Master of Philosophy in Bioethics

Purpose

The purpose of the Master of Philosophy in Bioethics is to build capacity and enhance expertise in Bioethics through the development of a comprehensive educational qualification with a focus on the African context while at the same time considering how global issues will influence the African context. This qualification will educate and train researchers to contribute to developing knowledge in bioethics through innovative empirical research and engagement at an advanced level. Graduates from this qualification will be prepared for an advanced career and/or specialised professional employment in the clinical and research ethics field both in the African setting and the global arena.

The qualification is therefore aimed at

• Ensuring a high level of knowledge in Bioethics, which includes a high level of analysis of existing and new information, the ability to deal with ethical dilemmas, and finding workable solutions to clinical and ethical challenges.
• Preparing learners who aspire to move to a higher level of academic research work for Doctoral studies and promoting an approach based on academic integrity and professional ethics.
• Preparing learners who can apply their knowledge in the field of bioethics as well as their underlying skills in answering relevant research questions in bioethics that will meet the critical needs of the country, Africa and internationally.
• Contributing to the pool of academics and professionals with the competence and critical intellectual abilities to ensure advancement in Bioethics and to make provision for the country and Africa's needs in a skilled scientific workforce of the highest calibre.
• Educating, training, and delivering learners who are:

> Lifelong learners and creative thinkers who can apply knowledge responsibly (An enquiring mind).

> Effective in diverse environments and acts as a leader and collaborator in the bioethics field (An Engaged Citizen).

> Innovative problem solvers in the field of bioethics (A dynamic professional).

> Well-rounded individuals take responsibility for their development while making and encouraging the making of informed and considered decisions.

On the completion of the qualification, qualifying learners will be able to

• Demonstrate critical thinking skills to address challenges and emerging issues in the bioethics field.
• Work in a team and contribute to the large group through active collaboration.
• Evaluate the challenges, opportunities, requirements, and ethical principles that apply to research and good clinical practice in health sciences.
• Contribute to the development of original knowledge in the field through empirical research.
• Appraise research findings, both in terms of the strength of the methodology and application.
• Accumulate knowledge of research methodology to guide the successful planning and execution of research in qualitative research paradigms.
• Criticise/defend the conceptual foundation of the four bioethics principles.
• Substantiate high-level moral reasoning and adherence to professional ethics.
• Demonstrate an in-depth understanding of bioethics research ethics to explore relevant theories, principles, and the construction of arguments to justify decision-making in healthcare research.
• Prepare, edit, and submit manuscripts on identified Bioethics research problems or topics for publication.
• Critically review the issues (legal, ethical and clinical) involved in the undertaking of clinical and health research.
• Critically review and interpret the literature relating to clinical and health research.
• Understand and critique health research involving children, the elderly, those with mental illness, indigenous populations - and other vulnerable populations children, who require special protection as it pertains to matters relating to bioethics, such as legal responsibility, consent, undergoing routine preventative health measures, and others.
• Conduct a thoughtful review of health research protocols from a scientific ethics perspective, considering research relevance, design, and methodology.

The qualification will prepare learners for a professional career in bioethics with a critical understanding of qualitative research in the field. The qualification will also produce graduates who will utilise an in-depth understanding of the field of bioethics to actively contribute to the development of new knowledge in the field while also rationally evaluating and solving complex problems in the field. Learners will be encouraged to use their expertise in the field and critically evaluate contextual examples within the field. They will apply their knowledge creatively and responsibly, act as effective leaders and collaborators in bioethics to solve problems innovatively and take responsibility for their own decisions.

Rationale

Africa has a rich diversity of cultures. However, the growth of bioethics on the continent varies as there are few trained bioethicists and few institutions of higher learning that teach bioethics. Inadequate resource mobilisation to fulfil the bioethics agenda, limited empirical research data, slow progress in bioethics education in Africa and the lack of a vibrant culture of bioethical discourse are among the challenges. The qualification will help address these needs and promote critical public engagement in bioethical debates.

There is an increasing interest among biomedical scientists, medical doctors, and other allied health professionals to specialise in this field and yet there are few bioethicists. In addition, clinical trials and health research at various tertiary institutions cannot proceed without the Research Ethics Committee (REC) approval, requiring broad bioethics expertise. The Faculty of Medicine and Health Sciences is also home to the state-of-the-art genomics facilities in South Africa and features the new Biomedical Research Institute (BMRI) of the institution, which conducts research in the biological sciences, including biobanking, genetics, genomics, gene-editing, cloning and new technologies in health sciences. The BMRI provides valuable data and context that would be utilised by this qualification.

This new BMRI is envisioned to be the largest genomics facility in Africa. It will also provide capacity building to other African countries as part of its support programme to the African Centres for Disease Control and Prevention and the World Health Organisation (WHO). This qualification will address the growing need for bioethics expertise in public and private hospitals, health sciences and health research institutions involved in the biological sciences.

This qualification will develop health science professionals with cutting-edge ethics expertise at a master's level in South Africa and other African countries. In South Africa, four different institutions offer ethics training at a master's level. However, some qualifications focus solely on the legal aspects of ethics and health law, others focus on applied ethics and/or bioethics with a focus on conceptual research. This qualification will have a dominant component of both clinical and research ethics, with modules in health law, public health ethics, clinical ethics, health research ethics, innovative and emerging technologies in healthcare, biobanking and HIV ethics. Skills development in constructing robust ethical arguments to resolve clinical ethical dilemmas is urgently needed. Although this is not a professional qualification, the Centre for Medical Ethics and Law has requested a letter of support from the Health Professional Council of South Africa (HPCSA).

Furthermore, healthcare at hospitals and clinics requires clinical ethics expertise from a Clinical Ethics Consultation or Committees (CECs). Therefore, specialised training with a high level of specialist knowledge is required by members of Research Ethics Committees (RECs) and CECs and educators and leaders in bioethics. The ongoing pandemic has highlighted the role and importance of bioethicists during a public health emergency. Medical litigation has increased in South Africa. Training in bioethics has become relevant to ensure that health professionals are well-informed in the ethical dimensions of healthcare and health research.

Internationally, both REC and CEC members are in demand. The World Health Organisation (WHO) has a network of 13 Collaborating Centres in Bioethics. The Centre for Medical Ethics and Law (CMEL) is the only one in Africa. Other centres must be developed in other parts of the African continent, but require effective leadership, dependent on recognised qualifications and experience in bioethics. The qualification will provide an essential step in training qualified bioethicists and provide them with a higher academic qualification. This qualification will also attract learners from other African countries where bioethics training programmes are suboptimal. CMEL previously enrolled over 50% of the foreign national learners in the Postgraduate Diploma and Doctoral Degree in Research Ethics and has presented a Postgraduate Diploma in Health Research Ethics since 2011. To date, 40 mid-career professionals from ten African countries have graduated with this qualification and the Centre is currently co-presenting a National Institutes of Health (NIH) funded Leadership programme in Bioethics with seven Doctoral Degree trainees.

Recognition of Prior Learning (RPL)

The institution applies the Regulation for Recognition of Prior Learning (RPL) and Credit Accumulation and Transfer (CAT) and the procedures outlined in the Faculty of Medicine and Health Sciences RPL and CAT guidelines.

RPL for access

• Learners who do not meet the minimum entrance requirements or the required qualification at the same NQF level as the qualification required for admission may be considered for admission through RPL.
• Applicants must submit a portfolio of evidence to the Advisory Committee and an interview will be conducted when necessary to assess the suitability of the candidate for the qualification.
• In compliance with the institution's RPL/CAT Regulation Policy, not more than 10% of a cohort of learners in a qualification should be admitted through in RPL process per intake year unless exceeding this limit was approved by the Higher Education Quality Committee (HEQC) as part of the programme's accreditation processes. This means that one (1) out of ten (10) learners are admitted per year.

RPL for credit

• Learners may also apply for RPL for credit for or towards the qualification, in which they must provide evidence in the form of a portfolio that demonstrates prior learning through formal, non-formal and/or informal learning to obtain credits towards the qualification.
• Learners may only be granted RPL for exemption for a maximum of 50% of the credits of a qualification and a maximum of 50% of the credits of a completed qualification may be transferred to another qualification.
• Faculties may impose further restrictions on the number of credits that may be exempted from years of specific academic programmes.

RPL for exemption of modules

• RPL for exemption is applied on a limited scale at the postgraduate level in cases where applicants request that formal-, informal- and/or non-formal learning be recognised in place of modules of a structured Postgraduate Faculty of Medicine and Health Sciences (FMHS) qualification.
• RPL will be awarded per module.
• Modules will be recognised where the curriculum, outcomes, credits and NQF level of the relevant module broadly match those of the required module in the qualification for which the applicant wishes to enrol.
• Recognition will also be accorded to modules where the content includes additional work that exceeds the requirements of the envisaged qualification, but not less than what the envisaged qualification requires.

Entry Requirements

The minimum entry requirement for this qualification is

• Bachelor of Arts Honours in Applied Ethics, NQF Level 8.

Or

• Bachelor of Health Sciences Honours, NQF Level 8.

Or

• Bachelor of Medicine and Bachelor of Surgery, NQF Level 8.

Or

• Bachelor of Laws, NQF Level 8.

Or

• Postgraduate Diploma in Health Services Management, NQF Level 8.

Or

• Postgraduate Diploma in Applied Ethics, NQF Level 8.

Or

• Postgraduate Diploma in Health Research Ethics, NQF Level 8.

This qualification consists of the following compulsory and elective modules at NQF Level 9 totalling 180 Credits.

Compulsory Modules, Level 9, 170 Credits

• Introduction to Bioethics and Human Rights, 20 Credits.
• Health Research Science and Ethics, 25 Credits.
• Innovative and Emerging Technologies in Healthcare Ethics, 20 Credits.
• Introduction to Clinical Ethics, 20 Credits.
• Public Health Ethics, 25 Credits.
• Bioethics Research Assignment, 60 Credits.

Elective Modules, Level 9, 10 Credits (Select one module)

• Introduction to Medical Law, 10 Credits.
• Ethical, Legal and Societal Issues (ELSI) of Biobanking, 10 Credits.
• HIV Ethics, 10 Credits.

1. Demonstrate an understanding of the philosophical basis of research ethics to explore relevant theories, principles, and the construction of arguments to justify decision-making in bioethics.
2. Demonstrate the ability to prepare, edit, and submit manuscripts on an identified Bioethics research problem or topic for publication.
3. Critically review the issues (including legal, ethical, and clinical) involved in the undertaking of clinical and health research.
4. Critically review and interpret the literature relating to clinical and health research.
5. Demonstrate the ability to critique research involving children, elderly, mental illness, indigenous populations - children, who require special protection.
6. Conduct a competent review of health research protocols from a scientific perspective-taking research relevance, research design and methodology into account.
7. Demonstrate critical thinking skills to address challenges and emerging issues in the field of bioethics.
8. Work in a team and contribute to the large group through active collaboration.
9. Evaluate the challenges, opportunities, requirements, and ethical principles that apply to research and good clinical practice in health sciences.
10. Contribute to the development of original knowledge in the field through the empirical research component.
11. Appraisal of research findings, both in terms of the strength of the methodology and application.
12. Demonstrate the ability to accumulate knowledge of research methodology to guide the successful planning and execution of research in qualitative research paradigms.
13. Demonstrate the ability to criticise/defend the conceptual foundation of the four principles of bioethics.
14. Substantiate high-level moral reasoning and adherence to professional ethics.

Associated Assessment Criteria for Exit Level Outcome 1

• Critically evaluate the philosophical basis of research ethics exploring relevant theories, principles, and the construction of arguments to justify decision-making in the review of health research
• Adequately justify, both orally and in writing the influence of African Philosophy on deliberations in research ethics in medical research.
• Critically evaluate the philosophical basis of research ethics, explore relevant theories, and principles and construct arguments to justify decision-making in the review of health research.

Associated Assessment Criteria for Exit Level Outcome 2

• Submit written arguments supported by research findings and graphical and/or statistical information.
• Use accurate, correct academic and professional terminology with minimal language and grammatical errors in all written submissions.

Associated Assessment Criteria for Exit Level Outcome 3

• Correctly and comprehensively discuss the history of health research and the relevant ethical, legal, and human rights issues that impact health research in developing countries both orally and in writing.
• Critically evaluate both orally and in writing the legal implications of violating medical research participant rights with the support of theory and research in the field.
• Provide accurate written and oral arguments identifying how adverse events that could critically impact current and future medical research can be dealt with
• Accurately and correctly make judgements on the importance of health research ethics and health research protocols.
• Construct thorough verbal and written arguments based on theory and research to defend, explain and/or identify the ethics review recruiting process and the importance of getting informed consent.
• Provide a thorough written review of the roles of the research ethics committee (REC) in participant protection for medical research with the support of relevant texts and research.
• Construct critical oral and written arguments to evaluate the role of the REC in participant rights related to medical research by using the information from different case studies.
• Prepare a written proposal and apply national and international guidelines in establishing a REC.
• Prepare a written proposal and compile Standard Operation Procedures (SOPs) for a REC.
• Provide an accurate and comprehensive written argument as to when infectious diseases can and should be reported to public health authorities.
• Formulate accurate arguments supported by relevant theory and research to critique how public health balances the interests of individuals with the interests of the broader public.
• Formulate comprehensive oral and written arguments, identify and elaborate on the roles and responsibilities of a bioethicist during a pandemic.
• Use reliable research and theory to formulate clear, justifiable arguments on the ethical and legal responsibility of medical practitioners and report communicable diseases to public health authorities.
• Correctly and accurately analyse and synthesise the responsibility of the different medical RECs.
• Formulate convincing arguments (orally and in writing) on the importance of ethics in formal medical publications.
• Formulate a written critical evaluation of the ethical issues that emerge in phase 1 research as compared with those that arise in phase three (3) clinical research, supported by relevant research and theory.

Associated Assessment Criteria for Exit Level Outcome 4

• Accurately and comprehensively critique the different methods and research that relate to the ethical handling of biological samples and research data related to medical research. > Conduct an accurate, comprehensive written review of health research protocols from a scientific perspective considering research relevance, research design and methodology.
• Comprehensively critique the different phases of clinical research by using applied research in support of a written and/or oral argument.
• Accurately and comprehensively critique the different methods and research that relate to the ethical handling of biological samples and research data related to medical research. > Provide a thorough written review, with the support of relevant texts and research, on the roles of the REC in participant protection for medical research.
• Construct critical oral and written arguments to evaluate the role of the (REC) in participant rights related to medical research by using the information from different case studies.
• Critically evaluate the relevance of clinical research as an ethical imperative.

Associated Assessment Criteria for Exit Level Outcome 5

• Critically evaluate the patient's rights regarding consent in receiving medical treatment and undergoing routine preventative health measures.
• Effectively deal with conflicts arising from patient's usage of other systems of medicine > Accurately and comprehensively critique the different methods and research related to the ethical handling of biological samples and research data related to medical research > Provide written and oral feedback, accurately assess and critically evaluate an informed consent form as part of an ethics review process
• Use relevant academic terminology and minimise unnecessary grammatical and language errors in all written submissions.

Associated Assessment Criteria for Exit Level Outcome 6

• Conduct accurate dual reviews of research that assess the science and ethics of medical protocols
• Provide comprehensive arguments both orally and in writing to identify the importance of consent during clinical research
• Formulate accurate written arguments supported by theory and research to justify the acceptability of using placebos for medical research considering the context of the specific research project
• Accurately and correctly make judgements on the importance of health research ethics and health research protocols
• Critically evaluate the relevance of clinical research as an ethical imperative.

Associated Assessment Criteria for Exit Level Outcome 7

• Accurately interpret and critically evaluate a variety of sources (publications, research data, etc.) related to the field of bioethics.
• Develop and support arguments related to bioethics challenges and emerging issues with the support of appropriate research data and literature.
• Make analytical and clear conclusions grounded in theory and literature.

Associated Assessment Criteria for Exit Level Outcome 8

• Work well with a group/team to achieve the objectives of the assignment.
• Integrate bioethics theory and key concepts in the deliverable assignment to respond to the questions raised.
• Actively engage with peers on a case study focussing on a bioethics challenge, or emerging issue, for example, by voicing your own opinions.
• Interact with peers to indicate an openness to both giving, receiving help from peers while involving all members in the decision-making process and acknowledging the contribution of team members.

Associated Assessment Criteria for Exit Level Outcome 9

• Rephrase bioethics research problems in your own words, identify the major issues, challenges, opportunities and ethical principles and apply them to the identified context.
• Analyse major facts, concepts and procedures when evaluating challenges, opportunities or ethical principles and apply them to both bioethics research and good clinical practice in health sciences.

Associated Assessment Criteria for Exit Level Outcome 10

• Directly synthesise appropriate material that shows insight into the issues raised by the research question focussing on a specific aspect of bioethics.
• Presents original arguments that show insight into the use of theory and empirical evidence in debate to present a strong case to address the research question.

Associated Assessment Criteria for Exit Level Outcome 11

• Insightfully and critically evaluate the research material while elaborating on alternative perspectives.
• Analyse, synthesise, integrate and evaluate the high-quality gathered data and information throughout the research and writing processes.

Associated Assessment Criteria for Exit Level Outcome 12

• Examine conceptual, theoretical and methodological issues related to bioethics research and apply them to a research question.
• Successfully incorporate planning and execute qualitative research using qualitative bioethics research design.
• Organise and clearly structure written presentation in the identified bioethics research question.
• Clearly express ideas and cogent argumentation to address the identified bioethics question.
• Adhere to the identified academic and professional, including ethical standards in the research assignment.

Associated Assessment Criteria for Exit Level Outcome 13

• Explore the influences of the four bioethics principles on the roles of the research ethics committee (REC) in participant protection for medical research.
• Adequately justify the influence the African Philosophy on deliberations in research ethics in medical research
• Correctly and comprehensively discuss both orally and in writing the history of health research and the relevant ethical, legal, and human rights issues that impact health research in developing countries.
• Critically evaluate the philosophical basis of research ethics, and explore relevant theories, principles, and construct the arguments to justify decision-making in the review of health research.

Associated Assessment Criteria for Exit Level Outcome 14

- Accurately examine the support from the following sources to gauge the truth of moral premises (moral principles)

> Other moral principles.

> Moral theories.

> Considered moral judgments.

- Accurately apply the following criteria of adequacy to a theory and its competitors

> Consistency with considered moral judgments.

• Consistency with the moral life experience.

> Workability in real-life situations related to professional ethics, bioethics and bioethics research.

• Substantiate high levels of accurate moral arguments/reasoning integrating bioethics theory and key concepts to respond to the questions raised.
• Accurately substantiate the high-level moral reasoning that influences higher levels of functioning of clinical performance and take greater account of patients' rights, institutional requirements, and peer and societal expectations.