IRB Global Education Application for Exempt Studies

PLEASE READ BEFORE SUBMITTING: This form is the first step in initiating a research project that will fall under the global education IRB protocol for the Departments of Emergency Medicine at Denver Health Medical Center and the University of Colorado. It is meant to prompt you to begin thinking about the details of your project and to initiate the process of performing an IRB exempt educational research study. FOLLOWING STEPS: 1. Review the exclusion criteria below. 2. Have your CITI Training Proof of Completion ready to upload at the end of this form. Additionally, please upload any additional documents you have prepared for your project at the end of this form. 3. If any of the form options do not apply to your study, type "N/A" in the space provided. Please don’t hesitate to contact Christopher Hoyte (christopher.hoyte@cuanschutz.edu) if you have any questions or would like to discuss the details of your project. This form was developed to maximize efficiency of project development and resource utilization.

Exclusion Criteria

• International projects. • Projects involving Denver Health or UC investigators performing study activities beyond the Denver Health or UC Anschutz campuses. • Projects which include protected health information (PHI) (e.g. the project should be able to have patient care data, as long as no PHI collected). • Projects which do not meet all criteria for exemption listed in 45 CFR 46.101(b)(1) and/or (2). https://rebrand.ly/1p6hfg0

Educational research protocols are exempt provided all of the following conditions are met:

1. It is conducted in a commonly accepted education setting. 2. It involves normal educational practices. 3. It does not increase the level of risk or discomfort attendant to normal, routine educational practices. 4. Provisions are made to ensure a non-coercive environment for students who choose not to participate. 5. Participating in research is not a required part of the curricula. Students will be able to refuse participation. Instructor-researchers should minimize the potential for coercion through the anonymous return of data collection instruments. This can be done by the involvement of a neutral third party, a drop box, and other mechanisms.



Basic Information


List the title of the study initiated under the blanket exempt protocol:

Please include all names of the investigators who conducted the study. i.e. Who is on your research team? (If you are a student or resident, you must have a faculty mentor who agrees to be the primary investigator on this study).

If the study is not yet complete by time of report, leave blank.

Project Description/Goals


A research question (or “specific aim” in research lingo) generally starts with a verb: “to investigate”, “to estimate”, “to describe”, “to compare”, “to validate” etc.

i.e. What do you think you will find? (X will be better than Y; X will be associated with Y; etc.)

If you plan to study this outside of Denver Health or UC, have you approached them? Do you have buy-in?

Who are you studying? (Type of learner? Curriculum? Evaluation technique?) How will you identify your subjects of interest? (Think inclusion/exclusion criteria)

Survey, evaluation, assessment, interviews/focus groups, etc.

What is your primary outcome? (i.e. "Did students perform better after curriculum?” “Did residents like the program?”) Think of all the variables that are associated with your primary outcome or confound your primary outcome. Look at previous literature.

Is this project funded? Do you plan to apply for funding for this study? Please describe.

Study Design and Research Methods


Please provide a brief description of the specific study design, aims, and procedures for the individual study.

Please describe your subject(s) inclusion and exclusion criteria.

Where will subjects be recruited from (ED, AUCC, DECC, Surgery, In-Patient Services, etc.)?

How will subjects be identified for enrollment?

In particular, how will they be informed that participation is voluntary?

If you are prospectively collecting data, please provide a draft of your Data Collection Instrument or survey. (This will stipulate the exact variables, or data, that will be analyzed for your project).

If you are using existing data, please provide a list of the variables you will use.

Is there a follow-up portion of the study? (If yes, please explain).

How many subjects will be enrolled?

Describe your plan for data analyses, if you have developed one.

What is the anticipated time to complete study enrollment and data analysis?

Resources


Who is doing data collection, data entry, data cleaning, and analyses?

Does this project require extra technology support or staff support from Nursing, Radiology, Lab, Pharmacy, Cardiology, etc.?

Does this project require support from any physicians, students or techs in the Emergency Department outside of your direct study team?

CITI Training Completion and Additional Files

Please upload your CITI Training Proof of Completion and any other additional documents you have prepared for your project.


Drag and drop files here or