Policy and Guidance
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
- New Application IRB Operations Flow Chart
- 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)
- Data Security: Guide to Security of Clinical Research Data Sets
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
VI. Special Research Topics