JHM IRB Forms

Changes in Research Application - No longer available. Use eIRB Change in Research to submit.

JHM IRB eFormA-Protocol  - For eIRB studies ONLY

Form A  - No longer available. Use eFormA in eIRB to submit a revised Form A.

Combined Informed Consent/Authorization Template(.rtf version)
For new research applications and changes in research use this template. Submissions not on this template will be returned.
For continuing review applications without changes:  Consent forms should not be submitted to the IRB.
Changes made to the template on 6/07/11

Johns Hopkins CIRB HIPAA Authorization/Consent Form Addendum 

Sample Research Assent Form for Children (.rtf version)

Oral Consent Form Script(.rtf version)

Oral Assent Form Script

Telephone Screening Script (.rtf version)

Short Form Consent for participants who do not speak English

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)

RF1 - Unanticipated Problem/Event Report Form
For paper studies; in eIRB use Problem/Event Report

RF2- Report of Death of a JHM Research Participant
For paper studies; in eIRB use Problem/Event Report

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.)

RF5 - IND Safety Report Transmission Report
(For paper studies only; list IND Safety Reports that the sponsor requires you to submit to the JHM IRBs.)

Biosafety Registration Form - Human tissue, infectious agents, pathogens, oncogens, or toxins

Biosafety Registration Form - Recombinant DNA (gene transfer or vaccine) component

Checklist for Submission of CIRB documents to JHM IRB

Certification for Translation

Investigational Drug Data Sheet (DDS)

Investigational New Drug Application

JHCP - Research Application Form

JHH - Research for Appproval of Nursing Research

JHH Imaging Form - Radiology Research Policy Document

Maternal Fetal Research Committee Form

Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption-(Optional Form 310)

Radiation Dosimetry Tables

Research Ethics Educational Activity Application

SKCCC CRO Checklist for New Protocol Submissions to JHM IRB (for cancer studies only)

Termination Report Form