Ethical Dimensions of Research Studies
Respond using one or more of the following approaches:
Ask a probing question, substantiated with additional background information, and evidence
Offer and support an alternative perspective using readings from the classroom or from your own review of the literature in the Walden Library.
Make a suggestion based on additional evidence drawn from readings or after synthesizing multiple postings.
Skloot, R. (2010). The immortal life of Henrietta Lacks. New York, NY: Crown Publishing Group.
Ethical Dimensions of Research Studies
Nursing research and research studies can offer many gains in the healthcare field and offer clear, conscience evidenced-based practices (EBP). Before diving into conducting a research study it is essential to understand ethical issues and ethical dilemmas. Research ethics demand necessity on daily work, the protection of test subject’s and the publicizing of information from the research (Fouka & Mantzorou, 2011). Ethical dilemmas are situations where the test subject’s rights are in conflict with the studies requirements (Polit & Beck, 2017). Nursing researcher need to be aware of any ethical issues and develop a research plan to help alleviate any problems or ethical dilemmas.
Transfusion of Prematures
Transfusion of Prematures (TOP) Trial was an open, parallel-group multicenter randomized controlled trial (RCT) analyzed by the intention to treat (Kirpalani et al., 2012). The main point of the TOP trial was to determine whether higher hemoglobin levels for giving transfusions to extremely low birth weight infants could result in higher hemoglobin levels leading to the improvements in neurodevelopmental impairment at 22-26 months of age and the primary outcome to be survival (ClinicalTrials, 2019). The trial explained that by avoiding a breach the current practice boundaries of the hemoglobin levels that would require an infusion by using a transfusion algorithm. This would avoid dilemmas and minimize risks to the test subject’s. There are no real results of this trial. The test subject’s will be seen for follow-up visits at around six years old to assess neurological and functional outcomes based on the transfusion threshold (Kirpaplani et al., 2012).
Three principles that standards of ethical conduct in research are based on are beneficence, respect for human dignity and justice (Polit & Beck, 2017). Beneficence can be explained as a duty to promote good and eliminate harm to the test subjects. The TOP trial was seen by the Institutional Review Board (IRB) as harmful by veering away from usual care and harmful risks were posed by the deviations (National Public Radio, 2013). The researcher could have maintained usual care and not deviate from routine care on the test subjects. The second ethical principle is respect for human dignity which is the right to know what will take place or full disclosure (Polit & Beck, 2017). The TOPS trial had defects and faced criticism for not telling all this risks that the subjects would face. In this trial the consent forms did not elaborate on previous studies about when to transfuse. The studies suggested that premature infants that had transfusions later had a higher chance of death, brain injury and emergency care for transfusions (National Public Radio, 2013). The researchers should have been honest to the test subject’s parents regarding the previous studies and the risks of participation in the study. The third principle is justice which allows for fair treatment and the right to have privacy (Polit & Beck, 2017). In the TOPS trial it was suggested that the subject’s parents were not aware of what was being asked. Parents were giving up their rights to a physician to make decisions on what they feel was in the best interest of the infant. This would impede on the right to fair treatment. The researchers need to make sure that the parents of the test subjects understand every aspect of the trial and have the rights to make decisions on what they feel is in the best interest of their child. The parent should have the say so in what is being done to their child and not a physician. Research can be done on sensitive issues while protecting the rights of the research subjects by following the ethical principles. Adopting the ethical principles will help avoid ethical dilemmas in research.
Nursing research has many benefits to the practice and can produce evidence- based practices to help provide the best care to our patients. Ethical dilemmas can be avoided by conducting a study that poses minimal conflicts with patient rights. Making patient safety the main goal is essential in the success of a research study. Keeping ethical principles of beneficence, respect for human dignity, and justice intertwined in the development or framework of the study is the only way to ensure that participants are being protected.
ClinicalTrials. (2019). Transfusion of Prematures (TOP). Retrieved March 18, 2019, from http://www.clinicaltrials.gov/ct2/show/NCT01702805.
Fouka, G., & Mantzorou, M. (2011). What are the major ethical issues in conducting research? Is there a conflict between the research ethics and the nature of nursing? Health Science Journal, 5(1), 3-14. Retrieved from the Walden Library databases.
Kirpalani, H., Bell, H., D’Angio, C., Hintz, S., Kennedy, K., Ohls, R., Poindexter, B., Schibler, K., Schmidt, B., Vohr, B., Widness, J., Das, A., Higgins, R., Zupancic, J., Roberts, R., Whyte, R., Chaudhary, A., & Johnson, K. (2012). Transfusion of Prematures (TOP) Trial: Does a Liberal Red Blood Cell Transfusion Strategy Improve Neurologically-Intact Survival of Extremely-Low-Birth-Weight Infants as Compared to a Restrictive Strategy? Neonatal Research Network. Retrieved from http://www.nichd.nih.gov/sites/default/files/about/Documents/ TOP_Protocol.pdf.
National Public Radio (2013). Another Study of Preemies Blasted Over Ethical Concerns. Retrieved March 18, 2019, from http://www.npr.org/sections/health-shots/2013/08/23/214800726/another-study-of-preemies-blasted-over-ethical-concerns.
Polit, D.F., & Beck, C.T. (2017) Nursing Research Generating and Assessing Evidence for Nursing Practice (10th ed.). Philadelphia, PA: Wolters Kluwer.