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. All recertification coursework and in-person activity requirements must be completed within the same year (12 months) in order to count towards their recertification. Any part of the requirement that falls outside of the year will need to be retaken.
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.
Questions about enrollment errors should be directed to the eIRB Help Desk at [email protected].
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 and ICH (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 [email protected] .
A combination of the 4 required modules and 1 of the in-person activity will result in the completion of PI recertification.
Pre-Approved Activities for "In-Person" Training Requirement
The following is a list of activities that have been pre-approved to meet the “in-person” training requirement:
- eIRB 101: An Intro to SOM IRB and Submitting an Application
- Good Clinical Practice (GCP) Fundamentals: Understanding and Applying GCP to Human Subject Research
- Research Integrity Colloquium
- IRB Basics
- IRB Office Hours
- Data Trust Research Data Subcouncil office hours - Must complete the Alternate In-Person Activity Form and email it to the SOM IRB Training Specialist at [email protected] to receive credit.
Options for in-person training may be identified via the search links below. If you wish to verify in advance whether a training will qualify for in-person credit, contact our Help Desk at [email protected]
- 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
To register, click on the appropriate link below to go to the recertification course in MyLearning. Then scroll to the bottom and click on the blue ADD TO Dev Plan. This will add the course to your development plan.
Principal Investigators can find more information about recertification requirements by clicking the following link: Principal Investigator Human Subjects Recertification
All other study team members can start here to find more information about recertification requirements.