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All researchers who are engaged in human subjects research are required to complete Human Subjects Research recertification. PIs and Study team members are required to complete HSR training recertification every 3 years after completion of their initial Basic Human Subjects Research course.
HSR recertification will be verified for all NEW APPLICATION submissions (all study team members) and CHANGE IN RESEARCH submissions (for any new study team members being added ). If the required recertification 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.
Effective 7/1/2019, This re-certification has been re-vamped to include GCP modules that meet the GCP training requirements as established by NIH for all NIH Awardees involved in NIH-funded Clinical Trials.
At the time of completion of this re-certification, you will have met the requirements of HSR Re-Certification as well as GCP Training.
Effective 5/1/2021, PIs and study team members will be automatically enrolled in recertification training one calendar year before the expiration date. The course will appear under the Auto-Enrollment tab in the user’s myLearning plan.
Questions about enrollment errors should be directed to the eIRB Help Desk at JHMeIRB@jhmi.edu.
Recertification for PIs and study team members includes 4 required online courses.
The four mandatory online courses include:
- Refresher Course: An Overview of Research with Vulnerable Subjects
- Refresher Course: Genetics Research
- Refresher Course: Records Based Research
- Good Clinical Practice (CITI) (13 modules)
Completion of the 4 required modules will result in the completion of study team recertification.
In addition to the 4 required online courses, PIs must complete 1 in-person activity. The list of in-person activities will include a variety of approved instructor-led courses and in-person workshops offered throughout the calendar year. Limited other learning activities at the institutional, departmental or divisional levels--such as Grand Rounds, lectures, conferences or seminars--may qualify towards the in-person recertification requirement. The content must focus on research ethics and the activity must be approved by the Human Research Protection Program. Those wishing to apply for in-person credit for their learning activity please complete the Alternate In-Person Activity Form and email it to the SOM IRB Training Specialist at jhmeIRB@jhmi.edu .
A combination of the 4 required modules and 1 of the in-person activity will result in the completion of PI recertification.
- For eIRB applications that are determined to be not human subjects research (NHSR), recertification is not required.
- Johns Hopkins Bloomberg School of Public Health (SPH) and Homewood study team members can submit human subjects recertification certificates from their local institution. Please note: SPH and Homewood are on a 5-year recertification. We will accept certificates that are <5 years old.
Recertification Registration Information
You will be automatically enrolled in recertification training one calendar year before your training expiration date. Please find your training course in your myLearning plan under the Auto-Enrollments tab.
Principal Investigators can find more information about recertification requirements by clicking the following link: https://lms14.learnshare.com/l.aspx?Z=Z3EX6qVJsTFhttVgCt1BW%2bqFM9j%2fOFNvVZPJFka%2bfXs%3d&CID=89
- All other study team members can find more information about recertification requirements by clicking the following link: https://lms14.learnshare.com/l.aspx?Z=0%2byEz%2fZW3oLiOcYA61K7G6XL6Z7e0XkXuDjLavNiaqA%3d&CID=89