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Mary A

 Protection of human subjects is one of the many ethical responsibilities nurses have when participating in research activities or evidence-based practice. During my time taking Ethics and Human Subject Protection: A Comprehensive Introduction course, I learned more about past events leading to current research practices and why it is important to protect the rights, dignity, safety, and well-being of human research participants. I believe it is important that science should never come at the cost of human rights. Documents such as the Nuremberg Code, the Declaration of Helsinki, and Belmont Report have laid the ethical groundwork for research involving human subjects and how nurses can conduct investigations ethically and responsibly while keeping our patients at the center of our research.

One key takeaway that I had from this course was the importance of respecting human subjects. I learned that this ethical principle acknowledges the autonomy of all human beings and provides extra protections for vulnerable populations. According to the Belmont Report (1979), humans have the right to make their own decisions about participating in research once they are provided with adequate information about the study’s purpose, procedures, risks, expected benefits, and available alternatives (paragraph 3). Informed consent is more than just asking someone to sign a document before participating in research. Informed consent is a process of communication between researchers and participants. Consent should be obtained in a manner where participants understand what the research is about and feel comfortable voluntarily participating in the study without pressure or undue influence. In addition, this concept will help me remember to provide extra protection when working with children, older adults with cognitive impairment, prisoners, people who are from low socioeconomic backgrounds, or other populations who may fall into vulnerable categories.

My second key takeaway concept is the ethical principles of beneficence and nonmaleficence. This concept taught me that researchers have an ethical obligation to reduce the risk of harm and maximize potential benefits. I learned that every study should be carefully scrutinized before participants are enrolled to ensure that potential benefits outweigh any physical, psychological, social, legal, and financial risks. Investigators also have a responsibility to continuously monitor participants for safety throughout the study and take precautions to reduce unnecessary harm if possible. The World Medical Association (20 24) reminds us in the Declaration of Helsinki that “the well-being of the research participant must take precedence over the interests of science and society” (paragraph 32). This statement stood out to me because we are learning more about artificial intelligence, genomic medicine, and large-scale EHR databases being used for research purposes.

Another lesson I learned throughout this course was the ethical principle of justice. Justice focuses on fairness during participant selection and equal distribution of research benefits and burden. In the past, populations were targeted to participate in research because of their easy access through hospitals, low socioeconomic status, institutionalized against their will, or inability to refuse. The Belmont Report teaches us that researchers have an ethical responsibility not to choose populations that will bear the risks of research while another population receives most of the benefits (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). Fair recruitment of participants and access to research opportunities can help decrease health disparities and promote trust within the research community.

Lastly, this course reminded me of the importance of institutional review boards (IRBs) and regulations that protect human subjects in research. Nurses should never conduct research without permission from an IRB. IRBs serve as a governing committee to review protocols before enrollment of research participants. Their duty is to ensure the research study follows ethical principles, federal regulations, and institutional policies. They assess the risks and benefits of research, informed consent documentation, confidentiality, and protection of vulnerable populations. Continuous monitoring of the research study can also help protect human subjects by identifying any unintended consequences or breach in protocol that should be reported to the IRB. Modifications and termination of studies can occur if there is increased risk to participants. These safeguards have helped build public trust in research.

Why we still need ethical guidelines and review committees today was demonstrated throughout the course with historical documents. After World War II, many atrocities were exposed where humans were used in experiments without consent. The Nuremberg Code was created to protect human subjects involved in research by establishing voluntary informed consent as one of the requirements of research (Shuster, 20 22). Later, the World Medical Association created the Declaration of Helsinki to ensure physicians follow international ethical guidelines when performing medical research. This document is consistently being updated as medicine continues to advance. The Belmont Report embedded these ethical documents into set regulations that we follow today to protect human subjects.

The concepts I learned throughout this class parallel the AACN Essentials (20 21). Ethical guidelines correlate with Essential 4: Scholarship for Nursing Practice by translating research into practice through scientific investigation and use of evidence-based resources to provide patient care. Essential 5 Quality and Safety states that DNP-prepared nurses are responsible for reducing harm to patients while improving the outcomes of care. Providing ethical patient care should reduce risks and follow professional standards of practice. Lastly, Essential 9: Professionalism emphasizes accountability, advocacy, and ethical guidelines when conducting research. Learning about human subject protection will help you be a DNPrepared nurse by incorporating ethics when protecting human subjects during research activities.

In conclusion, I believe the ethical principles of research learned in this course will allow me to be a DNP leader that values human life. Ethics in research involved more than just following regulations and guidelines. There are many ethical principles that help protect human subjects including autonomy, informed consent, beneficence, justice, confidentiality, and continuous monitoring during every stage of research. We learned about historical events that should never happen again to the participants involved in the studies. As nurses move forward with research and innovating new ways to provide care my hope is that we never forget about our patients and continue to protect their rights and dignity by following ethical guidelines when serving our communities.

References

American Association of Colleges of Nursing. (20 21). The essentials: Core competencies for professional nursing education . https://www.aacnnursing.org/Essentials

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research . U.S. Department of Health, Education, and Welfare. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html

Shuster, E. (20 22). Fifty years later: The significance of the Nuremberg Code in contemporary human subjects research. The New England Journal of Medicine , 386 (7), 601–603.

U.S. Department of Health and Human Services. (20 24). Office for Human Research Protections (OHRP): Regulations and policy. https://www.hhs.gov/ohrp/index.html

World Medical Association. (20 24). Declaration of Helsinki: Ethical principles for medical research involving human participants. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-participants