NURS 3151 – Foundations of Nursing Research Assignment Essay

NURS 3151 – Foundations of Nursing Research Assignment Essay

NURS 3151 – Foundations of Nursing Research Assignment Essay

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. NURS 3151 – Foundations of Nursing Research Assignment Essay.

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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. NURS 3151 – Foundations of Nursing Research Assignment Essay

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. NURS 3151 – Foundations of Nursing Research Assignment Essay

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. NURS 3151 – Foundations of Nursing Research Assignment Essay

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.

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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. NURS 3151 – Foundations of Nursing Research Assignment Essay

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. NURS 3151 – Foundations of Nursing Research Assignment Essay
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.

Research Involving Viable neonates: A viable neonate may be included in research only to the extent permitted by and in accordance with the policy and procedure on research involving children.

Research involving the placenta, the dead fetus or fetal material after delivery: When information associated with these materials is recorded for research purposes in a manner that living individuals, including the mother can be identified, directly or through identifiers linked to those individuals, those individuals are research participants and all human research protection relevant policies and policies apply.

Research involving fetal tissue for transplantation: There is a separate policy and procedure for research involving transplantation of fetal tissue.

Key Terms

Dead Fetus – A fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord.

Delivery – Complete separation of the fetus from the woman by expulsion or extraction or any other means.

Fetus –  The product of conception from implantation until delivery.

Neonate – A new born.

Nonviable neonate – Means a neonate after delivery that, although living, is not viable.

Pregnancy – Encompasses the period of time from implantation until delivery. A woman shall be assumed to be pregnant if she exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until the results of a pregnancy test are negative or until delivery.

Viable – As it pertains to the neonate, means being able, after delivery, to survive (given the benefit of available medical therapy) to the point of independently maintaining heartbeat and respiration. NURS 3151 – Foundations of Nursing Research Assignment Essay

PROCEDURE

Submission: The Principal Investigator must complete the panel on research involving pregnant women, nonviable fetus or fetus of uncertain viability in the IRB application.

Review Process: IRB Staff will ensure that protocols involving pregnant women, human fetuses, neonates of uncertain viability, or nonviable neonates are reviewed by at least one member who has appropriate expertise. In addition to their responsibilities listed in policy and procedure for Initial Review, the reviewer shall determine if all the conditions set forth in this policy are met.

Documentation: Protocol specific findings for research involving pregnant women, fetuses or neonates will be documented in the application form.

Special circumstances – Research not otherwise approval which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates needs approval by Secretary of the Department of Health and Human Services. CPHS should submit documentation to the Secretary certifying that the CPHS finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates. The Secretary, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, ethics, law) and following opportunity for public review and comment, including a public meeting announced in the Federal Register, has determined either the research satisfies the conditions of §46.204, as applicable; the following:

1. The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates; and
2. The research will be conducted in accord with sound ethical principles; and
3. Informed consent will be obtained in accord with the informed consent provisions of policy and procedure on Informed Consent. NURS 3151 – Foundations of Nursing Research Assignment Essay

Studies in which pregnancy is coincidental to subject selection – Any study in which women of childbearing potential are possible participants may inadvertently include pregnant women. Federal regulations require that, when appropriate, participants be provided a statement that the particular treatment or procedure may involve risks to the participant (or to the embryo or fetus, if the participant is or may become pregnant) which are currently unforeseeable as part of the informed consent process.

The CPHS shall judge whether the mother’s participation would pose any risk to the fetus or nursing infant.  In some studies, the CPHS may need to assure that non-pregnant participants are advised to avoid pregnancy or nursing for a time during or following the research. Furthermore, where appropriate, participants should be advised to notify the PI immediately should they become pregnant. In some instances, there may be potential risk sufficient to justify requiring that pregnant women either be specifically excluded from the research or studied separately.

Informed consent is an obligatory requirement for research participation¹. The process of informed consent states that certain measures must be followed to ensure a research participant has made an informed decision about their participation in a research study^2,3. Consent for research should be voluntary, informed, and understood by the consenting individual who must also be competent to do so. In the case of neonatal research informed consent is acquired from parent(s)/guardian(s) of a patient.

Informed consent in neonatal research is a controversial subject. International studies conducted in this area have highlighted variability from country to country^4,5,6,7. The Eur icon study found that only 59 parents of a total of 200 had given a valid consent or refusal to participate in neonatal studies⁸. The vulnerability of parents during the neonatal setting has been noted⁹. Generally, parents are supportive of neonatal research and have expressed altruistic motives for consenting^10,11. Studies have shown that, overall, consenting parents’ understandings are that involvement in neonatal research studies should not cause harm and should be of direct benefit their baby’s healthcare¹² and will help future generations of sick, newborn infants¹³.

The primary aim of this study was to investigate the perceptions parents and clinicians had of the informed consent process in neonatal research. Specific objectives explored included parental recall, reasons for consenting or refusing consent, the role of parent information leaflets, antenatal consent and a waiver of consent. NURS 3151 – Foundations of Nursing Research Assignment Essay

Methods

Two questionnaires were developed. Questionnaire one was administered to parents of infants admitted to the neonatal intensive care unit (NICU) of the Cork University Maternity Hospital (CUMH) after birth and questionnaire two was administered to clinicians working in an Irish hospital setting. Parents completed their questionnaire whilst attending a follow up appointment in the outpatient clinic in the CUMH. Clinicians completed their questionnaire whilst attending training seminars. An information leaflet detailing the rationale for the study was provided in conjunction with the questionnaire. The questionnaires incorporated questions and statements of a similar design and content. This included questions with yes/no answers, questions requiring free text answers and questions based on a Like rt scale. Like rt-type scale questions had two different five point scales; scale one asked respondents to rate their level of agreement to the importance of various statements (starting with “very important” and ending with “unimportant”), scale two rated the level of agreement respondents had to various statements starting with “strongly disagree” and ending with “strongly agree”).

The parental questionnaire was divided into three sections; background information, parental experience of the informed consent process and information relating to the research study parents were asked to consent their baby to. The clinician questionnaire was divided into two sections; background demographic information and the clinician’s views and experiences of the informed consent process.

Ethical approval for the study was granted by the Cork University Hospitals Research Ethics Committee in December 2014. Data analysis was performed using the statistical program-me IBM SPSS statistics version 22. NURS 3151 – Foundations of Nursing Research Assignment Essay

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Results

Parent Questionnaire
A total of 49 questionnaires were completed. Of these 6 were excluded from data analysis as they were completed by parents who did not fully satisfy the inclusion criteria. Of the 43 questionnaires analyzed, 33 were completed by mothers independently, 8 were completed solely by fathers and two were completed by both parents together.

Clinician Questionnaire
A total of 36 clinician questionnaires were completed. Of these 7 were completed by Specialist Registrars, four were completed by Registrars and 25 were completed by Senior House Officers.

Study Recall
Parents gave brief descriptions of the studies in which they were asked to consent. Statements included ‘brain activity’, ‘brain monitoring’ and ‘breast milk’. Although brief, the majority of explanations provided by parents reflected various studies that were on-going in the NICU at that time.

Increasingly in the nursing literature, theorists have examined the use of critical theory in nursing (especially as understood by Haber mas) and many have advocated it as a research approach to guide knowledge development in nursing. There has been limited analysis, however, of critical theory’s broader foundational implications for the discipline of nursing. Part of the difficulty stems from a failure to differentiate between the implications of Haber’s earlier work on knowledge interests and his later theory of communicative action. In this paper, Haber’s critical theory is explored along two dimensions: as a meta theoretical account of a methodology of critical theory as a research tradition; and as a theory of communicative action whose ideological and normative assumptions have profound implications for a post functionalist grounding of nursing as a discipline and professional practice. The authors argue that critical theory is necessary for nursing and may be sufficient as a paradigmatic philosophical base for the discipline. NURS 3151 – Foundations of Nursing Research Assignment Essay

BC Nursing Research Initiative

Since 1955, the American Nurses Foundation (ANF) has supported more than 900 studies through its research grants program. The purpose of the ANF Nursing Research Grants Program is to encourage the research career development of all nurses. To effectively achieve this goal, the program supports research of both beginning and experienced nurse researchers. Grant funding, ranging from $3500 to $20,000, comes from a variety of sources that includes endowments, individuals, and organizations. Named awards generated by ANF endowment funds include the Virginia Cleland Scholar, Dorothy Cornelius Scholar, Julia Hardy Scholar, Virginia Kelley, CRNA Scholar, Jean E. Johnson Scholar, Sayre Memorial Fund Scholar, Virginia Stone Scholar, and the Anne Zimmerman Scholar. Organizations who contributed to the ANF research program in 2002 include the ANA, ANF/Sigma Theta Tau, American Association of Critical Care Nurses, Aventis Pasteur, Burrell Family Foundation, Commission on Graduates of Foreign Nursing Schools, Friends of the National Institute of Nursing Research, Glaxo Smith Kline, Hyundai Motor America, Merck Company Foundation, Nurses Charitable Trust District V FNA, Regional Nursing Research Societies, Wyeth-Ayerst Women’s Health Research Institute, and Wyeth Lederle Vaccines. Individuals also have contributed awards. NURS 3151 – Foundations of Nursing Research Assignment Essay

Each application to the ANF Nursing Research Grants Program receives a careful review by the Research Review Committee. Proposals are judged on scientific merit with critique based on the following criteria: significance, approach, innovation, environment, strength of investigator and research team, attention to human subjects protection or other protections (animals), and justified budget, as defined in the 2004 ANF NRG booklet. The 12 members of the committee are expert, doctor ally-prepared nurse researchers from a wide range of specialty areas. The Committee is committed to contributing to the career advancement of nurse researchers by providing thoughtful feedback in the hope that they will advance their thinking about their program of research. Historically, grant applications are due on May 1st, and this year is no different! Watch the ANF Website carefully for detailed instructions related to submitting a research grant.

ANF is proud of their research grant recipients. The names of awardees are listed in The American Nurse (TAN), ANF Foundation Focus, and on the ANF Website. Since 1999, the abstracts of the scholars who have completed their research have been published in the ANF Annual Report. ANF also takes delight in the fact that past grant recipients have received subsequent funding to expand their programs of research based on findings from studies that were funded through the Nursing Research Grants Program. NURS 3151 – Foundations of Nursing Research Assignment Paper

The 2004 ANF NRG booklet is now available. Call the ANF Grants Hotline at (202) 651-7298 to be added to the mailing list, or e-mail [email protected]. For general information regarding the Nursing Research Grants Program, call (202) 651-7227, or visit www.ANFonline.org. ANF encourages nurse researchers to apply for NRG grants because nurse researchers continue to impact health outcomes, improve the processes of the delivery of care, and enhance the quality of work life for nurses. NURS 3151 – Foundations of Nursing Research Assignment Essay.