April 2011
HUMAN SUBJECTS RESEARCH - Back

Recertification/Training Program for Principal Investigators Conducting Human Subjects Research

The Johns Hopkins Medicine Human Subjects Protection Program has not had any requirements for recertification for principal investigators engaged in human subjects research. We are now joining with many of our peer institutions to institute a new recertification program for principal investigators. At this point, regulatory agencies are giving IRBs the freedom to institute recertification programs that are tailored to be relevant and useful to our research teams. Recertification should be viewed as an opportunity for continuing education in ethical research practices. Analogous to continuing education in clinical practice, compliance training recertification in human subjects research should help investigators reflect on how research ethics principles and standards apply to their research, learn about new regulations and strategies for protecting the rights and welfare of human research subjects, and demonstrate their commitment to ongoing quality improvement in their research.

Key points
Effective this month, the Johns Hopkins Medicine Human Research Protection Program will implement new compliance training recertification requirements for principal investigators engaged in human subjects research. Training recertification is only required for principal investigators at this time; recertification requirements for other study team members will not be implemented until 2012 or later.

The compliance training recertification for principal investigators will be tracked through myLearning at http://lms4.learnshare.com/l.aspx?CID=89&A=1&T=303570

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

  • Principal investigators must complete recertification within five years of initial certification and then complete recertification every five years. Those investigators who completed the Human Subjects Research course more than five years ago will have until January 1, 2012 to complete their recertification.
  • Recertification involves a point system for learning activities, which can be earned through a combination of learning activities. Completion of activities will be tracked through myLearning so investigators will have an ongoing tally of points earned.
  • Learning activities will include a menu of options, including online modules and in-person workshops, conferences, and courses. Online modules will be available through CITI (Collaborative Institutional Training Initiative); registration for the CITI courses is also on myLearning.
  • Educational experiences that include researchers sharing their approaches to human subjects research protection cannot be duplicated by online modules. More points will generally be offered for in-person, instructor led continuing education sessions compared to online modules.
  • In-person, instructor led continuing education will primarily be offered through a new course, Research Ethics Workshops about responsibilities and duties of scientists (REWards), which will replace the Course on Research Ethics (CORE). Attendance at REWards will be tracked through myLearning.
  • Limited other learning activities at the institutional, departmental or divisional levels--such as Grand Rounds, lectures, conferences or seminars--may qualify for points toward recertification. The content must focus on research ethics and the activity must be approved well in advance by the Human Research Protection Program. Those wishing to apply for recertification points for their learning activity can find the request form at: http://www.hopkinsmedicine.org/institutional
    _review_board/ forms/research_ethics_educational_activity.pdf
  • The first two lectures for which a PI may receive credits are:
    • April 11, 2011 Dr. Jerry Menikoff, Director, Office for Human Research Protections (OHRP)
      What Can Multiple-IRB Review Teach Us?
      Armstrong Medical Education Building, West Lecture Hall, 12:15-1:15
      Attendance will be tracked by badge swiping at hall entrance.
    • April 25, 2011 James Lavery, Ph.D - TBA
      Armstrong Medical Education Building, West Lecture Hall, 12:15-1:15
      Attendance will be tracked by badge swiping at hall entrance.

The approach to recertification we have chosen will involve substantial effort for tracking completion of educational modules. In exchange, you will have the opportunity and responsibility to choose training opportunities that are relevant to your own research and can be completed at the time you are facing decisions in your research where an additional perspective will be most valuable. Thank you for your continuing support of our Human Research Protection Program.

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April 2011 articles:
Recertification/Training Program for Principal Investigators Conducting Human Subjects Research
 
Seminar Series
Funding from Foundations/Private Sources
Edward Mallinckrodt, Jr. Foundation Award Program
William T. Grant Scholars Program for 2011
W.W. Smith Charitable Trust - Cancer and AIDS Research Program for 2011
NIH Publication Reporting Policy

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