From the Desk of the Vice Dean - Letters and memorandums from the Vice Dean for Clinical Investigation
April 2013:
January 2013:
November 2012:
- Updated Guidances:
- Obtaining and Documenting Informed Consent Of Subjects Who Do Not Speak English
- Exempt Research Studies Involving Human Subjects
- Research Projects Involving Social Services Administration of the State of Maryland Department of Human Resources Department of Social Services (Foster Children)
- Submission of De-Identified Specimens and Data to NIH Repositories for GenomeWide Association Studies (GWAS) and Similar Genotyping Projects: JHM Process to Obtain IRB Review and an Organization Certification of Review
- Updated Policies:
- Updated Form:
August 2012
June 2012
May 2012
- Training Requirements for Human Subjects Research
- Johns Hopkins/King Khaled Eye Specialist Hospital Informed Consent Template
- Combined Parental Informed Consent/Authorization
- Policy 116.3 on Translation of Consent Documentation
Policy SL.2 on State of Maryland Mandatory Disease and Condition Reporting - Diseases and Conditions Reportable by Health Care Providers and Others
April 2012
Updated forms:
- Johns Hopkins CIRB HIPAA Authorization/Consent Form Addendum
- HIPAA Form 1.1 - HIPAA Authorization Form for International Research
- Short Form Consent Chinese translation
February 2012
- Updated - Registration of Clinical Trials on ClinicalTrials.gov
- Increase in Fees for JHM IRB Review
- HIPAA Combined Informed Consent/Authorization Template (March 2012, Version 13)
- Oral Consent Form Script (March 2012, Version 3)
- JHMIRB February Newsletter
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
June 2011
January 2011
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
July 2010
- Training Requirements for Human Subjects Research
- Registration of Clinical Trials on ClinicalTrials.gov
June 2010
May 2010
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
October 2009
August 2009
- Significant Differences between FDA and DHHS Regulations
- Policy D403 Organization Policy on Research Involving Children
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
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