Human Research Protection (HRP) is responsible for providing administrative and regulatory support to the Drexel University Institutional Review Boards (IRB) and the University's Human Research Protection Program. HRP provides guidance on the responsible conduct of human research to Drexel's IRB members, faculty, investigators and their research assistants. HRP guidance documents and forms ensure compliance to local, state and federal regulations.
As Drexel University investigator and research staff member working on a human subject's study, you are expected to follow the federal, state and university policies regarding the protection of human subjects. The operations manual outlines Drexel's policies and procedures in detail.
On Wednesday, January 17, 2018, the U.S. Department of Health and Human Services (HHS) issued an Interim Final Rule delaying the implementation of the final revisions to the Federal Policy for the Protection of Human Subjects (a.k.a. the "Common Rule") until July 19, 2018. National Institutes of Health (NIH) policy changes (e.g., single IRB of Record) remained on schedule and went into effect as of January 25, 2018.
Review details of the Impact of Final Rule Delay for Drexel University [DOCX]. To ask a question, express concerns, or provide suggestions about human subjects research protections at Drexel, please send a message to firstname.lastname@example.org.
All IRB submissions are ONLY accepted via COEUS Lite
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 the Career Pathway calendar or contact email@example.com
or 215.762.3944 for more information or submit a request for online training at Human Research Protection request for blackboard access: eIRB COEUS training.
- Reference the COEUS eIRB user manual for detailed instructions.
- After launching the COEUS Lite platform, select the My IRB Protocols tab (center top on toolbar).
- On the next menu bar, select the action desired. For example, to create new protocol, select “create new protocol”.
- Using the screens on the left menu bar, enter the pertinent information to create and prepare an initial protocol submission.
- Attach all relevant documents required for protocol review (i.e. protocol, consents, advertisements, survey forms, telephone scripts etc.).
- To commence the submission process, select the "Submit to IRB" menu item from the column on the left.
- To request online training go to Drexel Human Research Protection Blackboard Access.
Note: The principal investigator, department chair or designee routes the protocol to the principal investigator’s department for review and electronic signature. Once routing is complete, the protocol is directed 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
*HRP has streamlined the “change in research personnel” process. For a modification that adds or removes study personnel, complete the required forms separately 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 COEUS Lite platform.
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.
Links to these policies are posted here 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.
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.
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, HRP 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 that most closely reflects the main emphasis of your work and the IRB committee to which you usually apply.
- Medical (health care providers, residents, fellows, medical students)
- Biomedical Engineering
- Public Health
- Investigators/staff submitting to Medical IRB #1, #4, or to Western IRB (WIRB).
- 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 requirements for 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)
- Conflict of Interest
- GCP (if funded by NIH or if protocol adheres to GCP)
- Export Compliance
Minimum training requirements for IRB Members/Research Administration
- Human Subjects Research
- Health Information Privacy & Security (HIPS)
- 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]
|When Protocol Design Involves
||Additional Training Required
|Evaluation of drugs, devices, biologics or interventional/behavioral treatments, NIH funding
||Good Clinical Practice-CITI Program
National Science Foundation (NSF) Funding
||Responsible Conduct of Research (RCR)
|Access and review of Protected Health Information (PHI)
||Access and review of Protected Health Information
|Health Information Privacy & Security (HIPS)
|Shipping Biologic samples (off of Drexel campus) Infectious Substance Packaging
||Use of recombinant materials, manipulation/alteration/modification
|Recombinant DNA Molecules training
||Use of processing of high-risk controlled chemical biologic agents
|Select Agents Policies and Procedures
||Collection and analysis of biologic specimens in a “non” CAP/CLIA certified lab
|Laboratory Training and Bloodborne Pathogen training
||Online safety training can be accessed
Drexel University Safety Training
Good Clinical Practice (GCP)
All investigators and key research personnel engaged in human subject clinical trials research (proposals involving drugs, devices, interventional/behavioral treatments and NIH supported research) must complete the online Collaborative Institutional Training Initiative (CITI) program for Good Clinical Practice (GCP) prior to IRB approval of a new or continuing review application.
Key research personnel are defined as the principal investigator, other investigators and research personnel who are directly involved in conducting and contributing substantially to the research with study participants or who are directly involved with the clinical trial, or handling private information (patient's medical records and charts) related to study participants during the course of a research project.
Responsible Conduct of Research
Established scientists and trainees should consider ethical issues in the sciences in order to ensure that:
- scientific research is conducted in as ethical a manner as possible;
- investigators are aware of and able to critically think through the ethical dimensions of their work;
- the public's trust in science is preserved.
The web based CITI Responsible Conduct of Research (RCR) course is available for researchers at Drexel University.
Both the NIH and the NSF require that persons working on funded projects receive instruction in the Responsible Conduct of Research. In order to meet NIH requirements, the bulk of this training must be face-to-face and must amount to at least 8-10 hours of contact time. In order to ensure the University’s compliance with federal requirements and to promote a culture of ethical research more broadly, the University has recently launched a one-credit RCR course, "Introduction to Responsible Conduct of Research (RCR): A Short Course for Investigators," developed jointly by the Office of Research, Graduate College and Dornsife School of Public Health. This course is required of all first-year doctoral students at the University unless the Office of Research or Graduate College has granted an exemption. For more information, please contact firstname.lastname@example.org.
For research not funded by NIH, the Human Research Protection office will accept either the Drexel University one-credit course or CITI training.
You will receive an automatic reminder from CITI approximately 90 days prior to your anniversary date for courses requiring recertification. Recertification training is completed by logging into your CITI account and selecting “add a course."
Investigator-initiated research involving interventional treatment on human subjects is a valuable component to the academic and research initiatives of Drexel University. This research is unique in that the investigator serves not only as the principal investigator, but also as the sponsor. Thus, the researcher can expect a higher level of preparation, consideration and responsibilities. Drexel University must also assume a higher level of responsibility and risk as the institution housing such research. Researchers should expect to meet additional institutional requirements based on the nature of the research.
In support of 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 and support of IRB application. The IISA Committee consists of 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 with 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. 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 or email Dr. Noreen Robertson - email@example.com.
The Human Research Protection Office is available to present educational sessions for faculty, professional staff, research teams and students. Each session is tailored to the needs of the audience. Contact firstname.lastname@example.org to schedule a session.