FAQ – Human Subjects Research and Engagement in Research

The federal regulations and MU IRB (Institutional Review Board) define research as:

A systematic investigation¹, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge². Does your project fit this definition?

If yes, proceed to the next question to determine if your project also involves human subjects. If the project is not research, the project does not require IRB review and you can stop here. FDA (Food and Drug Administration) regulated studies do not use this definition of research. Consult the IRB office if you have an FDA regulated study (a study investigating or using FDA regulated products).

A project only requires IRB review if the activity involves both research and human subjects. If you are unsure, you may complete our Human Subjects Research Determination Form in eCompliance for a formal determination or contact our office.

¹Systemic 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.

If no, please double check by reviewing the question below, “What are some common projects that do not require IRB approval because they don’t meet the definition of human subject research?”

Are you working with living individuals? If yes, are you intervening³ or interacting4 with the individual and/or obtaining, using, studying, analyzing, or generating identifiable private information⁵ or biospecimens?

If yes, your project involves human subjects. If your project also met the definition of research in the previous question, then 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 be readily ascertained by the investigator or associated with the information/biospecimen.

If no, please double check by reviewing the question below, “What are some common projects that do not require IRB approval because they don’t meet the definition of human subject research?”

The following are examples of projects that are not human subject research. If you are unsure whether your project involves human subjects research or need a formal determination, please complete our Human Subjects Research Determination Form located on the IRB Forms page in eCompliance. It is possible some publishers and journals will request an IRB determination, so it is recommended to submit for this purpose.

• Case Reports (medical record review of 3 or less cases): The retrospective medical chart review of three or less cases are not considered human subject research. Please contact MU Health Corporate Compliance at privacyofficer@health.missouri.edu or 573-882-5193 with questions on how to complete the case report form.
• Quality Improvement Projects: (where one or more of the following apply):
  • The purpose is to measure performance or determine the effect of a process change.
  • Data is being gathered solely for administrative purposes within the context of normal efforts to examine or improve services, or operations.
  • The individuals where the planned activity will take place could potentially benefit from the project.
  • The data is intended to be used by and in the entity where the project is taking place.
  • The project will involve a sample of the population ordinarily seen/present the institution where the project is taking place.
  • The project will involve a sample of the population ordinarily seen/present the institution where the project is taking place.
  • The risks to individuals involved in the project are no greater than what is normally involved in their daily lives.
  • The project’s purpose is to submit to a National or State registry/database mandated for improving clinical care delivery.
• Student Classroom Assignments: Class projects designed for pedagogical purposes only and not intended to be disseminated outside of the classroom (solely fulfilling a course requirement), do not require IRB review.
• Scholarly and Journalistic Activities focused on a person/family/group (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
• Analyzing De-Identified Biospecimens and/or Information
  • Typically, datasets requiring a contract or other data use agreement have the potential for re-identification making the dataset not truly “de-identified”. An IRB application would be required in this case.
  • De-identification must be completed by a third party. It cannot be done by the research team and be truly de-identified.
• Publicly or Commercially Available Biospecimens and/or Information/Data 
• Public Health Surveillance Activities

See the end of the MU IRB Initial Review SOP (Standard Operating Procedure) for additional examples and more information.

In general, individuals are considered to be engaged when they obtain data about subjects through intervention or interaction, obtain/access identifiable private information and/or obtain informed consent from subjects. Learn more about engagement in research.

The list below includes common examples of when investigators are not engaged in human subject research and would not need IRB approval. It is highly recommended you consult the IRB office when making this decision.

(1) you are only analyzing de-identified data and/or biospecimens;

(2) your activities are limited to assisting with recruitment and you are not part of the research team. Recruitment assistance only involves informing others about the study (i.e., forwarding emails, handing out flyers, etc.). It does NOT include answering questions about the study. Anyone answering questions about the study should be listed as part of the research team. Anyone obtaining informed consent must also be listed on the research team because they are interacting with subjects and therefore engaged in research.

(3) your activities involve performing commercial or other services, provided ALL the following conditions also are met:

• The services performed do not merit professional recognition or publication privileges.
• The services provided are typically performed by those institutions for non-research purposes. Examples include:
  • Laboratories conducting analysis as a commercial service.
  • Commercial transcription services
  • Blood draws and biospecimen collection provided as a commercial service.
  • X-rays performed as a commercial service.
• The institution’s employees or agents do not administer any study intervention being tested or evaluated under the protocol.

View more examples of when an investigator is not engaged.

If you need IRB oversight/approval, the next step would be to consult with MU IRB to determine whether MU IRB can rely on the lead institution’s IRB approval, or a separate application needs to be submitted to MU IRB.  

If you are engaged in human subjects research and only MU is engaged, start and submit an IRB Application under IRB Forms in eCompliance. The IRB application is the main form for all human subject research.

If you are engaged in a multi-site/collaborative study, please see applicable instructions below:

• MU IRB is the Single IRB – Submission Process: Instructions for requesting MU to be the IRB of record for external sites.
• MU IRB Relying on Another IRB – Submission Process: Instructions for requesting to rely on a commercial, central, institutional, or organizational IRB. MUR IRB has the final determination whether relying on another IRB is acceptable.

For more information, see our Single IRB and Reliance Procedures page.