This website is for educational purposes only. Please contact the Office of Research Integrity Assurance for information about applicable policies and regulations regarding research activities involving human beings or animals.
Historically, the term “human subject” largely referred to a person participating in medical, psychological, or other health-related research. Yet the term can apply to a broad range of research activities outside of those realms. Regardless of the type of research, significant ethical issues can emerge if human participants are involved.
A key ethical concept associated with human subjects research is called “informed consent.” Informed consent has three fundamental components:
- subjects being asked to participate in research should be adequately informed about the benefits and risks that may be associated with the research;
- subjects should not be coerced into making decisions about participating in the research, nor should they be forced to remain in the research if they decide to withdraw from it; and
- subjects must be competent to make decisions regarding their participation in research, which is in part determined by their age and mental capacity.
In general, each of the three components must be satisfied before a human being is enrolled in research. At a minimum, researchers should discuss the research protocol with potential subjects. Usually, they should also provide participants with a consent form, a document which is supposed to explain the proposed research in clear and thorough detail.
When conducting human subjects research, it is essential that researchers are familiar with the ethical principles delineated in the Belmont Report. These principles are: respect for persons, beneficence, and justice.
In accordance with federal regulations, each institution that receives federal funds for human subjects research must have at least one institutional review board (IRB). An IRB is responsible for reviewing the scientific, legal, and ethical merits of a research protocol involving human participants before the research starts and, depending on the type of research, while it is ongoing.
Researchers must check with an IRB before proceeding with a protocol involving human participants in order to ensure that those participants are adequately protected.
Other Links & Resources
- The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
- The Common Rule: Protection of Human Subjects (Title 45 Code of Federal Regulations Part 46)
- Federal Aviation Administration: Aerospace Medical and Human Factors Research
- FDA: Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs
- National Institutes of Health (NIH): Office of Behavioral and Social Science Research
- National Institutes of Health (NIH): Training & Resources - Human Subjects
- NIH Required Education in the Protection of Human Research Participants, June 5, 2000
- National Science Foundation: Human Subjects
- The Nuremberg Code
- U.S. Department of Education: Protection of Human Subjects in Research
- U.S. Department of Energy: Human Subjects Protection Program
- U.S. Department of Health and Human Services: Health Information Privacy
- U.S. Department of Health and Human Services: Office for Human Research Protections
- World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects