Human Subject Research

Human Subjects Protection Training

Required Human Subjects Protection Training

All research personnel planning to conduct human subject research are required to complete Web-based training on human subject protection and good clinical practice (GCP) on the Collaborative Institutional Training Initiative (CITI) website.

Instructions and registration for the CITI Training Program are also available through the UNMC Institutional Review Board (IRB) website on their CITI pages.

Additional training in clinical research is available for trainees, faculty, health providers, and research personnel at the annual Clinical Research Symposium coordinated by the Clinical Research Center (CRC). View the schedule and registration details on the CRC's website.

Training for Clinical Coordinators

Required training

Institutional Review Board

Introduction

The UNMC Institutional Review Board (IRB) reviews all human subject protocols conducted by anyone on the premises of UNMC, Nebraska Medicine, Children’s Hospital & Medical Center, Nebraska Medicine - Bellevue, and the University of Nebraska at Omaha (UNO) or conducted by UNMC or UNO faculty or students for adequate human subjects protection. The IRB serves as a resource for questions regarding clinical research and human subject protections at UNMC. IRB review and approval is required before human study protocols can be initiated.

If research involves both adult and pediatric populations, the IRB Office assesses which IRB will review the study based on the majority population and other considerations. Nevertheless, all IRB applications, adult as well as pediatric, will be submitted electronically using the online RSS-Research Support System. For questions, contact the IRB staff.

Studies classified as exempt or expedited are reviewed either by IRB Staff or IRB members outside of a convened meeting.

Key Contacts

The Office of Regulatory Affairs (ORA) can answer questions and assist with the IRB submission process.

402-559-6463
irbora@unmc.edu

Submission and Approval

All research involving human subjects conducted on site at UNMC, Nebraska Medicine, Children’s Hospital & Medical Center, Nebraska Medicine - Bellevue or UNO, or conducted by their employees or representatives at other sites, must receive approval by a designated IRB before the research may commence. Human subject research includes all research conducted with a human subject as defined as “a living individual about whom an investigator (whether professional or student) obtains: 1) data through intervention or interaction with the individual or 2) identifiable private information.”

Research involving data or human biological materials (HBM) with subject identifiers also requires IRB application and approval. A complete listing of included and exempt research can be found in the UNMC Human Research Protection Program (HRPP) Policies and Procedures Manual, Policy #2.6.

Not all work on human specimens constitutes Human Subject Research. The NIH rules can be complex, and useful information can be found on the NIH website.

There may be exemptions to requirements for human subject research rules, but the investigator cannot make that final determination, which must be made by the IRB. Contact the IRB staff for guidance whether your project requires IRB review and approval. HRPP Policies and Procedures, Policy #2.6.

Submitting an Application

All IRB applications are submitted online using the Research Support System (RSS). Use your UNMC NetID or Nebraska Medical Center email username and password. If you are unsure of which IRB application to complete, please contact the IRB Office.

The application requires an initial review and approval of scholarly merit and resource use by an authorized department member, such as the chairperson, an authorized delegate, or appointed review committee of the PI’s department or division, prior to submission.

Instructions are in the IRB e-manual.

The IRB charges a fee for review of full board or expedited industry sponsored studies. The Commercial Fee Form can be downloaded from the IRB website.

Additional Committee Reviews

Depending upon the nature of the research, proposals may be subject to additional review and approval by one or more of the following groups before obtaining IRB approval:

Final IRB approval will not be given until SPAdmin or UNeHealth has a fully executed contract (for industry-sponsored research) and all other reviews and the institutional requirements have been met.

Additional Documents to Submit

The following documents, as applicable, should be submitted with the IRB application:

Research Involving Children or Adolescents

UNMC and Children’s Hospital & Medical Center have a Joint Pediatric IRB. Deadlines and meeting dates for the Pediatric IRB can be found on the IRB website.

Biomedical and Behavioral-Social Science studies have an adult and pediatric application. All other applications types are the same for adult and pediatric study populations. If you are unsure of which application to complete, please contact the IRB Office.

Assistance Preparing the Application

The UNMC IRB in the Office of the Vice Chancellor for Research is available to assist investigators from initial submission to study completion. If you have any questions regarding the IRB application, contact the IRB office.

The Clinical Research Center (CRC) has research personnel who can prepare your clinical trial IRB application and all forms required for submission on a fee-for-service basis. See the CRC website for information about this service.

The Pediatric Research Office (PRO) staff can prepare your clinical trial IRB application and all forms required for submission for Pediatric Studies at UNMC and Children’s Hospital & Medical Center. The PRO charges a fee for this service. For more information, please see the PRO website.

Compliance and Regulatory Requirements for Human Subject Research

The Compliance Office and Officer answer questions related to research compliance. A listing of compliance areas and responsible officers is available on the academic affairs compliance website.

Managing risks associated with potential conflicts of interest begins with establishing a culture of transparency. UNMC utilizes a Web-based system called COI-SMART to assist in the disclosure process. COI-SMART identifies potential conflicts of interest, documents them, and when necessary, establishes plans to manage the risk.

Developing a Budget

Considerations for Preparing a Budget

For studies that require a grant or contract, the Investigator or representative is responsible for generating and/or negotiating the budget with the sponsor.

Initiation costs and Personnel time for start-up

Salaries and Effort

Supplies

Travel

Other expenses

Clinical Care costs

Overall budget considerations

Who are my key contacts for questions about budgeting and sources for fee information?

What is the Clinical Trials Master Matrix/Billing Grid (CTMM)

Completion of the Clinical Trials Master Matrix/Billing Grid can assist you with budget preparation in that it sets up the budget table for the study.

A research billing “matrix” must be submitted for any study that includes clinical care conducted at Nebraska Medicine/UNMC clinics or facilities. The matrix/billing grid guides investigators through determining costs associated with a clinical trial; it is stored on a secure drive and access must be requested from the Senior Research Billing Associate.

Where do I find hospital-based charges?

Hospital-based charges can be found in One Chart, under the separate Price Inquiry tab. Instructions on using Price Inquiry can be found in the “Tips & Tricks” in the Epic modules of the Learning Center.

What requires a professional fee?

Are there fees for Children’s Hospital & Medical Center facilities and services that I need for my study?

Yes. Questions regarding clinical research fees may be directed to the Pediatric Research Office.

How can I determine if study procedures, tests, items, which are “standard of care” can be billed to Medicare/insurance?

No costs for procedures completed solely for research purposes may be billed to insurance. Medicare Qualifying Criteria are outlined in NCD 310.1 “Routine Costs of Clinical Trials.” If the study meets the qualifying criteria, routine costs and costs for diagnosis and treatment of adverse events can be billed to Medicare.

If the study does not meet the qualifying criteria, nothing can be billed to Medicare, not even routine care costs. Coverage analysis is performed to verify that research procedures listed as paid by insurance are “standard of care” and can be billed to a third party payer (either private insurance or Medicare).

Coverage analysis also compares the matrix/billing grid, informed consent document, and preliminary budget to ensure that all costs are known. This process ensures that the final study budget reflects the true cost of the research project. For additional information, see the SPA Clinical Trials Billing FAQ.

The coverage analysis makes a general judgement on insurance coverage for participation in clinical trials based on Medicare rules. When a patient is identified for potential participation in a clinical trial, insurance pre-authorization is put in place to review the patient’s insurance policy and coverage. Information on the Insurance Pre-authorization process can be found at unmc.edu/cctr/resources.

Who initiates the insurance pre-authorization process?

It is the research coordinator or study staff’s responsibility to initiate the insurance pre-authorization process with Nebraska Medicine patient financial counselors.

Coverage Analysis

Performing Coverage Analysis

Clinical Trials Analysts perform coverage analyses for drug/biologics related clinical trials. Faculty/Coordinators who have questions or would like assistance can contact the Clinical Research Manager or the Senior Clinical Trials Analyst at 402-552-7817.

Is a coverage analysis required for all industry sponsored trials?

A coverage analysis is required for all adult, full board clinical trials. It should be completed for any study involving billing of clinical care at the same time of the, trial regardless of funding. The IRB may also require coverage analysis for specific trials.

The results of the coverage analysis are shared with the IRB to determine if subjects will be placed at additional financial risk as a result of study participation.

Coverage Analysis Fees

There is a fee for coverage analyses for industry funded research. Contact the Clinical Research Manager for the fee amount.

What can be charged to the sponsor in an industry-sponsored trial?

Charge time and effort for activities, including all persons involved (investigator, coordinator, research assistants, etc.). Also include supplies needed to conduct the study. If hospital services are used you should charge for them. You can also meet directly with the manager of the CRC to discuss budgeting.