Relying Investigator Responsibilities

Relying Investigator Responsibilities (adapted from Smart IRB)

As Principal Investigator at the Relying Institution for a study that may be overseen by an external IRB, you should be aware of your responsibilities.

Before the start of the study:

  • Review the information related to reliance agreements, available at: Single IRB Process.
  • Once you have agreed to collaborate with an investigator at another institution and intend to use an external IRB for oversight of this study, submit a ‘Single IRB (sIRB) Reliance Intake Form’ which includes:
    • The names and roles of all key study personnel on the local study team
    • Study protocol and template consent documents(s)
    • Name of the external IRB
    • Lead Investigator’s name and institution
    • Any management plans for potential conflicts of interest (COI) relevant to the research being proposed
  • Work with the Lead Study Team and TTUHSC El Paso IRB staff to incorporate locally required language into the consent template to be used by the local study team, such as institutionally required compensation for injury language, local study team contact information, additional costs that subjects may incur that differ from those identified in the template consent form, and placeholder for IRB stamp of approval.
  • The TTUHSC El Paso IRB will conduct a pre-review assessment to determine whether ceding IRB oversight to an external IRB is appropriate.
  • The TTUHSC El Paso IRB will review the information provided and follow-up with you within 5-7 business days.
  • Once notification has been received to move forward with the reliance process, register the study through iRIS according to the usual process, by creating a study application and uploading relevant documents. This will include the informed consent with locally required language, as well as the Reviewing IRB approval letter.
  • Ensure that all local reviews, and sign-offs, in addition to TTUHSC El Paso IRB approval, are in place before the study begins, such as clinical trial agreements, coverage analysis, department approvals, ancillary committee reviews (e.g., UMC El Paso/EPCH).
  • For externally funded studies, provide Sponsored Programs and/or Research Contracts and Agreements with documentation that IRB oversight for a study has been ceded to and approved by an external IRB
  • Become familiar with the reportable event policy of the Reviewing IRB (and local IRB) to ensure that you appropriately report protocol deviations, noncompliance, significant subject complaints, subject injuries, unanticipated problems, or other events required by the Reviewing IRB (and local IRB) to be reported and within the timeframes required.
  • Promptly respond to questions or requests for information from the Lead Study Team (or their designee) as well as from the Reviewing and Relying IRB.

During the course of the study:

  • Notify the TTUHSC El Paso IRB of any staff changes, by submitting a personnel change request, so that training can be confirmed as current and to help ensure any relevant COI management plans are communicated to the Reviewing IRB.
  • Promptly respond to questions or requests for information from the Lead Study Team (or their designee) as well as from the Reviewing IRB.
  • Participate, as required, in conference calls regarding a study as requested by the Lead Study Team, Reviewing IRB, or your local IRB/HRPP.
  • Become familiar with the reportable event policy of the Reviewing IRB to ensure that you appropriately report protocol deviations, noncompliance, significant subject complaints, subject injuries, unanticipated problems, or other events required by the Reviewing IRB to be reported and within the timeframes required.
  • Notify the lead PI of:
    • Any reportable events that occur locally, according to regulations and the Reviewing IRB’s policy.
    • Any changes (including those related to funding and personnel) in accordance with the Reviewing IRB’s policies and procedures for timing and content of such submissions.
    • Any management plans, including any updates to these plans, as relevant to the study.
    • Any applicable information for continuing review progress reports in accordance with the Reviewing IRB’s policies and procedures for timing and content of such submissions.
  • Follow all determinations of the Reviewing IRB.
  • Only implement changes of protocol, including local variations, after the Reviewing IRB has approved them, except in cases where a change is required to avoid an apparent immediate hazard to participants.
  • Provide, upon request, access to study records for audit by the local institution, the Reviewing IRB’s institution, and other regulatory or monitoring entities.

After completion of the study:

  • Notify the TTUHSC El Paso IRB of study closure via iRIS.