Post a 350- to 700-word response explaining how current laws and regulations have changed health care research as a New Message into the discussion area. Address the following:
- Do laws and regulations protect patients or do health professionals protect patients?
- How would the events that led to the discovery and experimentation with HeLa cells have been different if they occurred today?
Cite at least 2 peer-reviewed, scholarly, or similar references.
Format your citations according to APA guidelines.
Expert Solution Preview
Introduction:
Health care research plays a fundamental role in improving health outcomes, developing new treatments and diagnostic tools, and managing healthcare delivery. However, research involves several ethical, legal, and regulatory considerations that must be taken into account to ensure that patients are protected from harm and their rights are respected. In this paper, we will explore how current laws and regulations have changed health care research and how they impact patients and health professionals. Additionally, we will discuss how the events that led to the discovery and experimentation with HeLa cells would have been different if they occurred today.
Do laws and regulations protect patients or do health professionals protect patients?
Health care research is subject to various laws, regulations, and guidelines aimed at protecting patients from harm, ensuring their privacy and confidentiality, and promoting ethical conduct. These laws and regulations provide a framework for the research, defining the roles of researchers, sponsors, and regulators, and outlining the procedures for obtaining informed consent, protecting vulnerable populations, and reporting adverse events.
Therefore, laws and regulations do not solely protect patients, but they also protect health professionals from legal and ethical consequences of misconduct. By setting standards and guidelines for research, they help researchers to conduct the research in a manner that ensures the safety and protection of patients’ wellbeing. In addition, laws and regulations help health professionals make informed decisions about the potential risks and benefits of research while respecting patients’ autonomy.
How would the events that led to the discovery and experimentation with HeLa cells have been different if they occurred today?
The HeLa cells incident is one of the most significant ethical issues in medical research that has shaped current laws and regulations. If the events that led to the discovery and experimentation with HeLa cells occurred today, several aspects would be different from what happened in the past.
First, there would be more stringent guidelines and procedures for obtaining informed consent to ensure that patients or their relatives have the right to decide how their cells or tissues are used in research. The HeLa cells were taken without Henrietta Lacks’ consent, and her family subsequently were not informed about the use of her cells. However, with the current regulations, researchers must obtain explicit and informed consent from participants in research studies.
Second, there would be more emphasis on respecting the privacy and confidentiality of individuals participating in research studies. The HeLa cells controversy exposed the flaws in managing the confidentiality of research participants’ data, leading to questions about individuals’ privacy and confidentiality.
Third, researchers must ensure that the research they conduct is necessary and will lead to improved health outcomes. The HeLa cells were used for decades to study cancer and other diseases, leading to significant contributions to medical knowledge. However, in current times, researchers must justify the potential medical benefits of the research and ensure it is necessary and ethical.
Thus, laws and regulations developed over time would have prevented the issues surrounding the research of HeLa cells that occurred in the past. These regulations have brought medical ethics awareness and made researchers more accountable for their conduct while conducting research studies.
References:
National Academies of Sciences, Engineering, and Medicine. (2016). Informed Consent and Health Literacy. In Discussion Framework for Clinical Trial Data Sharing: Guiding Principles, Elements, and Activities. The National Academies Press.
Johansen, K., & Marulanda, F. (2021). Accountability of medical professionals and researchers. Oxford University Press.
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