Tesi: "Consent in research"

1

Gibson, Sara L. "Can Enthusiastic Consent Be Sexy? The Influence of Consent Type on Perceived Enjoyment and Sexiness of Sexual Encounters Related to Sexual Scripts and Consent Attitudes". Thesis, University of Louisiana at Lafayette, 2017. http://pqdtopen.proquest.com/#viewpdf?dispub=10245312.

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Recent efforts to improve sexual assault issues within American universities are being pursued diligently. Many of these efforts include changes to college campus policies regarding sexual consent, often by mandating affirmative consent. The current study investigated perceptions of different types of sexual consent related to sexual script endorsement and consent attitudes in order to better assess how receptive college students may be to affirmative consent standards.

An online survey included four vignettes that were constructed to depict processes of sexual consent that differed in the enthusiasm with which the female character indicated her consent. Perceptions of the vignettes were evaluated regarding sexiness of the content and each character’s enjoyment and internal consent. Further items assessed comparative evaluations of the vignettes. The Sexual Script Scale, External Consent Scale, and Sexual Consent Scale-Revised were also included in the survey. We expected that enthusiastic consent processes would be evaluated more positively than the unenthusiastic ones. We also predicted these evaluations would be significantly related to endorsement of traditional sexual scripts, external consent behaviors, and consent attitudes.

Full to partial support was found for each of our hypotheses, suggesting that college students are indeed receptive to affirmative consent regarding perceived enjoyment and sexiness when depicted as enthusiastically given.

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2

Ascheman, Paul L. "Informed consent to genetic research student participation and perception of risk /". [Ames, Iowa : Iowa State University], 2010. http://gateway.proquest.com/openurl?url_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:dissertation&res_dat=xri:pqdiss&rft_dat=xri:pqdiss:1475915.

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3

Bielby, Philip Richard. "The competence of cognitively vulnerable participants to consent to biomedical research". Thesis, University of Sheffield, 2006. https://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.434629.

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4

Lipworth, Wendy Louise. "Reconfiguring tissue banking consent through enrichment of a restricted debate". University of Sydney. History and Philosophy of Science, 2005. http://hdl.handle.net/2123/683.

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Tissue banks are thought to be an essential resource for medical research in the post-genomic age. Collections of tissue, usually removed in the course of diagnostic or therapeutic procedures, enable laboratory-based epidemiological studies to be carried out, linking abnormalities in the tissue to disease aetiology, prognosis and treatment responsiveness. There are, however, a number of technical, regulatory and ethical concerns that challenge those wishing to engage in tissue banking research. It is becoming increasingly apparent that tissue banking research is not without risk of harms, even though there is no direct physical risk to donors. This is because, in order to be most useful, banked specimens need to be linked to personal information about tissue donors and this poses the risk of inadvertent disclosure of personal─ particularly genetic─ information to those who might exploit such information (eg. insurance companies and employers). Furthermore, the long-term storage of specimens, and the impossibility of predicting all potential types of research programs for which they might be useful, raises the possibility that future projects will be carried out that are unacceptable to some (past) tissue donors. The ethical principles of autonomy and respect for persons demand that research subjects be informed of such risks and of the nature of the research, and that they participate willingly. On the other hand, there is a desire for science to progress unhindered by stringent consent requirements. For these reasons, a debate has emerged in the academic (bioethical and biomedical) literature and in the legal (law reform) sphere over what would constitute adequate consent. Despite an extensive discourse, it is still unclear whether it is permissible to carry out research on archival tissue that was originally taken for diagnostic purposes and whether project-specific (as opposed to open-ended) consent is required for research on tissue collected today. This lack of clarity is of concern to researchers, ethics committees and research subjects, all of whom recognise the importance of tissue banking research, yet fear that current consent procedures may be ethically or legally inadequate. Thus it is important that the consent dilemma be resolved as quickly and definitively as possible. Ongoing controversy and regulatory ambiguity are appropriate when morally contentious issues are at stake, and their existence does not, on its own, signal any flaws in the discourse process. There are, however, two reasons to suspect that the current �consent to tissue banking� debate, as portrayed in the academic literature and law reform documentation, is problematic. Firstly, the debate appears to be mired in an intractable conflict between those who want to maximise personal autonomy through stringent consent requirements, and those who want the scientific endeavour to progress in a manner that is unconstrained by what are viewed as arduous consent procedures. Secondly, the possible practical options (consent models) being generated by the debate are all limited because they are underpinned by a restricted notion of consent as an individualistic, legalistic and static activity, without consideration of any alternative conceptualisations of consent. Through a thematic analysis of the current �consent to tissue banking� debate in the academic and law reform literature (Section 3), this thesis shows that debate is essentially occurring between those who see individual autonomy (and stringent consent) as being of primary importance, and those who see unimpeded, market-driven scientific progress as the more important social good, which should not be impeded by unnecessarily stringent consent. Thematic analysis also confirms the existence of the two problems described above, and a failure of those engaged in the debate to reflect on, and challenge, the value-level assumptions underpinning their arguments and those of their opponents. It is argued that this lack of reflection accounts for the two problems: � Firstly, it precludes recognition of the cause of─ and, therefore, ways of resolving─ the intractable conflict at the centre of the debate. Value-level reflection shows that this is a result of the logical and moral conflict within western liberalism, between two modernist goods: individual freedom and scientific progress. � Secondly, it precludes the generation of varied conceptions of consent. Value-level reflection shows that the current range of consent models is restricted to procedures which are individualistic, abstract, static and legalistic, since they are underpinned by western liberal notions of autonomy and scientific progress. This recognition paves the way to consideration of alternative notions of autonomy, scientific progress and, therefore, consent, such as those derived from communitarian and feminist systems of values. A conceptually enriched model of tissue banking consent is then developed (Section 4). This model incorporates dominant (liberal) conceptions of autonomy and scientific progress as well as alternative notions of autonomy and scientific progress espoused by communitarian and feminist systems of values. It is argued that this conceptually-enriched model provides a practical solution to the two problems associated with the standard �consent to tissue banking� debate. In relation to the philosophically intractable conflict─ or what is termed the �modernist dilemma�─ between those privileging autonomy and those privileging scientific progress, it shows how the two apparently conflicting �modernist� goods can both be accommodated at a practical level, thus making the �consent to tissue banking� debate more tractable and fruitful. In relation to the restricted range of consent models being generated by the current debate, it provides new insights into the ways in which consent might be obtained such that a broader range of community values can be accommodated. More specifically, it stimulates the construction of a model that 1) involves communities, as opposed to merely individuals, in all stages of the scientific process; 2) is flexible and able to adapt consent procedures to specific contexts, rather than predefining procedures in abstract terms; and 3) is transactional and relational rather than static and legalistic. This outcome has interesting philosophical as well as practical implications. It shows that despite apparently unresolved, and possibly irresolvable, normative-level conflicts between the two modernist elements of western liberalism (autonomy and scientific progress), and between liberal, feminist and communitarian systems of values, a multi-perspectival, inclusive, model-building approach provides a practical solution that circumvents these normative-level conflicts.

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5

Douglas, Sara Klass Patricia Harrington. "The relationship of selected situational variables to consent rates in nursing research". Normal, Ill. Illinois State University, 1991. http://wwwlib.umi.com/cr/ilstu/fullcit?p9203028.

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Thesis (Ph. D.)--Illinois State University, 1991.
Title from title page screen, viewed December 9, 2005. Dissertation Committee: Patricia H. Klass (chair), Cheryl L. Cohn, John F. Chizmar, Ronald S. Halinski, Edward R. Hines. Includes bibliographical references (leaves 108-117) and abstract. Also available in print.

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6

Bull, Susan Jane. "Consent to research in a Gambian context : legal, social and ethical issues". Thesis, King's College London (University of London), 2007. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.619253.

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7

Fröander, Rebecca, e Nelli Halkosaari. "The construction of women’s sexuality : A critical discourse analysis on consent research". Thesis, Stockholms universitet, Institutionen för socialt arbete - Socialhögskolan, 2019. http://urn.kb.se/resolve?urn=urn:nbn:se:su:diva-166351.

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The aim of this study was to examine how women’s sexuality is constructed in consent research, and to discuss hypothetically how this construction could come to affect practical social work. We believe that the way that sexuality is defined and discussed can have an impact on how professionals treat women who have been subjected to sexual assaults and rape, and work with adolescents in the field of social work. We wanted to explore this further. By doing a critical discourse analysis on research articles about women’s sexuality and consent, we found that traditional sexual scripts were widely reproduced and the concept of women’s own desire was nonexistent. We then problematised this by discussing how it might be affecting practical social work in a negative matter, whilst trying to formulate possible reforms. Our conclusion was that it is possible that the discourses presented in the examined articles could contribute to retrogressive perspectives on women’s sexuality, which in turn could influence the practical social work and its approach to female clients.

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8

Flanagan, Ellen Cecelia. "AN URBAN BIOETHICS APPROACH TO PARENTAL INFORMED CONSENT FOR PEDIATRIC CLINICAL RESEARCH". Master's thesis, Temple University Libraries, 2018. http://cdm16002.contentdm.oclc.org/cdm/ref/collection/p245801coll10/id/537038.

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Urban Bioethics
M.A.
In the current healthcare landscape, parents generally make decisions regarding whether or not their children are allowed to take part in clinical research, with the general assumption being that parents know what is best for children. Investigations have been conducted regarding what is likely to lead parents to consent or not consent to their child’s participation in a trial, but research plans seldom incorporate the consideration that not all parents come into the consent process with equal social, academic, and economic footing. Since the burden of the ultimate decision lies primarily on the parents, it is supremely important that they are capable of making a well-informed and thoughtful choice. Bioethical understanding of the influence of parental decisions in clinical research must consider demographic variables and how they may affect parents’ decisions to allow or disallow their child to participate in a clinical trial. Those differences could affect the consent process and have ramifications for the research findings, as research results are affected in numerous ways by which children do, and do not, participate in studies. This paper looks specifically at parents in the process of informed consent for pediatric research, taking into account several social determinants of health and how they affect who participates in research and how that affects research as a whole.
Temple University--Theses

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9

Stjernschantz, Forsberg Joanna. "Biobank Research : Individual Rights and Public Benefit". Doctoral thesis, Uppsala universitet, Centrum för forsknings- och bioetik, 2012. http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-171898.

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The aim of this thesis is to investigate the relationship between individuals and society in the context of healthcare and medical research, more specifically concerning the rights and duties of individuals in regard to biobank-based research. My starting point is that we all have a strong vested interest in improved healthcare, and therefore the possibilities to conduct important research should be optimized. In the first article, I investigate whether individual results from research using samples in large-scale biobanks should be returned. I conclude that there is good reason not to implement such policies, and instead to allocate available resources to pursuing medical advances. In the second article, I compare consent for using stored samples in research with consent for organ donation, whereby many countries have adopted opt-out strategies in order to increase the number of organs available. I claim that the default position should be changed in biobank research as well, i.e. it should be presumed that individuals want to contribute rather than that they do not. In the third article, I argue that safeguarding autonomy by requiring informed consent for using samples in research not only defeats the interests of society but also runs counter to the interests of the individuals the policy purports to protect. Finally, in the fourth article I suggest that it is reasonable to view participation in medical research from the perspective of a social contract, built on our mutual need for medical advances, and that this implies that there is a moral duty to adhere to the contract by allowing one’s samples to be used in research. A central conclusion in this thesis is that biobank research should be viewed as a natural part of healthcare, like quality control, method development and teaching, and that as such, it ought to be endorsed and facilitated.

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10

Prinsen, Larisse. "An analysis of consent with specific regard to stem cell therapy and research". Thesis, University of Pretoria, 2016. http://hdl.handle.net/2263/60084.

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This thesis argues that stem cells cannot be properly regulated when understood in terms of medical treatment only. This is due to the uncertain scope and untested efficacy of stem cell therapy which renders treatment applications tantamount to research involving human subjects. This thesis therefore examines consent as regulatory instrument in context of stem cell related interventions and endeavours to introduce a sufficient consent model for such interventions. To this end, a clinical overview and explanation of stem cells is provided in order to establish an understanding of the field of science in need of regulatory control. This is followed by a background and introduction to consent, a discussion of specific aspects of consent and the National Health Act of 2003 and the Regulations made in terms of the Act to provide insight into consent as understood in South Africa. Consent in international instruments and international law is then examined. The law of the United Kingdom is also analysed by providing an examination of the legal systems in the United Kingdom which is then followed by a discussion of the Human Tissue Act of 2004 and the Human Tissue (Scotland) Act of 2006. Finally, dynamic informed consent is explained and introduced as the recommended consent format for the proper and valid regulation of stem cell therapy-research interventions. At the close of this thesis, the conclusions drawn throughout are compounded and pertinent recommendations are made regarding consent procedures and specifications.
Thesis (LLD)--University of Pretoria, 2016.
Public Law
LLD
Unrestricted

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11

Beasley, Amanda L. "The relationship between informed consent presentation styles and participants' comprehension in clinical research". Thesis, Capella University, 2015. http://pqdtopen.proquest.com/#viewpdf?dispub=3706503.

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The aim of this study was to investigate the comprehension of Phase I healthy subjects after they either read a standard informed consent form (control group) or viewed and listened to a video with the same information (experimental group). The findings of this study were to be applied to the efforts of clinical research personnel that perform the consenting process with these subjects. The approach to this dissertation was quantitative and experimental. The nonprobability, convenience sampling design was the best for obtaining access to a sample that could fit the inclusion criteria needed to answer the survey questions. The Cognitive Theory of Multimedia Learning suggests that receiving information through two channels, visual and auditory in this case, and incorporating it with previous knowledge improves comprehension. In this study, analysis of the data did not support the hypothesis that comprehension would be higher for the group that viewed the multimedia presentation. On average, participants in the control group (standard informed consent form presentation) scored 15.47 on the Deaconess Informed Consent Comprehension Test, while participants in the experimental group (multimedia informed consent form presentation) scored 14.67 out of a possible 28 points. These two group mean scores were not significantly different. Findings do suggest that informed consent form comprehension was very low on average, regardless of education, age, residence, occupation, gender, or predicted verbal IQ. Further research is needed to understand how to improve comprehension.

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12

Vaswani, Nileema Ajit. "The role of informed consent in the ethics of medical research on humans". Thesis, University of London, 2004. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.405938.

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13

Belfrage, Sara. "In the name of research : Essays on the ethical treatment of human research subjects". Doctoral thesis, KTH, Filosofi, 2014. http://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-144035.

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Essay 1: Traffic research shares a fundamental dilemma with other areas of empirical research in which humans are potentially put at risk. Research is justified because it can improve safety in the long run. Nevertheless, people can be harmed in the research situation. Hence, we need to balance short-term risks against long-term safety improvements, much as in other areas of research with human subjects. In this paper we focus on ethical issues that arise when human beings are directly affected in the performance of research by examining how the ethical requirements in biomedical research can inform traffic research. After introducing the basic ethical requirements on biomedical research, each of the major requirements is discussed in relation to traffic research. We identify the main areas where biomedical research and traffic research differ, and where the ethical requirements from the former cannot easily be transferred to the latter. We then point to some of the issues that need to be addressed for a systematic approach to the ethics of traffic research. Essay 2: The requirement of always obtaining participants’ informed consent in research with human subjects cannot always be met, for a variety of reasons. In this paper, research situations where informed consent is unobtainable are described and categorised. Some of these kinds of situations, common in biomedicine and psychology, have been previously much discussed, whereas others, more prevalent in for example infrastructure research, introduce new perspectives. The advancement of new technology may lead to an increase in research of these kinds. The paper also provides a review of methods intended to compensate for a lack of consent and their applicability and usefulness for the different categories of situations are discussed, thereby providing insights into one important aspect of relevance for the question of permitting research without informed consent: how well that which informed consent is meant to safeguard can be achieved by other means. Essay 3: This paper starts with the assumption that it is morally problematic when people in need are offered money in exchange for research participation if the amount offered is unfair. Such offers are called “coercive”, and the degree of coerciveness is said to be determined by the offer’s potential to cause exploitation and its irresistibility. Depending on what view we take on the possibility to compensate for the sacrifices made by research participants, a wish to avoid “coercive offers” leads to policy recommendations concerning payment for participation. For sacrifices considered compensable we ought to offer either no payment or payment at a level deemed fair, while for sacrifices deemed incompensable we always ought to offer no payment. Essay 4: It is commonly thought that transactions that are the result of voluntary gift-giving do not constitute exploitation. This paper argues that exploitation is indeed possible in such situations, by showing how gift-giving can fulfil the two commonly proposed criteria for exploitation, namely that in an interaction between two persons one receives disproportionally little and the other disproportionally much of the resulting benefits, and that this disproportion is caused by the latter making inappropriate use of a disadvantage of the former. A theoretical approach to what such inappropriate use would amount to in cases of gift-giving is lacking. The paper therefore aims at spelling out such an approach. The method of reflective equilibrium inspires this endeavour, which proceeds by testing intuitions about examples that embody a set of possible conditions. It is concluded that three of the conditions are necessary for exploitation of gift-giving, namely (1) the giver incurs a loss, (2) the recipient has aimed for the gift, and (3) the gift is undeserved.

QC 20140407

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14

Lasseter, Gemma Michelle. "Consent study : assessing the public's willingness to provide informed consent for their identifiable general practice medical records to be accessed for different research purposes". Thesis, University of Bristol, 2016. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.702735.

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Objectives: Patient involvement in primary care research is often hindered by confidentiality concerns regarding the use of their identifiable medical records. Consequently there is no universal 'pre-consent' process in England, whereby patients provide prior informed consent for their identifiable data to be accessed for different research purposes. This mixed-methods two-phase study investigated patients' opinions about this proposed 'pre-consent' process and the effectiveness of different invitation methods. Methods: Phase 1 used cognitive and semi-structured interview methods to optimise recruitment documents for, and ascertain participants' attitudes towards, providing an informed consent decision for the 'pre-consent' process. Phase 2 tested the feasibility of different recruitment documents ('standard' and 'modified') and invitation methods (postal, consultation and new) to determine the most effective in terms of allowing patients the opportunity to provide an informed consent decision. Results: Phase 1: Readability of the 'standard' recruitment documents impacted on participants' abilities to provide consent decisions, consequently a 'modified' version was created using participant feedback. Opinions about the 'pre-consent' process were chiefly affected by an individual's personal attitudes; key findings were 'data security' concerns and 'public benefit' motives. Phase 2: Recruitment documents affected response rates, with patients that received 'standard' documents 43% less likely to re~pond than those receiving the 'modified' documents. Postal, consultation and new invitation methods biased the types of patients invited, the number and types of patients responding, and the consent levels provided. Of the 2550 patients invited to participate in the 'pre-consent' process, only 30% (n=767/2550) responded, undermining the feasibility of this process. Discussion: The 'pre-consent' process seems currently unfeasible. However, engaging with the public to identify the most effective recruitment documents, invitation methods and consent options could streamline research in primary care. These approaches, employed on a study-by-study basis, would ensure primary care research remains cost-effective and representative of the general population.

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15

Sand, Kari. "Informed consent documents for cancer research : Textual and contextual factors of relevance for understanding". Doctoral thesis, Norges teknisk-naturvitenskapelige universitet, Institutt for kreftforskning og molekylær medisin, 2012. http://urn.kb.se/resolve?urn=urn:nbn:no:ntnu:diva-19797.

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Dersom pasienter eller friske personer er villige til å delta i medisinsk forskning, må de gi sitt informerte samtykke til denne deltakelsen. Informert samtykke innebærer at de har fått grundig informasjon om hva forskningen går ut på, og hva som er konsekvensene av å delta. Etter at de har mottatt muntlig og skriftlig informasjon, bekrefter pasientene at de er informert, og at de ønsker å delta i forskningen ved å signere en samtykkeerklæring. Den skriftlige informasjonen, pasientinformasjonsskrivet, er temaet for denne avhandlingen. Innholdet i slike skriv er regulert av internasjonale etiske retningslinjer for medisinsk forskning (hvorav den mest innflytelsesrike er Helsinkideklarasjonen utviklet av Verdens legeforening), nasjonalt lovverk og nasjonale og regionale retningslinjer, for eksempel fra regional komite for medisinsk og helsefaglig forskningsetikk (REK). REK skal også vurdere og godkjenne pasientinformasjonsskrivet før forskningsprosjektet kan starte. Målet med denne avhandlingen har vært å undersøke forhold som kan påvirke pasienters forståelse av pasientinformasjonsskriv, og hvordan tidligere forskning har målt pasienters forståelse av informasjonen de har fått i samtykkeprosessen. Kravene til hva pasientinformasjonsskriv skal inneholde er omfattende, og man kan spørre seg om skriv som etterfølger alle kravene, blir så kompliserte at det blir vanskelig for leserne å sortere ut hva som er det viktigste budskapet. Selv om reguleringene av innhold er laget i pasientenes interesse, så er det tenkelig at mange av innholdselementene ikke er relevante for leserne. Gjennom å intervjue lungekreftpasienter fant vi at pasientene var mest opptatt av praktisk informasjon om sin egen sykdom og behandling, og at kontekstuelle aspekter ved lesesituasjonen gjorde det vanskeligere å forstå skrivene. Pasientene var mindre opptatt av formell informasjonen om forskningsprosessen. De fleste var likevel klar over det overordna målet med forskning, dvs. å generere ny kunnskap som kan komme framtidige pasienter til gode. For å undersøke hvordan pasientinformasjonsskriv er skrevet, og om de er leservennlige ble det foretatt to dokumentanalyser. Den første var en undersøkelse av lengde og antall innholdselementer i 87 pasientinformasjonsskriv godkjent for bruk i studier mellom 1985 og 2007. Analysene viste at antall ord var nesten tredoblet i løpet av denne perioden, og at antall innholdselementer var mer en fordoblet. Antallet innholdselementer angående såkalte formaliteter, dvs. juridisk informasjon, finansiering, lagring av innsamlet materiale, erstatningsordninger, hadde økt mest. Problemer med å forstå et informasjonsskriv kan også skyldes skrivets lesbarhet, som i tidligere forskning har vært analysert vha. kvantitative lesbarhetsformler. I tillegg kan faktorer som tekststruktur, overskrifter og ordvalg være relevante for om skrivene er lesbare eller funksjonelle for de som faktisk skal lese og forstå dem. I en oppfølgingsstudie ble de ti eldste og de ti nyeste pasientinformasjonsskrivene av utvalget i ovennevnte studie analysert med mål om å finne ut hvilke tekstuelle faktorer som bidrar til funksjonelle pasientinformasjonsskriv og å sammenligne gamle og nye skriv i så måte. Resultatene viste at nye, lange informasjonsskriv ikke nødvendigvis var mindre funksjonelle enn de kortere, gamle skrivene. Nye informasjonsskriv var for eksempel mer rettet mot hovedtemaet i informasjonen (forskningen) og den viktigste handlingen som gjøres i skrivet (å spørre leseren om han er villig til å delta). Gamle informasjonsskriv var mer orientert mot pasientens sykdom og behandling, noe som ikke er funksjonelt som hovedtema i en tekst om medisinsk forskning. I Helsinkideklarasjonen påpekes det at legen har ansvar for at pasienten forstår informasjonen, men det utdypes ikke noe videre hva det egentlig innebærer å forstå informasjon om medisinsk forskning. En systematisk review av tidligere studier om forståelse ble gjennomført for å vise hvordan begrepet forståelse er definert og målt. Resultatene viste at tidligere studier ikke er basert på en felles definisjon av forståelse, at de fleste målemetodene er utviklet for hver enkelt studie, og at målemetodene er forskjellige med tanke på antall spørsmål og innholdet de dekker. Dette gjør det vanskelig å sammenligne tidligere studier for å finne ut hva som kjennetegner effektiv informasjon til forskningsdeltakere. Oppsummert viser studiene i denne avhandlingen at norske pasientinformasjonsskriv har blitt lengre og lengre de siste årene, og at de inneholder flere innholdselementer, men at de likevel ikke nødvendigvis blitt mindre leservennlige. Intervjuanalyser tydet på at innholdet i skrivene ikke var tilpasset det som pasientene var mest opptatt av. I forskningsfeltet mangler det dessuten standardmetoder for å måle pasienters forståelse av informasjon, samt en felles definisjon ‘forståelse’.
Participation in medical research must be completely voluntary, and a patient's or healthy volunteers’ decision to take part must be documented through an informed consent. Informed consent is the process in which the patient makes his/her decision about whether to participate or not based upon thorough information about the procedures of the research and the consequences of participating. After receiving oral and written information, the patients confirm that they are informed and that they are willing to participate in research by signing a consent form. The written information, the informed consent document (ICD), is the topic of this thesis. The contents of the ICDs are regulated by international ethical guidelines for medical research (the Declaration of Helsinki, developed by the World Medical Association, is the most important), national laws, and national and regional regulations, for instance developed by the Regional Committees for Medical and Health Research Ethics (REC) in Norway. An ICD is approved by REC before the actual reader receives it. The overall aim of this thesis has been to investigate factors that can affect patients’ understanding of informed consent documents, and how previous research has assessed patients’ understanding of consent information. The regulations regarding mandatory content of ICDs are extensive, and one might consider whether ICDs written according to the guidelines contain so much information that it becomes difficult for the reader to grasp the overall message. Even if lists of mandatory content in ICDs have been developed in the patient’s best interest, it is conceivable that several of the content elements are of no particular interest for the patients. Through semistructured interviews, we found that lung cancer patients were mostly concerned with information about their own treatment and prognoses, and that aspects surrounding the ICD reading situation might hamper the patient’s ability to understand it. The patients were less concerned with formal information about the research process. In order to investigate how the Norwegian ICDs are written, and whether they are patientoriented, two document analyses were performed. In the first one, the length and content of a sample of 87 ICDs approved for use in research from 1987 to 2007 were investigated. The results showed that there had been a threefold increase in the number of words in ICDs during this period, and that the number of content elements was more than doubled. The presence of formal content elements (juridical information, financing, insurance and storage of data) increased the most. However, difficulties with the understanding of ICDs might also be caused by the readability of the documents, which previously has been analysed by quantitative readability formulas. Additionally, aspects such as text structure, headings and vocabulary are possible contributing factors for making documents readable or functional for the actual audience. In order to investigate the functional readability of ICDs, the ten oldest and the ten newest ICDs from the above-mentioned study were analysed in order to find out which textual characteristics might contribute to making ICDs readable, and to compare the readability in old and new ICDs. The findings indicate that even though newer ICDs are longer than the old ones, they are not necessarily less readable. New ICDs were, for instance, more oriented towards the main topic of an ICD (the research) and the main function (to ask the patient to take part). The older ICDs were more oriented towards the patient’s disease and treatment, which are not functional as main topics in an ICD for medical research. The Declaration of Helsinki states that the physician must ensure that the potential research subject has understood the information. However, no further instructions are given to clarify what this means and how it should be done. A systematic review was conducted on the concept of understanding and how patients’ understanding of research information has been measured. The findings confirmed that a definition of the term “understanding” is lacking, and there is a large degree of variation between the measuring instruments, for instance concerning the number of questions and the content they cover. This variation hinders comparisons of findings, thus making it impossible to improve ICDs based upon the results of these empirical studies. In summary, the studies in this thesis showed that Norwegian ICDs had become increasingly longer during the last years, and that they contain more information, bur that newer ICDs not necessarily less readable than old ones. The interview analysis suggested that the content in the ICDs were not adjusted to the patients’ preferences. In the field of research, there is also a lack of standardized methods for measuring patients’ understanding of information and a common definition of the term ‘understanding’.

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Hamilton, Simon. "An investigation of the consent gained for the donation of breast tissue to research". Thesis, University of Leeds, 2004. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.414518.

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17

Agulanna, Christopher. "Informed Consent in Sub-Saharan African Communal Culture: The". Thesis, Linköping University, Centre for Applied Ethics, 2008. http://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-11963.

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Abstract (sommario):

Some scholars argue that the principle of voluntary informed consent is rooted in the Western ethos of liberal individualism; that it would be difficult to implement this requirement in societies where the norms of decision-making emphasize collective rather than individual decision-making (for example, Sub-Saharan Africa); that it would amount to “cultural imperialism” to seek to implement the principle of voluntary informed consent in non-Western societies. This thesis rejects this skepticism about the possibility of implementing the informed consent requirement in non-Western environments and argues that applying the principle of voluntary informed consent in human subjects’ research in Sub-Saharan African communal culture could serve as an effective measure to protect vulnerable subjects from possible abuses or exploitations. The thesis proposes the “multi-step” approach to informed consent as the best approach to the implementation of the principle in the African communal setting. The thesis argues that the importance of the “multi-step” approach lies in the fact that it is one that is sensitive to local culture and customs. On the question of whether the principle of voluntary informed consent should be made compulsory in research, the thesis answers that we have no choice in the matter.

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18

Erasmus, Pieter Miguel. "Informed consent and the secondary use of biospecimens in oncology research legal and bioethics perspectives". Master's thesis, University of Cape Town, 2012. http://hdl.handle.net/11427/4693.

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Abstract (sommario):

Includes bibliographical references.
Biospecimens1 collected during routine oncology diagnostic and therapeutic interventions may be stored for future medical purposes. In accordance with legal and ethical principles, the patient provides informed consent for removal of the tissue for diagnostic or therapeutic reasons. Informed consent gives permission for the violation of bodily integrity that is inevitable with tissue removal.

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19

Pieper, Ian J. "Relational autonomy in clinical research: Relational considerations of adult participation in clinical research". Thesis, Queensland University of Technology, 2022. https://eprints.qut.edu.au/231386/1/Ian_Pieper_Thesis.pdf.

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Abstract (sommario):

The requirement for consent to be both informed and voluntary is a keystone of contemporary bioethics. The need for consent before including people in clinical research demonstrates respect for participants. Demonstrating respect goes beyond mere acknowledgment of the right for people to make their own decisions. To be meaningful, consent must promote and support participant self-governance and enable decisions that align with participant values. A relational perspective of autonomy places people within a web of social and cultural histories and influences that frame the concept of respect. A relational approach to consent can create opportunities to promote respect for autonomy.

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20

Henderson, Alex. "Consent, choice and children in research : exploring decision making by parents of children with Duchenne muscular dystrophy considering participation in genetic research projects". Thesis, University of Newcastle Upon Tyne, 2008. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.485599.

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Abstract (sommario):

Background: Informed consent is a concept that is fundamental to the ethical inclusion of individuals in medical research projects. Theoretical and ethical analyses of consent has focused on important criteria including voluntariness, competence, provision of information, recommendation, understanding, decision making al!d authorisation. Study aims: (l) To explore the meaning of the concept of informed consent to parents who are contemplating including their sons in research projects, which are designed to develop and trial novel genetic treatments; (2) To assess the ways in which these parents engage in the consent process. Discussion: This thesis draws on qualitative interview data on the process ofconsent as experienced by parents of children with Duchenne muscular dystrophy. The results from an interpretative phenomenological analysis ofthe interviews indicate that there is significant dissociation between how parents are expected to think and choose, and how they actually behave in real life when ml)king consent decisions for their children. Many ofthe criteria which are used'for assessing adequacy of consent appear unrealistic, impossible or irrelevant to parents. This incongruence seems to result from a model, based on a principle-led form ofrational reasoning, which tends to abstract the process of consent from its clinical and social setting. There is a risk that a strict focus on a narrow analysis of consent, concentrating on elements such as competence, voluntariness, etc., can lead to consent becoming devoid ofmeaning to individuals. In tum, this threatens parents' participation in decision-making and provides some explanation for why many patients, parents, clinicians and researchers feel cynical, irritated, or despondent about consent. A more sophisticated understanding of how these decisions are made is important to ensure that ethical decisions about paediatric research participation can be made.

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Murad, Andrea M. "A Qualitative Study of Adolescents’ Understanding of Biobanks and Their Attitudes Towards Participation, Re-contact and Data Sharing". University of Cincinnati / OhioLINK, 2015. http://rave.ohiolink.edu/etdc/view?acc_num=ucin1427812492.

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22

King, Hillary S. "An Ethically Informed Consideration of the Use of a Waiver of Informed Consent in Emergency Medicine Research". Ohio University / OhioLINK, 2013. http://rave.ohiolink.edu/etdc/view?acc_num=ohiou1366042483.

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23

ATWERE, PEARL. "Evaluation of Informed Consent Documents used in Critical Care Trials". Thesis, Université d'Ottawa / University of Ottawa, 2015. http://hdl.handle.net/10393/33356.

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Abstract (sommario):

The literature suggests that informed consent documents (ICDs) are not well understood by research participants. The patient decision aid model may suggest improvements for the informed consent process, particularly in the critical care setting (ICU) because of patient capacity issues. Our goal was to evaluate the extent to which existing ICDs used in ICU research adhere to standards and recommendations for high quality informed consent. Eighteen items from recommendations specific to ICU trials were added to a previously developed ICD evaluation tool. A sample of ICU trials was identified from clinicaltrials.gov database and the investigators contacted for their trial ICD. Conformity to the recommendations was variable. Some information are found routinely in consent documents for critical care research and some are not. Efforts should aim to establish tools for measuring decision quality in the ICU with the goal of facilitating and helping patients and surrogates work through trial participation decisions.

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24

Johnsson, Linus. "Trust in Biobank Research : Meaning and Moral Significance". Doctoral thesis, Uppsala universitet, Centrum för forsknings- och bioetik, 2013. http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-192295.

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What role should trust have in biobank research? Is it a scarce resource to be cultivated, or does its moral significance lie elsewhere? How does it relate to the researcher’s individual responsibility? In this thesis I draw four general conclusions. First, trust is still very much present in at least some biobanking settings, notably in Sweden, but possibly also internationally. Second, a morally relevant conception of trust entails that to be trustworthy, researchers must consider the normative expectations that people have of them, and renegotiate expectations that are mistaken. Third, this conception differs from “public trust” assessed through surveys. The main use of the latter is to legitimate policy, not to identify moral duties. Fourth, in spite of ethics review, guidelines and informed consent procedures, ethical issues will always arise during the course of a research project. Researchers can therefore never avoid their individual moral responsibility. Ensuring that one is adequately trusted is one step towards conducting morally acceptable research. Study I indicates that few Swedes refuse storage of samples in healthcare-associated biobanks and their use in research. Study II suggests that people are somewhat more willing to donate samples than surveys indicate, especially when approached face-to-face by health care personnel. Relationships of trust might thus be important in people’s decision-making. Study III investigates trust as a moral concept. The trustee is often in a unique position to determine what the other’s trust amounts to. When it is mistaken, the trustee has an obligation to counteract it, compensate for it, or renegotiate the expectations that cannot be met. In Study IV, I critique the feasibility of guaranteeing the trustworthiness of the research apparatus through formal measures such as ethics review and guidelines. Not only are there limitations of such measures to consider. They also risk blinding researchers to ethical issues that are not covered by the rules, fostering moral complacency, and alienating researchers to ethics.

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Bolton, Talitha. "Consent and the construction of the volunteer : institutional settings of experimental research on human beings in the cold war". Thesis, University of Kent, 2008. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.515057.

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This study challenges the primacy of consent in the history of human experimentation and argues that privileging the cultural frameworks adds nuance to our understanding of the construction of the volunteer in the period 1945 to 1970. Historians and bio-ethicists have argued that medical ethics codes have marked out the parameters of using people as subjects in medical scientific research and that the consent of the subjects was fundamental to their status as volunteers. However, the temporality of the creation of medical ethics codes means that they need to be understood within their historical context. That medical ethics codes arose from a specific historical context rather than a concerted and conscious determination to safeguard the well-being of subjects needs to be acknowledged. The British context of human experimentation is under-researched and there has been even less focus on the cultural frameworks within which experiments took place. This study demonstrates, through a close analysis of the Medical Research Council's Common Cold Research Unit (CCRU) and the government's military research facility, the Chemical Defence Experimental Establishment, Porton Down (Porton), that the `volunteer' in human experiments was a subjective entity whose identity was specific to the institution which recruited and made use of the subject. By examining representations of volunteers in the British press, the rhetoric of the government's collectivist agenda becomes evident and this fed into the institutional construction of the volunteer at the CCRU. In contrast, discussions between Porton scientists, staff members, and government officials demonstrate that the use of military personnel in secret chemical warfare experiments was far more complex. Conflicting interests of the military, the government and the scientific imperative affected how the military volunteer was perceived.

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Kanellopoulou, Konstantina Nadja. "Group rights in biolaw : a model approach". Thesis, University of Edinburgh, 2009. http://hdl.handle.net/1842/5951.

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This thesis investigates legal, ethical and social aspects of group participation in genomic research. Groups in research are diverse. They can be families, patient groups, native tribes, local communities, ethnic collectives or entire national populations united by disease heredity, common cultural or personal ties. Despite rapidly rising scientific and policy interest in research with groups, legal protections for group rights and responsibilities are scarce. This work discusses current problems in defining what constitutes groups, together with dominant normative assumptions and ambiguities in existing research protections. It focuses on key issues of representation, accountability, resourcesharing and control in the management of scientific and commercial uses of group research. It highlights the increasing value of groups as research partners and examines emerging cooperative models, in the quest for appropriate legal frameworks for group protections. The thesis recommends a new concept of group empowerment and considers legal models for the implementation of the empowerment principle in modern research ethics. It proposes a way forward for law to focus on the collaborative aspects of group-researcher relationships, and to identify group research gifts as conditional, reciprocal returns of favours. Under the principle of group empowerment, reciprocity and cooperation are central in the development of adequate mechanisms for group protections. This new approach contributes to current thinking about ways to redress inequities in the balance of power between groups and researchers, build viable mechanisms for shared governance, and facilitate group involvement in genomic endeavours.

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27

Chaudhry, Shazia Hira. "Challenges in the Ethical Conduct and Ethics Review of Cluster Randomized Trials: A Survey of Cluster Randomization Trialists". Thèse, Université d'Ottawa / University of Ottawa, 2012. http://hdl.handle.net/10393/22880.

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Abstract (sommario):

Unique characteristics of cluster randomized trials (CRTs) complicate the interpretation of standard research ethics guidelines. Variable interpretation by research ethics committees may further complicate review and conduct. An international web-based survey was administered to corresponding authors of 300 randomly sampled CRT publications. We investigated ethics review and consent practices, investigator experiences with ethics review, and the perceived need for CRT-specific ethics guidelines. The response rate was 64%. Ethics review and consent were under-reported in publications. Ethics approval was obtained in 91%, and consent from individual and cluster level participants in 79% and 82% of trials. Consent varied by level of experimental intervention, data collection, and cluster size. Respondents cited variability among ethics committees (46%), and negative impacts of ethics review on their studies (38%). The majority perceived a need for ethics guidelines (73%), and guidance for ethics committees (70%). CRT-specific ethics guidelines are required to ensure practices meet ethical standards.

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28

Pagano-Therrien, Jesica. "Research Participation Decision-Making Among Youth and Parents of Youth with Chronic Health Conditions: A Dissertation". eScholarship@UMMS, 2016. https://escholarship.umassmed.edu/gsn_diss/44.

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Abstract (sommario):

The purpose and aims of this qualitative descriptive study were to describe how past experiences with research (including communication, information, values and support) may contribute to research fatigue among youth and parents of youth with HIV, CF, and T1D. Eighteen parents and youth were purposively recruited from outpatient subspecialty clinics at a major academic medical center. They took part in qualitative interviews, completed a demographics form, and the Decisional Conflict Scale. Youth participants also completed the Erikson Psychosocial Stage Inventory. Two major themes emerged: blurred lines and hope for the future. Research fatigue was not found in this sample. Results point to challenges with informed consent in settings where research and clinical care are integrated, and suggest that protective factors allow for continued participation without excess burden on youth and parents. Strategies to minimize research fatigue and support engagement in research are offered.

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29

Kruszewski, Zita. "The use of patient-derived tissue in biomedical research". Thesis, National Library of Canada = Bibliothèque nationale du Canada, 1998. http://www.collectionscanada.ca/obj/s4/f2/dsk1/tape11/PQDD_0006/MQ43899.pdf.

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30

Reid, Robert. "Acts of Dissension : how political theatre has been presented in the past and what strategies the playwright can employ to make issues of radical or alternative politics more accessible to a mainstream theatre audience". Thesis, Queensland University of Technology, 2007. https://eprints.qut.edu.au/16581/1/Robert_Reid_-_Pornography%2C_The_True_Confessions_of_Mandy_Lightspeed.pdf.

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Abstract (sommario):

The key focus of this research project is the marginalisation of radical and alternative politics in modern democratic societies, how they have been presented in a mainstream theatrical context and what strategies a political playwright can employ to present the issues of those politics while overcoming such marginalisation. Referencing cultural theorists including Noam Chomsky, Naomi Klein and Howard Zinn, this study argues that contemporary cultures operate within the boundaries of an internalised conservative value set propagated through systems of coercion utilised by the media, governments and corporations. With a specific interest in contemporary theatre, this study proposes that this internalisation functions as an efficient and nearly invisible censor, rendering more complex the task of the political playwright in communicating with a wider and more inclusive audience and that by examining the methods used in the manufacture of consent and then returning to the strategies utilized by political playwrights in the past and at present, we can better identify how to bypass that internal censor and do something more than " preach to the converted." This project comprises two interrelated components; one is an original full length play script, Pornography: The True Confessions of Mandy Lightspeed; the other is an exegesis which compliments and augments the play. The play script represents %60 and the exegesis the remaining %40 of the examinable output of this project, although both are considered integral (and integrate) parts of the whole. Central to both these texts is the question; " How has political theatre been presented in the past and what strategies can the playwright employ to make issues of radical or alternative politics more accessible to a mainstream theatre audience?"

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31

Reid, Robert. "Acts of Dissension : how political theatre has been presented in the past and what strategies the playwright can employ to make issues of radical or alternative politics more accessible to a mainstream theatre audience". Queensland University of Technology, 2007. http://eprints.qut.edu.au/16581/.

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Abstract (sommario):

The key focus of this research project is the marginalisation of radical and alternative politics in modern democratic societies, how they have been presented in a mainstream theatrical context and what strategies a political playwright can employ to present the issues of those politics while overcoming such marginalisation. Referencing cultural theorists including Noam Chomsky, Naomi Klein and Howard Zinn, this study argues that contemporary cultures operate within the boundaries of an internalised conservative value set propagated through systems of coercion utilised by the media, governments and corporations. With a specific interest in contemporary theatre, this study proposes that this internalisation functions as an efficient and nearly invisible censor, rendering more complex the task of the political playwright in communicating with a wider and more inclusive audience and that by examining the methods used in the manufacture of consent and then returning to the strategies utilized by political playwrights in the past and at present, we can better identify how to bypass that internal censor and do something more than " preach to the converted." This project comprises two interrelated components; one is an original full length play script, Pornography: The True Confessions of Mandy Lightspeed; the other is an exegesis which compliments and augments the play. The play script represents %60 and the exegesis the remaining %40 of the examinable output of this project, although both are considered integral (and integrate) parts of the whole. Central to both these texts is the question; " How has political theatre been presented in the past and what strategies can the playwright employ to make issues of radical or alternative politics more accessible to a mainstream theatre audience?"

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32

Castelhano, Marta Guilherme Pimentel. "Development and implementation of a veterinary biobank to support biomedical research : the Cornell Veterinary Biobank". Master's thesis, Universidade de Lisboa, Faculdade de Medicina Veterinária, 2017. http://hdl.handle.net/10400.5/15641.

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33

Araújo, Diego Vinicius Pacheco de. "A caracterização do alfabetismo funcional em usuários do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo: recomendações para a redação do termo de consentimento livre e esclarecido". Universidade de São Paulo, 2009. http://www.teses.usp.br/teses/disponiveis/7/7141/tde-11012010-123657/.

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Abstract (sommario):

Os objetivos deste estudo são: descrever o nível de alfabetismo funcional dos usuários do ambulatório do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo; comparar o nível de alfabetismo funcional dos usuários ambulatoriais do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP) com os do Hospital de Clínicas de Porto Alegre (HCPA); identificar recomendações para adequar a redação do Termo de Consentimento Livre e Esclarecido utilizado nas pesquisas do HCFMUSP ao nível de alfabetismo de seus usuários. Trata-se de um estudo transversal quantitativo com 399 sujeitos, a amostra foi intencional, selecionada entre usuários dos ambulatórios do HCFMUSP. A coleta de dados utilizou um instrumento que continha um texto em prosa compatível para a avaliação das habilidades de leitura necessárias para a compreensão de um TCLE. Os dados apontam que mais de 46,6% dos entrevistados foram classificados como analfabetos funcionais, desses, 12,7% sequer foram capazes de entender a tarefa proposta no texto lido. Apesar disto, quase 50% dos entrevistados declararam ter ao menos iniciado o ensino médio. Os resultados e as orientações para a redação de texto centrada no leitor permitiu que elaborássemos recomendações para tornar os termos de consentimento mais fáceis de ler. Recomendamos que o pesquisador elabore o TCLE como um texto em estrutura narrativa, dirigido ao leitor, usando palavras e termos familiares aos sujeitos, ou seja, termos comuns à linguagem dos sujeitos e à linguagem médica. Além de contribuir para melhorar a relação entre o sujeito e o pesquisador, acredita-se que estas recomendações possam contribuir para a diminuição do tempo de tramitação de projetos de pesquisa, já que os problemas na redação do TCLE motivam boa parte das pendências que retardam este andamento
This study aimed to describe the literacy of the patients at the Hospital das Clinicas, Faculty of Medicine, University of Sao Paulo; compare literacy between the patients at the Faculty of Medicine, University of Sao Paulo (HCFMUSP) and those at the Hospital de Clínicas de Porto Alegre (HCPA); and recommend how to suit the Consent Form in research protocols to HCFMUSP patients literacy .This is a quantitative cross-sectional study with 399 subjects. Sample was intentionally selected among users of ambulatory HCFMUSP. Data collection used a narrative text compatible for assessing the reading skills needed for understanding consent forms. Results point out that 46.6% of the respondents were funcionally illiterate, and 12.7% of them were not even able to understand the task presented in the questions. Despite this, almost 50% of the respondents declared that they had, at least, started the high school. Based on the results and guidelines for writing texts centered on subjects literacy we recommend how to make consent forms easier for reading. We recommend that researchers write consent forms as a narrative texts addressed to the research subject reader; use words and expressions suitable to subjects culture and literacy. In other words, researchers should use words common to both languages: the popular language spoken by the patients and the medical language. We believe that these recommendations might improve the relationship between researchers and subjects and, as well, reduce the time taken to obtain the ethical approval of research projects

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Sibley, Amanda Nicole. "Child assent to clinical research participation : how to determine a child's ability to assent". Thesis, University of Oxford, 2013. http://ora.ox.ac.uk/objects/uuid:c0de25b2-12ca-46a6-8442-7b1eaf559389.

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Assent, currently defined as “a child’s affirmative agreement”, is a way in which some children are included in the decision-making process regarding their participation in clinical research. Current guidelines for paediatric research do not provide clear directions for how assent should be handled, resulting in confusion among researchers. The goal of this research project was two-fold: to examine the ethical arguments for assent with a view to developing concrete moral justification for its being required, and to develop a framework of significant issues for an investigator to consider when deciding whether to gain assent from an individual child. After an in-depth analysis, it was determined that the ethical justification for assent arises from the researcher’s dual obligations to the child and his parents. A child’s parents are responsible for determining when and how he will develop his decision-making ability. The researcher has an obligation to engage with the child in a manner that complements their pedagogical style, while also treating the child as a being of moral worth. As a child’s family context has an influence on his participation in medical decision-making, further research on children’s daily decision-making within their families is needed. To this end, a three-phase research agenda was designed: a qualitative focus group study, a quantitative questionnaire study, and a discussion panel with paediatric experts. The children in these studies clearly desired to make decisions but did not express an interest in having complete control. They expected their parents to provide them with decision-making guidance in most aspects of their lives. Data collected from parents illustrated that they often tried to involve their children in decisions by providing them with limited options from which to choose and encouraging family discussion. Participants in the discussion panel stated that they did not expect children to make an independent decision regarding medical care, but they might attempt to give children smaller decisions, such as the arm used to provide a blood sample. These results indicate that the definition of assent should be revised, emphasising the child’s involvement in the overall decision making process, without an expectation of an “affirmative agreement”, likely mimicking a familiar decision-making setting from his family context. This could then be documented in the child’s clinical notes through a brief description of all relevant interactions and/or discussions with the child, resulting in an accurate portrayal of the entire assent process.

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Sakaguti, Nelson Massanobu. ""O conhecimento de usuários de serviços públicos de saúde envolvidos em pesquisas clínicas, sobre seus direitos"". Universidade de São Paulo, 2005. http://www.teses.usp.br/teses/disponiveis/23/23148/tde-06062005-155926/.

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O presente trabalho avaliou através de um questionário e entrevistas pessoais no período de maio a setembro de 2004, cinqüenta participantes voluntários sujeitos de pesquisas envolvendo seres humanos, nas unidades de saúde do âmbito da Secretaria Municipal de Saúde SMS, espalhadas pelo município de São Paulo e na Faculdade de Odontologia da Universidade de São Paulo FOUSP. Colheu a opinião destes, sobre a experiência da voluntariedade nos experimentos de que participaram nestes locais, abordando questões como: o motivo de terem contribuído, grau de conhecimento do Termo de Consentimento Livre e Esclarecido -TCLE e a importância dispensada a este documento, com que concordaram e autorizaram a participação, de acordo com a determinação da Resolução 196/96, diretriz nacional que regulamenta as pesquisas envolvendo seres humanos. O estudo observou que, passados oito anos da entrada em vigor da Resolução 196/96, o processo de obtenção do consentimento livre e esclarecido ainda carece de cuidados. Participantes efetivamente não são esclarecidos ou não entendem o que lhes foi proposto. Consideramos a necessidade de uma maior difusão, através de ações educativas, do assunto experimentação com seres humanos, para um maior entendimento dos voluntários de pesquisas dos seus direitos e deveres, no sentido de manter as pesquisas num elevado padrão ético. O presente estudo pretende contribuir com a hermenêutica desta Resolução e suscitar maiores discussões e reflexões sobre o assunto
The present assignment evaluated through a questionnaire and personal interviews in the period within May and September 2004, fifty volunteered participants subjects of researches involving human beings, in the units of health SMS) in São Paulo city and at Odontology University of São Paulo - FOUSP. It collected the opinion of these volunteers about the experience of voluntariness in the experiments that took part in these locals, tackling matters as: their reason of having contributed, knowledge degree of free consent form TCLE and the dispensed importance of this document, to which they agreed and authorized the participation, according to the determination of the Resolution 196/96, national guideline that regulates the researches involving human beings. The study observed that eight years after the Resolution 196/96 was put into effect, the obtainment process of the informed consent still lacks of cares. Participants are not clear or do not understand what they were proposed. We consider the need of a larger diffusion through educational actions, of the subject experimentation with human beings, for volunteers larger understanding of their right and duties, in the sense to maintaining the researches in an elevated ethical standard. The present study intends to contribute with the hermeneutics of this Resolution and to raise larger discussions and reflections on the subject

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Mendonça, Louise Camargo de. "Processo de consentimento : recomendações para os pesquisadores com base nas vivências dos participantes de pesquisa clínica". reponame:Biblioteca Digital de Teses e Dissertações da UFRGS, 2018. http://hdl.handle.net/10183/181269.

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A pesquisa clínica patrocinada no Brasil vem crescendo cada vez mais e gerando conhecimento científico em diversas áreas da saúde. O desenvolvimento desses ensaios clínicos envolve aspectos que vão além da geração de fármacos e produtos mais avançados. O grande alicerce da pesquisa clínica está também nos pacientes que aceitam participar de um estudo científico. Estes precisam passar por um processo de consentimento que envolve ter conhecimento sobre todos os aspectos que envolvem a sua participação no ensaio clínico. Dentro desse contexto, surge um grande desafio na área que é como realizar o processo de consentimento de maneira adequada. É preciso levar em consideração aspectos como compreensão, motivações, influências, coerção, benefícios, riscos, entre outros aspectos. O objetivo deste trabalho foi identificar quais os fatores vivenciados pelos participantes de pesquisa clínica durante o processo de consentimento. Foram aplicados questionários a respeito da sua percepção no que envolve a participação na pesquisa clínica. Com os dados gerados foi possível desenvolver um conjunto de recomendações visando o aprimoramento do processo de consentimento em projetos de pesquisa clínica.
Clinical research sponsored in Brazil has been increasing and generating scientific knowledge in several areas of health. The development of these clinical trials involves aspects that go beyond the generation of drugs and more advanced products. The key of clinical research is also in patients who accept to participate in a scientific study. These need to undergo a consent process that involves having knowledge about all aspects that involve their participation in the clinical trial. Within this context, a great challenge arises in the area that is how to carry out the consent process in an appropriate way. It is necessary to take into account aspects such as understanding, motivations, influences, coercion, benefits, risks, among other aspects. The objective of this study was to identify the factors experienced by clinical research participants during the consent process. Questionnaires were applied regarding their perception regarding the participation in clinical research. With the data generated, it was possible to develop a set of recommendations aimed at improving the consent process in clinical research projects.

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Soulier, Alexandra. "Défis techniques, problèmes éthiques : repenser l'éthique de la recherche en génomique humaine à l'ère des infrastructures de recherche". Thesis, Toulouse 3, 2017. http://www.theses.fr/2017TOU30177/document.

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Dans le champ de la recherche en génomique, comme dans d'autres domaines très informatisés, les bases de données et les biobanques sont organisées en infrastructures. Ce nouveau modèle organisationnel doit permettre de soutenir l'effort technique et collaboratif requis pour traiter des Big Data, c'est-à-dire des jeux de données trop volumineux et complexes pour être traités en utilisant les méthodes classiques. L'établissement de ces nouveaux environnements constitue un véritable défi technique et philosophique. Il requiert, pour être opérationnel, des cadres réglementaires adaptés, ouverts à la fois à l'internationalisation et à des perspectives de long terme, mais certains de ces changements ne sont pas compatibles avec les procédures éthiques courantes, notamment la procédure de consentement éclairé. L'éthique de la recherche en génomique doit donc être repensée. Faut-il puiser dans la technique les nouvelles solutions de gouvernance de la recherche ? Ou bien est-il plus juste de répondre à ces évolutions en analysant les situations de tension morale suscitées par de nouveaux développements et en décidant de les traiter en fonction de ce à quoi nous tenons collectivement ? L'enjeu de ce travail, qui relève d'une approche pragmatiste, consiste à cultiver une attitude réflexive à propos des changements en cours dans la recherche en génomique. Cette tâche suppose d'expliciter le rôle des biobanques et des bases de données dans la production, la validation et la publication de la recherche génomique. Il est également nécessaire de rendre compte des tensions auxquelles le développement de ces dispositifs donne lieu lorsqu'ils sont incompatibles avec les procédures actuelles. On peut alors examiner si les dispositifs tels qu'ils sont conçus sont désirables dans les contextes où ils sont développés, soulignant ainsi la dimension politique de l'éthique de la recherche. Cette thèse repose sur l'analyse de situations concrètes issues de projets de recherche dans lesquels nous avons été impliquée. Nous utilisons aussi plusieurs disciplines étudiant la science telle qu'elle se fait (philosophie, anthropologie, sociologie et histoire). Au cours de cet examen, l'idée régulatrice de personne-membre est proposée, pour favoriser la prise en compte des appartenances sociales et politiques du sujet de l'éthique de la recherche en génomique
In genomic research, as in other highly computerised scientific fields, databases and biobanks are today (re-)organised into infrastructures. This new organisational model should support the technical and collaborative effort needed to deal with Big Data, that is, data sets that are too large and too complex to be treated with conventional methods. Establishing these new environments is an actual technical challenge that requires, in order to be operational, appropriate regulatory frameworks that are both open to internationalisation and long-term prospects. But some of these changes are not consistent with current ethics procedures, including the informed consent process. The ethics of genomics research must therefore be reconsidered by asking whether it is in technology that we must draw new solutions for the governance of research or whether we must respond to these evolutions by proposing a political treatment to clarify what we value collectively. This work, which is based on a pragmatist approach, intends to cultivate a reflexive attitude on the changes being made in genomic research by describing situations of moral tension. This requires elucidating the role of biobanks and databases in the production, validation and publication of genomic research; accounting for the conflicts of values to which the development of these devices can give rise when they are incompatible with the current procedures and thus to examine whether the devices as conceived are desirable in the contexts where they are developed. This thesis is based on the analysis of concrete situations, resulting from research projects in which we have been involved or from studies of science in practices (philosophy, anthropology, sociology and history). During this examination, the regulatory idea of a person-member is proposed, in order to favor the consideration of the social and political affiliations of the subject of ethics to research in genomics

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Rodrigues, Filho Euripedes. "A DIMENSÃO ÉTICA DO PROCESSO DE CONSENTIMENTO LIVRE E ESCLARECIDO NA PESQUISA QUE ENVOLVE SERES HUMANOS". Pontifícia Universidade Católica de Goiás, 2014. http://localhost:8080/tede/handle/tede/2960.

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Made available in DSpace on 2016-08-10T10:54:11Z (GMT). No. of bitstreams: 1 EURIPEDES RODRIGUES FILHO.pdf: 1862437 bytes, checksum: 9bbde5e059417e2643ece305cfda4d7a (MD5) Previous issue date: 2014-03-12
The respect due to the human dignity and autonomy requires that all scientific research involving human subjects may only be conducted with due consent of the participant. It could say that for the Ethics Committee (EC), in Brazil, the most important for verifying the adequacy of the ethics of research projects involving human beings is the Informed Consent (IC) .Therefore, as shown by the literature, it is common ground point between most ethics committees of research centers in the world, the need for obtaining informed consent for any research involving human beings. Therefore, those shown by the literature, it is common ground point between ethics committees of most research centers in the world, the need for Obtaining informed consent for any research Involving human beings. Due to the risks related to privacy and confidentiality of data and that such waiver must be requested by the researcher to the CEP, with justification. Aimed to select, interpret, and critically evaluate studies that were focused understanding and readability of the informed consent; identify factors associated with the process of obtaining valid consent factors; identify the inner relationship between the principle of respect for autonomy and informed consent. The methodological procedures were performed in two stages: the first was used an integrative review to check the guiding question of the study, which to question the readability and understanding of informed consent in research involving humans. Included in the sample selected eleven of this review, national and international articles, four of which were in Portuguese (36.36%), one in Spanish (9.09%) and six in English (54.54%). The second was used content analysis to the verification of changes in guidelines for research involving humans in Brazil, referring to the principle of respect for autonomy of the research participant. From the themes "consent and approval", "document / consent" and "consent process", which allow the inference of the changes brought by the new rules on ethics in research involving human beings. The study results suggest that the informed consent should contain simple vocabulary, clarity of language, considering the socioeconomic, educational and cultural participant. Similarly suppose that the four necessary conditions for an autonomous decision are: intentionality, proper knowledge, the absence of external and internal control and authenticity. Concluded that the IC well understood is the key to autonomous decision making and, that authenticity gives the informed consent the essential nature of validity. It was found that the amount of related to informed consent in research involving humans, studies are still very low in the scientific community. Making is therefore a need for greater mobilization of the scientific and academic community for this matter of major interest to society.
O respeito devido à dignidade humana e à autonomia exige que toda pesquisa científica que envolve seres humanos só poderá ser realizada, com o devido consentimento do participante. Pode-se dizer que, para os Comitês de Ética em Pesquisa (CEP), no Brasil, o documento mais importante para a verificação da adequação da eticidade dos projetos de pesquisas que envolvem seres humanos é o Termo de Consentimento Livre e Esclarecido (TCLE). Por conseguinte, como atesta a literatura pertinente, é ponto pacífico entre a maioria dos comitês de ética dos centros de pesquisas do mundo, a necessidade da obtenção do TCLE para qualquer pesquisa que envolva seres humanos. Excetuam-se os casos especiais previstos nas resoluções e declarações nacionais e internacionais, que tratam da impossibilidade de se obter o TCLE de certos participantes, devido aos riscos relacionados à privacidade e à confidencialidade dos dados e, que essa dispensa deve ser solicitada pelo pesquisador ao CEP, com justificativa. Teve como objetivos selecionar, interpretar e avaliar criticamente os estudos que tiveram como enfoque a compreensão e a legibilidade do Termo de Consentimento Livre e Esclarecido (TCLE); verificar os fatores associados ao processo da obtenção do consentimento válido; explicitar a relação interna entre o princípio do respeito à autonomia e o consentimento livre e esclarecido. Os procedimentos metodológicos foram realizados em dois momentos: no primeiro, utilizou-se da revisão integrativa para a verificação da pergunta norteadora do estudo, que problematizou a legibilidade e a compreensão do consentimento livre e esclarecido na pesquisa que envolve seres humanos. Integram a amostra desta revisão onze artigos selecionados, nacionais e internacionais, dos quais foram quatro em Português (36,36%), um em Espanhol (9,09%) e seis em Inglês (54,54%). No segundo, utilizou-se da análise de conteúdo para a verificação das mudanças ocorridas nas normas de pesquisa que envolve seres humanos no Brasil, referente ao princípio do respeito à autonomia do participante da pesquisa, a partir das categorias temáticas consentimento e assentimento , documento / termo de consentimento e processo de consentimento , que permitem a inferência das mudanças trazidas com a nova norma sobre ética em pesquisa envolvendo seres humanos. Os resultados do estudo sugerem que os Termos de Consentimento Livre e Esclarecido devem conter vocabulário simples e clareza da linguagem, considerando o nível socioeconômico, de escolaridade e cultural do participante. Do mesmo modo supõem que as quatro condições necessárias para uma decisão autônoma são: a intencionalidade, o conhecimento adequado, a ausência de controle externo e interno e a autenticidade. Concluiu-se que o TCLE bem compreendido é a chave para a tomada de decisão autônoma e que a autenticidade confere ao consentimento livre e esclarecido o imprescindível caráter de validade. Constatou-se, também, que a quantidade de estudos relacionados ao consentimento livre e esclarecido em pesquisas que envolvem seres humanos ainda é muito reduzida no meio científico. Perfaz-se, portanto, a necessidade de maior mobilização da comunidade científica e acadêmica para esta temática de relevante interesse à sociedade.

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Gauthier, Isabelle. "Analyse de la norme sociale comme contrainte au consentement : l'exemple de la recherche biomédicale en situation d'urgence". Thesis, McGill University, 2000. http://digitool.Library.McGill.CA:80/R/?func=dbin-jump-full&object_id=31052.

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This thesis seeks to demonstrate, by way of a multidisciplinary study, that consent is, despite its legal definition which refers to the free and enlighted expression of individual will, in fact, at times limited if not eliminated, by social considerations, arising from the medical, economic and legal context. These considerations reflect what one might call the social norm. An appropriate understanding of consent serves, therefore, to express the social norm as a constraint, which, in turn, acts as a measure of what it means to belong in society. Thus, while consent is often presented as the fundamental principle to be respected in biomedical research, it is in reality, merely one principle to respect among others. These limitations connected to consent are exacerbated in emergency situations where consent is sometimes reduced to mere signature, and in some cases it has been recognized that research can be undertaken without the subject's prior consent.

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Illy, Margaux. "Du consentement en recherche clinique : approche philosophique des enjeux éthiques et déontologiques". Thesis, Aix-Marseille, 2019. http://theses.univ-amu.fr.lama.univ-amu.fr/190919_ILLY_195rthmc155im575u632pdsi_TH.pdf.

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Le consentement à la recherche clinique est une idée nouvelle concernant une pratique ancienne. Dès ses premières heures, l’expérimentation humaine témoigne d’une propension sacrificielle qui a durablement jeté la suspicion sur la recherche biomédicale. Le procès de Nuremberg marque une rupture juridique et symbolique majeure qui inaugure l’éthique médicale moderne, centrée sur le respect de l’autonomie des personnes. Bien que l’arsenal juridique se soit consolidé en vue de rendre la recherche indépendante et impartiale, des questions philosophiques relatives au consentement continuent à se poser. Pour contribuer à leur élucidation, nous avons mené une enquête qualitative auprès de volontaires malades. Leurs récits révèlent les paradoxes d’une liberté sous influence, les difficultés de l’information et l’importance de la confiance mutuelle. La doctrine paternaliste, sous couvert de bienfaisance, a longtemps conféré au praticien une forme de suprématie douteuse où la « confiance » (régressive) du patient était censée dispenser le médecin de lui demander un consentement libre et éclairé. Elle est aujourd’hui un état d’esprit du patient fondée sur la transparence et l’intégrité du médecin-chercheur. Nous avons alors interrogé des professionnels concernant leur rôle dans le processus de consentement, ainsi que leur rapport personnel à la déontologie. Cette étude fait apparaitre un réel souci des investigateurs d’agir en accord avec leur conscience et avec un sens aigu de leur responsabilité morale, bien qu’étant également exposés à des influences diverses opacifiant leurs motivations et leur rapport à la liberté. Il en ressort un certain nombre d’apories philosophiques
Consent to clinical research is a new idea about an old practice. From its earliest hours, human experimentation testifies to a sacrificial propensity that has durably cast suspicion on biomedical research. The Nuremberg trial marks a major juridical and legal breakthrough that inaugurates modern medical ethics, centered on respect for the autonomy of individuals. Although the legal arsenal has been strengthened to make research independent and impartial, philosophical questions about consent continue to arise. To contribute to their elucidation, we conducted a qualitative survey of sick volunteers. Their stories reveal the paradoxes of freedom under influence, the difficulties of information and the importance of mutual trust. Paternalistic doctrine, under the guise of beneficence, has long conferred on the practitioner a form of questionable supremacy in which the patient's (regressive) "trust" was supposed to dispense the physician from asking for free and informed consent. Today, trust is a patient state of mind based on the transparency and integrity of researchers. We then interviewed professionals about their role in the consent process, as well as their personal relationship to ethics. This study shows a real concern of the investigators to act in accordance with their conscience and with a keen sense of their moral responsibility, although they are also exposed to various influences opacifying their motivations and their relation to freedom. There emerges a number of philosophical aporias

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Atkin, Charlotte Jane. "Consent to participate in research by adults with intellectual disabilities : a systematic review of the literature and exploring the experiences of independent advocates and parents with intellectual disabilities following their involvement in child protection proceedings". Thesis, University of Birmingham, 2017. http://etheses.bham.ac.uk//id/eprint/7399/.

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This thesis comprises two volumes. Volume I presents research. Chapter one is a systematic review of studies investigating the ability of adults with intellectual disabilities (ID) to consent to participate in research. The review highlights the inconsistency and variation in findings in relation to consent ability, methods of providing research information and assessing ability to consent. A functional approach to consent is advocated, along with consideration of the relative benefits and risks of the research. Chapter two is an empirical paper examining the lived experiences of independent advocates and parents with ID in the context of child protection proceedings. The findings highlight the challenges advocates face and the key skills and qualities which underpin their work. Chapter three is a public dissemination document. Volume II presents five Clinical Practice Reports (CPR). CPR 1 details behavioural and systemic case formulations of a man aged 21 with autism and ID, presenting with anxiety and social difficulties. CPR 2 describes a Single Case Experimental Design to evaluate an environmental enrichment intervention for a man aged 59 with moderate ID, Down Syndrome and dementia, presenting with anxiety and behaviours that challenge. CPR 3 details an evaluation of psychology ‘drop-in’ services in five acute inpatient mental health units in a West Midlands city. CPR 4 describes a case study of a girl aged 13 presenting with anxiety, depression and low self-esteem. CPR 5 outlines an abstract of an oral presentation of a case study of a woman aged 69 presenting with anxiety and depression.

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Nascimento, Talita Garcia do. "Avaliação do processo de consentimento de participantes de pesquisa clínica". Universidade de São Paulo, 2017. http://www.teses.usp.br/teses/disponiveis/22/22133/tde-28112017-162459/.

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Abstract (sommario):

O consentimento informado consiste em um processo capaz de informar o participante de pesquisa sobre as intervenções médicas previstas a serem aplicadas no decorrer do estudo e faz com que este participe ativamente no processo de tomada de decisão. O Termo de Consentimento Livre e Esclarecido (TCLE) caracteriza-se por ser um documento explicativo, de forma escrita, no qual são abordadas informações referentes ao projeto de pesquisa, com o objetivo de garantir a voluntariedade do indivíduo. A qualidade do TCLE em pesquisa clínica é determinada pelo grau de compreensão que os participantes desenvolvem durante o processo de consentimento informado. O objetivo deste estudo consiste em avaliar o processo de consentimento dos participantes de pesquisa clínica. Trata-se de um estudo híbrido, com coleta prospectiva. Para o seu desenvolvimento dividiu-se nas seguintes fases: Elaboração e validação do formulário, Treinamento da Equipe de Entrevistadores, Estudo Piloto, Coleta de Dados e Avaliação da Legibilidade dos TCLEs. Foi realizada análise descritiva dos dados e comparação entre as variáveis por meio de análises univariadas. Dos 70 participantes que compuseram a amostra, 83% eram mulheres, a média de idade foi de 46,7 anos (S ±13.99 anos), 55,7% eram brancos, 45,75% casados, 52,9% analfabetos ou com ensino fundamental, 49,3% economicamente ativos e renda média de 1496,2 reais. Dos participantes, 35,7% desconheciam o tipo de estudo que participavam 38,6% não sabiam contar sobre a pesquisa que participavam, 64,7% não receberam informações referentes a outros tipos de tratamento, 62,7% não tinham informações sobre indenização, 66,2% não leram todo o TCLE antes de assinar, 86,8% relataram que o documento foi fácil de ser lido, 62,2% acharam o documento longo. Após o cálculo do ILFK dos 12 TCLEs analisados, 100% apresentaram valor de 0 a 30, considerado como leitura muito difícil. É de suma importância incentivar o desenvolvimento de estudos nacionais que avaliem a percepção dos participantes de pesquisa quanto aos seus direitos e a criação de instrumentos que possibilitem essa verificação na população brasileira
Informed consent consists a process that is able to inform, the research participant, of the planned medical interventions to be apply during the course of the study, and actively participate in the decision-making process. The Informed Consent Form (ICF) characterized by being an explanatory document, in written form, in which information about the research project is addressed, with the purpose of guaranteeing the individual\'s willingness. The quality of ICF in clinical research determined by the degree of understanding that participants develop during the informed consent process. The objective of this study is to evaluate the consent process of clinical research participants. It is a hybrid study, with prospective collection. For its development, it divided into the following phases: Elaboration and validation of the form, Training of the Team of Interviewers, Pilot Study, Data Collection and Evaluation of the Readability of ICF. A descriptive analysis of the data and a comparison between the variables performed using univariate analyses. Of the 70 participants, 83% were women, mean age was 46,7 years (S ± 13.99 years), 55,7% were white, 45,75% married, 52,9% illiterate or basic education, 49,3% economically active and average income of 1496,2 Reais. Of the participants, 35,7% didn\'t know the type of study they participated in, 38,6% didn\'t know about the research they participated, 64,7% didn\'t receive information regarding other types of treatment, 62,7% didn\'t have information about compensation, 66,2% didn\'t read the entire ICF before signing, 86,8% reported that the document was easy to read, 62,2% found the document long. After the ILFK calculation of the 12 ICF analysed, 100% presented values from 0 to 30, considered as very difficult reading. It is extremely important to encourage the development of national studies that evaluate the perception of research participants regarding their rights and the creation of instruments that enable such verification in the Brazilian population

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43

Noonan, Michael. "Laughing & disability : comedy, collaborative authorship and Down Under Mystery Tour". Thesis, Queensland University of Technology, 2010. https://eprints.qut.edu.au/48647/1/Michael_Noonan_Thesis.pdf.

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Abstract (sommario):

This thesis is an exploration of representation, authorship and creative collaboration in disability comedy, the centre piece of which is a feature-length film starring, co-created and co-written by three intellectually-disabled people. The film, entitled Down Under Mystery Tour, aims to entertain, and be accessible to, a mainstream audience, one that would not normally care about disability or listen to disabled voices. In the past, the failure of these voices to reach audiences has been blamed on poor training, marginal timeslots and indifferent audiences. But this project seeks an alternative approach, building collaboration between disabled and non-disabled people to express voice, conceive, construct and produce a filmed narrative, and engage willing audiences who want to listen.

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44

Peters, A. "A constant-depth laboratory model film fermenter". Thesis, Bucks New University, 1988. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.383857.

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45

Ouvrier, Mary-Ashley. "Anthropologie de la recherche médicale en milieu rural sénégalais". Thesis, Aix-Marseille 3, 2011. http://www.theses.fr/2011AIX32091.

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Cette thèse propose de documenter les dynamiques sociales dans un espace géographique en milieu rural sénégalais — l’aire de Toudinga — où des recherches principalement démographiques et médicales sont menées depuis 1964 dans le cadre des activités de l’IRD (Institut de recherche pour le développement), anciennement Orstom (Office de la recherche scientifique dans les territoires d’outre-Mer). Cette étude se situe au croisement de l’anthropologie de la santé, de l’ethnologie africaniste et de la sociologie des sciences et des organisations. Cette intersection permet d’aborder de multiples aspects socio-culturels relatifs au fonctionnement et aux enjeux de la recherche médicale en Afrique sub-saharienne. Ce travail traite en premier lieu du fonctionnement social de l’aire de Toudinga et présente une analyse des représentations de la recherche scientifique et des interactions entre les professionnels de la recherche et les habitants de la région. Il met également en évidence l’influence des facteurs historiques, identitaires et institutionnels sur la construction locale de l’éthique. Cette étude aborde également des thèmes plus généraux relatifs à l’anthropologie de la recherche médicale tels que l’influence du contexte social sur le recueil du consentement (rapports sociaux de sexe, de classe d’âge, don / contre-don), l’impact de la recherche médicale sur l’offre de soins locale ou encore l’analyse des facteurs sociaux expliquant la crédibilisation des rumeurs de vol de sang
This thesis documents the social dynamics that occur in a rural context in Senegal — the area of Toudinga— where essentially demographic and medical research have been held since 1964 by the IRD (Institut de recherche pour le développement) formerly Orstom (Office de la recherche scientifique dans les territoires d’outre-Mer). At the crossroads of medical anthropology and African ethnology and sociology of science and organizations, the theoretical position adopted in this thesis allows for the examination of numerous social aspects related to medical research in sub-Saharan Africa. This PhD deals with the social organisation of the area of Toudinga. It describes the representations of medical research and the interactions between the research professionnals and the inhabitants of the region and highlights the influence of historic, identity and instititional factors on the local construction of ethics. Futhermore, this work examines wider thematics related the anthropology of medical research such as the influence of the social context on the consentent collection (gender, age group, gift and conter-gift), the impact of medical research on local medical care and the analysis of blood stealing rumors

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46

Miller, Geoff. "Development of a constant-volume combustion apparatus for fuels research". Thesis, University of Cape Town, 2007. http://hdl.handle.net/11427/5502.

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This project, initiated by the Sasol Advanced Fuels Laboratory at UCT, was to develop a piece of apparatus in which single compression ignition events could be viewed and studied. The pressure and temperature at injection were to be independently variable. Following a literature survey into previous fuels research work and the associated equipment used, such as rapid compression machines and continuous flow combustion chambers, the decision was made to develop a constant volume combustion chamber (CVCC). This option provided the greatest potential for optical access. The development of the high pressure and temperature environment was to be achieved using a pre-charge combustion event as opposed to electrical heating. The combustion of a lean mixture of flammable gas resulted in the desired conditions being developed rapidly, avoiding the material strength limitations of sustained electrical heating. The CVCC has a cylindrically shaped chamber, 100mm in diameter and 50mm deep, which is formed by a martensitic tool steel vessel of 230mm nominal diameter. The chamber is optically accessible by means of sapphire windows on both ends as well as from a maximum of three 38mm diameter (medium-sized) circumferential ports. Flexibility of the experimental setup was ensured by the use of common porting, whereby the two ends, the four medium-sized ports and the four small circumferential ports were interchangeable with one another. All ports were sealed with Viton 0-rings that permitted a maximum operating temperature of 200°C. The CVCC could be electrically heated to 150°C to prevent condensation on the windows. The exhaust valve, which also served as a safety relief valve, was pneumatically powered and automatically controlled by a solenoid valve. The high pressure and temperature environment required for compression ignition combustion events were achieved by the introduction of predetermined amounts of Hydrogen and/or Acetylene, Nitrogen and Oxygen into the chamber. The gases were metered into the CVCC by means of a pressure transmitter feedback loop and a solenoid valve, both of which were controlled by the main computer that made use of a data acquisition card. The mixture was ignited by a spark plug, resulting in complete pre-charge combustion and a rapid pressure and temperature increase. Following pre-charge combustion, the temperature and pressure dropped relatively gradually due to heat lost to the walls of the vessel. At a pre-selected pressure, the fuel being tested was injected into the chamber by an electronically controlled high pressure injector via a common rail or accumulator system. The predetermined component of residual oxygen in the chamber, being dependent on the original constituents, could yield either an inert environment (for non-combustive fuel spray studies) or a range of environments supporting compression ignition (i.e. a range of oxygen concentrations including an equivalent atmospheric fresh charge). In this way, visual observations could be made of controlled compression-ignition combustion events. These events were also recorded in a high-speed pressure trace from the quartz pressure transducer within the chamber. A thermodynamic model was set up to determine the required fill pressure of each gas to be metered into the vessel. Testing up to 180bar was achieved and results showed that peak pressures were repeatable to within 4%. Up to 60 highquality image experiments were achieved in one day without significant fouling of the windows or degradation of the seals. A discrepancy of approximately 15% existed between predicted peak pressures and measured pressures (being lower). Several losses were known to cause this pressure shortfall, such as slight gas leakage from the exhaust valve, radiation losses through the windows and heat lost to, and reaction quenching at, the walls of the chamber. Recommendations for improvements to the CVCC included reducing the causes and rates of leakage and quantifying the impact of surface-area to volume ratio on losses at the internal surfaces.

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47

Bereterbide, France. "Recherche clinique et "double standard éthique" dans les pays du Sud : enjeu des processus de discussion dans les prises de décisions collectives et individuelles". Thesis, Paris 11, 2011. http://www.theses.fr/2011PA11T105.

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Nombre de « scandales éthiques » ont émaillé l’actualité de la recherche clinique dans les pays du Sud. Face à ce constat, il semble que les principes fondateurs de l’éthique de la recherche biomédicale admis et promulgués par les déclarations et les conférences de consensus internationales ne suffisent pas à protéger au Sud les volontaires participant à des essais cliniques. Nécessitant une adaptation hors du contexte qui a permis leur consolidation, bien que soit donné à voir à chaque nouveau scandale à quel point tout infléchissement des cadres normatifs peut être porteur de dérives inadmissibles, ces principes s’avèrent pour partie remis en question par la situation économique, sanitaire, sociétale des pays du Sud.Le concept de « double standard éthique » décrivant le double écueil auquel l’éthique de la recherche doit faire face, celle-ci s’avère captive d’une forme d’impérialisme des principes et des valeurs ou bien vouée au relativisme moral. La première alternative semble devoir conduire inexorablement à l’arrêt des recherches cliniques dans les pays ne permettant pas l’application stricte des normes qui les encadrent au Nord. La deuxième semble quant à elle mener à l’acceptation d’une réalisation irresponsable,dérégulée, d’essais cliniques aux finalités variables. Face à ce constat, se pose la question de savoir si cette alternative entre absolutisation de la norme et dérégulation peut être dépassée afin de penser une éthique de la recherche au Sud à la fois universelle et singulière.L’exploration de cette question permettra de redéfinir l’éthique comme processus de discussion et de priorisation des principes universels guidé par une compréhension de situations toujours singulières. De ce point de vue, l’adaptation des « conceptions internationalistes » de l’éthique de la recherche à la singularité des contextes apparaîtra non comme une nécessité externe, provoquée par un élément extérieur,mais comme un devoir inhérent à la nature même de la visée éthique. Plus encore, les questions posées par les contextes des pays du Sud à l’éthique de la recherche clinique serviront de révélateur en contribuant à montrer le bien fondé d’une remise encause des interprétations normatives de ses principes, au Nord y compris.7
Number of “ethical scandals” have punctuated the news of clinical research in developing countries. Given this fact, it seems that the founding principles of the ethics’ biomedical research accepted and promulgated by declarations and international conferences are not enough to protect the volunteers participating in clinical trials in South’s countries. Out of context enabling their strengthening, ethical principles require adaptation. If each new scandal shows how any shift in regulatory frameworks may carry unacceptable abuses, these principles are nevertheless found challenged by South’s economic, state of health and social organizations. The concept of “double standard ethics” describes the twin dangers to which the biomedical research ethics faces. Indeed, biomedical research is captive to a form of imperialism of principles and values, or devoted to moral relativism. The first alternative seems to lead inexorably to the cessation of clinical research in developing countries do not allow the strict application of the standards that govern the North. The second appears to lead to the acceptance of irresponsible and unregulated clinical trials.Given this situation, the question arises whether this alternative may be exceeded in order to assume a research ethics in the South at once universal and unique. The exploration of this issue will redefine ethics as a process of discussion and priorization of universal principles guided by an understanding of situations always singular. From this point of view, the adaptation of “internationalist conceptions” of research ethics to unique contexts appear not as an external necessity but as a duty inherent in the nature of the ethical aim. Moreover, questions asked by the contexts of the South’s countries to the ethics’ clinical research will serve as a contributing developer to show the merits of a challenge to normative interpretations of its principles, including in North’s countries

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48

Craft, Emalee, e Rachel Ogumbo. "Use of CONSORT Criteria for Reporting Randomized Controlled Trials in Pharmacy Journals". The University of Arizona, 2012. http://hdl.handle.net/10150/623596.

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Class of 2012 Abstract
Specific Aims: To explore whether publishing requirements for human-centered randomized control trials, particularly the CONSORT criteria, have any relationship to impact as measured by the Journal Citation Reports TM Impact Factor. Methods: A worksheet was used to evaluate a methodically selected list of journals, including types of articles published, requirements of authors for human-focused randomized control trials, JCR Impact Factor and other JCR metrics for each specific journal title. A worksheet was filled out for each journal by each member of the research team and answers combined for consensus. Group means and SDs were calculated and the Student’s t-Test applied to values for selected journals. Main Results: 50 candidate pharmacy journals were identified and 41 met the criteria for publishing human-centered randomized control trials. Journals were grouped according to whether they required CONSORT or had other reporting requirements for human RCTs, or had no requirements for such studies. Few (6; 15%) pharmacy journals required authors to use CONSORT; and additional 15 (37%) journals provided as least some author guidelines similar to CONSORT. Pharmacy journals using CONSORT or other guidelines had a higher average impact factor (3.5; SD = 1.5) than did journals without guidelines (2.4; SD = 0.9; p = 0.007). Conclusions: There appears to be a statistical difference in average JCR metrics between journals which require specific RCT guidelines and those which do not. The use of reporting guidelines, such as CONSORT, by pharmacy journals is associated with increased impact as represented by JCR influence measures.

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49

Gasa, Nolwazi Bright Khanyisile. "Cultural conceptions of research and informed consent". Thesis, 1999. http://hdl.handle.net/10413/5843.

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Abstract (sommario):

AIDS has had a negative impact on developing countries. Because most developing countries cannot afford the new antiretroviral drug therapies, it has been suggested that preventive vaccines might reduce the spread of the HIV/AIDS epidemic (Bloom, 1998). The clinical trials of AIDS vaccines do, however, present with complex ethical issues such as informed consent. Informed consent is primarily grounded on the Western principle of respect for individuals as autonomous agents. This may be at variance, however, with African societies' emphasis on the social embeddedness of the individual. The current study forms part of the HIVNET vaccine trials to be conducted in Hlabisa, in Northern Zululand, under the auspices of the South African Medical Research Council. The main aim of the study was to explore key informants' cultural conceptions of research and informed consent in order to facilitate community consultation and cultural sensitivity. Maximum variation sampling was used to select twenty-three key informants, who are in leadership positions within Hlabisa. An interview guide was used to facilitate narrative disclosure of cultural conceptions of research and informed consent. Perceptions of research, conceptions of the informed consent process, and projected motivations for why individuals agree to participate in studies were explored during interviews. Results suggest that members of the Hlabisa community have a limited understanding of the Western research process. Community education about research is therefore warranted. Informants indicated that community members would value the establishment of a relationship characterised by mutual respect for cultural differences between researchers and participants. This was perceived as likely to facilitate shared decision-making, and the reduction of the power differentials that exist between researchers and participants. While the involvement of key community leaders and family members was recommended by most informants, a few informants felt that participants could also make individual decisions about participation. The theoretical implications of the study are considered last.
Thesis (M.A.)-University of Natal, Pietermaritzburg, 1999.

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50

Rashad, A. M., Phipps Fiona E. MacVane e Melanie Haith-Cooper. "Obtaining Informed Consent in an Egyptian Research Study". 2004. http://hdl.handle.net/10454/6698.

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no
This article explores the concept of internationally acceptable codes of ethics within the context of an Egyptian nurse’s PhD studies. Theoretical work, including gaining ethical approval for the project, took place in the UK, while the data collection phase of the study was done in Egypt. This highlighted areas where the Arab Muslim interpretation of some ethical principles, especially around the issue of gaining informed consent, differed from that currently accepted in British research ethics. The authors argue that it may not be possible, or even desirable, to standardize codes of ethics globally in areas such as academic research. Ethical principles develop from a unique mix of culture and religion. It may be more important to develop cultural competence that includes the ability to understand and respect the way in which ethical principles are interpreted by various societies.

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Tesi sul tema "Consent in research"

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