Research, Innovation & Impact

Basic human subject research training must be completed before submitting an IRB application. 

Log into eCompliance  

1. Use your MU pawprint and password to access the Collaborative Institutional Training Initiative (CITI) program IRB training. CITI IRB training is the platform the MU IRB uses to document investigator training.
2. CITI IRB training is found by choosing the IRB Module in eCompliance, then “CITI Program IRB Training” on the next page called the IRB Dashboard.

Initial training: basic human subjects research 

You will be presented with three questions in CITI when adding a course: 

• Question 1: human subjects research & good clinical practice (GCP)
  Choose between biomedical, social behavioral or a combination of biomedical/social behavioral. Choose the best option for your type of study. You do not need to choose GCP unless you are involved in a clinical study. 
• Question 2: additional course selection list
  Skip unless you have specifically been asked to complete one of these (rare).
• Question 3: laboratory animal welfare
  Skip unless you happen to also do research with animals.

Recertification 

Upon completion of initial training, you will be granted a three-year certification. eCompliance will auto update within one day with your CITI IRB training. If you need it updated sooner, contact the IRB office at 573-882-3181. 

When you are notified that your training is about to expire, you will be asked to complete the refresher course, if you are still conducting human subject research. If you let your training expire, it will cause disruptions to your study. 

Already completed the CITI IRB basic training?  

If you already completed CITI IRB training at another institution, follow the instructions for affiliating with another institution and add University of Missouri-Columbia. 

The MU IRB uses eCompliance for all IRB related submissions. 

For students conducting research in fulfillment of their own academic milestones

Students must list themselves as Principal Investigator (PI) (when selecting your role on the IRB application in eCompliance). You must add an advisor on the project when prompted to add additional personnel. This can be an academic advisor or another faculty member working closely with you on the study submission. The IRB does not dictate who this must be, but it should be a faculty member familiar with the project and has experience to advise you.

Students not conducting research for their own academic requirements and who are only working with existing institutional faculty and staff to conduct research, do not list themselves as PI. Student investigator, research staff or coordinator may be a more appropriate description. 

Two-step submission process 

After you fill out the application, upload documents, and click on submit: 

1. The PI will be sent the PI Assurance Form to complete via email. 
2. The advisor will be sent the Advisor Approval Form to complete via email.  

This application will not officially be submitted to the IRB until these steps are complete. If you have not received an email notifying you that your application was submitted, it is very likely we are waiting for the PI assurance or the advisor approval to be completed. We can look it up for you to see what we are waiting for if you are unsure.  

Requirement to obtain your own IRB approval 

Students must have their own, separate IRB approval, per MU Graduate School policy, when conducting research in fulfillment of their own academic milestones (thesis/dissertation). A combination of projects is not accepted.  

For example, if a student wishes to use identifiable data from a faculty research project for their dissertation, the student must submit an IRB application to use the data.

MU graduate student-led projects (i.e., thesis, dissertation) must receive approval by the MU IRB even if activities are occurring at another site with an IRB.

The project must involve “research” and “human subjects.” Consider both definitions below. Also, you should consult your advisor/instructor as well to understand the expectations of the project. 

Is my project research? 

Are you conducting a systematic investigation¹, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge²? If yes, proceed with the human subjects definition. 

¹Systematic investigation is an activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question. 

²Generalizable knowledge means the project is designed to draw general conclusions, inform policy or generalize findings beyond a single individual or an internal program. 

Does my project involve human subjects? 

Are you working with living individuals? If yes, proceed with the next question. 

Are you intervening³ or interacting⁴ with the individual and/or are you obtaining, using, studying, analyzing or generating identifiable private information⁵ or biospecimens? If yes, your project involves human subjects and an IRB application is required. 

³Intervention includes both physical procedures by which information or biospecimens are gathered and manipulations of the subject or the subject’s environment that are performed for research purposes. 

⁴Interaction includes communication or interpersonal contact between investigator and subject. This includes online surveys and other interactions that are not necessarily in person. 

⁵Identifiable private information/biospecimen is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information/biospecimen. 

Unsure if you need IRB approval? 

If you are unsure whether your activity is considered human subjects research, you should email our office or call 573-882-3181.  

Note: The U.S. Food and Drug Administration (FDA) has different definitions for clinical investigations and human subjects. Please consult the IRB office if you are doing anything FDA regulated for guidance on how to proceed with your IRB application.

 Projects that do not require an IRB application form

• Classroom projects - If a project is conducted for purposes of a grade only and results are not disseminated outside the classroom, then these projects do not require an IRB application form (does not meet definition of research where the intent is to contribute to generalizable knowledge). 
• Quality improvement projects (does not meet definition of research) 
• Oral histories/journalistic activities (does not meet definition of research) 
• Project involving only analysis of de-identified information and/or biospecimens (does not meet definition of human subject) 

 
For the projects listed above, please submit the Human Subject Research (HSR) Determination Form in eCompliance.

You may have to scroll down to locate the Human Subjects Research Determination Form. 
 
A formal non-human subject research determination can be given to you after you submit the form in eCompliance. This form is not required, but highly recommended, for your documentation. It is sometimes needed if you are publishing the information and is often requested from publishers.  
 
For more information on these types of projects, please see the end of the Initial Review Standard Operating Procedure (SOP). 

Most of the methods below will qualify as exempt (see our Exempt FAQ page). When you begin your IRB application in eCompliance, it will ask questions to help us determine how your projects should be categorized. The IRB will ultimately make this determination. It's okay if your project does not qualify as exempt. The IRB application will guide you through preparing an expedited or full board application without needing to start a brand new one from scratch. 

Remember, you can start an IRB application and save it to finish later by accessing the Open saved IRB project page.

Online surveys 

Exemptions – most (but not all) online survey studies can be submitted as exempt under category two if: 

• The study involves minimal risk. 
• The study does not involve children. 
• The survey is anonymous (subject identifiers are not connected to their answers). If collecting identifiers, adequate protections must be in place to protect subject confidentiality. Using MU approved devices and methods of saving the information is required. Creating a code separating data from identifiers is recommended, or completely de-identifying the data at the earliest opportunity. 
• The survey does not ask sensitive questions that may cause emotional stress, induce trauma or are offensive. 

Attached files – the following documents should be uploaded to the application: 

• Survey questions 
  • Upload the final version of your survey questions.  
• Recruitment materials 
  • Upload what will be used to introduce the study. This may be a formal email, phone script, recruitment advertisement on social media or something less formal if using an online research recruitment panel such as MTurk with paid participants. Research panel sites often limit the amount of information that can be shared when first presented with the opportunity to complete a survey. 
    • When using online research panels, the subjects are considered “employees.” In section 4, be sure to check “employees” as your subject population. 
• Consent script 
  • For exempt studies, this can be combined with the recruitment material but does not have to be. 
  • This is usually presented as the first page of the online survey when it is not embedded in the recruitment materials. 
  • Consent templates for exempt and non-exempt online surveys can be found on our Researcher Resources page. The templates include all the required elements of consent so you don’t have to start from scratch.  
• Other items to consider: 
  • Subjects should be able to skip questions in an online survey. 
  • Compensation should be prorated if there are multiple surveys completed at different time points. 
  • If a survey should be anonymous, but you have plans to provide compensation, subjects should be taken to a separate URL to obtain their contact/identifying information that is not linked to the main survey answers. 
  • Subjects should be told they can print a copy of the consent if they want a copy. They can also reach out to the investigator for a copy. 

Focus groups and/or interviews 

Exemptions – most (but not all) studies with only focus groups and/or individual interviews can be submitted as exempt under category two if: 

• The study involves minimal risk. 
• The study does not involve children. 
• No identifiers are recorded (subject identifiers are not connected to their answers). If collecting identifiers, adequate protections must be in place to protect subject confidentiality and privacy. Using MU-approved devices and methods of saving the information is required. Creating a code separating the data from identifiers is recommended, or completely de-identifying the data at the earliest opportunity. 
• The study does not ask sensitive questions that may cause emotional stress, induce trauma or are offensive. 

Attached files – the following documents should be uploaded to the application: 

• Focus group and interview questions 
  • Upload the final version of your questions.  
• Recruitment materials 
  • Upload what will be used to introduce the study. This may be a formal email, phone script or recruitment advertisement on social media. 
• Consent script 
  • For exempt studies, this can be combined with the recruitment material but does not have to be. 
  • Consent templates for exempt and non-exempt studies can be found on our Researcher Resources page. The templates include all the required elements of consent so you don’t have to start from scratch.
• Other items to consider: 
  • Subjects should be able to skip questions. 
  • Compensation should be prorated if there are multiple sessions at different times. 
  • Subjects should be given a copy of the consent. 
  • Privacy should be respected. The location of the interviews/focus groups should also respect their privacy. 
  • If the focus group or interview is audio or video recorded, subjects must be told about the recording in the consent form. It should be addressed whether identifiers will be disclosed on the recordings and what will be done to protect the confidentiality of those recordings. Recordings should be maintained on a secure MU server approved by your department IT group. 

Medical record reviews 

Exemptions – most (but not all) studies with only review of medical records and no consent can be submitted as exempt under category four if: 

• The study involves MU Health records and every investigator is with MU Health.
• The study involves non-MU protected health information under HIPAA. 
• A HIPAA waiver is submitted within the IRB application. The subform will generate for you when you are conducting a medical record review. 
• Adequate confidentiality measures are in place to protect the information. 
• If you do not think the record review is exempt, you should contact our office to discuss. 

Attached files – there are typically no documents required for medical record reviews since the HIPAA waiver is a subform submitted within the IRB application. 

Research in an educational or school setting 

Exemptions – most (but not all) studies with only activities relevant to the educational or school setting can be submitted as exempt under category one if:

• The study involves minimal risk. 
• The study does not adversely affect the student’s normal learning environment.
• If collecting identifiers, adequate protections must be in place to protect subject confidentiality and privacy. 
• The study does not ask sensitive questions that may cause emotional stress, induce trauma or are offensive. 

Attached files – the following documents should be uploaded to the application: 

• Any interview, survey or focus group questions. 
• Any educational test or interventional materials. 
• Any documents/information subjects will be presented with. 
• Recruitment materials 
  • Upload what will be used to introduce the study. This may be a formal email, phone script or letter. 
  • There may be separate recruitment materials; one for children, one for parents/legal guardians. 
  • When selecting subjects for your study, make sure the selection process is free from coercion or undue influence. Give each student the ability to participate if they meet the criteria to be in the study. 
• Consent script/form 
  • Consider parental/legal guardian consent when recruiting children in a study or collecting their identifiable information. Parental consent can be achieved in different ways; sending a letter home, a phone discussion, etc. 
  • Consider child assent. Children have the right to decide whether they want to be in a research study. They should have the ability to decline to participate even when their parent/legal guardian consents.  
  • Consent templates for exempt and non-exempt studies can be found on our Researcher Resources page. The templates include all the required elements of consent so you don’t have to start from scratch.
• Other items to consider: 
  • If obtaining identifiable educational records, written consent may be required under FERPA law. 
  • Permission to work in schools may take time, so working on this process early is advised. Some districts have a research board to review studies prior to being implemented. 

International Research 

Exemptions – some international studies can be submitted as exempt if: 

• The study involves minimal risk. 
• If collecting identifiers, adequate protections are in place to protect subject confidentiality and privacy. 
• You do not ask sensitive questions that may cause emotional stress, induce trauma or are offensive. 

Attached files – the following documents should be uploaded to the application:

• Any interview, survey or focus group questions. 
• Any documents or information subjects will be presented with. 
• If non-English speaking subjects, translated documents are only required to be uploaded to non-exempt studies. These are submitted via the amendment after IRB approval of the English versions. 
• Recruitment materials 
  • Upload what will be used to introduce the study. This may be a formal email, phone script or letter. 
  • When selecting subjects for your study, make sure the selection process is free from coercion or undue influence.  
• Consent script or form 
• Consent templates for exempt and non-exempt studies can be found on our Researcher Resources page. The templates include all the required elements of consent so you don’t have to start from scratch.

Other items to consider: 

• Understand the local context in which you are conducting research. 
• Be ready to describe within the application the current social, economic and political conditions. Also, you will be asked to describe any risks that may result from participating in your study. 
• Permission may be required to conduct your study, so work early on this process to investigate what, if any, permission is required. 

Once your application is received, the IRB staff will work with you to ensure submissions are complete, accurate and in alignment with federal regulations. If changes are needed, you will be notified via email that your application has been returned outlining the necessary edits. 

When your projects is ready to be approved, you will receive an approval email from eCompliance with a link to the IRB approval letter. Do not initiate your research until you receive this documentation. 

Read the approval letter thoroughly for expectations moving forward. 

Access the attached files section in eCompliance to obtain the most recently reviewed/approved documents for use. 

Expedited/full board studies will have IRB approval stamps in the footer of the consent/assent forms. Use the stamped versions only.  

Exempt study consents are not stamped by our office. Use the highlighted green copy. 

Approved documents will be highlighted in green. 

Record retention/data storage

Maintain all research records in a secure, confidential manner. Research information should be kept on approved MU devices and locations. You should work directly with your advisor to maintain records in an area/location that is readily accessible for IRB or other inspections.  

Do not store research information on a personal laptop that is not approved by your departmental IT. 

Research records must be maintained at MU for a period of seven years following the completion of the study. If you leave the institution, you may take copies of the records with departmental permission, but originals must be maintained at MU. 

Amendments/changes

Prior to implementing any changes to your approved study, an Amendment Form must be submitted and approved.

Amendment forms are located under IRB Forms in eCompliance where the application was started. 

Changes may include; wording changes on a survey, adding a recruitment site or letter, adding or removing a survey, etc.  

If new documents are submitted for IRB approval, for example consent documents, be sure to pull the most recently approved documents to use in your research study. All approved documents are marked green, and older documents are marked replaced and should no longer be used after the amendment approval date. 

Personnel/investigator changes

Use the Personnel Change Form under IRB Forms in eCompliance to let us know when investigators are being removed or MU investigators are being added to your study. New investigators must complete CITI training. If you want to add non-MU investigators to the study, submit the amendment. 

Continuing review – annual updates

Most studies are approved for 12 months. Do not let your study expire. Complete the Annual Update Form when you are notified by the IRB that it is coming due and prior to the expiration date. Annual updates can be found under Open Saved IRB Project in eCompliance. 

Deviations – noncompliance

Complete the Event Report Form in eCompliance to report events (multiple events can be submitted on one form). 

This includes major deviations (noncompliance). 

This includes unanticipated problems (events that are unexpected, related or possibly related to the research and suggests the research places subjects or others at a greater risk of harm than was previously known or recognized).  

This includes any unresolvable complaints.  

This form must be submitted within five business days of becoming aware of the event.

Study closure

Studies can be closed when all interactions and interventions are complete and all data have been de-identified. When the study is complete and before you graduate, please be sure to close your study with the IRB. Do not leave it to your advisor to do it for you. They may lack the important details about the study to close it properly. Maintain all study documents for seven years following the completion of the study (when the IRB application is closed) according to the Record Retention SOP. 

Submit an Annual Update Form, if it has been requested by the IRB, or a Completion Report if the annual update is not due soon. 

Our office is here to help you from the beginning to the end of your research project. Contact the IRB office early and often for support with your human subject research. Especially under the following circumstances: 

• Assistance during grant proposal development or original project design. 
• Collaborating with other institutions as the IRB of record or as a relying site.  

Call us at 573-882-3181 or email us with your question.