Institutional Review Boards and Ethical Issues in Randomized Clinical Trials

2009 ◽  
pp. 136-140
Author(s):  
Shlomo Shinnar
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Ethical Issues ◽  
Institutional Review Boards ◽  
Institutional Review ◽  
Review Boards

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 The efficiency of single institutional review board review in National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network–initiated clinical trials

2018 ◽  
Vol 16 (1) ◽  
pp. 3-10 ◽  
Author(s):  
Michael P Diamond ◽  
Esther Eisenberg ◽  
Hao Huang ◽  
Christos Coutifaris ◽  
Richard S Legro ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Child Health ◽  
Clinical Research ◽  
Human Development ◽  
Reproductive Medicine ◽  
Institutional Review Board ◽  
Institutional Review Boards ◽  
Institutional Review ◽  
The Impact ◽  
Review Boards

Background/aims: Timely review of research protocols by institutional review boards leads to more rapid initiation of clinical trials, which is critical to expeditious translation from bench to bedside. This observational study examined the impact of a single institutional review board on time and efforts required to initiate clinical trials by the National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network. Methods: Collection of data from the same six main clinical sites for three current clinical trials and two past clinical trials, including time from institutional review board submission to approval, pages submitted, consent form length, number of required attachments, other regulatory requirements, order of review at central or local sites, and language in documents at individual participating sites. Results from two past clinical trials were also included. Results: While time required for actual institutional review board submission’s review and initial approval was reduced with use of a single institutional review board for multicenter trials (from a mean of 66.7–24.0 days), total time was increased (to a mean of 111.2 or 123.3 days). In addition to single institutional review board approval, all institutions required local approval of some components (commonly consent language and use of local language), which varied considerably. The single institutional review board relied on local institutions for adding or removing personnel, conflict of interest review, and auditing of activities. Conclusion: A single institutional review board reduced time for initial review and approval of protocols and informed consents, although time for the entire process was increased, as individual institutions retained oversight of components of required regulatory review. In order to best achieve the National Institute of Health’s goals for improved efficiency in initiation and conduct of multisite clinical research, greater coordination with local institutional review boards is key to streamlining and accelerating initiation of multisite clinical 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 Informed Consent and Approval by Institutional Review Boards in Published Reports on Clinical Trials

1999 ◽  
Vol 340 (14) ◽  
pp. 1114-1115 ◽  
Author(s):  
Miguel Ruiz-Canela ◽  
Miguel Ángel Martínez-González ◽  
Enrique Gómez-Gracia ◽  
Joaquín Fernández-Crehuet
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Institutional Review Boards ◽  
Institutional Review ◽  
Review Boards

scholarly journals Strategies to enhance recruitment methods in phantom limb pain clinical trials

2017 ◽  
Vol 4 (2) ◽  
pp. 72 ◽  
Author(s):  
Camila Bonin Pinto ◽  
Faddi Ghassan Saleh Vélez ◽  
Melanie N. French ◽  
Dian Zeng ◽  
David Crandell ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Large Scale ◽  
Randomized Clinical Trials ◽  
Phantom Limb Pain ◽  
Phantom Limb ◽  
Institutional Review Boards ◽  
Recruitment Strategies ◽  
Limb Pain ◽  
Recruitment Methods ◽  
Institutional Review

<p class="abstract">Phantom limp pain (PLP) was first described in 1551. To date, its mechanisms and novel interventions remain mostly untested. Only limited conclusions can be drawn from few and small sized randomized clinical trials (RCTs) on PLP. In this scenario, enhanced recruitment strategies are crucial in order to overcome inherent challenges to recruit and enroll PLP subjects for clinical trials. Although there are many general methods to enhance recruitment and also retention, in this article we discuss these methods based on a common topic; dissemination. We summarize and discuss ten strategies of recruitment related to the dissemination of information based on the notion that increased trial awareness may lead to both improved recruitment and also external generalizability. In addition, we include insights based on our experience recruiting PLP patients for the purposes of a large-scale and on-going NIH-sponsored clinical trial. Although specific regulatory considerations need to be considered when choosing the methods of recruitment (which may vary across different countries and Institutional Review Boards (IRBs)), these strategies may be applicable to most research settings.</p>

scholarly journals The Challenges of First-in-Human Stem Cell Clinical Trials: What Does This Mean for Ethics and Institutional Review Boards?

2018 ◽  
Vol 10 (5) ◽  
pp. 1429-1431 ◽  
Author(s):  
Roger A. Barker ◽  
Melissa K. Carpenter ◽  
Stuart Forbes ◽  
Steven A. Goldman ◽  
Catriona Jamieson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Stem Cell ◽  
Institutional Review Boards ◽  
Human Stem Cell ◽  
Institutional Review ◽  
Review Boards
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