New Investigator Toolkit

Write out and organize your research plan. You will need to have a clear design outlined before you will be ready to submit your application to the IRB. The following information is essential for completion of the application. ALL INVESTIGATORS should be prepared to provide this information:

• Background and Introduction. Identify the research area being studied and provide a review of the literature that provides the basis for understanding the objectives of the study. This review should be written such that scientists outside the investigator's area of expertise can understand the issues involved. Any information about previous research related to this study involving animals and/or humans should be summarized. Include studies on pregnant animals if the research is conducted on pregnant women, fetuses, or neonates.
• Objectives. The objectives should be stated in such a way that the reader can determine the appropriateness of the study design below. If appropriate, state the specific hypotheses being tested and/or study aims.
• Participant Selection Criteria. Participant-entry criteria should be as detailed as necessary to define the patient population under study and, for clinical studies, to reduce confounding treatments or diseases. Precise criteria for age, gender, or any other factors (e.g., in a clinical study: diagnoses, extremes in signs or symptoms, etc.) should be included. Specific exclusion criteria should be listed which could interfere with the study or which place participants at risk during the study.
• Design. A simple statement of the design methodology proposed to test your hypothesis(es) should be included. Randomization and control methods should be stated. Of primary importance is clearly showing how the trial design will collect the study data and lead to the analysis and interpretation proposed. Any interim analysis or criteria for stopping a clinical trial should be stated. For studies not proposing experimental design include detail about the scientific methods to be employed.
• Study Procedures. This section of the protocol should state both the chronological flow of the study and the procedures/activities that the participants must undergo. The investigational activities, treatments, or procedures must be clearly detailed as to how and when they will be performed. For clinical studies, a distinction should be made between the procedures for treatment evaluation versus procedures for safety evaluation. Treatment endpoints must be defined as well as interim procedures for dealing with adverse events. Schematic diagrams may be helpful for understanding the flow of a study.
  • Standard of Care vs. Research-Related Procedures. If applicable, please separate and explain what proposed procedures for this study are considered standard of care and which ones are strictly research-related.
  • Data and Safety Monitoring Plans. The information provided to the IRB should describe the process and mechanisms in place for assuring 1) the oversight of data integrity, and/or 2) the safety of research participants.
• Statistical Methods, Data Analysis, and Interpretation. The anticipated methods to be used for analysis and interpretation of the data should be stated. Naturally, these methods must compliment the design of the trial and the nature of the data which are being collected. The factors in the trial that determine the proposed sample size (e.g. power) should be stated.
• Administrative Responsibilities. Specify the resources available to conduct the research including qualified personnel, equipment, space, and what facilities will be involved. Include an explanation of the methods for maintaining confidentiality of the study data.
• Recruitment. If applicable, describe methods of participant recruitment which will be used to recruit participants such as newspaper/internet advertisements or flyers. Attach all recruitment materials to the application for review.
• References and Appendices. Citations from the literature should be included in the Background/Introduction section above and the references listed here. Other supporting information, such as your own publications, should be submitted if you feel it would allow a deeper understanding of the project.

The following information should also be prepared, as it applies to your study:

• Control of Investigational Devices/Drugs. If this project involves an investigational drug or device please provide a plan as to how you will control, store, and dispense investigational drugs/devices to ensure they are only used by the qualified investigator(s) for this study and the participants enrolled in this research project.
• Communication Plans for “Multi-Center” Studies (i.e. multiple sites around the city, state, nation, or world with a PI other than the local PI designated at each site). If you are the lead investigator for this study, or the University of Utah is the lead site for this study, please describe the management and communication among sites of information obtained in this research that may be relevant to the protection of research participants, such as: unanticipated problems involving risks to participants or others, interim results, and protocol modifications.
  • Please attach an IRB approval from each participating site to the Documents and Attachments page of the application under “Other Documents”.
    • If the site does not have its own IRB of record, please contact an IRB Administrator for assistance.
  • Please include contact information (address, phone, and email) for each participating site. This can be attached separately to the Documents and Attachments page of the application under “Other Documents”.
• Participating Sites Outside the University of Utah (i.e. multiple sites around the city, state, nation, or world where the local PI runs the study at each site). This section should discuss which other institutions are participating in the study for which you, as the PI, are responsible. Please describe the procedures, provisions and resources in place at the participating institutions to protect the safety of participants, and how unanticipated problems will be communicated to the PI and the University of Utah IRB. If the participating site is not adequately equipped to handle safety concerns, please explain the procedures and plan in place for the PI to respond to any such occurrences.
  • Please include contact information (address, phone, and email) for each participating site. This can be attached separately to the Documents and Attachments page of the application under “Other Documents”.
  • Please attach an IRB approval (if the site has its own IRB) or signed letter of support from each participating site to the Documents and Attachments page of the application under Other Documents.

There are many different ways to obtain consent for research; you will need to determine which method is appropriate for your study. You are encouraged to visit our Consent Process Models page as you design your process.

The Electronic Research Integrity and Compliance Administration (ERICA) system is the primary electronic resource for the IRB review process. ERICA is used to enter, submit, track review, and approve all studies submitted to the IRB. For information on completing this process, please see the ERICA Access Instructions page.

University of Utah investigators and study staff who conduct human subject research must complete an IRB approved method of human subjects research training before the IRB will approve their project. There are several options available to investigators to satisfy this requirement. Please review the Human Subjects Research Training page for more information.

In order to receive IRB approval, it may be necessary to provide information to and/or receive ancillary approval from one of the entities below.

• Clinical Cancer Investigations Committee (CCIC)
• Conflict of Interest (COI)
• Institutional Biosafety Committee (IBC)
• Primary Children's Medical Center (PCMC)
• Radiological Drug Research Committee (RDRC)
• Resource for Genetic and Epidemiological Research (RGE)
• Technology Commercialization Office (TCO)
• Veteran Affairs Salt Lake City Health Care System (VASLCHCS)

Some of the ancillary committees also conduct their reviews electronically via the ERICA system. Please review the Ancillary Committee Pathway Map to see the order an application will take through ancillary committee reviews once it is submitted in ERICA.

Each applicable committee has their own requirements for submission. Please check with the applicable committee for their current requirements.

The University of Utah IRB follows and adheres to the University’s Conflict of Interest policy (U Pol 1-006). The principal investigator and all faculty, staff, postdoctoral appointees, residents or students, whether paid by the University or not, who are responsible for the design, conduct or reporting of research conducted in whole or in part at the University must complete a Conflict of Interest Disclosure Form within the ERICA online system.

Investigators applying for any initial approval of a proposed research protocol must submit a completed ERICA New Study application.

The ERICA system uses a “smart form” application which requires specific information based upon the responses of the applicant. For example, the New Study application includes a specific page for placebo-controlled trials. This page will only generate for the investigator if he/she indicates earlier in the application that the study involves placebo. Applications which are missing responses in required fields cannot be submitted electronically.

Additional forms within the ERICA system and documents created outside of the ERICA system may be required to complete an ERICA New Study application. Forms should be completed within ERICA as indicated. Documents should be attached to the “Documents and Attachments” page of the ERICA New Study application.

Templates for documents can be found on the IRB Forms menus.

Required Forms and Documents for Biomedical/Covered Entity Projects (PDF)
Required Documents and Forms for Behavioral and Social Science Projects (PDF)