Research Compliance Training

Register for training courses or print your training certificates by visiting MyLearning.

Required Training

Full-time & Salaried Part-time Faculty

All full-time and salaried part-time faculty members must complete the following training, whether they are involved in research/sponsored projects or not.

	Conflict of Interest & Commitment *certificate is valid for 4 years	ERS Effort Reporting System – Certifiers
All Full-time & Salaried Part-time Faculty	X	X

Human Subject Research

Specified team members involved in human subject research must complete the following training requirements:

	Basic Human Subjects Research *certificate is valid for 3 years	Conflict of Interest & Commitment *certificate is valid for 4 years	HIPAA & Research	REWards
SON Principal Investigators (PIs), Postdoctoral fellows, and Pre-Doctoral students	X	X	X	X
SON Faculty, Staff, and students involved in research	X	X	X
Non-Hopkins study team members	X¹

Animal Research

Specified team members involved in animal research must complete the following training requirements:

	Animal Care and Use	Conflict of Interest & Commitment *certificate is valid for 4 years
SON Principal Investigators (PIs), Postdoctoral fellows, and Pre-Doctoral students	X	X
SON Faculty, Staff, and students involved in research	X	X
Non-Hopkins study team members	X¹

¹ NIH, CITI, or local institution certificate will be treated as equivalent.

Note: If research /sponsored projects involve clinical operations those study teams will be notified by the IRB if additional training is required.

Human Subjects Research Training

Required Training:

There are three types of training required to perform human subjects research:

IRB Compliance Training – Principal Investigators (PIs) and study team members are required to complete IRB compliance training prior to submission of a human subjects research eIRB application.For more information on IRB compliance training…

REWards – Required for PIs and Fellows. PIs must complete REWards training within 1 year from the date of their first eIRB submission of a human subjects research application. Fellows must complete REWards training by the end of their fellowship. For more information on REWards…

Recertification – Required for all PIs and study team members engaged in human subjects research. Currently, PIs must complete recertification within five years of their initial HSR compliance training, and then complete recertification every five years. Effective March 1, 2016, PIs will be required to complete HSR training recertification every 3 years, and then complete recertification every three years. Study team members must complete recertification within three years of their initial HSR compliance training, and then complete recertification every three years. For more information on Recertification…

IRB Compliance Training

PIs and study team members are required to complete IRB compliance training prior to submission of a human subjects research eIRB application. For eIRB applications that are determined to be not human subjects research (NHSR), IRB compliance training is not required If the required 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. IRB compliance training courses include:

Basic Human Subjects Research (BHSR):

This online course provides a broad overview of the ethical background for regulations in human subjects research, as well as an overview of the IRB review requirements to be met before a human subjects research project may begin. This course is administered through the Collaborative Institutional Training Initiative (CITI).

Who needs it: PIs and study team members listed on a Convened/Expedited/Exempt eIRB application

Exceptions: Non-affiliated study members and Clinical Research Network (CRN) study team members may submit their 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 three years old at the time of IRB submission, non-affiliated members will be required to take the JHM BHSR course. PIs and study team members listed on a NHSR eIRB application are not required to complete BHSR compliance training.

Conflict of Interest and Commitment (COI):

This online course is designed to introduce researchers to the topic of financial conflicts of interest in research, including what financial conflict of interest means, sources and risks of financial conflicts of interest in research, federal regulations and institutional policies designed to address the risks, and researchers’ obligations under the regulations and policies. The federal government’s regulation on conflict of interest (COI) in research, which is intended to promote research objectivity, was revised in August 2012. This course is designed to fulfill the training requirements included in the regulation and in Johns Hopkins policy.

Exceptions: CRN study team members may submit CITI or local institution conflict of interest training if it is not more than four years old at the time of IRB submission. If it is more than four years old, individuals must take the JHM IRB COI course. PIs and study team members listed on a NHSR eIRB application are not required to complete COI compliance training.

USF PIs, BSPH, Engineering, Arts and Sciences faculty, staff and students, and non-affiliated study team members are not required to complete this course.

HIPAA for Research (HFR):

This online course covers specific HIPAA requirements for research involving health information. This new course replaced “HIPAA For Research – 01” in December 2014.

Who needs it: PIs and study team members listed on a Convened/Expedited/Exempt eIRB application who are JHU SOM and SON faculty, fellows, staff, and students; staff at ACH, APL, JHH, JHCP, KKI, HCGH, Suburban Hospital, Sibley Memorial Hospital, USF faculty and staff, Cardiovascular Specialists of Central MD, Central MD Radiation Oncology Corporation; Engineering, Arts and Sciences faculty, staff and students. BSPH, CRN, and non-affiliated study team members (with the exception of USF) are not required to complete this course.

Exceptions: PIs and study team members listed on a NHSR eIRB application are not required to complete HIPAA for Research compliance training.

Please note: The JHM IRB will not track completion of any Johns Hopkins HIPAA privacy courses (i.e., “Privacy for Health Care Providers” or “Privacy Refresher Course for Health Care Providers”). However, This course assumes you have a basic understanding of the HIPAA requirements. If you are a JH workforce member who is required to complete this course, you must first complete the required, applicable basic privacy course in myLearning, as identified on the JH Privacy Office Intranet Site.

Clinical Research Billing Orientation (CRBO and Clinical Research Management Systems (CRMS):

This online course introduces study team members to the improved clinical research billing process. Live training sessions, reference materials and start-up support will supplement this overview.

Who needs it: 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.

Exceptions: PIs and study team members listed on a NHSR eIRB application are not required to complete CRBO or CRMS compliance training.

How do I Register?

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

https://hr.jhu.edu/learn-grow/compliance-training/ (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 myLearning to register for these courses.

myLearning will track your course completion. The BHSR course is administered through CITI. 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 your training and wish to receive a copy of the certificates, please contact the NORA at [email protected] or 410-614-7005.

IRB Compliance Training Requirements for Human Subjects Research
Affiliation	BHSR	COI	HIPAA for Research	CRBO/CRMS
Principal Investigators (PIs)	X	X	X	X
JHU SOM and SON faculty, fellows, staff, and students; staff at ACH, APL, JHH, JHCP, KKI, HCGH, Suburban Hospital, Sibley Memorial Hospital, Cardiovascular Specialists of Central MD, and Central MD Radiation Oncology Corporation	X	X	X	X
Engineering, Arts and Sciences faculty, staff and students	X		X	X
School of Public Health faculty, staff and students	X			X
University of South Florida PIs and study team members	X		X	X
Non-Hopkins study team members	X			X
Clinical Research Network study team members(AAMC, GBMC, INOVA, PRMC, RHS)	X	X		X

Recertification Training

The Johns Hopkins Medicine Human Research Protection Program has developed a compliance training recertification requirement for researchers who are engaged in human subjects research. To better align the Johns Hopkins recertification policy with peer institutions and funding agencies, as well as be consistent with study team member recertification requirements, effective March 1, 2016, PIs will be required to complete HSR training recertification every 3 years. Study team members must complete recertification within 3 years of their initial HSR compliance training, and then complete recertification every 3 years.

HSR recertification is required for NEW APPLICATION submissions only (all study team members) and CHANGE IN RESEARCH submissions (only study team members being added – not existing study team members). If the required recertification courses have not been completed by the PI and all study team members prior to submission of the new application, the application will be returned to the PI.

Who needs it?

For Principal Investigators (PIs), recertification will include 4 required online modules and 1 in-person activity (the 100 points system will no longer be used). The list of in-person activities will include a variety of instructor-led courses and in-person workshops offered throughout the calendar year. A combination of the 4 required modules and 1 of the in-person activities will result in the completion of PI recertification.
For all other study team members, recertification will include 4 required online modules and 2 additional courses available for choosing. A combination of the 4 required modules and 2 additional course available for choosing will result in the completion of study team recertification.

Exceptions:

Non-affiliated study team members and Clinical Research Network (CRN) study team members may submit their compliance training recertification for Basic Human Subjects Research (BHSR) from CITI, their local institution or another institution, such as NIH.
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

How do I register?

Principal Investigators should register for recertification courses through myLearning using the following link: http://lms14.learnshare.com/l.aspx?CID=89&A=2&T=554443
Please note: you MUST enroll in the available modules and lectures using the links provided above. You will receive credit for only those items listed within your recertification tracker.

Contact Information

For questions, please email [email protected].

eIRB Training

eIRB training is very helpful and strongly encouraged in facilitating the use of the electronic application system (eIRB). Below you will find useful tutorials that can help guide PIs and study team members through the eIRB system as well as information on upcoming in-person eIRB training sessions.

Tutorials:

If you have any questions after reviewing the tutorials below, please contact the eIRB Help Desk at 410-502-2092, or email [email protected] for further assistance.

How to Get Started with the IRB process
New Applications
Change in Research
Continuing Review
Convert Studies to eIRB
Emergency Use Request
Protocol Event Reports
Termination/Post Termination Reports
Other Useful Tutorials (IND safety reports, Radiation Calculator, etc.)

Other useful information:

eIRB FAQs
eIRB Updates
eIRB Wizards
System Requirements
New Application Workflow
Change in Research/Emergency Use Application Workflow
Continuing Review/Termination/Protocol Event Application Workflow

In-person Training:

“eIRB 101: Prepare and Submit an Application and Post Submission Actions” is an in-person training session offered on the 3^rd Friday of every month in Reed Hall 102. Registration is required to attend an eIRB technical training class.

Registration:

Registration for eIRB 101 Training is done through myLearning. Click here to register.

	Federal Cost Principles	Monitoring Sub Recipient Activity
SON Principal Investigators (PIs), Postdoctoral fellows, and Pre-Doctoral students	X	X
SON Faculty, Staff, and students involved in research
Program/Project coordinator or manager	X	X