Forms & Templates

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:

  • 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.

  • 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).

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Summary:

The IRB provides several protocol templates on this page. They follow the format of typical NIH and industry multicenter protocols and the Observational and Intervention templates are ICH GCP compliant. None of the templates may be perfect for a particular research study and therefore, it is expected that the investigator will adapt the template to suit their needs. The descriptive protocol is intended for simple, descriptive research studies, particularly those limited to review of existing (retrospective) medical records. Do not use this protocol for more complex studies such as cohort or case-control designs.

Summary:

The templates on this page are intended to help investigators construct documents that are as short as possible and written in plain language. The consent form (ICF) templates provided by the IRB comply with federal regulations and HIPAA. The IRB will accept and approve an ICF that differs from the templates, provided that the document contains all of the required and any applicable optional elements and it is well written. There are other webpages devoted to providing guidance for writing readable, compliant ICFs.

Summary:

The Short Form Consent process is an alternative to using a translated consent form. The process is intended for use when few non-English speaking subjects are expected or when few subjects who speak a particular language are expected (if at all). The short form consent is a document, translated into the subject's native language, that contains a description of the required elements of informed consent and notes that these elements, as they pertain to the study, will be presented orally to the subject or legally authorized representative.

Summary:

Well written cover letter that details exactly what is being submitted to the IRB can greatly assist the IRB Office and help make processing the action more efficient. This is particularly true for amendments and responses to the IRB's request for modifications. A cover letter is not usually necessary for a new protocol or for a continuing review application.

Cover letters should thoroughly explain how the investigator has addressed the IRB's concerns or explain the changes in the proposed amendment. To assist investigators in their communications with the IRB, example Cover Letters and directions for formatting a cover letter are included on this page.

Summary:

This page maintains the few paper forms still required for IRB submissions. These include Form DCC for data coordinating centers, the change in PI form and the application to serve as a PI. For all other forms, the eIRB system contains the required forms needed for submissions.

Summary:

Despite the implementation of its electronic IRB management system, the CHOP IRB still uses of checklists that are not embedded within the eIRB system. The checklists aid reviewers and IRB Office staff with several of less common or more specialized types of reviews. In addition, the IRB Office maintains checklists to ensure that the pre-review process is complete.

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