Human Subjects Certification

Human Subjects Certification

In the past sixty years, the protection of human subjects in research has become a primary concern. This concern became part of a public discourse after specific research abuses were identified. Notable examples of abuse include the Nazi experiments on concentration camp prisoners and the US Public Health Syphilis Study at Tuskegee. As a result, proper protections when working with human subjects were developed.

  • 1974 – 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
  • 1979 – National Commission published the Belmont Report establishing three basic principles when working with human subjects: respect for persons, beneficence, and justice. (For more information, visit the United States Department of Human and Health Services)


Three Basic Principles

Respect for persons

 To respect an individuals’ autonomy is to respect their right to make informed decisions without interference.


To not only protect an individual from harm, but also to work for their well-being. To assess the risks and benefits to participation.


The principle of fair process and outcomes in the selection of participants. 


  • 1981 – Department of Health and Human Services (HHS) Code of Federal Regulations Title 45, Part 46 (45 CFR 46) established protections of human subjects
  • 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 Board (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 (PIs), etc.) receive training on the proper protocol for conducting research. 

One training program that is 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.

Check with your organization or institution to verify what, if any, human subjects protection training is required.


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