Understanding the latest ethics guideline updates – and what they may mean in practice

Research Ethics Committees (RECs), researchers, sponsors and institutions have only recently become familiar with the release of Version 3 of South Africa’s Ethics in Health Research: Principles, Processes and Structures guideline, published in August 2024. This was followed by Version 3.1 in March 2025, which primarily removed the section on heritable human genome editing pending further engagement with national stakeholders.

Now, Version 3.2, released in May 2026, introduces a range of updates and clarifications that are worth taking note of.

The purpose of this blog is not to provide a comprehensive review of every amendment, but rather to raise awareness of some of the most noteworthy changes that may influence how researchers, sponsors, institutions and Research Ethics Committees (RECs) prepare, review and oversee health research in South Africa.

Although many of the amendments clarify existing expectations rather than introduce entirely new requirements, collectively they reinforce greater transparency, consistency, accountability and operational clarity across the research and ethics review lifecycle.

For those looking for a more detailed analysis, we have also developed the NDoH 2024 Version 3.2 – Key Changes and What They May Mean for Stakeholders guide.

Rather than following the guideline chapter by chapter, the guide organises the updates according to the research and ethics review lifecycle, making it easier to identify the changes most relevant to your role.

The guide includes:

  • What Changed – A concise summary of each amendment.
  • Why Was It Updated – A balanced interpretation of the likely intent behind the amendment.
  • What May This Mean In Practice – Practical considerations for researchers, sponsors, institutions and RECs.
  • Practical Takeaway – Suggested actions to help prepare for or respond to each change.

Read more about the guide here: NDoH 2024 Version 3.2 – Key Changes and What They May Mean for Stakeholders

A More Flexible Approach to Ethics Review

Version 3.2 now provides greater clarity on when observational research conducted in public – including virtual – spaces may be exempt from formal ethics review, provided no audio or visual recordings of identifiable individuals are made. This reflects the growing role of digital environments in research while helping reduce unnecessary review for genuinely low-risk studies.

The revised guideline also introduces greater flexibility around scientific review. Where a scientific review is still outstanding, RECs may now consider granting a conditional ethics approval, allowing aspects of the review process to proceed in parallel rather than strictly sequentially.

Clarifications to rapid review criteria and the reciprocal recognition of reviews conducted by NHREC-registered RECs further support more proportionate and efficient review pathways, particularly for multicentre research.

What this may mean in practice

Researchers and sponsors should consider whether their ethics submission strategies, timelines and supporting documentation reflect these updated pathways. RECs may also wish to review their procedures for conditional approvals, rapid reviews and reciprocal recognition to ensure consistency with the revised guidance.

Moving Beyond “Tick-Box” Ethics Applications

Several updates introduced in Version 3.2 are likely to have a direct impact on how applicants prepare ethics submissions, respond to REC feedback, and understand REC expectations during the review process.

One important update is the increased emphasis on demonstrating not only an intention to uphold ethical principles, but also explaining how those principles will be implemented in practice, rather than simply acknowledging them.

Similarly, RECs are expected to provide more detailed narrative feedback when requesting amendments or rejecting applications, supported by comprehensive meeting documentation that records the reasons behind decisions, ensuring feedback to applicants is sufficiently detailed and actionable.

The guidance on application timelines has also been strengthened. Applicants are expected to respond to REC comments within the stipulated timeframe or communicate with the REC if delays are anticipated. Where no response or communication is received within the required timeframe, the application may be removed from the agenda. If the study is still to proceed, a new application would need to be submitted; alternatively, the REC may require the researcher to formally withdraw the application.

Collectively, these updates encourage more constructive engagement between researchers and RECs while supporting better-informed ethical decision-making.

What this may mean in practice

Researchers /Applicants may benefit from reviewing their application templates and internal review processes to ensure submissions clearly demonstrate ethical reasoning. RECs may wish to evaluate whether their review documentation, meeting minutes and communication processes adequately reflect the updated expectations.

Strengthening RECs Governance and Accountability

A significant proportion of the Version 3.2 amendments focus on strengthening the governance of Research Ethics Committees.

The revised guidance provides greater clarity on the expectations around Terms of Reference, Standard Operating Procedures (SOPs), committee membership, chairperson appointments, administrative support, record management and annual reporting to the NHREC.

Viewed together, these amendments reinforce the importance of well-defined governance structures, transparent decision-making and effective and documented operational oversight.

Rather than introducing entirely new governance principles, the updates provide clearer expectations for how RECs should demonstrate compliance and maintain consistency within their own activities, but it also promotes greater standardisation across RECs.

What this may mean in practice

RECs may wish to review their governance documentation, committee structures, reporting systems and SOPs to identify any areas requiring alignment with Version 3.2.

Greater Emphasis on Competency and Training

The updated guideline also reinforces the importance of maintaining competency across the research community.

Researchers and students are now explicitly expected to complete research ethics training at least every three years, highlighting the importance of ongoing professional development rather than one-off certification.

Additional competency expectations have also been introduced for Animal Research Ethics Committee (AREC) members, with expanded guidance relating to harm assessment, animal welfare and post-study animal care.

The guideline also clarifies that international collaborators conducting research in South Africa are expected to demonstrate an understanding of the South African ethical and regulatory framework, alongside current ethics and Good Clinical Practice (GCP) training where applicable.

Collectively, these amendments recognise that effective ethical oversight depends not only on policies and procedures, but also on the knowledge, competency and ongoing development of the people responsible for implementing them.

Enhancing Clinical Trial Oversight

Version 3.2 also introduces an important clarification regarding responsibility for registration on the South African National Clinical Trial Register (SANCTR).

The guideline now explicitly places responsibility for SANCTR registration on the sponsor for commercially sponsored clinical trials, or the Principal Investigator where no commercial sponsor exists. This provides clearer accountability for a key regulatory requirement and reflects the removal of REC responsibility for SANCTR registration.

What this may mean in practice

Sponsors, Principal Investigators and research institutions may wish to review their study start-up procedures to ensure responsibility for SANCTR registration is clearly assigned and completed within the required timelines.

Key Takeaways

Although many of the Version 3.2 amendments appear modest when viewed individually, together they represent a meaningful evolution of South Africa’s ethics framework.

The updates consistently promote:

  • Greater clarity in ethical and regulatory expectations.
  • More transparent and consistent ethics review processes.
  • Stronger governance and accountability within RECs.
  • Enhanced competency through ongoing ethics education and training.
  • Improved efficiency across the clinical research lifecycle.

Perhaps most importantly, the revised guideline encourages a shift from simply demonstrating compliance to demonstrating how ethical principles will be implemented in practice.

For researchers, sponsors and RECs alike, this presents an opportunity not only to maintain compliance but also to strengthen the quality, consistency and integrity of health research conducted in South Africa.

Continue Your Learning

Understanding the updates introduced in NDoH (2024) Version 3.2 is only the first step. Applying the guideline confidently and consistently in day-to-day research practice requires a thorough understanding of the broader ethical and regulatory framework.

If you are looking to strengthen your knowledge or obtain formal certification, TASK Research Academy’s Ethics in Health Research course provides comprehensive training on the NDoH (2024) Ethics in Health Research Guidelines, including the latest Version 3.2 updates discussed in this article.

The course complies to all NHREC-registered Research Ethics Committees (RECs) training requirements and is designed for researchers, Research Ethics Committee members, sponsors, monitors, study coordinators and other professionals involved in health research.

Explore the course and enroll today: Ethics in Health Research – A Global Perspective