Policies and Guidance
Guidance
New NIH Grant Proposals Due On or After January 25, 2023:
NIH now requires researchers to submit data management and sharing plans with their grant proposals, which Data Services offers expertise on.
Please visit page or contact dataservices@jhu.edu to schedule a consultation. Please also visit for more information about resources available for support.
I. PHIRST Submissions
- Amendments
- Ancillary Reviews
- Continuing Review/Progress Reports
- Creating a PHIRST Guest User Account
- First Steps for Setting Up Your PHIRST Profile
- HIPAA Policy, Procedures, and Resources
- NHSR/NE
- Research Plans
- Single IRB and Reliance Agreements
- Unanticipated Problem Event
- User Guides
II. Getting Started
- Baltimore City Health Department Studies
- Biosafety Guidance
- Criteria for Requests for Review under the BSPH-SOM IRB Reciprocity Agreement
- 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 BSPH IRB protocol?
- What You Need to Know about the Revised Common Rule
- When is an institution or PI "engaged" in Human Subjects Research?
- Guidance: Submitting Formative/ Pre-Clinical/ Pilot Work
- Guidance on Fraud Prevention Regarding Use of Survey Instruments
III. Research in International Settings
IV. 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 BSPH IRB Requirements
V. Data Management and Sharing
- BSPH IRBs Data Sharing Guidance
- Contact BSPH 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)
- Document & Resources for Investigators
- 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?
VI. Consent Process, Consent Forms, Recruitment and Other Participant Interaction Issues
- Compliance with JHU Policy on Child Safety
- Enrolling Maryland Children under Social Services Administration Care
- Informed Consent: Understanding the Process and Documentation Requirements
- Key Information
- Radiation Risk Consent Form Language
- Remote Consent and E-Consent FAQs
Enrolling Children in Foster Care
- Guidance for Enrolling Children in Foster Care in Research
- SSA Instruction Sheet and Form for Enrolling Children in Foster Care
VII. Review Process
VIII. Special Research Topics
- Bioethics Commission report on Ethical Management of Secondary and Incidental Findings
- Ethical, Social, Behavioral Research with Adolescents
- Ethics in Research and Programming with Adolescents
- GDPR General Data Protection Regulation
- Guide to Ethical Conduct of Research on Child Marriage
- OHRP Webinar Slides: Conducting Internet Research
- Research in Schools: Use of Student Education Records in Research
- SACHRP Guidelines on Internet Research
CLIA