This page is intended to provide guidance for researchers on planning and setting up, and submitting research for IRB approval. This covers the considerations researchers should address to get started with a new research project at Children’s Wisconsin.

This section will help with

• Identifying the type of activity planned and getting the appropriate determinations (Is this a quality improvement activity, or human subject research requiring IRB approval and oversight, is Children’s Wisconsin engaged in the research activity).
• Considerations to address prior to submission of a project. This includes assessing feasibility, getting required approvals from CW departments and safety committees if needed, working with various CW departments to plan a research project. This includes considerations and requirements when proposing FDA regulated research, industry sponsored research, investigator initiated research and assessing any need for an IND or IDE, and special topics such as Humanitarian Use Devices and Expanded access treatment use of an investigational drug or device (compassionate use).
• The review and approval process of research to be conducted at Children’s Wisconsin, including the process of the CW local context review and what considerations are addressed during that local context review.

The Medical College of Wisconsin’s Institutional Review Boards (IRB) serve as the primary IRB for research conducted at CW. In addition, other IRBs may also serve as the IRB of record (IRBs at other institutions, commercial IRBs). However, Children’s Wisconsin maintains a Human Research Protection Program (HRPP), and its own FWA (Federal Wide Assurance), to oversee research conducted in Children's Wisconsin space or with Children's Wisconsin data. In addition to IRB approval, Children’s Wisconsin must also, as an institution, approve the research to be conducted at CW after conducting a review (local context review) to be sure that CW resources are available and able to support the research, that CW HRPP policies are followed, assess and manage any conflicts of interest, among other things.

There are a number of considerations and preparatory steps that must be taken before submitting an application for proposed research in the electronic submission system for CW HRPP and IRB approval. The submission of the application to the IRB of record should be the final step of preparing for a new research project to be conducted at Children’s Wisconsin.

These pre-submission considerations will guide what information to provide in your application, indicate the appropriate review pathway, ensure that it is feasible for the research to be conducted, and this preparation will help avoid delays in the review after submission.