In This Section      


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

Ancillary CommitteesIncidental Findings
 INDs for Products Not Marketed as Drugs
Access to Study Records - ParticipantsIND Safety Reports
Approval NoticesInformed Consent


Informed Consent - Adults Who Were Children When Enrolled in a Study

Approval Process for Research Involving Institutional Data Sets

BInformed Consent - FDA Regulated Studies
Baltimore City Health Department

Informed Consent - How to Prepare a Readable Consent Form

Biological Materials

Informed Consent - Minors

Blood or Bone/Tissue Bank

Insurance and Research Participant Financial Responsibility Information Sheet


International Research

Cancer ResearchInvestigational Medical Devices
 Investigational Product Returns from Research Participants
Case Report Publication

Investigator Brochure

Certificates of Confidentiality

Investigator Inquiry to the FDA about IND

Changes in Research

Investigator Responsibilities

Children - 

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

Clinical Engineering Services

Investigators as Study Participants

Clinical Genetics Research

Investigational Medical Devices

Clinical Research Network (CRN) 
Clinical Trials - Registration


Closed to Accrual

Johns Hopkins Clinical Research Network (CRN)

Collaborative Research and IRB Review - Johns Hopkins Medicine and University of Maryland Baltimore 
Common Rule (revised) - What You Need to Know

 JHHC Data Sharing Committee

Concerns or Complaints About Research

 JHH Nursing Research Approval

Consent - Expired 
Consent - HIV Testing


Consent - MinorsKennedy Krieger Inst. Research
Consent - Federal Reqs. to Obtain Permission from Both ParentsKennedy Krieger Inst. Nursing Research
Consent - Obtaining the Permission of Both Parents: Steps to Follow


Consent - MRI Language


Consent - Non-english speakers


Consent Waiver/AlterationMaryland Advanced Research Computing Center (MARCC)
Consent - Waiver of Documentation of Consent 
Continuing ReviewMaryland Law
Convened Review

 Monitoring Visits

Coordinating Center Functions

MRI Language for CFs

Research with a Community Focus



NIH Human Genomic Data Sharing Policy FAQs


Non-Compliance with IRB Approved Human Subjects Research


Nursing Research Approval - JHH



Dept. Communications to Patients about Ongoing Research

Oncology Research

Department of Defense (DoD) Requirements for the Conduct of Human Subjects Research 
Departmental Pre-ReviewP

Participants' Access to Study Records


Pathology Tissue/Specimen Use Committee

 Paying Research Participants - Procedures 
Drugs - Section 21 Tip SheetPayment to Research Subjects - Elimination of VCNs
Drug Research

Pharmacy Bayview


Pharmacy JHH

Engineering ServicesPhysician Consent Fact Sheet

Point-of-Care Testing

Exempt ResearchPost-Doctoral Fellows in Human Research

Posting of Consent Forms for Federally-Funded Clinical Trials

Expedited ReviewProtocol Deviations
 Publicly Available Data
 Public Health Surveillance Activities
Expired Protocols and Consent Forms



QA/QI flowchart

FDA Test Articles 
FDA vs OHRP RegulationsR
 Research Data Subcouncil
 Research Requiring the Services of the Johns Hopkins Blood Bank or Bone/Tissue Bank
Federal Requirements to Obtain Permission from Both Parents

Record Retention

FeesReasonable Payment (Remuneration)
Obtaining the Permission of Both Parents: Steps to Follow

Recruitment Document Formatting Requirements

Foster ChildrenRecruiting Study Subjects
 Recruitment and Referral - Patient
GRecruitment - Departmental Communications to Patients about Ongoing Research
Gadolinium for Research MRI ProceduresRecruitment of Students and Employees
Application of GCP to the Conduct of Clinical Research

Registration of Clinical Trials

GDRP Application in Research SettingsReporting Obligations Under Maryland State Law
GDPR FAQsReporting to Institution and Government Agencies
Gene Transfer


Requesting the Use of Patient Safety HERO and SCA Data for Purposes of Research

 Research with a Community Focus
Genetics ResearchResearch Protocol Management System

Research using the Precision Medicine Analytics Platform [PMAP]

GenomeWide Association Studies (GWAS)

Review Agreements

Genomic Data Sharing Policy FAQs

Review Fees
 Revised Common Rule (What You Need to Know)
HIPAA Guidances

Research 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


Sibley Memorial Hospital
 Sponsor IND Safety Reports
 State of Maryland Law and Consent for HIV Testing
 Suburban Hospital




Unanticipated Events Flowchart