Johns Hopkins Medicine

Human Research Protection Program Study Team Member

Compliance Training Recertification Overview and Documentation

Effective January 1, 2015 all Johns Hopkins employees listed as study team members on a JHM IRB eIRB application, must take Human Subjects Research Subjects recertification every three years. Recertification is the opportunity for continuing education in ethical research practices. The goals of recertification is to;

Remind study team members of research ethics principles and standards Learn about new regulations and strategies for protecting the rights and welfare of human research

subjects, and Demonstrate the Institution’s commitment to ongoing, high-quality education for research faculty

and staff.

Definitions

Study Team Member:For the purpose of this document a study team member is defined as:Faculty, fellows, staff or volunteers listed as a “Study Team Member” in the eIRB Application (Section 1 – General Information) who are not Principal Investigators (PIs) on another JHM IRB human subjects research study. All PIs must complete other training requirements as outlined on the IRB Website: http://www.hopkinsmedicine.org/institutional_review_board/training_requirements/index.html

Key points

Effective January 1, 2015, the Johns Hopkins Medicine Human Research Protection Program will implement new compliance training recertification requirements for study team members engaged in human subjects research.

The compliance training recertification for study team members will be tracked through myLearning at http://lms14.learnshare.com/l.aspx?CID=89&A=2&T=484959

The full details of how recertification will work are contained on the myLearning website. Following are the significant components of the compliance training recertification requirements:

All study team members engaged in human subjects research must complete recertification within three years of initial certification and then complete recertification every three years thereafter.

Study team members who completed IRB-required human subjects research training more than three years ago will have one year (January 1, 2016) to complete their recertification. Recertification will then be required every three years thereafter.

Recertification will include four required online modules and two additional elective online modules. All online modules will be available through CITI (Collaborative Institutional Training Initiative); registration for the CITI courses is also on myLearning.

Training dates will be tracked. As of January 1, 2016, any study team member who completed IRB-required human subjects research training more than three years ago and has not completed recertification will not be approved on new applications.

Required Courses

myLearning Title Est. Time of Completion (min.)

Refresher Course GCP: Conducting Investigator-Initiated Studies According to FDA Regulations and Good Clinical Practices 25

Refresher Course GCP: Informed Consent–An Ongoing Process 20

Refresher Course: An Over view of Research with Vulnerable Subjects 10

Responsible Conduct of Research (CITI) 315

Registration

Log-on to the myLearning site using your JHED ID: http://www.hopkinsmedicine.org/interactive_learning/my_learning/

If you have single sign-on engaged the site will open directly.

If not, simply enter your JHED ID and password.

Use the “Catalog Search” function to locate “Human Subjects Recertification – Study Team Members”.

Click “Take Course” to launch the recertification tool.

This application will provide you with four (4) mandatory courses/modules and several elective courses you can choose from to fulfill your recertification requirements. You must take two (2) of the elective courses, but are welcome to take as many as you like.

Click on the course title to view course descriptions and objectives Click “Go To Course" to enroll or “Close” to exit and return to the main menu.

Use the following key to determine the status of the courses listed:

Expired – This course was completed prior to June 1, 2014. You must complete the course again if you wish to receive credit towards your recertification.

Incomplete – This course has been added to your learning plan and is awaiting completion, or, you completed the course today. If you completed the course today, please allow up to 24 hours for the course to appear as “complete”.

Not Enrolled – You have not enrolled or completed this course.

Complete – You have completed this course and it will count towards your overall recertification goal.

As you enroll and complete courses, your progress will be tracked.

NOTE: Completions take up to 24 hours to appear in your learning history and in the recertification tool.

If you enroll in a course, the only way to be unenrolled is to contact the JHM e-IRB Help Desk at 410-502-2092 or email jhmeirb@jhmi.edu .

Once enrolled in the course, you can either click "Take Course" or close the window and return to the recertification tool.

You will receive an enrollment notification email. The email will provide a link to the course allowing you to return and take the course at any time.

To view courses you are enrolled in but haven't completed, select “My Learning Plan” from the left navigation bar. To open click "Take Course". There will be a short delay while making the connection to CITI to begin.

You will need to complete The Integrity Assurance Statement before beginning the course.

Click on the course to begin.

When you finish/pass your CITI module; your completion date of the course will be available to view in myLearning in 24 hours.

Log Out of the CITI Program to return to the recertification progress application.

**Please Note: Once ALL course completions appear in your learning history, you must click on the “Human Subjects Recertification – Study Team Members” link in your learning plan and re-launch the course. Doing so will produce a certification of completion, which will be available in your learning history**

To begin the recertification process, click here: http://lms14.learnshare.com/l.aspx? CID=89&A=2&T=484959

Contact Information:For questions regarding recertification please contact the JHM e-IRB Help Desk at 410-502-2092 or email JHMIRB@jhmi.edu.

Thank you for your continuing support of our Human Research Protection Program.

References

U.S. Department of Health and Human Services Food and Drug Administration, Guidance for Industry, Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects, October 2009

International Conference on Harmonisation, Guideline for Good Clinical Practice E6 (R1) 10 June 1996