Thesis (M. Med. Sc.)--University of Hong Kong, 2002. / Includes bibliographical references (leaves 55-64).

Thesis (M.Med.Sc.)--University of Hong Kong, 2002. / Includes bibliographical references (leaves 55-64). Also available in print.

Thesis (MPH)--University of Limpopo, 2010. / Background The National Health Research Ethics Council (NHREC) of South Africa (SA) is mandated to oversee health research ethics activities within the country. The oversight role is achieved through registration and auditing of Health Research Ethics committees (RECs). This study indicates that 22 RECs are registered with the NHREC. Purpose This study examines compliance levels of registered RECs with the SA DOH national health research ethics guidelines regarding composition and operational procedures as well as highlight commonalities and differences. Methods Secondary data of 22 RECs registered with NHREC were used to examine the level of compliance related to composition and operational procedures disaggregated by REC. Data were processed using Statistical Package for Social Scientists (SPSS). Categories of systematic compliance, non-systematic compliance and non-compliance were used to determine RECs compliance levels with the standards specified in the DOH national ethics guidelines in research. Results Registered RECs in South Africa have an average membership of 16 ranging from 6 to 35. The RECs membership on gender has a 6% marginal difference and is dominated (68%) by scientists or clinicians. Majority (82%) of RECs have lay persons and 77% legal representatives. Eighty six percent of RECs xvi complied with operational procedures as stipulated by DOH national health research ethics guidelines. Conclusions Most RECs in SA registered with NHREC have a functional structure and are well organized. However, RECs demonstrated a non-systematic compliance with composition and procedures of DOH national guidelines. Most RECs based at public hospitals, government department and private organizations experienced high variations. Disparities related to gender, professional identity, legal and lay representations are noticeable and could be easily addressed.

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).

BACKGROUND: Little research has been conducted to observe the impact that rural settings have on the structure and function of hospital ethics committees. Additionally, studies need to focus on ethics committees, as it is often the body which protects the values of the community as globalization increases. The purpose of this study is to provide an overview of ethics committees in rural hospitals in East Tennessee. METHODS: From a list of fifteen hospitals in East Tennessee, eleven hospitals in communities of 15,000 people or less were contacted, ten of which had functioning ethics committees. Phone calls were made to identify members of the ethics committee and interviews were set up with nine of the hospitals. A structured interview format was used to address the range of topics. Hospital size ranged from 6 to 230 beds. RESULTS: The most unique trait afforded to small hospital ethics committees was their ability to communicate effectively and efficiently due to their small size. The culture of the area subtly impacted the type of issues the committees faced as did the hospital network affiliation. CONCLUSIONS: While connection to a network provides abundant resources, small hospital size reduces the inefficiency created by the bureaucracy of larger hospitals and enhances communication. Ethics committees in rural hospitals are variably effective and contain a level of organization comparable to that of larger hospitals.

Previous research has noted that members of research ethics committees are unclear about the extent of their roles. In this study, research amongst members of independent ethics committees (IECs) about how the ‘expert’ and ‘lay’ roles are understood and operationalized offers an explanation for this lack of clarity. IECs were selected for study because they have only addressed one type of research (Phase 1 ‘healthy volunteer’ studies) and this limited remit suggested that it would be in such committees that the member roles would have become most pronounced. Drawing on findings from the sociology of professions and employing a phenomenological approach to understanding, 20 semi-structured interviews with both expert and lay members of these committees revealed that a number of members were not only unclear about the roles, but unclear too whether they, or certain of their colleagues, were in which membership category. Notwithstanding this fact, and paradoxically, the ‘expert’ designation was seen as granting its members a privileged position on the committees. The expert member was seen to be either a medically qualified member or one tightly associated with the medical model. Such a repository of expertise being with the medical model privileges this model in ethics review such that other matters formally to be scrutinized by ethics committees become marginalised. Participant safety was the prime concern of the ethics review for IEC members. This relegated other matters including the adequacy of the insurance arrangements, the readability of the consent forms, the fairness of the inclusion criteria, and so forth, into areas of lesser concern. That this occurs though when the science, the safety and the methodology of the trials are already – separately - subject to an independent analysis by a body of experts, whose statutory role is to concern itself with these issues such that no trial may occur without their sanction, is of significance. IEC members were cognizant of this duplication of role but unable to resolve it. The situation could be accounted for as due to capture by the medical model and a cognitive dissonant process. Members’ training and education were found to have been neglected because under the medical professions’ gaze no other type of knowledge was considered necessary in ethics review. The study revealed that the medical profession’s dominance of such committees accounts for the members’ role uncertainty and as such allies itself to Freidson’s theory of professional dominance. If such a concept has been thought to be an obsolete one, this study suggests such a notion of the status of the theory is premature. The medical model’s status is implicitly accepted such that nothing else need be considered. The research calls for further studies to corroborate such findings in other research ethics settings and for a debate about what society wants its ethics committees to focus upon in their review.

As technology advances, health care decisions have become increasingly complex. American hospitals, based on accreditation standards, are required to have a system and process to address ethics, patient rights, and responsibilities. These practices vary widely, and there is very little consistency and few standards across the country. Key court cases have provided minor structure, and the federal government has been silent in the formulation of these structures but not necessarily in this arena. Most often, these accreditation standards related to clinical ethics are managed by Healthcare Ethics Committees (HEC). Bioethics has become a growing field, the level of integration between this discipline and healthcare practice varies widely. Using qualitative methods based on Grounded Theory, this analysis presents six key thematic findings, as well as interpretations to identify current challenges and opportunities to make recommendations for improvement by enhancing clarity and reducing ambiguity.

The Western liberal approach to informed consent defines autonomy as an independent choice or decision made by an individual as the final authority in medical decision-making. This approach is so dominant that one can fail to see the merits of other traditional and cultural perspectives. In this dissertation, another approach to informed consent is considered -that of communal culture of Africa, a process used in African traditional medicine (ATM) wherein patients make medical decisions and give consent in consultation with the members of their community and the ATM doctor. Often, but not necessarily, the final consent rests on the consensus reached in consultation with the group rather than on that by the individual patient alone. <br>This dissertation argues that the ATM form of consent constitutes legitimate informed consent based on the concept of relational autonomy, commonly called relational autonomy in informed consent (RAIC) in this dissertation. To interpret and enlighten the significance of the ATM approach to RAIC, the analysis in this dissertation examines the ethics of care movement in Western bioethics which also advocates a relational approach to informed consent. This movement presents a concept of persons as relational beings who are socially embedded, thereby interpreting patient autonomy in their relationships with others. This movement provides the hermeneutic to enlighten the significance of the ATM approach as a legitimate model of RAIC. <br>By comparison of the ethics of care approach with that of ATM to RAIC, this dissertation further provides a relational approach to informed consent in order to inform the restrictive emphasis on individual autonomy practiced in Western bioethics, all with a view towards fostering current discourse on global bioethics. The dissertation also provides an applied example of the contribution of ATM's RAIC approach to ethics committees in Africa, focusing in particular, on the decision-making process for patient informed consent. <br>This dissertation is distinct insofar as it focuses on informed consent in ATM, employs ethics of care as a hermeneutic to interpret ATM, advocates integrated model of healthcare ethics committees in ATM. Because ATM forms a large portion of the healthcare systems in Africa, it follows that ATM and its practices should receive more attention in bioethics in the present global era. / McAnulty College and Graduate School of Liberal Arts; / Health Care Ethics / PhD; / Dissertation;