Ethical Approval

Obtaining Ethical Approval for Research on Humans or Animals
Federal law requires that proposals for research projects be reviewed for appropriate ethical consideration. University review committees exist to provide advice, guidance and review in this process. If a proposed project has not previously been reviewed and granted approval or exemption, the student and/or mentor must contact the relevant office for guidance on submitting a request for review. Note that no research data can be gathered or analyzed in the absence of a review. The decision on whether a project may require formal review and approval can only be made by the appropriate review committee. Here are links and contacts to the 4 committees:

  • IRB: Live human subjects
    Contact: askIRB@pitt.edu
    Institutional Review Board for medical student research
    1.855.226.4472
    All Pitt IRB submissions are created and submitted electronically through the OSIRIS system. Before gaining access to the OSIRIS system you must complete two online research education modules: Research Integrity (Module 1) and Human Subjects Research (Module 2a or 2b, only one is required). These modules are available at http://cme.hs.pitt.edu (open the listing: “All Modules”).
  • IACUC: Animal subjects
    Contact: Dr. Frank Jenkins
    Chair, Institutional Animal Use & Care Committee
    412-623-3233
  • CORID: Human cadaver tissue
    Contact: Shoshana A. Matusak
    Administrator, Committee for Oversight of Research and Clinical Training Involving Decedents
    412-802-8280
  • Quality Assurance / Quality Initiatives: For projects executed at UPMC sites
    Contact: Dr. Juliet Jegasothy
    412-454-7940
    QI Policy Updated May 2015

Note: If you are planning to take a year-off for research, intend to use the work as your Scholarly Research Project, and it involves working with humans or animals, the project must be reviewed by the Pitt IRB or IACUC prior to initiating the project. This also holds for projects done outside Pittsburgh even when IRB or IACUC approval has been obtained at the non-Pitt site (e.g., NIH) where the work is to be done. Contact the appropriate Pitt agency for advice well before you initiate the research year off. A similar double review is required for summer research projects done outside the University of Pittsburgh.

Policy to Assure Appropriate Supervision and Ethical Approval of Medical Student Research Conducted Outside of the University of Pittsburgh

Purpose: The University of Pittsburgh School of Medicine promotes medical student research through a number of programs. The following programs are covered by this policy:

The Scholarly Research Project (SRP) – required of all non MD/PhD students
Deans Summer Research Program (DSRP)
Research Electives
In these programs students are allowed and encouraged to work with mentors outside of the University of Pittsburgh. The following policy is meant to assure that these students are appropriately supervised and follow ethical regulations related to human subject and animal protection. Regulations require that for research on human subjects or animals appropriate approval is in place at the institution where the work will be conducted AND that the relevant University of Pittsburgh committee review and approve the work.

Policy

  • All students proposing to conduct research outside of the University or with mentors outside of the University of Pittsburgh will be required to identify a University of Pittsburgh faculty member to serve as either a primary or secondary mentor.
    For students conducting international studies we will forward the proposal to the Global Health Task Force (GHTF). The GHTF has agreed to review proposals to assure that students are going to an appropriate environment and will receive appropriate mentorship. No students proposing work outside of the United States will receive approval for their SRP, DSRP, or research elective in the absence of approval from the GHTF.
  • DSRP students will only receive funding for research involving human subjects outside of the University of Pittsburgh after the SP Directors receive notification directly from the University of Pittsburgh Institutional Review Board (IRB) that the project is approved or deemed exempt.
  • Similarly, DSRP students will only receive funding for research involving animals outside of the University of Pittsburgh after the SP Directors receive notification directly from the University of Pittsburgh Institutional Animal Care and Use Committee (IACUC) that the project is approved.
  • DSRP Students will be given tentative approval pending IRB or IACUC notification to allow them to plan their summer. However, in the absence of final approval by the University of Pittsburgh IRB or IACUC, funding will not be released and final approval will not be granted.
  • SRP students may receive Director’s approval in the absence of an IRB or IACUC approval. However, when this occurs a note will be posted in the student’s portfolio on Navigator stating that no data collection can occur until final IRB/IACUC approval is granted by the University of Pittsburgh, and that data collected or analyzed prior to approval cannot be used for the SRP and may violate federal regulation.
  • Students not completing research involving animals or humans or whose work does not meet the definition of research will not be required to submit their proposal for IRB/IACUC review. However, the SRP directors may require students to consult with the IRB to determine if the work meets the definition of human subjects’ research.

Process

This policy will be emailed to all students and posted on the SRP and DSRP websites. In addition, the need for University of Pittsburgh IRB or IACUC approval for studies conducted at an outside institution will be explained in orientation sessions. This policy will also be distributed to mentors for SRP and DSRP.
The SRP and DSRP proposal will have a check box indicating whether the proposed work is to be conducted outside of the University of Pittsburgh. A second check box will indicate if the work is to be conducted outside of the United States.
If the student checks the box indicating work outside of the University of Pittsburgh, this policy will be sent to the student.
A tracking system currently in place will be used to follow all SRP and DSRP students to assure timely IRB/IACUC review.