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Recertification Requirements for Human Subjects Research Study Team Members

In January 2015, the Johns Hopkins Medicine Human Research Protection Program implemented a new online recertification program for study team members engaged in human subjects research. Through the CTSA program, the NIH and leading academic research organizations have agreed to recertification of all study team members every three years. The recertification requirement goes 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 became available via myLearning. Study team members who completed IRB-required human subjects research training more than three years ago had one year—until Jan. 1, 2016—to complete their recertification.

The goals of recertification are 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
  • Demonstrate the institution’s commitment to ongoing, high-quality education for research faculty and staff members

The full details of how recertification will work will be contained on the myLearning website and on the IRB 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 IRB-required human subjects research training more than three years ago had one year—until Jan. 1, 2016—to complete their recertification. Recertification will then be required every three years thereafter.
  • Principal investigators (PIs) who are also study team members are only required to complete PI recertification, which is currently required every five years.
  • 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 Jan. 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.

If you have questions, please contact the Johns Hopkins Medicine IRB help desk at jhmeirb@jhmi.edu or IRB training manager Janelle Maddox-Regis at jmaddox3@jhmi.edu.

Thank you for your continuing support of our Human Subjects Protection Program, your continued commitment to ethical principles and standards and for protecting the rights and welfare of human research subjects.

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Kelsey Bennett