Reactions to Laboratory-Based Trauma Research in a Sample of Incarcerated Women

2021 ◽  
pp. 155626462110436
Author(s):  
Steven R. Lawyer ◽  
Kathleen Smith ◽  
Beena Thomas ◽  
Shelby Pemberton
Keyword(s):  
Research Participation ◽  
Incarcerated Women ◽  
Institutional Review Boards ◽  
Control Group ◽  
Cost Ratio ◽  
Trauma Research ◽  
Rape Survivors ◽  
Benefit Cost Ratio ◽  
Emotional Responding ◽  
Institutional Review

An evidence-based approach to research ethics is critical to ethical research but little is known about how trauma survivors—especially those from vulnerable populations—respond to laboratory-based trauma research. One hundred four incarcerated women ( N = 64 rape survivors) reported their traumatic life experiences, listened to and responded to an audio recording of a dating interaction that culminates in a completed rape, and then reported their responses to their participation. Compared to the control group ( N = 40), rape survivors ( N = 64) had more posttraumatic stress disorder symptoms and these symptoms were associated with more emotional responding. Both groups showed a positive benefit–cost ratio with regard to their participation did not differ on their overall reactions to research participation. These findings suggest that laboratory-based trauma research methods are associated with consistently positive experiences, which can help inform researchers and institutional review boards about the risks and benefits of such research.

Immediate and Delayed Reactions to Trauma-related Laboratory Research Among Rape Survivors and Controls

2021 ◽  
pp. 155626462199610
Author(s):  
Steven R. Lawyer ◽  
Brittney M. Holcomb ◽  
Kateřina Příhodová
Keyword(s):  
Mental Health ◽  
Research Participation ◽  
Emotional Reactions ◽  
Laboratory Research ◽  
Trauma Research ◽  
Rape Survivors ◽  
Ethical Implications ◽  
Posttraumatic Stress Disorder Symptoms ◽  
Benefit Cost ◽  
First Session

Ethical implications of laboratory-based experimental trauma research are not well studied. Female rape survivors ( N = 62) and controls ( N = 79) listened to an audio recording of a sexual assault and completed mental health measures and the Reactions to Research Participation Questionnaire-Revised in the first session and again several weeks later. In the first session, mental health symptoms were associated with stronger emotional reactions and personal benefits from participation. Rape survivors also reported stronger emotional reactions than controls, but also more personal benefits, more satisfaction, and fewer perceived drawbacks from participation. Several weeks later, both groups reported diminished posttraumatic stress disorder symptoms and rape survivors’ reports of stronger emotional reactions and greater satisfaction with their participation remained significant. Benefit–cost ratios indicate positive responses to participation across groups and time. Findings suggest significant benefits to laboratory trauma research for participants.

scholarly journals Researchers’ perspectives on the role of study partners in dementia research

2014 ◽  
Vol 26 (10) ◽  
pp. 1649-1657 ◽  
Author(s):  
Betty S. Black ◽  
Holly Taylor ◽  
Peter V. Rabins ◽  
Jason Karlawish
Keyword(s):  
Academic Research ◽  
Research Participation ◽  
Research Process ◽  
Institutional Review Boards ◽  
Enrollment Decisions ◽  
Caregiver Support ◽  
Institutional Review ◽  
Dementia Research ◽  
Role Responsibilities

ABSTRACTBackground:Study partners for dementia research participants are vital to the research process, but little is known about their role, responsibilities, and experiences. Study partners are usually family members or friends – often the patient's informal caregiver – who are knowledgeable about and usually accompany the participant to study visits. This study examines researchers’ perspectives on the role of study partners in dementia research.Methods:Qualitative data collection and analytic methods were used. Semi-structured individual interviews with principal investigators, study coordinators, and research nurses (i.e. researchers; n = 17) at two academic research sites were recorded, transcribed, and content analyzed to identify themes in the data.Results:According to researchers, study partners either make or help make research enrollment and post-enrollment decisions, serve as knowledgeable informants for the participants, manage the logistics that enable participants to comply with a study's protocol, and provide comfort and encouragement for the patient to engage in and complete a study. Researchers describe ideal qualities of study partners as being able to provide reliable information, being dependable and adherent to the protocol, and not expecting a benefit. They also report that study partners may face both practical and emotional challenges during research participation. However, researchers believe that study partners derive dementia-related education, caregiver support, and satisfaction from their involvement in research.Conclusions:Investigators, potential study partners, and institutional review boards should be aware of study partners’ research responsibilities, challenges, and their interests as caregivers.

Walking the Moral Tightrope: Respecting and Protecting Children in Health-Related Research

2002 ◽  
Vol 11 (3) ◽  
pp. 217-229 ◽  
Author(s):  
PAUL B. MILLER ◽  
NUALA P. KENNY
Keyword(s):  
Research Participation ◽  
Institutional Review Boards ◽  
Research Subjects ◽  
Related Research ◽  
Institutional Review ◽  
Regulatory Frameworks ◽  
Child Research ◽  
Health Related Research ◽  
Health Related ◽  
Scientific Questions

Special moral, regulatory, and scientific questions surround the inclusion of children in health-related research. These questions arise from a fundamental moral tension between the obligation to expose children to research participation to ensure that they share in the benefits that arise from it and the obligation to protect them from the harms associated with their inappropriate involvement in research. This tension is felt in the development of moral and regulatory frameworks for the protection of child research subjects and in the implementation and interpretation of these frameworks by institutional review boards (IRBs).

scholarly journals Adolescent Assent and Reconsent for Biobanking: Recent Developments and Emerging Ethical Issues

2021 ◽  
Vol 8 ◽  
Author(s):  
T. J. Kasperbauer ◽  
Colin Halverson
Keyword(s):  
Ethical Issues ◽  
Research Participation ◽  
The United States ◽  
Institutional Review Boards ◽  
Ethical Debate ◽  
Current State ◽  
Institutional Review ◽  
Recent Developments ◽  
Research Biobanks ◽  
Regulatory Challenges

Research biobanks that enroll minors face important practical, ethical, and regulatory challenges in reconsenting participants when they reach the age of 18. Federal regulations governing research in the United States provide minimal guidance and allow for a range of practices, including waiving the requirement to obtain reconsent. Some commentators have argued that institutional review boards should indeed grant such waivers, given the low risks of biobank-based research and the impracticality of contacting all participants when they turn 18. There is also significant ethical debate about the age at which adolescents can make authentic, autonomous decisions regarding their research participation. This paper reviews these issues in detail, describes the current state of the ethical discussion, and outlines evidence-based policies for enrolling minors into research biobanks.

scholarly journals Supplementation of Broilers Diet with Different Sources of Growth Promoters

2012 ◽  
Vol 12 ◽  
pp. 41-50 ◽  
Author(s):  
S Sanjyal ◽  
S Sapkota
Keyword(s):  
Body Weight ◽  
Basal Diet ◽  
Feed Consumption ◽  
Ocimum Sanctum ◽  
Control Group ◽  
Cost Ratio ◽  
Feed Conversion ◽  
Growth Promoters ◽  
Benefit Cost Ratio ◽  
Randomized Design

A study was conducted at the Institute of Agriculture and Animal Sciences (IAAS), Rampur, Chitwan from 29 August to 17 October, 2007 to compare the effects of antibiotic (chlortetracycline) and probiotic (Lactobacillus acidophilus) with three herbal growth promoters, Amala (Emblica officinalis),(EO), Tulsi (Ocimum sanctum), (OC) and Aswogandha (Withania somnifera),(WS) on growth performance, feed consumption, feed conversion efficiency, carcass characteristics, and economics of broiler production. The experiment was laid out in a completely randomized design with day-old broiler chick (192) randomly assigned to eight groups containing 8 chick in each and replicated three times. The control group received the maize-soybean based basal diet. In the treatment groups, the basal diet was supplemented with one of the following: antibiotic, probiotics, Tulsi, Amala, and Aswogandha and also in combination of herbs, forming eight treatments respectively. Results showed significantly better production in herbs. Significantly higher digestibility of all the nutrients (P<0.05) was observed in Amala+Tulsi+Aswogandha (T8) supplemented group. Highest body weight (1.440kg) was recorded in birds fed diet supplemented with Amala and Tulsi, and the lowest body weight (1.317kg) was seen in antibiotics (T2) fed birds. The highest income over expenditure (Rs.26.36) was recorded in birds fed diet supplemented with Tulsi (T6), although the difference was not significant among the treatments. Looking at the benefit cost ratio, highest B/C ratio was found in birds supplied with Tulsi (1.19) supplemented diet and minimum (1.12) was recorded in Amala supplied diet. Hence, this experiment showed that herbs as growth promoters can replace antibiotics in the diet of broiler chicken. However, it needs multilocational trials before recommendation for adoption by poultry growers.DOI: http://dx.doi.org/10.3126/njst.v12i0.6478 Nepal Journal of Science and Technology 12 (2011) 41-50 

scholarly journals Currents in Contemporary Ethics

2008 ◽  
Vol 36 (2) ◽  
pp. 413-418 ◽  
Author(s):  
Ana S. Iltis ◽  
Hisako Matsuo ◽  
Shannon R. DeVader
Keyword(s):  
Empirical Research ◽  
Conceptual Analysis ◽  
Research Participation ◽  
Institutional Review Boards ◽  
Institute Of Medicine ◽  
Institutional Review ◽  
Reported Data ◽  
Payment Policies ◽  
The U.S ◽  
Made In

An Institute of Medicine (IOM) panel charged with reviewing the system for overseeing research involving children concluded in 2004 that Institutional Review Boards (IRBs), institutions engaged in research, and study sponsors should “adopt explicit written policies on acceptable and unacceptable types and amounts of payments related to [children’s] research participation.” We previously reported data on practices and policies in the U.S. regarding payments to children who participate in research and their parents. Here, we report additional results from our study and identify some of the decisions that must be made in developing payment plans and on which payment policies will be expected to offer guidance. We conclude that further conceptual analysis and empirical research are necessary before IRBs, institutions, and sponsors can develop specific rules on numerous aspects of payment. Nevertheless, payment policies that promote the ethical treatment of children in research and their parents can be developed. We propose a structure for such policies.

scholarly journals The Blind Review: A Quality Assessment Measure for Review Standardization of Institutional Review Boards

2020 ◽  
Author(s):  
Sinyoung Park ◽  
Cho Rong Ahn ◽  
Yang Hee Noh ◽  
Sejung Park ◽  
Chung Mo Nam ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Institutional Review Boards ◽  
Control Group ◽  
Effective Measure ◽  
Mean Values ◽  
Blind Review ◽  
Severance Hospital ◽  
Institutional Review ◽  
Assessment Measure ◽  
Human Research Protection Program

Abstract Background: Challenging research environment while the multinational trials are increasing, standardization of IRB review has become more important. The inconsistency is often inevitable in that opinions on the ethical part may be different, but the standardization and understanding the differences is required to assure IRB review quality. Thus, we aimed to develop and suggest quality assessment measure of IRB named “Blind review” by reviewing the same research protocols by multiple IRB panels. We further describe an analyzed result of differences to understand the mechanism of IRB standardization.Methods: We present a description of the Blind review process. Based on the HRPP (Human research Protection Program) SOPs (Standard of Procedure), eight blind review results from January 2010 to December 2018 at a single institution with multiple panels were included using Severance Hospital HRPP database. Review results were analyzed with review scores ranged 0 to 60 points including GCP requirements and protocol issues. Panel agreement was estimated by observed multiple rater agreement. Differences between review scores according to expertise member and IRB member duration were analysed with Wilcoxon rank-sum test and Kruskal-Wallis test.Results: Observed multiple raters’ agreement was increased from 0.444 (95% CI: 0.167-1.000) in 2010 to 0.479 (95% CI: 0.271-0.708) in 2014~2018 as IRB review experiences increases. In order to analyze the review mechanism, three GCP requirements and three protocol issues were scored (range 0 to 60). Mean values for GCP requirement and protocol issues were 19.25±8.21 and 18.40±9.04, respectively. Mean score of the panels where experts participated (n=16, 28.13±10.47) is higher than control group (n=32, 25.16±10.96) (p=0.93). According to career duration of IRB members’, scores of the group whose career is less than 3 years was 25.0±10.0 (n=14), the score of group whose career is 3-5 years was 26.3±9.6 (n=23). The mean score of the group whose career was more than 5 years shown 27.3±14.2 (n=11), and it is statistically significant. (p=0.09)Conclusions: We suggest Blind Review as an effective measure for overseeing and ensuring IRB’s review quality and overall GCP compliance.

Is the Juice Worth the Squeeze? A Benefit/Cost Analysis of the District of Columbia Opportunity Scholarship Program

2013 ◽  
Vol 8 (1) ◽  
pp. 74-99 ◽  
Author(s):  
Patrick J. Wolf ◽  
Michael McShane
Keyword(s):  
United States ◽  
Private School ◽  
The United States ◽  
Control Group ◽  
Cost Ratio ◽  
Economic Returns ◽  
Benefit Cost Analysis ◽  
Benefit Cost Ratio ◽  
Scholarship Program ◽  
Benefit Cost

School voucher programs have become a prominent aspect of the education policy landscape in the United States. The DC Opportunity Scholarship Program is the only federally funded voucher program in the United States. Since 2004 it has offered publicly funded private school vouchers to nearly four thousand students to attend any of seventy-three different private schools in Washington, DC. An official experimental evaluation of the program, sponsored by the federal government's Institute of Education Sciences, found that the students who were awarded Opportunity Scholarships graduated from high school at a rate 12 percentage points higher than the students in the randomized control group. This article estimates the benefit/cost ratio of the DC Opportunity Scholarship Program, primarily by considering the increased graduation rate that it induced and the estimated positive economic returns to increased educational attainment. We find a benefit to cost ratio of 2.62, or $2.62 in benefits for every dollar spent on the program.

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