scholarly journals Rapid Ethical Appraisal: A tool to design a contextualized consent process for a genetic study of podoconiosis in Ethiopia

2017 ◽  
Vol 2 ◽  
pp. 99 ◽  
Author(s):  
Tewodros Tariku Gebresilase ◽  
Zebene Deresse ◽  
Girmay Tsegay ◽  
Tesfaye Sisay Tessema ◽  
Abraham Aseffa ◽  
...  
Keyword(s):  
Informed Consent ◽  
Genetic Study ◽  
Research Process ◽  
Genomic Research ◽  
Community Members ◽  
Factors Affecting ◽  
Institutional Review ◽  
Field Workers ◽  
And Gender ◽  
Healthy Community

Background: Obtaining genuine informed consent from research participants in developing countries can be difficult, partly due to poor knowledge about research process and research ethics. The situation is complicated when conducting genomic research on a disease considered familial and a reason for stigmatisation. Methods: We used a Rapid Ethical Appraisal tool to assess local factors that were barriers to getting genuine informed consent prior to conducting a genetic study of podoconiosis (non-filarial elephantiasis) in two Zones of Ethiopia. The tool included in-depth interviews and focus group discussions with patients, healthy community members, field workers, researchers/Institutional Review Board (IRB) members, elders, religious leaders, and podoconiosis administrators who work closely with patients. Results: Most patients and healthy community members did not differentiate research from routine clinical diagnosis. Participants felt comfortable when approached in the presence of trusted community members. Field workers and podoconiosis administrators preferred verbal consent, whereas the majority of patients and healthy community members prefer both verbal and written consent. Participants better understood genetic susceptibility concepts when analogies drawn from their day-to-day experience were used. The type of biological sample sought and gender were the two most important factors affecting the recruitment process. Most researchers and IRB members indicated that reporting incidental findings to participants is not a priority in an Ethiopian context. Conclusions: Understanding the concerns of local people in areas where research is to be conducted facilitates the design of contextualized consent processes appropriate for all parties and will ultimately result in getting genuine consent.

Lessons from a community-based participatory research study with transgender and gender nonconforming youth and their families

2018 ◽  
Vol 17 (2) ◽  
pp. 186-207 ◽  
Author(s):  
Sabra L Katz-Wise ◽  
Annie Pullen Sansfaçon ◽  
Laura M Bogart ◽  
Milagros C Rosal ◽  
Diane Ehrensaft ◽  
...  
Keyword(s):  
Participatory Research ◽  
Community Based Participatory Research ◽  
Well Being ◽  
Research Process ◽  
Lessons Learned ◽  
Community Partner ◽  
Community Members ◽  
Community Based ◽  
Gender Nonconforming ◽  
And Gender

Community-based participatory research (CBPR) involves community members collaborating with academic investigators in each step of the research process. CBPR may be especially useful for research involving marginalized populations with unique perspectives and needs. In this paper, we discuss successes and challenges of using a CBPR approach for the Trans Teen and Family Narratives Project, a longitudinal mixed-methods study to examine how the family environment affects the health and well-being of transgender and gender nonconforming youth. We describe considerations for using a CBPR approach with this population, including defining the community of transgender and gender nonconforming youth and families, engaging the community in the research process, managing conflicting agendas for community partner meetings, addressing insider/outsider status of the researchers, resolving researcher/community tensions regarding data collection tools, integrating academic and community members into a cohesive research team, developing safety plans to address participant suicidality disclosures, and differentiating the role of academics as researchers vs. advocates. We conclude by sharing lessons learned, which can inform future research to address the needs of transgender and gender nonconforming youth and families.

scholarly journals Informed Consent

2015 ◽  
Vol 06 (03) ◽  
pp. 466-477 ◽  
Author(s):  
F. Manion ◽  
K. Hsieh ◽  
M. Harris ◽  
S. H. Fenton
Keyword(s):  
Informed Consent ◽  
Medical Record ◽  
Health Systems ◽  
Research Process ◽  
Institutional Review ◽  
Consent Document ◽  
Information Governance ◽  
Informed Consent Document ◽  
Computer Based ◽  
Investigative Team

Summary Background: Despite efforts to provide standard definitions of terms such as “medical record”, “computer-based patient record”, “electronic medical record” and “electronic health record”, the terms are still used interchangeably. Initiatives like data and information governance, research biorepositories, and learning health systems require availability and reuse of data, as well as common understandings of the scope for specific purposes. Lacking widely shared definitions, utilization of the afore-mentioned terms in research informed consent documents calls to question whether all participants in the research process — patients, information technology and regulatory staff, and the investigative team — fully understand what data and information they are asking to obtain and agreeing to share. Objectives: This descriptive study explored the terminology used in research informed consent documents when describing patient data and information, asking the question “Does the use of the term “medical record” in the context of a research informed consent document accurately represent the scope of the data involved?” Methods: Informed consent document templates found on 17 Institutional Review Board (IRB) websites with Clinical and Translational Science Awards (CTSA) were searched for terms that appeared to be describing the data resources to be accessed. The National Library of Medicine’s (NLM) Terminology Services was searched for definitions provided by key standards groups that deposit terminologies with the NLM. Discussion: The results suggest research consent documents are using outdated terms to describe patient information, health care terminology systems need to consider the context of research for use cases, and that there is significant work to be done to assure the HIPAA Omnibus Rule is applied to contemporary activities such as biorepositories and learning health systems. Conclusions: “Medical record”, a term used extensively in research informed consent documents, is ambiguous and does not serve us well in the context of contemporary information management and governance. Citation: Fenton SH, Manion F, Hsieh K, Harris M. Informed Consent: Does Anyone Really Understand What Is Contained In The Medical Record? Appl Clin Inform 2015; 6: 466–477http://dx.doi.org/10.4338/ACI-2014-09-SOA-0081

On the Track of C/overt Research: Lessons From Taking Ethnographic Ethics to the Extreme

2017 ◽  
Vol 24 (7) ◽  
pp. 453-463 ◽  
Author(s):  
Tereza Virtová ◽  
Tereza Stöckelová ◽  
Helena Krásná
Keyword(s):  
Informed Consent ◽  
Research Ethics ◽  
Ethical Dilemmas ◽  
Research Participant ◽  
Research Process ◽  
Institutional Review Boards ◽  
Power Dynamics ◽  
Institutional Review ◽  
Growing Body ◽  
Anthropological Research

Despite the growing body of literature that critically assesses the ambiguous impacts of institutional review boards (IRBs) on anthropological research, the key standards on which the IRB evaluations are based often remain unquestioned. By exposing the genealogy of an undercover research in which the authors participated as ethnographer, supervisor, and research participant, this article problematizes some of these standards and addresses the issues of power dynamics in research, informed consent, and anonymization in published work. It argues that rather than addressing genuine ethical dilemmas, IRB standards and the ethical fiction of informed consent mainly protect researchers from having to openly face the uncertainties of fieldwork. As an alternative, the authors put forth the notion of c/overt research, which perceives any research as processual and, in effect, becoming overt only during the research process itself. As such, it forces researchers to cultivate sensitivity to research ethics.

PAR Method

2010 ◽  
Vol 3 (3) ◽  
pp. 355-375 ◽  
Author(s):  
Michelle Billies
Keyword(s):  
New York ◽  
Low Income ◽  
Critical Consciousness ◽  
Design Method ◽  
Participatory Action ◽  
Community Members ◽  
Context Analysis ◽  
Gender Nonconforming ◽  
The Social ◽  
And Gender

The work of the Welfare Warriors Research Collaborative (WWRC), a participatory action research (PAR) project that looks at how low income lesbian, gay, bisexual, transgender, and gender nonconforming (LG-BTGNC) people survive and resist violence and discrimination in New York City, raises the question of what it means to make conscientization, or critical consciousness, a core feature of PAR. Guishard's (2009) reconceptualization of conscientization as “moments of consciousness” provides a new way of looking at what seemed to be missing from WWRC's process and analysis. According to Guishard, rather than a singular awakening, critical consciousness emerges continually through interactions with others and the social context. Analysis of the WWRC's process demonstrates that PAR researchers doing “PAR deep” (Fine, 2008)—research in which community members share in all aspects of design, method, analysis and product development—should have an agenda for developing critical consciousness, just as they would have agendas for participation, for action, and for research.

scholarly journals Factors Affecting the Control of Chronic Rhinosinusitis With Nasal Polyps: A Comparison in Patients With or Without NERD

2021 ◽  
Vol 12 ◽  
pp. 215265672110038
Author(s):  
Markus Jukka Lilja ◽  
Anni Koskinen ◽  
Paula Virkkula ◽  
Seija Inkeri Vento ◽  
Jyri Myller ◽  
...  
Keyword(s):  
Chronic Rhinosinusitis ◽  
Nasal Polyps ◽  
Female Gender ◽  
Sinus Surgery ◽  
Logrank Test ◽  
Free Survival ◽  
Factors Affecting ◽  
Advanced Therapy ◽  
And Gender

Objectives The aim was to compare the control of chronic rhinosinusitis with nasal polyps (CRSwNP) after endoscopic sinus surgery (ESS), in patients with/without nonsteroidal anti-inflammatory drug exacerbated respiratory disease (NERD). Study Desing: A retrospective hospital-based sample of CRSwNP patients with/without NERD with follow-up. Setting Tertiary rhinology centers. Methods Electronic patient record data from 116 CRSwNP patients (46 with NERD and 70 without NERD) undergoing ESS during 2001–17 were studied. Mean follow-up time was 9.9 years (range 1.1–15.3). Endpoints reflecting uncontrolled CRSwNP were revision ESS, and need for rescue/advanced therapy (e.g. antibiotics, oral corticosteroids and/or biological therapy) during follow-up. NERD was variable of interest and gender, age, asthma, allergic rhinitis (AR), smoking, Lund-Mackay (LM) score of sinus computed tomography scans previous ESS and baseline total ethmoidectomy were used as covariates. Results Twenty-one (49.7%) NERD patients and 18 (25.7%) non-NERD patients underwent revision ESS within a mean ± SD of 4.3 ± 2.8 and 3.7 ± 2.6 years, respectively (p = .013, by Logrank test). In Cox´s regression models, NERD, female gender, young age, asthma, AR, previous ESS, and lack of total ethmoidectomy were associated with revision-ESS. In adjusted model, only the total ethmoidectomy predicted revision-free survival. In adjusted logistic regression model, there was an insignificant trend that NERD and LM score were associated with the need for rescue/advanced therapy in the follow-up. Conclusions Patients with NERD had higher risk of uncontrolled CRSwNP than patient group without NERD, as measured by revision ESS and/or need for rescue/advanced therapy in the follow-up. In addition, baseline total ethmoidectomy was associated with revision-free survival.

Informed Consent for Online Research—Is Anybody Reading?: Assessing Comprehension and Individual Differences in Readings of Digital Consent Forms

2021 ◽  
pp. 155626462110201
Author(s):  
Caitlin Geier ◽  
Robyn B. Adams ◽  
Katharine M. Mitchell ◽  
Bree E. Holtz
Keyword(s):  
Individual Differences ◽  
Informed Consent ◽  
Research Process ◽  
The Other ◽  
Consent Form ◽  
Online Research ◽  
Consent Forms ◽  
Potential Benefits

Informed consent is an important part of the research process; however, some participants either do not read or skim the consent form. When participants do not read or comprehend informed consent, then they may not understand the potential benefits, risks, or details of the study before participating. This study used previous research to develop experimentally manipulated online consent forms utilizing various presentations of the consent form and interactive elements. Participants ( n = 576) were randomly exposed to one of six form variations. Results found that the highly interactive condition was significantly better for comprehension than any of the other conditions. The highly interactive condition also performed better for readability, though not significantly. Further research should explore the effects of interactive elements to combat habituation and to engage participants with the parts of the consent form unique to the study.

scholarly journals Enacting Feminist Methodologies in Research Toward Reproductive Justice

2021 ◽  
Vol 20 ◽  
pp. 160940692110161
Author(s):  
Krista Johnston ◽  
Christiana MacDougall
Keyword(s):  
Research Question ◽  
Research Process ◽  
Feminist Research ◽  
Clear Understanding ◽  
Reproductive Justice ◽  
Design Data ◽  
Related Services ◽  
Ongoing Research ◽  
And Gender ◽  
Political Praxis

Reporting on the development of an ongoing qualitative research project with clients of midwifery care in New Brunswick, Canada, this article details the ways that methodology is complexly interwoven with political praxis. Working through the development of this project, this article models one way to enact politically engaged feminist research at each stage of the research process, from developing the research question, through research design, data collection, analysis, and theory generation. In the process, three core principles of feminist research methodologies are extended: co-construction of knowledge, researcher reflexivity, and reciprocal relationships in research. This research is caught up in and responds to a fraught political context where supports for reproductive healthcare are limited, and midwifery, abortion, and gender-affirming care are all framed as “fringe” services that exceed the austerity budget of the province. Participants engaged in this study with a clear understanding of this political terrain and approached interviews as an opportunity to share their experiences, and to advocate for the continuation and expansion of midwifery and related services in the province. Through the research process, it has become evident that midwifery must be understood as part of the struggle toward reproductive justice in this province. These reflections will direct further stages of the project, including ongoing research and dissemination.

scholarly journals Ethical issues in genomics research on neurodevelopmental disorders: a critical interpretive review

2021 ◽  
Vol 15 (1) ◽  
Author(s):  
S. Mezinska ◽  
L. Gallagher ◽  
M. Verbrugge ◽  
E.M. Bunnik
Keyword(s):  
Informed Consent ◽  
Neurodevelopmental Disorders ◽  
Cognitive Abilities ◽  
Social Impact ◽  
Mental Health Problems ◽  
Ethical Issues ◽  
Family Members ◽  
Genetic Diagnosis ◽  
Research Participation ◽  
Genomic Research

Abstract Background Genomic research on neurodevelopmental disorders (NDDs), particularly involving minors, combines and amplifies existing research ethics issues for biomedical research. We performed a review of the literature on the ethical issues associated with genomic research involving children affected by NDDs as an aid to researchers to better anticipate and address ethical concerns. Results Qualitative thematic analysis of the included articles revealed themes in three main areas: research design and ethics review, inclusion of research participants, and communication of research results. Ethical issues known to be associated with genomic research in general, such as privacy risks and informed consent/assent, seem especially pressing for NDD participants because of their potentially decreased cognitive abilities, increased vulnerability, and stigma associated with mental health problems. Additionally, there are informational risks: learning genetic information about NDD may have psychological and social impact, not only for the research participant but also for family members. However, there are potential benefits associated with research participation, too: by enrolling in research, the participants may access genetic testing and thus increase their chances of receiving a (genetic) diagnosis for their neurodevelopmental symptoms, prognostic or predictive information about disease progression or the risk of concurrent future disorders. Based on the results of our review, we developed an ethics checklist for genomic research involving children affected by NDDs. Conclusions In setting up and designing genomic research efforts in NDD, researchers should partner with communities of persons with NDDs. Particular attention should be paid to preventing disproportional burdens of research participation of children with NDDs and their siblings, parents and other family members. Researchers should carefully tailor the information and informed consent procedures to avoid therapeutic and diagnostic misconception in NDD research. To better anticipate and address ethical issues in specific NDD studies, we suggest researchers to use the ethics checklist for genomic research involving children affected by NDDs presented in this paper.

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