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Training Requirements for Human Subjects Research

As of August 1, 2010, the JHM IRB moved to Collaborative Institutional Training Initiative (CITI) for Basic 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:

If you have already completed the JHU SOM HSR and/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 (see chart below for more information regarding training requirements).

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:

The chart below lists the required courses for PIs and study team members listed on JHM IRB human subjects research applications.  Courses include:   Basic Human Subjects Research (BHSR), Conflict of Interest (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, the application will be returned to the PI.

Non-affiliated study members: 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 for Basic Human Subjects Research (BHSR) from CITI, their local institution or another institution, such as NIH. As of June 1, 2012, if the compliance training certificate is more than five years old at the time of IRB submission, study team members not affiliated with Hopkins will be required to take the JHM IRB compliance training course (see chart below for more information regarding training requirements). 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.

 

Affiliation

BHSR

COI

HIPAA &
Research

REWards

CRBO/CRMS

Principal Investigators (PIs)

X

X

X

X(1)

X

JHU SOM and SON faculty, fellows, staff, and students; staff at APL, JHH, JHCP, KKI, HCGH, Suburban Hospital, Sibley Memorial Hospital, Cardiovascular Specialists of Central MD, and Central MD Radiation Oncology Corporation

X

X

X

Fellows Only (1)

X (3)

Engineering, Arts and Sciences faculty, staff and students

X


X


X(3)

School of Public Health faculty, staff and students

X




X (3)

Non-Hopkins study team members

X(2)




X (3)

Clinical Research Network study team members(AAMC, GBMC, INOVA and PRMC)

 X(2)

  X(2a)



X (3)



(1) 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 information on REWards see http://www.hopkinscme.edu/rewards.html).

Exemptions will be made for those who have taken:
Research Ethics 550.860.01 (School of Public Health)
Research Ethics and Integrity: US and International Issues 306.665.01 (School of Public Health)
Science of Clinical Investigation: Ethical and Regulatory Issues in Clinical Research (Instructors Dr. Norm Fost and Dr. N. Franklin Adkinson)

(2) CITI, NIH or local institution human subjects research training certificate not more than five years old at the time of IRB submission. If more than five years old, individuals must take the JHM IRB BHSR course (http://training.jhu.edu/ComplianceTraining/noJHED).  

(2a) CITI or local institution conflict of interest training not more than five years old at the time of IRB submission.  If more than five years old, individuals must take the JHM IRB COI course.

(3) 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 and Completion:

 You may register for the required courses on the Hopkins myLearning website at:

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.

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.


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