scholarly journals Ethical Considerations about Genomic Medicine Implementation: Lessons Learned from the eMERGE III Study

2020 ◽  
Vol 10 (4) ◽  
pp. 195
Author(s):  
Kentaro Inamura
Keyword(s):  
Genomic Medicine ◽  
Lessons Learned ◽  
Phase Iii ◽  
Return Of Results ◽  
Institutional Review Boards ◽  
Genomic Information ◽  
Ethical Considerations ◽  
Institutional Review ◽  
Study Protocols ◽  
Implementation Studies

The development of high-throughput techniques has permitted the accumulation of enormous amounts of genomic information. As increasing numbers of studies aim to utilize individual genomic information for diagnostic, preventive, or therapeutic purposes, Institutional Review Boards (IRBs) have a greater opportunity to review such types of study protocols. An article published in the Journal of Personalized Medicine titled, “Ethical Considerations Related to Return of Results from Genomic Medicine Projects: The eMERGE Network (Phase III) Experience” identified the common concerns of IRBs in the process of reviewing such studies, and some concerns included the readability of informed consent materials, potential risks to participants, information sharing with family members, options for withdrawal or receiving limited results, and provisions to clear participant questions. Since there is an increase in the number of genomic medicine implementation studies worldwide, the insights provided by this study would assist future researchers in protocol preparation as well as aid project review by IRB members.

scholarly journals Ethical Considerations Related to Return of Results from Genomic Medicine Projects: The eMERGE Network (Phase III) Experience

2018 ◽  
Vol 8 (1) ◽  
pp. 2 ◽  
Author(s):  
Robyn Fossey ◽  
David Kochan ◽  
Erin Winkler ◽  
Joel Pacyna ◽  
Janet Olson ◽  
...  
Keyword(s):  
Genomic Medicine ◽  
Phase Iii ◽  
Return Of Results ◽  
Ethical Considerations ◽  
Emerge Network

Usability Testing for Rapid Fielding with Small Ns: Lessons Learned during an Army Operational Field Experiment

2007 ◽  
Vol 51 (26) ◽  
pp. 1622-1626
Author(s):  
Pamela A. Savage-Knepshield
Keyword(s):  
Human Factors ◽  
Lessons Learned ◽  
Advanced Technology ◽  
Institutional Review Boards ◽  
Iterative Design ◽  
Field Environment ◽  
Institutional Review ◽  
Qualitative Feedback ◽  
Usability Feedback ◽  
Survey Instrument Development

The Army's acquisition process is transforming to meet the needs of a force that must be agile, adaptive, and responsive to asymmetric threats. Advanced capabilities and technologies, which are urgently needed to enable rapid response to evolving military needs, are being developed and pushed out to troops at unprecedented rates. As a result, not all systems have undergone an iterative design process, received usability feedback from their target users, or had design support from human factors engineers to ensure that unit and Soldier considerations have been addressed. Subsequently, these systems may possess characteristics that induce high cognitive workload, fatigue, detectability, or trigger events that lead to fratricide. When human factors engineers encounter a system that has not derived these benefits, they too must become more agile, adaptive, and responsive to ensure that Soldier feedback is collected and that serious issues are identified and resolved before the system makes its way to the battlefield. Lessons learned while participating in advanced technology and experimentation programs include techniques that facilitate working with small Ns, institutional review boards, rapid survey instrument development, and the collection of qualitative feedback as well as the importance of having a “usability tool kit” available to facilitate data collection efforts in an operational field environment.

Differences between research ethics committees

2007 ◽  
Vol 23 (1) ◽  
pp. 17-23 ◽  
Author(s):  
Sarah J. L. Edwards ◽  
Tracey Stone ◽  
Teresa Swift
Keyword(s):  
Research Ethics ◽  
Ethics Committees ◽  
Institutional Review Boards ◽  
Research Ethics Committees ◽  
Ethical Considerations ◽  
Local Conditions ◽  
Ethical Judgments ◽  
Risks And Benefits ◽  
The United Kingdom ◽  
Institutional Review

Objectives:To examine differences in the ethical judgments made by Research Ethics Committees (RECs) or Institutional Review Boards (IRBs).Methods:We did a review of the literature and included any study that attempted to compare the ethical judgments made by different RECs or IRBs when reviewing one or more protocol.Results:There were twenty-six articles reporting such discrepancies across Europe, within the United Kingdom, Spain, and United States. Of these studies, there were only five reports of some RECs approving while others rejecting the same protocol. All studies, however, reported differences in the clarifications and revisions asked of researchers regarding consent, recruitment, risks and benefits, compensation arrangements, and scientific issues.Conclusions:The studies were generally anecdotal reports of researchers trying to do research. New rules requiring a single ethical opinion for multi-site research at least in European Member States may simply conceal problematic issues in REC decision making. In the last analysis, we should expect a certain degree of variation and differences if we are to keep a committee system of review, although there is a pressing need to investigate the way in which RECs make these judgments. In particular, we need to identify the source of any aberrations, distortions, or confusions that could arbitrarily affect these judgments. Furthermore, local conditions remain important ethical considerations and should not be sidelined in pursuit of greater “consistency.”

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

2017 ◽  
Author(s):  
Christian B. Ramers
Keyword(s):  
Informed Consent ◽  
Conflicts Of Interest ◽  
Institutional Review Boards ◽  
Ethical Considerations ◽  
Governmental Organizations ◽  
Institutional Review ◽  
The Us ◽  
Guidelines And Recommendations ◽  
Study Designs

Ethics and conflicts of interest are important considerations when planning and carrying out research. It is the role of the institutional review board to weigh these against protection of the research subject when evaluating research proposals. The ethical considerations when performing research include basic ethical principles (e.g., autonomy, confidentiality, non-maleficence, informed consent, beneficence, justice, and utility), as well as nuances such as appropriate study designs, investigator conflict of interests, and bias in all its forms. To help guide clinicians, a number of professional and governmental organizations have published guidelines and recommendations on various aspects of clinical research (e.g., the American Medical Association, the National Institutes of Health, and the US Food and Drug Administration).

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 Leveraging Interdisciplinary Teams to Develop and Implement Secure Websites for Behavioral Research: Applied Tutorial

10.2196/19217 ◽  
2020 ◽  
Vol 22 (9) ◽  
pp. e19217
Author(s):  
Christie L Martin ◽  
Eydie N Kramer-Kostecka ◽  
Jennifer A Linde ◽  
Sarah Friend ◽  
Vanessa R Zuroski ◽  
...  
Keyword(s):  
Research University ◽  
Interdisciplinary Teams ◽  
Lessons Learned ◽  
Health Habits ◽  
Digital Platforms ◽  
Research Participants ◽  
Institutional Review ◽  
Study Protocols ◽  
Viable Solution

Behavioral researchers are increasingly using interactive digital platforms, either as standalone or supplementary intervention tools, to facilitate positive changes in research participants’ health habits. Research-oriented interactive websites optimally offer a variety of participatory mediums, such as blogs, user-driven content, or health activities. Owing to the multidirectional features of interactive websites, and a corresponding need to protect research participants’ identity and data, it is paramount that researchers design ethical platforms that ensure privacy and minimize loss of anonymity and confidentiality. Authentication (ie, digital verification of one’s identity) of interactive sites is one viable solution to these concerns. Although previous publications have addressed ethical requirements related to authenticated platforms, few applied guidelines in the literature facilitate adherence to ethical principles and legally compliant study protocols during all phases of research website creation (feasibility, design, implementation, and maintenance). Notably, to remain compliant with ethical standards and study protocols, behavioral researchers must collaborate with interdisciplinary teams to ensure that the authenticated site remains secure and usable in all stages of the project. In this tutorial, we present a case study conducted at a large research university. Through iterative and practical recommendations, we detail lessons learned from collaborations with the Institutional Review Board, legal experts, and information technology teams. Although the intricacies of our applied tutorial may require adaptations based on each institution’s technological capacity, we are confident that the core takeaways are universal and thus useful to behavioral researchers creating ethically responsible and compliant interactive websites.

Compendium of Unpublished Phase III Trials in Oncology: Characteristics and Impact on Clinical Practice

2011 ◽  
Vol 29 (23) ◽  
pp. 3133-3139 ◽  
Author(s):  
Vincent C. Tam ◽  
Ian F. Tannock ◽  
Christine Massey ◽  
Jennifer Rauw ◽  
Monika K. Krzyzanowska
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Phase Iii ◽  
Institutional Review Boards ◽  
Negative Results ◽  
Institutional Review ◽  
Subsequent Publication ◽  
Phase Iii Trials ◽  
Asco Meeting ◽  
American Society

Purpose Many phase III trials presented at annual meetings of the American Society of Clinical Oncology (ASCO) remain unpublished. The results of these unpublished trials, if more generally known, might have an impact on clinical practice. Methods Abstracts of large phase III trials evaluating systemic cancer treatment were identified from conference proceedings of the 1989 to 2003 ASCO annual meetings. PubMed, Medline, and Embase were searched for corresponding publications. A compendium of unpublished phase III trials was assembled. Clinical significance of nonpublication was determined by disease site-specific oncology experts from two academic cancer centers in Canada. Results A total of 709 phase III trials were identified of which 66 (9.3%) remain without a subsequent publication at a minimum of 6.5 years of follow-up and 94 (13%) were published after a delay of ≥ 5 years from their initial presentation. Of the unpublished trials, 48% were presented as oral sessions at an ASCO meeting, and 71% of the abstracts reported negative results. The experts judged that 70% of the unpublished trials addressed an important question and 59% might have had clinical impact if their results had been published promptly. Conclusion A substantial number of cancer clinical trials with potential influence on clinical practice remain unpublished and many other trials are published after a substantial delay. Nonpublication of clinical trials breaks an implicit contract with participants, institutional review boards, and sponsors.

Virtual Research Ethics

2004 ◽  
pp. 1-26 ◽  
Author(s):  
Blaine F. Peden ◽  
Douglas P. Flashinski
Keyword(s):  
Content Analysis ◽  
Research Ethics ◽  
American Psychological Association ◽  
Institutional Review Boards ◽  
The Internet ◽  
Online Research ◽  
Ethical Considerations ◽  
Internet Surveys ◽  
Institutional Review ◽  
Behavioral Studies

This chapter presents a content analysis of Internet surveys and experiments. Our study explores guidelines for the conduct of online research by describing the extent to which psychological studies comply with Reips’ (2000) recommendations for Web researchers. Our study also explores ethical considerations and problems in the conduct of virtual research by describing the extent to which behavioral studies on the Internet comply with ethical standards for research (American Psychological Association, 2003). The chapter concludes with a discussion of aspects of virtual research ethics pertinent to future participants, Internet scientists and Institutional Review Boards. “We need not invent new ethical rules for online research. We need only increase our awareness of and commitment to established ethical principles.” – Jim Thomas, 1999, p. 8

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