The IRB aims to provide timely and thorough reviews of all complete protocol submissions. Approval times for new projects may vary depending on the availability of reviewers, meeting dates and the need for protocol revisions. If you have questions regarding the approval status of any protocol submission, please contact the IRB office at (414) 266-7454.

*EFFECTIVE MARCH 1, 2008*

All studies MUST be submitted through IRBNET (User Guide).

Submission types

Other supporting resources

Data or Tissue Banks

• Consent for Banking

Chart/data collection

When a chart/data request is approved, it should have a two-year life span (including data analysis). All data is to be existing at the time of approval. If investigators are using prospective data, a short consent form should be developed. The principal investigator also may submit an amendment to request an extension, with an explanation of why the study should remain open at the time of continuing review.

• Checklist - Data Collection
• Categories of Expedited Review
• Chart/Data Review Form
• HIPAA Request for Privacy Board Waiver
• Preparatory Research Form

Clinical Translational Science Institute/Translational Research Unit

The Clinical Translational Science Institute's Translational Research Unit is staffed with nurses and equipped to support the conduct of various clinical research projects.

• Consent template - non-English speaking subjects.
• Consent template - phone interview.
• Consent template - short.
• Consent template - short, Spanish.
• Consent to photograph form.
• Limited data set user agreement.
• Preparatory research form.
• Radiology research study criteria.
• Research support/access request.
• Study support for non-IRBNet users.

Emergency/compassionate use

Emergency situations may arise where there is a need to use an investigational device in a manner inconsistent with the approved investigational plan or by a physician who is not part of the clinical study. Emergency use of an unapproved device may occur before an Investigational Device Exemption is approved. The compassionate use provision allows access for patients who do not meet the requirement for inclusion in the clinical investigation but for whom the treating physician believes the device may provide a benefit in treating and/or diagnosing their disease or condition. This provision typically is approved for individual patients, but also may be approved to treat a small group.

• Emergency use form.
• Emergency use process.

Exempt - Human

If the IRB chair or designee reviewer believes that a protocol should not be approved and feels any level of discomfort in his or her review, the study must be referred to the full IRB for consideration.

• Abstract template.
• Assent form template.
• Categories of exempt review.
• Chart/data review form.
• Checklist - exempt.
• Consent form template.
• Consent template - non-English speaking subjects.
• Consent template - phone interview.
• Consent template - short.
• Consent template - short, Spanish.
• Consent to photograph form.
• Database review.
• HIPAA request for privacy board waiver.
• Preparatory Research Form.
• Summary template.

Exempt - Non-human/QI or QA projects

An investigator may request a determination that an activity is non-research or non-human subjects research, but the final determination will be made by the IRB.

• Categories of exempt review, non-human.
• Checklist - non-human, Q1 or QA.

Expedited

If the study involves prisoners, it cannot be expedited and the study must be sent to full committee for review. If the IRB chair or designee reviewer believes that a protocol should not be approved and feels any level of discomfort in his or her review, the study must be referred to the full IRB for consideration.

• Abstract template.
• Assent form template.
• Categories of expedited review.
• Checklist - expedited.
• Consent form template.
• Consent template - non-English speaking subjects.
• Consent template - phone interview.
• Consent template - short.
• Consent template - short, Spanish.
• Consent to photograph form.
• Database review.
• HIPAA authorization form.
• HIPAA authorization form - Spanish.
• HIPAA request for privacy board waiver.
• Limited data set user agreement.
• Preparatory research form.
• Summary template.
• Waiver of consent form.

Full committee

The two reviewers assigned to your protocol may contact you prior to the IRB meeting date. Please return their calls or e-mails in a timely manner so any issues may be resolved prior to the meeting. Do not make any changes to your documents until after the meeting. Excerpts of the meeting and requested changes will be e-mailed to you within three days after the meeting.

• Abstract template.
• Assent form template. 
• Checklist - full committee.
• Consent form template.
• Consent template - non-English speaking subjects.
• Consent template - phone interview.
• Consent template - short.
• Consent template - short, Spanish.
• Consent to photograph form.
• HIPAA authorization form.
• HIPAA authorization form - Spanish.
• HIPAA request for privacy board waiver.
• Limited data set user agreement.
• Preparatory research form.
• Radiology research study criteria.
• Research support/access request.
• Study support for non-IRBNet users.
• Summary template.
• Waiver of consent form.

HDE/HUD

If you are collecting data, this may be considered research and the full committee checklist for research should be used.

• Abstract template.
• Assent form template.
• Checklist - HDE/HUD.
• Consent form template.
• HIPAA authorization form.
• HIPAA authorization form - Spanish.
• HIPAA request for privacy board waiver.
• Summary template.

National Cancer IRB

National Cancer IRB protocols may take up to two weeks for review. If there are any major concerns, the study will be brought to full committee. The IRB Office will link the primary reviews from NCIRB to your submission. The investigator is responsible for submitting any amendments, continuing reviews, on-site SAE reports and termination notices to the IRB Office.

• Abstract template.
• Assent form template.
• Checklist - NCIRB.
• Consent template - non-English speaking subjects.
• Consent template - phone interview.
• Consent template - short.
• Consent template - short, Spanish.
• Consent form template.
• Consent to photograph form.
• HIPAA authorization form.
• HIPAA authorization form - Spanish.
• Limited data set user agreement.
• Preparatory research form.
• Radiology research study criteria.
• Research support/access request.
• Study support for non-IRBNet users.
• Summary template. 

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 templatecan 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 Patty Longhurst.

Decision charts

• Is this research?
• OHRP Research decision charts.
• Levels of risk.
• Should you submit your study to Children's Hospital or The Medical College of Wisconsin?

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 a Medical College user.
• 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 considered to be incomplete and cannot be processed until all the required information is present.
  
• Children's Hospital support.
• IRBNet user guide.
• Study support for non-IRBNet users.

Principal investigator

Only the following individuals may serve as the principal investigator in the conduct of clinical research at Children's Hospital and its affiliates:

• Children's Hospital affiliates.
• Medical Staff member in good standing.
• Children's Hospital affiliate employee.
• Children's Research Institute investigator.

If a study requires patient care tests, procedures or medications and is conducted at a Children's Hospital affiliate site, a member of the Medical Staff or employee of a Children's Hospital affiliate must serve as PI for the study. Non-Medical/Dental Staff members who are approved by Children's Research Institute may independently serve as PI on studies that do not involve medical or surgical tests, procedures or medications. Students, residents and fellows must have a Children's Hospital Medical Staff member, Children's Hospital and Health System employee or Children's Research Institute investigator listed on the study team.

PI responsibilities:

• Conduct investigation with the protocol, FDA regulations and IRB conditions.
• Make changes in investigation only with appropriate sponsor and IRB approval except where immediate intervention is required to protect subjects.
• Ensure informed consent requirements are met for all subjects, including those used as controls.
• Report adverse events.
• Keep current records.
• Personally conduct and/or supervise investigation.
• Read and understand investigator's brochure.
• Ensure that an IRB reviews and approves the study initially and on a continuing basis.

Signatures

All protocol submissions require proper signatures in IRBNet.

• Exempt or expedited: The PI 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.

Support services

• Translation services.

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.

• Code of ethics.

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) 337-7105 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.

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/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 almost exclusively by a single kind of exposure. A case report has no hypothesis, data analysis or generalizable conclusion. Children's Hospital administration has decided that if you are doing a review of one case report and there are no identifiers being used, then 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 to 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 is through 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.

Reopening a closed study

• If the study is expedited or just being reopened to data analysis only, then a letter of explanation of why the study should be reopened should be submitted along with any revised documents.
• If a full committee study is being reopened to enrollment, a letter of explanation and the entire protocol needs to go back to full committee for review.
• If you are resubmitting due to the continuing review not being submitted, then a Continuing Review Form also needs to be completed.
• If the study originally was in paper format, you must submit on IRBNet along with a new Registration Page (using the IRBNet Wizard). We then pull the old file from the warehouse and scan in any old documents.