NURS 3151 Week 6 Assignment Essay

NURS 3151 Week 6 Assignment Essay

NURS 3151 Week 6 Assignment Essay (Walden University)

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Every year in the hospital setting, medical errors account for more than ten thousand (10,000) hospitalization complications and injuries every day, at an estimated cost of more than $1 trillion dollars; while contributing to more than four hundred thousand (400,000) deaths per year in the United States alone (James, 2013; Stefanacci and Riddle, 2016). Highlighting the seriousness of medication administration errors (MAEs) in the healthcare setting, facilities all over the world continuously look for ways to reduce the number of MAEs by implementing changes in practice, such as using medication carts, room based nurse servers, computerized medication verification systems, and signs.

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NURS 3151 – Foundations of Nursing Research Assignment Paper

Nurses must understand research in order to effectively participate in the provision of evidence-based nursing care. Students in this course learn the foundational elements of the research process, refine information-literacy skills, and develop an understanding of ethical research. Students investigate each step of the research process and complete a critical examination of quantitative and qualitative research relevant to their nursing practice. Students are given the tools to analyze nurse-sensitive indicators and clinical practice guidelines.

It is difficult to do scientifically rigorous research on treatments that must be administered urgently or emergent. Therefore, such treatments are often provided without a strong evidence base. Research would be facilitated if it were permissible to waive the requirement for parental consent. However, that raises a different set of concerns. Federal regulations allow waiver of the requirement for consent but only if studies meet certain conditions. Institutional review boards must decide whether those conditions are met. Sometimes, reasonable people disagree. We present and analyze a protocol for which investigators request a waiver of consent.

Background: Recruitment into research studies in the neonatal intensive care unit has been problematic. Therefore suggestions have been made to take decision making about enrollment out of the hands of the parents.

Objective: To understand parental perceptions of the process of recruitment and enrollment for research in the neonatal intensive care unit.

Method: A questionnaire was developed and used in both a retrospective survey and a prospective study of parents whose newborns were enrolled in trials in a neonatal intensive care unit. Closed ended and open ended questions were included, as well as demographic questions.

Results: The retrospective survey had a 79% response rate (29 of 38). Overall, 90% of parents felt that they had made informed decisions, and 93% were against the option that a doctor decide if the newborn should be enrolled into a study, rather than the parent. Although some parents (38%) found that recruitment did add “stress to an already stressful situation”, 90% felt that they had made informed decisions and understood the elements of the study. Most parents had been requested to enrol their newborn into more than one trial, and, on average, they thought that they would be comfortable with enrolment into two studies (range 0–6). When asked how the process could be improved, parents suggested that information be made available before delivery. The responses of parents in the prospective study were mostly consistent with those from the retrospective survey.

Conclusions: Overall the parents did not support the suggestion that decision making about enrollment be taken away from parents and put into the hands of doctors. The healthcare team should support parents in their role of decision maker, enhance availability of the research staff, and provide more information about the research.

Research Involving Pregnant Women, Fetuses, Neonates

POLICY

Conditions for Involving Pregnant Women or Fetuses in Research: Pregnant women or fetuses may be involved in research if all of the following conditions are met:

  1. Where scientifically appropriate, clinical studies, including studies on pregnant animals, and clinical studies, including studies on non-pregnant women, have been conducted and provide data for assessing potential risk to pregnant women and fetuses; and
  2. The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus; or if there is no such prospect of benefit, the risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means; and
  3. Any risk is the least possible for achieving the objectives of the research; and
  4. No inducements, monetary or otherwise, will be offered to terminate a pregnancy; and
  5. Individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy; and
  6. Individuals engaged in the research will have no part in determining the viability of the neonate.

Consent for Research Involving Pregnant Women or Fetuses

  1. If the research holds out the prospect of direct benefit to the pregnant woman, the prospect of a direct benefit both to the pregnant woman and the fetus, or no prospect of benefit for the woman nor the fetus when risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means, her consent is obtained in accord with the informed consent provisions according to regulations; and
  2. If the research holds out the prospect of direct benefit solely to the fetus then the consent of the pregnant woman and the father is obtained in accord with regulations, except that the father’s consent need not be obtained if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest; and
  3. Each individual providing consent under paragraph (D) or (E) of this section is fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate; and
  4. For children who are pregnant, assent and permission are obtained according to regulations.

Research Involving Neonates of uncertain viability and nonviable neonates – Neonates of uncertain viability and nonviable neonates may be involved in research if all of the following conditions are met:

  1. Where scientifically appropriate, clinical and clinical studies have been conducted and provide data for assessing potential risks to neonates; and
  2. Each individual providing consent is fully informed regarding the reasonably foreseeable impact of the research on the neonate; and
  3. Individuals engaged in the research will have no part in determining the viability of a neonate; and
  4. The requirements of the paragraphs of this policy on neonates of uncertain viability or nonviable neonates have been met as applicable.

Research Involving Neonates of Uncertain Viability:  Until it has been ascertained whether or not a neonate is viable, a neonate may not be involved in research covered by this section unless the following additional conditions have been met and the CPHS determines that:

  1. The research holds out the prospect of enhancing the probability of survival of the neonate to the point of viability, and any risk is the least possible for achieving that objective, or
  2. The purpose of the research is the development of important biomedical knowledge which cannot be obtained by other means and there will be no added risk to the neonate resulting from the research.
  3. The legally effective informed consent of either parent of the neonate or, if neither parent is able to consent because of unavailability, incompetence, or temporary incapacity, the legally effective informed consent of either parent’s legally authorized representative is obtained. The consent of the father or his legally authorized representative need not be obtained if the pregnancy resulted from rape or incest.

Research Involving Nonviable Neonates: After delivery, nonviable neonates may not be involved in research unless all of the following additional conditions are met:

  1. Vital functions of the neonate will not be artificially maintained; and
  2. The research will not terminate the heartbeat or respiration of the neonate; and
  3. There will be no added risk to the neonate resulting from the research; and
  4. The purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means; and
  5. The legally effective informed consent of both parents of the neonate is obtained and cannot be waived or altered. However, if either parent is unable to consent because of unavailability, incompetence, or temporary incapacity, the informed consent of one parent of a nonviable neonate will suffice. The consent of the father need not be obtained if the pregnancy resulted from rape or incest.
  6. The consent of a legally authorized representative of either or both of the parents of a nonviable neonate will not suffice to meet the requirements of this paragraph.