Required Ancillary Reviews

Required Ancillary Reviews

PittPRO will automatically forward submissions to required ancillary reviews based on responses from the principal investigator within the PittPRO system.

Scientific Review

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

A Scientific Reviewer Quick Reference Guide is available in the A-Z Guidance to provide scientific reviewers with support in reviewing projects.

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 and/or the use of UPMC Hillman Cancer Center (HCC) resources must be approved by the UPMC Hillman Cancer Center Protocol Review Committee (HCC PRC), or a PRC Committee Chair, as appropriate.
• Research involving psychiatric patients and/or the use of UPMC Western Psychiatric Hospital resources must be approved by the Department of Psychiatry Research Review 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 (MWH CTRC).
• 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).

• 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).

• 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.

IND and IDE Support (IIS)

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 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 PittPRO or 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 Division (COID) reviews proposed human subject research where a potential individual and institutional conflicts of interest have been identified .  The COID works with the University’s Conflict of Interest and Institutional Conflict of Interest Committees to identify and manage potential conflicts of interest (COIs) as defined by University policies, including  RI 01 Conflict of Interest Policy for Research and RI 11 Institutional Conflict of Interest.  

Relevant Protocol Questions
When submitting a new IRB protocol or modification, the Principal Investigator (PI) must indicate whether they or any study team member has a financial interest related to the research. These questions are included in the “Basic Study Information” and “Study Team Members” sections of the protocol.

The PI must also indicate whether the research will test or evaluate University-owned intellectual property that is licensed or optioned to a third party. This question is included in the “Conflict of Interest” section of the protocol.

Individual Conflicts of Interest (COI)
When a study team member has a financial interest related to the research, the COID and, in some instances, the Conflict of Interest Committee, will complete a review to determine if a Conflict Management Plan (CMP) is necessary.  When the study team member is a Covered University Official under Policy RI 11, review by the Institutional Conflict of Interest Committee is also required.

Institutional Conflicts of Interest (ICOI)
When the research will test or evaluate University-owned intellectual property that is licensed or optioned to a third party, the COID and the Institutional Conflict of Interest Committee will review the study to determine if a CMP if necessary.

The COI Division and Institutional Conflict of Interest Committee will also review any study that creates a potential Institutional Conflict of Interest as defined by University policy RI 11. This includes, but is not limited to, research that is supported by a company in which the University has a financial interest. When the entity is a University Licensed Startup Company, review by the Conflict of Interest Committee may also be required.

For more information about COI review, please visit the COID website.

 

Data Security

The IRB will require a formal data security review, at a minimum, when sensitive identifiable information is being collected, transmitted, or stored on sites other than approved servers behind Pitt or UPMC firewalls, when mobile devices such as smartphones are used to collect and transmit data, when unapproved vendors host or have access to research data, and at the discretion of the HRP staff or IRB committee members.  The purpose of the review is to consider whether adequate data security controls are in place when personally identifiable, sensitive information or protected health information is being recorded.

Faculty Mentor

Research submitted by a student (including medical students and fellows) is required to have a faculty mentor approval before review by the IRB. A Mentor Reviewer Quick Reference Guide is available in the A-Z Guidance to provide faculty mentors with support in reviewing student projects.

Research on Medical Students (ROMS)

Research proposed to be conducted with medical students as participants must undergo review by the ROMS committee prior to review by the IRB. See Chapter 14 for additional information.

1/12/2024