Protecting Human Research Participants’ Reflection

Some critical circumstances significantly influenced the need for an effective policy that would help in protecting human subjects during research. First, this need arose as a result of different ethical concerns and historical events that surrounded the treatment of people who were participating in research studies. The circumstances were marked by the exploitation of subjects and the potential for harm during research. This led to the creation of regulations and guidelines that would help in ensuring the well-being and safety of participants. Another circumstance that forced the creation of the Nuremberg Code and other critical policies was the mass-scale atrocities committed toward the Jews and other prisoners during the Holocaust and the Second World War (Anabo et al., 2019). During these events, the Nazi doctors were engaged in trials that exposed individuals to deliberate mutilation, torture, murder, and mutilation.

There are specific ways in which human research subjects are likely to be exposed to harm during research studies. For example, there was a case whereby oxygen experiments were done on premature babies without consent from their mothers. Some studies have also been conducted have been conducted to find out if kidneys were cooled before transplants, they would generate fewer complications (U.S. Department of Health and Human Services, 2013). These studies were conducted with a lack of sufficient risk assessments for the recipients. Another example is the use of new gene editing technologies like CRISPR-Cas9. These technologies significantly pose serious challenges and risks to the protection of participants’ rights. Other examples are the Nazi medical experimentation and the Tuskegee Syphilis investigation. The need for laws and safeguards to guarantee that people who take part in investigation studies receive treatment ethically and that their liberties are safeguarded was made clear by these cases. Subjects involving humans have treated ethically today thanks to regulations like the Common Rule and the Belmont Report. Participants may suffer physical or psychological injury as a result of research practices or privacy violations.

Children, expectant mothers, and prisoners are three groups that need extra protection. Children lack the capacity for informed consent and may not completely grasp the hazards involved; fetuses are sometimes put at risk by experimental operations or treatments; inmates may feel pressured to participate because of their jail status (National Achieves, 2017). Aside from gaining informed consent, making sure subjects and their legal representatives are fully aware of the risks and advantages, and putting extra measures in place to protect participants’ welfare and rights, conducting experiments amongst these at-risk groups is subject to standards and limits. These conditions/restrictions are typically adequate, but there is ongoing discussion over the particular safeguards needed for these groups; ongoing assessment and improvement are required for the successful safeguarding of the rights and well-being of individuals participating in research.

I think beneficence is the most critical ethical principle followed by respect for participants and finally justice in the Belmont Report. Having the best interests of those participating in the study in mind might be interpreted broadly as beneficence. Researchers work to reduce risks to participants while maximizing advantages to individuals as well as society per the idea of beneficence (Anabo et al., 2019). The principle of beneficence, for instance, should prompt us to investigate other options for obtaining the same knowledge that poses fewer risks for subjects when deciding on a research design. However, being beneficent requires healthcare professionals to take into consideration specific circumstances and remember that what is advantageous for a particular individual probably isn’t advantageous for all patients. Respect for participants is also critical. It entails that everyone involved should be understandably given pertinent information before willingly agreeing to engage. The last one is justice. The division of the study’s costs and rewards is addressed by the justice principle. Putting it a different way, it ought not to be the case that one segment of society pays for study while another group benefits from it. When it comes to subject selection, justice-related considerations are more important.

References

National Achieves. (2017). Federal Policy for the Protection of Human Subjects. Federal Register. https://www.federalregister.gov/documents/2017/01/19/2017-01058/federal-policy-for-the-protection-of-human-subjects

Anabo, I. F., Elexpuru-Albizuri, I., & Villardón-Gallego, L. (2019). Revisiting the Belmont Report’s ethical principles in internet-mediated research: Perspectives from disciplinary associations in the social sciences. Ethics and Information Technology, 21(2), 137-149. https://doi.org/10.1007/s10676-018-9495-z

U.S. Department of Health and Human Services. (2013, December 4). Biobanking: When Issues with Tissues Come a Knockin’ [Video]. YouTube. https://www.youtube.com/watch?v=9r8cpgWs7j4