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.

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 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.

scholarly journals Prevalence and Associated Risk Factors of Sarcopenia Among Elderly With Diabetes in Japan and Taiwan

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 177-178
Author(s):  
Yuko Yamaguchi ◽  
Chieko Greiner ◽  
Hirochika Ryuno ◽  
Pi-Hsia Lee ◽  
Hsin-Yen Yen ◽  
...  
Keyword(s):  
Risk Factors ◽  
Health Management ◽  
Cross Sectional Study ◽  
Institutional Review Boards ◽  
Cross Sectional ◽  
Effective Strategies ◽  
Institutional Review ◽  
Significant Difference ◽  
Associated Risk Factors ◽  
Medical University

Abstract The aim of this study was to investigate the prevalence of sarcopenia and its associated risk factors among elderly with diabetes in Japan and Taiwan. A cross-sectional study was conducted through convenience sampling. This study was approved by the institutional review boards of Kobe University Graduate School of Health Sciences (No. 543) and Taipei Medical University (No. N201905065). Of the 114 Japanese participants (24.9% females) and 226 Taiwanese participants (75.1% females), the mean age were 73.7±6.9 years and 74.2±6.6 years, respectively. Sarcopenia was found in 10.6% in Japan and 11.1% in Taiwan with no significant difference between both countries. Older age, poor relationships with neighbors, and poor consciousness for health management were significantly associated with sarcopenia in both countries. Additionally, Japanese participants with sarcopenia had significantly longer duration of diabetes, higher level of emotional distress assessed by the Problem Areas In Diabetes (PAID) scale, and lower level of total protein, but no significant differences were shown in Taiwanese participants. Binomial logistic regression analyses were performed to detect risk factors related to sarcopenia. After adjusting for age, sarcopenia was found to be significantly associated with poor consciousness for health management in Japanese participants (OR:0.12 P=0.02) and significantly associated with poor relationships with neighbors and poor consciousness for health management in Taiwanese participants (OR:0.18 P=0.008 and OR:0.45 P=0.04, respectively). These findings are expected to contribute to the development of effective strategies for preventing sarcopenia among elderly with diabetes in Japan and Taiwan.

Symposium on Human Subjects Research: Redux

2002 ◽  
Vol 30 (3) ◽  
pp. 358-360
Author(s):  
Jesse A. Goldner
Keyword(s):  
Quality Improvement ◽  
Human Subjects ◽  
Institutional Review Boards ◽  
Human Subjects Research ◽  
Institutional Review ◽  
New Directions ◽  
Short Run ◽  
Research Protections ◽  
Review Boards

Two years ago, the Journal of Law, Medicine & Ethics published volume 28, number 4, devoted to a symposium entitled Human Subjects Research and the Role of Institutional Review Boards - Conflicts and Challenges. I had the good fortune to be asked to serve as editor of that issue. In her introduction to the symposium, the then editor-in-chief of the journal, Ellen Wright Clayton, observed that the country is currently undergoing a major reexamination of how biomedical research is conducted. While that reexamination has continued in the interim, some very recent events raise questions about the extent to which this will continue, at least in the short run, with equal vigor. The intervening years have witnessed a variety of new directions and events. The federal Office of Human Research Protections (OHRP), directed by Dr. Greg Koski, who wrote a brief commentary for the last symposium,L has taken a new direction, strongly stressing the need for institutions and their institutional review boards ORBS) to engage in extensive educational and quality improvement efforts with both researchers and their own member.

Ethical Conduct of Laboratory Experimental Research on Fear and Anxiety: Review and Recommendations

2013 ◽  
Vol 15 (3) ◽  
pp. 148-159
Author(s):  
Steven R. Lawyer ◽  
Ralph Baergen ◽  
Bena Kuruvilla
Keyword(s):  
Experimental Research ◽  
Human Subjects ◽  
Research Literature ◽  
Institutional Review Boards ◽  
Research Strategies ◽  
Cue Exposure ◽  
Ethical Concerns ◽  
Institutional Review ◽  
Fear And Anxiety ◽  
The Impact

Experimental research concerning fear and anxiety often involves exposing human subjects to fear-cue stimuli. Several aspects of fear-cue exposure may generate ethical concerns on the part of institutional review boards (IRBs) charged with protecting human research participants from harm. The goal of this article is to provide researchers with a framework for effectively addressing ethical concerns raised by some fear and anxiety research. We highlight the ethical considerations raised by fear-cue exposure procedures, review the extant research literature relevant to these concerns, make recommendations on how to address IRB ethical concerns, and recommend various research strategies that might clarify the impact (positive or negative) of fear-cue exposures on human subjects participating in anxiety research. IRBs may raise a variety of important concerns about fear-cue exposure research. Some of these concerns can be addressed by adequate justification within the IRB protocol using existing research findings. Further research is needed to address a variety of potential ethical concerns. Such research may help address concerns regarding research involving fear-cue exposure.

scholarly journals Barriers to Development of an App for Improving Staff-Family Communication at Israeli Geriatric Facilities

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 192-193
Author(s):  
Rinat Cohen ◽  
Gal Maydan ◽  
Shai Brill ◽  
Jiska Cohen-Mansfield
Keyword(s):  
Mobile App ◽  
Institutional Review Boards ◽  
Staff Members ◽  
Institutional Review ◽  
Implementation Planning ◽  
Institutional Adoption ◽  
Communication Needs ◽  
The University ◽  
And Control ◽  
To Receive

Abstract Family caregivers (FCs) of institutionalized noncommunicative older persons reported multiple unmet communication needs focusing on the need to receive reliable and regular updates on the patient’s condition. We have developed a mobile app for improving communication between FCs and healthcare professionals (HPs), based on 152 interviews with FCs and 13 discussion groups with HPs from four Israeli geriatric facilities. Both parties participated in app planning, tailoring it to their needs and abilities. App use implementation encountered major obstacles including the bureaucratic process concerning signing contracts between the university and software development firms, which hindered the process for a full year; data security department required disproportionate security levels that interfered with user experience and delayed the development process; the study’s definition varied across different ethics/Helsinki committees (Institutional Review Boards; IRBs), which led to different demands, e.g., insurance for medical clinical trials although no drugs or medical device were involved; lack of cooperation by mid-level staff members despite the institutional adoption of the app project; low utilization by HPs resulted in FCs not receiving timely responses. Despite these and other obstacles, we tested app use for 15 months in one facility in a pre-post-design with intervention and control groups, and we have since begun testing it in another facility. FCs who had used the app had positive feedback and wished to continue using it. App use optimization requires implementation planning, assimilating changes in each facility’s work procedures and HP’s engagement and motivation and thus depends on institutional procedures and politics.

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).

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