Institutional Review Board (IRB)
Institutional Review Board (IRB) Overview
The Institutional Review Board (IRB) is a standing committee established at KHCC in 2003. It aims at protecting the rights and welfare of human research subjects recruited to participate in research conducted at KHCC. It primarily accomplishes this by reviewing proposals for research and determining the level of risk. All research activity involving human subjects (direct interaction/intervention or indirect through medical data, material) conducted at, by or under the auspice of KHCC, whether funded or not and whether conducted by administrators, faculty, staff, or students, must be prospectively reviewed and approved by the IRB before the research begins. The IRB has the authority to approve, require modifications, or disapprove all research activities that fall within its jurisdiction as specified by local institutional policy.IRB is composed of faculty members, administrators, community members and lawyers divided into regular and alternate members. IRB office coordinator oversees and streamlines the whole submission process and acts as a liaison between the IRB chair/ members, the investigators and the research office.The full IRB board meets bimonthly to review studies and discuss various administrative issues.KHCC-IRB functions in accordance with national and international regulations including the Good Clinical Practice (GCP). It is approved by the Jordan Food and Drug Administration (JFDA) and is registered with the Federalwide Assurance (FWA).
IRB Process
Investigator submits documents to IRB office according to assigned type of review.
Exempt review: if the research has no risk to human subjects and the identity of research subjects is not known.
Documents submitted to the IRB as soft and hard copies:» IRB submission FORM A.» CV(s) of principal investigator(s) (PIs).» Confidentiality agreement for "Chart Reviewer(s)" only.» Grant application (if any).» Consent form (if any) or request for waiver of consent form. (only for questionnaire/survey).» Questionnaire or survey (if any).» Data collection sheet (if any).» Other study related documents
Study reviewed by IRB Chair.
Decision
Expedited review: If the research poses no more than minimal risk to human subjects and subject identification would not reasonably place the subject at risk of any liability.
Full board review: if the research poses more than minimal risk or the research does not fall under exempt or expedited reviews like in interventional studies.
Documents submitted to the IRB as soft and hard copies:» IRB submission FORM B. » CVs of all investigators.» Financial conflict of interest disclosure form for all investigators.» Confidentiality agreement for all investigators.» The certificate of completion of the "Human Participant Protections Education for Research Teams" course for all investigators.» Grant application (if any).» Consent form (if any) or request for waiver of consent form.» Questionnaire or survey (if any).» Data collection sheet (if any).» Other study related documents.
Study sent to Clinical Research and Cancer Registry Office (CRRO) to be scientifically reviewed. CRRO sends the review to the IRB. IRB sends the review to the PI. PI addresses the comments in the review form, modifies the submission form accordingly and sends it back to the IRB.
Expedited studies are reviewed by IRB Chair then Decision or Full board studies are reviewed in a full board IRB meeting (bimonthly) then IRB Decision
KHCC-IRB 2004-2010
Year Number of IRB Reviewed Studies2004 172005 132006 342007 382008 582009 892010 96
For more information, please contact IRB at office phone number 00962 6 5300460 Extension 1669 or send an email to IRBOffice@KHCC.JO
