Belmont Rundown- Justice

By Brent Collinsworth

Published in 1979, the Belmont Report is the key document establishing a foundation of ethical research on human subjects. It notes the difference between ‘research’ and ‘practice’ and also outlines the three primary ethical principles for activities that meet the definition of human subjects research.  In a series of three IRB Connection Newsletter articles we are exploring these three principles:

• Respect for persons (August 2016)
• Beneficence (October 2016)

In December 2016, part 3 will conclude the series and cover the ethical principle of Justice and its application to human subjects research.

Justice:

The ethical principle of Justice can be summed up in a simple question: who receives the benefits and who bears the burden? Justice is concerned with what is fair and unfair. As it pertains to human subjects research, justice requires that participant selection be fairly distributed amongst the population. This means that no one group, population, or class of people should bear the burden of research alone without proper justification, and that the possibility of benefits in research should also be fairly available as well.

There are examples of violations of the ethical principal of Justice in human subjects research in the past. Many unethical studies in history put groups in society at risk simply because they were devalued by society at the time, or were already vulnerable. The Tuskegee syphilis study is a famous example of this. The subjects of the Tuskegee syphilis study were all underprivileged African-Americans that knew very little about their condition. The lead researchers capitalized on their lack of knowledge about syphilis and medical treatment in order to lie to them about their condition. This allowed the researchers to study the untreated progression of their disease for around 40 years. This would be a grave violation of Justice by today’s standards. There were individuals of all races and socioeconomic levels with syphilis who would have been able to participate in the study, but researchers chose to study a group that they saw as “lesser than” to bear the burden of participation. The syphilis study was not the only example of this type of violation, however. In America alone, there were countless other studies that disproportionally burdened prisoners, people in asylums, orphans, and other members of society seen as unvalued. Eventually, public outrage about these studies led to the National Research Act, which led to the publication of the Belmont Report specifying the ethical principles for conducting research involving human subjects.

It should be noted that researchers are not banned outright from conducting research with people who are economically or educationally disadvantaged, people of color, or even prisoners. But upholding the principle of Justice in research means that the inclusion of these subjects to the exclusion of all others must have a scientific reason or justification. In some cases, these justifications are required by regulations. For instance, Subpart C of the Code of Federal Regulations for the Protection of Human Subjects (45 CFR 46) puts specific restrictions on the type of research that can be conducted involving prisoners as subjects. Prisoners were once used as a convenient sample, ‘a captive audience,’ for research studies, and researchers were able to conduct research on them that was directly harmful and had no potential for benefit simply because they could. But now, according to the federal regulations for protecting human subjects, prisoners can only be used in a study when the study is directly related to imprisonment, or if there is a reasonable probability that the prisoners would benefit from the study. This will hopefully ensure that such kinds of violations of research ethics will never happen again.

The ethical principle of Justice also includes the concept that those who stand to benefit from the conduct of the research should also bear the burden of participating in it.  This means not conducting high-risk research in populations who do not stand to benefit from the results of the study.

Application:

The principle of justice most often comes into play when discussing participant recruitment. Researchers should address the principle of Justice on two levels: social justice and individual justice. Individual justice is concerned with the fair selection of participants, which means that researchers should not simply pick vulnerable or “undesirable” groups for participation in risky research. This ensures that the risks of research are evenly distributed. Social justice is concerned with whether researchers should use entire classes of subjects based on their vulnerability.

In order to properly ensure social justice, researchers should ensure that risky research is not conducted on groups that are potentially vulnerable, dependent, or unable to give free consent when other, less-burdened groups could participate. For instance, if researchers conduct high-risk research with no prospect of direct benefit on children when they could be using adults instead, it may be a violation of the principle of Justice. Researchers should be aware of the principle of social justice and attempt to find less vulnerable classes of persons to bear the burden whenever possible.

In order to address individual justice, researchers should ensure that they are not recruiting solely from vulnerable groups for research. Researchers should justify recruitment from a vulnerable subject group. For instance, researchers may want to study the relationship between extreme poverty and mental health. In this case, it may not make sense to recruit people of all socioeconomic backgrounds, since the results would not address the research question. In this case, researchers would have to justify the recruitment of predominately low-income individuals, to ensure that they are not overburdening a potentially vulnerable group without cause.

Researchers should follow the principles and guidelines in the Belmont Report to ensure ethical participation in research, proper management of risk and benefit, and equitable subject selection. Once researchers ensure these guidelines are followed, they will be well on their way to conducting human subjects research in a manner that protects the rights and welfare of all subjects.