Guidelines

A I
Ancillary Committees Incidental Findings
Access to Patient Data for Research: Frequently Asked Questions INDs for Products Not Marketed as Drugs
Access to Study Records - Participants INDs/IDEs - Requirements for JHU Investigator-Held
Approval Notices IND Safety Reports
Apps - Research Involving Apps and Software Informed Consent
Apps - APPs in the Research Setting - A Checklist for Researchers Informed Consent - Adults Who Were Children When Enrolled in a Study
Apps - JHU Guidance Regarding Security of Custom Developed Mobile and Web Applications Informed Consent - FDA Regulated Studies
  Informed Consent - Minors
Approval Process for Research Involving Institutional Data Sets Instructions for Requesting Interpretation Services through Language Access Services
B Insurance and Research Participant Financial Responsibility Information Sheet
Baltimore City Health Department International Research
Blood or Bone/Tissue Bank Investigational Medical Devices
  Investigational Product Returns from Research Participants
C Investigator Brochure
Cancer Research Investigator Inquiry to the FDA about IND
Case Report Publication Investigator Responsibilities
Certificates of Confidentiality Investigators as Study Participants
Changes in Research Inventors Whose Intellectual Property (IP) is Licensed to Startups
   
Children - 

Compliance with JHU’s Policy on Safety of Children in University Programs

J

Clinical Engineering Services

Johns Hopkins Clinical Research Network (CRN)
Clinical Genetics Research JHHP Data Sharing Committee
  JHHCG - Research Requiring Home Care Services at Johns Hopkins
Clinical Research Network (CRN) JHH Nursing Research Approval
Clinical Trials - Registration K
Closed to Accrual Kennedy Krieger Inst. Research
Collaborative Research and IRB Review - Johns Hopkins Medicine and University of Maryland Baltimore Kennedy Krieger Inst. Nursing Research
Common Rule (revised) - What You Need to Know L
Concerns or Complaints About Research

 M

Consent - HIV Testing Maryland Advanced Research Computing Center (MARCC)
Consent - Minors Maryland Law
Consent - Federal Reqs. to Obtain Permission from Both Parents Monitoring Visits
  Monitors - FAQ for File Sharing
Consent - Obtaining the Permission of Both Parents: Steps to Follow MRI Language for CFs
Consent Language Requirements for Department of Defense (DoD)-Funded Research N
Consent - MRI Language

NIH Human Genomic Data Sharing Policy FAQs

Consent - Non-english speakers Non-Compliance with IRB Approved Human Subjects Research
Consent - Requesting an Interpreter for Research Consent Nursing Research Approval - JHH
Consent Waiver/Alteration  
Consent - Waiver of Documentation of Consent O
Continuing Review Oncology Research
Convened Review P
Coordinating Center Functions Participants' Access to Study Records
Research with a Community Focus Pathology Tissue/Specimen Use Committee
  Paying Research Participants - Procedures 
  Payment to Research Subjects - Elimination of VCNs
D Pharmacy Bayview
Databases -  Consideration for proposed submissions to an NIH GWAS database (such as dbGaP) Pharmacy JHH
Definitions Physician Consent Fact Sheet
Dept. Communications to Patients about Ongoing Research PMAP
Department of Defense (DoD) Requirements for the Conduct of Human Subjects Research  
Department of Justice Point-of-Care Testing
Departmental Pre-Review Post-Doctoral Fellows in Human Research
Deviations Posting of Consent Forms for Federally-Funded Clinical Trials
Devices Protocol Deviations
DocuSign Publicly Available Data
Drugs - Section 21 Tip Sheet Public Health Surveillance Activities
Drug Research  
E Q
Electronic and Remote Consent  
Engineering Services  
Exempt Research R
Expedited Review Research Data Subcouncil
  Research Data Management - Best Practices
  Research Requiring Home Care Services at Johns Hopkins
F Research Requiring the Services of the Johns Hopkins Blood Bank or Bone/Tissue Bank
FDA Test Articles Record Retention
FDA vs OHRP Regulations Reasonable Payment (Remuneration)
Federal Requirements to Obtain Permission from Both Parents Recruitment Document Formatting Requirements
Fees Recruiting Study Subjects
File Sharing with Monitors  
Florida Laws - Human Subjects Research  
Obtaining the Permission of Both Parents: Steps to Follow Recruitment and Referral - Patient
Foster Children Recruitment - Departmental Communications to Patients about Ongoing Research
  Recruitment of Students and Employees
G Registration of Clinical Trials
Gadolinium for Research MRI Procedures  
Application of GCP to the Conduct of Clinical Research Reporting Obligations Under Maryland State Law
GDRP Application in Research Settings Reporting to Institution and Government Agencies
GDPR FAQs Requesting the Use of Patient Safety HERO and SCA Data for Purposes of Research
Gene Transfer Requirements for Conducting Research Funded by the United States Department of Justice
Genetics Research Research with a Community Focus
GenomeWide Association Studies (GWAS) Research Protocol Management System
Genomic Data Sharing Policy FAQs Research using the Precision Medicine Analytics Platform [PMAP]
Consideration for proposed submissions to an NIH GWAS database (such as dbGaP) Research Using Social Media Data with No Participant Interaction
  Review Agreements
H Review Fees
HIPAA Guidances Revised Common Rule (What You Need to Know)
Humanitarian Use Device (HUD) Research Requiring Point-of-Care Testing at Johns Hopkins
 

Reliance:

T
School of Nursing Pre-Review Telemedicine and Research
School of Nursing Project Ethical Review Committee (PERC)
Terminated
School of Public Health Reciprocity Agreement - Criteria for Requests for Review  Transferring Human Biospecimens to Outside Organizations
Sedation  TriNetX Databases
Self-experimentation
 
Sibley Memorial Hospital
 
Sponsor Contracted Third-Party Collaborators
 
Sponsor IND Safety Reports
 
State of Maryland Law and Consent for HIV Testing
 
Student Education Records in Research (JHU)
 
Submitting Formative/Pre-Clinical/Pilot Research Activities to the JHU IRBs
 
What Must Investigators Submit to the JHU IRBs?
 
Suburban Hospital