IRB FAQs

If the study meets the definition of “research” and “human subjects” as defined by 45 CFR 46, the study requires IRB review.

• Research [45 CFR 46.102(l)] - a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. 
• Human Subjects [45 CFR 46.102(e)] - means a living individual about whom an investigator (whether professional or student) conducting research:
  • Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
  • Obtains, uses, studies, analyzes, or generates identifiable private information or indentifable biospecimens. 

If you are unsure if your proposed study meets these definitions, you should submit the study to the IRB for review. Ultimately, it is up to the IRB to determine if the research meets the definition of human subjects research and what level of oversight or continued review is required.

Graduate work (thesis or dissertation) which involves research on human subjects requires IRB Review.

If you are a Missouri State student or Missouri State faculty member, your research should receive review by the Missouri State IRB.

Student projects or assignments involving collection of data from human subjects may or may not meet the definition of research. Course instructors are responsible for making the decision whether the activities meet the definition of research. Course instructors are encouraged to call the IRB or ORC if they have any questions.

Student project means a study in which a student investigator (individually or as part of a group) gathers or analyzes information in a systematic manner, primarily for pedagogical purposes. It is not intended to contribute to generalizable knowledge and is not to be presented outside the class in which the research is being done or published/disseminated (including publication on the Internet or social media) in any way, presented, archived, or compiled with similar research for later publishing or presentation.

Research conducted for a senior project, master’s thesis, or seminar project does not fall under the definition of student project, and therefore, would require IRB review.

The following elements should be included on all marketing (emails, flyers, social media posts, etc.)

• Study title and/or IRB study number
• The word “research.” Make it clear that this is a research study
• “Missouri State University”
• The PI’s name
• A contact name with either a phone number or e-mail address
• Eligibility criteria, if applicable, should be noted briefly. Especially if payment depends on meeting these criteria. For example, “English speaking only,” “Women only,” etc.
• State whether participants will be paid for their time and effort or not
• Acceptable:
• “No compensation will be given for your participation.”
• “You will be compensated for your participation.”
• “You will receive a gift card to X for [amt.] for your participation.”
• “Participants will be compensated.”
• The amount of payment may be included but should not be the most prominent element on the page. Compensation should not be excessive considering the nature of the project. Payment should be stated as a range of amounts or stated as “at least” or “up to” for payments dependent on the amount of participation.

If the study meets the definition of “research” and “human subjects” defined by 45 CFR 46, the study requires IRB review.

• Research [45 CFR 46.102(l)] - a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. 
• Human Subjects [45 CFR 46.102(e)] - means a living individual about whom an investigator (whether professional or student) conducting research:
  • Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
  • Obtains, uses, studies, analyzes, or generates identifiable private information or indentifable biospecimens. 

All study data (consent, surveys, etc.) should be stored on a University OneDrive folder that is only accessible by the researchers. If physical data has been collected, these should be scanned and added to the OneDrive folder as well. If you do not know how to create a OneDrive folder, your department's IT specialist should be able to help you set one up.

At minimum, Federal regulations require research records to be retained for at least 3 years after the completion of the research (45 CFR 46). Research that involves identifiable health information is subject to HIPAA regulations, which require records to be retained for at least 6 years after a participant has signed an authorization. Finally, funded research projects may require longer retention periods, you may need to follow the sponsoring agency guidelines.

Yes. All changes (including study personnel changes) to a study must be approved by the IRB.

If your research involves biomedical/medical information then you take the Biomedical training, otherwise you take the Social-Behavioral-Educational training.

HIPAA is applicable to you if your college or department uses Protected Health Information in connection with certain covered transactions. Legal counsel with guidance from Deans and other Missouri State officials have determined which colleges and departments engage in covered transactions and thus are covered by HIPAA. Because of its size and the diversity of its activities, the Missouri State University is designated as a hybrid entity which means that some departments/colleges are regulated by HIPAA and others are not. An entity, or its covered departments or colleges, that is regulated by HIPAA is called a Covered Entity (CE).

If you are employed in a Missouri State Covered Entity component and create, access or share Protected Health Information, HIPAA applies to your research.

If in your research you collect Protected Health Information from a Missouri State Covered Entity and your department/college is deemed outside of the Covered Entity, HIPAA applies to your access of the Protected Health Information.

 

Researchers not in the Covered Entity may need an authorization form:

 

• to access PHI for their study; or,

• if they are conducting part of their study in the Covered Entity.

Please contact the ORC for further information on revised authorization/consent form.

If the IRB has "Post-2018 Rule" approval (approved past year 2020) and is expedited or exempt, there should not be an expiration date on the IRB. A few expedited studies will have an expiration date if the reviewer/committee feels continuing review is needed for the study. A "Study Administrative Check-In" email reminder will be sent annually on the anniversary of approval as a reminder to the PI this study is still open. A renewal is not needed for this check-in.

If the IRB has "Pre-2018 Rule", is a Full Board Review, or is one of the few expedited studies needing continuing review, an expiration date will be shown. An "Impending Expiration of IRB Approval" email will be sent stating that the PI must renew the study in Cayuse. Please make sure Org Approval is obtained and the renewal is in "Pre-review" in Cayuse before the expiration date.  

Studies that have expired due to submissions past the expiration date are subject to review with a new application to the IRB. A "Study expired" email will be sent and all study activities should stop including new participant enrollment and engagement with all participants. Once a new submission is completed and approved as a continuation, participant enrollment and engagement can continue. 

The continuation of research after the expiration date is a violation of federal regulations [21 CFR 56.103(a)]. Therefore, all research activities pertinent to the study should stop and no new enrollment should occur. You may submit a new application for the continuation of the project, which will go through the typical IRB review process. The ORC will be pleased to provide necessary assistance to secure approval for this project with minimal delays.

All exempt and most all expedited protocols do not have an expiration. All full board review protocols are approved for one year or less, depending on the level of risk. Continuing reviews are required at a frequency determined by the IRB at the time of approval to ensure the rights and welfare of research subjects.

IRB policy requires investigators to maintain their research records (includes data collection form(s), source documents, and case report form(s) for at least three (3) years after completion of the study. For research which falls under authority of other agencies or statutes with longer research record retention requirements, the longer retention period applies.

Investigators are responsible for ensuring that research involving humans conforms to generally accepted scientific principles, and that it is based on a thorough knowledge of the scientific literature and other relevant sources of information. The methods to be used should be appropriate to the objectives of the research and the field of study.

Pilot studies designed to determine the feasibility of conducting a larger study usually do not require IRB approval. However, if you intend to conduct a pilot study, you should still submit to the IRB for review. This will allow the IRB to review your methods and goals and ultimately determine if your study meets the definition of a pilot study or if continued oversight is required.

Pilot studies typically address issues regarding research design, instrumentation or methods of data collection. Studies may qualify as pilot studies if:

1. they are small in scale (i.e. <10 subjects);
2. their purpose is to refine data collection procedures instrumentation, research design, or teaching proven methods that will be used to conduct research (i.e., blood drawing training, interview techniques, etc.);
3. there is minimal risk to participants;
4. no sensitive data is collected;
5. no vulnerable populations are involved; and
6. there is no intent to publish or disperse the pilot study data and thus no intent to contribute to generalizable knowledge (if the data will later be used in a larger study, then this would not qualify as a pilot).

Research conducted at Missouri State University that has been reviewed and approved by another qualified IRB may qualify for Single IRB Review. The Principal Investigator must complete a Request for Single IRB Review through the Cayuse system.  The request can be made on the General Information tab of the application.

It depends. Please contact the Office of Research Administration to discuss your research.  Email: IRB@missouristate.edu