Ethical issues in neuroimaging health research:an IPA study with research participants

Neuroimaging is increasingly used to understand conditions like stroke and epilepsy. However, there is growing recognition that neuroimaging can raise ethical issues. We used interpretative phenomenological analysis to analyse interview data pre-and post-scan to explore these ethical issues. Findings show participants can become anxious prior to scanning and the protocol for managing incidental findings is unclear. Participants lacked a frame of reference to contextualize their expectations and often drew on medical narratives. Recommendations to reduce anxiety include dialogue between researcher and participant to clarify understanding during consent and the use of a `virtual tour' of the neuroimaging experience.

Do GPs Make Good Research Participants?

Background Childhood cancers cause the largest numbers of deaths by disease in children aged 0-14 years1 with more than 400 children a year dying from cancer in the UK.2 Parental preference for their child to die within the family home2 coupled with the speciality of children’s palliative care medicine being still in its infancy, highlights the importance of the GP’s role in this highly specialised area of clinical practice. An understanding of the GP’s role will help inform the development of this specialty and identify best collaborative practice. A NIHR/CAT CL funded study examined the role of the GP in paediatric oncology palliative and bereavement care from the perspective of both the GP and the bereaved parent. This presentation will detail how GPs were approached and recruited, the reasons GPs declined participation and factors influencing the actual data collection. Methods The mixed method study used both qualitative and quantitative data collection methods. Phase 1: Semi-structured interviews to explore the experiences of GPs and parents. Phase 2: Q methodology with GPs who had a child with cancer on their caseload. Q methodology is a research tool that uses statistical analysis to cluster participants’ experiences according to similarity of their viewpoint Results The method and effectiveness of recruiting GPs for both phases of the study will be presented. In addition factors influencing collecting such emotive and sensitive data will be discussed. Conclusions Researcher flexibility and perseverance in participant recruitment was rewarded by the rich data collected. Findings from this study have identified four different GP role viewpoints and have provided a new dimension in understanding GP viewpoints on their role in this arena.

Serving two masters: a reflective narrative of reconciling the tensions faced in designing doctoral research

This paper presents a reflective narrative of the process of designing a PhD project. Using the analogy of the play 'One Man, Two Guvnors' , this paper discusses the tensions a beginning researcher faces in reconciling her own vision for a project with the academic demands of doctoral-level study. Focusing on an ethnographic study of a reading group for visually-impaired people, the paper explores how the researcher's developing understanding of the considerations necessary when working with disabled people impacted on the research design. In particular, it focuses on the conflict faced by doctoral students when working in a paradigm that requires actively involving research participants, thereby relinquishing some control over the project. The aim of the paper is to provide an honest narrative that will resonate with other beginning researchers.

Research methods in TESOL and digital literacies

One of the biggest challenges of integrating research in TESOL with research in digital literacies is that the research methodologies of these two traditions have developed out of different ontological and episte- mological assumptions about what is being researched (the object of study), where the research is located (the research site), and who is being researched (the research participants).

Post-trial access to study medication: a Brazilian e-survey with major stakeholders in clinical research

Objectives To analyse the perspective of clinical research stakeholders concerning post-trial access to study medication. Methods Questionnaires and informed consents were sent through e-mail to 599 ethics committee (EC) members, 290 clinical investigators (HIV/AIDS and Diabetes) and 53 sponsors in Brazil. Investigators were also asked to submit the questionnaire to their research patients. Two reminders were sent to participants. Results The response rate was 21%, 20% and 45% in EC, investigators and sponsors' groups, respectively. 54 patients answered the questionnaire through their doctors. The least informative item in the consent form was how to obtain the study medication after trial. If a benefit were demonstrated in the study, 60% of research participants and 35% of EC answered that all patients should continue receiving study medication after trial; 43% of investigators believed the medication should be given to participants, and 40% to subjects who participated and benefited from treatment. For 50% of the sponsors, study medication should be assured to participants who had benefited from treatment. The majority of responders answered that medication should be provided free by sponsors; investigators and sponsors believed the medication should be kept until available in the public health sector; EC members said that the patient should keep the benefit; patients answered that benefits should be assured for life. Conclusions Due to the study limitations, the results cannot be generalised; however, the data can contribute to discussion of this complex topic through analysing the views of stakeholders in clinical research in Brazil.

Book Review of “Frontiers of Social Research: Japan and Beyond”. 351 pages, Trans Pacific Press, 2007, edited by Akira Furukawa

The title ‘Frontiers of Social Research’ implies a pioneering spirit, embarking upon unchartered territories. However, the most fascinating and insightful moments of this book are those which explore age-old Japanese research techniques and the potential for new methodologies to look to the old. The key theme of the work is the role of the researcher and the researcher’s relationships with research participants, the research audience and with knowledge itself.

Investigator/IRB-led community communication in genetic research: A descriptive feasibility pilot study

This pilot study, conducted in the Houston, TX, area, established a structured dialogue among a university Institutional Review Board, its researchers, and its local community members (i.e. pool of potential research participants) for the purpose of further educating all three parties about genetic research and community concerns related to such research. An IRB-designed educational presentation aimed at assisting potential subjects in making an informed decision to participate in genetic research was provided to four community groups (n=54); this presentation also included a current example of genetic research being conducted in the community as explained by the researcher, and a question-and-answer session designed to assist the IRB and the researcher in understanding the community's concerns about genetic research. Comparisons of pre- and post- presentation community questionnaires indicate that the joint presentation was effective in increasing community knowledge about genetic research, most notably related to the risks and benefits of this research to the individual, as well as the understanding that protections are in place for research participants. While researchers are optimistic about the idea of a collaborative effort with the IRB and the community, the feasibility of such a program and the benefit to the participating researchers remain unclear; additional research is necessary to establish the most effective method of communication for all groups involved, as well as to obtain statistically significant results with regard to race/ethnicity, gender, and education levels of community participants. ^

A systematic review of the methods used to assess race and racial disparities in uterine fibroid research

Context: Black women are reported to have a higher prevalence of uterine fibroids, and a threefold higher incidence rate and relative risk for clinical uterine fibroid development as compared to women of other races. Uterine fibroid research has reported that black women experience greater uterine fibroid morbidity and disproportionate uterine fibroid disease burden. With increased interest in understanding uterine fibroid development, and race being a critical component of uterine fibroid assessment, it is imperative that the methods used to determine the race of research participants is defined and the operational definition of the use of race as a variable is reported for methodological guidance, and to enable the research community to compare statistical data and replicate studies. ^ Objectives: To systematically review and evaluate the methods used to assess race and racial disparities in uterine fibroid research. ^ Data Sources: Databases searched for this review include: OVID Medline, NML PubMed, Ebscohost Cumulative Index to Nursing and Allied Health Plus with Full Text, and Elsevier Scopus. ^ Review Methods: Articles published in English were retrieved from data sources between January 2011 and March 2011. Broad search terms, uterine fibroids and race, were employed to retrieve a comprehensive list of citations for review screening. The initial database yield included 947 articles, after duplicate extraction 485 articles remained. In addition, 771 bibliographic citations were reviewed to identify additional articles not found through the primary database search, of which 17 new articles were included. In the first screening, 502 titles and abstracts were screened against eligibility questions to determine citations of exclusion and to retrieve full text articles for review. In the second screening, 197 full texted articles were screened against eligibility questions to determine whether or not they met full inclusion/exclusion criteria. ^ Results: 100 articles met inclusion criteria and were used in the results of this systematic review. The evidence suggested that black women have a higher prevalence of uterine fibroids when compared to white women. None of the 14 studies reporting data on prevalence reported an operational definition or conceptual framework for the use of race. There were a limited number of studies reporting on the prevalence of risk factors among racial subgroups. Of the 3 studies, 2 studies reported prevalence of risk factors lower for black women than other races, which was contrary to hypothesis. And, of the three studies reporting on prevalence of risk factors among racial subgroups, none of them reported a conceptual framework for the use of race. ^ Conclusion: In the 100 uterine fibroid studies included in this review over half, 66%, reported a specific objective to assess and recruit study participants based upon their race and/or ethnicity, but most, 51%, failed to report a method of determining the actual race of the participants, and far fewer, 4% (only four South American studies), reported a conceptual framework and/or operational definition of race as a variable. However, most, 95%, of all studies reported race-based health outcomes. The inadequate methodological guidance on the use of race in uterine fibroid studies, purporting to assess race and racial disparities, may be a primary reason that uterine fibroid research continues to report racial disparities, but fails to understand the high prevalence and increased exposures among African-American women. A standardized method of assessing race throughout uterine fibroid research would appear to be helpful in elucidating what race is actually measuring, and the risk of exposures for that measurement. ^

Attitudes of the autism community to early autism research

Investigation into the earliest signs of autism in infants has become a significant sub-field of autism research. This work invokes specific ethical concerns such as use of 'at-risk' language, communicating study findings to parents and the future perspective of enrolled infants when they reach adulthood. This study aimed to ground this research field in an understanding of the perspectives of members of the autism community. Following focus groups to identify topics, an online survey was distributed to autistic adults, parents of children with autism and practitioners in health and education settings across 11 European countries. Survey respondents (n = 2317) were positively disposed towards early autism research, and there was significant overlap in their priorities for the field and preferred language to describe infant research participants. However, there were also differences including overall less favourable endorsement of early autism research by autistic adults relative to other groups and a dislike of the phrase 'at-risk' to describe infant participants, in all groups except healthcare practitioners. The findings overall indicate that the autism community in Europe is supportive of early autism research. Researchers should endeavour to maintain this by continuing to take community perspectives into account.

BEHIND THE COMPUTER SCREEN: WHAT IRB PROFESSIONALS REALLY THINK ABOUT SOCIAL MEDIA RESEARCH

Thesis (Master's)--University of Washington, 2016-06

Investigating the dilemmas of ethical social research

The author’s work with a university ethics committee and field research in Pacific New Caledonia is used as a basis to problematise the biomedical research models used by universities in Australia for assessing social research as ethical. The article explores how culturally specific Western emotional bases for ethical decisions are often unexamined. It expresses concerns about gaps in biomedical models by linking the author’s description of field interactions with research participants to debates about the creation of knowledge.

The ethics of paying drug users who participate in research: a review and practical recommendations

THE PAYMENT OF RESEARCH PARTICIPANTS raises ethical and empirical questions that have special importance in addictions research involving drug-dependent participants. Despite a now large literature on human subjects payment, what is still needed is practical guidance for investigators and ethics committees. This paper reviews the literature on: current payment practices and guidelines; defining features of undue and due incentives and fair reimbursement; and the significance of risks and harms that may arise from paying drug using participants. We conclude that research payments are ethically acceptable in most circumstances of addictions research, but should be closely scrutinized in situations where these may exacerbate existing harms or create additional risks for participants and investigators. General principles, key questions and procedural options are highlighted for an applied approach to ethical research payments. Future research directions are identified.

Doing Research with Vulnerable Populations: The Case of Intravenous Drug Users

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Doing Research with Vulnerable Populations: The Case of Intravenous Drug Users

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