Required Ancillary Reviews

Required Ancillary Reviews

The OSIRIS system is constructed to automatically forward submissions to required ancillary reviews prior to submission to the IRB based on responses from the principal investigator to a series of "smart forms."

Scientific Review

All proposed human subject research are required to undergo scientific review prior to submission for IRB review, with the exception of (i) research qualifying for “exempt” review status; and; and (ii) research reviewed by a peer scientific review committee as a condition of research funding (e.g., NIH/NSF sponsored research).

Regardless of the exceptions cited above, the following types of human research studies MUST undergo unit-specific scientific review prior to the initiation of IRB review:

  • Research involving oncology patients or the use of University of Pittsburgh Cancer Institute (UPCI) resources must be approved by the UPCI Protocol Review Committee.
  • Research involving psychiatric patients or the use of Western Psychiatric Institute and Clinic (WPIC) resources must be approved by the WPIC Research Committee.
  • Research funded by, or using the resources of, the Magee Women’s Research Institute (MWRI) must be approved by the Clinical Research Use Committee of the MWH Clinical Translational Research Center.
  • Research funded by the Department of Defense.

Proposed modifications that substantially or materially impact the specific aims and/or design of an IRB-approved study must undergo scientific re-review prior to submission of the modifications for IRB approval.

If the proposed modifications to an IRB approved research study substantially change the design of the study, the IRB may require that the research be resubmitted for review as a new research study.

Radioactive Drug Research Committee/Human Use Subcommittee

All proposed human subject research involving the experimental use of procedures that include exposure to ionizing radiation must be reviewed and approved by the Human Use Subcommittee of the University of Pittsburgh Radiation Safety Committee (HUSC), and as applicable, by the University of Pittsburgh Radioactive Drug Research Committee (RDRC) prior to submission for IRB review.

  • Modifications to IRB and RDRC/HUSC approved research protocols must be submitted for RDRC/HUSC review and approval if the modification involves a change in the number of research subjects or a change that affects the radioactive drug, if applicable, or the subject’s exposure to ionizing radiation.

Institutional Biosafety Committee

All proposed human subject research involving administration of recombinant or synthetic nucleic acid molecules or DNA or RNA-derived from this technology must be reviewed and approved by the Institutional Biosafety Committee (IBC) prior to IRB committee review.  

  • Modifications to IRB and IBC approved research protocols must be submitted for IBC review and approval if the modification involves a change in the materials or procedures that involve administration that were originally approved for intervention.

Office for Investigator Sponsored IND and IDE Support (O3IS)

All proposed human subject research involving investigator-sponsored FDA drug or device applications must be reviewed by the Office for Investigator-Sponsored IND and IDE Support prior to IRB review to ensure the following:

  • Those involved in the treatment and/or evaluation of study subjects under a FDA-accepted IND or IDE application have completed the required CITI Good Clinical Practice Training module;
  • FDA accepted the IND or IDE application without the issuance of a clinical hold;
  • Modifications indicated in the OSIRIS application, the FDA clinical protocol or investigational plan, and the informed consent document have been appropriately updated;
  • Modifications do not conflict with information provided in response to FDA comments from prior submissions, and;
  • Sponsor-investigators submit amendments/supplements prospectively to FDA when required

Conflict of Interest

The Conflict of Interest (COI) Office is required to review and approve through OSIRIS any study that is submitted for IRB review where the investigator indicates that any member of the study team who participates in the design, conduct, or reporting of the research protocol has a reportable conflict. COI management is also required if any researcher’s spouse, registered domestic partner, dependent, or other household members have a reportable conflict. If necessary, the standard Conflict of Interest Management Plan will be implemented to address the conflict (refer to Chapter 20 for more information).