scholarly journals Ethical Issues in Pharmacologic Research in Women Undergoing Pregnancy Termination: A Systemic Review and Survey of Researchers

2012 ◽  
Vol 2012 ◽  
pp. 1-5 ◽  
Author(s):  
Christelle Gedeon ◽  
Alejandro A. Nava-Ocampo ◽  
Gideon Koren
Keyword(s):  
Western Europe ◽  
Ethical Issues ◽  
Pregnancy Termination ◽  
Systemic Review ◽  
Institutional Review Boards ◽  
Maternal Fetal Medicine ◽  
Fetal Medicine ◽  
Institutional Review ◽  
Medical Institutions ◽  
Pharmacological Studies

Objective. To evaluate the ethics of performing research in the field of maternal-fetal medicine involving women undergoing pregnancy termination.Methods. We identified published pharmacological studies performed during elective pregnancy termination. In addition, a questionnaire was administered to investigate whether this research would be acceptable to professionals performing research in the field of maternal-fetal pharmacology.Results. The majority of participants believe that this form of research is necessary to furthering our understanding of drug use in pregnancy. Twenty studies were identified in women undergoing a pregnancy termination where exogenous drug was administered and drug measurement conducted during an abortion. The majority of studies were completed by international groups and not in North America or Western Europe.Conclusions. While a majority of respondents to the survey felt that, although research in women undergoing a pregnancy termination is ethically acceptable, 40% stated that it is not likely to be approved by institutional review boards of most North American medical institutions.

scholarly journals Action Research in Education: Addressing Gaps in Ethical Principles and Practices

2007 ◽  
Vol 36 (7) ◽  
pp. 401-407 ◽  
Author(s):  
Amanda L. Nolen ◽  
Jim Vander Putten
Keyword(s):  
Action Research ◽  
Teacher Educators ◽  
Ethical Issues ◽  
Professional Associations ◽  
Institutional Review Boards ◽  
Systematic Research ◽  
Institutional Review ◽  
Research In Education ◽  
K 12 ◽  
Review Boards

Action research in education has gained increasing attention in the past 20 years. It is viewed as a practical yet systematic research method that enables teachers to investigate their own teaching and their students’ learning. However, the ethical issues unique to this form of insider research have received less attention. Drawing on several professional associations’ principles for research practice, the authors identify a series of potential ethical issues inherent in action research in K–12 schools and the corresponding difficulties that action researchers encounter with the policies and procedures of institutional review boards. The authors conclude with recommendations for future practice addressed to three groups: institutional review boards, K–12 school professionals and teacher educators, and national professional and representative organizations.

scholarly journals Some Questions of Ethics in RCTs

2021 ◽  
Author(s):  
Reetika Khera
Keyword(s):  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Ethical Issues ◽  
Human Subjects ◽  
Belmont Report ◽  
Institutional Review Boards ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Institutional Review ◽  
Areas Of Concern

Questions of ethics in Randomized Controlled Trials (RCTs) in development economics need greater attention and a wider perspective. RCTs are meant to be governed by the three principles laid out in the Belmont Report, but often violated them, e.g. when local laws are flouted. In other cases, the framework of the Belmont Report itself has proved inadequate: for instance, when there are unintended outcomes or adverse events for which no-one is held accountable. Primarily using RCTs conducted in India, this paper highlights eight areas of concern. RCTs also have a disproportionate influence on shaping research agendas and on policy. Though ethical issues have been raised, there has been little engagement from the RCT community – a manifestation of its power in the profession. As current safeguards (such as oversight by Institutional Review Boards) have failed to protect human subjects, the concluding section discusses possible ways to resolve these issues.

Ethical Issues in Maternal-Fetal Medicine

2020 ◽  
pp. 139-147.e2
Author(s):  
Wybo J. Dondorp ◽  
Guido M. de Wert
Keyword(s):  
Ethical Issues ◽  
Maternal Fetal Medicine ◽  
Fetal Medicine

Cross-cultural validation of the moral sensitivity questionnaire-revised Chinese version

2016 ◽  
Vol 23 (7) ◽  
pp. 784-793 ◽  
Author(s):  
Fei Fei Huang ◽  
Qing Yang ◽  
Jie Zhang ◽  
Qing Hua Zhang ◽  
Kaveh Khoshnood ◽  
...  
Keyword(s):  
Factor Analysis ◽  
Moral Responsibility ◽  
Ethical Issues ◽  
Empirical Studies ◽  
Daily Practice ◽  
Institutional Review Boards ◽  
Ethical Sensitivity ◽  
Moral Sensitivity ◽  
Best Interest ◽  
Institutional Review

Background: Ethical issues pose challenges for nurses who are increasingly caring for patients in complicated situations. Ethical sensitivity is a prerequisite for nurses to make decisions in the best interest of their patients in daily practice. Currently, there is no tool for assessing ethical sensitivity in Chinese language, and no empirical studies of ethical sensitivity among Chinese nurses. Research objectives: The study was conducted to translate the Moral Sensitivity Questionnaire–Revised Version (MSQ-R) into Chinese and establish the psychometric properties of the Moral Sensitivity Questionnaire–Revised Version into Chinese (MSQ-R-CV). Research design: This research was a methodological and descriptive study. Participants and research context: MSQ-R was translated into Chinese using Brislin’s model, and the Translation Validity Index was evaluated. MSQ-R-CV was then distributed along with a demographic questionnaire to 360 nurses working at tertiary and municipal hospitals in Changsha, China. Ethical considerations: This study was approved by the Institutional Review Boards of Yale University and Central South University. Findings: MSQ-R-CV achieved Cronbach’s alpha 0.82, Spearman-Brown coefficient 0.75, significant item discrimination (p < 0.001), and item-total correlation values ranging from 0.524 to 0.717. A two-factor structure was illustrated by exploratory factor analysis, and further confirmed by confirmatory factor analysis. Chinese nurses had a mean total score of 40.22 ± 7.08 on the MSQ-R-CV, and sub-scores of 23.85 ± 4.4 for moral responsibility and strength and 16.37 ± 3.75 for sense of moral burden. Discussion: The findings of this study were compared with studies from other countries to examine the structure and meaningful implications of ethical sensitivity in Chinese nurses. Conclusion: The two-factor MSQ-R-CV (moral responsibility and strength, and sense of moral burden) is a linguistically and culturally appropriate instrument for assessing ethical sensitivity among Chinese nurses.

scholarly journals Negotiating Responsibility for Navigating Ethical Issues in Qualitative Research: A Review of Miller, Birch, Mauthner, and Jessop’s (2012) Ethics in Qualitative Research, Second Edition

2015 ◽  
Author(s):  
Michelle McCarron
Keyword(s):  
Qualitative Research ◽  
Research Ethics ◽  
Ethical Issues ◽  
Ethics Committees ◽  
Institutional Review Boards ◽  
Research Ethics Committees ◽  
The United Kingdom ◽  
Institutional Review ◽  
Technological Advances ◽  
Research Ethics Boards

Ethics in Qualitative Research (Miller, Birch Mauthner, & Jessop, 2012), now in its second edition, uses a feminist framework to present a variety of issues pertinent to qualitative researchers. Topics include traditional challenges for qualitative researchers (e.g., access to potential participants, informed consent, overlapping roles), as well as those that have garnered more attention in recent years, particularly with regard to uses and consequences of technological advances in research. The book is critical of committees whose function it is to review proposed research and grant research ethics approval (e.g., University Research Ethics Committees [URECs], Research Ethics Boards [REBs], and Institutional Review Boards [IRBs]). The authors of this book are situated within the United Kingdom. The editors take the position that ethics oversight by the researchers themselves is preferable and that such boards and committees are not well equipped to review qualitative research. A rebuttal to this position is presented within this review. Ethics in Qualitative Research provides a good overview of ethical issues that researchers face and is effective in merging theory with practice. It would be strengthened by avoiding the debate over URECs or by offering concrete suggestions for how URECs can improve their reviews of qualitative research.

Qualitative research ethics on the spot

2015 ◽  
Vol 23 (4) ◽  
pp. 455-464 ◽  
Author(s):  
Christine Øye ◽  
Nelli Øvre Sørensen ◽  
Stinne Glasdam
Keyword(s):  
Qualitative Research ◽  
Informed Consent ◽  
Research Ethics ◽  
Ethical Issues ◽  
Ethical Dilemmas ◽  
Institutional Review Boards ◽  
Ethical Guidelines ◽  
Ethical Considerations ◽  
Institutional Review ◽  
Review Boards

Background: The increase in medical ethical regulations and bureaucracy handled by institutional review boards and healthcare institutions puts the researchers using qualitative methods in a challenging position. Method: Based on three different cases from three different research studies, the article explores and discusses research ethical dilemmas. Objectives and ethical considerations: First, and especially, the article addresses the challenges for gatekeepers who influence the informant’s decisions to participate in research. Second, the article addresses the challenges in following research ethical guidelines related to informed consent and doing no harm. Third, the article argues for the importance of having research ethical guidelines and review boards to question and discuss the possible ethical dilemmas that occur in qualitative research. Discussion and conclusion: Research ethics must be understood in qualitative research as relational, situational, and emerging. That is, that focus on ethical issues and dilemmas has to be paid attention on the spot and not only at the desktop.

Ethical Issues in the Neonatal SUPPORT Trial

2018 ◽  
pp. 59-87
Author(s):  
John D. Lantos
Keyword(s):  
Ethical Issues ◽  
Institutional Review Boards ◽  
Positive Pressure ◽  
Fundamental Issue ◽  
Advocacy Group ◽  
Consent Forms ◽  
Premature Babies ◽  
Institutional Review ◽  
Public Citizen ◽  
Research Protections

The controversy over the neonatal Surfactant, Positive Pressure, and Oximetry Randomized Trial (SUPPORT) study of oxygen saturation targets in extremely premature babies was intense and polarizing. The fundamental issue turned on whether or not there were reasonably foreseeable risks to the babies who were enrolled in the study and, if so, whether that should have either (a) been disclosed in the consent form or (b) led institutional review boards to never approve the study in the first place. The federal Office for Human Research Protections (OHRP) took the first view. The advocacy group Public Citizen (PC) took the second. This chapter suggests that both views were wrong. Being in the study was, in fact, safer than not being in the study. The mistakes made by both OHRP and PC have dangerous implications for research ethics and regulation. They could lead to mandates for consent forms that are inaccurate and misleading.

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