Forms, Tools, and Templates Related to the Revised Common Rule (required for all NEW studies submitted after January 21, 2019)
For a list of all guidelines, policies, forms, tools, and templates related to the Revised Common Rule click HERE.
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 This form may ONLY be used for projects originally approved prior to January 21, 2019 which qualified as a retrospective chart review. eFormBs may no longer be used for any new application type. New applications submitted with an eFormB will be returned and the application will not be processed until the correct forms are submitted Instead, please submit the eForm S: see description below.
- JHM IRB eFormE This form should be used for projects thought to qualify for exemption. This may include, interviews, surveys, public observations, educational tests, research conducted in normal educational settings or some behavioral interventions, if the intervention is considered to be benign. The only exception is secondary research activities. While some secondary research activities may qualify for exemption, for these projects, the eForm S should be used.
JHM IRB eFormQ This form should be used for projects thought to qualify as quality improvement projects. Applications submitted on or after 6/1/22 will be returned to use the revised eForm Q, version 3, dated 5/10/22 [Please note: Investigators must complete and upload in their eIRB application the following tool for assistance with determining whether a project is research or quality improvement, however the IRB will make the final determination: https://www.hopkinsmedicine.org/institutional_review_board/forms/QI_determination_worksheet.docx ]
JHM IRB eFormR eFormRs (used for research resource protocols) are required for all protocols designed to cover the creation or set-up of a research resource as of 01/03/2019. Common examples of research resources are a data or biospecimen repository and a recruitment database. Generally the purpose of a research resource is to help support current and future research rather than to answer any discrete research questions. If you intend to create a research resource, a separate IRB application is required for creation of the resource itself. Use this form to describe the resource you are creating, how it will be managed and how it will be accessed for future research use. eFormAs or eFormBs will no longer be acceptable for protocols designed to create a research resource.
eForm R Template: This instructional template provides guidance and template language that can be used to develop an eForm R protocol for projects that will involve creating a new research resource in the Precision Medicine Analytics Platform (PMAP) platform. The eForm R template should be downloaded from the link above. This tool serves as a guide for completing that form.
For step-by-step instructions for completing an eIRB application using an eForm R, please click HERE.
JHM IRB eFormS This form should be used for secondary research using identifiable private information and/or identifiable biospecimens. Data or samples are not required to be in existence at the time of the submission to the IRB in order to use this form. Projects involving secondary research of identifiable private information and/or identifiable biospecimens may qualify for exemption or may require expedited review. The IRB will make this determination as part of the review process. In certain cases, the identifiability of the data/biospecimens may be unclear, or may have had identifiers removed. However, this form should be used to describe all secondary research projects.
eForm S Template: This instructional template provides guidance and template language that can be used to develop an eForm S protocol for projects that will involve analysis of a data projection from an existing resource protocol [eForm R]. The eForm S template should be downloaded from the link above. This tool serves as a guide for completing that form.
eProgress Report - eIRB Continuing Review Progress Report
- JHM IRB Combined Informed Consent/HIPAA Authorization Template (December 2018, Version 16): For use when submitting new applications to be initially approved after 1/21/2019. Please click HERE for more details regarding the use of this template.
- JHM IRB Combined Informed Consent/HIPAA Authorization Template (June 2015, Version 15): ONLY for use for studies initially approved before 1/21/2019
- JHM IRB Combined Parental Informed Consent/HIPAA Authorization Template (June 2015, Version 3): ONLY for use for studies initially approved before 1/21/2019
- 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
- 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)
- Waiver of Documentation of Consent /Oral Consent 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)
High Risk Review Forms
- Johns Hopkins Infusion Center Locations Accepted by the JHM IRB for Research Infusion Activities
- Bayview CRU Template
- JHH CRU Template
- First Time PI Information Collection Form
- Information Collection Form
NCI CIRB Forms
These forms should only be used for applications where the NCI CIRB is the IRB of record
- Johns Hopkins Boilerplate for NCI CIRB Studies (Ped & Adult)
- CIRB Approval JHU Institutional Worksheet
- Instructions for adding study-specific language to CIRB consents
- NCI CIRB HIPAA Authorization
- Johns Hopkins Boilerplate for NCI CIRB Studies (Ped & Adult) *SPANISH VERSION*
- NCI CIRB HIPAA Authorization *SPANISH VERSION*
- Certification of Accuracy - Spanish Language Documents
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
- External IRB Submission Checklist – Investigators NCI CIRB Studies
- 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
- Biosafety Registration Form -
- Biosafety Registration Form -
- Biospecimen Transfer Information Form
- Checklist for Submission of CIRB documents to JHM IRB
- Certification for Translation
- De-identified Human Subject Certification
- 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 Services Form - Radiology Research Form
- Radiology Research Agreement
- Maryland Advanced Research Computing Center (MARCC) Statement of Responsibilities
- Maternal Fetal Research Committee Form
- JHCP Quality Improvement Data Collection Form
- Quality Improvement (QI) Determination Worksheet
- Radiation Form and Worksheets (RCU 5) Form (pdf)
- Radiation Dosimetry Tables
- Recruitment Ad Template
- Research Ethics Educational Activity Application
- Research Faculty Resignation Questionnaire
- Sample Data Collection Sheet
- Volunteer Program Participant Agreement