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Institutional Review Board

USciences Investigator Information

Any project involving human subjects, research, sponsored or non-sponsored, conducted by employees of University of the Sciences, or involving non-public information held by the University will be reviewed and approved by the Institutional Review Board for research using criteria similar to those applied to federally-funded research and consistent with the principles outlined in the Belmont Report.


All "personnel" listed on the proposal are required to complete training in human subjects research with regard to common concepts, principles, and issues related to protection of human participants, including principles of bioethics and basic legal standards. Proof of completion of such training is a required document for protocol submissions to the IRB. (See Resources for Investigators below.)

 

Application for Human Subjects Research Project Review

All protocols for IRB approval (including revisions and renewals) must be submitted electronically via IRBNet, and all review decision letters will be issued electronically via IRBNet.

Please review the IRBNet User Guide document for information and instructions.

  • Certain research projects involving human subjects may be exempt from IRB review or may qualify for expedited review, in accordance with 45 CFR 46. The IRB is responsible for making this determination.
  • All projects that access or use Protected Health Information (PHI) require HIPAA research subject authorization or an IRB request for waiver of HIPAA authorization. If the work is carried out at an outside institution where a HIPAA authorization form is available, no additional document is required for USciences

Authorization Agreements - Available in IRBNet.org

University of Pennsylvania and Temple University

Whenever a project involves these Universities an Authorization Agreement is required to determine the IRB of record. This means the IRB of record is the only IRB you will need to submit detailed documentation to receive IRB approval. Contact irb@usciences.edu for details on how-to process this agreement.

Cooper Hospital

Whenever there is a Cooper Hospital research project submitted to the USciences IRB a detailed review is no longer required.  We now have a Memorandum of Understanding that we may rely on Cooper’s IRB whenever there’s a project that is joint between USciences and Cooper.  The purpose behind this is to decrease the burden on our faculty when they have clinical patients at Cooper. You do not need to submit to USciences IRB for review, however we will maintain records of your projects.  Provide to USciences using IRBNet all project documents submitted to Cooper for approval.  You do not complete the USciences “Request for Protocol Review Form.”

Submit in IRBNet:

  1. All documents submitted to Cooper (this would be Cooper’s application for review form)
  2. Cooper Approval letter and approved documents (consent form, advertisement, etc.)
  3. Title the documents: Cooper approved….(this way the IRB administrator knows it’s  a Cooper submission)

You Receive:

The IRB administrator will issue an acknowledgement that states “we acknowledge this submission as a project approved by Cooper and have recorded the submission.”

If you have any questions about this process contact: irb@usciences.edu


Research Project Continuing Review/Termination Report

All projects are reviewed periodically depending on degree of risk, but in no case less frequently than every 12 months. Investigators are required to submit a project report for IRB continuing review or termination of a project. The Continuing Review or Termination Report form is available below.

Protocol Amendments

Any changes in the approved research protocol or consent form must be approved by the IRB prior to implementation. Submit a “Request for Protocol Review” form as an amendment:

    • check the "Amendment Box" at the top of the form.
    • complete ALL of Section 1.
    • complete only the sections that will change in Sections 2 thru 7.

    Health Insurance Portability and Accountability Act of 1996 (“HIPAA”)

    The U.S. Department of Health and Human Services (“HHS”) issued the Privacy Rule to implement the requirement of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). A major goal of the Privacy Rule is to assure that individuals’ health information is properly protected while allowing the flow of health information needed to provide and promote high quality health care and to protect the public's health and well being. Researchers are advised to review the HIPAA Privacy Rule for Research to determine if protocol requires HIPAA.

    USciences Template for HIPAA

    Request for HIPAA Waiver

    USciences Institutional Review Board Forms & Templates

    Policies & Procedures:

    University of the Sciences IRB Policies & Procedures

    IRB FAQs

    IRBNet User Guide

    Templates:

    Consent Form

    Audio/Video Consent Form

    Assent Form

    Forms:

    Request for Protocol Review

    Continuing Review/Termination Report Form

    Non-Human Research Certification (For Faculty Advisors ONLY)

    IRB Committee Meetings Calendar

    Protocols that require full IRB Committee review should be submitted at least 2 weeks prior to the scheduled meeting date. Investigators are encouraged to attend the meeting on the day when their protocol is being reviewed; if you plan to attend an IRB meeting please notify OSPR at least one week in advance. All meetings are held in Wilson Hall room 205 from 6:15pm - 7:15pm.

    Protocol form due to OSPR

    IRB Committee Meets

    6/18/2013

    7/2/2013

    07/23/2013

    8/6/2013

    8/20/2013

    9/3/2013

    9/17/2013

    10/1/2013

    10/22/2013

    11/5/2013

    11/19/2013

    12/3/2013

    12/24/2013

    1/7/2014

    1/21/2014

    2/4/2014

    2/18/2014

    3/4/2014

    3/18/2014

    4/1/2014

    4/22/2014

    5/6/2014

    5/20/2014

    6/3/2014

    IRB Registration and Assurance

    The USciences IRB is registered with the United States Department of Health & Human Services. The IRB Federalwide Assurance (FWA) Protection for Human Subjects (FWA00001629) is in effect until October 18, 2018.

    Resources for Investigators

    Food and Drug Administration 
    • Information Sheets - Guidance for Institutional Review Boards and Clinical Investigators - 1998 Update
    45 CFR 46
    • Code of Federal Regulations Title 45: Public Welfare. Department of Health & Human Services. Part 46 - Protection of Human Subjects 
    Computer-Based Training (CBT) Program for Researchers 
    • Protecting Human Research Subjects at the NIH: Education in Human Subjects Research. This program was developed for NIH staff and is an educational requirement for all researchers in NIH's Intramural Research Program and other NIH employees who conduct or support research involving human subjects. Non-NIH individuals may take this CBT.

     NIH Office of Human Subjects Research (OHSR)
    • Information about the OHSR; links to online training programs for researchers and IRB members; information on topics related to human subjects research, including: research forms, checklists and guidelines. 
    NIH's Bioethics Resources Website   
    • Compilation of annotated web links and resources on topics related to bioethics, including human subjects research
    Office for Human Research Protections (OHRP)
    • U.S. Department of Health and Human Services (DHHS) website (formerly Office for Protection from Research Risks [OPRR]) for research policy and assurances. Research regulations, including 45 CFR 46; research guidance and educational materials; informed consent information; project assurance information and sample documents; general DHHS information, including  
      Public Health Service (PHS) grants and NIH research information. 

    Educational materials related to human subjects research are also available at University of the Sciences. For additional information, email Karen Mitchell IRB Administrator, or telephone 215-596-7491.


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