1,721,033 research outputs found
Microbicide research in developing countries: have we given the ethical concerns due consideration?
Full text linkAbstract Background HIV prevention research has been fraught with ethical concerns since its inception. These concerns were highlighted during HIV vaccine research and have been elaborated in microbicide research. A host of unique ethical concerns pervade the microbicide research process from trial design to post-trial microbicide availability. Given the urgency of research and development in the face of the devastating HIV pandemic, these ethical concerns represent an enormous challenge for investigators, sponsors and Research Ethics Committees (RECs) both locally and internationally. Discussion Ethical concerns relating to safety in microbicide research are a major international concern. However, in the urgency to develop a medically efficacious microbicide, some of these concerns may not have been anticipated. In the risk-benefit assessment of research protocols, both medical and psycho-social risk must be considered. In this paper four main areas that have a potential for medical and/or psycho-social harm are examined. Male partner involvement is controversial in the setting of covert use of microbicides. However, given the long-term exposure of men to experimental products, this may be methodologically, ethically and legally important. Covert use of microbicides may impact negatively on relationship dynamics leading to psychosocial harm to varying extents. The unexpectedly high rates of pregnancy during clinical trials raise important methodological and ethical concerns. Enrollment of adolescents without parental consent generates ethical and legal concerns that must be carefully considered by RECs and trial sites. Finally, paradoxical outcomes in recent trials internationally have advanced the debate on the nature of informed consent and responsibility of researchers to participants who become HIV positive during or after trials. Summary Phase 3 microbicide trials are an undisputed research and ethical priority in developing countries. However, such trials must be conducted with attention to both methodological and ethical detail. It is imperative that guidelines are formulated to ensure that high ethical standards are maintained despite the scientific urgency of microbicide development. Given the controversy raised by emergent ethical issues during the course of microbicide development, it is important that international consensus is reached amongst the various ethics and regulatory agencies in developing and developed countries alike.</p
HIV Vaccine Trial participation in the Third World : an ethical assessment
Full text linkThesis (M.Phil.) -- University of Stellenbosch, 1999.ENGLISH SUMMARY: This essay examines the issue of trial participation in the proposed my Vaccine Trials in
South Arica. It is set against the backdrop of ethical issues relating to research in the
Third World in general.
Trial participation is examined in the context of the ethical tension that exists between
international ethical research standards based on Liberal Individualism and local
standards of care and cultural norms in the Third World. Two areas of conflict are
inherent here: universality versus particularity on the one hand and individualism versus
communitarianism, on the other.
The Tuskegee Syphilis Study as well as the HIV Vertical Transmission Trials are used as
a point of departure to set the stage for the controversy surrounding the proposed HIV Vaccine Trials.
The important concepts of informed consent, the risk-benefit ratio and fair treatment of
trial participants are framed within the Four Principle Approach of autonomy,
beneficence, non-maleficence and justice. These principles form the cornerstone of the
Declaration of Helsinki. This Western ethical guideline - grounded in universality - has
become the mantra of all liberal democracies the world over and is chanted slavishly by
the international research community. It bears the hallmark of liberal individualism with
its mandate that "the concern for the interest of the individual must always prevail over
the interests of science and society". Followed to its logical conclusion, any
infringements of the moral interests of trial participants must be viewed using a subject-oriented
approach. Such an approach sees the trial participant as being of paramount
importance and views research as "highly desirable but morally optional". Clearly, this would mean the end of the road for medical research, especially in the Third
World, where a truly subject oriented approach would render research tantamount to
exploitation of vulnerable, educationally disadvantaged persons.
In Africa, in traditional, rural communities, a moderate form of communitarianism
referred to as "Ubuntu" or "communalism" is still prevalent. In such communities, the
concept of personhood is embedded in the community or society. In these communities, a
balancing approach, in which infringements on the rights of trial participants are
permissible in the name of science or society, provided the subject is not placed at
significant risk, would be acceptable. However, liberal individualism is making inroads
here too. As such, the ethical tension between liberal individualism and
communitarianism, which is unavoidable in research settings, is growing.
This essay highlights many internal contradictions in liberal individualism - especially
where research ethics is concerned in Third World countries. One of the outcomes of
such contradiction is the attempt by the World Medical Association to amend the
Declaration of Helsinki - in the name of ethical relativism: different standards for
different countries or cultures.
Surely, such liberal individualism cannot be seen as the "endpoint of mankind's
ideological evolution" as Fukuyama phrases it, nor can it be the final solution to the
problems of the world and, as such, "the end of history".
In the context of the HIV Vaccine Trials, individual good clashes with societal good,
universality with particularity and ultimately, modernism with postmodernism.
In Western cultures, the individual enjoys priority; in other cultures, society is more
important - somewhere in between, we need to find common ground which can be
incorporated into a balancing approach with minimal risk to the individual when
infringement of rights is unavoidable.Maste
Teaching Medical Ethics to Undergraduate Students in Post-Apartheid South Africa, 2003-2006
No full textThe apartheid ideology in South Africa had a pervasive influence on all levels of education including medical undergraduate training. The role of the health sector in human rights abuses during the apartheid era was highlighted in 1997 during the Truth and Reconciliation Commission hearings. The Health Professions Council of South Africa (HPCSA) subsequently realised the importance of medical ethics education and encouraged the introduction of such teaching in all medical schools in the country. Curricular reform at the University of Stellenbosch in 1999 presented an unparalleled opportunity to formally introduce ethics teaching to undergraduate students. This paper outlines the introduction of a medical ethics programme at the Faculty of Health Sciences from 2003 to 2006, with special emphasis on the challenges encountered. It remains one of the most comprehensive undergraduate medical ethics programmes in South Africa. However, there is scope for expanding the curricular time allocated to medical ethics. Integrating the curriculum both horizontally and vertically is imperative. Implementing a core curriculum for all medical schools in South Africa would significantly enhance the goals of medical education in the country
Medical research on human subjects in South Africa : a critical assessment of the work of research ethics committees
Full text linkThesis (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.Doctora
Family practice ethics : postmodern ethics for a postmodern discipline?
No full textCITATION: Moodley, K. 2000. Family practice ethics: Postmodern ethics for a postmodern discipline? South African Family Practice, 22(2): 5-9.The original publication is available at http://www.safpj.co.zaThis paper is aimed at describing an ethics of Family Practice. ln order to achieve this, universal ethical theories and the four principles of ethics - autonomy, beneficence, non-maleficence and justice - are placed in perspective. The concepts of modernism and postmodernism are also introduced and explored.
The principles of Family Medicine are examined within the context of postmodernism and a parallel is drawn. In keeping with this concept, the revival of virtue ethics is highlighted. In conclusion, a practically relevant approach to ethics is proposed as an ethical model for Family Practice, in which elements of pre-modern, modern and postmodern ethics are combined to complement one another and to form a relevant framework for the resolution of ethical dilemmas in family practice.http://www.safpj.co.za/index.php/safpj/article/view/2182Publisher's versio
An Investigators perspective on litigation in clinical trial research.
No full textPlease help us populate SUNScholar with the post print version of this article. It can be e-mailed to: [email protected] vir Bio-etiek (Tygerberg
Physician-assisted suicide : an oxymoron?
Full text linkThe original publication is available at http://www.samj.org.zaCITATION: Moodley, K. 2000. Physician-assisted suicide: An oxymoron? South African Medical Journal, 90(7):657.No abstract availablePublisher’s versio
The ethics behind mandatory COVID-19 vaccination post-Omicron: The South African context.
Full text linkThe legitimacy of mandatory vaccine policies is underscored by a public health ethics framework based on the principles of limited autonomy, social justice and the common good. Ideally, vaccine uptake ought to occur on a voluntary basis as an act of solidarity to ensure that everyone is protected. Given that the altruistic approach has failed and vaccine uptake remains sub-optimal in South Africa, in this paper, I argue for vaccine mandates, in a post-Omicron context. This viewpoint is substantiated by several considerations. Healthcare workers are fatigued after 2 years of treating COVID-19 and many are still treating patients with post-viral syndromes, mental health conditions and cardiovascular complications. Health systems remain under pressure as people with non-COVID diseases, neglected during the pandemic, are also now presenting to medical practices and hospitals. Although South Africa has emerged from a relatively less severe fourth wave of COVID-19, there have been many deaths. Vaccine and natural immunity in a relatively young general population has been advantageous. However, the country has a high prevalence of HIV and those who are untreated may not be able to clear the coronavirus easily. Similarly chronic illnesses place many at risk for severe disease from COVID variants, especially if unvaccinated. The future is shrouded in uncertainty. The next variant could be similar to or less severe than Omicron, yet still impact negatively on health systems, education and the economy. Physical distancing is not ideal in many low socio-economic settings, making vaccines an importantcomponent of our prevention toolbox. Our safest option now is to ensure that as many South Africans as possible are vaccinated and receive boosters. Vaccine mandates work to achieve this end.Significance:The legitimacy of COVID-19 vaccine mandates post-Omicron is explored from an ethical perspective, given that the fifth wave remains unpredictable in South Africa – a country with a high prevalence of HIV, vulnerable unvaccinated adults and children, and fragile public health systems. The emergence of new variants is uncertain. However, vaccines are central to an appropriate response to protect public health, health systems and the economy
The fabricius decision on the Stransham-Ford case – an enlightened step in the right direction
Full text linkCITATION: Moodley, K. 2015. The fabricius decision on the Stransham-Ford case – an enlightened step in the right direction. South African Medical Journal, 105(6):434-435, doi:10.7196/SAMJ.9790.The original publication is available at http://www.samj.org.zaMany diseases are associated with incredible pain and suffering. Others impair function and independence to the extent that human dignity is eroded. In many instances the natural history of such conditions often leads to death within a reasonable period of time. In some cases, protracted ill health, pain, suffering and indignity ensue. Such circumstances have since time immemorial triggered the debate on euthanasia – a debate on what it means to have a good death. Acting compassionately, many South African doctors have, to some extent, either passively or actively assisted patients in achieving a good death.http://www.samj.org.za/index.php/samj/article/view/9790Publisher's versio
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