Aim: To determine the resources and needs of local Ethics Review Committees in South Western Nigeria. Method: This is a questionnaire-based descriptive study, where data was collected from the chair and administrators of eight Ethics Review Committees (ERCs) in South Western Nigeria. Findings: This study found that six of the ERCs reviewed were established 5 years ago and 75% of them were registered with NHREC. Of the ERCs reviewed, 75% are aware of the national ethics code (NHREC code). The majority of these ERCs (75%) had professionals, including doctors and scientists, as well as laypersons and nonscientists as members. Meetings were held once a month and when needed for 37.5% of the committees, while 25% of the ERCs usually meet every 2 months. Only a third (37.5%) of the ERCs pay their members. The majority (87.5%) of the ERCs have standard operating procedures (SOPs) and review an average of 6–10 or 10 protocols per month. Most of the ERCs (87.5%) need research ethics training regarding risk-benefit assessment, scientific design and HIV vaccine trials. Half of the ERCs reviewed have funding and financial support and 50% charge a fee for reviewed protocols. All the ERCs have computers, office space and stationery, while 50% lack access to a library. None of the committees studied have a bank account and facsimile, while 50% do not have internet access, telephone and photocopy machines Outcome: The majority of ERCs in South Western Nigeria have an adequate number of members, are familiar with international ethics guidelines and are registered with the NHREC. They also have adequate physical resources, but lack internet access and a library. Ongoing training of members is a challenge, as well as providing training programmes for new members and monitoring of research. / Thesis (M.Soc.Sc.)-University of KwaZulu-Natal, Pietermaritzburg, 2011.

Thesis (Psy. D.)--Wheaton College Graduate School, 2005. / Abstract. Includes bibliographical references (leaves 46-48).

Thesis (Psy. D.)--Wheaton College Graduate School, 2005. / Abstract. Includes bibliographical references (leaves 46-48).

<p>We now live in an era of experts on virtually everything, among which we have professional medical ethicists, who gained prominence in the late 60s due to dramatic advances in medical technology. Before then, medical ethics issues were not thought as separable from the warp and woof of the everyday life. Medical technology’s advancement cascades legions of moral problems in medicine and biomedical research. Series of innovative interventions in medicine raise throngs of ethical questions. In most cases that have to do with issues of life and death, there are perceived moral conflicts. Due to this swath of problematic issues that need solutions, some apologists favour medical ethics experts as fit for the job, while critics argue that no one has the knowledge or skill for dealing with moral quandaries because objective truth is not feasible in ethics and moral judgment is relative to cultures, beliefs and values. The necessity for medical ethicists to take active role in Medical Ethics Debates, either in Committees at the institutional level, or at any other decision-making mechanisms is justified in this thesis. In addition to this, the thesis also justifies medical ethicists’ role as expert consultants to clinicians and individuals alike This justification is based on complex moral problems accentuated by medical technology, which are far from being easily solved through mere appeal to individual reason, but rather by involving medical ethicists based on their specialized knowledge and high level understanding of research and practice. Although critics question the authority with which experts speak on these issues, nevertheless, the thesis unravels the roles, functions, significance and components of expert’s expertise that separate him/her from the crowd. Arguments are critically analysed and medical ethicists’ limits and professional flaws are addressed, with a view to establishing a virile foundation for the profession of medical ethics.</p>

We now live in an era of experts on virtually everything, among which we have professional medical ethicists, who gained prominence in the late 60s due to dramatic advances in medical technology. Before then, medical ethics issues were not thought as separable from the warp and woof of the everyday life. Medical technology’s advancement cascades legions of moral problems in medicine and biomedical research. Series of innovative interventions in medicine raise throngs of ethical questions. In most cases that have to do with issues of life and death, there are perceived moral conflicts. Due to this swath of problematic issues that need solutions, some apologists favour medical ethics experts as fit for the job, while critics argue that no one has the knowledge or skill for dealing with moral quandaries because objective truth is not feasible in ethics and moral judgment is relative to cultures, beliefs and values. The necessity for medical ethicists to take active role in Medical Ethics Debates, either in Committees at the institutional level, or at any other decision-making mechanisms is justified in this thesis. In addition to this, the thesis also justifies medical ethicists’ role as expert consultants to clinicians and individuals alike This justification is based on complex moral problems accentuated by medical technology, which are far from being easily solved through mere appeal to individual reason, but rather by involving medical ethicists based on their specialized knowledge and high level understanding of research and practice. Although critics question the authority with which experts speak on these issues, nevertheless, the thesis unravels the roles, functions, significance and components of expert’s expertise that separate him/her from the crowd. Arguments are critically analysed and medical ethicists’ limits and professional flaws are addressed, with a view to establishing a virile foundation for the profession of medical ethics.

The Council of Australian Therapeutic Advisory Groups (CATAG) (2013) define a Pharmaceutical and Therapeutics Committee (PTC) as a ‘multi-disciplinary team committee with a commitment to the overall governance of the medicines management system in health service organizations to ensure the judicious, appropriate, safe, effective and cost-effective use of medicines’. The multi-disciplinary team includes the health care providers, who are actively participating in the health care systems, such as doctors, pharmacists, nurses, administrators, finance officers, quality improvement managers and other staff members who participate in the medicine use processes according to their knowledge and skills. The major role of this committee is to evaluate and promote rational drug use by health care providers and consumers. In addition, this committee is responsible for developing systems and strategies to prevent adverse medicine reactions and medication errors, enhance rational prescribing and dispensing, provide educational activities and ensure the use of quality and cost-effective medicines. This is a cross-sectional study that was aimed at exploring the structure, activities and functions of public sector institutional Pharmaceutical and Therapeutics Committees (PTC) in the Eastern Cape (EC) Province in South Africa (SA). The primary objectives of the study were to (i) investigate and describe the structure, functions and the activities of the institutional PTCs, and (ii) explore and describe the perception of PTC secretariats on the functionality of the institutional PTCs. A purpose-designed questionnaire including both quantitative and qualitative aspects adapted from other international studies was piloted prior to being used for data collection. The secretariats of the institutional PTCs were requested to complete the questionnaire. Data were analysed using descriptive statistics for the quantitative aspects and thematic analysis for the qualitative component of the questionnaire. Data collection commenced after approval by the relevant ethics committees had been granted. The findings of the study reflected that the majority of the PTCs in the EC province, SA are district/sub-district PTCs which are a cluster of a number of health care institutions in close proximity. The PTC members were appointed by the executive authority as recommended by the literature and other guiding documents. As expected the nurses were dominant as the members of the PTCs in these district/sub-district PTCs. The secretariats were the pharmacists where pharmacists were available and chairperson were doctors. These findings correspond to the recommendations by the National Department of Health PTC policy (2015) and the studies conducted in other countries. A number of PTCs had sub-committees formed e.g. ABC analysis review committee, medicine utilization evaluation (MUE) committee and pharmacovigilance committee to optimise their functionality. Out of 15 PTCs only five PTCs with sub-committees reported functions and interventions, establishment of policies and SOPs. The rest had no outcomes or interventions reported. Poor production of policies and SOPs was observed which differs from other countries’ PTCs. The focus of sub-committees in other countries is the development of formulary and policies related to medicine use. These findings pose a question regarding the functionality and effectiveness of the existing institutional PTCs in the province. In addition, the basic documents that are required to run the PTC were unavailable in a number of PTCs. Barriers to the functionality of PTCs were reported i) Lack of pharmacists and training in PTCs. ii) The rural nature of the EC province and iii) Unavailability of resources including lack of re-imbursement of personal costs. These findings reveal that budget allocation for institutional PTCs is crucial for their functionality. It can be concluded that in the EC province the institutional PTCs which are active and effective are low in number and do not cover all geographical areas. Secondly there is a need for training and educating the PTC members on the role of the PTC members, role of sub-committees, development of policies, SOPs and the basic documents for the functionality of the committee. It is also important that during training the monitoring and evaluation of the effectiveness of the committee is emphasised. Therefore, the choice of the PTC objectives should be measurable as they can assist as indicators of effectiveness. Support by the executive authority has been observed.

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.