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Guidelines

AI
Ancillary CommitteesIncidental Findings
Access to Patient Data for Research: Frequently Asked QuestionsINDs for Products Not Marketed as Drugs
Access to Study Records - ParticipantsINDs/IDEs - Requirements for JHU Investigator-Held
Approval NoticesIND Safety Reports
Apps - Research Involving Apps and SoftwareInformed Consent
Apps - APPs in the Research Setting - A Checklist for ResearchersInformed Consent - Adults Who Were Children When Enrolled in a Study
Apps - JHU Guidance Regarding Security of Custom Developed Mobile and Web ApplicationsInformed Consent - FDA Regulated Studies
 Informed Consent - Minors
Approval Process for Research Involving Institutional Data SetsInstructions for Requesting Interpretation Services through Language Access Services
BInsurance and Research Participant Financial Responsibility Information Sheet
Baltimore City Health DepartmentInternational Research
Blood or Bone/Tissue BankInvestigational Medical Devices
 Investigational Product Returns from Research Participants
CInvestigator Brochure
Cancer ResearchInvestigator Inquiry to the FDA about IND
Case Report PublicationInvestigator Responsibilities
Certificates of ConfidentialityInvestigators as Study Participants
Changes in ResearchInventors 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 ResearchJHHC Data Sharing Committee
 JHHCG - Research Requiring Home Care Services at Johns Hopkins
Clinical Research Network (CRN)JHH Nursing Research Approval
Clinical Trials - RegistrationK
Closed to AccrualKennedy Krieger Inst. Research
Collaborative Research and IRB Review - Johns Hopkins Medicine and University of Maryland BaltimoreKennedy Krieger Inst. Nursing Research
Common Rule (revised) - What You Need to KnowL
Concerns or Complaints About Research

 M

Consent - HIV TestingMaryland Advanced Research Computing Center (MARCC)
Consent - MinorsMaryland Law
Consent - Federal Reqs. to Obtain Permission from Both ParentsMonitoring Visits
 Monitors - FAQ for File Sharing
Consent - Obtaining the Permission of Both Parents: Steps to FollowMRI Language for CFs
Consent Language Requirements for Department of Defense (DoD)-Funded ResearchN
Consent - MRI Language

NIH Human Genomic Data Sharing Policy FAQs

Consent - Non-english speakersNon-Compliance with IRB Approved Human Subjects Research
Consent - Requesting an Interpreter for Research ConsentNursing Research Approval - JHH
Consent Waiver/Alteration 
Consent - Waiver of Documentation of ConsentO
Continuing ReviewOncology Research
Convened ReviewP
Coordinating Center FunctionsParticipants' Access to Study Records
Research with a Community FocusPathology Tissue/Specimen Use Committee
 Paying Research Participants - Procedures 
 Payment to Research Subjects - Elimination of VCNs
DPharmacy Bayview
Databases -  Consideration for proposed submissions to an NIH GWAS database (such as dbGaP)Pharmacy JHH
DefinitionsPhysician Consent Fact Sheet
Dept. Communications to Patients about Ongoing ResearchPMAP
Department of Defense (DoD) Requirements for the Conduct of Human Subjects Research 
Department of JusticePoint-of-Care Testing
Departmental Pre-ReviewPost-Doctoral Fellows in Human Research
DeviationsPosting of Consent Forms for Federally-Funded Clinical Trials
DevicesProtocol Deviations
DocuSignPublicly Available Data
Drugs - Section 21 Tip SheetPublic Health Surveillance Activities
Drug Research 
EQ
Electronic and Remote Consent 
Engineering Services 
Exempt ResearchR
Expedited ReviewResearch Data Subcouncil
 Research Data Management - Best Practices
 Research Requiring Home Care Services at Johns Hopkins
FResearch Requiring the Services of the Johns Hopkins Blood Bank or Bone/Tissue Bank
FDA Test ArticlesRecord Retention
FDA vs OHRP RegulationsReasonable Payment (Remuneration)
Federal Requirements to Obtain Permission from Both ParentsRecruitment Document Formatting Requirements
FeesRecruiting Study Subjects
File Sharing with Monitors 
Florida Laws - Human Subjects Research 
Obtaining the Permission of Both Parents: Steps to FollowRecruitment and Referral - Patient
Foster ChildrenRecruitment - Departmental Communications to Patients about Ongoing Research
 Recruitment of Students and Employees
GRegistration of Clinical Trials
Gadolinium for Research MRI Procedures 
Application of GCP to the Conduct of Clinical ResearchReporting Obligations Under Maryland State Law
GDRP Application in Research SettingsReporting to Institution and Government Agencies
GDPR FAQsRequesting the Use of Patient Safety HERO and SCA Data for Purposes of Research
Gene TransferRequirements for Conducting Research Funded by the United States Department of Justice
Genetics ResearchResearch with a Community Focus
GenomeWide Association Studies (GWAS)Research Protocol Management System
Genomic Data Sharing Policy FAQsResearch 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
HReview Fees
HIPAA GuidancesRevised Common Rule (What You Need to Know)
Humanitarian Use Device (HUD)Research Requiring Point-of-Care Testing at Johns Hopkins
 

Reliance:

 S
 School of Nursing Pre-Review
 School of Nursing Project Ethical Review Committee (PERC)
 School of Public Health Reciprocity Agreement - Criteria for Requests for Review
 Sedation
 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
 T
 Telemedicine and Research 
 Terminated
 Transferring Human Biospecimens to Outside Organizations
 TriNetX Databases
 UVWXYZ
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