4.68
(37 Ratings)

Ethics in Health Research

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About Course

The 2024 third edition of the South African Ethics in Health Research: Principles, Processes and Structures, issued by the National Health Research Ethics Council (NHREC), aligns with Section 72 of the National Health Act 61 of 2003. The NHREC’s primary mandate is to establish, promote, and uphold ethical norms and standards for all health-related research conducted in South Africa. These guidelines are essential for ensuring that research respects the rights, dignity, and welfare of participants. These guidelines serve as a national benchmark for ethical conduct in health research, applicable across multiple disciplines and research methodologies.

In line with the 2024 SA Ethics in Health Research Guidelines (3rd ed.), we have developed an 8-hour training program that enables all researchers working with humans or animals to complete their theoretical ethics training. Proof of ethics training within the past three years is required to meet NDoH expectations.

Why This Training Is Essential

  • Mandatory for all researchers conducting health-related research involving humans or animals in South Africa.

  • Ensures compliance with the NDoH 2024 Guidelines and builds capacity for scientific integrity, ethical protocol conduct, and participant safety.

  • Satisfies the requirement for documented proof of ethics training, which must be renewed every three years.

What the programme includes:

🔹 NDoH 2024 3rd ed training

🔹 Ethics in health research: founding principles

🔹 Compliance with the requirements of NDoH 2024

🔹 HPCSA Accredited certificate valid for three years

 

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Course Content

1.0 Overview of Ethics in Health Research Module
This training programme introduces a structured, multi-module approach designed to ensure full compliance with the 2024 South African Ethics in Health Research Guidelines (3rd Edition). It provides a comprehensive foundation in ethical principles, national standards, and regulatory expectations governing health research in South Africa. Accredited by the Health Professions Council of South Africa (HPCSA), the course offers a certificate valid for three years and meets the mandatory requirements set by the National Department of Health (NDoH). The training is essential for all researchers conducting studies involving human or animal participants and equips them with the knowledge required to uphold scientific integrity, ensure participant safety, and adhere to ethical conduct throughout the research lifecycle. In addition to covering the NDoH 2024 guidelines, this module explores broader foundational and international ethical frameworks. These include the Nuremberg Code, the Belmont Report, the Declaration of Helsinki (WMA), and the CIOMS Guidelines, ensuring that researchers are not only compliant with national expectations but also grounded in globally accepted ethical standards. The programme emphasises the importance of researcher competence, theoretical ethics training, and formal assessment. It reinforces that ethical research demands more than just procedural compliance—it requires an informed, principled approach rooted in both local and international norms.

  • Lesson overview and Introduction
    05:00

2.0 Origins and History- Health Research Ethics founding norms
In this session we embark on a journey through the origins and history of health research ethical oversight requirements. It's a story that begins in an era where new drugs were not mandated to undergo premarket safety assessments, leading to therapeutic disasters and shocking atrocities. Understanding this historical context is crucial, for it not only sheds light on the mistakes and missteps of the past but also paves the way for ethical, responsible, and patient-centered medical research practices today. We will embark on this enlightening journey together, exploring the challenges faced, lessons learned, and the evolution of health ethics The course materials reflect on past atrocities in medical research The learners will understand that, alongside the potential benefits of scientific research, there are potential risks to the people who participate in the journey that makes breakthroughs possible The module lays a foundation for the following modules on the principles and guidelines that are fundamental ethical principles in medical research

3.0 Founding Ethical Principles in Health Research
The foundation of ethical conduct in health research is built upon internationally recognised declarations and guidelines that continue to shape the way we protect human participants and promote scientific integrity. One of the most influential documents in this regard is the Declaration of Helsinki (DoH), developed by the World Medical Association (WMA). First adopted in 1964, it is widely regarded as the cornerstone of research ethics involving human participants. The Declaration outlines ethical principles for medical researchers engaged in human experimentation and has undergone several updates to remain relevant to modern challenges in clinical research. The most recent revision, adopted at the 2024 WMA General Assembly, strengthens: Protections for vulnerable populations Requirements for transparency in clinical trials Commitments to fairness, equity, and justice in research participation and benefit-sharing Alongside the Declaration of Helsinki, the CIOMS Guidelines represent another key pillar of global health research ethics. The Council for International Organizations of Medical Sciences (CIOMS), founded in 1949 by WHO and UNESCO, works to advance public health through technical guidance on ethical and policy matters related to research. In collaboration with the World Health Organization (WHO), CIOMS developed the International Ethical Guidelines for Health-related Research Involving Humans, last updated in 2016. These guidelines consist of 21 ethical principles that provide practical direction for: Respecting autonomy and human dignity Ensuring informed consent and equitable participant selection Addressing risks and benefits Providing post-trial access and community engagement Together, the Declaration of Helsinki and CIOMS Guidelines form the ethical backbone of contemporary clinical research and guide researchers, sponsors, ethics committees, and policymakers in upholding the highest standards of integrity and human protection. Declaration of Helsinki

4.0 South African NDoH 2024

5.0 Informed consent: Vulnerability and Incapacity

6.0 Human and Animal Biological Material and Data for Research

7.0 Health Research Infrastructure and Research Ethics Commitees

Ethics in Health Research Examination
Passing Requirement: A minimum score of 80% is required to successfully pass the examination. Attempt Limit: Learners are permitted up to three attempts to achieve the passing score. Certification: Upon successful completion of the exam, a certificate will be issued to acknowledge your accomplishment.

Student Ratings & Reviews

4.7
Total 37 Ratings
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PL
2 months ago
Great course. It provided valuable insights and deepened my understanding of ethical principles, informed consent, and the role of ethics committees in research. I truly appreciate the clarity and practical guidance it offered.
RC
2 months ago
it was a well designed course easy to understand
A
2 months ago
informative and educational
subjects discussed that I did not previously think about
EI
3 months ago
The course is insightfull, informative very relevant to what it intended to teach.
The quizs are relevants to the contents being evaluated.
I am very glad that i have opted to adventure in the Health Research field.
Thank you.
LN
4 months ago
Very straightforward, easy to understand
LS
4 months ago
This was a very good course
It was a Good course
AS
7 months ago
The course was quite comprehensive and covers in-depth all areas
BM
7 months ago
Great course, even better recorded slides.
Galaletsang Nkwe
7 months ago
I have learned so much and it has been intensely insightful. The importance of Ubuntu and important principles/protocols that cannot be compromised in Health Research is my take-home. The knowledge I have gained will definitely play a huge role in my career growth and it will surely be implemented without compromise. Thank you Afrileadthech for this course!
This course strengthened my understanding of research ethics and regulatory frameworks, which is directly relevant to my current work in drug discovery and cancer research. It aligns perfectly with my aspiration to conduct ethically sound, impactful research and advance in the pharmaceutical field.
SX
8 months ago
The course was very highly informative
MN
9 months ago
it a great course
Ralph Kandiwa
9 months ago
The course material was very extensive and well-researched. IT was designed to fully equip the learner about the nuances of research
its a great course
CM
9 months ago
I have learned a great deal from the ethics in research module; it has been both informative and broad in scope.
Phunyuka Ngwenya
9 months ago
Very informative and easy to understand. I love the quiz because it makes one think about real situation events
SW
10 months ago
Excellent course
MK
10 months ago
Very informative. Quiz was well designed to test the knowledge
DN
10 months ago
Very informative but too much information in a short space of time

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