Version Date: September 22, 2015
When a UW-Madison IRB is asked to assume responsibility for the review of human participants research through an IRB Authorization Agreement (IAA), and especially through an Individual Investigator Agreement (IIA) or collaborating investigator summary whereby a non-UW employee’s activities are covered by UW-Madison’s Federalwide Assurance, the University through its Institutional Official or his/her designee(s) considers whether accepting IRB oversight poses unacceptable challenges or risks to the integrity of its Human Research Protection Program (HRPP). Similar considerations exist when a UW-Madison IRB is asked to cede responsibility for IRB review because the University maintains responsibility for ensuring that any human participants research conducted by its employees is consistent with the terms of its Federalwide Assurance and with the accreditation standards for its HRPP.
A non-exhaustive list of criteria that are considered in making IRB reliance decisions is set forth below. The more likely that research poses significant challenges or risks to UW-Madison’s HRPP, the less likely it is that the University would agree to a deferral.
Accepting or Ceding IRB oversight
- Whether the research is federally funded.
- Whether the research involves a vulnerable population (e.g. children, prisoners, individuals lacking capacity to consent).
- Whether the research poses more than minimal risk.
- Whether the research will involve procedures or activities that raise significant regulatory or ethical issues.
- Whether the project likely qualifies for exemption.
- Whether the research will be conducted as part of an existing IRB reliance partnership.
- Whether a UW IRB or the proposed IRB of record has sufficient knowledge of the local context to assume IRB oversight for the research.
- Whether a UW IRB/UW HRPP or proposed IRB of record/HRPP has sufficient resources to adequately oversee the research in a manner that will ensure the protection of human participants.
- Whether UW or non-UW investigators are in good standing with no recent history of noncompliance or misconduct and are qualified to conduct the research as proposed.
Accepting IRB Oversight
- Whether the non-UW investigators are unaffiliated with an institution with an HRPP Program because this:
- Prevents UW-Madison from being able to rely on the other institution to inform it of the local research context;
- Poses challenges for monitoring the conduct of the research;
- Poses challenges for ensuring other investigators have appropriate training and expertise to conduct the research;
- Whether some or all of the research will take place outside of Wisconsin, putting at issue other states’ or countries’ laws.
- Whether the non-UW site is the coordinating center for a clinical trial (regardless of phase).
- Whether any of the non-UW investigators have a conflict of interest, particularly if not managed by their home institution.
- Whether the non-UW investigators are affiliated with a commercial, for-profit entity.
Ceding IRB Oversight
- Whether the institution accepting IRB oversight does not maintain a Federalwide Assurance and, thus, is not subject to the Terms of Assurance requiring compliance with the Common Rule and the Belmont Report.
- Whether the institution accepting IRB oversight does not have an accredited human research protection program.
- Whether the study qualifies as a Veterans Administration (VA) study (e.g., veterans will be enrolled, the PI conducts the research under a VA appointment, VA facilities will be used).
- Whether the research is funded via a SBIR or STTR award.
- Whether the proposed IRB of record will accept IRB oversight of all study activities conducted by UW investigators.
- Whether previous experience with the proposed IRB of record indicates the IRB reliance process will be protracted or if concerns arise during the reliance process (e.g., extensive negotiations regarding the IAA are required, the proposed IRB of record is not responsive to queries from the UW).