The IRB has implemented the eIRB system. The eIRB Portal which provides access to the system. eIRB has been mandatory since August 2009 for all new submissions and all continuing reviews of approved studies. All active studies are in the eIRB system. The IRB therefore, no longer relies on paper forms. However, the IRB still requires written protocols, consent forms and several other documents
IRB Forms and Templates
This page provides a way to quickly link to the templates and forms developed by the IRB as a service to our investigators. The following groupings of templates can be linked to through this page:
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Protocol Templates:
This page includes four different protocol templates for developing a variety of different new research protocols. There are templates for Interventional, Observational, Retrospective Descriptive and Biorepository studies. There is information on the page regarding choosing the most appropriate template as a starting point - most studies require some modification or additions to the content areas in the templates.
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Consent Form Templates:
This for developing a consent form that is compliant with the regulations and is well-formatted and written at an appropriate grade level. There are also several different signature pages that can be used for less common situations (e.g. the only subjects are adults or children and parents).
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Short Form Consent Forms:
The IRB maintains a library of short form consent documents that can be used for non-English speaking subjects. These forms do not need to be submitted to the IRB.
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IRB Reliance Agreements and Determination Forms:
This page includes information about Single IRBs and IRB Reliance Agreements. There are determination forms for when CHOP or UPenn serve as the IRB of record for each other and for studies that fall under the Master Common Reliance Agreement. For studies where a Master Reliance Agreement is not in effect and CHOP will be the Reviewing IRB, CHOP's standard, single-study reliance agreement is generally the agreement that will be used as the basis for the agreement between the Relying Site and CHOP.
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Other Forms and Templates:
This page includes forms to supplement the eIRB application including, Form DCC when the CHOP PI is part of multicenter research oversight, when there is a change in PI and when requesting privileges to serve as the PI for a human subjects research protocol.
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Example Cover Letters:
Cover letters are often appropriate accompaniment to an IRB submission so that the investigator can explain which change have been made and the rationale for the changes. This page includes example cover letters for amendments and for responses to stipulations (requests for modifications), which are the submission types that most often need an expanded explanation.
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IRB Checklists:
The IRB uses reviewer checklists to ensure that research meets the regulatory requirements for approval (Subpart B and C) and for internal office purposes, so that the IRB Office staff can ensure that submissions are complete and ready for review.