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Human Subjects Research (HSR) Compliance Training
Principal Investigator (PI) and Study Team Member Training Requirements
IRB compliance training is required for all PIs and Study Team Members who are engaged in human subjects research. Initial training must be completed prior to submission of a human subjects research application in eIRB.
Initial Compliance Training includes the following required online courses:
- Human Subjects Research-Biomedical Research Training (previously Basic Human Subjects Research)
- Conflict of Interest and Commitment
- Researchers (previously Health Privacy Issues for Researchers)
- Clinical Research Billing Orientation (for PI and study team members who will obtain consent)
If this is your first time completing compliance training please access compliance training using the following MyLearning links:
- Initial IRB Compliance Training Bundle (This includes Human Subjects Research-Biomedical Research Training (previously Basic Human Subjects Research), Conflict of Interest, and Researchers (previously Health Privacy Issues for Researchers)
- Clinical Research Billing Orientation
For instructions on how to enroll in Initial IRB Compliance Training Bundle as well as GCP and recertification courses click here.
For more detailed information on IRB compliance training, visit: https://www.hopkinsmedicine.org/institutional_review_board/training_requirements/compliance_training.html
Research Ethics Workshops About Responsibilities and Duties of Scientists (REWards) Training Requirements
REWards training is required for all new Principal Investigators within one calendar year of their initial application submission. Please find more information and the link to register on the Continuing Medical Education website
Principal Investigator (PI) and Study Team Member Human Subjects Research Recertification Training Requirements
Human Subjects Research Recertification training is required for all PIs and study team members every 3 years. Please note- The recertification requirements for PIs and Study Team members are different. You will be automatically enrolled in the recertification course assigned to the role you reported at the time of your most recent course completion (PI or study team members) one calendar year before your training expiration date. Questions about errors in course enrollment or how to change your assigned course if your role has changed should be directed to the eIRB Help Desk at jhmeIRB@jhmi.edu.
If you are a SOM-affiliate Principal Investigator ** (PI of your own studies in eIRB), please click the following link to find more information about Principal Investigator Human Subjects Recertification training.
If you are a SOM-affiliate and are not a PI of your own studies in eIRB, please click the following link to find more information about Study Team Member Human Subjects Recertification training.
**Please note that your relationship to eIRB and NOT your role on a specific application determines which recertification course you complete.
Good Clinical Practice (GCP) Training
National Institute of Health (NIH) leadership released a new policy requiring GCP training as of January 1, 2017. PIs and study team members who are subject to this policy can meet the training requirement by completing the CITI GCP training course. Other GCP training will be accepted as meeting the requirement if the course is approved by TransCelerate.
The JHM IRB now offers certified GCP training through CITI and through live virtual sessions that satisfy the NIH training requirement.
- Click here to register for the CITI Good Clinical Practice compliance training: http://lms14.learnshare.com/l.aspx?CID=89&A=2&T=521555
- Click here to register for virtual live Good Clinical Practice Fundamentals compliance training: http://lms14.learnshare.com/l.aspx?CID=89&A=2&T=339728
- Click here to register for virtual live JHACH – Operationalizing GCP Principles in Pediatric Clinical Research compliance training: http://lms14.learnshare.com/l.aspx?CID=89&A=2&T=2636985
Researchers completing JHM Human Subjects Recertification training automatically fulfill the GCP training requirement.
For more detailed information about GCP compliance training requirements, visit: https://www.hopkinsmedicine.org/institutional_review_board/training_requirements/gcp_training.html
Required Training for External IRB Studies
All new (NIH) grant applications and competitive renewals for multi-site research require a plan for use of a single IRB. The JHM IRB routinely serves as the single IRB, but there are also cases where Johns Hopkins will be asked to rely on an external IRB.
For external IRB applications submitted on or after January 1, 2019, any PI named on an external IRB application will be required to complete an online training course: Relying on an External IRB. The training will review the initial steps to request reliance on an external IRB, outline how to submit an external IRB application to the JHM IRB and review the roles and responsibilities of local site PIs and study teams when relying on an external IRB.
The training must only be completed once. While required for PIs, completion of the training is also encouraged for investigators and other study team members who will be working with external IRBs. A copy of the completion certificate must be uploaded with the external IRB application [Section 2 – Study Team Compliance Training, Question 2].
eIRB Training Tools:
The JHM Office of Human Subjects Research (OHSR) also offers voluntary technical training consisting of online tutorials and virtual in-person classes for those who may be new to the eIRB system or who want a refresher course. Visit the IRB website for downloadable tutorials.
Please use the following link to register for live virtual eIRB 101 session (offered every 3rd Friday of the month): http://lms14.learnshare.com/l.aspx?CID=89&A=2&T=358053
Information for School of Public Health and Homewood affiliates:
The training information on this page is specific to SOM, SON, KKI and JHHS affiliates.
Please visit the School of Public Health or Homewood IRB websites for training requirements for PIs and study team members whose primary affiliation is within the School of Public Health or Homewood Schools.