The categories in the menu below link to lists of Institutional policies and guidances governing human subjects research at Johns Hopkins Medicine. If you are having trouble finding a specific topic please use the search box feature on the left to find specific information within the JHMIRB website. The Office of Human Subjects Research invites your comments and suggestions about how to improve this site.
I. Investigator Responsibilities - Coordinating Center Functions
- Payment
- Reciprocity Agreements
- Recruitment, training
- Recordkeeping
- Reporting requirements
- Subject or staff complaints
- Termination
| II. Research Activity - IRB Review - Is it human subject research?
- Exempt, Expedited, Convened Review
- Changes in Research
- Reciprocity Agreements
| III. Specific Types of Research
- Use of Human Specimens
- FDA regulated research, and Emergency/Compassionate Use
- Gadolinium
- Gene Transfer Research
- Research Databases
| IV. Consent - Process
- Waiver of Consent; waiver of documentation
- Vulnerable Populations: children, pregnant women, prisoners, etc.
- Templates for consent forms, assent forms and oral consent scripts
| V. Compliance, Laws/Regulations - FDA vs. OHRP Regulations
- Maryland Law
- CLIA
- HIPAA
| VI. Online Resources - Research Protocol Management System
- eIRB
- Compliance Training
| VII. Reporting Requirements - Unanticipated Events
- Protocol Deviations
- IND Safety Reports
- Reporting the death of a research participant
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