Ethical Issues in Academic Global Reproductive Health

2021 ◽  
pp. 247-261
Author(s):  
Kayte Spector-Bagdady ◽  
Timothy R. B. Johnson
Keyword(s):  
Global Health ◽  
Community Involvement ◽  
Ethical Issues ◽  
Global Health Research ◽  
Institutional Review Boards ◽  
Mutual Benefit ◽  
University Partnerships ◽  
Fiscal Transparency ◽  
Institutional Review ◽  
Clinical Program

This chapter addresses the ethical issues relevant to all academics and academic institutions engaging in global health, with a focus on international experiences in women’s health. The ethical issues for educational and clinical program development, such as sustainability, mutual benefit, and transparency, are relatively new interests. The authors discuss the ethical issues involved with global health research, including funding, community involvement, and informed consent and institutional review boards and argue that sustainability, mutual benefit, and fiscal transparency should be part of formal agreements and memoranda of understanding between academic global health partners; exchanges of learners should be bilateral and equitable; funding should be sustainable and fairly distributed; transcultural and translational issues must be welcomed and valued; research must be ethically grounded because of fundamental disparities between universities in low- and high-income countries; and issues of governance and institutional autonomy must be considered as transnational university partnerships are developed.

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.

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.

scholarly journals Adolescent Assent and Reconsent for Biobanking: Recent Developments and Emerging Ethical Issues

2021 ◽  
Vol 8 ◽  
Author(s):  
T. J. Kasperbauer ◽  
Colin Halverson
Keyword(s):  
Ethical Issues ◽  
Research Participation ◽  
The United States ◽  
Institutional Review Boards ◽  
Ethical Debate ◽  
Current State ◽  
Institutional Review ◽  
Recent Developments ◽  
Research Biobanks ◽  
Regulatory Challenges

Research biobanks that enroll minors face important practical, ethical, and regulatory challenges in reconsenting participants when they reach the age of 18. Federal regulations governing research in the United States provide minimal guidance and allow for a range of practices, including waiving the requirement to obtain reconsent. Some commentators have argued that institutional review boards should indeed grant such waivers, given the low risks of biobank-based research and the impracticality of contacting all participants when they turn 18. There is also significant ethical debate about the age at which adolescents can make authentic, autonomous decisions regarding their research participation. This paper reviews these issues in detail, describes the current state of the ethical discussion, and outlines evidence-based policies for enrolling minors into research biobanks.

scholarly journals Experiment on identical siblings separated at birth: ethical implications for researchers, universities, and archives today

2020 ◽  
pp. medethics-2019-105983
Author(s):  
Robert L. Klitzman ◽  
Adam M. Kelmenson
Keyword(s):  
Ethical Issues ◽  
Ethics Committees ◽  
Institutional Review Boards ◽  
Yale University ◽  
Ethical Problems ◽  
Ethical Implications ◽  
Nature Versus Nurture ◽  
Institutional Review ◽  
Study Participants

Several films, including Three Identical Strangers, examined ethical problems in an experiment that involved identical siblings who were adopted as infants and separated into different families to examine the effects of nature versus nurture. The study was primarily designed and directed by Dr Peter Neubauer. The experiment, conducted in the 1960’s through 1980’s, serves as an important cautionary case study, raising several critical and ongoing ethical issues faced by researchers, universities and archives today. The organisation coordinating the study donated the research records to Yale University under the condition that they remain sealed until 2065, and has impeded study participants’ full access to research material. This case raises questions of what investigators, their descendants, research ethics committees or institutional review boards (IRBs), universities and archives should do with study records when researchers retire or die—whether universities should accept researchers’ donations of archival records that may contain patient or participant data, and if so, under what conditions. This study also poses crucial issues for IRBs—for example, whether researchers themselves or their designates should control all access to study records, particularly if controversy or lawsuits ensue. These questions will become increasingly crucial since the amount of research has burgeoned over recent decades, and investigators, on retirement or death, may want to donate their archives to universities. This experiment thus highlights ethical questions to which researchers, IRBs, universities, healthcare institutions, archivists and libraries should attend.

An Examination of Ethical Issues Raised in the Pretreatment of Normal Volunteer Granulocyte Donors With Granulocyte Colony-Stimulating Factor

1999 ◽  
Vol 123 (6) ◽  
pp. 508-513
Author(s):  
Emily E. Volk ◽  
Ronald E. Domen ◽  
Martin L. Smith
Keyword(s):  
Side Effects ◽  
Ethical Issues ◽  
Normal Volunteer ◽  
Best Interests ◽  
Institutional Review Boards ◽  
Granulocyte Colony Stimulating Factor ◽  
Colony Stimulating Factor ◽  
Healthy Individuals ◽  
Institutional Review ◽  
Stimulating Factor

Abstract Objective.—To explore some of the ethical issues surrounding the administration of granulocyte colony-stimulating factor (G-CSF) to healthy individuals for the purpose of retrieval of granulocytes. Design.—Review of the historical precedent of drug administration to normal blood donors and review of the literature concerning the side effects of G-CSF administration to healthy individuals, particularly as related to granulocyte collection. We identify and discuss some of the ethical questions regarding this issue. Results.—Although the short-term side effects of G-CSF use in normal donors are generally felt to be benign, little is known about the long-term side effects. Ethical questions regarding the administration of this drug to normal donors for the purpose of collecting large numbers of granulocytes include the following: Does the potential benefit to a patient/recipient justify the unknown risks to the medicated granulocyte donor? Who should act as an advocate for donors so that their best interests are protected? What is the role and quality of informed consent for donors undergoing G-CSF administration? Is monetary compensation appropriate for donors administered G-CSF as part of a research protocol? Conclusions.—We recommend the establishment of a donor registry to collect the needed data on the side effects of G-CSF on normal donors. Until adequate data are collected, the use of G-CSF and similar agents in normal donors should be regarded as experimental and subject to review by institutional review boards.

Ethical Conduct of Clinical Trials, Institutional Review Boards, Informed Consent, and Financial Conflicts of Interest

2019 ◽  
pp. 545-548
Author(s):  
Christian B. Ramers
Keyword(s):  
Informed Consent ◽  
Ethical Issues ◽  
Conflicts Of Interest ◽  
Ethical Conduct ◽  
Institutional Review Board ◽  
Institutional Review Boards ◽  
Institutional Review ◽  
Essential Components ◽  
Financial Conflicts Of Interest

Describe the essential components of the ethical conduct of research, the role of the institutional review board, the process of informed consent, the potential areas of conflict of interest for clinicians participating in research, and other ethical issues related to research in HIV medicine.

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