Introduction

Human research has been crucial for advancing human health and well-being (University of Alaska Fairbanks, n.d.). It is essential to prioritize the safety of human research subjects in studies and experiments (University of Alaska Fairbanks, n.d.). Ethical guidelines play a critical role in preventing unethical treatment or abuse of study participants (University of Alaska Fairbanks, n.d.). Maintaining the integrity of these studies requires stringent measures to protect human research subjects from any form of exploitation.

History and Importance of Human Subject Protection

The protection of human subjects has evolved significantly over the past century in response to unethical research practices (White, 2020). Historically, vulnerable groups such as children and inmates were exploited as research subjects without informed consent (White, 2020). Notable instances include the Tuskegee Experiment and experiments conducted in German concentration camps during World War II (White, 2020). For example, the Tuskegee Experiment involved 399 syphilis patients and 201 uninfected controls who were denied both informed consent and treatment (White, 2020). In German concentration camps, captives were subjected to harmful medical procedures resulting in suffering, illness, and death (White, 2020).

Types of Research Activities Involving Human Subjects

According to the Health and Human Services Policy for Protection of Human Research Subjects, human subjects encompass individuals whose personal data and biological samples are investigated, examined, or evaluated by researchers (National Institute of Dental and Craniofacial Research, 2022). This definition extends to those whose private information or biospecimens are used in research settings (National Institute of Dental and Craniofacial Research, 2022). Human subject research encompasses two main types: observational studies, which involve data collection without specific interventions, and interventional studies, which modify biological or cognitive systems through participant or environmental changes (National Institute of Dental and Craniofacial Research, 2022).

Strategies to Minimize Risks to Research Participants

Throughout history, human research subjects have faced risks without adequate understanding or consent (White, 2020). Various strategies have been implemented to mitigate these risks, such as The Nuremberg Code, established in response to unethical research practices in German concentration camps, which delineates fundamental principles for human subject research (White, 2020). The Belmont Report, released in 1979, introduced principles of respect for persons, beneficence, and justice, emphasizing informed consent, risk assessment, and subject selection (CITI Program, n.d.) (White, 2020).

Ethical Standards in Research

Before the Belmont Report, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research developed Institutional Review Boards (IRBs) to oversee biomedical research involving human subjects (White, 2020). IRBs are authorized bodies that ensure adherence to federal and institutional standards, thereby safeguarding the rights and well-being of research participants (US Food and Drug Administration, 2019).

Protections for Vulnerable Populations

Federal regulations, including the Common Rule issued by the Department of Health and Human Services, provide specific protections for vulnerable populations participating in human research (US Department of Health & Human Services, 2020). These regulations include subparts aimed at safeguarding pregnant women, human fetuses, neonates, prisoners, and children (CITI Program, n.d.) (US Department of Health & Human Services, 2020).

Conclusion

Human research is indispensable for advancing medical knowledge and improving public health. By upholding the rights and welfare of human subjects, we facilitate critical scientific advancements while ensuring equitable and respectful treatment of study participants. The evolution of ethical standards in human research underscores the necessity for robust safeguards to protect the well-being of all individuals involved.

References

CITI Program. (n.d.). Retrieved from https://about.citiprogram.org/en/homepage/

National Institute of Dental and Craniofacial Research. (2022, June). Human subjects research overview. Retrieved from https://www.nidcr.nih.gov/research/human-subjects-research

The National Commission for the Protection of Human Subjects of Bio