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Human Research Protection

Human Research Protection (HRP) is responsible for administrative and regulatory support to the Drexel University Institutional Review Boards (IRB) and the University's Human Research Protection Program. Human Research Protection provides guidance to our IRB members, faculty, investigators and their research assistants regarding the responsible conduct of human research. Human Research Protection guidance documents and forms ensure compliance to local, state and federal regulations.

Common Rule Changes

Please review the following documents (effective January 2018):

Information is available below or by contacting our office at 215.762.3944 or hrpp@drexel.edu.

The Final Rule: Impact on Research Operations

The HRP Office will not accept any new protocol submissions after November 24, 2017. Any new protocol submitted after November 24, 2017 must use consent templates and other requirements set forth by the Final Rule. These will be processed on or after the January 18, 2018 compliance date. This hold on submissions will allow the HRP office to finish all protocol reviews that fall under the Common Rule and to remain compliant with the changes.

Institutional Review Board (IRB) Application Process

All IRB submissions are ONLY accepted via the COEUS Lite platform.

To gain access to COEUS Lite eIRB:

  • Complete COEUS eIRB Authorization Form
  • Attend at least one eIRB training session.  The HRP Office will hold training sessions. Please reference career pathways calendar or  contact HRPP@drexel.edu or 215-762-3944 for more information.
  • Reference the COEUS eIRB user manual for detailed instructions.
  • After launching the COEUS Lite platform, click the My IRB Protocols tab (center top on toolbar).
  • On next menu bar click “action” desired-i.e. to create new protocol click “create new protocol”.
  • Utilizing the screens on the left menu bar, enter the pertinent information to create and prepare an initial protocol submission.
  • Attach all relevant documents requiring review for protocol (i.e. Protocol, consents, advertisements, survey forms, telephone scripts etc.)
  • To commence the submission process, click the Submit to IRB menu item from the column on the left-hand side.

Note: the Principal Investigator, the Department Chair or his /her designee, routs the protocol to the PI’s department for review and electronic signature.  The first “stop” after the approval routing is complete, will be to the IRB Regulatory Reviewer. Once all appropriate reviewers electronically approve the protocol, the IRB will assign the initial protocol application appropriately.

Note changes in required forms

  • For researchers (*except those at St Christopher’s Hospital for Children), the HRP-211-Initial Submission Form, HRP 212- Continuing Review and HRP 213-Modification forms are no longer required. The questions are imbedded in the COEUS platform.
  • Researchers at St. Christopher’s Hospital for Children must attach the above forms into the COEUS platform.

*The HRP Office has streamlined the “change in research personnel” process.  For a modification that add or remove study personnel, complete the required forms separate from other modifications. A New HRP 201 contact information form only has to be attached IF the individual is not already in the COEUS database. All others are “searchable” in the COEUS Lite platform

Record Data Management

In order to better serve the needs of investigators, Human Research Protection has posted informational web links to Drexel University institutional policies regarding use, retention, and transmission of confidential, educational, financial and other personal health information.

These policies have been posted within the HRP website to facilitate investigator awareness of their responsibilities to protect and manage data accordingly.  Specific questions regarding these policies are best addressed to the departments or individuals noted as authoring the policy.

Policies

Additional policies regarding IRT

Training requirements and investigator responsibilities

Drexel is part of the Collaborative Institutional Training Initiative (CITI). If key research personnel have taken CITI training elsewhere, the previously completed training is accepted at Drexel, with the caveat that key research personnel must complete any CITI modules required by Drexel that have not already been completed.

Training Requirements

All key research personnel at Drexel or affiliated sites for whom the Drexel IRB has provided approval must complete the online CITI program as well as any other necessary courses. IRB approval of any individual application is contingent upon the fulfillment of this requirement. IRB members, HRPP administrative officials and staff are required to complete this training.

CITI Required Training

During CITI registration, you will be prompted to add a course. Select the courses required for your research. After you select the courses, the next screen will prompt you to select Medical-Social Behavioral or IRB/Research administration. Select the group most closely reflects the main emphasis of your work and IRB committee to which you usually apply. 

Medical

  • Medical (Healthcare Providers, residents, fellows, medical students)
  • Biomedical Engineering
  • Nursing
  • Public Health
  • Nutrition
  • Psychology
  • Investigators/staff submitting to Medical IRB #1, #4, or to Western IRB (WIRB).

Social/Behavioral

  • Social, Behavioral and Educational Research Investigators (Education, Creative Arts Therapists, IST, Business, Law, Library science)
  • Investigators/staff submitting to the Social and Behavioral IRB #3.

Minimum training requirement Medical and Social/Behavioral

  • Human Subjects Research
  • Health Information Privacy & Security (HIPS)* (Only required for Learner Group 2 if you plan to collect or access PHI)
  • Drexel Core Module HIPAA I and HIPAA II
  • Conflict of Interest
  • GCP (if funded by NIH or if protocol adheres to GCP)
  • Export Control
  • Minimum training requirement for IRB Members/Research Administration

    • Human Subjects Research
    • Health Information Privacy & Security (HIPS)
    • Drexel Core Module HIPAA I and HIPAA II
    • Good Clinical Practice (GCP)
    • Responsible Conduct of Research (RCR) for Administrators

    Additional Training Requirements

    Requirements to complete any supplemental training modules are based upon your specific research protocol design and activities to be conducted on behalf of the protocol. Descriptions and examples of when additional training may be required are listed below. Training Table [PDF]

    Investigator Initiated Research

    Investigator-initiated research involving interventional treatment on human subjects is a valuable component to the academic and research initiatives of the Drexel University.  This research is unique in that the investigator serves not only as the principal investigator but also the sponsor.  Thus, the researcher can expect a higher level of preparation, consideration, and responsibilities. In addition, Drexel University must also assume a higher level of responsibility and risk as the institution housing such research. Researchers should also expect to meet additional institutional requirements based on the nature of the research.

    In support of our investigators and their protocols of this design, Drexel has formed the Investigator Initiated Study Advisory (IISA) committee to assist and guide investigators through a review process in advance of, and support of IRB application.  The Investigator-Initiated Study Advisory Committee (IISA Committee) is a group consisting of Drexel University members from various administrative departments (i.e. Clinical Research Group, Human Research Protection, Office of General Counsel). 

    The IISA Committee was established to provide researchers an early assessment of their research to identify additional regulatory and institutional requirements imposed on such research. The early assessment will allow researchers to plan for these additional requirements. In addition, the early assessment will also allow Drexel, as the research institution, to conduct a risk and cost analysis. Such early assessment is aimed to reduce the delays in initiating such research.  

    If you would like to arrange an IISA review or speak with the team please contact the IISA at 215-762-4889, Dr. Noreen Robertson - noreen.robertson@drexelmed.edu

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