Guidance and Policies

Policies

I. Getting Started

• Baltimore City Health Department Studies
• Biosafety Guidance
• Conflict of Interest in Human Subjects Research
• Criteria for Requests for Review under the JHSPH-SOM IRB Reciprocity Agreement
• Determining Public Health Practice from Public Health Research
• Document Submission to the IRB
• Monetary and Other Incentives in the Research Context
• Planning Phase Applications
•  VCN Guidance
• Verbal Autopsy Guidance
• What needs review by IRB?
• What am I agreeing to do when I become a Principal Investigator on a JHSPH IRB protocol?
• When is an institution or PI "engaged" in Human Subjects Research?

II. 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
• Research Plan Instructional Template
• Study Team Roles and JHSPH IRB Requirements
• What will the IRB reviewer look for? 

III. Data Security

• Information Systems/IRB Guidance
• Data Security Guidelines for Community Based Research
  (Best practices document prepared by ad-hoc committee of the Department of International Health)

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

• About Consent Form Template and Process Changes
• Enrolling Foster Children
• Enrolling Maryland Children under Social Services Administration Care 
• SSA Instruction Sheet and Form for Enrolling Children in Foster Care
• Informed Consent: Understanding the Process and Documentation Requirements
• Radiation Risk Consent Form Language
• Recruitment Materials

V. Review Process

• Fast Track Procedure
• Documentation of IRB Approval