Research Ethics and Integrity

Categories: SARIMA COURSES

About Course

The advancements in knowledge and technology are a direct result of biomedical research conducted in the past decades. Some of this research has relied on human beings as participants. In the past century, however, society has become increasingly sensitive to ethical issues in research involving humans, especially the risks research participants are exposed to during its conduct. “Society has also become very sensitive to the potential exploitation of research volunteers who make sacrifices by being placed at the risk of harm for the good of society” (Ndebele, 2011).

Ethical requirements have therefore been developed to minimise the risk of exploitation and harm by ensuring that research participants are not merely used as a means to an end but are treated with respect while contributing to the social good. Several historical events have led to the development of these ethical requirements, as well as to the current drive towards ethical research.

Course Information

Structure:

  • Module 1: Historical perspective of research ethics and human research protections
  • Module 2: Applying ethical principles in research
  • Module 3: Research ethics and integrity
  • Module 4: Scientific misconduct and unacceptable practices
  • Module 5: Research protocol development and good research practice
  • Module 6: Ethical review and research ethics committees

Successful completion:

  • Module 1 – 6 material studies with Progress Checks
  • Module 1 – 6 contribution to Discussion Forum (5% of course mark)
  • Course Assignment (35% of course mark)
  • Course Exam (60% of course mark)

Outcomes:

  • Describe the historical perspective/background of research ethics and the evolution of laws and guidelines in research ethics
  • Articulate important international documents in human research ethics
  • Outline the research ethics principles
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What Will You Learn?

  • The advancements in knowledge and technology are a direct result of biomedical research conducted in the past decades. Some of this research has relied on human beings as participants. In the past century, however, society has become increasingly sensitive to ethical issues in research involving humans, especially the risks research participants are exposed to during its conduct. “Society has also become very sensitive to the potential exploitation of research volunteers who make sacrifices by being placed at the risk of harm for the good of society” (Ndebele, 2011).
  • Ethical requirements have therefore been developed to minimise the risk of exploitation and harm by ensuring that research participants are not merely used as a means to an end but are treated with respect while contributing to the social good. Several historical events have led to the development of these ethical requirements, as well as to the current drive towards ethical research.

Course Content

SARIMA ONLINE SHORT COURSE STUDENT ACKNOWLEDGEMENT

  • STUDENT ACKNOWLEDGEMENT
  • Student Acknowledgement

Introduction

Module 1: Historical perspective of research ethics and human research protections
The advancements in knowledge and technology are a direct result of biomedical research conducted in the past decades. Some of this research has relied on human beings as participants. In the past century, however, society has become increasingly sensitive to ethical issues in research involving humans, especially the risks research participants are exposed to during its conduct. “Society has also become very sensitive to the potential exploitation of research volunteers who make sacrifices by being placed at the risk of harm for the good of society” (Ndebele, 2011). Ethical requirements have therefore been developed to minimise the risk of exploitation and harm by ensuring that research participants are not merely used as a means to an end but are treated with respect while contributing to the social good. Several historical events have led to the development of these ethical requirements, as well as to the current drive towards ethical research. This module discusses the historical background of the development of research ethics requirements.

Module 2: Applying ethical principles in research
Today, it is generally agreed that all research involving human beings as participants should be conducted “in accordance with the three basic ethical principles, namely respect for persons, beneficence and justice” (Health Research Library, c2018). An additional principle of non-maleficence, which is the opposite of beneficence, is often cited in the literature as the fourth basic ethical principle. Over time, general agreement has emerged around these principles as they are accepted to have equal moral force. The principles guide the preparation of proposals for studies conducted with high ethical standards. It is also common for these principles to be expressed differently in different settings and to be assigned different moral weight. As a result, their application may lead to different decisions regarding appropriate courses of action.

Module 3: Research ethics and integrity
In this module, we discuss what research integrity means and its importance in research management. The confidence of society in research and the support for research are largely based on public trust and the honesty of individual researchers and research institutions. They are accountable to society and responsible for creating and fostering research environments that promote integrity in the conduct of research. This also requires promoting high ethical standards and a commitment to the continual professional development of researchers. This module focuses on the principles of research integrity and describes the requirements for creating and maintaining research organisations that support the responsible conduct of research.

Module 4: Scientific misconduct and questionable research practices (QRPs)
In this module, we will discuss the meaning of scientific misconduct and improper research practices, and focus on publications and publication ethics. We will look at the characteristics of scientific misconduct and the various forms of research misconduct, including falsification, fabrication, and plagiarism, as well as other questionable or unacceptable research practices. We will also learn who can be considered an author and the various forms of authorship misconduct. Finally, we will discuss ways to detect research misconduct and the roles of research institutions, research managers, and researchers in this process.

Module 5: Research protocol development and good research practice
In this module, we will focus on developing strong research proposals. We will discuss the roles and responsibilities of investigators, sponsors, ethics committees, and other parties in ensuring adherence to good research practices. This module will also address the essential elements of a research proposal or protocol from a good research practice perspective. This module borrows heavily from Good Clinical Practice Guidelines (GCP). GCP is an international standard that aims to ensure the protection of research participants as well as the credibility of research data. GCP is, therefore, based on the highest scientific and ethical standards. Even though GCP is focused on clinical research, its principles can be applied to other research involving human participants. It is important that all research managers understand the rigour with which research has to be assessed based on the general principles of research that are embedded in GCP.

Module 6: Ethical review and research ethics committees
Research on human subjects is vital to improving the well-being of individuals and society as a whole. This is mainly seen in health science where the research leads to the improvement of health practices, protocols and policies. The emergence of new diseases, for example, would necessitate clinical trials and drug research, and the potential risks for any humans participating in the associated research are variable and would depend on the type of research proposed and its stage of development. A credible and recognised research ethics committee (REC) is needed to review the different types of research. In some contexts, RECs are referred to as institutional review boards (IRBs) or ethics review boards (ERBs) or ethics review committees (ERCs) (Kruger, Ndebele and Horn, 2014).

COURSE ASSIGNMENT

Exam

SARIMA Online Short Course Evaluation

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