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OFFICE OF HUMAN SUBJECTS RESEARCH

Institutional Review Board

IRB Compliance Training

PIs and study team members are required to complete IRB compliance training prior to submission of a human subjects research eIRB application. For eIRB applications that are determined to be not human subjects research (NHSR), IRB compliance training is not required If the required courses have not been completed by the PI and all study team members prior to submission of the application, the application will be returned to the PI.

School of Medicine IRB Compliance Training Courses include:   

Initial IRB Compliance Training Bundle (CITI)  


Register: Use the following link to register for the Initial IRB Compliance Training Bundle https://lms14.learnshare.com/l.aspx?Z=bEERrgqY%2bjMcjZCd5tlY4X5cNzOz5eODD9W5ORl32zo%3d&CID=89

Courses Included:

  • Human Subjects Research-Biomedical Research Training (previously Basic Human Subjects Research): This online course provides a broad overview of the ethical background for regulations in human subjects research, as well as an overview of the IRB review requirements to be met before a human subjects research project may begin. This course is administered through the Collaborative Institutional Training Initiative (CITI)
    • Who needs it: PIs and study team members listed on a Convened/Expedited/Exempt eIRB application
  • Conflict of Interest and Commitment (COIC): This online course is designed to introduce researchers to the topic of financial conflicts of interest in research, including what financial conflict of interest means, sources and risks of financial conflicts of interest in research, federal regulations and institutional policies designed to address the risks, and researchers’obligations under the regulations and policies. The federal government’s regulation on conflict of interest (COI) in research, which is intended to promote research objectivity, was revised in August 2012. This course is designed to fulfill the training requirements included in the regulation and in Johns Hopkins policy.
    • Who needs it: PIs and study team members listed on a Convened/Expedited/Exempt eIRB application who are JHU SOM and SON faculty, fellows, staff, and students; staff at JHACH, APL, BSPH, JHH, JHCP, KKI, HCGH, Suburban Hospital, Sibley Memorial Hospital, Cardiovascular Specialists of Central MD, and Central MD Radiation Oncology Corporation.
    • Exceptions: PIs and study team members listed on a NHSR eIRB application are not required to complete COI compliance training. Engineering, Arts and Sciences faculty, staff and students, and non-affiliated study team members are not required to complete this course.
  • Researchers (previously Health Privacy Issues for Researchers (HPIR)): This online course covers specific HIPAA requirements for research involving health information. This new course replaced “HIPAA For Research" –  June 15, 2018.
    • Who needs it: PIs and study team members listed on a Convened/Expedited/Exempt eIRB application who are JHU SOM and SON faculty, fellows, staff, and students; staff at JHACH, APL, BSPH, JHH, JHCP, KKI, HCGH, Suburban Hospital, Sibley Memorial Hospital, Cardiovascular Specialists of Central MD, Central MD Radiation Oncology Corporation; Engineering, Arts and Sciences faculty, staff and students. 
    • Exceptions: PIs and study team members listed on a NHSR eIRB application are not required to complete HIPAA for Research compliance training. 

      Please note: The JHM IRB will not track completion of any Johns Hopkins HIPAA privacy or security courses (i.e., Patient privacy for Workforce Members” or “Electronic Information Security and Data Management Training”).  However, this course assumes you have a basic understanding of the HIPAA privacy and security requirements.  If you are a JH workforce member who is required to complete this course, you must first complete the required, applicable privacy and security courses in myLearning, as identified on the JH Privacy Office Intranet Site: http://intranet.insidehopkinsmedicine.org/privacy_office/quick_links/learn_what_training_you_need.html

For instructions on how to enroll in Initial IRB Compliance Training Bundle click here.

Responsible Conduct of Research

According to current policy, all School of Medicine “faculty, postdoctoral trainees and staff engaged in research at JHU” are required to complete the Responsible Conduct of Research Program, which has three components:

  • the Responsible Conduct of Research (CITI) course,
  • attendance at two Research Integrity Colloquia, and
  • attendance at a Department/Division meeting focused on an RCR topic.

Each of these requirements must be completed every four years.

More information on all of this is available at: 
https://www.hopkinsmedicine.org/research/resources/offices-policies/OPC/Research_Integrity/responsible_conduct_RCRprogram.html

Clinical Research Billing Orientation (CRBO) and Clinical Research Management Systems (CRMS):

This online course introduces study team members to the improved clinical research billing process. Live training sessions, reference materials and start-up support will supplement this overview.

Register: http://lms14.learnshare.com/l.aspx?CID=89&A=2&T=469836 

Who needs it: If there will be billing for study procedures, CRBO is required for PIs, and for study team members who will consent participants. When a new research application is submitted in eIRB, you will be notified by Clinical Research Support Services (CRSS) if you are required to take CRBO. If your study requires CRBO training, you will also be required to track study enrollment in the CRMS. CRMS training must be taken by the PI and the study team members responsible for entering data in the CRMS. 

Exceptions: PIs and study team members listed on a NHSR eIRB application are not required to complete CRBO or CRMS compliance training. 

Course Completion

myLearning will track your course completion. The BHSR and HPIR courses are administered through CITI. It will take 24 hours for the CITI course completion information to transfer to myLearning. Click on “My Learning History” on the left side navigation to obtain a copy of your course completion report. This report should be uploaded in the eIRB application (Section 2 – Study Team Compliance Training) if your training dates are not already displayed.

If you have already completed JHU SOM HSR, JHU SOM COIC, or HPIR, and you wish to receive a copy of the certificates, please contact the eIRB Help Desk at [email protected] or 410-502-2092.

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