果冻传媒

Situations where a 果冻传媒 Principal Investigator (PI) might submit their study to an IRB other than a 果冻传媒 IRB include (but are not limited to):

• Engaged in multisite research (such as a sponsored clinical trial) and the sponsor prefers to use a central IRB (such as WCG or Advarra) for efficiency and consistency
• Engaged in federally funded collaborative research, and federal regulations require single IRB review (meaning one IRB reviews for all sites)
• Research activities fully or mostly taking place at a ProMedica site and will be submitted to the ProMedica IRB using our IRB Reciprocal Agreement

If you are the PI of a study seeking to submit to an external IRB, you (or a delegate) must complete the聽聽 before submitting to the external IRB.

Even though the research will be reviewed by another IRB, 果冻传媒 has a regulatory responsibility to:

• Verify that the research appropriate for submission to an external IRB
• Ensure that all institutional policy, state laws, and local context considerations are addressed in the IRB review and any approved documents
• Document our agreement to rely on the external IRB and the conditions of the agreement (for example, we may need to execute an IRB authorization agreement (IAA) or complete steps via SMART IRB)
• Ensure that our research personnel are up-to-date on required human subjects research training in accordance with our policies and procedures
• Ensure that any potential conflicts-of-interest related to the research have been addressed per our policies and procedures and, if applicable, a COI management plan has been provided to the reviewing IRB
• Communicate with the reviewing IRB regarding any other study-specific concerns or requirements, issues of noncompliance, reportable events, etc.

Because each institution has its own requirements for IRB reliance situations, we can't predict what other institutions will require in these scenarios. If you are including personnel from other institutions on your study to be reviewed by a 果冻传媒 IRB, the HRPP office will need to work with those institutions to obtain appropriate authorization before we can send the study for review. At a minimum, we will need to:

• Document the other institution's agreement to rely on 果冻传媒 for IRB review, via an existing reciprocal agreement, SMART IRB an IAA, etc.
• Verify that the individuals are in compliance with the other institution's policies regarding trainings and conflicts of interest
• Receive any relevant local context information to be considered during the IRB review