Doctor of Philosophy in Clinical and Research Ethics

Purpose

The purpose of the Doctoral programme in Clinical and Research Ethics is to provide opportunities for advanced studies and innovative research in Clinical and Research Ethics so that the student would have mastered the knowledge, skills and attitudes to be an original, competent and independent researcher in Clinical and Research Ethics and to occupy a leadership position in ethics.

The qualifying learner will be able to

• Develop the necessary critical insight, maturity of judgment and experience to undertake independent advanced study and original research in clinical and research ethics.
• Develop a comprehensive and deep knowledge base within the field of clinical and research ethics by generating new knowledge, understanding and insight, and exploring unchartered territory.
• Harness opportunities to engage in academic discourse within the national and international community of bioethics scholars, and therefore to participate in and contribute not only to the universal pursuit of knowledge but also the needs of the country.
• Apply advanced skills in conceptualising, analysing and solving clinical and research ethics problems in the relevant context with increasing independence.
• Ability to undertake independent advanced study and original research in Clinical and Research Ethics.
• Develop advanced skills in presentation of research findings at national and international conferences and in publication of research in national and international journals.
• Ability to generate and defend a comprehensive and new knowledge base in clinical and research ethics have the ability to produce a scientifically sound and original research dissertation or compilation of 4 to 5 research papers.
• Develop skills to develop further capacity in colleagues at the institutional level.
• Develop competencies to sustain scholarly careers in leadership positions by teaching bioethics, leading ethical review of research and providing clinical and research ethics consultation.

Rationale

The Doctor of Philosophy (PhD) in Clinical and Research Ethics will address the local needs for ethics expertise in public and private hospitals and health science research institutions. Health research at various tertiary institutions cannot proceed without Research Ethics Committee (REC) approval which requires expertise in both clinical and research ethics. Furthermore, healthcare at hospitals and clinics requires clinical ethics expertise from a Clinical Ethics Consultation or Committee (CEC). High level expertise with doctoral training is required by members of RECs and CECs as well as by educators and leaders in the field of bioethics.

The National Health Research Ethics Council of South Africa was established in 2006. Some members are currently in their 3rd term of office as a result of limited high level expertise in health research ethics. The PhD (Clinical and Research Ethics) has the potential to fulfil a very important national need for leadership in the field both in South Africa and in other African countries with national research ethics regulatory bodies.

Internationally, both REC and CEC members are in demand. The World Health Organisation (WHO) has a network of 7 Collaborating Centres in Bioethics. Only one is located in Africa (our Centre for Medical Ethics and Law). Other such centres need to be developed in other parts of the African continent but require effective leadership.

There are at least 400 REC members in South Africa (SA), of which at least 40 have Masters level training in bioethics/applied ethics/research ethics. A further 40 mid-career professionals from SA and other African countries have graduated with Postgraduate Diploma (PGDip) training in Health Research Ethics from 2011 to 2015 as part of the Fogarty/NIH ARESA program. Prior to the ARESA program, approximately 90 students graduated from the IRENSA PGDip program at UCT. At least 25% of these graduates are interested in doctoral level training in ethics. Every 2 years, approximately 8-10 students graduate from the Master of Philosophy (MPhil) in Applied Ethics from Prof Anton van Niekerk's Centre for Applied Ethics, Stellenbosch University. Some of these graduates may wish to pursue a doctorate in clinical and research ethics. The SARETI program at University of Kwa-Zulu Natal has offered a Masters level program in Research Ethics for the past 12 years. Approximately 21 Masters students have graduated from this program since 2003. A proportion of these students may wish to apply for a PhD (Clinical and Research Ethics).

Recognition of Prior Learning (RPL)

The Recognition of Prior Learning (RPL) policy will be applied as laid out in the Faculty Procedures for RPL. As such, RPL routes are used at Masters Level, but not at Doctor of Philosophy (PhD) Level.

Entry Requirements

The minimum entry requirement for this qualification is

• A Masters Degree in Bioethics.

Or

• A Similar Qualification at Level 9.

This qualification comprises compulsory modules at Level 10 totalling 360 Credits.

Compulsory Modules Level 10, 360 Credits

• Doctor of Philosophy (PhD) (Clinical and Research Ethics) Dissertation, 360 Credits.

1. Demonstrate expertise and critical knowledge in an area at the forefront of the field, discipline or practice; and the ability to conceptualise new research initiatives, and create new knowledge or practice. Demonstrate knowledge literacy, in respect of which a learner is able to demonstrate an ability to contribute to scholarly debates around theories of knowledge and processes of knowledge production in an area of study.
2. Develop new methods, techniques, processes, systems or technologies in original, creative and innovative ways appropriate to specialised and complex contexts.
3. Apply specialist knowledge and theory in critically reflexive, creative and novel ways to address complex practical and theoretical problems.
4. Identify, address and manage emerging ethical issues, and to advance processes of ethical decision- making, including monitoring and evaluation of the consequences of these decisions where appropriate.
5. Make independent judgements about managing incomplete or inconsistent information or data in an iterative process of analysis and synthesis, for the development of significant original insights into new complex and abstract ideas, information or issues.
6. Produce substantial, independent, in-depth and publishable work which meets international standards, is considered to be new or innovative by peers, and makes a significant contribution to the discipline, field, or practice; and an ability to develop a communication strategy to disseminate and defend research, strategic and policy initiatives and their implementation to specialist and non-specialist audiences using the full resources of an academic and professional or occupational discourse.
7. Demonstrate an understanding of theoretical underpinnings in the management of complex systems to achieve systemic change; and an ability to independently design, sustain and manage change within a system or systems
8. Demonstrate intellectual independence, research leadership and management of research and research development in a discipline field or practice.
9. Operate independently and take full responsibility for his or her work, and where appropriate to lead, oversee and be held ultimately accountable for the overall governance of processes and systems.

The following Associated Assessment Criteria will be assessed in an integrated manner across the Exit Level Outcomes

• Undertake independent advanced study and original research in clinical and research ethics as a result of the development of critical insight, maturity of judgment and experience.
• Generate new knowledge, understanding and insight, and explore unchartered territory as a result of acquiring a comprehensive and deep knowledge base within the field of clinical and research ethics.
• Harness opportunities to engage in academic discourse within the national and international community of bioethics scholars, and to participate in and contribute not only to the universal pursuit of knowledge but also the needs of the country.
• Apply advanced skills in conceptualizing, analyzing and solving clinical and research ethics problems in the relevant context with increasing independence.
• Undertake independent advanced study and original research in Clinical and Research Ethics with rigor and integrity.
• Develop advanced skills in presentation of research findings at national and international conferences and in publication of research in national and international journals.
• Generate and defend a comprehensive and new knowledge base in clinical and research ethics.
• Produce a scientifically sound and original research dissertation or compilation of 4 to 5 research papers.
• Develop further capacity in colleagues at the institutional level.
• Sustain scholarly careers in leadership positions by teaching bioethics, leading ethical review of research and providing clinical and research ethics consultation.

Integrated Assessment

Assessment is aligned with the University's policy for the assessment and examinations of doctoral Degrees

The Doctor of Philosophy (PhD) Degree is awarded in recognition of high quality, original research and is conventionally assessed based on a dissertation. In addition a PhD Degree may be obtained in an alternative way, namely primarily based on 4-5 published scientific articles in peer reviewed journals. Examiners are provided with a standard template to use in assessment of a dissertation or doctorate via publication. This template is based on criteria outlined below.

The criteria for effective assessment as per the assessment policy and practices at Stellenbosch University include the following:

• Validity-the assessment method must measure the outcomes outlined above.
• Reliability.
• Academic integrity.
• Transparency.
• Fairness-students are made aware of how assessment will occur at the beginning of the process.
• Achievability.
• Timely feedback.

The PhD Degree is not regarded as basis for registration as a specialist with the Health Professions Council of South Africa, but can indeed be registered as an additional qualification.