Exempt Review

Exempt is when a project fits into one or more exempt categories included in the IRB regulations.  Since these studies involve minimal risk and research activities are generally benign, the MU IRB has implemented an abbreviated review process to ensure basic ethical principles are being followed. Most reviews occur administratively except for some activities needing a limited review by a board member.  

IRB regulations mostly apply to research that is not exempt, but MU requires ethical standards and institutional requirements to be met, and informed consent be obtained when there is a subject interaction. Exempt does not mean IRB review is not required. This is a common misconception. Our institution and accreditation standards do not allow an investigator to make their own exempt determinations, the determination is the responsibility of the MU IRB. 

Your project is exempt if it fits under one or more of the following categories briefly summarized below. Each of the six categories has nuances and exclusions that must be considered before assuming your project falls under that category. Please read through the additional FAQs below that are specific to each category for more information. 

• Category 1: Research conducted in established or commonly accepted educational settings that specifically involve normal educational practices.  
• Category 2: Research that only includes interactions involving educational tests, survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording). 
• Category 3: Research involving *BENIGN behavioral interventions in conjunction with the collection of information from an ADULT subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection. 
• Category 4: Secondary research for which consent is not required. Secondary research uses of identifiable private information or identifiable biospecimens. 
• Category 5: Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of federal department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects). 
• Category 6: Taste and food quality evaluation and consumer acceptance studies. 

The regulations include a 7th and 8th category, but the MU IRB does not use those exemptions. 

The IRB application will help guide you with questions regarding your study and staff will be reviewing your submission to ensure the appropriate category is assigned to your study. Additional guidance is provided in the following FAQs to help you identify which category or categories may apply to your study. 

Category 1: Research conducted in established or commonly accepted educational settings that specifically involve normal educational practices. 

• The activities do not adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction.
• This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. 
• The research can only be conducted in established or commonly accepted educational settings. This includes, but is not limited to, schools and colleges. It may include other sites where educational activities regularly occur, such as after-school programs, preschools, alternative education programs, and online learning.
• All study activities and/or interventions are minimal risk, benign, brief, and harmless, and do not intentionally involve students who are experiencing behavioral or emotional problems/issues/disorders without the support of the school/educational setting.
• Children may fall under this category. 
• Normal educational practices are activities that would occur regardless of whether the research is conducted. 
• Surveys, interviews and focus groups may be included in this category. 
• The study does not involve new, unproven educational practices/activities or the collection of sensitive, identifiable information.
• If collecting data from student records, FERPA will apply and signed consent forms will need to be obtained from parents, as well as signed assent from minors (when students are capable). 

Category 2: Research that only includes interactions involving educational tests, survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording). 

• Children can only be involved if their participation is limited to (1) educational tests or (2) observations of public behavior when the investigator(s) do not participate in the activities being observed. 
• Survey & interview procedures are not anticipated to influence or change a participant's social, behavioral, or educational outcomes.
  • Be sure to upload copies of all surveys and interview questions to e-Compliance for review.
• Observation of Public Behavior would be limited to public observations where subjects would not have an expectation of privacy.
• Educational tests are limited to cognitive, diagnostic, aptitude, and achievement.
• If privacy and confidentiality are of any concern, or need additional review, to ensure the exemption is appropriate, the study will undergo limited IRB review (review by one board member).
• If the data you are collecting may be considered sensitive, you will need to describe the steps you will take to minimize risks associated with the sensitive nature of the questions in the application and consent. Examples for minimizing risks include:
  • Allow subjects to skip questions that make them feel uncomfortable or to stop participation at any time.
  • Provide subjects with copies of the questions you will ask in advance or give examples of sensitive topics/questions in the consent form.
  • Provide referral information to subjects should they become upset and need services. 

Category 3: Research involving *BENIGN behavioral interventions in conjunction with the collection of information from an ADULT subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection. 

• Benign behavioral interventions are brief, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects. Behavioral interventions are not physically invasive when they do not involve the introduction or administration of instruments, substances or energy onto or into the body.
• Interventions are behavioral (not biomedical or other). This would include the study of psychological states and processes, cognition, ideas and attitudes, or behavior, and do not include physical (bodily) tasks or physical manipulations (e.g., range of motion, physical exercise) unless these are minor activities that are incident to the behavioral intervention and do not increase risk. Application of physical procedures (i.e., blood pressure monitoring, EEG, blood draw, swabs) do not fit this exemption and must be reviewed expedited.
• The investigator has no reason to think the subjects will find the interventions offensive or embarrassing. 
• If the study involves deceiving the subjects regarding the nature or purposes of the research, this exemption does not apply UNLESS the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.
• No children can be included under this category. Interventions only include adult participants able to consent on their own behalf. Research requiring decision-making on behalf of the participant by a legally authorized representative would not qualify for the exemption.
• If privacy and confidentiality are of any concern, or need additional review, to ensure the exemption is appropriate, the study will undergo limited IRB review (review by one board member).
• The study is not funded by the US Department of Justice.

Category 4: Secondary research for which consent is not required. Secondary research use of identifiable private information or identifiable biospecimens. The study must fit into one of the following 3 options: 

1. The identifiable private information or identifiable biospecimens are publicly available.
2. Information which may include information about biospecimens:
   • is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, and 
   • the investigator does not contact the subjects, and 
   • the investigator will not re-identify subjects.
3. The research involves only information collection and analysis, that either:
   • COMMON: involves the investigator's use of identifiable protected health information (PHI) regulated under HIPAA. 
     • When using MU Health PHI, at least one listed investigator must be an employee of MU Health or affiliates otherwise the study must be reviewed expedited.
     • OR
   • UNCOMMON: research conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for non-research activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 or Privacy Act of 1974, 5 U.S.C 552a. 

Additional clarification for Category 4: 

• See the Biospecimens FAQ for specific information about biospecimens and allowable levels of review.
• There should not be an interaction or intervention with subjects, therefore no informed consent of subjects is sought. Consent forms should not be uploaded to e-Compliance if research falls under category 4 UNLESS:
• The exception would be if you are using medical data for prescreening purposes to obtain contact information on potential subjects to complete a survey or interview, who will later be presented with a HIPAA authorization and consent form prior to enrollment. The example might fall under category 4 and category 2.
• Most category 4 research involves the use of PHI, which requires a HIPAA waiver when obtaining HIPAA authorization is not practical. Please see our HIPAA FAQs for more information on completing your HIPAA waiver (which is a subform within the IRB application). 
  • If obtaining consent and HIPAA authorization is practical (i.e., the study involves future access of the medical record, and/or there is a subject interaction or intervention, then you should obtain consent/HIPAA authorization. HIPAA waivers are usually not approved when obtaining consent/HIPAA authorization is practical. 
• If you are only conducting data analysis on information that has been de-identified by a third party not part of your study team, it does not meet the definition of Human Subjects Research. Please submit a “Human Subjects Research Determination Form” instead.
• The study is not funded by the US Department of Justice.

Category 5: Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of federal department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects).  

• The research is designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs.
• The research must be conducted pursuant to specific statutory authority of the US federal government. 
• There is no statutory requirement that an IRB review the research. 
• The research does not involve significant physical invasions or intrusions upon the privacy of participants. 

Category 6: Taste and food quality evaluation and consumer acceptance studies: 

• if wholesome foods without additives are consumed; or
• if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture. 

• Studies aimed at including prisoners.
• FDA regulated studies (unless Exempt Category 6) 
• Randomized controlled trials involving sensitive and identifiable information. 
• Studies establishing a biorepository and/or database for future unspecified research uses.
• Studies involving greater than minimal risk to subjects, as determined by the MU IRB.
  • Greater than minimal risk: Probability and magnitude of harm or discomfort anticipated in the research are greater in and of themselves than those ordinarily encountered in daily life or during performance of routine physical or psychological examinations. 
• Disclosure of information collected for the research would reasonably place subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing. 
• Certain categories cannot involve children, specifically category 3 and some activities in category 2 (surveys, interviews). 

The regulations define minimal risk as the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.  

This means that your study would not place subjects at greater harm than what they would normally experience in their daily life. The IRB will consider the subject population and their normal daily routine/situation to determine whether the study itself is what may cause them harm or discomfort. 

If any of the following apply to your study, they must be uploaded to your application within the “Attached Files” section (last section of the application). The MU IRB requires a complete submission prior to review and will return the application if it is incomplete for required information/documents. 

• Recruitment materials (for example, flyers, scripts, emails, ads, postings). See our Recruitment FAQs for additional guidance.
• Survey and/or Interview Questions (in general, anything the subject will see, do, hear, or read for the research) 
• Adult Consent and/or Child Assent Documents. See our exempt templates. 
• Supporting documents prompted to be uploaded within the IRB application. 

Research objectives and goals should be included in the application. In other words, explain the research question(s) you are trying to answer and what steps will you take to try and answer those questions? Specifically, and most importantly, we need to know what you are asking subjects to do as participants in the research. Describe all the activities involving subjects' participation in detail. 

The IRB staff will review your exempt application to see if it meets the criteria. The turnaround time for complete submissions is approximately 3-5 business days (complete submissions mean all questions are answered appropriately and documents uploaded). If the study requires limited IRB review (discussed in another question), or it involves a request with a HIPAA waiver, the review time may be extended a few days to allow those additional reviews to occur. You can always contact the IRB office to check on your project status. 

The Principal Investigator will be notified in writing of the approval of the project. Advisors and other personnel who were marked “primary contacts” in the application will also receive notification. The IRB determination letter is uploaded to your attached files when it is emailed to you. 

If the application does not meet criteria for exemption, the Principal Investigator will be notified.  Possible notifications may indicate that: 

• the project did not meet requirements for human subject’s research, or
• modifications are necessary to allow the research to be exempt, or
• the investigator must complete the expedited and full board sections of the application.   

The following elements should be included in an exempt consent (see our Adult Consent and Child Assent templates for Exempt projects).   

• A statement that the activity involves “research” 
• A description of what they will be doing, including duration/time commitment
• A statement that participation is voluntary 
• A statement about compensation, if any
  • See Compensation FAQs for additional help with appropriate language
• A statement the participant must be an adult, if the study is limited to adults 
• Your name and contact information; (use MU official email address, not personal email addresses)
• IRB contact information (see standard language below taken from our exempt consent template). 
  • If you have questions about your rights as a research participant, please contact the University of Missouri Institutional Review Board (IRB) at 573-882-3181 or muresearchirb@missouri.edu. The IRB is a group of people who review research studies to make sure the rights and welfare of participants are protected.

• Exempt studies typically do not require a subject’s signature unless:
  • The study is regulated under FERPA – study requires permission to release student records;
  • The IRB determines it is needed in your study to document parental consent for enrolling children;
  • Release of identifiable information/pictures/videos outside of the research team; or 
  • Any other reason the IRB deems necessary.
• Consent forms can be combined with recruitment materials on exempt studies. It does not have to be a separate document.
• If you are audio or video recording subjects as part of the research this must be disclosed in the consent form along with steps you will take to protect the recorded data.
• If you are collecting sensitive information, this should be disclosed within the consent form (you can give examples of questions or topics that are sensitive). Then, include the steps you are taking to protect the sensitive data as well as the procedures in place should a subject become upset while participating in the research. This is usually only applicable for Limited IRB Review studies.
• If you are disclosing potential risks, please state that the study involves “no more than minimal risk” rather than “no risk.” Loss of confidentiality is a minimal risk on most exempt studies.
• If you are stating benefits to participation, please acknowledge that participants “may receive no direct benefit,” if that is the case. In general, using the word “may” instead of “will” is usually appropriate when describing benefits. Compensation should never be listed as a benefit.
• If compensation is being provided, describe the compensation. See our Compensation FAQs for additional guidance.
• If HIPAA applies, you should include the HIPAA authorization language in the consent. See HIPAA FAQs for more information related to HIPAA requirements.
• When uploading your consent form to e-Compliance, be sure to select “Consent (Exempt Studies Only)” for the Document Type in the drop-down list to appropriately label your document. 

Exempt studies involving investigators from other US-institutions have the option to submit the project to each IRB or submit to one and let the other IRBs accept that exemption determination (without a formal reliance process where IRB agreements must be in place).  

If the project ends up being submitted to the MU IRB, the MU IRB may also determine it is acceptable to add external investigators to the MU IRB application with documented CITI training instead of requiring the investigator to submit to their local IRB for an exemption (with the acceptance of the local IRB of course).  

If you already received an exemption determination from another IRB, complete the “Collaborative Exempt Notification Form” in e-Compliance to notify the MU IRB about collaborative exempt research. MU’s role in the study must have been included in the review determination. The MU IRB will review the determination, and if the MU IRB agrees with the exempt determination, you do not need to submit a separate exempt application here. The MU IRB reserves the right to request the project also be submitted to the MU IRB. 

The MU IRB still must review the project even when activities are occurring internationally. The investigator must complete the “International Research Subform” as part of the IRB exempt application. External international investigators may be added to the IRB application on a case-by-case basis at the request of the local, MU investigator. Each investigator would be required to create an external account in eCompliance and complete the MU required CITI training. The MU IRB may require execution of the Individual Authorization Agreement.  

If subjects are part of the European Union, additional privacy laws will be addressed within the IRB application. 

Additional guidance for international research standards you should be aware of when conducting international research. 

When a study involves non-English speaking subjects, the MU IRB will approve the English versions of documents that will be communicated or shown to subjects, and the investigator must translate the documents to match the approved versions. The translated documents do not need to be submitted to the MU IRB for review and approval on exempt studies. Questions related to their language and translation are asked within the IRB application. 

• On an annual basis, the investigator must submit an “Annual Exempt Form” to keep the study open if so desired. This form is auto generated when you receive your reminder and can be accessed under the “Open Saved IRB Project” section of eCompliance.
• When the study is complete, an “Annual Exempt Form” or the “Completion Report” must be submitted to close the study. The Annual Exempt Form is processed automatically within eCompliance based on your status request to remain open or closed.
• An “Exempt Amendment Form” must be submitted to the IRB for review and approval prior to initiating changes to the exempt study. The IRB will confirm the study still meets the exempt criteria and changes are acceptable.
• Changes can include adding or removing surveys or survey questions, revising consent, recruitment, or other study documents, adding a site for recruitment, adding funding, etc. The IRB may need to ask for tracked changes document(s) if we are unable to readily identify changes within clean documents. Contact the IRB if you are unsure whether an amendment is needed.
• Personnel changes can be made on the “Personnel Change Form.”
• The investigator must report noncompliance within 5 business days on an exempt study. For exempt research, non-compliance is typically reviewed administratively, and education is provided. The IRB may request the “Event Report” to be submitted or simply document the issue and resolution in eCompliance.