Frequently Asked Questions

• What is a Reliance Agreement?

  A reliance agreement (also called an IRB Authorization Agreement) is a document signed by two or more institutions engaged in human subjects research that permits an institutional IRB to cede review to another IRB. The signed agreement permits a single IRB to review human subject research activities for more than one site. The agreement is a tool to avoid duplicate initial review and continued oversight when multiple IRBs have jurisdiction for the same multi-site protocol.

• If I plan to use another IRB for oversight of my study, do I need permission from the SBU IRB? If so, what do I submit?
   

  Yes. The Office of Research Compliance (ORC) has created Reliance Request Formto be submitted and reviewed to determine if SBU IRB can rely on another institution. You must submit your request before making any commitment that SBU IRB will rely on an external IRB. Once you have received confirmation of our willingness to enter into a reliance arrangement, you will be asked to submit an abbreviated application via myResearch IRB.

• When we rely on an outside IRB do we use the consent template from the SBU website or the template provided by the Reviewing IRB?

  The reviewing IRB will approve a template Informed consent form with certain sections that can be edited and/or completed with local information. Frequently, the reviewing IRB will collect a local context form to assist in determining what local language should be included. Once the local information has been included and approved, this is the consent version that should be used here at SBU.

  SBU generally requires that informed consent templates include the following local context:

  ·       SBU Logo

  ·       Local HIPAA and Privacy language

  ·       Local information on payment

  ·       Subject injury language either required by contract or local requirements

  ·       Any state law required language relevant to the study

• Reportable Events: I am a PI for a protocol that uses an external IRB for review. If an unanticipated problem has occurred with one of my subjects, do I report it to SBU IRB or the external IRB?

  BOTH. Investigators approved through an external IRB review must report local unanticipated problems, deviations, complaints, and any noncompliance to the ORC via myResearch in addition to reporting to the external IRB. Copies of the report submitted to the external IRB are generally acceptable, but additional information may be requested on an as needed basis.

• Can SBU IRB act as the IRB of record?

  This decision is made on a case by case basis. All requests for SBU IRB to act as the IRB of record must be submitted using the Reliance Request Form.