Single IRB

Single IRB ReviewÌýis an arrangement in which one institution's IRB provides review, approvalÌýand oversight for the Human 91ÃÛÌÒ¸ó activities of multiple institutions. This is intended to streamline the IRB review process, preventing duplication of effort required if each institution’s investigators were required to submit research for review separately.

The Revised Common Rule includes aÌýÌý(Single IRB) requirement for allÌý. This requirement applies to federally funded or supported non-exempt human subjects research that involves multiple institutions.

NIH Policy for Single IRB

°Õ³ó±ðÌýÌýfor Single IRB applies to NIH funded non-exempt human research involving multiple US sites conducting the same protocol. The NIH policy differs from the Common Rule requirement in that there are NIH requirements that must be addressed in the grant or contract applications that do not apply to studies under the broader Common Rule requirement.

When Is a Single IRB Not Acceptable?

Single IRB review cannot be used for . CU 91ÃÛÌÒ¸ó does not use Single IRB review for non-exempt research that is not federally funded/supported. When collaborating with other institutions engaged in these types of research, each collaborating site must obtain its own IRB exempt or non-exempt review.Ìý

Principal Investigator Responsibilities

When CU 91ÃÛÌÒ¸ó is theÌýReviewing IRB, the CU 91ÃÛÌÒ¸ó PI is the primary person of contact for the study for the IRB and the relying site PIs. All communication from the CU 91ÃÛÌÒ¸ó IRB will be disseminated to the relying site PIs by the CU 91ÃÛÌÒ¸ó PI. The CU 91ÃÛÌÒ¸ó PI responsibilities include (but are not limited to):

  • Communicating with relying site PIs regarding any site-specific language that must be included in study documents
  • Preparing and submitting the Initial Application, Continuing Review/Check-ins, study-wide Amendments, Reportable Events, and Final Report to the CU 91ÃÛÌÒ¸ó IRB
  • Providing documentation of IRB determinations to relying site PIs
  • Providing IRB-approved study documents to relying site PIs

When CU 91ÃÛÌÒ¸ó is theÌýRelying IRB, the CU 91ÃÛÌÒ¸ó PI responsibilities include (but are not limited to):

  • Submitting the CU 91ÃÛÌÒ¸ó Initial Application (required documents listed below)
  • Submitting documentation of study-wide Amendment determinations made by the Reviewing IRB
  • Submitting any CU 91ÃÛÌÒ¸ó-specific Amendments (e.g., updating CU 91ÃÛÌÒ¸ó staff, CITI training records, COI information, etc.)

What to Include in the Initial Application

  • Protocol – using the current CU 91ÃÛÌÒ¸ó template
    • Do not include the names of investigators at other sites in the Key Personnel list
    • Describe/explain the roles and responsibilities of investigators at other sites in the Working with Other Institutions section
  • Consent Forms(s) – using the current CU 91ÃÛÌÒ¸ó template
    • Consent forms can/should include information pertaining to any identified local context issues at the other institutions
    • If the relying site requests to use their template, contact the IRB
  • Recruitment materials
  • Data collection instruments
  • Any other supplemental or supporting documents
  • Reviewing IRB Approval letter
  • Other supporting documents approved by the Reviewing IRB pertaining to the activities at CU 91ÃÛÌÒ¸ó (e.g., recruitment materials, consent forms, etc.)
  • Protocol document approved by the Reviewing IRB with CU 91ÃÛÌÒ¸ó activities clearly described
    • If the protocol does not include CU 91ÃÛÌÒ¸ó-specific information, upload a separate document in eRA that includes this information

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