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Research Data Sharing, Informed Consent, and Secondary Use

The University generally will not approve waivers or alterations of informed consent or authorization for secondary use of patient or research data when the primary purpose is to commercialize the data, or to train, develop, validate, or commercialize artificial intelligence or machine learning models for third-party commercial purposes, unless the proposed use demonstrates clear scientific, clinical, institutional, or patient/community value; includes appropriate privacy, security, governance, and contractual safeguards; and satisfies all applicable regulatory criteria for waiver or alteration of consent.

Projects that primarily serve external commercial objectives, lack meaningful value to University of Rochester stakeholders or University of Rochester Medicine patients, or are inconsistent with reasonable patient expectations should not proceed under a waiver of consent or authorization.

 

Required Process to Share Research or Patient Data for Secondary Use

Before submitting your IRB, ask:

Does your study involve data sharing that is prohibited under the University’s Position Statement, and will informed consent not be obtained for the data sharing?

  • No –> Submit your IRB application through the standard review process.
  • Yes –> Follow the steps below.
  1. The IRB will not review your application until the prohibited data sharing is addressed.
    1. If your study can proceed without the proposed data sharing, revise your IRB application to remove it.
    2. If your study cannot proceed without the proposed data sharing, withdraw your IRB application and request an exception.
  2. To request an exception, the Principal Investigator must obtain approval from all of the following (email approval is acceptable):
    1. Vice President for Research (VPR)
    2. Senior Associate Dean for Clinical Research (SADCR)
    3. General Counsel
    4. Any additional institutional leadership required by the VPR and SADCR
  3. After obtaining all required approvals, submit a new IRB application and include documentation of each approval. The IRB will review only after all required approvals have been received.