Human Subjects Research

Need help determining if your project requires IRB approval? Please take our quiz, “Do You Need To Submit Your Project For IRB Approval?” by clicking the green button below.

Do you need to submit your project for IRB approval?

How do I know if a Research Study is Human Subjects Research and What Does it Really Mean?

How is “research” defined?

The federal definition of research is a “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.[1]

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” (46.102 (1)).

For purposes of this part, the following activities are deemed NOT to be research:

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]
2. Public health surveillance activities, including the collection and testing of information or bio specimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public 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, bio specimens, 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.

What constitutes research with human subjects?

Research with human subjects involves research on living individuals “about whom[3]  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.

What types of research need to be submitted to the IRB?

Generally research that involves contact with human subjects or obtaining data about living human beings requires review when that data will be used to generalize findings or draw conclusions. For more information on whether or not your project requires IRB approval, please review this guidance on when IRB review is needed.

[1] "Generalizable knowledge" is information where the intended use of the research findings can be applied to populations or situations beyond that studied.

[2] Multiple oral histories conducted to understand general social processes, how social movements generally develop, or how racial ethnic minority group members generally cope with discrimination would be human subject research.

[3] “About whom” – a human subject research project requires the data received from the living individual to be about the person.