Archive: Letters from the Vice Dean

2021

2021 Fee Change Announcement

Update on External Onsite Monitoring and Site-Initiation Visits for Clinical Research Protocols

2020

Clinical Research Restart Progress

Expectations for Registering Research Participants in CRMS and Research Consent Form Availability

JHU COVID-19 Requirements for Visits by External Monitors and Site Initiation Visits

Important Announcement from the JHU IRBs related to Coronavirus and Research with Human Participants

2018

Change in JHM IRB Review Fees for Commercially-Funded Studies

2017

Change in JHM IRB Review Fees for Commercially-Funded Studies

2015

Policy on Documentation of Physician Consent
Policy on Informed Consent and Pediatric Subjects Reaching Adulthood

2014

Study Team Member Recertification

2013

eIRB 2 Launch and Information Sessions

2012

Recertification Reminder for Principal Investigators 

2011

December 2011: Increase in JHM IRB Review Fees
November 2011: Reminder: Recertification Training Requirements
November 2011: Associate Dean for Research in the Capital Region - Dr. Theodore Abraham
April 2011: Culture of Safety in Research
March 2011: Recertification Training Requirements

2010

October 2010:  IRB Paper Study Conversion Reminder
July 2010: New Compliance Training Requirements for Participation in Human Subjects Research
June 2010: International Research
June 2010: Updates to Clinical Trials Insurance Coverage and New CRMS Requirements
April 2010:  Insurance and Research Participant Financial Responsibility Information Sheet
March 2010: Recent Issues Raised Regarding HSR

2009
December 2009: Revised Prospective Reimbursement Analysis Process
September 2009: eIRB September 2009 Updates: Converting Paper Studies, Incidental Findings, Department and Division Chairs Notifications

2008
December 2008: JHM IRB Change in Policy for Expiration Dates in Consent Documents
June 2008: New Research Billing Initiative
June 2008: Reaccreditation of the JHM Human Subjects Research Program
April 2008: Clinical Trials Registration

2007
July 2007: Event Reporting Updates to the JHM IRB Website
June 2007: Departmental Billing Process for IRB Review Fees
May 2007: eIRB Revised Application

2006
April 2006: Changes in Johns Hopkins Medicine Protocol Review by WIRB

2005
September 2005: C.O.R.E. Reminder
July 2005: eIRB ready for on-line submission
July 2005: Clinical Trials Registration Notice
June 2005 : AAHRPP Accredits JHM
 June 2005: Change in IRB 3 Membership 
June 2005 : AAHRPP Accreditation
April: FDA Inspections
February: JHM IRB Reciprocity
January: IRB Accreditations

2004
 December: Revised Training Requirements for Human Subjects Research
July: JHM IRB and Medstar Reciprocity Agreement
June: Triage of Research Protocols to WIRB
June: IRBs and Blood/Tissue Specimens

2003
October: On-line human Subjects Research Training
September: Conflict of Interest and Commitment Training Modular Required by December 21, 2003
August: New IRB Review Procedures
August: Office of Human Subjects Research is Moving
July: New JHU WIRB Liaison
July: Reorganization of the OHSR Office

2002
January: Submission of new protocols to the IRB
February: Study Sample Size Issue
February: New Consent Form Template
July: OHRP Site Visit/BSPH Reciprocity/Web-based Access
September: Web-based Access
October: Expired Consent Forms
October: Change in Triage of new applications to IRB
November: Research Fellows in Human Subjects Research

2001
January: Changes in JCCI/JHBMC IRB Guidelines and Forms
October: IRB Review of New Protocols
November: Web-based Access