Compliance Training Guidelines

1
Compliance TrainingGuidelines

• jhmeirb_at_jhmi.edu

2
Compliance Training Guidelines

• There is an institutional requirement for
  compliance training which must be completed
  before IRB approval may be granted. 
• Guidelines for Compliance Training are available
  online at http//irb.jhmi.edu/Guidelines/training.
  html.
• The IRB does not monitor, maintain, or have
  access to the compliance training websites.
• For assistance with the compliance training
  websites contact the Institute for Clinical and
  Translational Research (ICTR) at
  http//ictr.johnshopkins.edu/connection/. 

3
Compliance Training

• It is not necessary to send compliance training
  certificates in advance of an eIRB submission.
• If compliance training dates are incorrect or
  missing as displayed on the eIRB application
  screen 2 - Study Team Compliance Training,
  question 1.0
• Upload copies of training certificates into
  question 2.0.
• We will enter the dates into the eIRB system upon
  submission of the application.
• For assistance with the compliance training
  websites contact the Institute for Clinical and
  Translational Research (ICTR) at
  http//ictr.johnshopkins.edu/connection/. 

4
Compliance Training Requirements
Guidelines for Compliance Training are available
online at http//irb.jhmi.edu/Guidelines/training.
html.
5
Compliance Training Websites

• Human Subjects Research (HSR), Conflict of
  Interest (COI), General Privacy Issues (GPI), and
  the Course on Research Ethics (CORE) are
  available online at the Compliance Training
  website http//secure.lwservers.net/.

The IRB does not monitor, maintain, or have
access to this website. Contact the Institute
for Clinical and Translational Research (ICTR) at
http//ictr.johnshopkins.edu/connection/ for
assistance.
6
Compliance Training Websites

• HHIPAA Research, CRBO, and CRMS courses are
  available online at Johns Hopkins Medicine
  Interactive http//www.Hopkinsinteractive.org .
• GPI is a pre-requisite for HIPAA Research.

The IRB does not monitor, maintain, or have
access to this website. Contact the Institute
for Clinical and Translational Research (ICTR) at
http//ictr.johnshopkins.edu/connection/ for
assistance.
7
Compliance Training Websites

• Information about CORE is available online at
  Continuing Medical Education http//www.hopkinscme
  .net/CORE.html.

The IRB does not monitor, maintain, or have
access to this website. Contact the Institute
for Clinical and Translational Research (ICTR) at
http//ictr.johnshopkins.edu/connection/ for
assistance.
8
C.O.R.E. Requirements

• All principal investigators of active IRB
  protocols are required to complete the Course on
  Research Ethics (CORE) or its equivalent. 
• Individuals who were not active PIs as of October
  1, 2006 have one year from the date of first
  submission to complete the CORE requirement. 
• Fellows must complete the CORE course before the
  end of their training period.

9
C.O.R.E. Requirements

•  If you can provide documentation that you have
  completed one of the research ethics courses
  listed below you will not need to complete the
  C.O.R.E. requirement
• Research Ethics 550.860.01 (School of Public
  Health)
• Research Ethics and Integrity US and
  International Issues 366.665.01 (School of Public
  Health)
• Science of Clinical Investigation Ethical and
  Regulatory Issues in Clinical Research
  (Instructors Dr. Norm Fost and Dr. N. Franklin
  Adkinson)

10
Non-Hopkins Affiliated

• Non-Hopkins affiliated study team members are
  required to upload a copy of your Human Subjects
  Research compliance training certification from
  the outside institution into the application.  
• We will accept research compliance training
  certification from your local institution,
  Collaborative Institutional Training Initiative
  (CITI), or another institution, such as NIH.
• We will assume that your institution has
  conducted all requisite HIPAA training and no
  additional HIPAA training certifications will be
  required.

11
Non-Hopkins Affiliated

•  A copy of your Human Subjects Research
  compliance training certification from your
  institution should be uploaded into eIRB
  application screen 2 - Study Team Compliance
  Training, question 2.0.
• IRB staff will enter the dates into the eIRB
  system upon submission of the application.
• For assistance with the compliance training
  websites contact the Institute for Clinical and
  Translational Research (ICTR) at
  http//ictr.johnshopkins.edu/connection/. 

12
Compliance TrainingGuidelines

• jhmeirb_at_jhmi.edu