Guidance

I. Getting Started

• Baltimore City Health Department Studies
• Biosafety Guidance
• Criteria for Requests for Review under the JHSPH-SOM IRB Reciprocity Agreement
• Document Submission to the IRB
• Monetary and Other Incentives in the Research Context
• New Application IRB Operations Flow Chart
• Payments to Participants - Elimination of Use of VCN Form
• Planning Phase Applications
• Public Health Surveillance Activities: Guidance for Investigators
• Publicly Available Data
• Recruitment Materials Guidance
• Verbal Autopsy Guidance
• What am I agreeing to do when I become a Principal Investigator on a JHSPH IRB protocol?
• What You Need to Know about the Revised Common Rule
• When is an institution or PI "engaged" in Human Subjects Research?
• What do I need to Submit?
  • What do I need to Submit?
  • Guidance: Submitting Formative/ Pre-Clinical/ Pilot Work

II. Research in International Settings

• Guidance for International Research
• Investigator Checklist for HSR in International Settings

III. Execution Tips for the Research Application

• Biospecimens: NIH Powerpoint (Things to think about)
• Biospecimens: What should be included in the Research Plan?
• Document Control for Human Subjects Research Study Documents
• Recruitment Materials
• Research Plan Instructional Template
• Study Team Roles and JHSPH IRB Requirements
• What will the IRB reviewer look for? 

IV. Data Security and Retention

• Contact JHSPH IT about Data Security and Storage  
• Data Protection LifeCycle
• Data Security Guidelines for Community Based Research (Best practices document prepared by ad-hoc committee of the Department of International Health)
• JHU Guidance Regarding Security of Custom Developed Mobile and Web Applications
• Guidelines for Retention and Disposal of Data
• Storage and Computer Options 
• Tips on Data Management Plans for JH Clinical Data 
• Why do I need a Data Management Plan?

V. Consent Process, Consent Forms, Recruitment and Other Participant Interaction Issues

• About Consent Form Template and Process Changes
• Compliance with JHU Policy on Child Safety
• Enrolling Foster Children
• Enrolling Maryland Children under Social Services Administration Care
• Informed Consent: Understanding the Process and Documentation Requirements
• Key Information
• Radiation Risk Consent Form Language
• SSA Instruction Sheet and Form for Enrolling Children in Foster Care

VI. Review Process

• Documentation of IRB Approval

VII. Special Research Topics

• Bioethics Commission report on Ethical Management of Secondary and Incidental Findings
• GDPR General Data Protection Regulation
• OHRP Webinar Slides: Conducting Internet Research
• Research in Schools:  Use of Student Education Records in Research
• SACHRP Guidelines on Internet Research

       CLIA

• CLIA and Clinical Research 
• Research Testing and CLIA