• Voluntariness of consent to HIV clinical research : a conceptual and empirical study.

      Wassenaar, Douglas Richard.; Mamotte, Nicole. (2015-08-06)
      While obtaining voluntary informed consent for research participation is an ethical imperative, there appears to be little consensus regarding what constitutes a voluntary consent decision. As a result, considerable controversy exists in the research ethics literature, with researchers and ethicists advancing numerous concerns about the voluntariness of consent to research. For example, concerns about the voluntariness of consent to research are frequently raised when financial compensation or care and treatment are offered in return for research participation, when participants are recruited by their health care providers, when risks are more than minimal, and when research is conducted in developing countries by developed country researchers. However, without a valid conceptualisation of voluntariness and an appropriate means of assessing it is impossible to determine whether commonly expressed concerns about voluntariness are well founded. As such, a comprehensive conceptual and empirical review of voluntary consent was conducted. The conceptual and empirical review revealed that voluntary consent to research consists of a legal imperative that consent be free from controlling influences of other people and a moral imperative that consent be perceived as voluntary by the person providing consent. On the basis of this conceptualisation the Voluntariness Assessment Instrument was developed. The Voluntariness Assessment Instrument was piloted on 100 women enrolled in two South African HIV clinical trials. The study found high levels of perceived voluntariness. A desire to please the researchers, feelings of having no alternative to research participation as well as a need for money were significantly associated with lower perceived voluntariness. An absence of controlling influences from others was also observed for the overwhelming majority of research participants. Overall the data suggests that it is possible to obtain voluntary and valid consent from research participants in ethically complex HIV clinical trials in developing country contexts.
    • Voluntariness of consent to research: a preliminary empirical investigation

      Lidz, Charles W.; Appelbaum, Paul S.; Klitzman, Robert (eScholarship@UMMS, 2009-12-26)
    • Voluntariness of Consent to Research: A Preliminary Empirical Investigation

      Appelbaum, Paul S.; Lidz, Charles W.; Klitzman, Robert (2016-01-09)
    • Voluntariness to Consent to Research in a Voluntarily and Involuntarily Hospitalized Psychiatric Population

      Van Der Veer, Nancy L; Drachman, David; Ahad, Sami; Silvers, George; Ramos, Gilbert (2016-01-09)
      The purpose of our study was to examine rates of consent to participate in research in voluntarily and involuntarily hospitalized psychiatric patients in order to evaluate factors that may influence the decision to participate in research. We used logistic regression models to evaluate differences and found that involuntary patients were less likely to consent to participate. After adjustment for covariates, we found that consent rates did not differ between the involuntary and voluntary population, but that lower Global Assessment of Functioning (GAF) scores and psychosis negatively affected the decision to consent to research. We discuss the implications of our findings.
    • Voluntary Assent in Biomedical Research With Adolescents: A Comparison of Parent and Adolescent Views

      Brody, Janet L.; Scherer, David G.; Annett, Robert D.; Pearson-Bish, Melody (2016-01-09)
      An informed consent and voluntary assent in biomedical research with adolescents is contingent on a variety of factors, including adolescent and parent perceptions of research risk, benefit, and decision-making autonomy. Thirty-seven adolescents with asthma and their parents evaluated a high or low aversion form of a pediatric asthma research vignette and provided an enrollment decision; their perceptions of family influence over the participation decision; and evaluations of risk, aversion, benefit, and burden of study procedures. Adolescents and their parents agreed on research participation decisions 74% of the time, yet both claimed ultimate responsibility for the participation decision. Both rated most study procedures as significantly more aversive than risky. Parents were more likely to rate aspects of the hypothetical study as beneficial and to provide higher risk ratings for procedures. Disagreements concerning research participation decisions and decision-making autonomy have implications for the exercise of voluntary assent in biomedical research.
    • Voluntary informed consent and good clinical practice for
 clinical research in South Africa : ethical and legal perspectives

      Britz, Retha; Le Roux-Kemp, Andra (Health and Medical Publishing Group (HMPG), 2013-07-03)
      The original publication is available at http://www.samj.org.za
    • Voluntary informed consent in research and clinical care : an update

      Cahana, Alex; Hurst, Samia (2008)
      Informed consent is important: in research, it allows subjects to make an informed and voluntary choice to participate--or refuse to participate--in a project where they will be asked to take risks for the benefit of others. In both research and clinical care, informed consent represents a permission to intervene on a person's private sphere. The elements of informed consent are usually described as disclosure, understanding, decision-making capacity, and voluntariness. Each poses distinct difficulties, and can be amenable to improvements. However, research on the quality of informed consent and on strategies intended to improve it have only become the object of research relatively recently. In this article, we describe some results of this research, and outline how they can be relevant to informed consent in research and clinical care. Although much of the data suffers from limitations, it does suggest that disclosure has improved, but is still uneven, comprehension is often poor, for both patients and research subjects. Moreover, trust is a motivating factor for research participation, and thus we run risks if we allow false expectations and prove ourselves unworthy of this trust. Although improving consent forms does not have a clear effect on understanding, improving the consent process may help. Finally, better information may decrease anxiety and seems to have at most a small negative effect on research recruitment.
    • Voluntary participation and informed consent to international genetic research

      Marshall, Patricia A.; Adebamowo, Clement A.; Adeyemo, Adebowale A.; Ogundiran, Temidayo O.; Vekich, Mirjana; Strenski, Teri; Zhou, Jie; Prewitt, Elaine; Cooper, Richard S.; Rotimi, Charles N. (2011-07-12)
      OBJECTIVES: We compared voluntary participation and comprehension of informed consent among individuals of African ancestry enrolled in similarly designed genetic studies of hypertension in the United States and Nigeria. METHODS: Survey questionnaires were used to evaluate factors associated with voluntariness (the number of people volunteering) and understanding of the study's genetic purpose. A total of 655 individuals (United States: 348; Nigeria: 307) were interviewed after participation in the genetic studies. RESULTS: Most US respondents (99%), compared with 72% of Nigerian respondents, reported being told the study purpose. Fewer than half of the respondents at both sites reported that the study purpose was to learn about genetic inheritance of hypertension. Most respondents indicated that their participation was voluntary. In the United States, 97% reported that they could withdraw, compared with 67% in Nigeria. In Nigeria, nearly half the married women reported asking permission from husbands to enroll in the hypertension study; no respondents sought permission from local elders to participate in the study. CONCLUSIONS: Our findings highlight the need for more effective approaches and interventions to improve comprehension of consent for genetic research among ethnically and linguistically diverse populations in all settings.
    • Voluntary participation and informed consent to international genetic research

      Marshall, Patricia A.; Adebamowo, Clement A.; Adeyemo, Adebowale A.; Ogundiran, Temidayo O.; Vekich, Mirjana; Strenski, Teri; Zhou, Jie; Prewitt, Elaine; Cooper, Richard S.; Rotimi, Charles N. (2011-07-12)
      OBJECTIVES: We compared voluntary participation and comprehension of informed consent among individuals of African ancestry enrolled in similarly designed genetic studies of hypertension in the United States and Nigeria. METHODS: Survey questionnaires were used to evaluate factors associated with voluntariness (the number of people volunteering) and understanding of the study's genetic purpose. A total of 655 individuals (United States: 348; Nigeria: 307) were interviewed after participation in the genetic studies. RESULTS: Most US respondents (99%), compared with 72% of Nigerian respondents, reported being told the study purpose. Fewer than half of the respondents at both sites reported that the study purpose was to learn about genetic inheritance of hypertension. Most respondents indicated that their participation was voluntary. In the United States, 97% reported that they could withdraw, compared with 67% in Nigeria. In Nigeria, nearly half the married women reported asking permission from husbands to enroll in the hypertension study; no respondents sought permission from local elders to participate in the study. CONCLUSIONS: Our findings highlight the need for more effective approaches and interventions to improve comprehension of consent for genetic research among ethnically and linguistically diverse populations in all settings.
    • Volunteering for early phase gene transfer research in Parkinson disease

      Kim, S.Y.h.; Holloway, R.G.; Frank, S.; Beck, C.A.; Zimmerman, C.; Wilson, R.; Kieburtz, K. (2011-07-12)
    • Volunteering for early phase gene transfer research in Parkinson disease

      Kim, S.Y.h.; Holloway, R.G.; Frank, S.; Beck, C.A.; Zimmerman, C.; Wilson, R.; Kieburtz, K. (2011-07-12)
    • Volunteers in Research and Testing

      Close, Bryony; Combes, Robert; Hubbard, Anthony; Illingworth, John (2015-05-05)
    • Vous avez dit « Âges de la vie » ? Introduction

      Laboratoire d'Anthropologie et d'Histoire de l'Institution de la Culture (LAHIC) ; Centre National de la Recherche Scientifique (CNRS)-Ministère de la Culture et de la Communication (MCC)-École des hautes études en sciences sociales (EHESS); Mission Ethnologie (MISSION-ETHNOLOGIE) ; Ministère de la Culture et de la Communication (MCC); Noël Barbe et Emmanuelle Jallon; Barbe, Noël; Jallon, Emmanuelle (HAL CCSDMusées départementaux de la Haute-Saône, 2004-11-24)
      National audience
    • Vous avez dit : « Mettre en œuvre le principe de laïcité de manière éthique et responsable » ?

      NRC Herzberg Institute of Astrophysics ; National Research Council of Canada (NRC); Institut universitaire de formation des maîtres - Montpellier (IUFM Montpellier) ; Université Montpellier 2 - Sciences et Techniques (UM2); Véran, Jean-Pierre; Moutot, Gilles; Veran, Jean-Pierre (HAL CCSDMontpellier : IUFM de Montpellier, 2012-04-01)
      International audience
    • Vršnjačko nasilje na news portalima: studija slučaja "Splitske srednjoškolke" 2018.

      Majstorović Jedovnicki, Dunja; Dunatov, Kristina (Sveučilište u Zagrebu. Fakultet političkih znanosti. Odsjek za novinarstvo i medijsku produkciju.University of Zagreb. The Faculty of Political Science. Department of Journalism and Media Production., 2019-09-17)
      Vršnjačko nasilje je problem o kojem se govori već dugi niz godina. Postoji više vrsta nasilja među djecom i mladima kao što su fizičko, verbalno, a u posljednje vrijeme pojavio se termin i „digitalno“ nasilje ili cyberbulling koji se događa na internetskim mrežama. Iako vršnjačko nasilje seže od davnina, dojam je da je u zadnje vrijeme ono sve češća pojava. Zapravo, u današnjem vremenu interneta i smartphone-a izloženiji smo puno većem broju informacija pa tako i raznim primjerima vršnjačkog nasilja koje se dijeli na društvenim mrežama bilo u obliku snimke ili poruke. Bez obzira na osvještenost da se nasilje među djecom i adolescentima događa, u Hrvatskoj nije provedeno mnogo istraživanja vršnjačkog nasilja, a društvo ne poduzima dovoljno u sprječavanju vršnjačkog nasilja. U ovom radu prikazano je na koji način su hrvatski news portali obradili vijest o vršnjačkom nasilju, a to je snimka tučnjave dviju srednjoškolki u Splitu koja je objavljena na internetu te je podigla mnogo prašine u javnosti. Metodom analize sadržaja članaka objavljenih o ovom događaju, prikazalo se na koji način su određeni hrvatski portali prenijeli ovu vijest i jesu li se pritom pridržavali pravila novinarske struke.
    • Vulnerability and Children with Disabilities: Ethical Spheres of Concern in Research and Practice

      Kliewer, Chris; Etscheidt, Susan (UNI ScholarWorks, 2015-09-18)
      The U.S. Department of Health and Human Services requires that research involving children, including highly vulnerable social categories of children, detail adequate provisions to solicit the assent of children (in addition to receiving parental permission). The purpose appears to recognize the autonomy of children. In this presentation, we raise questions about the autonomy and rights of children in both research projects and educational/therapeutic practices (often the focus of research projects). Commonly, justification for research and/or practices proceeds from two seemingly complementary orientations: (1) a deficit/deficiency model of disability and (2) a utilitarian ethical consideration focused on a rather narrow analysis of costs and benefits. The deficit model of disability (often referred to as a medical model) presumes an inherent and objectively measurable deficiency to social behavior and engagement that fall outside perceived norms. In a simplified sense, research and practices are implemented to correct or normalize the child. These efforts are presented as non-ideological, apolitical, and self-evidently positive. Rarely do we see legitimate efforts made to solicit the assent of children or to fully express to parents who exactly is benefitting from their signatures of permission and how. A brief history in disability research will be provided. We will self-critically examine how this combination of deficit model and narrow cost/benefit analyses has colored certain of our own research efforts and IRB procedures. In other arenas, we will provide examples of how this has deeply influenced the trajectory of special education research and practice through so-called gold standard approaches involving Applied Behavior Analysis and adaptive skill development through means such as social scripting. Recently, a social model of disability has emerged to challenge the dominant deficit model. Born of the disability rights movement, the social model suggests that human variation associated with disability need not inherently be interpreted as deficient. Differences might be just that, differences and not deficiencies. For example, the emergent neurodiversity movement argues that performances associated with the autism spectrum should not be approached as behaviors in need of correction and normalization, but should be recognized as part of the broad spectrum of being human. People labeled with autism are now generating a whole new genre of critique exploring their subjugation at the hands of researchers and therapists throughout their childhood. They are raising the demand of legitimate assent being procured prior to becoming human subjects. This is captured in the disability rights call to action: “Nothing about us without us.” In response, we will propose a broad spectrum involving spheres of ethical concern that move us beyond utilitarian analyses. Included will be spheres that return us to issues of children’s vulnerability and autonomy as well as considerations associated with human emancipation and social justice. Multiple questions will be raised with the audience. Prominent among these is the gnawing concern over where the line is between research and practice as liberation versus research and practice as coercion and a demand for social conformity: Who decides and on what basis?
    • Vulnerability and ethics of social sciences research: current perspectives

      Santi, María Florencia (Universidad Militar Nueva Granada, 2015-07-15)
      The purpose of this article is to address the issue of the inclusion of vulnerable individuals and groups in social sciences research. In recent years has increased the bibliography devoted to analyze the concept of vulnerability in biomedical research. However, in the specific field of social sciences research remains a topic rarely addressed in specialized bibliography and ethical guidelines, although much of the social research involves extremely vulnerable individuals and groups.In this article I will analyze, in the first place, how it has been addressed the concept of vulnerability in the most important guidelines of bioethics and research ethics. Then, I will present the main perspectives on vulnerability in biomedical and social research ethics; and I will point out the scope and limitations of these perspectives. Towards the end of the article I will develop a concept of vulnerability more suitable for the ethical analysis of social research than the current concepts.
    • Vulnerability in Biomedical Research: A Framework for Analysis

      Zoboli, Elma Lourdes Campos Pavone (2016-01-08)
    • Vulnerability in research and health care; describing the elephant in the room?

      Hurst, Samia (2008)
      Despite broad agreement that the vulnerable have a claim to special protection, defining vulnerable persons or populations has proved more difficult than we would like. This is a theoretical as well as a practical problem, as it hinders both convincing justifications for this claim and the practical application of required protections. In this paper, I review consent-based, harm-based, and comprehensive definitions of vulnerability in healthcare and research with human subjects. Although current definitions are subject to critique, their underlying assumptions may be complementary. I propose that we should define vulnerability in research and healthcare as an identifiably increased likelihood of incurring additional or greater wrong. In order to identify the vulnerable, as well as the type of protection that they need, this definition requires that we start from the sorts of wrongs likely to occur and from identifiable increments in the likelihood, or to the likely degree, that these wrongs will occur. It is limited but appropriately so, as it only applies to special protection, not to any protection to which we have a valid claim. Using this definition would clarify that the normative force of claims for special protection does not rest with vulnerability itself, but with pre-existing claims when these are more likely to be denied. Such a clarification could help those who carry responsibility for the protection of vulnerable populations, such as Institutional Review Boards, to define the sort of protection required in a more targeted and effective manner.