Preparation for Study Submission

To prepare for a submission to the IRB, the investigator must develop a protocol, any relevant consent form(s), recruitment materials (written or printed in alternative media), 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 still requires 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.

  • 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.

  • 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;

  • 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.

  • Submissions for a Determination:

    Not all of the submissions to the IRB involve human subjects research requiring review and approval. These ages provide guidance related to those research activities that are not considered human subjects, human subjects research that is exempt from the regulations and activities preparatory to research.

  • Research Requiring IRB and Approval:

    These pages provide information and guidance related to both expedited and full board for human subjects research.

  • 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
  • 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.

  • IRB Timelines:

    The IRB currently receives over 800 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.

Summary:

The IRB must make a number of determinations in order to ensure that the study meets all of the regulatory requirements for approval. The protocol serves many purposes, one of which is to provide the IRB with the necessary information to assure that the study will follow principles of sound scientific design and that the research will be conducted in accordance with federal regulations, state law and CHOP IRB and CHOP Research Institute policies. T

Summary:

This section of the IRB's website provides guidance for investigators preparing consent documents. The IRB provides template consent documents but any format that is both readable and understandable is acceptable. For example, if the sponsor provides a template consent form, it can be used as the basis for the CHOP informed consent form (ICF). However, the IRB cannot approve a consent document that is not written in readable, understandable language or formatted in an approachable style.

Summary:

Scientific review of protocols is required by the CHOP Research Institute. The Office of Clinical and Translational Research is responsible for this initiative. For more information go to the Scientific Review of Protocols page for the office of Clinical and Translational Research.

Summary:

The IRB not only reviews and approves human subjects research subject to the federal regulations, it also review several other types of applications for activities that do not require IRB approval. While not approving these activities, the IRB does acknowledge that they agree with the investigator's determination that the research does not require IRB review and approval.

Summary:

All new protocols must use the electronic submission process in the eIRB module of eResearch. Investigators benefit from the elimination of all paper documents, the automatic routing of protocols to ancillary committees, the ability to follow the status of each submission as it moves through the approval process and the storage and tracking of all documents.

Summary:

Waivers are frequently requested but are amongst the least well understood topics. Investigators may request a complete waiver or an alteration for the requirements for consent, documentation of consent, assent or written authorization (HIPAA).

Summary:

In a multicenter research study, the an individual or group of individuals charged with study oversight, coordination and overall conduct need to be identified. Those responsible could be simply the study Principal Investigator or there could be a more formal study Steering Committee or Data Coordinating Center (DCC). In addition, oversight may be the responsibility of a single entity or divided between multiple organizations. For industry sponsored studies the study sponsor or their designated CRO(s) (contract research organization) are required by the FDA to provide trial oversight.

Summary:

Submissions that require full Board review are scheduled for the next available IRB Meeting Agenda. Each Committee meets monthly. If your submission requires full Board review, you will be notified in eIRB when the submission is scheduled. Most submissiosn to the IRB do not require full Board review.

Top