Learn eCORE frequently blogs on topics related to protecting the rights and welfare of human research participants.  This guest blog, from Solutions IRB, addresses a very basic but common question in research: How to determine if a study involves human subjects research.   Thanks to the Solutions IRB team for letting us share this with our readers.

What is Human Subjects Research?

National and international ethics codes form a framework for the protection of rights and welfare of human participants in research. These codes have developed over time in response to research misconduct such as the horrific experiments conducted on prisoners by Nazi doctors during World War II and the withholding of proven treatment from poor Black male participants in the Tuskegee study of untreated syphilis in Alabama. The Belmont Report Principles, the Nuremberg Code, and the Declaration of Helsinki led to the development of the U.S. federal Protection of Human Subjects regulations (45 CFR part 46) that we have today.

These regulations list two criteria that must be met for a study to be considered human subjects research.

• First, the study must be considered research according to 46.102: “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
• Second, the study must involve human subjects as defined in in  46.102 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 following questions can help researchers determine whether their study fits the criteria of human subjects research:

• Does the study meet the regulatory definition of “research”? If the answer is ‘No’, the study is not considered human subjects research.
• If yes, does the research involve human subjects as defined by the regulations?  If the answer is ‘No’, then it is not human subjects research. If it is yes, then the study is considered to be human subjects research. 

Will the study involve only secondary data or biospecimens collected for purposes other than this study?  If the answer is “yes,” the study may not be human subjects research, provided the data/biospecimens come only from deceased individuals, or none of the researchers have access to living participant identifiers, including waiver of documentation of consent if appropriate.

If the researchers have access to identifiers, the secondary research may qualify as exempt human subjects research category 4 or category 8 (with broad consent), or it may be non-exempt human subjects research (see §46.116 , §46.117, and §46.104 ).

An institutional review board (IRB) can serve as a valuable resource for helping investigators determine if the human subjects regulations described above are applicable to a specific research project.

About the Author: Dr. Mary Lannon is a public safety professional with a background in police and fire communications. She holds a PhD in Business Administration with a specialization in Homeland Security, and a master’s degree in Emergency and Disaster Management. Mary has nearly 10 years of experience teaching in programs related to emergency management, homeland security, criminal justice, and business. She also works with doctoral students as a dissertation chair and committee member, research topic reviewer, and research methods consultant. Mary has been with Solutions IRB since 2019 working as an IRB Reviewer and Quality Assurance Auditor.

About Solutions IRB:  Solutions IRB is a private, commercial, AAHRPP accredited Institutional Review Board. They are a team of experienced reviewers readily supporting researchers with IRB services, including the review of exempt, expedited, full board, minimal and greater than minimal risk studies. Solutions IRB is committed to protecting research participants, monitoring approved protocols, and providing outstanding customer service to our researchers. They provide quality and timely IRB review for many facets of studies, including social-behavioral, vulnerable populations, international, clinical trials, medical device, non-significant risk, and non-investigational new drug studies. Feel free to schedule a time here to discuss your research and what services they can provide for you!