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. Examples include horrific experiments conducted on prisoners by Nazi doctors during World War II and the withholding of proven treatment from poor Black men as part of a study of untreated syphilis in Alabama. The Belmont Report, the Nuremberg Code, and the Declaration of Helsinki led to the development of the human subjects in research codes we have today.
Two criteria must be met for a study to be considered human subjects research. First, the study must be considered research according to §46.102: “Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Second, it must involve human subjects. According to §46.102, a human subject is “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:
Is the study considered research according to §46.102? If the answer is ‘No’, the study is not considered human subjects research. If the answer is ‘Yes’, the study is most likely human subjects research.
Will the study involve only secondary data or biospecimens collected for purposes other than this study, or belonging to deceased individuals? If the answer is “yes,” the research may not be considered human subjects research, provided the data/biospecimens come from deceased individuals, the researchers do not have access to participant identifiers, and/or a broad consent or waiver of documentation of consent has been obtained (see §46.116 and §46.117).
Author: Mary Lannon, PhD