IRB Health Sciences and Behavioral Sciences (HSBS)

Federal regulations define a human subject as a "living individual about whom an investigator (whether professional or student) conducting research: (i) obtains information or biospecimens through intervention or interaction with an individual, and uses, studies, or analyzes the information or biospecimens; or (ii) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens." ~ 45 CFR 46.102

• Data includes information or specimens collected from living subjects
• About whom indicates that the data must be personal information about an individual
• Intervention includes physical procedures, manipulations of the subject, or manipulations of a subject's environment for research purposes (e.g., taking saliva or blood samples, havin a subject view a video)
• Interaction refers to communication (e.g., face-to-face, internet, mail, phone, etc.) between the investigator and the subject 
• Identifiable means that the subject's identity is or may be readily ascertained by the investigator or others, or is associated with the information or biospecimen.
• Private information includes information about behavior that occurs in a context in which the subject can reasonably expect that no observation or recording is taking place; or, information provided for specific purposes by the subject in which the subject can reasonably expect will not be made public (e.g., medical records, academic records, personal journals). 

NOT human subjects research:

• Research using data from the 1880 Census because the data isn't from living individuals
• Survey that collects data about an organization's activities because the data isn't about individuals
• Research using de-identified data sets because the data are not individually identifiable

If you can answer "yes" to the following questions, you need to submit an IRB application in eResearch for IRB review:

1.  Is it research?

Research is a systematic investigation (including research development, testing, and evaluation) designed to develop or contribute to generalizable knowledge  ~ Federal definition, 45 CFR 46.102(l)

• Systematic investigation is an activity designed to test a hypothesis and to draw conclusions as described in a formal protocol that sets forth an objective and procedures to reach that objective.
  • Activities such as the practice of public health, medicine, counseling, or social work are not research. 
• Generalizable knowledge is information expressed in theories, principles, and statements of relationships that can be widely applied (e.g, by publishing findings or presenting findings at a professional meeting).
  • Studies for internal management purposes (e.g., program evaluation, quality assurance, or quality improvement) are not research because the intent is not to provide generalizable knowledge but to apply findings only to the program or activity.

2.  Does the research involve human subjects?

Human subjects research is a project that involves a living individual about whom the investigator (whether student or professional) (i) obtains information or biospecimens through interaction/intervention with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) obtains, uses studies, analyzes, or generates identifiable private information or indentifable biospecimens. ~ Federal definition 45 CFR 46.102(e)(1) 

3.  Is the university engaged in the conduct of the research?​​

The university is "engaged" when the research is conducted by U-M faculty, staff, trainee, or other agent acting in connection to their university responsibilities.  See OHRP's Guidance on Engagement of Institutions for more information and examples.

Caveats:

• Direct awards from federal sponsors that meet criteria #1 and #2 are always reviewed by a U-M IRB, whether or not the university is engaged in the research.  
• If you answer "no" to any of these questions, you may have other obligations than IRB review.  See the U-M HRPP Operations Manual Part 4, Section V for more information about regulated/non-regulated research.