Research & Economic Development

Office of the Vice Chancellor

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Is an activity research involving human subjects? 


 

To determine whether or not IRB review is required, the first step is to determine whether or not the study is research.  The next step is to determine whether or not the study involves human subjects.  Some projects that may require careful consideration for this type of determination include: case studies and quality improvement studies, etc.  IRB staff will assist the researchers in making this decision.

According to the new 2018 Common Rule Regulations, the following have been deemed to NOT be research and thus not requiring IRB review:

  • Scholarly and journalistic activities (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.
  • Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
  • Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
  • Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

Please see below for the regulatory definitions of research and of human subjects.

Research:  a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities.  

Human subject: a living individual about whom an investigator (whether professional or student) conducting research:

(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or

(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Intervention includes both physical procedures by which information or biospecimens are gathered (e.g.,venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. 

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

Identifiable biospecimen iis a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

To request a UMKC Human Subjects Research Determination.

For help identifying the necessary information prior to submitting an application via eProtocol check out what questions the IRB Office will ask.


Human Subjects Decision Charts

The Office for Human Research Protections (OHRP) provides the following graphic aids as a guide for institutional review boards (IRBs), investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46.