Guidelines
A
- Ancillary Committees
- Access to Patient Data for Research: Frequently Asked Questions
- Access to Study Records - Participants
- Approval Notices
- Apps - Research Involving Apps and Software
- Apps - APPs in the Research Setting - A Checklist for Researchers
- Apps - JHU Guidance Regarding Security of Custom Developed Mobile and Web Applications
- Approval Process for Research Involving Institutional Data Sets
B
- Baltimore City Health Department
- Biospecimen Transfer Requests - Umbrella Protocols
- Biospecimens - Transferring to Outside Organizations
- Biospecimens - Frequently Asked Questions Related to Biospecimen Transfer Committee (BTC) Review
- Blood or Bone/Tissue Bank
C
- Cancer Research
- Case Report Publication
- Certificates of Confidentiality
- Changes in Research
- Changes in Research - Study Team Member Only
- Compliance with JHU’s Policy on Safety of Children in University Programs
- Clinical Engineering Services
- Clinical Genetics Research
- Clinical Research Network (CRN)
- Clinical Trials - Registration
- Closed to Accrual
- Collaborative Research and IRB Review - Johns Hopkins Medicine and University of Maryland Baltimore
- Common Rule (revised) - What You Need to Know
- Concerns or Complaints About Research
- Consent - HIV Testing
- Consent - Minors
- Consent - Federal Reqs. to Obtain Permission from Both Parents
- Consent - Obtaining the Permission of Both Parents: Steps to Follow
- Consent Language Requirements for Department of Defense (DoD)-Funded Research
- Consent - MRI Language
- Consent - Non-english speakers
- Consent - Requesting an Interpreter for Research Consent
- Consent Waiver/Alteration
- Consent - Waiver of Documentation of Consent
- Continuing Review
- Convened Review
- Coordinating Center Functions
- Research with a Community Focus
D
- Databases - Consideration for proposed submissions to an NIH GWAS database (such as dbGaP)
-
Data Sharing Tiers for Broad Sharing of Clinically Derived Data
- Data Trust - Genomic Data Risk Tiers
- Data Trust - Levels of Identification of Data
- Decentralized Clinical Trials (DCTs) FAQs
- Definitions
- Dept. Communications to Patients about Ongoing Research
- Department of Defense (DoD) Requirements for the Conduct of Human Subjects Research
- Department of Justice
- Departmental Pre-Review
- Deviations
- Devices
- DocuSign
- Drugs - Section 21 Tip Sheet
- Drug Research
E
- Electronic and Remote Consent
- Emergency Preparedness Plan
- Engineering Services
- Exempt Research
- Expedited Review
F
- FDA Test Articles
- FDA vs OHRP Regulations
- Federal Requirements to Obtain Permission from Both Parents
- Fees
- File Sharing with Monitors
- Florida Laws - Human Subjects Research
- Foster Children
- Fraud Prevention Regarding Use of Survey Instruments
G
- Gadolinium for Research MRI Procedures
- Application of GCP to the Conduct of Clinical Research
- GDRP Application in Research Settings
- GDPR FAQs
- Gene Transfer
- Genetics Research
- GenomeWide Association Studies (GWAS)
- Genomic Data Risk Tiers
- Genomic Data Sharing Policy FAQs
- Consideration for proposed submissions to an NIH GWAS database (such as dbGaP)
H
I
- Incidental Findings
- Inclusion of a JHSCS Facility as a Study Site in JHM IRB Approved Research
- INDs for Products Not Marketed as Drugs
- INDs/IDEs - Requirements for JHU Investigator-Held
- IND Safety Reports
- Informed Consent
- Informed Consent - Adults Who Were Children When Enrolled in a Study
- Informed Consent - FDA Regulated Studies
- Informed Consent - Minors
- Instructions for Requesting Interpretation Services through Language Access Services
- Insurance and Research Participant Financial Responsibility Information Sheet
- International Research
- Investigational Medical Devices
- Investigational Product Returns from Research Participants
- Investigator Brochure
- Investigator Inquiry to the FDA about IND
- Investigator Responsibilities
- Investigators as Study Participants
- Inventors Whose Intellectual Property (IP) is Licensed to Startups
J
- Johns Hopkins Clinical Research Network (CRN)
- Johns Hopkins Health Plans Data Sharing Committee
- JHHCG - Research Requiring Home Care Services at Johns Hopkins
- JHH Nursing Research Approval
- Johns Hopkins Surgery Centers Series (JHSCS) as a study site for JHM IRB Approved Research
K
M
- Maryland Advanced Research Computing Center (MARCC)
- Maryland Law
- Monitoring Visits
- Monitors - FAQ for File Sharing
- MRI Language for CFs
N
- NIH Human Genomic Data Sharing Policy FAQs
- Non-Compliance with IRB Approved Human Subjects Research
- Nursing Research Approval - JHH
O
P
- Participants' Access to Study Records
- Pathology Tissue/Specimen Use Committee
- Paying Research Participants - Procedures
- Payment to Research Subjects - Elimination of VCNs
- Pharmacy Bayview
- Physician Consent Fact Sheet
- PMAP
- Point-of-Care Testing
- Post-Doctoral Fellows in Human Research
- Posting of Consent Forms for Federally-Funded Clinical Trials
- Protocol Deviations
- Publicly Available Data
- Public Health Surveillance Activities
R
- Research Data Subcouncil
- Research Data Management - Best Practices
- Research Requiring Home Care Services at Johns Hopkins
- Research Requiring the Services of the Johns Hopkins Blood Bank or Bone/Tissue Bank
- Record Retention
- Reasonable Payment (Remuneration)
- Recruitment Document Formatting Requirements
- Recruiting Study Subjects
- Recruitment and Referral - Patient
- Recruitment - Departmental Communications to Patients about Ongoing Research
- Recruitment of Students and Employees
- Registration of Clinical Trials
- Reporting Obligations Under Maryland State Law
- Reporting to Institution and Government Agencies
- Requesting the Use of Patient Safety HERO and SCA Data for Purposes of Research
- Requirements for Conducting Research Funded by the United States Department of Justice
- Research with a Community Focus
- Research Protocol Management System
- Research using the Precision Medicine Analytics Platform [PMAP]
- Research Using Social Media Data with No Participant Interaction
- Review Agreements
- Review Fees
- Revised Common Rule (What You Need to Know)
- 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
- Sponsor Contracted Third-Party Collaborators
- Sponsor IND Safety Reports
- State of Maryland Law and Consent for HIV Testing
- Student Education Records in Research (JHU)
- Study Team Member Only Change in Research FAQs
- Submitting Formative/Pre-Clinical/Pilot Research Activities to the JHU IRBs
- What Must Investigators Submit to the JHU IRBs?