Moodley, Keymanthri (2004-12)
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
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
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.
Please refer to this item in SUNScholar by using the following persistent URL: http://hdl.handle.net/10019.1/16065
﻿ Kling S. (2010)
Conflicts of interest (COI) arise when secondary interests, such as financial gain, influence professional judgement regarding a primary interest, such as patient welfare or research results. COI arise from a particular ...
﻿ Broekmann, Reginald J. (Reginald John) (Stellenbosch : Stellenbosch University, 2000-04)
ENGLISH ABSTRACT: This paper examines aspects of power within the physicianpatient
relationship. The historical development of the
physician-patient relationship is briefly reviewed and some of
the complexities of the ...
﻿ De Villiers, Suzanne (Stellenbosch : Stellenbosch University, 2002-04)
ENGLISH ABSTRACT: The implementation of eugenic policies reached its peak during the zo" century
when thousands of people with intellectual disabilities and other "undesirable
qualities" were involuntary sterilized. ...
﻿ Horn, Lynette Margaret (Stellenbosch : University of Stellenbosch, 2010-12)
Enkele etiese probleme rondom sterwe en dood
﻿ Van Deventer, Mike,1947- (Stellenbosch : Stellenbosch University, 1972)
From principles to virtues : a critical analysis of the principles of biomedical ethics, with special reference to end-of-life decisions
﻿ Van Zyl, Liezl L (Stellenbosch : Stellenbosch University, 1997)
﻿ Howarth, Graham Robert (Stellenbosch : Stellenbosch University, 1999)