The three Belmont principles (respect for persons, beneficence, and justice) have been interpreted and described in a series of ethical norms. These norms operationalize the principles, describing actions that should or should not be taken when conducting research with human subjects. To conduct ethical research with human beings, investigators must incorporate these norms into their protocols. IRB members evaluate the procedures found in research protocols against these norms and ensure that the research will be conducted ethically (e.g., according to these ethical norms) before approving a protocol. If only life were this easy.
The National Commission intended for each of the principles to have equal moral force, and there is no rank order of these principles to resolve disputes when they conflict (which inevitably happens). However, the norms derived from the principles do not have equal moral force. The requirements of some norms must be met before others are even evaluated. For example, if the research design is poor or the investigator is not competent, the research will not result in generalizable knowledge and there will be no benefit to society if the research is conducted. The IRB will not approve the protocol after reviewing the first two ethical norms (good research design and competent investigators), and there is no need for the IRB to evaluate the protocol for compliance with other norms such as a favorable balance of harm and benefits, informed consent, and equitable selection of subjects.
But what happens in cases where protocols have good research design, the research will be overseen by competent investigators, and other norms conflict? In these cases, the IRB must judge the forcefulness of the norms in conflict based on the facts before them and select, in its view, the most ethical solution. In some cases the Federal regulations have anticipated some common conflicts and provide guidance to the IRB. For example, an investigator may conduct a study reviewing medical records without the consent of the individuals whose data he or she is reviewing. In this example, the ethical norm (informed consent) derived from the principle of respect for persons and the ethical norm (favorable balance of harm and benefit) derived from the principle of beneficence are in conflict. The regulations allow for a waiver of informed consent in the interest of pursuing benefits if certain conditions are met. Implicitly the regulations say that beneficence prevails when there is very little at stake with regard to self-determination. In other cases there is no direct regulatory guidance on which IRBs can base their decisions. The weighing and prioritizing of conflicting ethical norms is a difficult task and is routinely carried out by investigators and IRBs as they write, review, and approve research protocols through discussion and debate. The ethical norms derived from the Belmont principles are binding unless they are in conflict with other norms or there is some other ethical justification for overriding the norms’ requirements.
The rest of the modules in this resource describe some of these ethical norms and provide practical guidance on meeting their requirements in various research settings.