All IRBs must operate by the same set of regulations; however universities may have their own additional policies.
The Nuremberg Code
The Nuremberg Code is a set of international research standards written during the Nuremberg Trials after World War II. The Code sets out ten points, focusing on the need for the informed consent of human subjects in research, willingness of researchers to terminate research at any point where human subjects are at risk. Additionally, the Code states that research should always have some value to society.
The Belmont Report
The Belmont Report is the standard for HHS research regulations. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research wrote this basic set of ethical research principles in 1979.
The three basic principles of ethical research are “respect for persons,” “beneficence” and “justice.” In other words, researchers must treat subjects respectfully by seeking informed consent (respect for persons), minimize risks to subjects (beneficence) and ensure that distribution of subjects is fair through sound research design and procedures (justice).
Federal Regulation 45.CFR.46
45.CFR.46 (or Title 45, part 46 in the Code of Federal Regulations) comes from the National Research Act of 1974, which outlines four kinds of human protections: (1) universal protections for all human research subjects, (2) additional protections for women, unborn and newborn infants, (3) additional protections for prisoners and (4) additional protections for children.
Documents like the Nuremberg Code and Belmont Report are important standards for IRBs to reference, but they are general guidelines that don’t account for the differences between human subjects. 45.CFR.46 makes specific protections to fill in the gaps, though these regulations don’t apply outside the United States.
CITI Program
The GCU IRB requires researchers to complete the “Basic Research” and “Responsible Conduct of Research” courses through the CITI Program, which certifies learners for five years. This requirement directly affects learners, who will need to have a strong understanding of research ethics under IRB oversight.