Informed Consent

Instructions are inside the attachment (Rubric, Guidelines and Other Requirements). This is based on Chapter 1 and 2 from the book: “The Ethics of Research with Human Subjects Protecting People, Advancing Science, Promoting Trust” by Resnik, David B.

ANSWER

Informed Consent

Introduction

Informed consent is a legal and ethical requirement for research involving human participants (Chatterjee and Das, 2021). In the research process, informed consent entails informing participants about all phases of the trial which are substantial for the participant to make judgments and after examining all the phases of the trial, the participant freely agrees their willingness to take part in a certain clinical trial and significance of the research for social welfare and advancement of medical knowledge (Resnik, 2018). Clinical research has been a cornerstone in the medical advancement and is vital to advancement of understanding of the diagnosis, epidemiology, treatment and disease results. This paper will focus on the issue of informed consent among patients during a clinical research among patients in an intensive care unit.

Informed Consent in Intensive Care Unit Clinical Research

Considerably, clinical research has remained a significant contributor to medical understanding and is a vital part of the medical world. After a number of Nuremberg trials during the Second World War, there were many documents published on ethical of clinical research. The documents focused on the need to respect human subjects with voluntarily participation being foremost among the ethical principles (Chatterjee and Das, 2021). The voluntarily participation has been enhanced by written informed consent.  Ethical principles such as respecting the patient autonomy ensure that informed consent has been obtained from the subjects during clinical research. However, clinical research in intensive care units has made it challenging to obtain informed consent. Several factors have influenced the content process in an intensive care unit especially among the critically ill patents. For instance, the critically ill patients are incapable of making decisions due to their condition. Relatively, the workload pressure and time constraints on attending physician may limit the consent opportunities leading to loss of eligible patients thus bias clinical trials and limited generalizability of their results.

In the last five decades, the need to recognize the moral right of clinical research participants to make their own decisions has been on the rise especially for clinical trials involving human subjects. An informed consent focuses on three vital and essential elements including information disclosure, voluntarism and decision making capacity (Bhatt, 2015). For a real informed and ethically valid consent, these critical elements need to be fully employed. However, one of the major issues in establishing informed consent among critically ill patients is that most have lost their capability to make judgment and comprise of vulnerable population that need reinforced and special protection (Ecarnot, Quenot, Besch and Piton, 2017). Decision making capacity of an individual compromises voluntarism. Decision capacity involves four elements of rational manipulation of the information, communicating and understanding. A capable individual needs to have a factual understanding of the given information which allows them to understand the risk, benefits and purpose of the clinical research.

Apart from the obvious circumstance of incapacity to make decisions, other conditions may rise that create ethical challenges. For instance, patients that are perceived to have decision capacity and approached for informed consent in an intensive care unit may have challenges with the consent forms that are complicated, long and hard to comprehend for patients that are coping with the life threatening health condition (Sorice, 2022). Relatively, there may be a mismatch between the levels of education required to understand the informed consent form or a mismatch between the patient and the information provider. This means that communication may fail to realize the objective of passing truthful information to the patient about the clinical research.

Conclusion

In summation, obtained informed consent during a clinical research remains a complex and sensitive ethical issue. Obtaining informed consent among patients in an intensive care unit during clinical research is challenging due to the conditions that pose practical issues where informed consent cannot be obtained from a real subject. Despite the fact that a standard informed consent is vital in clinical research, it is challenging to warrant the ethical principle in an intensive care unit clinical research.

References

Bhatt, A. (2015). Improving quality of informed consent in clinical research. Journal of postgraduate medicine, 61(4), 221.

Chatterjee, K., & Das, N. K. (2021). Informed consent in biomedical research: Scopes and challenges. Indian Dermatology Online Journal, 12(4), 529.

Ecarnot, F., Quenot, J. P., Besch, G., & Piton, G. (2017). Ethical challenges involved in obtaining consent for research from patients hospitalized in the intensive care unit. Annals of translational medicine, 5(Suppl 4).

Resnik, D. B. (2018). The ethics of research with human subjects: Protecting people, advancing science, promoting trust (Vol. 74). Springer.

Sorice, V. (2022). Valid informed consent and decision-making capacity in clinical trials. Nursing Times.