scholarly journals Research Ethics Training Needs in Thailand and Vietnam

2019 ◽  
Author(s):  
C Jason Wang ◽  
Uma Palam Pulendran ◽  
Diana Wise ◽  
Monika Thomas-Uribe ◽  
Punkae Mahaisavariya ◽  
...  
Keyword(s):  
Research Ethics ◽  
Human Subject ◽  
Online Survey ◽  
Human Subjects ◽  
Significant Proportion ◽  
Research Area ◽  
Ethics Training ◽  
Institutional Review Boards ◽  
Formal Training ◽  
Institutional Review

Abstract Background To describe the types of research being conducted and the availability of research ethics training and research ethics review in Thailand and Vietnam. Methods An English survey with four major domains, Research Area, Societal Conditions, Research Ethics, and Basic Information was translated into Thai and Vietnamese by native training partners from the NIH Fogarty Research Ethics Training Program. Setting/Participants The survey was administered in two modes - an online survey distributed via an email link in Thailand, and an onsite paper survey in Vietnam. Participants were Thai and Vietnamese trainees and investigators from prestigious universities. Results In Thailand, there were 363 respondents (9.3% online response rate); in Vietnam there were 117 survey participants. Among those who conduct research, 81% in Thailand and 92% percent in Vietnam reported that their research involves human subjects. Among human subject researchers, 83% in Thailand reported having ethics training, and among these, only 44% reported having formal training. In Vietnam, 66% reported having research ethics training; among them, 72% had formal training. Human subject research reported include clinical observations (26% from Thailand and 26% from Vietnam) and clinical interventions (29% from Thailand and 26% from Vietnam). Significant proportion of respondents reported that their institutions have guidelines (97% in Thailand; 89% from Vietnam) and have established Institutional Review Boards (92% in Thailand; 77% in Vietnam). 76% and 79% of respondents in Thailand and Vietnam respectively reported no experience in teaching research ethics. Lack of trained research ethics teachers (38% in Thailand and 59% in Vietnam), training materials (34% in Thailand; 43% in Vietnam), and an adequate curricular “delivery platform” (58% in Thailand; 49% in Vietnam) are most pressing issues. Conclusions We identified gaps in research ethics training in these two South East Asian countries undergoing rapid socioeconomic transition and identified future curricular focus opportunities.

scholarly journals Characterizing Current Attitudes and Practices for Human Subject Safety in Studies Involving Pupil Dilation

2020 ◽  
pp. 155626462096898
Author(s):  
Jacob Szpernal ◽  
Joseph Carroll ◽  
Ryan Spellecy ◽  
Jane A. Bachman Groth
Keyword(s):  
Informed Consent ◽  
Adverse Effects ◽  
Vision Research ◽  
Human Subject ◽  
Human Subjects ◽  
Pupil Dilation ◽  
Institutional Review Boards ◽  
Human Subjects Research ◽  
Attitudes And Practices ◽  
Institutional Review

Standards in pupil dilation practices regarding the safety of human subjects are not present in vision research despite the potential for significant adverse effects. We developed two surveys to examine current practices around pupil dilation among vision researchers and individuals associated with oversight of human subjects research. While both groups note an absence of adverse events associated with pupil dilation, vision researcher practices differed with informed consent use and measures taken to minimize complications. For Institutional Review Boards, general risk assumption associated with dilation was not unanimous and there was a lack of specific guidance available to researchers for minimizing risk. These results uncover the need for standardized practices regarding pupil dilation in human subjects research.

Vulnerability as a Regulatory Category in Human Subject Research

2009 ◽  
Vol 37 (1) ◽  
pp. 12-18 ◽  
Author(s):  
Carl H. Coleman
Keyword(s):  
Research Ethics ◽  
Human Subject ◽  
Institutional Review Boards ◽  
Human Subject Research ◽  
Human Subject Protection ◽  
Research Ethics Review ◽  
Institutional Review ◽  
Research Regulations ◽  
Vulnerable Subjects ◽  
The Common

The concept of vulnerability has long played a central role in discussions of research ethics. In addition to its rhetorical use, vulnerability has become a term of art in U.S. and international research regulations and guidelines, many of which contain specific provisions applicable to research with vulnerable subjects. Yet, despite the frequency with which the term vulnerability is used, little consensus exists on what it actually means in the context of human subject protection or, more importantly, on how a finding of vulnerability should affect the process of research ethics review.The Common Rule, the centerpiece of the U.S. human subject protection regulations, uses the word vulnerable three times. First, it provides that institutional review boards (IRBs) that regularly review research involving a vulnerable category of subjects should consider including one or more individuals who are knowledgeable about and experienced in working with these subjects.

Process, Power, and Impact of the Institutional Review Board in Criminology and Criminal Justice Research

2021 ◽  
pp. 155626462199224
Author(s):  
Elaine Gunnison ◽  
Jacqueline B. Helfgott
Keyword(s):  
Criminal Justice ◽  
Online Survey ◽  
Assessment Tool ◽  
Human Subjects ◽  
Institutional Review Boards ◽  
Social Scientists ◽  
Institutional Review ◽  
Research Bias ◽  
American Society ◽  
Criminology And Criminal Justice

While research on Institutional Review Boards (IRBs) has been conducted on issues ranging from quality, process, and effectiveness, gaps remain. Social science researchers have raised issues regarding decisions by IRBs applied to the social sciences based on biomedical research. To date, little is known about the experience of social scientists in criminology and criminal justice with IRBs and this research seeks to fill this gap. An online survey, including open- and closed-ended questions drawn from the validated IRB-Researcher Assessment Tool, was administered to members of the Academy of Criminal Justice Sciences and the American Society of Criminology about their experiences with IRBs. Results revealed that researchers report experiencing challenges with their IRBs including timeline delays of their research, bias against their research, and decisions that protect legal liability rather than human subjects ethics. Recommendations for improving IRB reviews of protocols and challenges unique to criminology and criminal justice are discussed.

What the ANPRM Missed: Additional Needs for IRB Reform

2013 ◽  
Vol 41 (2) ◽  
pp. 390-396 ◽  
Author(s):  
Charles W. Lidz ◽  
Suzanne Garverich
Keyword(s):  
Data Collection ◽  
Research Ethics ◽  
Human Subjects ◽  
Ethics Committees ◽  
Institutional Review Boards ◽  
Limited Time ◽  
Research Ethics Committees ◽  
Human Subjects Research ◽  
Institutional Review ◽  
The World

The federal Common Rule, which governs the conduct of research with human subjects, specifies the criteria and procedures by which Institutional Review Boards (IRBs) should review such research. Although there is wide agreement that IRBs, or Research Ethics Committees as they are called in most of the world, are essential to assuring that human subjects research meets common standards of ethics, IRBs have always come under considerable criticism. Some have critiqued IRBs for using important resources inefficiently, including the large amount of time researchers put into submitting applications, modifications, and reports and delaying the start of data collection within the limited time that grants and contracts provide. Others have critiqued the inconsistency of review of multi-site projects.

A Non-Paternalistic Model of Research Ethics and Oversight: Assessing the Benefits of Prospective Review

2012 ◽  
Vol 40 (4) ◽  
pp. 930-944 ◽  
Author(s):  
Alex John London
Keyword(s):  
Research Ethics ◽  
Political Correctness ◽  
Human Subjects ◽  
Current System ◽  
Ethics Committees ◽  
The United States ◽  
Institutional Review Boards ◽  
Iron Cage ◽  
Institutional Review ◽  
Exposed Population

To judge from the rash of recent law review articles, it is a miracle that research with human subjects in the U.S. continues to draw breath under the asphyxiating heel of the rent-seeking, creativity-stifling, jack-booted bureaucrethics that is the current system of research ethics oversight and review. Institutional Review Boards (IRBs), sometimes called Research Ethics Committees (RECs), have been accused of perpetrating “probably the most widespread violation of the First Amendment in our nation's history,” resulting in a “disaster, not only for academics, but for the whole nation.” One member of the President's Council on Bioethics went so far as to assert, “There has been no greater damage to academic freedom in the United States in my lifetime. And my lifetime encompasses McCarthy and it encompasses political correctness, both.” Locked in the bureaucratic “iron cage” of IRB oversight, critics charge that researchers have been transformed into a vulnerable, exposed population, subject to domination, that has been likened in one case to a kind of “Tuskegee in reverse.”

MRI Research Proposals Involving Child Subjects: Concerns Hindering Research Ethics Boards from Approving Them and a Checklist to Help Evaluate Them

2011 ◽  
Vol 20 (1) ◽  
pp. 115-129 ◽  
Author(s):  
J. DEBORAH SHILOFF ◽  
BRYAN MAGWOOD ◽  
KRISZTINA L. MALISZA
Keyword(s):  
United States ◽  
Research Ethics ◽  
Gold Standard ◽  
The United States ◽  
Institutional Review Boards ◽  
Scientific Review ◽  
Initial Development ◽  
Institutional Review ◽  
Research Ethics Boards ◽  
A Current

The process of research is often lengthy and can be extremely arduous. It may take many years to proceed from the initial development of an idea through to the comparison of the new modalities against a current gold-standard practice. Each step along the way involves rigorous scientific review, where protocols are scrutinized by multiple scientists not only in the specific field at hand but related fields as well. In addition to scientific review, most countries require a further review by a panel that will specifically address the ethics of the proposed research. In Canada, those panels are referred to as Research Ethics Boards (REB), with the United States counterparts known as Institutional Review Boards (IRB).

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.”

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.

IRB Creep: Federal Regulations Protecting Human Research Subjects and Increasing Instructors' Responsibilities

2009 ◽  
Vol 24 (1) ◽  
pp. 31-43 ◽  
Author(s):  
Diane A. Riordan ◽  
Michael P. Riordan
Keyword(s):  
Review Process ◽  
Human Subjects ◽  
Institutional Review Boards ◽  
Federal Regulations ◽  
Federally Funded ◽  
Research Subjects ◽  
Accounting Faculty ◽  
Institutional Review ◽  
Human Research Subjects ◽  
Review Boards

ABSTRACT: Federal regulations require oversight of federally sponsored research involving human subjects. Universities have responded by forming Institutional Review Boards (IRBs). Although these regulations only apply to federally funded projects, universities have extended the oversight to include all projects involving human subjects. From our own experience, we observe that not all accounting faculty are aware of their responsibilities to their local boards. The sanctions for failing to follow required procedures depend on the infraction, and range from an order to cease work on the project to termination of university service for the faculty member and expulsion for the student. This report helps accounting faculty understand how the review process may affect their role as instructors and serves as encouragement to them to become familiar with the requirements of local review boards.

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