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 Data Services at NIH Data Management and Sharing Plan Support page or contact dataservices@jhu.edu to schedule a consultation. Please also visit this link 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 and Procedures (for JHM data and non-JHM data)
• 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
• 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 BSPH 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

III. Research in International Settings

• Guidance for International Research
• Investigator Checklist for HSR 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)
• 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 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
• 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

• Documentation of IRB Approval

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

• CLIA and Clinical Research 
• Research Testing and CLIA