What Requires IRB Approval

Research projects meeting the regulatory definition of human subjects research require review and approval by an Institutional Review Board.  

The federal regulations define Research (45CFR46.102(l)) as "a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.  For example, some demonstration and service programs may include research activities. 

Key aspects of this definition:

  • Systematic investigation – data are collected in a systematic manner; the same tests, measurements, interventions, or questions for everyone in the subject population. 
  • Development, testing and evaluation – this means that a pilot study or a small project that is part of a larger study that could be research.
  • Designed to develop or contribute to generalizable knowledge – It is research if the person conducting the project will draw conclusions or make generalizations based on the information gathered and apply them to a broader population. The intent or purpose of research is to further scientific knowledge in a particular field of study.

What Does Not Require IRB Approval

There are four activities specified in the federal regulations that do not require IRB approval.  The following activities are deemed not to be research requiring IRB approval:

  1. 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.
  2. 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).
  3. 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.
  4. Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

Who is a Human Subject?

The federal regulatory definition of a Human Subject (45 CFR 46.102(e)(1)) as:

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 identifiable biospecimens.

The regulations further define: 

  • Intervention (45 CFR 46.102(e)(2)) 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 (45 CFR46.102(e)(3)) includes communication or interpersonal contact between investigator and subject.
  • Private information (45 CFR46.102(e)(4)) includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g. medical record)
  • Identifiable private information (45 CFR 46.102(e)(5)) 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 (45 CFR46.102(e)(6)) is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

Human Subjects Research Determinations

Investigators who are unsure of whether a project is “human subjects research” may submit a Human Subjects Research Determination (HSRD) form through HawkIRB. This form collects all of the information an IRB Chair or Chair Designee needs to determine if the project needs IRB approval.  

  • If it is NOT human subjects research, a determination memo will be attached to the form. Follow the instructions in the automated message from HawkIRB to find the memo. This requires changing the filters in the Projects section of the PI’s HawkIRB inbox. 
  • If the project is human subjects research, a DRAFT New Project will be started in the PI’s HawkIRB inbox. It will be pre-populated with information provided in the Human Subjects Research Determination (HSRD) form.  The PI must complete and submit the DRAFT New Project form to start the IRB review process.  Research cannot begin until the projects is approved by the IRB. 

Investigators can also submit an HSRD form for projects that do not appear to meet the regulatory definition of human subjects research. If the project yields publishable results, the determination memo may be useful if a journal requests documentation of IRB approval. It is possible to publish the results of a project that is not human subjects research without obtaining IRB approval.  

When filling out an HSRD form, provide a thorough description of the purpose and procedures. In Section HSRD I.5, if you indicate plans to conduct “a systematic investigation…designed to develop or contribute to generalizable knowledge,” the IRB Chair will be compelled to determine that the project requires IRB approval. 

Any investigator who is unsure of whether his/her proposal constitutes “human subjects research” may submit a Human Subjects Research Determination form (HSRD) form through HawkIRB. The IRB Chair and/or their designee will determine if their Human Subjects Research Determination request meets the definition of human subjects research. More information about HSRD forms and processes can be found here.

Exempt Research

Some research may qualify for exemption from certain federal regulations 45 CFR 46.104) (OHRP) and 21 CFR 56.104 (FDA).  The IRB chair or their designee can determine whether your research meets the exempt criteria, based on review and approval of your Exempt New Project application to the IRB.  See more information on Exemption categories of review at the UI on the Types of IRB Review page.

Important: Research meeting the criteria for exemption is still considered human subjects research, and requires IRB approval.  If your study qualifies for exemption, you still need to submit an exempt application in HawkIRB and receive approval before conducting the research. 

Resources:

"Do I need IRB Review? Is This Human Subjects Research? A Guide for Investigators" 

This guide provides a basic explanation of the regulations and provides examples of what may or may not constitute human subjects research.  As noted in this booklet, there are certain studies which may have the characteristics of human subjects research, but may not meet the regulatory definition. Studies which meet the definition require IRB review. 

UI Investigator’s Guide\IRB Standard Operating Procedures

  • Section I, Part 4.B “Scope of IRB Review at the University of Iowa
  • Section I, Part 9 “Institutional Requirements for IRB Review”
  • Section I, Part 12 “University of Iowa Projects Involving Human Subjects or Their Data”
  • Section I, Part 13 “Exempt Human Subjects Research”  

Also see the Office for Human Research Protections (OHRP)  ‘What is Research and What it isn’t’ human subjects research.