Postgraduate Diploma in Health Research Ethics

Purpose

The central mission of the Postgraduate Diploma: Health Research Ethics is to build capacity and enhance expertise in health research ethics, primarily through the development of a comprehensive and locally-relevant educational programme targeting experienced researchers, clinicians, academics and research ethics committee members from Southern Africa.

On completion of this qualification graduates will

• Have acquired a thorough and systematic knowledge of the history of health research and the relevant ethical, legal and human rights issues that impact on health research in developing countries.
• Have developed an understanding of 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.
• Have developed the skills to conduct a competent review of health research protocols from a scientific perspective, taking research relevance, research design and methodology into account.
• Have developed an understanding that research in developing countries often involves vulnerable populations - children, the elderly, mental illness, indigenous populations - who require special protection.
• Be able to ask a relevant research question related to the field of health research ethics, to systematically assess the literature, to design an appropriate research project, to critically analyse the data and to formulate valid evidence-based conclusions, to present the results in a scientific format, in compliance with requirements of regulatory authorities and accept responsibility and accountability for the work performed.
• Be able, as mature midcareer professionals, to assume or resume leadership roles on their return to their institutions/countries and provide the necessary training to younger, less experienced REC members at their institutions.
• Be able to complete grant applications and prepare articles for publication.

Rationale

Southern Africa is a popular choice for a wide range of research endeavours due to the enormous burden of infectious disease in the region and large numbers of treatment-na�ve patients. Poverty and inequities in healthcare result in the exposure of vulnerable participants to these research projects. Research Ethics Committees (RECs) are tasked with reviewing research protocols with a view to protecting the rights of research participants. There are 27 RECs in South Africa with almost 300 REC members. The previous Research Ethics Programmes, the International Research Ethics Network for Southern Africa (IRENSA) and South African Research Ethics Training Initiative (SARETI) have trained about 90 members to date. Definite training needs still exist on RECs especially for those who were historically disadvantaged. Comprehensive research ethics mentorship and training of a gender-balanced group of mid-level professionals will make a positive, substantial and lasting impact on their home institutions and the wider community.

Most RECs in Southern Africa are composed of part-time members with several other commitments who serve on RECs on a voluntary basis. Concerted efforts in research ethics training has the potential to equip individuals with a level of expertise in the field of research ethics that is sufficient to encourage them to choose a career path in research ethics and/or to integrate research ethics training or requirements into their home institutions. In the face of dire need for continued research ethics training in Southern Africa the Postgraduate Diploma: Health Research Ethics can only add value in building research ethics capacity in a region with exponentially increasing research activity.

This qualification includes a structured array of practical experiences and career-development activities directly relevant to the ethical analysis and review of research involving human participants in resource constrained settings. It is particularly focussed on matters of social responsibility, accountability and human rights considerations that arise when research is conducted on vulnerable populations and individuals in culturally diverse and resource constrained contexts. There is currently no Postgraduate Diploma: Health Research Ethics on offer at any of the institutions of higher learning in South Africa. This qualification aims to train midcareer professionals in research ethics.

Comprehensive research ethics mentorship and training aims to make a positive, substantial and lasting impact on home institutions and the wider community. The research ethics training will be particularly responsive to questions of social responsibility, accountability and human rights considerations that arise when research is conducted on vulnerable populations and individuals in culturally diverse and resource constrained contexts.

It is assumed that learners entering this qualification are able to communicate, read and write in the language of tuition at an academic level equivalent to NQF Level 7, have competency in the use of computers and have an understanding of basic of research methodology.

Recognition of Prior Learning (RPL)

The Health Research Ethics programme conforms to the University's Policy for the Assessment and Recognition of Prior Learning (ARPL) as well as the ARPL policy of the Faculty of Health Sciences. This may be a very important application in this qualification as some members of RECs may be lay members or community representatives. In such cases the minimum requirement will be a matriculation exemption, and a minimum of 5 years experience of serving on a REC together with one previous certificate course in research ethics or their field of prior training. Such applicants will need to submit a portfolio to the Advisory Committee. If necessary, an interview will be conducted to assess the suitability of the candidate; writing skills may be assessed as part of this interview. The final decision on RPL admission lies with Senate.

The policy defines the process that must be followed in the assessment of an application for Recognition of Prior Learning (RPL) at Postgraduate level and provides information pertaining to assessment tools that can be used in the assessment of RPL applications. The APRL process is subjected to the Faculty's quality assurance process.

Access to the Qualification

Applicants should have

• A Bachelor's Degree in one of the Health Sciences, Law, Social Sciences or the Humanities, including Philosophy and Theology.

Or

• Recognition of Prior Learning admission status from the Senate of this institution.

Students must complete all four core modules of 30 Credits each to be awarded the qualification.

Modules

• Introduction to Bioethics, Health Law and Human Rights.
• Dual Review of Research as an ethical imperative.
• Research and Vulnerability.
• Research Assignment.

1. Demonstrate and apply an advanced understanding of the ethical, legal and human rights issues pertinent to health research ethics.
2. Discuss the dual roles of science and ethics in health research.
3. Demonstrate a deep understanding of vulnerability as it relates to health research.
4. Conduct research and present a report related to the field of health research ethics.

Critical Cross-Field Outcomes

• Complex problems are identified and problems solved through innovative thinking, critical analyses, application of scientific and philosophical methods, and responsible, evidence-based decision making.
• Data are efficiently collected, organised, stored, analysed, evaluated, integrated and applied.
• The scope and limitations of various scientific methods and technologies, as well as the efficient and responsible application of these methods are understood and demonstrated.
• The importance of continued self-study and of staying abreast of new developments in the field is understood and demonstrated.
• Personal self-development, organisation and self-management are understood and demonstrated.
• Effective verbal and written communication and the competent audio-visual presentation of data using the necessary linguistic, graphical, statistical and computer proficiency is demonstrated.
• The ability to work in a team, add value to the larger group through constructive collaboration and cooperation understood and demonstrated.
• Understanding of the importance of research in health sciences in general, and the ethical dimension of health research in particular, to the community through the communication of knowledge and the transfer of relevant developments is demonstrated.

Associated Assessment Criteria for Exit Level Outcome 1

1.1 A thorough and systematic knowledge of the history of health research and the relevant ethical, legal and human rights issues that impact on health research in developing countries is acquired.

1.2 An understanding of the philosophical basis of research ethics is developed wherein the relevant theories, principles and the construction of arguments to justify decision-making in the review of health research are discussed.

1.3 The influence of African Philosophy on deliberations in research ethics is discussed.

1.4 The role of the research ethics committee (REC) in participant protection is analysed.

1.5 The legal implications of violating research participant rights are evaluated.

1.6 National and international guidelines in establishing a REC are applied.

1.7 Standard Operating Procedures (SOPs) for a REC are compiled.

1.8 An informed consent form is assessed as part of an ethics review process.

Associated Assessment Criteria for Exit Level Outcome 2

2.1 The responsibility of RECs in conducting dual review of research assessing both the science and the ethics of protocols is demonstrated.

2.2 The relevance of research as an ethical imperative is discussed.

2.3 A competent review of health research protocols from a scientific perspective is conducted, taking research relevance, research design and methodology into account.

2.4 The different phases of clinical research are described and discussed.

2.5 The ethical issues that emerge in phase 1 research are identified and compared to those that arise in phase 3 research.

2.6 The acceptability of the use of placebos in research is debated.

2.7 The rigour involved in scientific writing and the importance of ethics in publication are understood and applied.

Associated Assessment Criteria for Exit Level Outcome 3

3.1 The term 'vulnerability' is explained and the various kinds of vulnerability that should be taken into account in evaluating the ethics of research studies are discussed.

3.2 Vulnerability connected to special populations, such as research with children and mental health research is discussed.

3.3 Vulnerability related to research on specific health conditions such as genetic and oncology research is assessed.

3.4 Vulnerability at individual and community levels is compared and contrasted.

3.5 Arguments to support and refute payment of research participants are built.

3.6 Ethical issues related to post trial obligations of researchers are debated.

3.7 Ethical issues regarding infectious disease control and associated principles of public health ethics are discussed.

Associated Assessment Criteria for Exit Level Outcome 4

4.1 A relevant research question related to the field of health research ethics is compiled.

4.2 The relevant literature is systematically assessed.

4.3 An appropriate research project is designed or a conceptual analysis is conducted or both are carried out.

4.4 The data are critically analysed and valid conclusions based on evidence and/or conceptual analysis are formulated.

4.5 The results are presented in a scientific format, in compliance with requirements of regulatory authorities/editorial boards.

4.6 Responsibility and accountability for the work performed is fully accepted.

Integrated Assessment

The mode of delivery of the Postgraduate Diploma: Health Research Ethics programme is part-time contact. All internal and external assessment and moderation will take place in accordance with institutional policy.

Internal assessment will be conducted in line with the University of Stellenbosch policy on assessment practices. Programme coordinators are responsible to ensure that assessment practices are explicit, valid and reliable, in line with the policy.

Internal assessment will include both formative and summative forms of assessment. Formative assessment will occur during class in the form of feedback to students and the provision of constructive criticism.

Student learning is assessed in the programme via regular discussions between the lecturers and individual students. Students have to complete and submit a research assignment to the Programme coordinator.

The procedures for external assessment and moderation are as follows

An external examiner who has been approved for this purpose by the Senate of the Stellenbosch University will perform the final written and practical moderation and assessment.

Summative assessment

Summative assessment will take the form of the class mark, class assignment mark and the research assignment mark.

The Academic Planning Committee monitors the accuracy of the levels of the academic programmes presented at the Stellenbosch University.