Single IRB Institutional Review Board

Write out and organize your research plan. You will need to have a clear design outlined before you are 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 complement 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 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-Site” 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 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”. 

There are many ways to obtain consent for research; you will need to determine which method is appropriate for your study.

You should be prepared to provide a consent template for your participating sites to submit to their local Human Research Protection Programs (HRPP) for review. Visit our SIRB consent guidance [link to: “Design Your SIRB Consent Template”} page for help preparing your template(s).

Investigators and study staff who conduct human subject research must complete an IRB approved method of human subjects research training and a Good Clinical Practices (GCP) course before the University of Utah IRB will approve their project.

There are several options available to investigators to satisfy this requirement. Please review the Human Subjects Research Training page on the IRB website for more information. 

If your study is investigating a drug, device, or biologic, or is planning a design that will require an Exception from Informed Consent (EFIC), contact the FDA to ensure any Investigational Drug Numbers (IND), IND exemptions, Investigational Device Exemptions (IDE), or EFIC waivers have been obtained or are in process.

If you are preparing a grant application, make sure to budget for SIRB costs and fees. Learn more about budgeting for SIRB fees {Link to: video “Budgeting for SIRB Fees”} by watching our video. 

When preparing a grant for a multi-site study, many funding agencies require that you identify which single IRB (SIRB) you plan to use for the study. If you plan to use the University of Utah as the SIRB for your study, the grant language {Link to: SIRB Grant Language page} we recommend investigators use available on our website. 

Learn more about the SIRB Site Assessment {Link to: “SIRB Site Assessment” page} process on our website.