The protection of human subjects in research has become a primary concern over the last 60 years, especially after specific research abuses were identified. Notable examples of abuse include the Nazi experiments on concentration camp prisoners and the U.S. Public Health Syphilis Study at Tuskegee. As a result, a set of protections for human subjects were developed.
In 1974, the United States Congress passed the National Research Act, which established the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research and the requirement that human subjects in research be protected.
In 1979, the Commission published the Belmont Report, establishing three basic principles when working with human subjects.
Three Basic Principles
| Respect for Persons | To respect an individual's autonomy is to respect their right to make informed decisions without interference. |
| Beneficence | To not only protect an individual from harm but also to work for their well-being; to assess the risks and benefits to participation. |
| Justice | The principle of fair process and outcomes in the selection of participants. |
For more information, visit the United States Department of Health and Human Services.
In 1981, the Department of Health and Human Services (HHS) Code of Federal Regulations Title 45, Part 46 (45 CFR 46) established protections for human subjects.
In 1991, 45 CFR 46, or the Common Rule, was adopted by several federal agencies and departments, providing protection for human subjects and requiring institutional review boards (IRBs) to oversee research involving human subjects.
To ensure that regulations are followed when working with human subjects (study participants), it is important and often required that researchers (data collectors, principal investigators, etc.) receive training on the proper protocol for conducting research.
One training program affiliated with many organizations and universities is the Collaborative Institutional Training Initiative (CITI). An online training course and certification is offered on this site. To fully participate in the CITI certification, you must be associated with a participating institution.
Every organization and institution has its own guidelines on what, if any, human subjects protection training is required.