Dissertations / Theses on the topic 'Medicine Research Moral and ethical aspects Australia'

Over the past few years, embryo research has been a widely discussed topic. New techniques such as embryo stem cell research or therapeutic cloning are considered by scientists to be very promising. Nevertheless, opponents of these experimentations warn against the commodification of human life forms and argue that the moral status of embryos should protect them from being destroyed purely for research.
Legislations on this topic have been enacted in most Western countries, though they are still much criticised. Is there an adequate way of regulating embryo research? Our argument suggests that consensus can only be procedurally obtained. That is, we believe that only legislative assemblies should have authority to take a position on this controversial topic, which is subject to moral disagreement, and as such, judges should only have a minor role.

Numerous ethical guidelines are referred to when medical research is conducted on human participants. These guidelines include the Nuremberg Code, the Declaration of Helsinki, and the International Ethical Guidelines for Biomedical Research Involving Human Subjects. From a Western viewpoint, these guidelines may seem like well-reasoned, universally applicable codes for conducting medical research on human subjects. Some of the guidelines, however, merely impose Western values on developing countries without giving adequate consideration to their worldviews. I explore the applicability of current codes and guidelines of ethics on medical research with human subjects to the Zulu of South Africa and the Kikuyu of Kenya. Through a study of African traditional religions and philosophy and the community mindset that flows out of them, I have gained insight into the limitations of current universal codes when applied to traditional Kikuyu and Zulu communities.

Thesis (DPhil)--University of Stellenbosch, 2004.
ENGLISH ABSTRACT: Human participant research raises a conflict between medical progress as a societal good and the protection of participants as an individual good. Prior to 1960 the discretionary authority for the protection of participants resided in the hands of individual investigators. However, a wave of research atrocities from Tuskegee in 1932 to the Beecher expose in 1966 stimulated a change to a principle based system of regulation. Research Ethics Committees (RECs) and Institutional Review Boards (IRBs) were henceforth charged with the responsibility of human participant protection. Since 1966, this system of research review was established internationally and at one institution in South Africa. In 1997, placebo-controlled HIV vertical transmission trials in a number of developing countries including South Africa raised unprecedented controversy in research ethics internationally and nationally. In 2000, the fraudulent breast cancer trials conducted by Dr Bezwoda at Baragwanath Hospital drew international attention to research ethics in South Africa. However, the events that called into question the efficiency of the system of ethical review most poignantly were the recent deaths of volunteers in research at centres of excellence in the United States. It was charged that if there were deficiencies in the research ethics review system in developed countries, these were more likely to be present in developing countries. Around the same time the Interim National Health Research Ethics Committee (INHREC) was established in South Africa to explore and regulate the ethical review system in South Africa. Cognisant of these issues, the current study was undertaken to establish the various structural, procedural and substantive ethical challenges facing justifiable and ethical review of research in South Africa. A combination of conceptualphilosophical reflection and empirical research was employed in this dissertation. The empirical work employed both quantitative and qualitative research methodology. The quantitative survey explored the composition of RECs reviewing clinical trials research in South Africa with an emphasis on committee composition and structure as well as the review process. The qualitative research was conducted using semi-structured interviews of ten REC Chairpersons in South Africa to explore complex substantive issues like informed consent, standards of care and participant remuneration, inter alia. While the review system in South Africa is functioning at a reasonable level, there is wide variation from one REC to the next. RECs are geographically distant and function in isolation without opportunity to communicate and share ideas. Amongst institutional RECs, there is a stark contrast between historically disadvantaged institutions and historically advantaged institutions. REC membership, ten years into democracy remains white male dominated. Community representation is inadequate. Most RECs are dominated by scientists and clinicians. The review process is widely variable with delays in review ranging from ten days to ten weeks. Procedural and bureaucratic demands impact on the ability of REC members to engage in debate on important substantive ethics issues like standards of care, informed consent and participant remuneration. Research ethics training and educational needs vary widely across the country. Serious attention must be paid to the way in which RECs are constituted in South Africa. Restructuring of RECs with a view to improving representation in terms of race, gender and religion must be prioritized. There is a need for community representation and non-scientific membership to be explored. RECs in South Africa need to revisit the question of whether they should be conducting both scientific and ethics review or ethics review alone. The review process requires a paradigm shift in emphasis from adverse event reporting to monitoring, from informed consent forms to a culturally relevant informed consent process. Aparadigm shift is indicated to shift the focus from informed consent to a more comprehensive review framework. Policies regarding standards of care and participant remuneration must be clarified and articulated. Although the role of RECs in human participant protection has been questioned, it is clear that in the vast majority of cases, they are fulfilling an important role. Their function could certainly be enhanced. This is being facilitated by training programs and an electronic newsletter. However, responsibility for human participant protection does not reside in the domain of the REC alone. A collective responsibility shared by researchers, institutions, research ethics committees, sponsors and participants is integral to human participant protection and the generation of new, valid and relevant scientific knowledge.
AFRIKAANSE OPSOMMING: Navorsing op menslike subjekte gee aanleiding tot ‘n konflik tussen mediese vooruitgang as ‘n voordeel vir die samelewing en die beskerming van deelnemers as iets waarby die individu direkte belang het. Voor 1960 het die diskresionêre gesag vir die beskerming van deelnemers by die individuele navorsers berus. ‘n Golf van navorsingsvergrype, van Tuskegee in 1932 tot die Beecher onthulling in 1966, het egter veranderinge in die rigting van ‘n stelsel van beginsel-gebaseerde regulasie gestimuleer. Navorsingsetiekkomitees (NEKs) en Institusionele Beoordelings- en toesigrade (IBRs) is gevolglik belas met die verantwoordelikheid om toe te sien dat mense wat deelneem, sover moontlik beskerm word. Sedert 1966 is hierdie stelsel van navorsingshersiening en -toesig internasionaal tot stand gebring – ook, aanvanklik, by een instansie in Suid-Afrika. In 1997 het plasebo-beheerde HIV-vertikale oordrag-proewe in ‘n aantal ontwikkelende lande, insluitend Suid-Afrika, tot ongekende kontroversie op die terrein van navorsingsetiek aanleiding gee, internasionaal en nasionaal. In 2000 het die bedrog met borskankerproewe, uitgevoer deur dr Bezwoda by Baragwanath Hospitaal, internasionale aandag op navorsing in Suid-Afrika gevestig. Hierdie gebeure het egter die effektiwiteit van die stelsel van etiese toesig in Suid-Afrika en elders in die wêreld bevraagteken. Die mees kommerwekkende onlangse insident was die dood van navorsingsvrywilligers by sentra van uitmuntendheid in die Verenigde State. Daar is beweer dat as daar tekortkominge in die navorsingsetiektoesigsisteem in ontwikkelende lande is, daar ‘n groter moontlikheid bestaan dat dit ook (en moontlik meer) in ontwikkelende lande voorkom. Ongeveer dieselfde tyd is die Interim Nasionale Gesondheidsnavorsings-etiekkomitee (INGNEK) [Interim National HealthResearch Ethics Committee (INHREC)] in Suid-Afrika gestig om die etiekoorsigstelsel in Suid-Afrika te ondersoek en te reguleer. Met dit in gedagte is die huidige studie onderneem om die verskillende strukturele-, prosedurele- en substantiewe etiese uitdagings wat regverdigbare en etiese oorsig van en toesig oor navorsing in Suid-Afrika in die gesig staar, vas te stel. Daar is van ‘n kombinasie van konseptuele, filosofiese refleksie en empiriese navorsing in hierdie proefskrif gebruik gemaak. Die empiriese werk maak gebruik van sowel kwantitatiewe as kwalitatiewe navorsingsmetodes. Die kwantitatiewe opname bestudeer die samestelling van NEKs wat toesig hou oor kliniese proewe in Suid-Afrika, met die klem op komiteesamestelling, -struktuur en die toesigproses. Die kwalitatiewe navorsing is gedoen met behulp van van semi-gestruktureerde onderhoude van tien NEK-voorsitters in Suid-Afrika om die komplekse substantiewe aspekte, soos onder andere ingeligte toestemming, standaard van versorging en deelnemervergoeding, te ondersoek. Terwyl die etiek-toesigstelsel in Suid-Afriks op ‘n redelike vlak funksioneer, is daar ‘n groot verskil tussen verskillende NEKs. NEKs is geografies verspreid en funksioneer dikwels in isolasie sonder ‘n geleentheid om te kommunikeer en idees te deel. Ten opsigte van die institusionele NEKs bestaan daar ‘n duidelike kontras tussen histories benadeelde instansies en histories bevoordeelde instansies. NEK-lidmaatskap word, tien jaar na demokrasie, steeds gedomineer deur blanke mans. Gemeenskapsverteenwoordiging is onvoldoende. Die meerderheid NEKs word gedomineer deur wetenskaplikes en klinici. Die toesig- en hersieningsprosesse in die verskillende komitees verskil grootliks, met vertragings wat wissel van 10 dae to 10 weke. Prosedurele- en burokratiese vereistes het ‘n impak op die vermoëns van NEK-lede om by debatte oor belangrike substantiewe etiese aangeleenthede betrokke te raak, soos byvoorbeeld die standaard van versorging, ingeligte toestemming en deelnemervergoeding. Opleiding en opvoedkundige behoeftes verskil wyd oor die land.Ernstige aandag moet geskenk word aan die wyse waarop NEKs in Suid-Afrika saamgestel is. Herstrukturering van NEKs met ‘n visie op verbeterde verteenwoordiging in terme van ras, geslag en geloof is ‘n prioriteitsvereiste. Gemeenskapsverteenwoordiging en lidmaatskap van nie-wetenskaplikes moet verder ondersoek word. NEKs in Suid-Afrika moet die vraag of hulle sowel wetenskaplike- as etiektoesig moet uitvoer, of sl slégs etiektoesig, opnuut ondersoek. Die nasiensproses vereis ‘n paradigmaskuif, vanaf ‘n klem op rapportering van gebeurtenisse, na monitering van ingeligte toestemmingsvorms sowel as na ‘n kultureel toepaslike ingeligte toestemmingsproses. ’n Paradigmaskuif is noodsaaklik ten einde die fokus te verskuif vanaf ingeligte toestemming na ‘n meer omvattende toesig- en nasiensraamwerk. Beleid rakende standaard van versorging en deelnemervergoeding moet verduidelik en geartikuleer word. Alhoewel die rol van NEKs in die beskerming van menslike deelnemers aan navorsing bevraagteken word, is dit duidelik dat NEKs in die meerderheid van gevalle wel ‘n belangrike rol vervul. Hul funksie kan natuurlik uitgebrei word. Dit sal gefasiliteer word deur opleidingsprogramme en ‘n elektroniese nuusbrief. Verantwoordelikheid vir die beskerming van mense wat deelneem aan navorsing berus egter nie uitsluitlik by NEKs nie. ‘n Kollektiewe verantwoordelikheid, gedeel deur navorsers, instellings, navorsingsetiekkomitees, borge en deelnemers is ‘n integrale vereiste vir hierdie beskerming sowel as vir die verwerwing van nuwe, geldige en relevante wetenskaplike kennis.

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.

In this thesis, the author studies the ethical and legal aspects of research conducted on stored tissue samples of deceased persons in North America.
The first part of this thesis presents an overview of what constitutes human tissues and how are they used in research. The author describes the process in which human tissues are acquired and stored by health facilities, their utility for scientific research, and currently used techniques.
The second part is dedicated to the analysis of the current normative framework associated with research involving human tissue samples in North America. The author underlines the presence of two different normative regimes depending on whether the human tissues were removed before or after death. Finally, the author examines international documents in order to evaluate whether or not they can provide guidance to North American national legislation.
The third part evaluates the normative limitations associated with the use of stored tissue samples of deceased persons for research. The author considers that these limitations are related to the presence of conflicting interests, the difficulties in establishing rights over human tissues, the difficulties of establishing the rights of the dead, and the limitations of the theory of informed consent with regards to stored tissue samples.
The last part of this thesis suggests that stored human tissues should be interpreted as if they were part of an individual's medical record. After presenting some of the philosophical arguments in favour of such an interpretation, the author underlines the presence of legal precedents supporting the "tissue as information" model. The author finally examines the legal implications and the potential limitations of this proposal.

Dissertation in compliance with the requirements for the Master's Degree in Technology: Journalism, Durban University of Technology, 2013.
Ethical behaviour by investigators is the cornerstone of scientific research. Recognizing, declaring and avoiding a conflict of interest are key responsibilities for biomedical researchers, particularly since commercial enterprises, such as pharmaceutical companies, have become major funding sources of research. Proactive disclosure of researchers' financial relationships is now a requirement for publication in most scientific journals. The question that arises is whether this same increased scrutiny of financial disclosure and potential for conflict of interest has extended to the mainstream press in Canada. A content analysis of biomedical research articles that appeared in Canadian daily newspapers from 2001 to 2008 showed that 82 per cent of the articles failed to identify the financial connection that existed between the researcher(s) and the commercial funder, and nearly half of the articles did not even identify the commercial funding source of the research. A text analysis showed that 94 per cent of the articles were positive about the drug/device cited by the research, and positive, optimistic words such as “breakthrough”, “significant”, “hope” and “promising” were often used in the news articles. Reporters frequently frame biomedical research articles using a battle-like template that describes a fight between good and evil. Another common approach was to frame the article as a message of hope for the future. A genre analysis showed that the genre of medical research news articles published in newspapers is highly dissimilar to the genre of medical research articles published in scientific journals. It is likely these two genres have been constructed to appeal to very different target audiences. The study results show overwhelmingly that readers are not provided with key information about potential financial conflicts of interest involving the researchers and the commercial sources of funding for the research. Such lack of transparency thwarts the reader’s ability to reach informed conclusions about whether or not the research has been either explicitly or implicitly influenced by the researcher’s potential conflict.

In the history of public health vaccines have proven to be among the most effective disease prevention tools. It is clear that in the fight against HIV that new and powerful preventive technology such as a vaccine is badly needed. Ethically, however the processes of developing a vaccine against HIV have been distinctly different from that of any previous pharmaceutical products. HIV vaccine trials can be ethically complex for a number of reasons. In 2004 the HIV I AIDS Vaccine Ethics Group undertook a research initiative that aimed to collect data from various South African stake holders of HIV vaccine trials to ascertain what they perceived as the ethical challenges related to HIV vaccine trials. A quantitative content analysis on the data from 31 semistructured interviews revealed that the ethical issue listed spontaneously by most of the respondents was that of informed consent. Further probing and discussion on informed consent identified a number of sub issues which the respondents thought would pose important challenges to HIV vaccine trials in the South African context. This study undertook to do a more in-depth qualitative analysis of the data to ascertain whether the challenges and concerns the stakeholders have are consistent with or different to those already identified in the literature and ethical guidelines on informed consent in medical research. What variables may be impacting on the position stakeholders take was also of interest. Results indicated that many concerns relating to the substantive and procedural elements of informed consent were consistent with those debated in the literature. These issues related to first person consent, the voluntariness of participants' consent, practicing cultural sensitivity, dealing with language issues, promoting and assessing understanding of material disclosed, issues around the vulnerability of .. participants, children and adolescents' capacity to consent and the role of the media. More specific to the South African context, stakeholders were concerned about the legal framework under which the trials take place, the general lack of education and training about HIV vaccine trials, a lack of communication and coordination between stakeholder groups, and the historical influences of apartheid on black South African participants' capacity to consent. The main variables that appeared to impact on the position stakeholders took related to the role the stakeholders play within the trials, the philosophical position underpinning their ethical viewpoints, stakeholders' understanding of vulnerability and capacity to consent, and how they view the universality or relativity of ethical issues.
Thesis (M.A.)-University of KwaZulu-Natal, Pietermaritzburg, 2008.

Bibliography: p. 379-394.
xi, 394 p. ; 30 cm.
Title page, contents and abstract only. The complete thesis in print form is available from the University Library.
Thesis (Ph.D.)--University of Adelaide, Dept. of Public Health, 1988

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.

Paediatric clinical trials are crucial to ensure safety and efficacy of medicines in children. This study explored parents’ perceptions in Gaborone, Botswana, regarding children’s participation in clinical trials. One hundred participants completed a self-administered questionnaire. The results showed that 93% of the participants had a good knowledge of clinical trials; 74% thought that children would benefit from clinical trial participation; 63% would not enrol their children in clinical trials; 55% suggested that children should only be enrolled once they have reached the age of 18 years; and 71% reported that only children with an active disease should be enrolled. A large proportion (82%) reported that children’s participation should be voluntary, while joint parental consent was supported by 93% of responders. Regarding children’s assent 91% deemed respect for children’s assent essential, although 52% thought that children’s assent should not override the parental decision. There was a statistically significant correlation between finding clinical trials in general important and children’s participation in clinical trials (p=0.008, Fisher’s Exact Test), as well as the need for individual consent p<0.0001, Chi-Square). There was also a statistically significantly association between respondents, who would allow their children’s participation in clinical trials and who would encourage their family members and friends’ participation in clinical trials (p=0.0001, Chi-Square). An overwhelming 94% advocated for special regulations in Botswana to govern paediatric clinical trials. Almost all participants (99%) explicitly expressed the opinion that there should be global regulations for paediatric clinical trials.
Thesis (M.Soc.Sc.)-University of KwaZulu-Natal, Pietermaritzburg, 2012.

In received biomedical research wisdom, randomized controlled trials (RCTs) revolutionized post-World War II health research. By blending statistical analysis with the testing of new procedures and interventions, RCTs have enabled investigators to circumvent the influence of a variety of biases on research outcomes so that the effectiveness of interventions can be ascertained with high levels of confidence. While extant literature addresses the epistemological history of RCTs from the scientific community's perspective, the history of public health would be significantly enhanced by a broader, more detailed consideration of social dimensions of RCTs. Similarly, while a plethora of bioethical literature has been written on RCTs and human subject research, we currently lack a historical analysis that considers ethical shifts over time as they relate to RCTs. This dissertation describes the key political, economic, intellectual, and cultural events in the history of RCTs from their origins to 1980 and analyzes how these events influenced RCT norms. I describe the barriers to the implementation of RCTs throughout the late nineteenth and early twentieth centuries--namely the dominance of individualistic ideologies in clinical research and an absence of governmental regulatory or funding structures to require or support RCTs. I then describe how large, multi-site RCTs grew out of a Cold War political environment that supported public investment in scientific structures; how post-WWII research regulations influenced the proliferation of RCTS in the US; how politics and regulations influenced shifts in the demographics of RCT research subjects; and how ethical norms changed over time through interaction with broader ethical shifts and governmental regulations.

This dissertation examines the legal position relating to the participation of children in research, especially in HIV preventive clinical research in South Africa. HIV/AIDS presents a real threat to humanity and particularly to the welfare of children. The participation of children in this type of trials is therefore vital. Children, as vulnerable participants, must also be protected from harm resulting from research. The study also considers the nature of HIV preventive clinical research, pointing to the inconsistencies in the legislation governing children’s participation in HIV preventive vaccine trials. The dissertation concludes that the question of the participation of children in HIV preventive clinical research poses many challenges, as the position in the South African law and relevant ethical guidelines are inconsistent and contradictory. The study recommends in the final instance that the relevant statutory provisions and ethical guidelines be harmonised in order to clear up the inconsistencies.
Jurisprudence
LL.M. (Legal Aspects of HIV/AIDS)