In This Section      
 

Guidelines

** List of Guidelines and Policies updated during the 2016 AAHRPP reaccreditation process **

AI
Ancillary CommitteesIncidental Findings
 INDs for Products Not Marketed as Drugs
Access to Study Records - ParticipantsIND Safety Reports
Approval NoticesInformed Consent
Apps - Research Involving Apps and SoftwareInformed Consent - Adults Who Were Children When Enrolled in a Study
Apps - APPs in the Research Setting - A Checklist for ResearchersInformed Consent - FDA Regulated Studies
Approval Process for Research Involving Institutional Data SetsInformed Consent - Minors
BInsurance and Research Participant Financial Responsibility Information Sheet
Baltimore City Health DepartmentInternational Research
 Interpreter for Research Consent - Online Instructions
Biological MaterialsInvestigational Medical Devices
Blood or Bone/Tissue BankInvestigational Product Returns from Research Participants
CInvestigator Brochure
Cancer ResearchInvestigator Inquiry to the FDA about IND
 Investigator Responsibilities
Case Report PublicationInvestigators as Study Participants
Certificates of ConfidentialityInvestigational Medical Devices
Changes in ResearchJ
Children - 

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

Johns Hopkins Clinical Research Network (CRN)
Clinical Engineering ServicesJHHC Data Sharing Committee
Clinical Genetics ResearchJHH Nursing Research Approval
Clinical Research Network (CRN)K
Clinical Trials - RegistrationKennedy Krieger Inst. Research
Closed to AccrualKennedy Krieger Inst. Nursing Research
Collaborative Research and IRB Review - Johns Hopkins Medicine and University of Maryland BaltimoreL
Common Rule (revised) - What You Need to Know

 M

Concerns or Complaints About ResearchMaryland Advanced Research Computing Center (MARCC)
Consent - ExpiredMaryland Law
Consent - HIV TestingMonitoring Visits
Consent - MinorsMRI Language for CFs
Consent - Federal Reqs. to Obtain Permission from Both ParentsN
Consent - Obtaining the Permission of Both Parents: Steps to Follow

NIH Human Genomic Data Sharing Policy FAQs

Consent - MRI LanguageNon-Compliance with IRB Approved Human Subjects Research
Consent - Non-english speakersNursing Research Approval - JHH
Consent - Requesting an Interpreter for Research Consent 
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
 Pharmacy JHH
DefinitionsPhysician Consent Fact Sheet
Dept. Communications to Patients about Ongoing ResearchPMAP
Department of Defense (DoD) Requirements for the Conduct of Human Subjects ResearchPoint-of-Care Testing
Departmental Pre-ReviewPost-Doctoral Fellows in Human Research
DeviationsPosting of Consent Forms for Federally-Funded Clinical Trials
DevicesProtocol Deviations
 Publicly Available Data
Drugs - Section 21 Tip SheetPublic Health Surveillance Activities
Drug Research 
EQ
Engineering ServicesQA/QI flowchart
Exempt Research 
Expedited ReviewR
Expired Protocols and Consent FormsResearch Data Subcouncil
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
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 ProceduresReporting Obligations Under Maryland State Law
Application of GCP to the Conduct of Clinical ResearchReporting to Institution and Government Agencies
GDRP Application in Research SettingsRequesting the Use of Patient Safety HERO and SCA Data for Purposes of Research
GDPR FAQsResearch with a Community Focus
Gene TransferResearch Protocol Management System
Genetics ResearchResearch using the Precision Medicine Analytics Platform [PMAP]
GenomeWide Association Studies (GWAS)Review Agreements
Genomic Data Sharing Policy FAQsReview Fees
HRevised Common Rule (What You Need to Know)
HIPAA GuidancesResearch Requiring Point-of-Care Testing at Johns Hopkins
Humanitarian Use Device (HUD)S
 School of Nursing Pre-Review
 School of Public Health Reciprocity Agreement - Criteria for Requests for Review
 Sedation
 Self-experimentation
 Sibley Memorial Hospital
 Sponsor IND Safety Reports
 State of Maryland Law and Consent for HIV Testing
 Suburban Hospital
 T
 Terminated
 Transferring Human Biospecimens to Outside Organizations
  
 U

 

Unanticipated Events Flowchart

 

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