Draft Guidance Paper

Other important provisions to uphold are provisions eight and nine. These two provisions are very closely linked because provision eight requires that the nurse collaborates with other healthcare professionals in efforts to improve the quality of health care. This ties in with provision nine because it states that “the nurse also collaborates with other health care professionals and the public to promote community, national, and international efforts to meet health needs and for shaping social policy.” (Fowler, 2010, p. 124). For example, I am upholding provision eight by volunteering as a co-chair of a council partnership meeting (CPM) in the hospital that I work for. In CPM, we meet once a month to formulate ways to improve patient’s safety. At the same time, I am able to meet the standards of provision nine because we collaborate with others to conduct research to reform our policies and procedures to benefit our patient’s needs. To further illustrate, we recently have adopted the John Hopkins fall risk assessment score because research studies have shown that it has proven to be more effective in screening the patients based on their fall history, elimination of bladder and bowel, how many fall risk medications they are on,

In the famous Belmont Report, several guidelines regarding informed consent, assessment of risk and benefits, and selection of subjects in addition to ethical practice and procedure in the area of human research are outlined. The Belmont Report attempts to summarize the basic ethical principles identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (Belmont Report, 1979). In particular I would like to discuss the standards for informed consent, assessment of risk and benefits, and selection of test subjects drawn out by the Belmont Report. These three areas of interest are said to be the applications of the general

This temptation happens when the research question, such as a cure for cancer, is extremely important and the answer could save lives. If the investigators cared more about the scientific or medical advancement than the well-being of their participants, they would cross a line that prohibits treating human subjects as a means to an end. When this line is crossed, there is little left to protect patients from a callous disregard of their welfare for the sake of research goals. Informed consent would not matter because of the unbalanced relationship between the knowledge and authority among the researcher and the subject. Approval by an institutional board, although it is important, can be subject to change in its responsiveness to patients’ interests when they conflict with the welfares of the researchers. Going back to Paul’s case, he agrees to enter a clinical trial which was suggested by his oncologist. The study, that Paul has agreed to enter, has claimed that this research team has created a new drug that may be on its way to cure cancer. Obviously to a father and husband, this trial looks very appealing. However, the researchers knowingly form two groups that will compare two treatments. What Paul doesn’t know, is that one of the treatments is better than the other. One group will receive this new drug and the other group will receive a placebo. Comparing this new treatment

P2 Understand ethical issues relating to research in health and social care Ethical principles Protection from harm- In any health care setting it is always important to make sure that all the individuals in all the aspects of the area are being protected from harm. In any organization the most important policy is the protection policy this enables the staff to make sure that all the individuals feel safe. Protection from harm does not only mean being protected from abuse It could be protecting people's health and wellbeing and enabling them to live free from harm, neglect and abuse.

“Provision 1: The nurse, in all professional relationships, practices with compassion and respect for the inherent dignity, worth, and uniqueness of each individual, unrestricted by considerations of social or economic status, personal attributes, or the nature of health problems (American, 2014).”

This outlines the fact it is crucial to have the best external evidence including both clinical and professional inputs. It also highlights the patients’ rights preferences and their autonomy should be without doubt taken into account during the research process.

Institutional Review Boards (IRBs) are groups that are formally designated by an institution to protect the rights and the welfare of human subjects. This is done by reviewing, approving and monitoring the medical research (Layman & Watzlaf, 2009). However, in order to do this efficiently, there are 3 ethical theories that the IRB must rely on. The first theory is beneficence which means “do no harm/promote good”. The second theory is autonomy, and the third theory is justice. Furthermore, IRBs review all the research that is conducted via data sources regarding human participation (i.e. medical records, tumor registry, and Medicare data). That said, IRBs are important because they help protect the rights and welfare of those participating

Clinical Trial Participation In the popular television drama, Grey’s Anatomy, the main stars conducted a series of clinical trials that introduced Seattle into a new form of research. After their trial called the “Shepard Method” grew into a success, the program's audience became aware of clinical trials in reality. In the previous years, clinical trials have evolved and made a big impact on society. However, there is controversy about whether or not one should take part in clinical trials.

In the US, the initial system concentrated on physician knowledge about an intervention and not the patient requirement, i.e., the physician was to decide the best practice as well as information to disclose to a patient. However, there was a recognizable trend towards the informed consent (Culhane et al., 2012). A case between Salgo and Leland Stanfors Jr. University Board of Trustees clearly provided a clear indication of the court resistance and struggle to adopt the autonomous approach rather than the physician paternalism (Culhane et al., 2012). The jury argued that the patient has the right to information of any risk associated with a practice. However, they argued for the physician in the sense that he/she is placed in a position to make choices that protect the patient.

According to the American Nurses Association (ANA) states on the safeguarding and promotion of human rights pertaining to medical services in an essential function of the association. The nurses should be aware in the events where individuals have limited or diminished ability to exercise their rights and the ethical issues in particular the children, mentally disabled, and critically ill. (ANA, 2001).

The author believes that biomedical research is the way of better understanding medicine and without randomized clinical trials the field of medicine will have insufficient information. He argues that randomized clinical trials are the most scientifically sound and ethically correct means of evaluating new therapies. The belief of a physician being unethical when running randomized clinical trials is rejected by this article because previous trials on patients can have a better outcome on future patients. This article stresses that randomized clinical trials must be carefully designed that has an intended purpose of gathering data to improve the wellbeing of patients. If the patient is to endure a clinical trial he/she must be properly informed of the risks of the trial and the health of the patient should be high priority. Overall this article explains the importance of randomized clinical trials and debunks the idea of randomized clinical trials as being unethical. This article uses a utilitarian point of view and gives reasons why these trials can be in the best interests for both the patient and society.

As a professional nurse, I understand that prior to initiating nursing care and doing any procedure, it is very essential to obtain the client’s consent whether it is a non-invasive procedure and most especially if it is an invasive procedure. Obtaining consent before initiating any procedure means that they understand the whole process, the purpose, implications, advantages and disadvantages, risk factors, and possible adverse reaction of any procedure. It also means respecting their privacy and promoting their rights as a patient. Prior to assessment, before doing any physical examination or before touching and assessing any

or what they are undergoing. It is unethical to not be honest and open with participants about what

The vast majority of ethical dilemmas regarding research and the involvement of human participants is associated with concerns that are decidedly monetary in nature. Of course, the most fundamental concerns for any such research would be to protect the health and the welfare of those human participants (Callahan 1998). This statement becomes particularly true when such a population group pooled for research includes specialty subjects such as elderly people, pregnant women, and subsets that may be considered especially vulnerable. Although this consideration is widely viewed as something of a foregone conclusion concerning the subject of ethical dilemmas in research, it is actually an integral component of many of the pecuniary considerations regarding the ethics of human research. One of the principle questions of ethics in research is whether or not the information gained from human participants can be considered valid, when such participants are being paid or compensated in some way that could, conceivably, affect the results of whatever research is performed. Another ethical concern is raised by the efficacy and veracity of Institutional Review Boards who approve or validate the techniques of human research. Situations may very well arise in which members of those review boards have conflicts of interests with their professional duties as board members and the results of certain types of research.

Innovation and the “Change” process have gripped the clinical research Industry in the last few years. Evolution in technology and Risk Management processes consequently lead to release of the latest International Council of Harmonization (ICH) Good Clinical Practice (GCP) E6 R2 step 4 in Nov 2016. Change in the Clinical Research landscape also lead to revisions towards modernization and reinforcement of the “Common Rule” in Jan 2017 besides the Food and Drug administration’s (FDA) ongoing initiatives for paperless trials with the release of multiple guidance documents including electronic informed consent (Federal Register, 2017 and Mitchel & Helfgott, 2017). Other highlights of the Research Industry are FDA propagating