Patient Advocacy and Autonomy
Grand Canyon University: HLT 312V
Patient Advocacy and Autonomy
On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (Office, 2018). The Belmont Report summarizes the basic ethical principles identified by the Commission in the course of its deliberations. The Belmont Report is one of the leading works concerning ethics and health care research. Its primary purpose is to protect subjects and participants in clinical trials or research studies. The Belmont report consists of three principles: beneficence, justice, and respect for persons. It also consists of three applications: Informed Consent, Assessment of Risks and Benefits, and Selection of Subjects.
Significance of Autonomy
Patient autonomy is described as a fundamental ethical principle in healthcare. It is the right of the patient to determine their own health issues. Physicians are required to respect patients’ autonomy by giving them the information needed to understand all of the risks and benefits of a proposed intervention/ treatment; as well as the reasonable alternatives if there are some and sometimes there are no alternatives available; all of this is completed so that the patient can make an independent decision. Expressing respect for patients’ autonomy means that you acknowledge that patients who have decision making capacity have the right to make their own decisions regarding their care even if it goes against the wishes of the providers recommendations (Sedig, 2016).
A patient advocate helps patients communicate between their health care providers so that they can get all of the information that is needed to make a decision about their health care plans. Having the patients’ best interest should always be a top priority. We need to also make sure when we are being an advocate for the patients’ that they clearly understand the information so that they can make the best decision for themselves. If they don’t understand something but still continue on with the study it could end up being a big issue later on in the study.
Informed consent is a voluntary un-coerced decision made by a competent autonomous individual to accept or reject some proposed course of action. Valid informed consent for research must include three major elements: (1) disclosure of information, (2) competency of the patient (or surrogate) to make a decision, and (3) voluntary nature of the decision. US federal regulations require a full, detailed explanation of the study and its potential risks (Hammami, 2014).
When Adolf Hitler came to power, Nuremberg became the heart of Nazi rule, home to the Nazi leaders and center of anti-Semitic propaganda (Jarmusik, 2019). The Nuremberg trials were held for the purpose of bringing Nazi war criminals to justice. The Nuremberg trials were a series of 13 trials that were carried out in Nuremberg, Germany, between the years of 1945 and 1949. Judges from the following Allies; Great Britain, France, the Soviet Union, and the United States presided over the hearings of 22 major Nazi criminals (Jarmusik, 2019). The Nuremberg Code is one of the most influential documents in the history of clinical research to date. The Nuremberg Code aimed to protect human participants from enduring the kind of cruelty and exploitation that the Jewish prisoners endured at concentration camps. The 10 elements of the Nuremberg code are:
•Voluntary consent is essential
•The results of any experiment must be for the greater good of society
•Human experiments should be based on previous animal experimentation
•Experiments should be conducted by avoiding physical/mental suffering and injury
•No experiments should be conducted if it is believed to cause death/disability
•The risks should never exceed the benefits
•Adequate facilities should be used to protect subjects
•Experiments should be conducted only by qualified scientists
•Subjects should be able to end their participation at any time
•The scientist in charge must be prepared to terminate the experiment when injury, disability, or death is likely to occur.
The Nuremberg Code is one of several foundational documents that influenced the principles of Good Clinical Practice (GCP). Good Clinical Practice is an attitude of excellence in research that provides a standard for study design, implementation, conduct and analysis (Jarmusik, 2019).
Declaration of Helsinki
The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. It is the duty of the physician to promote and safeguard the health of the patients (NIH, 2019).
The ethical principles that nurses must adhere to are the principles of justice, beneficence, no maleficence, accountability, fidelity, autonomy, and veracity. Justice is fairness (NIH, 2019). The goal of clinical research is to develop generalizable knowledge that improves human health or increases understanding of human biology (NIH, 2019). People who participate in clinical research make it possible to secure that knowledge and help pave the way for future generations. The path to finding out if a new drug or treatment is safe or effective, for example, is to test it on patient volunteers. But by placing some people at risk of harm for the good of others, clinical research has the potential to exploit patient volunteers. The purpose of ethical guidelines is both to protect patient volunteers and to preserve the integrity of the science (NIH, 2019).
The ethical guidelines in place today were primarily a response to past abuses, the most notorious of which we all know is the Concentration camps during World War 2. Some of the influential codes of ethics and regulations that guide ethical clinical research include the following:
•Nuremberg Code (1947)
•Declaration of Helsinki (2000)
•Belmont Report (1979)
•U.S. Common Rule (1991)
Institutional Review Board
In order to minimize potential conflicts of interest and make sure that a study is ethically acceptable before it even begins, an independent review panel with no vested interest in the study at question should review the proposal and ask important questions (NIH, 2019). Questions such as: Is the study free of bias? Is the study doing all it can to protect the volunteers? Has the trial been ethically designed and is the risk/ benefit ratio favorable? Independent review of clinical research by an IRB is required for US studies funded by the Department of Health and Human Services (DHHS) and other US federal agencies, as well as for research testing interventions—such as drugs, biologics, and devices—that are under the jurisdiction of the US Food and Drug Administration (FDA) (Enfield, 2008). Institutional review boards (IRBs) or research ethics committees provide a core protection for human research participants through advance and periodic independent review of the ethical acceptability of proposals for human research. IRBs were codified in US regulation just over three decades ago and are widely required by law or regulation in jurisdictions globally (Grady, 2015).
Examples Belmont Report has helped
Just as the principle of respect for persons finds expression in the requirements for consent, and the principle of beneficence in risk/benefit assessment, the principle of justice gives rise to moral requirements that there be fair procedures and outcomes in the selection of research subjects (Office, 2019). Some great examples where the Belmont Report has helped in research are with prisoners. Some feel that if you’re a prisoner you should not have any rights anymore. The Belmont Report makes sure that even prisoners have rights when it comes to their health care. The resulting analysis emphasizes five broad actions to provide prisoners involved in research with critically important protections: (1) expand the definition of the term prisoner; (2) ensure universally and consistently applied standards of protection; (3) shift from a category-based to a risk-benefit approach to research review; (4) update the ethical framework to include collaborative responsibility; and (5) enhance systematic oversight of research involving prisoners (Gostin, 2007).
Another great example is with minors, informed consent cannot be given until someone has reached the age of 18. However minors can still participate in research as long as their legal guardian signs consent on their behalf. Some studies might even start when they are not 18 and continue after they turn 18 and at that point a new consent has to be signed because they are of age.
All of these guidelines are in place so nobody is taken advantage of or abused. We all have rights and these guidelines helped make sure no boundaries are crossed. It holds everyone accountable for their actions and if something is done out of context it is addressed accordingly. Research will always be part of health care; new medications, new cures and hopefully helping those who need the help get better.
Enfield KB, & Truwit JD. (2008). The purpose, composition, and function of an institutional review board: balancing priorities. Respiratory Care, 53(10), 1330–1336. Retrieved from https://search-ebscohost-com.lopes.idm.oclc.org/login.aspx?direct=true&db=ccm&AN=105568230&site=eds-live&scope=site
Gostin, L., Vanchieri, C., & Pope, A. (2007). Ethical Considerations for Research Involving Prisoners. Retrieved from https://www.nap.edu/read/11692/chapter/2.
Grady, C. (2015, November). Institutional Review Boards: Purpose and Challenges. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4631034/.
Hammami, M. M., Al-Gaai, E. A., Al-Jawarneh, Y., Amer, H., Hammami, M. B., Eissa, A., & Qadire, M. A. (2014, January 10). Patients’ perceived purpose of clinical informed consent: Mill’s individual autonomy model is preferred. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3897892/.
Jarmusik, N. (2019, April 9). The Nuremberg Code And Its Impact On Clinical Research. Retrieved from https://www.imarcresearch.com/blog/bid/359393/nuremberg-code-1947.
NIH. (2019). Ethics in Clinical Research. Retrieved from https://clinicalcenter.nih.gov/recruit/ethics.html.
Office for Human Research Protections, & Ohrp. (2018, January 15). Read the Belmont Report. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html.
Sedig, L. (2016, January 1). Whats the Role of Autonomy in Patient- and Family-Centered Care When Patients and Family Members Dont Agree? Retrieved from https://journalofethics.ama-assn.org/article/whats-role-autonomy-patient-and-family-centered-care-when-patients-and-family-members-dont-agree/2016-01.
The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. [Bethesda, Md.]: The Commission.