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Study Team Member Recertification

December 18, 2014

Dear Colleagues,

In 2011, the Johns Hopkins Medicine Human Subjects Protection Program implemented a new recertification program for principal investigators engaged in human subjects research. We are now implementing an online recertification program for study team members engaged in this research. The study team member recertification courses will be offered starting Jan. 1, 2015, and the recertification requirement will go into effect on Jan. 1, 2016. Recertification should be viewed as an opportunity for continuing education in ethical research practices.

Key Points

On Jan. 1, 2015, the recertification courses will be available online via myLearning. Study team members who completed Institutional Review Board-required human subjects research training more than three years ago will have one year—until Jan. 1, 2016—to complete their recertification. The goals of recertification include:

  • Reminding study team members of research ethics principles and standards
  • Learning about new regulations and strategies for protecting the rights and welfare of human research subjects
  • Demonstrating the institution’s commitment to ongoing high-quality education for research faculty and staff

The full details of how recertification will work will be contained on the myLearning website and on the Institutional Review Board website.


The following are 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 Institutional Review Board-required human subjects research training more than three years ago will have one year—until Jan. 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 the Collaborative Institutional Training Initiative. Registration for these courses is also on myLearning.
  • Training dates will be tracked. As of Jan. 1, 2016, any study team member who completed Institutional Review Board-required human subjects research training more than three years ago and has not completed recertification will not be approved on new applications.

 

If you have questions, please contact the Johns Hopkins Medicine eIRB Help Desk at jhmeirb@jhmi.edu or the Institutional Review Board training manager, Janelle Maddox-Regis, at jmaddox3@jhmi.edu. I appreciate your continuing support of our Human Subjects Protection Program.


Thank you for your continued commitment to ethical principles and standards and for protecting the rights and welfare of human research subjects.


Daniel E. Ford, M.D., M.P.H.
David M. Levine Professor of Medicine
Director, Institute for Clinical and Translational Research
Vice Dean for Clinical Investigation
Johns Hopkins School of Medicine