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Upcoming Training Sessions

Training Sessions: Single IRB Requirement for Cooperative Research(JHM IRB)

Since January 25, 2018, the NIH has required use of a Single IRB [sIRB] for the review of NIH-funded multisite studies where each site will conduct the same protocol involving non-exempt human subjects research. The Revised Common Rule, which sets forth federal regulatory requirements regarding Human Subjects Protections, went into effect on January 21, 2019 and extends the sIRB review requirement to all “cooperative research” [Research involving one or more institutions] funded by a federal agency that is a signatory to the rule. The required implementation date for this provision is January 20, 2019.

This purpose of this training opportunity is to provide an overview of the sIRB requirements, describe the process for requesting reliance on JHM IRB or an External IRB, and to discuss how the cooperative research provision affects new and existing human research studies.

Please register via this link: https://lms14.learnshare.com/dashboard/dash.home.aspx?Z=yuwNQHQOn%2fVXP64UBzsjlcoRXj5lQ9JfRZYjWe%2fl6PrF2IXzJpbDzp7Q6Qhj3jjs

Session dates/times:

9/23/2019 - 10:30 - 12 p.m.

10/14/2019 - 2 - 3:30 p.m.

10/30/2019 - 10 - 11:30 a.m.

Training Sessions: Problem Event and Adverse Event Reporting (JHM IRB):

This course will focus on the new prompt reporting policy, protocol event report and adverse event reporting.  This course is open to all and will count towards PI-recertification.

Please register via this link: https://lms14.learnshare.com/dashboard/dash.home.aspx?Z=jIktU77XC5eZwHkzxsYlzqok6wubDr4cdDQkQQCZM%2fG7nyjwxK5dL9VOrnMR91Gh

Session dates/times:

8/22/2019 - 10 - 11 a.m.

9/19/2019 - 10 - 11 a.m.

Training Sessions: eIRB101 (JHM IRB)

eIRB101 is a 2 hour in-person beginners course designed to introduce new researchers to the IRB website and the JHM electronic Institutional Review Board (eIRB) System.  Topics covered include:  

-IRB Compliance Training Requirements
-Turn-around Time and Workflow Process
-Who's Who in the IRB
-Accounts and Websites
-Application Workspace
-Application Screens (i.e., Study Protocol, Consent Form)
-Finalizing Application and Adding Study Team Members
-Responding to IRB Issues
-Creating a Further Study Action (intro)

Please register via this link: https://lms14.learnshare.com/l.aspx?CID=89&A=2&T=358053

Session dates/times:

Classes are held the 3rd Friday of each month (10:00 a.m. - 12:00 p.m.)

Training Sessions: Good Clinical Practice (GCP) Fundamentals: Understanding and Applying GCP to Human Subjects Research (JHM IRB)

Good Clinical Practice or ‘GCP’ training for investigators and study-team members is increasing becoming required by institutions, sponsors, and the NIH.  This 90 minute course will explain the elements of the International Conference for Harmonization’s (ICH) principles and specific guidelines for Good Clinical Practice.  Attendees will be introduced to the GCP Principles, and will explore investigator responsibilities in human subject research, focusing on the areas of trial conduct (experience, resources, and physician duties); performance (communication with the IRB, protocol compliance, and investigational product management); ethical research (safety oversight and informed consent); and recording/reporting (data acquisition, progress summaries, and safety-event reporting).

Please register via this link: http://lms14.learnshare.com/l.aspx?CID=89&A=2&T=339728

Session dates/times: 

Classes are held the 4th Friday of each month (10:00 a.m. - 11:30 a.m.)

 

 

Check back for future dated sessions/times