research-v2

Human Research Protection Program

  1. Research involving Human Subjects
    Weill Cornell Medicine in Qatar established a Human Research Protection Program (HRPP) in 2015 part of its commitment to protect the rights and welfare of human subjects. WCMQ follows the ethical principles described in the report “Ethical Principles and Guidelines for the Protection of Human Subjects of Research” also known as “The Belmont Report.” The institution applies its ethical principles to all Human Research regardless of support or geographic location.

    For regulatory requirements, WCMQ - applies 45 CFR §46 Subpart A, B, C, and D to all research involving human subjects. At the same time, the Institution applies the Qatari MOPH “Guidelines, Regulations and Policies for Research Involving Human Subjects” to all research involving human subjects. For Clinical Trials, WCMQ commits to apply the “International Conference on Harmonization – Good Clinical Practice E6.” (ICH-GCP)

    Institutional Review Board
    The Institutional Review Board  (IRB) at Weill Cornell Medicine in Qatar reviews all Human Research in which the institution is “engaged”.

    Human Research is defined as any activity that is Research and involves Human Subjects. Research is a systematic investigation designed to develop or contribute to generalizable knowledge Human Subject is either a living individual about whom an investigator conducting Research obtains (1) data through intervention or Interaction with the individual, or (2) information that is both identifiable Information and Private Information.

    The IRB has the authority:
    • To approve, require modifications to secure approval, and disapprove all Human Research activities overseen and conducted by WCMQ
    • To suspend or terminate approval of Human Research not being conducted in accordance with HRPP requirements or that had been associated with unexpected serious harm to participants
    • To observe, or have a third party observe, the consent process and the conduct of the Human Research
    • Determine whether an activity is Human Research
    • Determine whether WCMQ is engaged in Human Research
    • To decide whether financial interests Related to the Research and the management, if any, allow approval of the Human Research

    IRBNET is the web-based electronic system used for the IRB review. It is accessible to all research community, IRB members & IRB staff at anytime, anywhere through this link https://www.irbnet.org/release/index.html

    The IRB follows written policies and procedures.  These materials describing the Human Research Protection Program (HRPP) are available to all members of the institution through the IRBNET Library.
      
  2. Research involving Stem Cells
    The Tri-Institutional Stem Cell Initiative Embryonic Stem Cell Research Oversight Committee (Tri-ESCRO) http://www.trisci.org administers research involving human embryonic stem cells.

    NOTE: The Tri-Institutional Human Embryonic Stem Cell Research web pages are not available to the public at large. If you are unable to access these pages, please contact Kathleen Pickering, Executive Director, Tri-Institutional Research Program at kap2013@med.cornell.edu

    Tri-Institutional Stem Cell Initiative Embryonic Stem Cell Research Oversight Committee approval is required for all research involving human embryonic stem cells, research involving the transplantation of human pluripotent stem cells derived from non-embryonic sources (hPS) into laboratory animals at any stage of development or maturity, and research involving the use of hPS cells in in vitro experiments designed or expected to yield gametes.

    Research personnel conducting human embryonic stem cell research must complete Training for Human Embryonic Stem Cell Research to ensure compliance with applicable regulatory and institutional requirements.