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NR439 Week 4: Ethical and Legal Issues

This is a graded discussion: 50 points possible

Week 4: Ethical and Legal Issues

Stefaniak, M., & Mazurkiewicz, B. (2017). The importance of adhering to high standards of research ethics. British Journal of Nursing, 26(1), 62. http://proxy.chamberlain.edu:8080/login?url=http://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=120706824&site=eds-live&scope=site

 (Links to an external site.)

Feeney, S., & Freeman, N. K. (2016). Ethical issues: Responsibilities and dilemmas. YC: Young Children, 71(1), 86. http://proxy.chamberlain.edu:8080/login?url=http://search.ebscohost.com/login.aspx?direct=true&db=edb&AN=114680496&site=eds-live

Questions for first article:

  1. Describe one reason for adhering to high standards in ethics.
  2. What are the dangers of conflict of interest?

Questions for second article:

  1. Discuss the difference between ethical responsibility and ethical dilemma.
  2. Share an experience of ethical dilemma or moral distress in nursing today.

 Class,

Research integrity rests on the ethical principles of respect, beneficence, and justice in its treatment of human subjects. The goal of research is always to minimize the risks and maximize the benefits for human subjects.
National and global guidelines have been put into place to protect people that participate in the study. Consider vulnerable populations and how can we protect them in a research study (Houser, 2018).
Remember required reading does not count toward outside resources.
Happy Reading!!
Dr. Taulbee

Dr. Taulbee and Class,
Ethical responsibility and ethical dilemmas are about choices. Responsibility involves doing what is known to be right or wrong. It involves mandates or rules that are set forth by the code of ethics and tells you what you can and cannot do.
The article describes a dilemma as a, “Situation for which there are two possible resolutions, each of which can be justified in moral terms. It requires a person to choose between two actions, each having some benefits but also having some costs. In a dilemma the legitimate needs and interests of one individual or group must give way to those of another individual or group”. (Feeny & Freeman, 2016).
One ethical dilemma or moral distress in nursing today is, the use of medical marijuana. Marijuana is legal in a lot of states and medical marijuana is becoming more popular in the use for a multitude of illnesses, especially cancer patients, as an appetite stimulant and for glaucoma. There are some nurses who are against the use of marijuana and some who are for it. With marijuana being legal in a lot of states and proven beneficial in the medicinal realm, its use is still frowned upon by a lot of society.
Germaine
                                                          Reference

Feeney, S., & Freeman, N. K. (2016). Ethical issues: Responsibilities and dilemmas. YC: Young Children, 71(1), 86.

Dear Germaine,
I appreciate your post about medical marijuana. There really does seem to be some benefits to its use by certain groups of patients. Your argument in the post could have been strengthened by a reference to studies that confirm the benefits. At this point in your education and in this class, you must support your opinions with research. Please take this post to you as a gentle reminder to double check all your ideas with recent literature that is scholarly.
Your post is well organized and clear to read. Good job.
What is the role of the institutional review board in research?
Thanks,
Dr. Taulbee

Thank you Dr. Taulbee ,
“Despite large gaps in knowledge regarding marijuana’s potential benefits and side effects, most researchers agree that the drug and its principal chemicals, or cannabinoids, have shown at least some use in reducing pain, alleviating nausea and vomiting, and stimulating appetite. “Both cannabis and cannabinoid pharmaceutical can be helpful for a number of problems, including many affecting patients with cancer”, concludes a recent review in a CA: A Cancer Journal for Clinicians”. (Cancer Cytopathology, 2015).
                                                        Reference
Medical Marijuana: Hints of Headway? Despite a conflicted regulatory landscape, support for medical marijuana is growing amid increasing evidence of potential benefits. (2015)(n.d). CANCER  CYTOPATHOLOGY, 123(2), 67-68. Available from: Science Citation Index, Ipswich, MA. Accessed November 18, 2017
What is the role of the institutional review board in research?
Dr. Taulbee and Class,
“The IRB is made up of a wide variety of professionals who evaluate a study from their area of expertise. There is a lot of research experience on the IRB. Its members pays particular attention to the risks and benefits of each study, and it is clear their focus is on protecting the rights of subjects. But they can also give you excellent advice and suggestions to make your study stronger and ensure it is ethical. They also give good feedback about the soundness of the overall study design and the ability of the study team to perform this particular research” (Houser, 2018).
There are three categories of research review by an IRB: Depending on risk and subject demographic, a proposal will fall into one of three categories: exempt, expedited, or full board review.
An Exempt Research review is a proposal that the IRB has determined that it does not requiring a review. The subject proposed is considered low risk. Some low risk subjects are those in, involving normal educational practices, surveys, and consumer acceptance studies.
Expedited Review involves proposals that do not qualify as an exempted review. It poses minimal risk to subjects and requires one or two IRB members participation. An example of am exempted review are those that doesn’t include intentional deception, employ sensitive populations or topics, and includes appropriate informed consent procedures. For example, the collection of physical data through non-invasive procedures is eligible for an expedited review, including: Race, gender and marital status.
A Full review is a proposal that pose more than minimal risk to subjects, that do not qualify for exempt status, and in which the full IRB committee participates. It involves, research that is judged to involve more than minimal risk, or involves protected populations such as children, prisoners, or disabled individuals, must undergo a full board review. Projects may provide misleading information to participants and plan to use procedures that are intrusive, stressful, or potentially traumatic.
                                                          Reference
Houser, J. (2018). Nursing research: Reading, using, and creating evidence (4th ed.). Sudbury, MA: Jones & Bartlett. pp. 49-78


Thank you for your informative post. I agree with the use of medical marijuana when treating diseases that it has been effective in treating. When I worked in long-term care we used a pill version of marijuana for the residents that had a loss of appetite when nothing else worked and it did increase their appetite but they don’t use this form of medication anymore.
Tyangala


 Professor and Class,
One major reason for adhering to high standards of ethics is so that the quality of research can remain at high levels. Without ethics, research and studies have the possibility of becoming littered with researchers racing to publish their information before others and publishing unreliable information (Stefaniak & Mazurkiewicz, 2017). Also, money talks. With questionable or low standards of ethics, there would surely be an onslaught of research funded by corporations in an effort to promote their products or ideas. Both unreliable information or corporately funded studies have the possibility of getting out wrong or biased information to the public (Stefaniak & Mazurkiewicz, 2017). Once an unethical research study is discovered, that causes lack of respect for the scientific community.
A major danger of conflict of interest in research is the withholding of information to the public and patients in order to keep a company or a product in good light. For example, if a study is completed on the efficacy of a medication produced by a company and that company funded the study, then it is more likely that the researchers will exclude any negative data they find regarding the medication. Sitges-Sierra (2014) describes a situation in which he and his researchers were basically blocked out of publishing their findings of the issues caused by bacteria during the initial manipulation of intravascular catheters in major medical journals. Because their findings contradicted the expert information previously reported in the medical journals about the complete safety of the catheters, thousands of cases of catheter-related sepsis harmed patients until 2001 when the United States issued guidelines that assisted in the prevention of contamination (Sitges-Serra, 2014).
Sitges-Serra, A. (2014). Clinical guidelines at stake. Journal of Epidemiology and Community Health, 68(10), 906. doi:http://dx.doi.org.chamberlainuniversity.idm.oclc.org/10.1136/jech-2014-203862
Stefaniak, M., & Mazurkiewicz, B. (2017). The importance of adhering to high standards of research ethics. British Journal Of Nursing (Mark Allen Publishing), 26(1), 62. doi:10.12968/bjon.2017.26.1.62

The Belmont Report focuses on 3 different principles.  The areas surrounding the Belmont report are to ensure safety of the human population in clinical research studies. The 3 types of principles are beneficence, justice and respect for a person. (Sims, Jennifer M)

Sims, Jennifer M. MSN, RN, ARNP, CCRN. “A Brief Review of the Belmont Report: Dimensions of Critical Care Nursing.” LWW, 2010, journals.lww.com/dccnjournal/Abstract/2010/07000/A_Brief_Review_of_the_Belmont_Report.7.aspx

Dr. Taulbee,
The Belmont Report is the summary of the ethical principles the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research considered while discussing the National Research Act of 1974. During the four days of deliberation, the Commission came up with three ethical principles that should be followed in order to ensure that the human research subjects were involved in a safe and ethical manner. These principles were:
Respect for Persons – meaning that all subjects agreed to be a part of the study. As a further precaution, if a subject was to no longer have the capacity to choose to be part of the study then they are entitled to protections. Basically, all participants of the study must be made aware, understand what they are agreeing to, and give their consent to be a human research participant.
Beneficence – the researchers must always have the safety and health of the research subject as the ultimate goal when conducting a research study.
Justice – “Fairness in distribution” and “what is deserved.” This is to ensure that vulnerable populations are not being singled out to participate in the study because they are easy to manipulate. Also, this principle is to ensure that once the study is completed only those wealthy enough to purchase the medications or devices (or basically whatever the subjects were being tested with) are the ones to reap the benefits of the human research study participants.
Department of Health, Education, and Welfare. (2016, March 15). The Belmont Report. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html

Dr. Taulbee and Class,
Its full title is the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Published in 1979, The Belmont Report is one of the leading works concerning ethics and health care research. It allows for the protection of participants in clinical trials and research studies. “The Belmont Report is an important document for research today. One purpose of this document is to protect the rights of human subjects in clinical trials. These rights are protected through the use of 3 ethical principles: (1) beneficence, (2) justice, and (3) respect for persons.” (Sims)
Outlined by Jennifer Sims in her article “A brief review of the Belmont Report”, she states 7 things nurses, as primary caregivers for individuals participating in a study, must do to ensure the rights of the participant is met.

          • Ensure the study is approved by an IRB
          • Get informed consent from the patient
          • Ensure that the patient understands the full extent of the experiment, and if not, will contact the study coordinator
          • Ensure the patient wasn’t coerced into doing the experiment by means of threatening or bullying
          • Be careful of other effects of the clinical trial that were not mentioned, and report it to the proper study coordinator
          • Support the privacy of the patients identity, their motivation to join or refuse the experiment.
          • Ensure that all patients at least get the minimal care needed for their condition\
          • Reference: Sims, Jennifer, MSN, RN, ARNP, CCRN (2010) A Brief Review of the Belmont Report, Dimensions of Critical Care Nursing, Volume 29(4), July/August 2010, pp 173-174 Retrieved from http://ovidsp.tx.ovid.com.chamberlainuniversity.idm.oclc.org/sp-3.27.1a/ovidweb.cg
      • Kimberly,
        As you said standards of ethics play a major role in good quality research. Allot if this data that is gathered during research could determine management for many different patient issues. Standards of ethics in research could determine the outcome of many different patients.
        Bryan Alvarez
        Stefaniak, M., & Mazurkiewicz, B. (2017). The importance of adhering to high standards of research ethics. British Journal Of Nursing (Mark Allen Publishing), 26(1), 62. doi:10.12968/bjon.2017.26.1.62
  • Dr. Taulbee & class,
    Ethics is by far one of my favorite things to discuss. Houser (2018) defines ethics as a type of philosophy that studies right and wrong. Sounds simple right? Wrong. The difficulties when it comes to ethics is described in the second article, Ethical issues: Responsibilities and dilemmas. Feeney & Freeman (2016) discuss the difference between ethical responsibility and ethical dilemma, stating the two can never overlap, the case in question will be one or the other. Ethical responsibility is abiding by the code of conduct. There is no grey area, the rules are explained, and it is the ethical responsibility that those rules are followed. An ethical dilemma is that when the choices are not so black and white. Feeney and Freeman put it simply, saying it is choosing between two rights.
    I would like to share an ethical dilemma I had a few years back that still upsets me today. We had a patient who was in and out of the hospital as he was coming close to the end of his life. He was older, in his 80s and had recently lost his wife, he had verbalized multiple times (in prior admissions) he was done suffering and wanted to join his wife in heaven. His last admission he was disoriented, unable to make decisions for himself with no quality of life, and a lot of pain. We had to involve his Health Care Proxy for end-of-life care decisions, which was his daughter. She was unwilling to stop treatment and due to his status, we were unable to effectively treat his pain. He declined a little more each day, it got to the point where a PEG tube was placed for nutrition because he stopped intake orally. We had to watch this man suffer for weeks. His daughter was educated by multiple healthcare professionals about prognosis and quality of life, but she loved her dad so much and truly believed he would “pull through”. “Families playing the crucial role of surrogate or proxy are emotionally attached to the incapacitated patient and hence their moral interest (emotional, financial pressure, etc.) may be diversified in opting for a treatment or declining them” (Karmik & Kankar, 2016). I remember going back and for in my own head, being angry with the daughter but then sympathizing with her, all while feeling terrible, knowing we are treating this man who does not want treatment, it was an awful feeling. Because of that situation, I do not take advance directives lightly. I educate my patients, as well as my family and friends, on the importance of getting your wishes in writing and choosing the proxy wisely. I practice in New York State and we now have Electronic Medical Orders for Life-Sustaining Treatment (EMOLST). Once a patient completes the EMOLST, it can not be changed by anyone but the patient. It is kept in a secure electronic database, so it can be easily accessed and never “lost”. I feel this will help decrease ethical dilemmas with end-of-life decision making.
    Have a great week!
    Shannon
    Feeney, S., & Freeman, N. K. (2016). Ethical issues: Responsibilities and dilemmas. YC: Young Children, 71(1), 86. http://proxy.chamberlain.edu:8080/login?url=http://search.ebscohost.com/login.aspx?direct=true&db=edb&AN=114680496&site=eds-live (Links to an external site.)Links to an external site.
  •  (Links to an external site.)
  • Houser, J. (2018). Nursing research: Reading, using, and creating evidence (4th ed.). Sudbury, MA: Jones & Bartlett.
    Karnik, S., & Kanekar, A. (2016). Ethical issues surrounding end-of-life care: A narrative review. Healthcare, 4(2), 24. doi:10.3390/healthcare4020024

    • Instructor and class,
      Stefaniak and Mazurkiewicz (2017) have addressed the theme of adhering to the high standards of research ethics. Ethical principles are moral guidelines researchers rely on when making a decision. The first principle in both Nursing Codes of Ethics and Codes of Ethical research include the very important concept of beneficence. Neither a practicing nurse nor a nursing researcher should ever aim to cause pain or adverse treatment to a patient or a study participant (Stefaniak & Mazurkiewicz, 2017). An adverse treatment would be to disregard a patient’s privacy rights in order to do research. Much research is done through the review of patient records. The Health Insurance Portability and Accountability Act requires that the privacy of all consumers of health care in America should be protected (Parahoo, 2014). Caring for the human subjects and their privacy should be first and foremost in the researcher’s set of responsibilities. Informed consent does not only entail completing and signing a consent form, it should aim at creating awareness among participants on the facts about the research, including its use, before they can decide whether to take part in it (Parahoo, 2014).
      The dangers of the conflict of interest are manifold with the threat to the research rigor being the most significant. Conflict of interest may result in research bias and can lead to manipulations with research data in order to acquire the results excepted by certain party (Houser, 2015). For instance, pharmacological companies can “order” research studies that will demonstrate the effectiveness of medications they produce.
      References
      Houser, J. (2015). Nursing research: Reading, using and creating evidence (3rd ed.). Denver, C.O.: Jones & Bartlett Publishers.
      Parahoo, K. (2014). Nursing research: principles, process and issues. London: Palgrave Macmillan.
      Stefaniak, M., & Mazurkiewicz, B. (2017). The importance of adhering to high standards of research ethics. British Journal of Nursing, 26(1), 62.

      The difference between quality improvement and reasearch are described below. I did some research with a few different places and they all seemed to say the same thing. According to the American Nurse Today QI explains it as “improves performance or processes to strengthen patient care” while reasearch is basical “answers a question or hypothesis to advance general knowledge” (Kathreena C. Merrill, 2015)
      Yenisleydi,
      Responsibilities of an ethical nurse researcher can be found in Table 3.2 in our text by Houser (2018), the one I found to be the most universal in all areas of nursing is “to minimize potential harm and to maximize possible benefits for all subjects enrolled.” Following these criteria (Table 3.2) can assure ethical standards are met. In your post, you mentioned HIPPA, in today’s research world this is of uppermost importance due to social media and online participation methods. Protecting privacy and anonymity in this type of modern research can be tricky. Informed consent can even be abused as researchers study feeds and search patterns without our knowledge. Gibson (2017) brings up important concepts such as “public health implications” such as altered emotional health from social media research. Gibson (2017) also suggests that social media research should follow other human ethical research standards as delineated in the Declaration of Helsinki and even register in clinical trial s registries. There are many ethical issues facing nursing, medicine, and research. It is important to stay abreast of current trends as our options for performing research grow.
      Yvette Salas
      Reference
      Gibson, M. (2017). The democratization of medical research and education through social media: The potential and the peril. JAMA: Journal of the American Medical Association, 2(1), 9-11. doi:10.1001/jamacardio.2016.4933
      Houser, J. (2018). Nursing research: Reading, using and creating evidence (4th ed.). Sudbury, MA: Jones & Bartlett.
       
    • Shannon,
      Such a sad, yet very common ethical dilemma you shared.  I have seen that same issue many times in my career.  I’ve even seen a patient that was an inpatient at the hospital for more than a year because he was accidentally shot by the police and he was not from the U.S. and what little bit of family he did have here was not capable of taking care of him.  So we all watched this patient whittle away because he was unable to eat or drink  or speak, huge open abdominal wound.  Eventually was being fed by TPN but all his lines would either be pulled out or infected but nobody would make him a DNR or say enough was enough, so he finally passed away, but years after initial accident, tied to a bed starving to death.  It was completely heart breaking but the hospital was stuck between a rock and a hard place.  You would think it would be common sense to let him go and stop the treatments but the family wanted full treatment.  One reason for this kind of disagreement is “that all people recognize some common ethical norms but interpret, apply, and balance them in different ways in light of their own values and life experiences” (Resnik, 2015).
      Kim Evans
      References:
      Resnik, D. (2015).  National Institute of Environmental  Health Sciences.  What is Ethics in Research & Why is it Important?  Retrieved from: https://www.niehs.nih.gov/research/resources/bioethics/whatis/index.cfm

 

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