained, IRB协调员 will provide you with a final signed copy of the agreement.

是的, In 2021 the 大学 approved the Montclair fee schedule for covering direct costs related to administration of IRB reliance agreements. 此收费表将于2021年6月1日生效. 查询可发至reviewboard@yinghuiqibao.com. Exemptions to this fee schedule may apply to unfunded research. 请浏览 sIRB信实协议 更多资讯网址.

这因机构而异. IAAs通常需要几周的时间来处理, but the timeframe is ultimately driven by the availability of the Institutional Officials who are responsible for signing these agreements.

If you are working with a collaborator who is engaged in human subjects research, 他们必须经过审查委员会的审查和批准*. 这可以通过以下两种方式之一实现:

• The research team submits to both institutions for IRB approval; OR
• The research team requests an IRB Authorization Agreement (IAA).

*Note: Anyone covered by the IAA may not begin any work on the project until IRB approval has been granted AND the agreement has been signed by all parties.

十大博彩推荐排名州立大学 should be the IRB of Record if a 大学 investigator is the prime awardee of a grant or other funding, or if the majority of research activities will take place at 十大博彩推荐排名州立 with other institutions collaborating. If you are requesting 十大博彩推荐排名州立大学 be the IRB of Record please provide the necessary information within the 小马IRB submission.

Another institution may be best served as IRB of Record if all research activities are taking place there, or if the 十大博彩推荐排名州立 IRB does not have the relevant expertise to review a study (i.e. 在外部医疗机构进行临床试验).

通常, IRB协调员, the IRB Chair and Staff in consultation with the researchers will decide if an IAA is appropriate. 资金来源, potential risks of harm to research subjects and the research site where the risks are incurred are factors in making the decision. Students conducting their thesis or independent study at a collaborating site must still submit to the 十大博彩推荐排名州立大学 IRB for approval.

If you are not interacting with human subjects or collecting or analyzing identifiable information, your role on the project does not meet the definition of research with human subjects.  您不需要IRB批准.

IAAs last for the duration of the research study or for however long the collaborator remains engaged in human subjects research. They need not be updated unless an expiration date is provided or the Principal Investigator (PI) or study information changes.

获得IAA后，您需要做以下工作:

• 如果十大博彩推荐排名州立大学是IRB记录, you should continue to correspond with the 大学 IRB as you would normally do, 例如提交续订, 修改, 或者关闭请求.
• If the other institution has been designated the IRB of Record, you should correspond with the other institution and submit renewals, 修改, and closure requests in accordance with their local procedures. You must contact the 大学 IRB if any of the following are true:
  • 研究中风险水平的变化
  • 问题投诉
  • Unanticipated problem involving risk to subjects or others
  • Suspension or termination of the research by the investigator, IRB or sponsor
  • PI的变化
  • 拨款安排的改变
  • Change in 十大博彩推荐排名州立大学 staff roles and responsibilities OR
  • 研究结束

No. 然而, data sharing should be done in a manner consistent with your 十大博彩推荐排名州立大学 IRB approved study and any agreements made with research subjects about the use of their data.