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RTF | Word
DOC | Adobe
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New Application Forms |
New Human Subject Research and Exempt Applications - Not available After September 1, 2005
Submit applications electronically on eIRB at : http://irb.jhmi.edu/eIRB/ |
| eFormA (Protocol) For eIRB studies ONLY | 06/2007 | |  | |
| Research Determination Worksheet | 07/2007 | |
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| Change in Research Forms (Amendment) |
Changes in Research Application | 12/2006 | |
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| Form A (Protocol) Paper studies ONLY
(Submit with Changes in Research Application when making changes to the protocol. | 01/2006 |
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Consent Forms |
Combined Informed Consent/Authorization Template
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. The IRB will reissue the existing consent form with a new expiration date. The consent form does not need to be moved to the new template. | 10/2007 |
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Humanitarian Use Device (HUD) Informed Consent and Privacy Authorization | 04/2006 | | | |
Sample Research Assent Form for Children
Click here for more information on Assent Form | 04/2004 |
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Oral Consent Form Script | 07/2007 |
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| Oral Assent Form Script | 07/2007 | | | |
| 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) | | | | |
Continuing Review Forms |
Continuing Review Application
If changes are being made at the time of continuing review, a Changes in Research Application should be submitted along with the Continuing Review Application. | 05/2007 |
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Problem/Event Report Forms/Summary Sheets | | | | |
RF1 | Unanticipated Problem/Event Report Form
For paper studies; in eIRB use Problem/Event Report | 07/2007 | | | |
| RF2 | Report of Death of a JHM Research Participant
For paper studies; in eIRB use Problem/Event Report | 07/2007 | | | |
| RF3 | Event Report Summary Sheet | 07/2007 | | | |
| RF4 | Protocol Deviation Summary Sheet
(Attach to the Continuing Review application to summarize administrative and minor departures from protocol.) | 07/2007 | | | |
| 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.) | 07/2007 | |
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| Additional Forms |
| FDA 1571 and FDA 1572 | Expires
05/31/09 | |
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Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption-(Optional Form 310) | Expires
11/30/08 | | | |
| Checklist for Submission of CIRB documents to JHM IRB | 04/2005 | |
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| Certification for Translation | 07/2005 | |
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Investigational Drug Data Sheet (DDS) | 05/2007 | |
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Biosafety Registration Form - Human tissue, infectious agents, pathogens, oncogens, or toxins | 05/2006 | | | 
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Biosafety Registration Form - Recombinant DNA (gene transfer or vaccine) component | 05/2006 | | |
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| JHCP - Research Application Form | 10/2007 | |
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| JHH - Research for Appproval of Nursing Research | 09/2005 | |
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JHH Imaging Form - Radiology Research Policy Document | | | | |
Maternal Fetal Research Committee Form | | | | |
Radiation Form and Worksheets
(RCU 5) Form | 10/2007 | | |
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| Radiation Dosimetry Tables | 07/1994 | | |
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SKCCC CRO Checklist for New Protocol Submissions to JHM IRB
(for cancer studies only) | 02/2004 | | | |
Termination Report Form | 04/2007 | |
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