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.
- Investigator Manual - This manual is intended to provide investigators planning to do research at Children’s Wisconsin with important information and guidelines about considerations when planning the research and steps to be taken prior to submitting your project for IRB approval.
This manual also covers guidelines and information related to the ongoing conduct of research at Children’s Wisconsin. Investigators should also be familiar with and refer to Children’s Wisconsin SOP manual which outlines federal regulatory, local, and institutional requirements to be followed when conducting research at Children’s Wisconsin
- Children’s Wisconsin HRPP SOP Manual
- Children’s Wisconsin Policy – Conduct of Research on Human Subjects at Children’s Hospital and Health System
- Pre-Submission Checklist – This is a tool for investigators that includes considerations and steps to take when assessing feasibility prior to submitting the proposed research. Use of this tool will help to ensure an efficient and timely Local Context and IRB review process.
- Policy: Conduct of Research on Human Subjects at Children’s Hospital and Health System
- Children’s Wisconsin HRPP SOP Manual – Section 23
- FDA Investigator Responsibilities – For PIs of FDA Regulated Research
- Guidance: Multi-site Research and Investigator Responsibilities - Review for considerations when an investigator is not a Children's Wisconsin provider.
- Children's Wisconsin departmental sign offs
- Form: CW Research Resources Request – Some departments utilize the online REDCap CW Research Resources Request Form to assess their ability to support a research activity and provide approval. The request only needs to be filled out once even if services of more than one department are needed. The form will be auto routed to the appropriate areas for review and approval.
- Guidance: CW Departmental Sign Off – Departmental approval from departments that currently do not use the CW Research Resources Request process.
- Safety Committee approvals are needed when a research project includes radiation through imaging, radiation administration, or MRI imaging for research purposes. This may include MCW safety committee approvals as well as CW safety committee approvals.
- In same cases involving radiation approval from the Wisconsin Department of Health and Human Services is also needed.
- When MRIs for the research are being done OUTSIDE CW hospital space, an MRI safety form will need to be included with the submission.
- When a Children's Wisconsin Research Resources request for Imaging is submitted, the imaging manager will assist in navigating this. The CW HRPP office is also available to assist.
- MRI Safety and Plan for MRI Research Outside of Children's Wisconsin
- Guidance: Safety Committee
- Guidance: Imaging in Research at Children's Wisconsin
- Guidance: Radiation and Imaging in Research at Children's Wisconsin Flowchart
- Appendix M Variance (for State of WI Approval)
- Guidance: Children's Research – Record Retention Policy for Human Subjects
- Request to Access PHI for Prep to Research
- Data Analytics and Tools
Acceptable Storage for Children's data (PHI):
- Children's or Medical College of Wisconsin shared drives (intranet)
- Children's Box
- REDCap
- Florence eBinders - OnCore
- Encrypted laptop
- Encrypted flash drive
PHI cannot be stored in cloud services. Potentially coded or de-identified data could be stored in a cloud service. Children's Corporate Compliance reviews data storage plans for new submissions. Reach out to Children's Corporate Compliance for questions or if the plan includes a platform that is not on this list.
- OHRP Guidance: Information on Special Protections for Children as Research Subjects
- Guidance: Obtaining and Documenting Assent for Research at Children’s Wisconsin
- FDA Subpart D – Additional Safeguards for Children in Clinical Investigations
- If minor subjects will reach the age of majority while still participating in the research (this includes collection or use/analysis of identifiable data), a plan for obtaining and documenting consent of these subjects when they turn 18 is required in the submission.