Toolbox
Billing and Budget Information
Budgeting
All research requires effort and costs. Building a proper study budget is a critical step in preparing for the conduct of research. A complete and accurate budget will give researchers a good idea of time, effort and expenses for the conduct of a research protocol. The billing plan template can be edited to fit the specific needs of nearly any protocol. Use this template to design a study budget accounting for all study events that will occur. A detailed budget also puts you in a better position to negotiate with study sponsors. Remember that for many protocols, there are both Children's Hospital charges and Medical College professional fees. Both need to be accounted for. Additional items often over looked in budgeting include:
- Start up effort.
- Ongoing regulatory effort.
- Complex procedures that often have sub-charges such as anesthesia, pathology professional fees, supply fees, etc.
- Pharmacy fees.
- Lab processing fees that are sent out.
- Long-term record retention expenses.
- Overhead charges.
Budgets for studies with Children's Hospital billable events (including those designated as routine care) must be approved by Children's Hospital Finance. Contact Patricia Stachowiak for more information.
Billing
Research billing is a critical component in the conduct of clinical research at Children's Hospital. Events that occur in the course of research, specifically for research that may not be billed to the research subjects or their insurance. If, however, a study event would happen as part of routine care for a patient regardless of their participation in the study, the event may then be billed to insurance or the patient.
Researchers also need to notify the proper billing specialists when a study subject is seen and which charges should be directed to the insurance versus the study account.
The Children's Hospital research billing contact is Barb Hodges.
Minimal Risk Order Sets for Research
Non-provider researchers are now able to place protocol specific, minimal risk, diagnostic orders on behalf of their PI. The need to place protocol directed orders for simple diagnostics like blood samples and ECGs was recognized by the CRI Clinical Research Infrastructure Task Force as an item that could be addressed and greatly aid efficient conduct of research at CHW. Working with a broad spectrum of CHW leadership we have conducted a successful pilot test project and obtained approval for the use of pre-signed order sets for research diagnostics and sampling.
Please note: These order sets may not be used to order medications of any type, nor may they be used for procedures that are above minimal risk, including those that involve radiation exposure (i.e. X-rays and CTs).
These pre-signed written orders for research set document will remove the need for a research coordinator or nurse to locate a provider to who can write an order for a simple protocol directed diagnostic test. This will also serve as the written order backing the
Order set application process
- Download Order Set Template.
- Customize with your minimal risk orders.
- List all personnel who may use the order set.
- Have PI sign the form where indicated.
- Coordinators should not sign the form until the date it is to be used with a study subject.
- Submit form to Greg Anderson in the IRB office.
- Form will be reviewed to confirm that all orders are minimal risk and appropriate for use with this process.
- Order set will be programmed into
- Once programming is complete, users will be asked to attend
- Upon completion of training approved users of the order set may begin to place orders on behalf of the PI.
- Once a subject is enrolled, the order set form can be completed with subject specific information, date, and coordinator signature.
- Researcher will then be able to access
- A written copy of the order set must be submitted to Medical Records. A copy should be kept in the researcher's study records.
Case Reports and Studies
A case report is the retrospective review of a single patient's clinical course and usually includes a literature review related to the noteworthy aspect of the case. It is the account of "an interesting person with an interesting issue or problem." A case report may provide clues in identifying a new disease or adverse health effect from an exposure. It is most likely to be used when the disease is uncommon and caused exclusively or primarily by a single kind of exposure. A case report has no hypothesis, data analysis or generalized conclusion. According to Children's Hospital of Wisconsin's administration, if you are doing a review of one case report and no identifiers are being used, it is not considered research and does not require IRB submission. If you are looking at more than one case report on the same person or subject, it is considered research.
A case study is a qualitative research method. It is the in-depth analysis, empirical inquiry or investigation of a person or group in a natural, uncontrolled setting. This research method is done from the participants' perspective and studies how they make meaning of the world, not how researchers manipulate it. Qualitative researchers study things in their natural settings, attempting to make sense of, or interpret, phenomena in terms of the meanings people bring to them.
A case study includes multiple data sources, such as interviews, documents, archival records, direct observations and physical artifacts. Analysis includes description, themes and assertions. Researchers from many disciplines (such as social/behavioral, educational or epidemiological) use this method to build upon, produce new and dispute current theory. A case study requires IRB submission.
A case series is a group of two or more case reports. A case series requires IRB submission.
Decision Charts
- Office of Human Research Protections research decision charts.
- Is my project research?
- Levels of risk.
- Children's Hospital or The Medical College of Wisconsin: Which IRB should you use?
IRBs
- BloodCenter of Wisconsin.
- Clinical Translational Science Institute/Translational Research Unit.
- The Medical College.
- Clement J. Zablocki VA Medical Center.
- Frequently asked questions.
IRBNet
Use the Children's Hospital IRBnet support line, (414) 337-7818, for all IRBnet-specific questions. All other calls should be directed to the main HRRB Office number, (414) 266-7454.
The IRB staff will assist you promptly. If we are unavailable at the time you call, leave a message and we will contact you as soon as possible. So we can better assist you, leave your IRBnet Protocol ID number or Children's Hospital IRB number, principal investigator name and contact information.
IRB offers monthly training sessions for new IRBnet users. Training sessions are held 1:30 p.m. on the last Friday of the month at Children's Corporate Center, Suite C720. Call (414) 266-7454 to reserve a space.
Tips to speed up review times:
- When you are ready for IRB to review your protocol, hit the submit button. If you see "work in progress," you have not submitted the protocol.
- Register as a Children's Hospital user, not the Medical College.
- Remember to get all needed approvals before submitting your protocol. The principal investigator must sign all new protocol packages. Full committee review protocols need signatures from the department chair, managers of all units impacted by the conduct of research and Children's Hospital financial reviewers if the study generates bills for services provided. Protocol applications that do not have all required signatures are incomplete and cannot be processed until all the required information is submitted.
- Children's Hospital support.
- IRBNet user guide *2.18.11*
- Study support for non-IRBNet users.
Shipping/handling of specimens for protocols outside Children's Hospital of Wisconsin
Shipment of hazardous materials
Federal law requires specific training for any person shipping or supervising the process of shipping or causing the shipment of biological or hazardous materials. Online training for shipment of non-infectious diagnostic samples is available through Children's University for Children's Hospital employees and on the Medical College's Angel system for non-hospital employees. Trainees must sign their certificates and forward the certificate and quiz results to Children's Research Institute for signature. Fax them to (414) 337-4925 or send to C670, Children's Corporate Center. Training is not valid without signature per federal regulations.
This training only is required for those who ship hazardous materials. Researchers not shipping diagnostic or known hazardous materials are not required to complete this training.
Shipping reference materials:
- Diagnostic specimen packing and transportation requirements.
- Transporting infectious substances safely.
If researchers are shipping known infectious materials, additional training is required. The preferred training option for shipping known infectious materials is available commercially from Saf-T-Pak.
Signatures
All protocol submissions require proper electronic signatures in IRBNet.
- Exempt or expedited: The principal investigator must sign.
- Full committee review: The PI, department chair, managers for any units or clinics supporting the conduct of the study (such as Laboratory, Pharmacy, Day Surgery or Infusion Clinic) must sign. Incomplete signatures on full committee submissions will delay the review of the protocol. Use the contact list to determine which signatures are needed for units or clinics.
Training
Children's Research Institute has established training standards for clinical research in the following areas: human research protection, biomedical ethics and shipping of hazardous materials. Incomplete training of research staff will delay approval of research projects. Please confirm training of all study staff members prior to submitting your research. See the training policy summary.
Protection of Human Subjects
The approved training program is the Collaborative Institutional Training Initiative in Human Research. Children's Research Institute and Children's Hospital IRB require completion of this program for all clinical researchers. Biomedical, social behavioral and community partner tracks all are available to accommodate the best fit for training depending on the research focus. Once initial certification is obtained, the CITI Refresher Course must be completed every two years.
Research Ethics
All new research personnel handling, recording, generating, analyzing or publishing scientific data must complete a one-time training in research ethics. The approved training for research ethics is the Responsible Conduct of Research module developed by CITI. This module focuses on data integrity, authorship, publication rights, mentoring, conflicts of interest and other ethical issues. All research personnel are required to reaffirm their understanding of these ethical standards every two years by reading and signing the Children's Research Institute Code of Ethics. Researchers who previously have completed a code of ethics are not required to complete the RCR module.
Shipment of hazardous materials
Federal law requires specific training for any person shipping or supervising the process of shipping or causing the shipment of biological or hazardous materials. Online training for shipment of non-infectious diagnostic samples is available through Children's University for Children's Hospital employees and on the Medical College's Angel system for non-hospital employees. Trainees must sign their certificates and forward the certificate and quiz results to Children's Research Institute for signature. Fax them to (414) 447-7105 or send to C745, Children's Corporate Center. Training is not valid without signature per federal regulations.
This training only is required for those who ship hazardous materials. Researchers not shipping diagnostic or known hazardous materials are not required to complete this training.
Shipping reference materials:
- Diagnostic specimen packing and transportation requirements.
- Transporting infectious substances safely.
If researchers are shipping known infectious materials, additional training is required. The preferred training option for shipping known infectious materials is available commercially from Saf-T-Pak.
Accessing Research Data after leaving CHW or MCW
If a researcher leaves Children's Hospital or the Medical College and wishes to have continued access to data that was accumulated, the researcher must complete the Limited data set user agreement. The agreements need to be submitted, along with supporting documents regarding the data, to the IRB office for review and then must be signed by Tom Twinem, Corporate Compliance.