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 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.

Vulnerability in Research with Prisoners

2021 ◽  
Author(s):  
Paul P. Christopher
Keyword(s):  
Predisposing Factors ◽  
Institutional Review Boards ◽  
Ethical Foundation ◽  
Ethical Concerns ◽  
Effective Strategies ◽  
Institutional Review ◽  
Conceptual Clarity ◽  
Research Population ◽  
Research Protections ◽  
Further Development

Prisoners are often described as a vulnerable research population. This designation, while intuitively appealing, leaves unclear what is meant by “vulnerability” in the context of research with incarcerated individuals. Conceptual clarity would provide the ethical foundation needed to identify the full scope of research protections to afford prisoners. It would also militate against a tendency among some to view all prison research as irredeemably problematic and prohibitive. Drawing on a prior taxonomy of vulnerability, this chapter specifies eight vulnerability types that apply to prisoner research. It describes their predisposing factors and the ethical concerns they raise. It also considers possible strategies for addressing these concerns and highlights areas where effective strategies are lacking or need further development. This framework is intended to guide researchers and institutional review boards in the planning and review of protocols involving prisoners so that they may safeguard prisoners from abuse and promote the ethical advancement of science.

scholarly journals Perinatal Outcomes of Subjects Enrolled in a Multicenter Trial with a Waiver of Antenatal Consent

2020 ◽  
Author(s):  
Anup C. Katheria ◽  
Phillip Allman ◽  
Jeff M. Szychowski ◽  
Jochen Essers ◽  
Waldemar A. Carlo ◽  
...  
Keyword(s):  
Perinatal Outcomes ◽  
Multicenter Trial ◽  
Institutional Review Boards ◽  
Positive Pressure ◽  
Minimal Risk ◽  
Delayed Cord Clamping ◽  
Clinical Trial Registration ◽  
Institutional Review ◽  
Cord Clamping ◽  
Waiver Of Consent

Objective This study aimed to determine whether outcomes differed between infants enrolled in the PREMOD2 trial and those otherwise eligible but not enrolled, and whether the use of waiver effected these differences. Study Design The multicenter PREMOD2 (PREmature infants receiving Milking Or Delayed cord clamping) trial was approved for waiver of antenatal consent by six of the nine sites institutional review boards, while three sites exclusively used antenatal consent. Every randomized subject delivered at a site with a waiver of consent was approached for postnatal consent to allow for data collection. Four of those six sites’ IRBs required the study team to attempt antenatal consent when possible. Three sites exclusively used antenatal consent. Results Enrolled subjects had higher Apgar scores, less use of positive pressure ventilation, a lower rate of bronchopulmonary dysplasia, and a less frequent occurrence of the combined outcome of severe intraventricular hemorrhage or death. A significantly greater number of infants were enrolled at sites with an option of waiver of consent (66 vs. 26%, risk ratio = 2.54, p < 0.001). At sites with an option of either approaching families before delivery or after delivery with a waiver of antenatal consent, those approached prior to delivery refused consent 40% (range 15–74% across six sites) of the time. Conclusion PREMOD2 trial demonstrated analytical validity limitations because of the variable mix of antenatal consent and waiver of consent. A waiver of antenatal consent for minimal risk interventional trials conducted during the intrapartum period will be more successful in enrolling a representative sample of low and high-risk infants if investigators are able to enroll all eligible subjects. Clinical Trial Registration ClinicalTrials.gov identifier: NCT03019367. Key Points

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.

scholarly journals Assessing the Quality and Performance of Institutional Review Boards: Levels of Initial Reviews

2020 ◽  
Vol 15 (5) ◽  
pp. 407-414
Author(s):  
Min-Fu Tsan ◽  
Bruce Ling ◽  
Ulrike Feske ◽  
Susan Zickmund ◽  
Roslyn Stone ◽  
...  
Keyword(s):  
Human Subject ◽  
Institutional Review Boards ◽  
Human Research ◽  
Institutional Review ◽  
Review Procedure ◽  
Research Protections ◽  
And Performance ◽  
Board Review ◽  
Protocol Review ◽  
Review Boards

How well institutional review boards (IRBs) follow Common Rule criteria for levels of initial protocol review has not been systematically evaluated. We compared levels of review as determined using the Office for Human Research Protections (OHRP) human subject regulations decision charts of 313 protocols that had been approved by IRBs. There was a 97.8% agreement between 140 protocols that were reviewed by full board and the levels of review according to OHRP criteria. Likewise, there was a 93.8% agreement between 113 protocols that were reviewed using an expedited review procedure and OHRP criteria. However, there was only 75% agreement for exempt protocols. Specifically, 10 (16.7%) of the 60 exempt protocols were found to require IRB review, that is, six protocols requiring expedited review and four protocols requiring full board review. Conducting non-exempt research without prior IRB approval constitutes serious noncompliance. Our data suggest that exempt protocols need more scrutiny.

Making Research Consent Forms Informative and Understandable: The Experience of the Indian Health Service

1994 ◽  
Vol 3 (4) ◽  
pp. 510-521 ◽  
Author(s):  
William L. Freeman
Keyword(s):  
Informed Consent ◽  
Health Service ◽  
American Indian ◽  
Alaska Native ◽  
Institutional Review Boards ◽  
Indian Health Service ◽  
Research Model ◽  
Consent Forms ◽  
Indian Health ◽  
Institutional Review

The mission of the Indian Health Service (IHS) affects what research is done and how It is reviewed and managed and in turn affects the forms and process used to obtain informed consent. Consent forms must be Informative and understandable to American Indian and Alaska Native (AI/AN) potential volunteers; the process used to obtain informed consent must minimize any institutional pressure to participate. The IHS Institutional Review Boards (IRBs) developed seven research Model Volunteer Consent Forms (available from the author).

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