Training Requirements for Human Subjects Research

July 2011

As of August 1, 2010, the JHM IRB moved to CITI (Collaborative Institutional Training Initiative) for Basics Human Subjects Research (BHSR) and Conflict of Interest (COI) training.  Registration for these courses, along with HIPAA & Research and other JHM IRB courses is available through the Hopkins myLearning website at http://training.jhu.edu/ComplianceTraining/ (for users with JHED ID) or http://training.jhu.edu/ComplianceTraining/noJHED (for non-JHED users). If you have already completed the JHU SOM HSR or JHU SOM COI courses, you are not required to take the CITI courses. 

The JHM IRB will not track completion of a Johns Hopkins HIPAA privacy course (i.e., "Privacy for Health Care Providers" or "Privacy Refresher Course for Health Care Providers") other than the "HIPAA & Research" course. (1)

Recertification Requirements:

The Johns Hopkins Medicine Human Research Protection Program has implemented a new compliance training recertification requirement for Principal Investigators who are engaged in human subjects research. Principal Investigators must earn a total of 100 points in order to meet their recertification requirement. A variety of learning activities are available, including online and instructor-led courses and in-person workshops. Each activity is assigned a point value, with more points being offered for in-person and instructor-led continuing education sessions compared to online modules. Principal Investigators must complete their recertification requirement within five years of their initial human subjects research training. For more information, please visit the following link: New Training Recertification Requirements.

Course Requirements:

For study team members (investigators, consent designees and others listed on a study) who are not affiliated with Hopkins, the JHM IRB will accept research compliance training certification from CITI, their local institution or another institution, such as NIH. A copy of the research compliance training certification from the outside institution should be submitted with the eIRB application. We assume the local institution has conducted all requisite HIPAA training and do not require HIPAA training certifications.

The Bloomberg School of Public Health, the Schools of Nursing, Engineering and Arts and Sciences, and the Applied Physics Lab determine the overall training requirements for their institutions. To participate in research reviewed by the JHM IRB, however, faculty, staff and students from these schools are required to complete the courses listed below.

The chart below lists the required courses for PIs and study team members listed on JHM IRB human subjects research applications.  Courses include:  BHSR, COI, HIPAA & Research, Research Ethics Workshops About Responsibilities and Duties of Scientists (REWards -  formerly CORE), Clinical Research Billing Orientation (CRBO) and Clinical Research Management Systems (CRMS).  If the required courses have not been completed by all study team members prior to submission of the research application, the application will be returned to the PI.

(1) "The Privacy for Health Care Providers" or "Privacy Refresher for Health Care Providers" is a pre-requisite for HIPAA and Research; however, the JHM IRB does not track completion of the pre-requisite Johns Hopkins HIPAA privacy course. The individuals who have completed Privacy Issues Relating to Research (also known as IRR) are not required to complete HIPAA & Research.

(2) All PIs of active IRB protocols are required to complete REWards or its equivalent. Individuals who were not active PIs as of October 1, 2006 have one year from the date of their first eIRB submission to complete the REWards requirement. Fellows must complete REWards by the end of their fellowship (for exemption information please click here).

(3) CITI, NIH or local institution human subjects research module.

(4) 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. 

Registration & Completion:

You may register for the required courses on the Hopkins myLearning website at http://training.jhu.edu/ComplianceTraining/ (for users with JHED ID) or http://training.jhu.edu/ComplianceTraining/noJHED (for non-JHED users). You will be asked a few questions to determine your required courses, and then will be instructed to log in to register for these courses. If you are required to take both Basic Human Subjects Research and Conflict of Interest, you will register for a combined CITI course called Basic human Subjects Research/Conflict of Interest.

MyLearning will track your course completion. 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 COI, or IRR, the certificates are available online at https://secure.lwservers.net.

For more information on training requirements go to http://www.hopkinsmedicine.org/Research/ora/training/compliance_reqs.html.