Preparing an IRB Submission | CHOP Research Institute
 

Preparing an IRB Submission

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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 eIRB Portal provides access to the IRB’s electronic submission system. 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.

Resources to Assist with Preparing an IRB Submission

Tools to determine if a proposed activity meets the human subjects research definition.

Initial submission types in the CHOP electronic IRB submission system.

Guidance on when a protocol is needed and how to design and write one.

Guidance for investigators preparing consent documents.

When does HIPAA apply and what needs to be in a HIPAA authorization.

Regulatory requirements for assent and how it should be documented.

Requirements for scientific review at CHOP.

Requirement for approval by department/division before research studies can be processed by the IRB ...

 

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.