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School of Medicine
JHM IRB Forms
Forms, Tools, and Templates Related to the Revised Common Rule
- JHM IRB Combined Informed Consent/HIPAA Authorization Template (December 2018, Version 16) - For use when submitting new applications on or after 12/15/2018. Please click HERE for more details regarding the use of this new template.
- Key Information Guidance - This guidance is designed to assist researchers in addressing the new Revised Common Rule requirement that “Key Information” be presented first.
- Informed Consent General Guidance - Please refer to this guidance for general information and instructions for preparing the JHM IRB Combined Informed Consent/HIPAA Authorization document.
- MRI language - If your study includes research imaging in an MRI scanner, the language options outlined in this document should be included in the consent form.
- Biospecimen testing language - If your study includes gene sequencing, creation of cell lines, genome/exome sequencing, or creation of pluripotent stem cells please use the suggested language in this document in your consent form.
All new research applications, including exempt applications, must be submitted to the JHM IRB for review through eIRB. eIRB is an informatics tool that supports electronic, on-line submission of applications to the Johns Hopkins Medicine IRBs.
- JHM IRB eFormA-Protocol - For eIRB studies ONLY
- JHM IRB eFormB eFormBs (used for retrospective chart reviews only) are required to be on the revised eFormB as of January 15, 2016. eFormBs not on the new template that are received after January 15, 2016 will be returned and the application will not be processed until the correct forms are submitted.
- Data Security Checklist
- Data Security Profile
- eProgress Report - eIRB Continuing Review Progress Report
- Changes in Research Application - No longer available. Use eIRB Change in Research to submit.
- Continuing Review Application - No longer available. Use eIRB Continuing Review Application to submit.
- Form A - No longer available. Use eFormA in eIRB to submit a revised Form A.
- Research Determination Worksheet - We no longer accept Research Determination Worksheets in order to issue official IRB determinations. For Not Human Subjects Research (NHSR) projects, submission to the IRB is voluntary; if you would like documentation of an IRB determination of NHSR, submit an eIRB application checking "NHSR" at Screen 1, Question 6. For exempt projects, submission to the IRB is required; submit an eIRB application checking "Exempt" at Screen 1, Question 6.
- Combined Informed Consent/Authorization Template NOTE: Continuing reviews do not require submission of consent form(s) and do not require the transfer of the approved consent form(s) to the Version 15 Informed Consent Template. For more information on the changes in Version 15...
- Combined Parental Informed Consent/Authorization Template Use when ALL study participants are under 18 years of age and parent(s)/guardian(s) consent is required
- Compassionate/Emergency Use Informed Consent/Authorization
- Consent for Continued Participation in a Research Study By a Participant Who has Reached Age 18
- Documentation of Physician Consent
- Johns Hopkins CIRB Pediatric Consent Form Template
- Johns Hopkins CIRB Adult Consent Form Template
- Genomic Data Sharing/Genome-Wide Association Studies (GWAS) Consent Language
- Humanitarian Use Device (HUD) Consent/Authorization Template NOTE: This form is designed to serve as an informed consent template for off-label clinical uses of HUDs (i.e. in a manner inconsistent with their FDA-approved indications as detailed in Humanitarian Device Exemption (HDE) issuance documentation). Consent for uses of HUDs for their FDA-approved indications should be obtained using a clinical consent form, which does not need to be submitted to or approved by the IRB.
- Human Pluripotent Stem Cell Research consent form template
- Sample Research Assent Form for Children (.rtf version)
- Oral Consent Form Script
- Oral Assent Form Script
- Telephone Screening Script
- Short Form Consent for participants who do not speak English
- Johns Hopkins/King Khaled Eye Specialist Hospital Informed Consent Template
- National Institute on Drug Abuse (NIDA) Consent (Not available; use either the JHM IRB consent or available from NIDA)
- Singapore HIPAA - Combined Informed Consent/Authorization (Use the template provided by the local Singapore site)
Problem/Event Report Form
- RF3 - Event Report Summary Sheet
Attach to the Continuing Review Application to summarize anticipated problems/events or Submit if sponsor requires adverse event reporting that does not meet JHM IRB requirements
- RF4 - Protocol Deviation Summary Sheet
(Attach to the Continuing Review application to summarize administrative and minor departures from protocol.)
- External IRB Submission Checklist – Investigators
- Addition of Relying Site Process and Workflow
- FWA Information Sheet
- JHM Consent Language
- Statement of PI Responsibilities when Relying on an External IRB
- Sample Local Context Application
- Relying Sites List
- Biosafety Registration Form -
- Biosafety Registration Form -
- Biospecimen Transfer Information Sheet
- Checklist for Submission of CIRB documents to JHM IRB
- Certification for Translation
- GWAS/Genomic Data Sharing Form
- HIV+ to HIV+ Transplant Under the HOPE Act Checklist for Investigators and IRB Review
- Investigational Drug Data Sheet (DDS) Please note that a separate IDDS must now be submitted for each site (HCGH, Sibley Memorial, Suburban, JHBMC) at which the IND will be dispensed.
- Investigational New Drug Application
- JHHC Data Request Application
- JHHS - Request for Approval of Nursing Research
- JHH Imaging Form - Radiology Research Policy Document
- Radiology Research Agreement
- Maternal Fetal Research Committee Form
- Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption-(Optional Form 310)
- Quality Improvement Data Collection Form
- Radiation Form and Worksheets (RCU 5) Form (pdf)
- Radiation Dosimetry Tables
- Recruitment Ad Template
- Research Ethics Educational Activity Application
- Research Faculty Resignation Questionnaire
- Maryland Advanced Research Computing Center (MARCC) Statement of Responsibilities
- Verification of Confidential Nature (VCN) form (this is a form found on the JH Shared Services website)