News

From the Desk of the Vice Dean - Letters and memorandums from the Vice Dean for Clinical Investigation

September 2011

• Inclusion of Sibley Memorial Hospital as a study site in JHM IRB Approved Research
• Inclusion of Suburban Hospital as a study site in JHM IRB Approved Research

January 2011

• CIRB Facilitated Review Procedures
• CIRB HIPAA Authorization/Consent Form

December 2010

• AAHRPP: Updates/Additions to Guidances
• AAHRPP: Updates/Additions to Policies
• HIPAA Authorization: International Language

October 2010

• The Johns Hopkins Clinical Research Network
• Policy IDS.1 Organization Policy on Investigational Drug Services Disclosures for Participant Safety Reasons

August 2010

• Department of Defense (DoD) Requirements for the Conduct of Human Subjects Research

July 2010

• Training Requirements for Human Subjects Research
• Registration of Clinical Trials on ClinicalTrials.gov

June 2010

• Obtaining and Documenting Informed Consent Of Subjects Who Do Not Speak English

 May 2010

• Policy 102.3 Organization Policy on Single Case Reports and Case Series

March 2010

• Policy 102.4 Organization Policy on Research Involving Human Embryonic Stem Cells, Germ Cells, and Stem Cell-Derived Test Articles
• Plans for Detecting and Managing Incidental Findings Associated with Research Imaging Procedures

January 2010

• HIPAA Combined Informed Consent/Authorization Template

October 2009

• Policy OHSR.2 Organization Policy on JHM Response to Sponsor Requests for Economic Data

August 2009

• Significant Differences between FDA and DHHS Regulations
• Policy D403 Organization Policy on Research Involving Children
• Plans for Detecting and Managing Incidental Findings Associated with Research Imaging Procedures

• Policy OHSR.1 Organization Policy on Incidental Findings Associated with Research Imaging Procedures

July 2009

• Policy 111.8 Organization Policy on Research Involving Vulnerable Populations
• Fees for JHM IRB and WIRB Review of Research Protocols

June 2009

• Research Projects Involving Social Services Administration of the State of Maryland Department of Human Resources Department of Social Services (Foster Children)
• DSS Submission Form
• Application of GCP to the Conduct of Clinical Research at JHM
• Sample GCP Checklist

February 2009

• HIPAA Form 3 "Authorization to Contact You About Future Research Studies"
• HIPAA Form 4 "Application for IRB Waiver of HIPAA Privacy Authorization"

January 2009

• Training Requirements
• JHH Nursing Research Approval
• School of Nursing Requirements
• Monitoring Program
• Oncology Research