Guidances Relating to Specific Types of Research

• Oncology Research

• Clinical Engineering Services and Human Subjects Research Activities

• Registration of Clinical Trials

Emergency Use of a Drug/Device

• Requests for Emergency Treatment Use of FDA Test Articles in Clinical Care Situations Without Prior Convened JHM IRB Review

FDA regulated Device trials

• Clinical Engineering Services and Human Subjects Research Activities
  CES review is requirements
• Investigational Medical Devices
  Investigational Device Exemptions – general information
• Organization Policy on Clinical Investigations with FDA “Test Articles”
  IND and IDE studies
• Research Using FDA Test Articles
  Guidance on Research Using FDA Test Articles
• Significant risk and non-significant risk devices

• Organization Policy on Clinical Investigations with FDA “Test Articles”
  Investigational New Drug studies
• Drugs and Complementary & Alternative Medication (CAM)
• Organization Policy on Drug Use and Control in Clinical Investigations
  Drug Use for Clinical Investigation (DUCI Policy)
• Pharmacy (IDS) Service at JHH
• Pharmacy (IDS) at Bayview
• IND Application Process – FDA/CDER site 
• Investigator Inquiry to the FDA About the Need for an Investigational New Drug Application (IND)
  Ask the FDA if you need an IND
• Investigator Brochure submission
• Application of GCP to the Conduct of Clinical Research

• Research Projects Involving Social Services Administration of the State of Maryland Department of Human Resources Department of Social Services (Foster Children)
• DSS Submission Form

• Administration of Gadolinium for Research MRI Procedures

• Clinical Genetics Research
  

• Gene Transfer Research

Humanitarian Use Devices

• Organization Policy on Humanitarian Use Devices
  Consent requirements, emergency use
• Humanitarian Use Devices

• Humanitarian Use Device (HUD) Informed Consent and Privacy Authorization

• Plans for Detecting and Managing Incidental Findings Associated with Research Imaging Procedures

• International Research

• Organization Policy on Review of In Vitro Diagnostic Device Protocols (with or without Commercial Sponsors)
• Organization Policy on Clinical Investigation with FDA "Test" Articles

• QA/QI Flowchart

• Research Databases
  How to set up a research database protocol

• Use of Human Biological Materials In Research
  Prospective collection vs. existing , w/identifiers or not , sharing specimens with other investigators
• JHM Pathology Tissue/Specimen Use Committee Guidance