To prepare for a submission to the IRB, the investigator must generally develop a protocol (not required for studies that meet the criteria for exemption), any relevant consent form(s), recruitment materials (written or printed in alternative media, as applicable), and complete the IRB's electronic application in eIRB. The related pages provide directions for preparing these materials.
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 may still require written protocols, consent forms and several other documents.
Webpage Sections to Assist with Preparing an IRB Submission
Investigators developing a new clinical research project should start by reviewing the information on the webpages in this section. Poorly written protocols and consent forms are probably the two leading causes for delay in IRB approval. Putting in time and effort prior to IRB submission can prevent delay in approval.
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Protocol
This section includes several pages the include discussion of the purpose of the protocol for human subjects research, a discussion of various study designs, guidance on writing a protocol and protocol templates.
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Informed Consent Forms
This section includes pages with guidance regarding the regulatory requirements for consent form, guidance for writing a readable consent form, standard language for consent forms and consent form templates;
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Scientific Review:
The CHOP Research Institute requires scientific review for all clincal research studies that involve prospective enrollment of participants. This page summarizes the requirements and provides links to the Research Institute's related pages.
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Initial Submission Types
A project may or may not involve human subjects research requiring review and approval. These pages provide guidance on how to submit to the IRB, including human subjects research that meets the criteria for exemption or requires expedited or full board review, clinical investigations involving a single human subject, research activities that are not considered human subjects research, activities preparatory to research, or grants.
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Research Requiring IRB Review and Approval:
These pages provide information and guidance related to both expedited and full board for human subjects research.
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Waivers:
A variety of waivers related to consent, assent and HIPAA authorization may be requested. There are individual pages outlining the regulatory requirements for each type of waiver including:
- Waiver or alteration of Consent
- Waiver or alteration of HIPAA Authorization
- Waiver of assent
- Waiver of documentation of consent
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Considerations for Multicenter Studies:
When CHOP serves as the Data Coordinating Center for a clinical study, there are additional issues that must be dealt with regarding the overall management of the other sites.
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IRB Timelines:
The IRB currently receives over 1,000 submissions of various types per month. This page provides information regarding the expected review times for each type of submission.
Using Microsoft Word Style Sheets
The IRB's protocol templates and consent form templates use MS Word Style Sheets to assist with formatting the documents. Style Sheets simplify the formatting of complex documents. By applying a style to a section, the font, the size, the color, the margins and the paragraph spacing are automatically selected. To ensure that the indexing of protocols is correct, apply the correct Heading Style. To ensure that consent forms are formatted correctly, apply the correct Style (e.g. Normal, Heading 2, 3 or 4, List Bullet 2) to the various sections.
For those who are not familiar with the feature, Microsoft has a tutorial that explain how to use and the create Style Sheets. In addition, there is a video tutorial (on right) that reviews how to use Style Sheets.